Tulane Medical Center

Based on record review and interview, the Hospital failed to meet the requirements for the Condition of Participation for Patient Rights as evidenced by:

Failing to ensure patients under PEC (Physician Emergency Certificate) received care in a safe setting in the Emergency Department (ED) for 2 of 2 sampled PEC patients reviewed (#11 and #19) out of a total sample of 44 sampled patients as evidenced by:

a) Failing to implement the hospital policy titled, Suicidal Prevention Plan. The hospital failed to ensure that 1:1 observation of PEC patients in the ED was performed as ordered by the physician and according to hospital policy. The RN (registered nurse) assigned untrained staff to monitor a PEC patient resulting in the elopement of Patient #11 from the Emergency Department (ED) on 10/13/12 and;

b) Failing to ensure a level of observation was ordered by the physician for Patient #19 who had been PEC'd for suicidal ideations. The RN failed to assign the monitoring of Patient #19 to a staff member and relied on the patient's guardian to ensure the safety of the patient while in the ED. (Tag A-144)

On 11/13/12 at 4:25 p.m., the Vice President of Operations (S27) and the Vice President of Nursing (S15) for the off-site campus were notified of an immediate jeopardy situation. The immediate jeopardy situation was:

The hospital failed to ensure PEC (Physician Emergency Certificate) patients were provided care in a safe setting by failing to implement their policy titled Suicide Prevention Plan as evidenced by failing to provide observation of PEC patients as ordered by the physician and assigning untrained staff to monitor PEC patients which resulted in Patient #11 eloping from the Emergency Department (ED) on 10/13/12.

The hospital failed to ensure a level of observation was ordered by the physician for PEC Patient #19 on 11/12/12, resulting in the staff instructing the patient's guardian to stay with the patient. There remains a potential risk for patients who present to the Emergency Department and are PEC'd not to have observation and monitoring to prevent harm and elopement according to hospital policy and physician orders.

There was no evidence of an investigation into the incident on 10/13/12 for Patient #11. There was no evidence of policy revision, staff education, training, or increase in staff to provide 1:1 supervision for suicidal patients since the incident. The immediate jeopardy continues for all suicidal/PEC'd patients presenting to the ED.

On 11/14/12 at 12:10 p.m., the Chief Nursing Officer (S59), Vice President Operations (S27), Vice President Nursing (S15), and Vice President Quality/Risk Management (S58) presented a plan of removal to the survey team. The plan did not include ED physician education and ED staff education on the Suicide Prevention Plan policy. The plan of removal did not include a competency assessment of the staff, other than a written test. The plan did not include the function of the 24 hour coverage of the ED by the sheriff's department staff. The plan did not include concurrent monitoring of compliance with the plan of removal and did not include what actions would be taken if monitoring found less than 100% compliance. The plan or removal was rejected by the survey team.

On 11/14/12 at 4:15 p.m., the Chief Nursing Officer (S59), Vice President Operations (S27), Vice President Nursing (S15), and Vice President Quality/Risk Management (S58) presented a plan of removal to the survey team. Review of the plan of removal included the following:

Immediate precautions to ensure safety of the patient with a Physician Emergency Certificate (PEC) in place:

Action Plan:

Twenty-four (24) hour (Local sheriff's office) coverage at off-site campus will go into effect November 14, 2012 at 7 p.m. as trained observers. A Trained Observer is deemed to be a person who:

1. Has met and passed the attached educational course, Suicidal Tendencies: Screening for Risk of Self-Harm, and passed the accompanying post test with a score of 80% or greater.

2. Has been trained, reviewed and acknowledged understanding of the appropriate monitoring form, Suicide Monitoring Record....

3. Has reviewed policy Suicide Prevention Plan NSG 4.26 and acknowledges that they understand the policy and agree to abide by the contents by a signed attestation....

4. Competency will be validated through direct observation or simulation by qualified personnel, i.e., nursing educator, nurse or security manager/director.

5. Staff will not be permitted to function as a trained observer without completion of the above requirements.

All emergency room physicians will review policy Suicide Prevention Plan NSG 4.26 and acknowledge that they understand the policy and agree to abide by the contents by a signed attestation and will be completed prior to their next scheduled shift.

Procedure:

1. Upon receipt of a PEC, the RN responsible for direct patient care will implement and maintain physician ordered level observation for the patient until trained observer arrives at the bedside to maintain safety precautions and observation....

2. Upon arrival of the trained observer, the RN providing direct patient care and the trained observer assuming physician ordered level observation will document appropriately. The RN maintains the responsibility for the nursing care provided to the patient for the duration of the patient's stay in the facility. Documentation of the physician ordered level of observation will be performed, at minimum, every 15 minutes as per current policy or as ordered by the physician using the Suicide Monitoring Record....

Just in Time Training for Both Campuses:

All Emergency Department personnel on campuses, as well as (Local sheriff's office) and Off-site campus security staff, will obtain the above listed trained observer qualifications prior to assuming patient care duties starting November 14, 2012. All other nursing staff who care for PEC patients outside of the Emergency Department will be trained and complete the above educational module prior to assuming patient care duties for next shift....

The policy titled, Physician Emergency Certificate (PEC)/Coroner's Emergency Certificate (CEC) Patient Admission will be revised to include physician ordered levels of observation and will refer to the Suicide Prevention Plan for the appropriate observation monitoring procedure.

Monitoring Plan:

1. Validate trained observer competencies prior to caring for a PEC patient.

2. Validate Physician attestations.

3. To assess compliance with implementation of physician ordered observation.

4. To assess compliance with documentation of the physician ordered observation using the Suicide Monitoring Record.

A four month monitor will be put into place immediately to include 100% concurrent review of PEC patient's records over the next four months. If any reviews demonstrate less than 100% compliance then retraining of those individuals identified as non-compliant will take place immediately by the nursing director or designee.... The CNO (Chief Nursing Officer), Vice President of Nursing at off-site campus, and the Vice President of Quality and Risk Management will be responsible for ensuring the attainment of 100% compliance in all of the above areas.

This plan of removal was rejected by the survey team due to no evidence of physician and staff training and competencies were provided for review, and the revised policy, Physician Emergency Certificate (PEC)/Coroner's Emergency Certificate (CEC) Patient Admission was not provided for review.

On 11/15/12 at 2:05 p.m., after review of the revised policy, Physician Emergency Certificate (PEC)/Coroner's Emergency Certificate (CEC) Patient Admission, and review of documentation of staff training, competency evaluations, and physician attestations for all ED staff on both campuses from 11/14/12 to present, the CNO (S59), Vice President Nursing (S15), and Vice President of Quality/Risk Management (S58) were notified the immediate jeopardy was lifted.

Condition level non-compliance remained for the Condition of Participation for Patient Rights.

Based on record review and interview, the hospital failed to ensure any incidents of abuse or neglect were reported as required by applicable local, State, and Federal Laws and Regulations. This deficient practice was evidenced by failure of the hospital to report two patient elopement incidents from the emergency department within 24 hours to Louisiana Department of Health- Health Standards Section for 2 (#2, #3) of 3 (#1, #2, #3) sampled patients' complaints reviewed.

Findings:

Review of hospital policy titled Abuse & Neglect: Identifying and Reporting Cases revealed in part:

VI: Incidents of allegations and/or suspicion of abuse/neglect occurring within the facility:

This will self-report knowledge of incidents of allegations and/or suspicion of abuse/neglect occurring within the facility in accordance with the Louisiana Department of Health, Health Standards Section, Self-Reporting Process for Hospitals Abuse/Neglect.

A review of Patient #2's incident report revealed Patient #2 eloped from the emergency department on 08/13/2021. Further review revealed the hospital reported the alleged neglect to Louisiana Department of Health- Health Standards Section on 08/18/2021, 5 days later.

In an interview on 10/14/2021 at 1:58 p.m. S4Qual verified the hospital abuse/neglect initial report for Patient #2 was sent to Louisiana Department of Health- Health Standards Section 5 days after the alleged neglect.

A review of Patient #3 incident report revealed Patient #3 eloped from the emergency department on 09/16/2021 at 1150. He was returned to the emergency department at 11:58 a.m. Further review revealed the hospital failed to report the alleged neglect to Louisiana Department of Health Standards Section.

In an interview on 10/14/2021 at 8:55 a.m., S4Qual verified Patient #3 had eloped from the emergency department and the hospital did not notify Louisiana Department of Health Standards Section.

Based on observations and interviews, the Hospital's Infection Control program failed to identify, prevent, and control infection control issues and/or breeches. This deficient practice is evidenced by failure to ensure a sanitary environment was maintained in all surgical areas.

Findings:

On 12/23/19 from 9:30 a.m. to 12:00 p.m. an observation was conducted of the restricted/semi-restricted areas of the surgical department, the surgical area clean equipment storage room, and of the sterile processing department.

The following issues related to breaches in the sanitary environment were noted during the observations:

1. OR Room 2:

a. Tape noted on positioning belt, unable to be properly disinfected;

b. Cuts in the covering of the high backed stool (on the seat and on padded back support) with foam exposed- unable to be disinfected properly;

c. Cloth positioning belt noted on the floor under a metal stand;

d. OR table foot pad noted to have a puncture in the covering with foam exposed - unable to be disinfected properly.

e. The upper body pad of the OR table had a slice in it, approximately + inch in length, with foam exposed - unable to be disinfected properly; and

f. Roll board noted to be propped up against the wall, contacting both the wall and the floor.

2. OR Room 5:

a. Roll board noted to be propped up against the wall, contacting both the wall and the floor.

b. cuts in the covering of the high backed stool (on the seat and on the padded back support) with foam exposed- unable to be disinfected properly;

c. OR surgery table wheels noted to have pits in surface and rust - unable to be disinfected properly;

d. Roll board noted to be propped up against the wall, contacting both the wall and the floor; and

e. A coating of dust noted on the wall vent located on the lower portion of the wall, near th floor.

3. Surgical area clean equipment storage room:

a. Equipment cart covered with a greyish-green cloth secured to the top of the cart with several layers of clear adhesive tape. S1ADSurg, present during the observation, indcated he had no idea when the cloth covered cart had last been cleaned and agreed the tape also prevented the cart from being properly disinfected.

b.Battery chargers with batteries being charged were noted to be stored on the above referenced cart and the charger base had a fine coating of dust;

c. A blue bin containing batteries was also observed on the cart and noted to have a covering of dust inside of the bin; and

d. 2 - Candy cane stirrup pads observed to have cloth sleeves on them. S1ADSurg was present and verified the cloth sleeves should not have been on the stirrup pads.

S1ADSurg confirmed all of the above referenced sanitary environment breaches during the observation.

Based on observations, interviews and record reviews, the hospital failed to ensure the policies governing surgical care designed to assure the achievement and maintenance of high standards of medical practice and patient care were implemented and enforced. This deficient practice is evidenced by:

1) failure to ensure organization of the surgical services provided qualified personnel to furnish the surgical services offered by the hospital. This deficient practice was evidenced by failure to:

a. have a supervisor of the Central Sterilization department with experience and training in surgical sterile processing; and

b. ensure surgical staff skills competencies were assessed and documented annually, as set forth in the hospital competency assessment policy, for 8 (S1ADSurg, S6RN, S7ST, S8IT, S12ST, S15IT, S16IT, S17ORAsst) of 9 (S1ADSurg, S6RN, S7ST, S8IT, S12ST, S15IT, S16IT, S17ORAsst, S20IntDirSurg) total sampled personnel records reviewed;

2) failure to ensure established standards for inspection of surgical instruments was followed by staff in the CSD when assembling surgical trays as evidenced by an observation of sterile processing personnel's failure to inspect all instruments for rust/damage, complete cleaning, and failure to test the sharpness of surgical scissors during assembly of a surgical tray;

3) failure to ensure a system was in place to monitor/track/trend instruments, instrument sets, and equipment returned to CSD for actual or potential contamination and missing, damaged, or malfunctioning instruments and/or equipment returned to CSD for reprocessing;

4) failure to ensure staff followed AORN guidelines and hospital policy for attire in restricted and semi-restricted areas, as evidenced by multiple observations of:

a. hair not contained within the surgical head covering,

b. personal cloth head covers not laundered by the hospital's contracted laundry service, and not completely covered with a hospital supplied bouffant cap in the restricted areas,

c). masks worn hanging around necks,

d). a vendor of surgical supplies/equipment reentering the hospital with uncovered surgical scrubs and a mask hanging from his neck, and

e). personnel with nail polish while working in the OR;

5) failure to ensure safe injection practice policies and procedures were followed, as evidenced by 2 observations of, medications in ORs being set-up for surgical procedures, that were not properly labeled, empty syringes left unattended by anesthesia staff that had prepared them, and an observation of a nurse, in OR, drawing up an injectable medication without first cleaning the rubber septum on the vial with alcohol;

6) failure to ensure sterile surgical instruments set up for a pending surgical case had not been left in the OR suite unattended by hospital OR staff, prior to the patient arrival and starting the surgical procedure.

Findings:

1) Failure to ensure organization of the surgical services provided qualified personnel to furnish the surgical services offered by the hospital.

Review of AORN Guidelines for Perioperative Practice (2018 Edition) revealed in part the following: under Instrument Cleaning, Recommendation XV, Perioperative team members with responsibilities for cleaning and care of instruments used in surgery should receive initial and ongoing education and complete competency verification activities related to cleaning and care of surgical instruments., and under Environment of Care, Part 1, Recommendation XI, Perioperative personnel should receive initial and ongoing education and complete competency verification activities for establishing and maintaining a safe environment of care.

Review of the hospital policy titled, Competency Assessment, Policy number: HR.LD.001, effective date: May 1, 2015, provided by S13QA as current, revealed in part:

Scope: Applies to all employees excluding Physicians Services Group. Employee groups listed as At will in the limitations of Employment Policy HRE.ER.019, employees with a written agreement, and volunteers. Contract staff will be held to the same standards as employees and the records must be maintained by the business.

Purpose: To define mechanisms used to assess and maintain competency of employees as required for the position and by regulatory agencies.

Definitions: 1. Competency refers to the skills, knowledge, abilities, and behaviors required to perform assigned duties and responsibilities safely and aptly. 2. Competency Assessment: Competency Assessment is conducted initially as part of orientation. Ongoing competency assessment occurs at a minimum annually.

Responsibilities: 1. Management is responsible for ensuring a mechanism exists to identify area specific competency requirements. 2. Employees are responsible for demonstrating competencies as required for each area or department.

Requirements: 3. Ongoing competency assessment is an essential process for verifying an individual's ability to perform their assigned job role by evaluating the ability to apply knowledge, perform skills and demonstrate critical thinking.

Review of the hospital's organizational chart, presented as current by S13QA, revealed the position of sterile processing supervisor was marked as vacant. Further review revealed S20IntDirSur was the interim Director of Surgical Services and the department of sterile processing fell under his line of authority.

Review of the personnel files for S1ADSurg and S20IntDirSur, provided by S19HR, revealed no documented evidence of training or experience in Sterile Processing.

Review of the personnel file for S15IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 6/21/17. Further review revealed no documented evidence S15IT had been deemed competent to perform competency evaluation of other CSD employees.

Review of the personnel file for S8IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 7/25/18. Further review revealed no documented evidence S8IT had been deemed competent to perform competency evaluation on other CSD employees.

Review of the personnel file for S16IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 12/26/19 (after surveyor request for skills competency assessments). There were no documented initial skills competency assessments. S13QA confirmed HR could not find any documented skills competency assessments in S16IT's personnel file prior to 12/26/19.

Review of the personnel file for S7ST revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S12ST (date of hire: 7/11/06), revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S6RN, (date of hire: 6/7/11), currently in the position of OR Circulator, revealed the last documented evidence of job specific skills performance competency evaluations was dated 4/13/15 and the competencies were not for OR skills. Further review of a competency evaluation, dated 6/26/19, revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills related to aseptic and/or sterile technique and use of job performance related equipment.

Review of the personnel file for S17ORAsst, (date of hire: 2/13/06), placed in position of OR assistant 9/14/14, revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S1ADSurg, (date of hire: 2/13/06), revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills (OR) since 2016.

S13QA and S19HR, assisting with personnel file reviews on 12/26/19, verified the above referenced findings in the sampled personnel records reviewed.

In an interview, during an observation of the hospital's sterile processing department, on 12/26/19 at 11:50 a.m., S1ADSurg confirmed the hospital's previous central sterilization department supervisor had resigned approximately a week ago. He indicated S20IntDirSur was the interim Director of Surgical Services and the Sterile Processing Department (Central Sterilization Department) . He further indicated S20IntDirSur was currently on vacation and he (S1ADSurg) was covering for S20IntDirSur. S1ADSurg confirmed he was responsible for management of Surgical Services and the Central Sterilization Department in S20IntDirSur's absence. S1ADSurg confirmed he did not have training or experience in the sterile processing department.

In a phone interview on 12/26/19 at 2:36 p.m. S20IntDirSur confirmed he was currently interim Director of Surgical Services and was also the interim Central Sterilization Department Director. S20IntDirSur reported he had 16 years of experience as Operating Room Director and his specialty in perioperative services was Recovery. He confirmed there was a current gap in having someone who is knowledgeable in Sterile Processing to serve as the CSD Director. S20IntDirSur confirmed sterile processing is a critical process and it is a position that requires a high level of knowledge and competence. He confirmed they don't currently have anyone competent in sterile processing to oversee the hospital's CSD. S20IntDirSur reported they also need to make sure they have an appropriate number of qualified staff to work in the sterile processing department. He confirmed the sterile processing department was short staffed at this time.

In an interview on 12/26/19 at 3:32 p.m. with S1ADSurg, he confirmed no one in current management/supervisory positions are knowledgeable enough about sterile processing to adequately supervise and evaluate whether processing is being done appropriately. S1ADSurg reported scrub techs had been sent to assist with coverage in sterile processing to work alongside other sterile processing employees. S1ADSurg confirmed the scrub techs had not had their decontamination and sterilization processing knowledge and skills competencies verified prior to them being sent to help out in sterile processing.

In an interview on 12/26/19 at 4:39 p.m. with S13QA, she confirmed the hospital did not currently have anyone in management positions in Surgical Services, on this campus, who possessed the knowledge and experience to provide oversight of the hospital's sterile processing department

In an interview on 12/26/19 at 10:00 a.m. with S8IT, she reported she was oriented by S15IT, another instrument tech who works in the sterile processing department. S8IT explained S15IT had walked her through each step of how to do things in SPD. S8IT indicated she was not observed and checked off on performance of her duties. S8IT reported she has been employed for 3 years and they only did her skills competency checks on hire.She said they do an evaluation to show their improvements, but it is a verbal evaluation that does not include watching her perform her skills/job duties.

In an interview on 12/26/19 at 11:09 a.m., with S16IT, she reported she has worked at the hospital for 1 year. She reported S8IT had oriented her.

In an interview on 12/26/19 at 1:00 p.m. with S12ST, he confirmed his annual evaluations were verbal discussions. S12ST indicated there were no skills competency evaluations performed that involved anyone observing him perform his job duties. He indicated he thought once you were assessed as competent you were always considered competent.

In an interview on 12/26/19 at 1:47 p.m. with S7ST, she confirmed she did not have observed competency evaluations that included demonstration of specialized skills.

In an interview on 12/26/19 at 2:15 p.m. with S6RN, she indicated she had not had observed competency evaluations that included demonstration of specialized skills.

In an interview on 12/26/19 at 3:16 p.m. with S18ORSup, she confirmed OR staff evaluations did not include observation of demonstration of specialized skills. She reported all training is on Health-stream online.

In an interview on 12/26/19 at 3:32 p.m. with S1ADSurg, he confirmed skills competencies for OR staff and CSD staff had not been performed annually and any documented competency evaluations had not included observed demonstration of job skill performance, adherence to sterile technique, adherence to sterile processing procedures. He confirmed the hospital's surgical service and CSD practices were based on AORN standards.

2) Failure to ensure policies and procedures were established and implemented according to standards for inspection of surgical instruments was followed by staff in the CSD when assembling surgical trays as evidenced by an observation of sterile processing personnel's failure to check instruments for rust/damage and failure to test sharpness of surgical scissors during assembly of a surgical tray.

Review of AORN guidelines for Perioperative Practices, 2018, revealed the following, in part:

Under Instrument Cleaning, Recommendation X, Surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective, should be removed from services until they are cleaned or repaired: Items that are not clean or do not function can put a patient at risk for injury or SSI. Inspection and evaluation provide an opportunity to identify soiled or damaged instruments and to remove from service until clean or repaired. Xa. Items should be inspected and evaluated for: *cleanliness, *correct alignment, * corrosion, pitting, burns, nicks, cracks, *sharpness of cutting edges, *wear and chipping of inserts and plated surfaces; *missing parts; *...correct functioning; and *other defects.

Review of Sterile Processing policies and procedures, provided in response to surveyor request for all policies and procedures related to the decontamination, processing, and sterilization of surgical instruments, revealed no policy and procedure was provided for the steps and processes related to decontamination, cleaning, inspection, packaging, and sterilization of surgical instruments and equipment in CSD.

An observation was conducted 12/26/19 at 11:06 a.m. in CSD, of S8IT assembling a Hand & Foot instrument set, to be sterilized. S8IT was observed to inspect only some of the instruments for residual contaminants, rust, alignment of teeth, or any burrs or damage to the 2nd half of the instruments. S8IT did not test the sharpness of any of the scissors in the instrument tray. S8IT confirmed she had not inspected all of the instruments and did not test the surgical scissors for sharpness. S8IT confirmed she should have inspected each instrument, and that all scissors should be tested for sharpness. S8IT reported that there are some times that instrument trays or sets are returned from the OR to be reprocessed because there was something found in the tray or the sterility was questioned, but could not provide an approximate number or frequency that this happened. She reported that OR staff did not notify them (CSD staff), but just put them in the decontamination room. S8IT reported no list or documentation of any surgical instruments or equipment that was returned for reprocessing. S8IT reported she and another IT were the only staff working today.

3) Failure to ensure a system was in place to monitor/track/trend for potential sterile processing issues related to contaminated/potentially contaminated surgical trays being returned to sterile processing for decontamination/reprocessing.

Review of policies and procedures provided for surgical services and sterile processing revealed no reference to a procedure for surgical instruments and equipment returned to the sterile processing department related to contamination or possible contamination. No procedure was provided for reporting and tracking these events.

Review of logs in CSD revealed no documentation of surgical instruments and equipment that were returned from the ORs for possible or actual contamination or equipment failure.

An observation 12/26/19 at 10:56 a.m. in CSD of a processed, sterile Ankle Distractor surgical instrument kit, opened by S1ADSurg for surveyor inspection revealed the kit had old adhesive stuck on the right corner, a small piece of silver metal flake sitting in the bottom of the tray and small area of rust-colored discoloration on a roll pin, an area approximately 3 x + inches in the tray of dark brown substance/discoloration that was easily removed with an alcohol swab by S1ADSurg. S1ADSurg confirmed the observations and reported their process did not include documentation of which staff member assembled the instrument tray in preparation for sterilization. S1ADSurg confirmed the provider had no process in place for the documentation, tracking, or trending of instruments sets potentially contaminated or incorrectly processed.

In an interview 12/23/19 at 11:03 a.m. in CSD, S8IT reported that surgical instruments were sometimes returned from OR prior to surgery to be reprocessed. She reported she couldn't say how often, but maybe several times a month. S8IT reported that there is no log or documentation related to returned sets. She reported that the instruments/instrument sets were just brought to decontamination and dropped off.

In an interview 12/26/19 at 9:55 a.m. S12ST reported occasionally surgical instrument sets had to be returned to CSD for repossessing prior to a surgical procedure. He reported he guessed that happened a couple times a month. He reported the instruments were returned to CSD. He reported he was not aware of any specific process of notifying management or documenting the occurrence.

In an interview 12/26/19 at 9:44 a.m. S1ADSurg reported the hospital did not have a process in place to track potentially damaged or contaminated surgical instruments and equipment returned to CSD for reprocessing. S1ADSurg reported he did not know how frequently this occurred, as it was not reported, documented, and tracked. He reported there had been instances where instrument sets were returned because of bone fragments identified in the sets.

In an interview on 12/23/19 at 2:53p.m. S14ICO confirmed she was the IC Officer for the main campus and this offsite campus. She reported the hospital did not have a process in place to track potentially damaged, contaminated trays returned to central processing.

4) Failure to ensure staff followed AORN guidelines and hospital policy for surgical attire in restricted and semi-restricted areas, as evidenced by multiple observations of:

a. hair not contained within the surgical head covering,

b. personal cloth head covers not laundered by the hospital's contracted laundry service, and not completely covered with a hospital supplied bouffant cap in the restricted areas

c). masks worn hanging around necks, and,

d) a vendor of surgical supplies/equipment reentering the hospital with uncovered surgical scrubs and a mask hanging from his neck, with no staff aware that he had left the hospital with surgical attire and ensuring it was changed before reentering the restricted area(s); and

e). OR staff wearing nail polish while working in the OR.

Review of AORN Guidelines for Perioperative Practice revealed the following under Surgical Attire, in part:

Clean surgical attire should be worn in the semi-restricted and restricted areas of the perioperative setting ...The collective body of evidence supports wearing clean surgical attire in the perioperative setting to reduce the number of microorganisms in the environment and the patient's risk for developing and SSI. Clean scrub attire has been laundered in a health care-accredited laundry facility and has not been previously worn ... (Recommendation I) and personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a healthcare-accredited laundry facility after each daily use ...(I.b.5) ... a fresh surgical mask should be donned before the health care worker performs or assists with each new procedure (1.h.3). Surgical masks should not be worn hanging around the neck (I.h.4). Further review revealed all individuals who enter the semi-restricted and restricted areas should wear scrub attire that has been laundered at a health care accredited laundry facility or disposable scrub attire provided by the facility and intended for use within the perioperative area (Recommendation II). Recommendation III documented personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair.

Review of the hospital policy and procedure # POP.GEN.008, titled Uniform Policy for surgical services restricted areas, last reviewed 07/10/18 and provided by S13QA as current, revealed the following in part : Under definition of semi-restricted area: ...Personnel are required to wear surgical attire and cover all head and facial hair ....

Personnel: II.2 ...Fingernail polish is not to be worn ...5. After daily use, reusable surgical attire are placed in the appropriate receptacle for laundering ...8. Personnel should cover head and facial hair including sideburns and necklines. A single use head covering is to be worn over reusable head coverings ...12. Masks left dangling around the neck are not acceptable and should be removed ...17. Personal clothing should be covered by surgical attire. 18. Surgical attire should not be washed in the home. References: AORN Recommended Practices for Surgical Attire

An observation on 12/23/19 at 9:20 a.m., made upon entering the hospital at the front entrance, revealed S4Vendor entering the hospital via the front entrance in Tulane surgical scrubs and attire with a surgical mask hanging from his neck. S4Vendor reported at that time he was a surgical vendor and had just run out to his car to get something. He verified he was wearing surgical scrubs.

In an interview 12/23/19 at 9:30 a.m. S1ADSurg identified the vendor, observed by surveyors, re-entering the hospital at the same time surveyor entered at the main/front entrance. S1ADSurg reported they were unaware the vendor had left the hospital in the surgical scrubs and could not confirm the surgical vendor had changed into clean scrubs upon his return. S1ADSurg confirmed the vendor should not have had his surgical mask on outside the OR, and not hanging from his neck.

Observations made in the restricted and semi-restricted of the surgery department 12/23/19 from 9:30 a.m. to 11:15 a.m. accompanied by S1ADSurg revealed the following:

-A person identified as a medical student, but S1ADSurg unable to identify his name, was observed in the restricted hallway wearing a disposable surgical skull cap with his head hair exposed from under the cap.

-S22ST in the restricted area/OR hallway with his hair uncovered from under a disposable skull cap;

-S6RN setting up OR 3 in preparation for a patient surgery, then walking out into the restricted hallway with hair exposed from under a disposable bouffant cap at the sides and back lower portion of her head;

-S7ST in hallway, exiting OR 3, which was being set up for a surgical procedure, with a cloth surgical hat, exposed approximately 1-1 + inches from under the front of her disposable bouffant surgical cap. S7ST reported that she keeps her cloth head covering in her locker. S7ST further reported her personal cloth head covering was not laundered by the health care-accredited contract laundry service, and that she did not launder it herself, but just continued to use it.

-S23MD exited an OR, after completing a surgical procedure, with his hair exposed from beneath his disposable skull cap.

Observations in the restricted and semi-restricted surgical areas, made 12/26/19 from 9:30 a.m. - 11:15 a.m., accompanied by S1ADSurg and S2CNO revealed the following, in part:

-S3Vendor exiting the restricted area into the public hallway with a surgical mask hanging from his neck;

-S10ST sitting in staff break room with a surgical mask hanging from her neck;

-S11MD with surgical mask hanging from his neck, exited OR and walked in to the lounge

S1ADSurg, present for the above noted observations confirmed all observed breeches in surgical attire.

An observation, made during an interview, 12/26/19 at 1:47 p.m. revealed S7ST was wearing nail polish. S7ST confirmed her position was as a surgical scrub technician, that she was working that day, scrubbing in on surgical cases, and was wearing nail polish. S7ST reported she wasn't sure what the hospital policy was regarding surgical staff wearing nail polish or artificial nails.

An observation, during an interview 12/26/19 at 2:15 p.m. revealed S6RN wore nail polish on her fingernails. S6RN confirmed she worked in the OR as an RN Circulator, was working that day, and was wearing nail polish. S6RN reported she wasn't sure of the policy for OR staff wearing nail polish, but reported scrub techs should not wear it.

5) Failure to enforce safe injection practices policies and procedures, as evidenced by 2 observations of medications in ORs being set-up for a surgical procedure that were not properly labeled and opened empty syringes being left unattended by anesthesia, and observation of an RN in OR drawing up a medication without first cleaning the top of the vial with alcohol.

Review of AORN periOperative Guidelines (2018) revealed, under Medication Safety, V.k. The rubber septum on all vials should be disinfected with alcohol and allowed to dry before each entry. The evidence supports disinfecting the rubber septum to remove any contaminant present on the stopper ...V.1.2, The syringe should never be left unattended and should be discarded at the end of the procedure.

Review of a Nursing Practice and Skill document titled, Administration of Medication: Withdrawing Medication from a Vial, provided by S13QA as the procedure following by nursing staff, revealed under How to withdraw medication from a Vial, Clean the rubber seal/stopper by wiping it vigorously with an alcohol swab ...

An observation on 12/23/19 at 9:40 a.m., in OR 3 revealed 4 unwrapped hypodermic syringes lying on the top of the anesthesia cart with no labels. The OR was observed to be set up for a surgical procedure with opened surgical instruments on the surgical table. No OR staff were noted to be in the OR at the time of the observation. S1ADSurg, present for the observation verified the observation and the syringes should not have been opened and left on the cart.

In an interview on 12/23/19 at 9:50 a.m., in OR 3, S5CRNA reported he had opened the syringes in OR 3 and left them unattended. He confirmed the sterile syringes should not have been opened and left unattended.

An observation on 12/23/19 at 10:05 a.m. in OR 4 revealed on top of the unattended anesthesia cart were the following hypodermic syringes: a 5 ml syringe with 5 ml clear liquid with no label, a 10 ml syringe removed from the wrapper, and a 30 ml syringe removed from the wrapper. On top of the anesthesia drug machine were: an opened,empty 3 ml syringe with a label with only preprinted Fentanyl with no other labeling, an opened, empty 3 ml syringe, and an opened, empty 10 ml syringe with a white blank label on it. S1ADSurg, present for the observation confirmed the findings.

An observation on 12/26/19 at 10:45 a.m. in on OR revealed S21RN open a vial of Adrenalin 30mg/ml and withdraw medication for adding to irrigation fluid, in preparation for a surgical procedure. S21RN did not clean the rubber septum upon opening the vial, before puncturing the septum and withdrawing the medication. S21RN, at the time of the observation confirmed she did not clean the rubber septum of the new vial of medication because she thought it was already sterile, and was not aware that the rubber septum on injectable medication vials should be cleaned with alcohol prior to inserting the needle, whether they were previously opened or not.

6) Failure to ensure sterile surgical instruments set up for a pending surgical case had not been left in the OR suite unattended by hospital OR staff, prior to the patient arrival and starting the surgical procedure.

Review of AORN Guidelines for Perioperative Practice, (2018) revealed, in part under Sterile Technique, Recommendation VII, Sterile fields should be constantly monitored. The sterile field is subject to unrecognized contamination by personnel, vectors (e.g. Insects), or breaks in sterile technique if left unobserved. VII.a.: Once created, a sterile field should not be left unattended until the operative or other invasive procedure is completed.

Review of hospital policy #POP.GEN.011, titled Sterile Technique, provided by S13QA as current, revealed in part, the Surgery Department will adhere to the hospital's policies for infection prevention ... Procedure... F. A sterile field should be constantly monitored and maintained ....4. Unguarded sterile fields are considered contaminated.

An observation in OR3 on 12/23/19 at 9:40 a.m. revealed the room being set up for an orthopedic surgical procedure. During the time the surveyors were in the OR making observations, staff left the room unmonitored with the surgical table set with sterile instruments and supplies, uncovered. During this unoccupied room with sterile table set with uncovered surgical instruments.

In an interview 12/23/19 at 9:50 a.m. S1ADSurg confirmed the OR with opened instruments should not be left unmonitored by OR staff. S1ADSurg reported the hospital's surgical department followed AORN guidelines.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure the nursing staff developed and kept current, individualized and comprehensive nursing care plans. This deficient practice was evidenced by failure of the nursing staff to include all problems, goals and interventions for 3 (#2, #3, #5) of 5 (#1 - #5) total patients sampled for care planning.

Findings:

Review of the hospital policy titled Interdisciplinary Treatment Planning presented as current policy revealed in part, the purpose is to ensure plans for care, treatment and services are individualized to meet the patient's needs and circumstances.

Patient #2

Review of the medical record of Patient #2 revealed a [AGE] year old admitted on [DATE] under a PEC and CEC with a history of depression admitted for suicidal ideation.

Further review of her medical record revealed she was admitted from the hospital (she was awaiting medical clearance) after a 3 night stay where she was treated for pneumonia, urinary tract infection and bladder spasms.

Review of Patient #2's orders revealed in part, the following admission orders:

Augmentin 875 mg PO Q 12 hours (for infection); and

Pyridium 100 mg PO daily (for bladder spasms).

Review of #2's nursing care plan revealed no documented evidence a care plan was developed and implemented for her infections.

Patient #3

Review of the medical record of Patient #3 revealed a [AGE] year old admitted on [DATE] under a PEC and CEC with a history of dementia admitted for agitation and hallucination.

Further review of his medical history revealed he had the diagnoses of Diabetes Mellitus and Urinary Tract Infection.

Patient #3 was discharged on [DATE].

Review of Patient #3's orders revealed in part, the following orders:

01/29/19 at 4:26 p.m. Cipro 500 mg PO BID (for UTI);

01/29/19 at 11:09 p.m. Amaryl 2 mg PO daily (for diabetes);

01/29/19 at 11:09 p.m. Glucophage 1000 mg PO BID (for diabetes);

01/31/19 at 11:02 a.m. accucheck ac and hs; and

02/09/19 at 3:05 p.m. Humulin R SQ sliding scale ac and hs.

Review of Patient #3's whole blood glucose lab values resulted in a range between 58 and 172 mg/dl.

Review of Patient #3's nursing care plan revealed no documented evidence a care plan was developed and implemented for his Diabetes Mellitus nor his Urinary Tract Infection with a foley catheter.

Patient #5

Review of the medical record of Patient #5 revealed a [AGE] year old admitted on [DATE] under a PEC and CEC with a history of depression admitted for suicidal ideations.

Further review of his medical history revealed he had a diagnosis of Diabetes Mellitus.

Patient #5 was discharged on [DATE].

Review of Patient #5's orders revealed in part, the following orders:

12/16/18 at 9:07 a.m. Amaryl 2 mg PO daily (for diabetes);

12/16/18 at 9:27 a.m. Insulin Glargine 15 units SQ daily (for diabetes);

12/16/18 at 5:25 p.m. Blood Glucose Monitoring BID (7:00 a.m. and 9:00 p.m.); and

12/17/18 at 7:00 a.m. Humulin R SQ sliding scale ac and hs.

Review of Patient #5's whole blood glucose lab values resulted in a range between 149 and 257 mg/dl.

Review of Patient #5's nursing care plan revealed no documented evidence a care plan was developed and implemented for his Diabetes Mellitus.

In an interview on 05/21/19 at 10:15 a.m. with S4RN, she stated the nurses do not place the patients' medical diagnoses which are related to maintenance medication and treatments on the care plan because these are the patients' baseline. She further stated they put in the patients' care plan the behavioral admitting diagnosis and goals.

In an interview on 05/21/19 at 1:15 p.m. with S2CNO and S3QD verified the care plans for the behavioral health unit do not include medical diagnoses even if the patient is on medication for their medical condition because this is considered standard. It was further revealed they focus on the top 3 mental health problems which can be treated while in the behavioral health unit.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the hospital failed to insure the medical staff was accountable to the Governing Body for the quality of care provided to patients. This deficient practice was evidenced by 2 (#1, #2) of 2 patients determined by a physician to be a danger to themselves or others not receiving a psychiatric evaluation prior to discharge while being treated for acute medical conditions.

Findings:

Review of an Internet website for Lakeview Regional Medical Center, an offsite campus of Tulane Medical Center, revealed in part under services the following: Behavioral Health, Emergency Care, Heart Care, Maternity & Obstetrics, Orthopedic Care, Rehabilitation, Stroke Care, Surgery, and Women's Care.

Patient #1

Review of Patient #1's medical record revealed he was a [AGE] year old sent to the ED 5/15/19 from his residence, a nursing home, for inappropriate sexual behavior. He was PEC'd at that time and a CEC was signed 5/15/19 at 9:03 p.m. The ED physician diagnosed new onset [DIAGNOSES REDACTED]and the patient was admitted to the acute care hospital to evaluate and stabilize his Atrial Fibrillation. Further review revealed a Psychiatric consult was ordered and S5MD's (psychiatrist) office was called and a message was left. The EMR documented that the physician was not taking new patients. The order for a psychiatric consult was canceled. The patient's PEC/CEC remained in place throughout his inpatient admission. He was discharged 7 days later, on 5/22/19 to an inpatient psychiatric facility, also an offsite campus of Tulane Medical Center. No psychiatric consult was done during the patient's 7 day inpatient stay.

Patient #2

Review of Patient #2's medical record, with S7RN and S8RN, revealed he was admitted to the Lakeview Behavioral Health, an offsite facility of Tulane Medical Center located on the same property as the acute care facility. Patient #2 was transferred from [Facility B's] ED under a PEC/CEC for depressive symptoms and suicidal ideation 2/11/19. Review of a patient evaluation dated 2/11/19 and signed at 9:09 a.m. by S9PMHNP, from the Behavioral Facility, documented the following:

This is an [AGE] year old male who reported to [Facility B] due to positive SI, decreased appetite, decreased sleep. It is noted that patient was very active until last week, riding bike and walking, patient complained of should pain and hip last week and insomnia, went to (sending facility name) for Angio last week, patient had stent placed, ever since discharged , patient has become more withdrawn, poor appetite, no interest in activities, son was called to his parents' house this evening by his mom, she told him that his dad said 'I can't live like this anymore, just let me kill myself'. On 2/11, (Patient #2) was admitted to LVR Behavioral Health for further treatment and evaluation. Upon evaluation on 2/11 (Patient #2) was seen with some acute distress...as he appears to be SOB, but calm and cooperative. Staff discussed findings with Medical Team, with EKG ...etc. and (S3MD, Medicine) reports that he would be sent to Telemetry for further medical treatment, as he is in Heart Failure and has edema. At this time, he is not medically stabilized per (S3MD), with Direct admit to Telemetry, with Cardiology Consult... He reports Depression, Anxiety, rating them both at 9/10, but cannot further explain why. He reports that he has had poor appetite for about 6 days, no weight loss reported, and poor sleep for the past 5-6 days. He reports being 'weak and tired' and HOH, only able to hear in the left ear. He still reports being Suicidal, with a plan to kill himself, 'any way he could', so he will have the proper procedures in place, with him being high risk, on the medical floor. He reports 'I just don't want to do it anymore, I'm just tired, beat up'. His problem list was documented as: 1) Suicidal ideation, 2) Depression, 3) Major depressive disorder, recurrent episode, severe with anxious distress, 4) Depressive disorder due to another medical condition with major depressive-like episode. The plan documented was 1) Continue to monitor symptoms of [DIAGNOSES REDACTED]. Start Remeron 15 mg po every hs for Insomnia, Start Lexapro 10 mg po Daily for Depression/Anxiety. 2. Consult Internal Medicine to follow all acute and chronic needs.

Patient #2 was admitted to Lakeview Regional Medical Center's acute care campus, under the services of S4MD with the diagnosis of [DIAGNOSES REDACTED].m. (11 days) when he was discharged to Hospital A for skilled nursing and rehabilitation (Physical Therapy/Occupational Therapy). Further review of the medical record revealed a physician's order dated 2/11/19 for a Psychiatry Consult, with the reason for the consult documented as Suicidal Ideation. Noted on the detail portion of the order, was that the consulted physician's office (S5MD) was notified 2/11/19 at 4:36 p.m. and a message left. A physician's order dated 2/22/19 at 9:38 a.m. by S4MD documented an order to rescind the patient's PEC, CEC. Further review of the record revealed no progress note or other documentation by S4MD regarding an assessment or rational for the order to rescind the PEC/CEC.

Review of Patient #2's progress note by S6FNP dated 2/22/19 at 9:48 a.m. revealed the patient's chief complaint as CHF and elevated Troponin. The progress note also noted the patient had also been placed on PEC for SI and since felt not to have any SI. The patient was documented as having a flat affect, delayed speech. Under Diagnosis, Assessment, and Plan documentation for the documentation included, Depression/ Suicidal Ideation/Insomnia- PEC with suicide precautions; Psych consult still pending ...Patient had a reported episode a few days ago of AMS/unresponsiveness. He has not been acting himself and recently had SI. Psych consult pending ...

Review of Patient #2's progress noted, dated 2/22/19 at 1:41 p.m. and authored by S6FNP, revealed the patient was discharged to a Nursing Home for skilled nursing care for rehabilitation.

Review of discharge instructions sent with the patient included discharge to SNF, Cardiac diet, PT/OT 5 times a week, physician follow up appointment - PCP not known in 1-2 weeks, S4MD's name and phone # provided. Further review of Patient #2's record revealed no documentation of a psychiatric consultation during his inpatient admission or a cancellation of a Psychiatric Consult.

The findings from Patient #1's and Patient #2's medical records were verified by S7RN and S8RN, reviewing the medical records with the surveyor.

In an interview 5/22/19 at 1:10 p.m. S4MD verified he was the admitting physician for Patient #1 and for Patient #2. The physician confirmed he practiced in Medicine, not in Psychiatry. S4MD reported Patient #1 was PEC/CEC'd from a nursing home for inappropriate sexual behaviors. He also reported the patient was in his 90's and had dementia. He said he didn't find the patient to be a risk of harm to himself or others. He verified the psych consult was canceled. He said he would have rescinded the PEC/CEC, but he spoke with the patient's family and his son wanted his father to go to the inpatient Behavioral hospital. He said he thought the son was fearful that the nursing home would kick his father out of the nursing home if he didn't get treatment. S4MD said there wasn't much that could be done for this patient because of his dementia, as far as cognitive behavior therapy, but he could be medicated to control his behavior. S4MD verified Patient #2 was admitted to his service. After a brief review of the medical record with S10FNP, also present for the interview, S4MD reported Patient#2 was sent to the Geri-psych for having SI, but when he got there they realized he was not medically cleared to be admitted there because of some cardiac problems/symptoms and he was admitted to the acute care hospital. He reported the patient had [cardiac] stents placed recently at another facility, and had another Cardiac Cath during this inpatient admission. He reported there was an episode where they thought he had a stroke and Patient #2 was transferred to the ICU, and then moved back to the medical surgical floor after that for the rest of his admission. S4MD confirmed he did rescind the CEC order because he did not feel the patient was still suicidal, and thought that his depression and SI was probably a result of his worsening medical conditions. He verified that he did not document any assessment or rationale for his order to remove the CEC. When asked about the patient not having a psychiatric consult during his 11 day admission, S4MD confirmed the patient did not and reported he did not feel the patient needed a psychiatric evaluation any longer as the patient's mood was improved with medication adjustment. He reported the patient was prescribed Remeron and Lexapro on admission. The physician reported he did not feel the patient was still suicidal. As to the order for a psychiatric consult, he said it slipped through, not getting canceled. He reported he did not always get a psychiatric consult on a patient if they were admitted with a PEC/CEC in place.

Review of a LDH/HSS OTIS report investigative findings submitted by Facility A 2/28/19 revealed that on the morning of 2/24/19, the 2nd day after his discharge from Lakeview Regional Medical Center, Patient #2 was found in the bathroom of Facility A with a cord wrapped around his neck and tied to the grab bar, without respirations or a pulse. Further review revealed the report documented the patient was transported to a hospital via EMS, but expired at the hospital.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the hospital failed to ensure the nursing staff developed and kept current a nursing care plan as part of the patient's medical record. This deficient practice was evidenced by the documented nursing plans including only the nursing needs for the admitting diagnosis/diagnoses, and not including other nursing needs for 5 of 5 (#'s 1-5) medical records reviewed for nursing care plans from a total sample of 5.

Findings:

Patient #1

Review of the medical record for Patient #1 revealed he was a [AGE] year old sent to ED 5/15/19 from a nursing home for inappropriate sexual behavior and was PEC'd/CEC'd. He was admitted to the acute care facility for 7 days as an Inpatient, to treat [DIAGNOSES REDACTED]diagnosed in the ED, before being discharged to an inpatient behavioral health facility of the hospital. Review of a transfer summary for Patient #1, found on his medical record, from the Long Term Care Nursing Facility in which the patient resided included the following diagnoses[DIAGNOSES REDACTED]. Review of a hospitalist note titled, Brief Discharge Note by S11FNP 5/21/19 at 11:25 a.m., revealed his problem list to include 1) Dementia with behavioral disturbance, and 2) Afib with RVR. Further review revealed the following diagnoses[DIAGNOSES REDACTED]], 6) Hypertension. Further review of the medical record revealed a case management report with notes under discharge planning evaluation that documented: ADL Limits: Mobility or ambulation, Dressing, Bathing, Toileting, and Durable Medical Equipment used as a walker. Review of the patient's care plan, provided by S7RN, revealed Patient #1's care plan did not address actual or potential problems related to his hypertension, Sicca syndrome, Alzheimer's/dementia, his cognitive communication deficit, lack of coordination/unsteadiness on his feet, or his need for assistance with ADLs. Further review of the care plans revealed they were not individualized to Patient #1, did not provide measurable goals, or individual interventions. The care plan for Patient #1 included the following:

-Diagnosis/Problem: Facility Standard of Care, Outcome: Standard of Practice will be met

-Diagnosis/Problem: Cardiac Output Alteration, change in or modification of the pumping action of the heart or blood vessels; Outcome: See Health Plan of Care ---- Diagnosis/Problem: Sexuality Pattern Alteration, change in or modification of a person's sexual response; Outcome: See Health Plan of Care

-Skin Integrity Alteration: Change in or modification of skin conditions; Outcome: See Health Plan of Care

-Medication Risk, Increased chance of negative response to medicinal substances; Outcome: See Health Plan of Care. No interventions were listed.

Patient #2

Review of the medical record for Patient #2, with S7RN and S8RN, revealed he was admitted to the Lakeview Behavioral Health, an offsite facility of Tulane Medical Center located on the same property as the acute care facility. Review of a patient evaluation dated 2/11/19 and signed at 9:09 a.m. by S9PMHNP, from the Behavioral Facility documented the following::

This is an [AGE] year old male who reported to [Facility B] due to positive SI, decreased appetite, decreased sleep. It is noted that patient was very active until last week, riding bike and walking, patient complained of shoulder pain and hip last week and insomnia. He was not medically stabilized per (S3MD), with Direct admit to Telemetry, with Cardiology Consult... He reports Depression, Anxiety, rating them both at 9/10, but cannot further explain why. He reports that he has had poor appetite for about 6 days, no weight loss reported, and poor sleep for the past 5-6 days. He reports being 'weak and tired' and HOH, only able to hear in the left ear. He still reports being Suicidal, with a plan to kill himself, 'any way he could', so he will have the proper procedures in place, with him being high risk, on the medical floor. His problem list was documented as: 1) Suicidal ideation, 2) Depression, 3) Major depressive disorder, recurrent episode, severe with anxious distress, 4) Depressive disorder due to another medical condition with major depressive-like episode. The plan documented was 1) Continue to monitor symptoms of [DIAGNOSES REDACTED]. 2. Consult Internal Medicine to follow all acute and chronic needs. Under Diagnosis, Assessment, and Plan, documentation included, Depression/ Suicidal Ideation/Insomnia- PEC with suicide precautions; Psych consult still pending ...Patient had a reported episode a few days ago of AMS/unresponsiveness. He has not been acting himself and recently had SI. Psych consult pending ... Review of a progress noted, dated 2/22/19 at 1:41 p.m. and authored by S6FNP, revealed The patient was discharged to a Nursing Home for skilled nursing care for rehabilitation. Review of discharge instructions sent with the patient included discharge to SNF, Cardiac diet, PT/OT 5 times a week, physician follow up appointment - PCP not known in 1-2 weeks, S4MD's name and phone # provided.

S7RN, reviewing care plan with surveyor, verified there was no documentation of a care plan for patient needs related to diagnoses that included [DIAGNOSES REDACTED].

Patient #3

Review of the medical record for Patient #4 revealed she was admitted [DATE] through the ED from home with auditory and visual hallucinations. The patient had been discharged from an inpatient psychiatric facility, the day before presenting to ED, for treatment of exacerbation of her schizophrenia. Listed in the in past medical history of [DIAGNOSES REDACTED] ... Initial workup shows dehydration and acute renal insufficiency ...she had wheezing and a COPD exacerbation. Patient was given nebulizer treatments. Was unable to fully clear patient for psychiatric admission due to renal insufficiency and concerns that she may have nephrotoxicity related her HIV medications. She will require IV rehydration, monitoring of renal function, neb treatments, and further evaluation. Review of a brief discharge note by S6FNP 4/10/19 at 10:48 a.m. revealed problems listed and treatments as follows:

-COPD exacerbation- nebulizers, O2 as needed, decrease steroids, monitor

-Seizure disorder-seizure precautions, PRN benzodiazepines

-Bipolar Mood disorder/schizophrenia-psych consulted, adjust meds as needed

-auditory hallucinations-psych consulted, social services consulted, adjust meds, once medically cleared can go to IP rehab

-Acute kidney injury-possibly related to HIV meds, improved, continue current treatment, monitor intake and output

-Hypothyroid- elevated TSH, started on oral meds

Diabetes mellitus II- accuchecks before meals and at bedtime, medications ordered, including insulin.

-Hypertension- continue current treatment, adjust meds as needed, and

-Hyperkalemia- medication as ordered, monitor in AM.

The patient was medically cleared for inpatient psychiatric placement.

Psych consult done 4/6/19 by Dr. Sureshkumar Bhatt; recommendation: inpatient psych after medically stabilized.

Review of the care plan, provided by S12QA, revealed the patient's care plan included

-alteration in respiration, Outcome: See Health Plan of Care;

-Facility Standard of Care/Facility Standard of Practice, outcome: Standard of practice will be met;

- Decreased Independence/Self Care/A -decreased functional independence with self-care and daily living related to injury, surgery, or disease process. Potential for injury related to decreased function and safety awareness, Outcome: See OT initial Evaluation;

-Decreased physical Function/Mobility/A Decreased physical function/mobility related to injury, surgery, or disease process. Potential for injury related to decreased function. Potential for skin breakdown related to decreased mobility, Outcome: See PT initial evaluation. STG and LTG; and

-Thought process alteration, A change in or modification of thought and cognitive processes, Outcome: See Health Plan of Care.

Further review of the care plan revealed no care plans related to the patient's seizure disorder, her acute kidney injury, her [DIAGNOSES REDACTED], her Diabetes, hypertension, her positive HIV status, anxiety, or medication monitoring. Care plan diagnoses were not individualized to the patient's diagnoses and/or symptoms, goals were not specific to the patient and measurable, and interventions weren't documented in the plan of care.

Patient #4

Review of the medical record for Patient #4 revealed he was admitted to the hospital from the ED 4/17/19, and discharged to an inpatient psychiatric facility 4/19/19. He was admitted to the telemetry floor, then moved to ICU for 1:1 monitoring when he became combative with staff. The patient was evaluated, and cleared by cardiology. Review of a History and Physical 4/17/19 at 11:10 p.m. revealed in part , his chief complaint was chest pain, and the patient , per the ED note reported he had visual hallucinations and felt very anxious and then progressed to some chest pain. The note documented the patient reported the chest pain resolved, but he continues to feel very anxious. The patient was discharged to an inpatient facility 4/19/19 on a cardiac diet, after he was medically cleared. Review of the care plan for Patient #3 revealed the following:

-Facility Standard of Care, Facility Standard of Practice; Outcome: Standard of Practice.

- Cardiac Output Alteration Change in or modification of the pumping action of the heart or blood vessels, Outcome: See health plan

-Comfort Alteration: Change in or modification of sensation that is distressing; Outcome: See Health plan of care

Further review revealed no specifics to define the patient's alteration in cardiac output, his discomfort (actual or potential), or his aggressive behavior. No interventions or measurable goals were noted.

Patient #5

Review of the medical record for Patient #5 revealed she was an [AGE] year old admitted to the hospital 4/1/19 after presenting to the ED, with family, for alteration in mental status. The patient was admitted for evaluation of an elevated Troponin and medical clearance for transfer to an Inpatient Psychiatric facility. The patient was PEC'd. Review of the History and Physical documented a history of Hypertension and Coronary Artery Disease, Transient ischemic attack, placement of a pacemaker, cardiac ablation, and Carotid endarterectomy. Review of a Brief Discharge Note revealed a problem list that included acute psychosis, Insomnia, Elevated troponin, and Hallucinations. Further review of the Brief Discharge Note revealed the patient was transferred to an inpatient geriatric psychiatric unit for further evaluation on a cardiac diet.

Review of the nursing care plan for Patient #5, provided by S12QA, revealed the following diagnoses[DIAGNOSES REDACTED]

-Facility Standard of Care, Facility Standard of Practice, and Outcome: Standard of Practice will be met;

-Cardiac Output Alteration, Change in or modification of the pumping action of the heart or blood vessels; Outcome: See Health Plan of Care;

-Neurological Alteration, Change in or alteration of mental processes, Outcome: See Health Plan of Care ;( no documentation of what mental process was changed or altered)

-Injury Risk, Increased chance of danger or loss, Outcome: See Health Plan of Care.

(No documentation as to what risks or potential risk was identified)

Further review revealed the care plan was not individualized for Patient #5, had no documentation of measurable goals, or documented interventions.

In an interview 5/21/19 at 2:40 p.m. S7RN reported the hospital EMR no longer had interventions listed. She reported the interventions were embedded into the EMR, in that the interventions were the physicians' orders for treatments and medications, and the assessments done by the nurse. She reported it was the expectation that nurses are able to verbalize interventions. When asked about the outcome documented as See health plan of care, S7RN reported, In the policy the nurse needs to be able to speak to what the plan is for each patient. Like what the doctor has ordered for that plan. S7RN reported they only care plan the patient's top priority diagnoses. An example was provided as: If a patient had Diabetes or chronic pain, but it is not one of the diagnoses for which they were admitted , they would say that it is not a problem and we can't measure any improvement while the patient is here, because we consider that diagnosis as their baseline. She confirmed this is the case even if the patient received diabetic medications including insulin, blood glucose monitoring, and diabetic diets, or if the person with chronic pain, or pain needs not related to their top admitting diagnoses. S7RN stated, We only care plan the patient's top priority problems. When asked about the diagnoses not being specific to the patient, and the goals not being measurable, such as Patient #1's Skin integrity Alteration, S7RN provided no answer. S7RN reported that if a patient had to be turned every 2 hours to prevent skin breakdowns the intervention is not documented or care planned. She reported that the staff charts by exception, and that need would be captured by skin assessments done by the nurses every shift.

Based on record review and interviews, the hospital failed to ensure a patient's grievance was thoroughly reviewed as evidenced by failure to have documented evidence that a patient grievance submitted by Patient #3 was thoroughly reviewed and investigated. There was no documented evidence that interviews had been conducted with staff RNs providing care to Patient #1, the security officer who handcuffed Patient #3, the access center personnel who was involved in finding placement at an inpatient facility for Patient #3, and the RN who arranged for placement. This was evident in the review of 1 (#3) of 1 grievance.

Findings:

Review of the policy titled Patient Grievance Management, presented as a current policy by S1DPS, revealed that investigation of complaints will begin within 24 hours to address the specific issue/concerns that were communicated by the patient/family. Written response of findings will be documented on the Grievance Form and sent to the Patient Relations Department within 72 hours.

Review of a grievance received on 07/07/17 submitted by Patient #3 to S9PRM revealed that Patient #3 indicated her psychiatrist had advised her to go to the ER after she had informed her psychiatrist that she was having thoughts of suicide. Further review revealed that shortly after she was PEC'd, she was informed that she would be sent to an inpatient facility. Patient #3 informed the nurse that she would like to be sent to a specific hospital that was covered by her insurance plan. Further review revealed that when Patient #3 was informed that she was being sent to a facility in Lake Charles, she refused to go, and the staff called security. Patient #3 indicated that 4 security officers went into her room and handcuffed her. Documentation revealed that she complained to the officers that the cuffs were too tight, but no adjustments were made, and she was left with a bruised and swollen arm. She reported that was still experiencing pain and swelling in her arm a week later, went to an urgent care clinic, and was diagnosed with a contusion of the right forearm.

Review of the Patient Grievance Form documented by S9PRM revealed reports were documented from S2ERM and S10MSEP. There was no documented evidence that interviews were conducted with the RNs who provided care to Patient #3, the security officer who actually handcuffed Patient #3, S8Access who handles inpatient placement for PEC'd patients, and the RN who actually received placement at the Lake Charles facility.

In an interview on 11/21/17 at 9:55 a.m., S1DPS indicated the initial grievance investigation was done by S9PRM, Manager of Patient Relations, who is no longer employed. He further indicated he was involved in the investigation on the back end related to the handcuffing situation. He indicated he didn't receive the CAD report documented by the sergeant who actually handcuffed Patient #3 until 11/20/17, and he had not been given the authority yet to release it to the surveyor. S1DPS confirmed the investigation was not thorough and didn't include interviews with all staff and security officers involved in Patient #3's care on 06/23/17 and 06/24/17.

A request was made to interview the sergeant who handcuffed Patient #3 and to review the report documented by the sergeant. This request was not met as of the time of exit on 11/21/17 at 2:15 p.m.

Based on observations, record reviews, and interviews, the hospital failed to ensure patients received care in a safe setting as evidenced by failing to have a safe patient room and bathroom free of ligature and safety risks for patients who were PEC'd in the ER due to being suicidal and a danger to self and having physician orders for suicide and elopement precautions. This was evident for 2 (#1, #2) of 2 PEC'd patients (assessed as suicidal and a danger to self) observed on 11/17/17 and 11/20/17 in the ER.

Findings:

Observation on 11/17/17 at 11:30 a.m. with S1DPS and S2ERM present revealed Patient #1 (who was PEC'd due to being suicidal and a danger to self and ordered to be on suicide and elopement precautions) was in Room a with his mother and grandmother at his bedside. Further observation revealed S3PCA was seated in a chair across the hall from the entrance to Room a. Room a had a glass front that allowed S3PCA to view Patient #1. Further observation revealed ligature risks in the room that included the wires extending from the cardiac monitor hanging freely, the suction tubing hanging from the machine, and a curled stretchable cord hanging from what looked like an otoscope. Further observation revealed 3 boxes of gloves mounted on the wall that were filled with gloves that could be a risk for suffocation. There were 4 plastic bags with disposable blood pressure cuffs and a plastic bag with oxygen tubing in a bin on the table in the room. The plastic bags presented a risk for suffocation.

Observation on 11/17/17 at 12:05 p.m., Patient #1 was observed going to the bathroom near Room b alone with no staff present while he was in the bathroom.

Observation on 11/20/17 at 9:50 a.m. in Room b revealed Patient #2 (who was PEC'd due to being suicidal and a danger to self and ordered to be on suicide and elopement precautions) was sitting up in the bed with S4PCA at the bedside. Further observation revealed the room had a mounted sharps container on the wall and a mounted container of Purell hand sanitizer on the wall at the foot of the stretcher, both which were safety risks for a suicidal patient.

Observation of the bathroom outside Room b on 11/20/17 at 9:52 a.m. revealed the trash can had a plastic liner which could be used for suffocation. Further observation revealed a container of Purell hand sanitizer was mounted on the wall, the towel dispenser had sharp serrated edges in the area where the paper towel was released, the sink and toilet plumbing were not contained, and the screws in the room were not tamper-resistant, all which presented safety risks for a suicidal patient. These observations were confirmed by S6CNO as risks for safety for PEC'd patients.

Review of the policy titled Suicide Prevention Plan, presented as a current policy by S1DPS, revealed that staff were to maintain a safe and therapeutic environment for all patients. All potential ligatures and sharps were to be removed from the environment, and the Safe Environment Guidelines contained in Attachment A were to be utilized. Review of Attachment A revealed the following was to be done: room placement not near an exit or exit stairwell or fire pull station; patient use of bathroom must have patient verbal confirmation continuously with staff during use; remove plastic liners from trash cans; all cords need to be removed/secured; all sharps containers are removed (if can't be removed, a new sharp container must be placed in the room on admit and will be changed when it one-fourth filled); all glove boxes/gloves are removed; secure all supplies in the room that are sharps/plastics/ligature prone.

In an interview on 11/17/17 at 11:30 a.m., S3PCS indicated her role as a PCA Sitter is to monitor the patient every 15 minutes. She further indicated she doesn't go into the bathroom with the patient when he/she goes to the bathroom unless the patient requires assistance or supervision. S3PCA confirmed that Patient #1 went to the bathroom alone during the time she was observing him.

In an interview on 11/17/17 at 11:50 a.m., S2ERM indicated Patient 31 was ordered to be on every 15 minute observations and didn't have to be in the line of sight of staff.

In an interview on 11/17/17 at 12:00 p.m. S1DPS confirmed the ER does not have a psych safe room.

In an interview on 11/20/17 at 9:58 a.m., S2ERM asked the surveyor what the problem was with having a plastic liner in the trash can, and S6CNO answered and told him it presented an opportunity for suffocation.

In an interview on 11/20/17 at 10:10 a.m., S5DIP presented a container of Purell hand sanitizer with the label attached. She confirmed that Purell hand sanitizer had an active ingredient of Ethyl alcohol 70% and could be a safety risk to suicidal patients.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interviews, the hospital failed to ensure the RN supervised and evaluated the nursing care of each patient as evidenced by:

1) The RN failed to reassess each PEC'd patient who was suicidal and a danger to self for suicide risk every 8 hours as required by hospital policy for 3 (#1, #2, #3) of 4 (#1, #2, #3, #8) patient records reviewed for suicide risk reassessment of patients who were PEC'd due to being assessed as suicidal and having orders for suicide precautions.

2) The RN failed to ensure the patient's Suicide Monitoring Record, used by the PCA to document every 15 minute observations, included the patient's ordered level of observation and special precautions ordered by the physician for 4 (#1, #2, #3, #8) of 4 patient records reviewed for observation monitoring by the PCA.

Findings:

1) The RN failed to reassess each PEC'd patient who was suicidal and a danger to self for suicide risk every 8 hours as required by hospital policy:

Review of the policy titled Suicide Prevention Plan, presented as a current policy by S1DPS, revealed that reassessment of suicidality will occur every 8 hours by the RN for any patient on suicide precautions or who exhibits a sudden or significant change in mental status.

Patient #1

Review of Patient #1's ER record revealed he presented to hospital's off-site campus ER on 11/16/17 at 1:18 p.m. and was ordered to be on Level 1 Standard Observation (monitor and observe minimally every 15 minutes) and on suicide and elopement precautions at 1:03 p.m. on 11/16/17. Further review revealed he was assessed for suicide risk on 11/16/17 at 1:18 p.m. at the off-site campus. Patient #1 was transferred to Tulane medical center's ER on 11/16/17 at 4:38 p.m. and was PEC'd on 11/17/17 at 9:30 a.m. due to being suicidal and a danger to self. There was no documented evidence that he was reassessed for suicide risk from the time of his initial assessment, and he was transferred to an inpatient facility on 11/17/17 at 12:09 p.m. (more than 22 hours without a reassessment of suicide risk rather than every 8 hours as required by hospital policy).

Patient #2

Review of Patient #2's ER record revealed she (MDS) dated [DATE] at 6:25 p.m.. She was PEC'd on 11/19/17 at 8:45 p.m. as suicidal and dangerous to self. Further review revealed physician orders were received on 11/19/17 at 6:31 p.m. for Level 1 Standard Observation and suicide and elopement precautions. Further review revealed she was assessed for suicide risk on 11/19/17 at 6:54 p.m. and 6:58 p.m. There was no documented evidence that Patient #2 was reassessed for suicide risk as of record review on 11/20/17 at 9:40 a.m. (more than 14 hours).

Patient #3

Review of patient #3's ER record revealed she (MDS) dated [DATE] at 3:36 p.m. and was transferred to an inpatient facility on 06/24/17 at 6:08 p.m. Further review revealed a suicide risk assessment was done on 06/23/17 at 3:42 p.m. and 4:30 p.m. There was no documented evidence that Patient #3 was reassessed for suicide risk from 4:30 p.m. on 06/23/17 through the time of transfer on 06/24/17 at 6:08 p.m. (more than 25 hours).

In an interview on 11/21/17 at 11:20 a.m. with S1DPS and S2ERM present, S2ERM confirmed the above findings after he reviewed the ER records of patients #1, #2, and #3. He indicated the RN does a shift assessment (every 12 hours) but was not required to do a suicide risk assessment after the initial suicide risk assessment was done. He further indicated he didn't know that the policy required a suicide risk assessment to be done every 8 hours by the RN.

2) The RN failed to ensure the patient's Suicide Monitoring Record, used by the PCA to document every 15 minute observations, included the patient's ordered level of observation and special precautions ordered by the physician:

Review of the policy titled Suicide Prevention Plan, presented as a current policy by S1DPS, revealed that suicide precautions are to be clearly indicated on the assignment sheet and specific rounds sheets.

Patient #1

Review of Patient #1's Suicide Monitoring Record for 11/16/17 and 11/17/17 revealed no documented evidence that the level of observation and special precautions ordered by the physician were documented.

Patient #2

Review of Patient #2's Suicide Monitoring Record for 11/19/17 revealed no documented evidence that elopement precautions, which were ordered by the physician, were documented on the monitoring record. Further review revealed the Suicide Monitoring Record for 11/20 17 had no documented evidence of the level of observation and special precautions ordered by the physician.

Patient #3

Review of Patient #3's Suicide Monitoring Record for 06/23/17 revealed suicide precautions which were ordered by the physician were not documented on the monitoring record. Further review revealed the record for 06/24/17 had no documented evidence of the level of observation and special precautions ordered by the physician.

Patient #4

Review of Patient #4's Suicide Monitoring Record for 06/23/17 and 06/24/17 revealed no documented evidence of the level of observation and special precautions ordered by the physician.

In an interview on 11/21/17 at 11:20 a.m. with S1DPS and S2ERM present, S2ERM confirmed the above findings after he reviewed the ER records of patients #1, #2, #3, and #8.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the RN (Registered Nurse) failed to reassess a patient's care needs regarding a patient's weight for 1 of 1 (#3) patient after a recorded weight loss as evidenced by failing to reassess the patient's care on an on-going basis when the patient's admit weight was documented as 190# (pounds) on 05/22/17 and with a documented weight of 164# on 05/30/17 indicating a 26# weight loss in 7 days.

Findings:

A review of the policy titled Nursing Admission Assessment, Reassessment, and Plan of Care, provided by S1VP/QA as the most current, revealed in part: The plan of care is updated at least once a shift and target dates and goals are established and re-assessed based on a patient's current condition. A change in condition warrants a re-assessment.

Patient #3

A review of the patient's medical record at the hospital's Rehab (Rehabilitation) Unit revealed the patient was admitted on [DATE] for rehabilitation services. A review of the patient's care plan revealed a care plan for nutritional needs and weekly weights. A review of the Dietary and Meal Intake notes revealed documentation that the patient required assistance with all meals by staff. A further review of the medical record revealed the patient's admit weight was documented as 190# (pounds) on 05/22/17 and with a documented weight of 164# on 05/30/17 indicating a 26# weight loss in 7 days.

In an interview on 0 8/16/17 at 5:30 p.m. with S7RN/Rehab, Clinical Rehab Specialist, he indicated that he conducted the pre-screening evaluation for the patient to ensure the patient met rehab criteria prior to admit to the Rehab Unit. He indicated the patient's weight of 190# was a weight reported to him by the discharging hospital's staff and he did not know how the staff had measured the patient's weight that was reported to him. S7RN/Rehab indicated that he usually tried to get accurate weights from staff on patients being admitted to the Rehab Unit and he did not ask the staff how they measured the patient's weight. S7RN/Rehab indicated the patient's weight was a reported weight.

In an interview on 08/16/17 at 5:40 p.m. with S5MgrRehab she indicated that she attended the patient's ID (Interdisciplinary ) team conferences on 05/23/17 and 05/30/17. She was asked if the patient's weight loss was addressed by the ID team. S5MgrRehab reviewed the ID team's documented notes and she indicated that the patient's weight loss was not addressed by the ID team during those conferences. S5MgrRehab indicated that since the patient's lab values were within normal range and the RD's (Registered Dietician) nutritional assessments on the patient on 05/23/17 and 05/30/17 were assessed at low risk for malnutrition that the weight loss was probably not viewed as a negative outcome.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview the RD (Registered Dietitian) failed to reassess a patient's nutritional status regarding a patient's weight for 1 of 1 (#3) patient after a recorded weight loss as evidenced by failing to re-address the patient's nutritional status on an on-going basis when the patient's admit weight was documented as 190# (pounds) on 05/22/17 and with a documented weight of 164# on 05/30/17 indicating a 26# weight loss in 7 days.

Findings:

A review of the Dietary policy titled Continuous Nutrition Monitoring, as provided by S8DirDietary as the most current, revealed in part: Clinicians will continue to monitor patients for nutritional risks by predetermined criteria based on feeding modality, nutrition care order, condition, and diagnosis - to identify patients at potential nutritional risk not identified during the initial nutrition screening completed by nursing upon admission.

A review of the Dietary policy titled Re-assessment and Follow up, as provided by S8DirDietary as the most current, revealed in part: The purpose of the policy is to monitor the effectiveness of multidisciplinary nutrition care plan and to reassess the patient's nutritional status, as changes occur during the course of hospitalization to include: changes in weight status.

Patient #3

A review of the patient's medical record at the hospital's Rehab (Rehabilitation) Unit revealed the patient was admitted on [DATE] for rehabilitation services. A review of the patient's care plan revealed a care plan for nutritional needs and weekly weights. A review of the Dietary and Meal Intake notes revealed documentation that the patient required assistance with all meals by staff. A further review of the medical record revealed the patient's admit weight was documented as 190# (pounds) on 05/23/17 and with a documented weight of 164# on 05/30/17, indicating a 26# weight loss. A further review of the patient's medical record upon the patient's discharge from the Rehab Unit on 06/05/17 had a documented weight of 150#, which was a total weight loss of 40# in 2 weeks.

A review of S3RD nutrition assessment notes dated 05/23/17, the day after the patient was admitted to the Rehab Unit, revealed in part: The patient's weight was recorded at 190# and indicated that the weight of 190# was a reported weight. The patient was on a heart healthy pureed diet. The patient's nutritional risk appears to be normal. The patient did not meet clinical indicators for malnutrition. Goal: Maintain adequate nutrition and hydration. Patient will be able to meet nutritional needs with current diet. Continue current diet, advancing consistency per Speech Therapist evaluations. If oral intake declines, provide Ensure with meals.

A review of S4RD nutrition assessment notes dated 05/30/17, revealed in part: Diet - heart healthy mechanical soft. Eating 50-75% of meals per nursing documentation. New weight: 164# (bed scale weight). S4RD documented a possible measurement error from the reported weight on 05/23/17 of 190#. Patient's nutritional risk appears to be normal. Patient did not meet clinical indicators for malnutrition. Goal: Maintain adequate nutrition and hydration. Patient will be able to meet nutritional needs with current diet. Continue current diet, advancing consistency per Speech Therapist evaluation. If oral intake declines, provide Ensure with meals.

In an interview on 08/16/17 at 6:00 p.m. with S3RD she was asked about the patient's weight loss of 26# from 05/23/17 to 05/30/17 (7 days). She indicated that she conducted the initial RD nutritional assessment upon the patient's admit to the Rehab Unit on 05/23/17. She indicated that the weight she documented on 05/23/17 was a reported weight from S7RN/Rehab's clinical notes. She was asked about the documented patient weight of 164# on 05/30/17 from S4RD, which indicated a weight loss 26# in 7 days. S3RD indicated that she could not speak for S4RD, but that S4RD indicated in her notes that the weight discrepancy was probably a measurement error. S3RD indicated that the patient's weight loss was probably not addressed by the ID team since he had a reported good appetite and he had no clinical indicators for malnutrition and since the patient had hypertension and congestive heart failure issues that losing weight was probably a benefit for him since he was in the obese range. A further review of the patient's medical record with S3RD revealed a discharge weight of 150# on 06/05/17 which was a total weight loss of 40# in 2 weeks. She indicated that a rapid weight loss in a patient would normally trigger a nutritional concern that would need to be evaluated and addressed and indicated that the patient's nutritional status should have been reassessed.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure a Discharge Planning Evaluation was completed within 48 hours according to hospital policy as evidenced by failing to conduct a Discharge Planning Evaluation for 2 (#4, #5) of 5 (#1- #5) sampled patient medical records reviewed for Discharge Planning Evaluations.

Findings:

A review of the policy titled Interdisciplinary Discharge Planning, as provided by S1VP/QA as the most current, revealed in part: The discharge planning interdisciplinary process begins on admission and involves the patient, the patient family, and all team members and identifies all patients who are likely to suffer adverse outcomes when there is inadequate discharge planning. Each patient is screened within 24-48 hours of admission or next business day. SW (Social Workers) and CM (Case Managers) utilize the risk assessment, by completing the patient Psychosocial Assessment tool.

Patient #4

The patient was admitted through the ED (Emergency Department) to a hospital inpatient room on 07/24/17 and was discharged on [DATE]. The patient was a [AGE] year old male with [DIAGNOSES REDACTED], chronic right lower extremity ulcer who presented to the emergency room with leg pain of his extremity. Patient was admitted for further evaluation for hypoxia due to de-saturation on room air while in the ED.

A review of the patient's medical record revealed that no psychosocial initial assessment was conducted by a discharge planner staff member that documented a Discharge Planning Evaluation. There was no documented evidence of a Discharge Planning Evaluation that was completed within 48 hours by a discharge planner on the patient's medical record.

Patient #5

The patient was a [AGE] year old male admitted as an inpatient on 04/11/17 and was discharged on [DATE] to home. The patient had a history of end stage renal disease, chronic cirrhosis, and had a history of endocarditis that required a prior heart valve repair. He was admitted to the Intensive Care Unit from the Operating Room after a hypotension episode on induction during an elective hernia repair.

A review of the patient's medical record revealed that no psychosocial initial assessment was conducted by a discharge planner staff member that documented a Discharge Planning Evaluation. There was no documented evidence of a Discharge Planning Evaluation that was completed within 48 hours by a discharge planner on the patient's medical record.

.

In an interview on 08/16/17 at 11:00 a.m. with S2DirCM/SW she indicated that a psychosocial assessment was not conducted by a discharge planner on Patient #4 and Patient #5 and therefore a discharge plan was not formulated upon admit and present in the patient's medical record within 48 hours, as per discharge planning policy. She indicated that a Discharge Planning Evaluation should be formulated for all inpatients and placed in the medical record within 48 hours. S2DirCM/SW further indicated that a Discharge Planning Evaluation helped prevent discharge oversights from occurring. She indicated that the discharge planners are supposed to do their own psychosocial assessments upon a patient's admit within 48 hours, separate from the nurse's admit psychosocial assessment.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interview, the hospital failed to ensure a Discharge Planning Evaluation was completed within 48 hours according to hospital policy and placed on the patient's medical record for 2 (#4, #5) of 5 (#1- #5) sampled patient medical records reviewed for Discharge Planning Evaluations.

Findings:

A review of the policy titled Interdisciplinary Discharge Planning, as provided by S1VP/QA as the most current, revealed in part: The discharge planning interdisciplinary process begins on admission and involves the patient, the patient family, and all team members and identifies all patients who are likely to suffer adverse outcomes when there is inadequate discharge planning. Each patient is screened within 24-48 hours of admission or next business day. SW (Social Workers) and CM (Case Managers) utilize the risk assessment, by completing the patient Psychosocial Assessment tool.

Patient #4

The patient was admitted through the ED (Emergency Department) to a hospital inpatient room on 07/24/17 and was discharged on [DATE]. The patient was a [AGE] year old male with [DIAGNOSES REDACTED], chronic right lower extremity ulcer who presented to the emergency room with leg pain of his extremity. Patient was admitted for further evaluation for hypoxia due to de-saturation on room air while in the ED.

A review of the patient's medical record revealed no documented evidence of a Discharge Planning Evaluation on the patient's medical record.

Patient #5

The patient was a [AGE] year old male admitted as an inpatient on 04/11/17 and was discharged on [DATE] to home. The patient had a history of end stage renal disease, chronic cirrhosis, and had a history of endocarditis that required a prior heart valve repair. He was admitted to the Intensive Care Unit from the Operating Room after an hypotension episode on induction during an elective hernia repair.

A review of the patient's medical record revealed no documented evidence of a Discharge Planning Evaluation on the patient's medical record.

In an interview on 08/16/17 at 11:00 a.m. with S2DirCM/SW she indicated that a psychosocial assessment was not conducted by a discharge planner on Patient #4 and Patient #5 and therefore a discharge plan was not formulated upon admit and present in the patient's medical record within 48 hours, as per discharge planning policy. She indicated that a Discharge Planning Evaluation should be formulated for all inpatients and placed in the medical record within 48 hours.

Based on record review and interview, the hospital failed to ensure the QAPI (Quality Assessment and Performance Improvement) Program included QI (Quality Indicators) and QA (Quality Assurance) activities to review the hospital's Discharge Planning process in an on-going manner.

Findings:

A review of the Discharge Planning QA indicators, provided by S2VP/QA, revealed no documented evidence of QI (Quality Indicators) developed/implemented by the hospital to review their discharge planning process in an on-going manner through any QAPI activities.

In an interview 10/20/16 at 1:00 p.m. with S2VP/QA she indicated that she was responsible for the hospital's QAPI program. She was asked for the QAPI - QIs for the discharge planning process review to assure the hospital's discharge processes/policies were identifying issues in discharge planning. She indicated that she had only been in the QA position for 5 months and she was not sure if this was being collected in QAPI. She indicated that she would have to look into this and check with other QAPI members who have been here longer than her. After checking with other QAPI members and after reviewing the QAPI binder and the QAPI meeting minutes, she indicated that there was no documented evidence of QI's in QAPI for the review of the hospital's discharge planning process to identify concerns or problems. S2VP/QA further indicated that QAPI was not collecting data on the discharge planning process and QAPI was not tracking, trending or analyzing discharge planning processes and therefore, she had no data to present to demonstrate whether the hospital's discharge planning process had identified any problems in the discharge planning process for needed review/revisions. S2VP/QA indicated that the hospital was not reviewing the discharge planning process in QAPI, at present.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interview, the hospital failed to ensure that staff members responsible for discharge planning activities followed the hospital's policy for discharge planning evaluation for 1(#5) of 5 (#1-#5) sampled patients reviewed for discharge planning screening evaluations.

Findings:

A review of the hospital policy titled, Interdisciplinary Discharge Planning, as provided by S3DirCM as the most current policy for discharge planning, revealed in part: Discharge planning is an interdisciplinary process which begins on admission and involves the patient and all members of the health care team as appropriate. This process must identify all patients who are likely to suffer adverse outcomes when there is inadequate discharge planning. Discharge planning will be on-going during the hospital stay. Each patient is screened within 24-48 hours of admission. Patients/family must be involved with anticipated discharge needs. Patient discharge is coordinated in advance by the Case Manager/Social Worker in collaboration with the treatment team, patient, and family.

Patient #5

A review of the medical record for Patient #5 revealed the patient was admitted on [DATE] with an admitting diagnoses of seizure disorder. A review of the medical record revealed the patient was previously admitted on [DATE] also for seizure disorder. A further review of the patient's medical record revealed no documented evidence of any discharge screening/assessment or planning for 3 days. A review of the medical record revealed no documented evidence of a discharge screening assessment or any Social Worker/Case Management progress notes for 3 days.

In an interview on 10/20/16 at 11:30 a.m. with S3DirCM, she reviewed the medical record of Patient #5 and indicated that there was no documentation of a discharge screening assessment/planning in the medical record for Patient #5 and she indicated that she was unable to find any documentation of discharge planning progress notes for this patient for 3 days following admit. S3DirCM indicated that the discharge screening assessment tool should have been used for risks identified with re-admissions. She further indicated that there was no documented evidence of a review of additional medical equipment, home health needs or family involvement during those 3 days. She indicated that without the screening risk assessment being completed for re-admission there was no way to know if further needs were identified or if the patient's family was involved. She indicated that Patient #5 had been in the hospital for 3 days and the case manager or social worker should have addressed discharge planning needs; such as, home health, medical equipment needed and whether the patient had a support system available. She indicated that staff members responsible for discharge planning activities did not follow hospital policy regarding discharge screening assessment to be completed within 24-48 hours upon patient admission.

Based on record review and interview, the hospital failed to have a process in place for on-going reassessment and review of its discharge planning process that tracked and trended readmissions for potential problems in discharge planning or in implementations of discharge plans in order to identify preventable readmissions and make needed changes to its discharge process/policy that addressed any identified discharge planning problems.

Findings:

A review of the Discharge Planning QA indicators, provided by S3DirCM, revealed no documented evidence of Quality Indicators developed/implemented by the hospital to review their discharge planning process in an on-going manner through any QAPI activities.

In an interview on 10/20/16 at 11:00 a.m. with S3DirCM she indicated that she was the Director of Case Management that included discharge planning. She was asked for the hospital's QA indicators/activities used to review their discharge planning process that included tracking and trending of readmissions in order to identify potential factors to prevent readmissions. S3DirCM indicated that her department was not reviewing the discharge planning process and that she was not collecting any data on the discharge planning process for QAPI, nor was she tracking readmissions as part of discharge planning review and therefore, had no data to present to demonstrate whether readmissions were due to implementation of the prior discharge plan to identify problems in the discharge planning process. She indicated that she used to track and trend about 5 key indicators (such as, lack of family support, transportation, medicine non-compliance or inability to pay for medicines) that she would collect data on, relating to patient's readmissions and she would put this data on a spread sheet and track and trend to determine what went wrong and then this would be discussed in the IDT (Interdisciplinary Team) conferences for patients so that all team members were aware of the prior barriers. S3DirCM indicated that she stopped doing this around 2013 due to lack of sufficient staff and the increased workload in her department. S3DirCM indicated that the hospital had no process in place, at present, for an ongoing reassessment of its discharge planning process that identified preventable readmission factors. S3DirCM further indicated that the hospital was not conducting any in-depth review of its discharge planning process in order to revise/modify their discharge planning and/or related processes.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record review and interviews, the hospital failed to ensure the RN appropriately evaluated and assessed a patient's care needs, health status, and potential for injury in the emergency department for 1 (#1) of 5 (#1 - #5) patient records reviewed as evidenced by:

1) a patient assessed as a high fall risk was allowed to ambulate without the accompaniment of any emergency room staff; and

2) failure to assess the neurological status after a patient had a seizure and sustained an injury to the head/face while in the emergency department.

Findings:

1) a patient assessed as a high fall risk was allowed to ambulate without the accompaniment of any emergency staff

A review of the medical record for Patient #1 revealed she was a [AGE]-year-old female who was brought to the ED via ambulance on 12/27/15 at 2:58 p.m. for active seizures.

A review of a policy entitled Fall Prevention Policy (Policy #: 3.16), presented as current, revealed, in part: . . . 5. Definition of high fall risk: Patient demonstrates at least one of the fall risk elements listed below in Section 2 of the Procedure . . . 2. Patients should be assessed for the presence of the following high fall risk elements: . . . e. confused at times; f. fall history (last 3 months); h. lethargic/sedated. 3. Prevention of falls is the responsibility of all hospital personnel. The Fall Prevention Program consists of the following interventions: . . b. Customized interventions will be implemented for patients identified as being at risk of injury from a fall to include: iii. Patients will be provided with mobility assistance (i.e. walkers, walking/transfer belt).

A review of the ED nurses notes dated 12/27/15 by S4RN revealed Patient #1 was assessed to be a high risk for falls.

A review of the Risk Management Report-Patient dated 12/27/15 revealed, in part, Patient #1 was found on the floor outside of the bathroom in the emergency department actively seizing and bleeding from her mouth on 12/27/15 at 5:00 p.m. by an emergency room nurse. The report further stated the RN had observed, in passing, Patient #1 and a female friend outside the emergency department bathroom having casual conversation (no ED staff present with Patient #1). The RN documented she turned the corner to reach her destination, and she heard screams for help. When the RN returned to the location, the second female informed the RN that Patient #1 had fallen and hit her head on the floor.

In an interview on 02/23/16 at 10:33 a.m., S2ED Manager reviewed Patient #1's medical record and confirmed Patient #1 was allowed to ambulate to the bathroom unaccompanied by ED staff, and Patient #1 should not have been allowed to ambulate without ED staff present and should have been taken to the bathroom in a wheelchair by an ED staff member.

In an interview on 02/24/16 at 9:20 a.m., S4RN indicated he did not accompany Patient #1 to the bathroom, and he allowed Patient #1 to ambulate to the bathroom accompanied only by a female friend and no ED staff member. S4RN agreed, in hindsight, Patient #1 should not have been allowed to ambulate to the bathroom unaccompanied by an ED staff member.

In an interview on 02/24/16 at 11:00 a.m., S5RN indicated when patients are on fall precautions, especially high risk for falls for patients with seizures, changes in level of consciousness, etc. patients should not get up by themselves without a staff member present. She further indicated patients on high risk fall precautions should not be allowed to ambulate, but be transported in a wheelchair accompanied by a staff member. S5RN reviewed the medical record for Patient #1 and confirmed Patient #1 was allowed to ambulate to the bathroom in the ED without a staff member present, and Patient #1 should have been placed in a wheelchair and taken to the bathroom accompanied by an ED staff member.

2) failure to assess the neurological status after the patient sustained an injury to the head/face while in the emergency department.

A review of a policy entitled Seizure Precautions (NSG 4.25), presented as current, revealed, in part: I. Purpose. The purpose of this policy is to provide nursing care and prevent injury to a patient who has a seizure. II. Policy: Any patient with a history of seizure disorder shall be placed on seizure precautions. Seizure precautions may be implemented as a nursing order. The physician will be notified of a patient placed on seizure precautions. V. Procedure: 8. a. After the seizure, monitor vital signs until stable. V. Documentation. 1. After a seizure the nurse is responsible for documenting the following: a. Seizure activity: time of onset, duration, description of seizure (motor involvement, tonic-clonic, type, etc.), time of intervals between seizure activity. b. Frequent vital signs, until stable. c. Level of consciousness. d. Any trauma/injury. f. Duration of the Post-Ictal phase.

A review of the Patient #1's medical record revealed the only assessment documented after Patient #1 had a seizure and fell and hit her head/face in the ED was a blood pressure assessment (120/90) taken by S4RN on 12/27/15 at 5:10 p.m. Further review revealed S4RN documented on 12/27/15 at 5:01 p.m., post-ictal state at this time. There were no other vital signs, no description of the seizure activity, and there was no neurological assessment performed and documented by S4RN. Review of Patient #1's medical record revealed the first neurological assessment performed and documented (Glascow Coma Scale) after the patient had a seizure while in the ED and hit her head/face was on 12/27/15 at 6:11 p.m. by S6RN.

In an interview on 02/23/16 at 10:33 a.m., S2ED Manager reviewed Patient #1's medical record and confirmed the above findings and agreed that a full set of vital signs and a neurological assessment should have been performed and documented by S4RN immediately after the seizure and injury to Patient #1's head/face occurred. S4ED Manager also agreed post-ictal state at this time does not constitute a neurological assessment, and a neurological assessment should have included an assessment utilizing the Glascow Coma Scale.

In an interview on 2/24/16 at 11:00 a.m., S5RN reviewed the medical record for Patient #1 and, S5RN confirmed there was no documented neurological assessment performed on Patient #1 immediately after the patient had another seizure while in the ED and fell on the floor and hit her head/face resulting in a laceration to her lips, and there should have been neurological assessments performed and documented immediately after the seizure and head injury occurred.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews (environmental observations by hospital staff), observations, and interviews, the hospital failed to ensure the Infection Control Officer implemented and maintained effective policies and procedures to ensure maintenance of a sanitary physical environment as evidenced by:

1) During a tour of the emergency room (ER) on 11/07/12 at 1:15 p.m. through 2:20 p.m. with the Performance Improvement Coordinator (S5PI) and Director of ER (S55RN), the following items were noted:

a) Inside the Ambulance Entrance there were two spine boards with an approximately 1 foot round spot of a dried red substance on each spine board. The area where the top of the boards were touching the glass window was stained with a brownish/red substance in an area approximately 2 feet round. The area where the spine boards touched the carpet on the floor had dark stains on the carpet measuring approximately 2 feet by 1 foot.

In an interview with S5PI and S55RN, the above observations were confirmed. S55RN stated that the problem was a delay in getting the ambulance service to retrieve the spine boards. S55RN was asked who placed the boards there without cleaning or bagging them, and she responded it was hospital staff.

b) Two red biohazard bins located near the ambulance entrance could not be opened by use of the foot pedal to prevent touching the bin when discarding bio-hazardous material.

In an interview with S5PI and S55RN, the above observations were confirmed. Both stated this would require staff to open the bin by hand.

c) ER Room f contained an IV (intravenous pump) that was not covered.

In an interview with S5PI and S55RN, it was confirmed that a bag is to be placed over the IV pump indicating it has been cleaned between patients. S5PI and S55RN stated that ER Room f was therefore dirty and not ready for patient use. Prior to the room being cleaned another patient was placed into ER Room f at 2:00 p.m..

This observation was confirmed by S5PI and S55RN. S55RN stated that there is currently no policy in place for staff to know when a room cleaning has been performed and that the room is ready for another patient.

d) The entire ER floors and walls had numerous black/brown substance spots. This finding was confirmed by S5PI.

e) Multiple linen bins in the ER were noted to have white plastic covers that were now brownish in color. In an observation made with S55RN it was noted that the brownish substance was easily removed by use of a sani-wipe found in the ER.

f) In an observation during the same tour it was noted that S54RN, ER, exited Room g with an EKG (electrocardiogram) machine without gloves and was observed to not perform handwashing or use of alcohol based hand sanitizer prior to leaving the room. S54RN proceeded to get a sticker off of the wall nearby and immediately entered ER Room h with the EKG machine. The EKG machine leads were not sanitized between patient use.

S54RN was interviewed at the time of the observation and stated she should have performed hand hygiene between patients.

The observations were confirmed by S5PI and S55RN.

g) In an observation of ER Room i there was noted to be two Blanketrol Systems machines and 2 Blood warmers with no plastic bags covering them.

S55RN stated that these items must be considered dirty due to not being covered and that a patient was placed into this room.

h) An observation of ER Room j revealed an approximately 4 X 4 hole in the wall near the door.

S55RN confirmed this finding.

i) An observation of the soiled linen basket revealed a white plastic covers that was now brownish in color. In an observation made with S55RN it was noted that the brownish substance was easily removed by use of a sani-wipe found in the ER.

j) An observation in the pediatric area of the ER revealed that clean linens were stacked on top of a linen cart.

S55RN confirmed that clean linens should be placed inside of the covered cart.

k) An observation was made of Housekeeper (S57) entering ER Room k with gloves on. S57 exited the room with a biohazard bag in one hand and a trash bag in the other and deposited each into its respective container. S57 then rolled the trash bin and biohazard bin to room l, entered the room touching the door handle, and exited with a biohazard bag and a trash bag and deposited them into the respective containers, touching the bins. S57 then headed towards ER Room m where a pediatric patient was located. S57 was asked if there was a policy regarding changing gloves and/or sanitizing hands between rooms. S57 replied she was just emptying trash. S57 then responded she should have changed gloves between rooms but did not state that her hands should be sanitized between glove use.

S55RN confirmed these observations.

l) An observation of ER Room n was made. The room was empty and S55RN was asked if the room was clean and ready for a patient. S55RN confirmed the room was ready for patient use. An observation was made of the bed revealing multiple rust spots, a dark black substance under the mattress area that was easily removed with an alcohol prep, dust on the base of the Dinamap vital signs base, and dust on the computer stand base located in the room. S55RN stated the rust spots cannot be disinfected with a surface wipe as it would not penetrate the irregular surface. During the observation a staff member was escorting a patient to place into Room n. S55RN stopped them before entry and the room was closed pending cleaning.

In an interview on 11/15/12 at 3:45 p.m. with Quality/Risk (S58VP), Infection Control Preventionist (S6ICP) and Quality/Risk (S58VP) stated that the environmental items identified were previously identified by the hospital. She further stated the hospital is in the process of scheduling ER rooms for thorough cleaning and the plan will be rolled out so rooms can be closed to allow time for cleaning. All were asked if any plan was developed and implemented to ensure a sanitary environment based on the items found during the internal observations. S8ICP stated an e-mail of the observations is sent to the ER Director. The hospital could provide no documentation that any changes were made to existing policy or that a new policy/procedure was developed or implemented in regards to the findings.

Review of an e-mail dated August 6, 2012 at 8:21 a.m. from Risk Management (S11) to S5PI regarding environmental rounds made in the ER revealed in part: ...These are my findings...The soiled room - specimen of urine on the counter, used HCB test sitting on top of unopened clean test kit, very strong urine smell in the room. Clean Supplies - boxes on floor, top shelf is stocked too high, messy and dirty...The patient's nutritional room and fridge - the supply closet where the crackers and juice are kept - very messy and the floor was dirty. Expired milk in the fridge and dirty. Nurses' stations are messy and dirty with drinks and food all over...EOC (environment of care) Rounds 8/1/12 Emergency Department - Infection Prevention. Out of date milk found in refrigerators. Not all patient food dated. Boxes and bags found on the floor of the storage area. Items stored too high on the top shelf in the supply room. Wheel chairs stored in supply room, when asked nurse about cleaning process verbalized the wheelchairs are cleaned after each use. Dirty disposable blood pressure cuffs attached to dinamaps as well as to blood pressure monitors in the patient rooms...Ice machine needs cleaning. Microwave needs cleaning. Refrigerators need cleaning. Urine receptacle found under sink along with a piece of Xerox machinery...One linen cart covered but there is linen on the floor next to the linen cart. Physician office is very dirty and opened vials of medication on counter with drinks setting all around the desk...Triage area had uncovered linens. Sharps containers full in procedure room. Torn covers on the stools in patient areas...Peds (pediatric) crash cart is stored in front of a sink used for hand hygiene.

Review of a hospital policy titled Cleaning Emergency Department, policy number 8008, effective 11/2012, presented as current hospital policy revealed in part: Policy: The Emergency Department and Environmental Services Department personnel will clean all areas of the Emergency Department on a daily basis 24 hours per day and seven days per week. Emergency response services are available 24 hours a day...Procedure: After every patient discharge, Emergency Department personnel will: Strip room of all soiled linen and place in soiled linen hampers in hallways. Damp wipe all surfaces using approved, germicidal product including, but not limited to, stretchers (including railings and mattress), sinks, countertops, cables, monitor wires, etc. Remake stretcher with clean linens. At least once per day, Environmental Services Department personnel will:..High dust lights, vents, ledges, cubicle curtain tracking, etc. Damp wipe counters, furniture, telephones and receivers, etc., with the hospital approved germicidal solution. Clean and disinfect all multi-use patient equipment and mobile devices, per Infection Control Policy. Spot clean walls...

Review of a hospital policy titled Environmental Services, policy number IC.VI.E.5, effective February, 2011, revealed in part: ...I. Purpose. To maintain an aesthetic and sanitary healthcare environment which is important for quality patient care. II. Policies for personnel in department...B. Policy on Hand Washing/Gloves...Employees are instructed to wash hands thoroughly, or utilize the alcohol-based waterless hand cleanser if their hands are not visibly soiled...between the changing of gloves...

Review of a hospital policy titled Laundry/Linen, policy number IC.VI.L2, effective February, 2011, presented as current hospital read in part: Policy: The provision of adequate linen and laundry services is a fundamental requirement of direct patient care and a hospital activity that contributes to its commitment to meet standards of quality services...Procedure:..V. Clean Linen:...G. Linen is stored is usher areas in either covered carts or closed linen closets.

2) During a tour of the kitchen area on 11/08/12 from 7:15 a.m. through 11:15 a.m. with Assistant Dietary Director (S53), the following items were observed:

a) At 7:35 a.m., there was a yellow blower machine located in the main hallway area observed that was caked with grey, white, black, and orange colored substance/debris at 7:35 a.m..

b) At 7:40 a.m., there was a clean metal linen cart noted with a whitish substance caked on both bottom side rails in the hallway.

c) In the dish room area, there was a yellow blower machine caked with grey, white, black, and orange colored substance/debris and the fan motor shield was covered with brown, black, and orange debris/substance at 7:41 a.m..

d) At 7:48 a.m., the ceramic tile in the wash area had caked with black, brown substance in the grooved area.

e) At 7:50 a.m., the wash station's back metal panels were observed with two (2) streaks of white caked substance/debris that ran down both sides of the panels.

f) At 8:00 a.m., the front metal panel on the coffee pot machine was observed covered with an orange, brown rust build up.

g) From 8:05 a.m. to 8:15 a.m., there were 2 metal food cart's front panels covered with a gray sticky substance/debris.

h) At 8:06 a.m., walk-in refrigerator #1 and walk-in refrigerator #2 had metal carts covered with orange, brown, and black substance/debris and the floor tile's cracks (grooved areas) were covered with black/brown debris.

i) At 8:15 a.m., walk-in refrigerator #3 had a green rack located on the second shelf with the grooved areas covered with a white substance.

j) At 8:20 a.m., the floor tile in walk-in refrigerator #4 was covered/caked with a black substance.

k) At 8:30 a.m., there were four (4) large muffin tins observed on a metal cart that were caked with orange, brown, and black substance/debris.

l) There were two (2) sets of 2 double ovens observed side by side each other at 8:30 a.m.. Further observation revealed all four ovens had caked brown, black, orange debris/substance on the inside racks and sides of each oven. There was rice that was brown, black, and white in color that was located on the outside of the door on the first double oven.

m) At 8:31 a.m., the inside panel and racks of the rational oven were covered with a caked brown/black debris/substance.

n) There were twelve (12) large baking pans observed caked with brown, orange, black substance/debris at 8:32 a.m..

In an interview on 11/08/12 from 7:15 a.m. through 11:15 a.m., Assistant Dietary Director (S53) confirmed the yellow blower machine, fan motor and linen cart in the main hallway, ceramic tiles in the wash room area, back panels in the wash station, front panel on the coffee pot, front panels on the metal food cart in the preparation area, metal cart in walk-in refrigerator #1 and #2, floor tiles in walk-in refrigerator #1 and #2, green rack located on the second shelf in refrigerator #3, four (4) large muffin pans/tins, 4 double oven racks and outer doors, inside panels and racks of the rational oven, and 12 large baking pans were covered/caked with brown, black, grey, whitish, and/or orange substances/debris.

Review of the policy titled, Infection Control Policies & Procedures Manual, Policy Number: IC.VI.F.1, Policy Origin Date: February 1993, Effective Date: February, 2011, Supersedes Policy: IC.VII.F.1, Dated: May 2000 January 2006, revealed the policy indicated all food grinders, chopper, mixers, blenders, etc., will be disassembled, cleaned, sanitized, dried and reassembled after each use. All food carts should be sanitized after each meal with a sanitizer. Ranges and grills should be cleaned daily. All work surfaces and equipment should be cleaned and sanitized after each use. All floor surfaces must be wet-mopped daily. Storage refrigerators must be cleaned and sanitized once a week. It is the authority and responsibility of the Food Service Director, Assistant Directors, Managers and dietary employees for insuring that the above policy is adhered to.

The policy titled, Infection Control Policies & Procedures Manual, Policy Number: IC.VI.F.1, Policy Origin Date: February 1993, Effective Date: February, 2011, Supersedes Policy: IC.VII.F.1, Dated: May 2000, January 2006, indicated an unsanitary food service can play s significant role in disease transmission. Maintenance of sanitation standards is important in the medical-care facility. The prevention of infection in the Food Service Department requires health personnel, properly maintained equipment, uncontaminated supplies and an ongoing awareness of proper sanitization. The Food Service Director is responsible to evaluate the cleanliness of food preparation and provide a safe food service for patients.

3) An observation was made on 11/14/12 at 2:25 p.m. in the ED at the main campus with Risk Management (S4). The following was observed:

Registered nurse was observed exiting Room e while kicking blankets into the hallway.

In an interview on 11/14/12 at 2:30 p.m. with Registered Nurse (RN) (S16), she said her patient was in 4 point restraints and had urinated on himself. S16 said she and Registered Nurse (S17) and ED technician S18 had changed the bed. She said S17 had kicked the soiled blankets into the hallway, but she should have put them into a bag instead.

In an interview with S17, she said she was the one who had kicked the urine soaked sheets into the hallway. She said she did not know why she had done it, but she should have picked them up and placed them into a bag instead.

In an interview with Risk Management (S4), she verified the urine soaked blankets should not have been kicked out of Room e into and down the hallway in the ED. She said the dirty linens should have been placed into a bag outside of the door to the room by the nurse or technician.

Review of the policy titled Handling Soiled Linen, Policy No: 7009, Effective Date: 11/2012 revealed in part:

Any soiled linen pulled from any patient care areas will be placed in blue bags. Nursing or other clinical personnel will be responsible for disposal of soiled linen.

4) An observation was made on 11/8/12 at 3:25 p.m. in the Neonatal Intensive Care Unit (NICU) at the off-site campus with Director of Women's and Children's Services (S28). The following was observed with S28 present:

Registered Nurse (RN) (S71) was assisting other staff members change blankets for Patient #41. While the other staff member held the infant, S71 removed the dirty linens while not wearing gloves. After washing her hands, S71 then picked up the dirty linens she had removed from the bed while still ungloved, and placed them into a hamper. She then opened a supply drawer and touched supplies with her dirty hands. She then put on one glove, and walked into the clean supply room. S71 exited the clean supply room carrying two boxes of gloves while still wearing only one glove. She then was observed touching the infant on the head with the ungloved hand.

Review of the medical record for Patient #41 revealed she was a female infant born on 10/31/12 and admitted to the NICU for prematurity and possible sepsis.

In an interview on 11/8/12 with Director of Women's and Children's Services (S28), she stated S71 should have been wearing gloves while in contact with Patient #41. S28 also verified S71 should have washed her hands after contact with the soiled linen and before touching clean supplies.

Review of the Policy titled Hand Hygiene in the NICU, Policy No: NSG-NICU-4.19, Reviewed 01/12 revealed in part:

-Hand hygiene is indicated:

Before patient contact

After contact with patient surroundings

-Wear gloves during any contact with body substances, contaminated surfaces ...

-if gloves are used, discard gloves after each task and clean hands.

5) An observation was made on 11/7/12 at 1:45 p.m. and 2:15 p.m. in the Pediatric Intensive Care Unit (PICU). The following was observed:

a) On 11/7/12 at 1:45 p.m., X ray technician (S23) was observed entering the PICU and approaching Patient #2's bed. She donned gloves without cleaning her hands after entering the unit. S23 was then observed to have touched Patient #2, the patient's bed, the x ray plate, and the x ray machine. When finished, S23 removed her gloves and exited the PICU without washing or sanitizing her hands.

Medical record review for Patient #2 revealed she was a 5 year old female admitted on [DATE] following a MVA (motor vehicle accident).

In an interview on 11/7/12 at 1:50 p. m. with the PICU Manager (S22), she verified S23 did not wash her hands before or after touching Patient #2. S22 said S23 should have washed or sanitized her hands before and after contact with a patient.

In an interview on 11/7/12 at 2:00 p.m. with x ray technician (S23), she verified she had not washed her hands before or after contact with Patient #2. S23 also stated she was sorry and should have washed her hands before and after contact.

b) An observation was made on 11/7/2 at 2:10 p.m. in the PICU. Two suction tubes were observed on the floor next to Patient #1's bed.

In an interview on 11/7/12 at 2:12 p.m. with PICU Manager (S22), she stated the 2 dirty suction tubes on the floor had been changed by the staff and dropped on the floor while new tubing was connected to the patient. S22 said the dirty tubes remained on the floor because Patient #1 had a lot of wires connected to her and the staff would probably pick them up tonight. When asked if the dirty tubing should remain on the floor until tonight, S22 said probably not and asked staff to remove the tubing.

6) An observation was made on 11/08/12 at 8:40 a.m. in the Emergency Department (ED) of the off-site campus with Director of ED Patient Services (S21). The following was observed:

Room d was observed to have an accumulation of dust on the floor below the foot of the stretcher. The floor was observed to be soiled on both sides of the stretcher.

The emergency cart in the room was observed to have an accumulation of dust on the suction machine located on the top of the cart.

Emergency medication were observed to be stored in the 5th drawer of the emergency cart. This drawer and the 6th drawer were observed to have a large accumulation of dust. S21 indicated Room d was ready for patient use at the time of the observation. S21 confirmed the above findings at the time of the observation. S21 stated they, struggle with housekeeping. S21 verified the floor in Room d was not clean.

Room o was observed to be vacant and ready for patient use. The side rails of the stretcher in Room o were raised and blue pads were observed to be attached to both side rails. A white/tan substance was noted on both pads. S21 confirmed the pads were not clean at the time of the observation.

Review of a hospital policy titled Cleaning Emergency Department, policy number 8008, effective 11/2012, presented as current hospital policy revealed in part:

Policy: The Emergency Department and Environmental Services Department personnel will clean all areas of the Emergency Department on a daily basis 24 hours per day and seven days per week. Emergency response services are available 24 hours a day...

Procedure: After every patient discharge, Emergency Department personnel will:

Strip room of all soiled linen and place in soiled linen hampers in hallways.

Damp wipe all surfaces using approved, germicidal product including, but not limited to, stretchers (including railings and mattress), sinks, countertops, cables, monitor wires, etc.

Remake stretcher with clean linens.

At least once per day, Environmental Services Department personnel will:..

High dust lights, vents, ledges, cubicle curtain tracking, etc.

Damp wipe counters, furniture, telephones and receivers, etc., with the hospital approved germicidal solution.

Clean and disinfect all multi-use patient equipment and mobile devices, per Infection Control Policy. Spot clean walls...

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, interviews, and record reviews, the hospital failed to ensure the facility and all equipment was maintained in a manner to ensure an acceptable level of safety and/or quality as evidenced by:

a) failing to ensure the functionality of nurse call buttons located on the handrails of 70 licensed hospital beds at the off-site campus and 232 licensed hospital beds at the main campus of the hospital;

b) failing to ensure daily maintenance for laboratory centrifuge equipment was done as required for 4 of 4 centrifuges at the off-site campus;

c) failing to ensure the handrails, mayo stands and emergency carts were free of tape (including sections of sticky residue from tape) resulting in the inability to have a smooth wipeable surface for disinfection;

d) failing to ensure ongoing maintenance of the facility as evidence by missing, peeling Formica from patient doors on the rehabilitation unit resulting in an uneven surface for disinfection and a safety hazard for patients/visitors/staff, and an open, exposed electrical outlet in the ED of the off-site campus;

e) failing to ensure clean equipment, ready for patient use was not stored with soiled linen and trash in the Out Patient Surgery Department.

Findings:

a) failing to ensure the functionality of nurse call buttons located on the handrails of 70 licensed hospital beds at the off-site campus and 232 licensed hospital beds at the main campus of the hospital:

An observation was made on 11/8/12 at 9:40 a.m. of a patient bed in a room on the post-partum unit. A button on the handrail was observed to have a picture of a nurse. When the button was pushed, no signal was activated in the hallway or the nursing station.

In an interview on 11/8/12 at 9:45 a.m. with the Director of Women's and Children's Services (S28), she stated all of the handrails on the beds on the post-partum unit had buttons with a picture of a nurse. She stated it was a call button for the nurses' station, but it was not functional. S28 said the patient rooms had call buttons on a cord that was connected to the walls. She said the patients had been oriented to use the call buttons connected to the wall. When asked if it was possible for a patient to be confused or sedated and think the call button on the rail was functional, she said it could be possible. When asked if a family member that had never been oriented to the wall call system may mistakenly try to use the call button on the bed in an emergency, she said it could be possible.

On 11/09/12 at 1:35 p.m., an observation was made of 5 patient beds in 5 patient rooms on the rehabilitation unit with Vice President of Operation (S27) at the off-site campus. A button on the handrail was observed to have a picture of a cross. When the button was pushed, no signal was activated in the hallway or the nursing station. S27 confirmed the button was a nurse call button, but the call buttons in the handrails were not functional. S27 stated they had 17 beds on the rehabilitation unit and all the beds had a nurse call button in the hand rails. S27 indicated there was a nurse call button on a cord that patient's were instructed to use and stated they needed to cover the call buttons on the hand rail. S27 verified the non-functioning call button in the hand rail could be confusing for disoriented patients or family members who had missed the staff instruction to use the call system on the cord.

Review of a list presented by the Vice President of Operations (S27) at the off-site campus revealed the hospital had 70 licensed hospital beds with call lights on the handrails that were not functional. A list was presented by the hospital on [DATE] that revealed 232 licensed hospital beds were located at the main campus with call lights on the handrails that were nonfunctional.

b) failing to ensure daily maintenance for laboratory centrifuge equipment was done as required for 4 of 4 centrifuges at the off-site campus:

On 11/09/12 at 1:15 p.m. an observation was made in the off-site campus laboratory with S72, Manager at off-site Laboratory. 4 Centrifuge machines were observed to have maintenance logs positioned beside or above the machines. Review of the maintenance logs revealed the following:

General Purpose Variable Speed Centrifuge

Model: Stat Express 4 (M510), Serial number: 1113M 548 - no documentation of daily maintenance checks for 11/03/12, 11/04/12, and 11/08/12.

Model: Hettich, Serial number: 9 - no documentation of daily maintenance checks for 11/03/12, 11/04/12, and 11/08/12.

Model: Elite, Serial number: 670 - no documentation of daily maintenance checks for 11/03/12 and 11/08/12.

Model: Abbott, Serial number: 4 - no documentation of daily maintenance checks for 11/03/12, 11/04/12, and 11/08/12.

S72 verified the above maintenance procedures for the laboratory's centrifuge machines was not done daily as required. S72 was unable to explain why the daily maintenance was not done.

c) failing to ensure the handrails, mayo stands and emergency carts were free of tape (including sections of sticky residue from tape) resulting in the inability to have a smooth wipeable surface for disinfection;

On 11/08/12 at 8:40 a.m., observations were made in the Emergency Department (ED) of the off-site campus with Director of ED Patient Services (S21). In Room b, the side rails of the stretcher were observed to have a sticky residue on the side rails. The mayo stand in Room b was observed to have tape on the edges of the stand. In Room c the mayo stand was observed to have tape on the edges of the stand. In Room d, the emergency cart was observed to have a sticky residue and pieces of tape on the drawer containing emergency medications. Pieces of tape were observed on the side rails of the stretcher in Room d. Tape was observed on the side rails of the stretchers in Room o and Room p. S21 confirmed the above findings at the time of the observation.

On 11/09/12 at 1:35 p.m., observations were made in the Rehabilitation Unit of the off-site campus with Vice President of Operations (S27). Room q was observed to be vacant and isolation supplies were observed on the door to the room. Tape was observed on the side rail of the bed. S27 confirmed the finding of tape on the side rails and verified the last patient that was in the room was on contact isolation.

d) failing to ensure ongoing maintenance of the facility as evidence by missing, peeling Formica from patient doors on the rehabilitation unit resulting in an uneven surface for cleaning and a safety hazard for patients/visitors/staff, and an open, exposed electrical outlet in the ED of the off-site campus.

On 11/08/12 at 8:40 a.m., observations were made in the Emergency Department (ED) of the off-site campus with Director of ED Patient Services (S21). The protective plate on one electrical outlet was observed to be broken with the side of the outlet open and exposed. S21 confirmed the finding at the time of the observation and verified the open plate of the outlet posed a hazard to patients, visitors, and staff.

On 11/09/12 at 1:35 p.m., observations were made in the Rehabilitation Unit of the off-site campus with Vice President of Operations (S27). The doors to Rooms r, s, and t were observed to have 12-13 inches of peeling, missing Formica. Rough, splintering edges were observed where the Formica was missing from the door. S27 confirmed the missing Formica from the doors to patient rooms at the time of the observation.

e) failing to ensure clean equipment, ready for patient use was not stored with soiled linen and trash in the Out Patient Surgery Department:

On 11/09/12 at 9:00 a.m., observations were made in the Out Patient Surgery Department of the off-site campus with Vice President of Nursing (S15) at the off-site campus, and Risk Manager (S11). The storage room of the department was observed to have 2 wheel chairs, and 4 IV (Intravenous) poles ready for patient use. Also observed in the storage room was a soiled linen container with soiled linen present, and a Trash container with trash observed in the container. The above findings were confirmed with S15 and S11 at the time of the observation.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interviews, the hospital failed to ensure that drugs and biologicals were prepared and administered according to physician orders and accepted standards of practice.

1) The hospital failed to develop and implement a system to ensure that physician orders for medications included a specific dose and frequency with the specific instructions for use as evidenced by having a hospital policy that allowed medication ranges to be ordered. This resulted in physician orders for medications with ranges in dose and no order for frequency between repeated dosing for 4 of 6 patients' records reviewed who had a surgical procedure (#31, #32, #33, #42) and 1 of 6 Medical - Surgical patients' records reviewed (#23) from a total of 44 sampled patients.

2) The hospital failed to ensure nursing staff clarified medication orders for completeness before administering medications with no specified route for 4 ( #1, #2, #21, #41) of 44 sampled patients.

3) The hospital failed to ensure nursing staff administered medications as ordered by the physician for 1 (#43) of 44 sampled patients.

Findings:

1) Develop and implement a system to ensure that physician orders for medications included a specific dose and frequency with the specific instructions for use:

Patient #23

Review of the medical record for patient #23 reflected the patient was a [AGE] year old male who had diagnoses that include [DIAGNOSES REDACTED]

Review of physician's orders dated 11/13/12 reflected an order for Morphine Sulfate 5 - 10 mg every 2 hours as needed for pain.

Review of the patient's Medication Administration Record (MAR) reflected an order for Morphine Sulfate 5 - 10 mg orally every 2 hours as needed.

There was no documentation in the record to reflect a clarification order regarding the specific dose of medication to be administered.

Interview with S19, Director of the Medical/Surgical unit on 11/14/12 at approximately 9:15 a.m. confirmed the above finding. S19 revealed the hospital was currently working on the policy for range orders.

Patient #31

Review of Patient #31's medical record revealed that she was a [AGE] year old female who had a Laparoscopic Cholecystectomy on 11/09/12.

Review of her Anesthesia PACU (post anesthesia care unit) Orders revealed a verbal order was received by RN (registered nurse) S60 on 11/09/12 at 1350 (1:50pm) to give Morphine 2 to 3 mg (milligrams) IVP (intravenous push) as needed for pain to a maximum dose of 10 mg. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

Review of the e-MAR (electronic medication administration record) revealed that RN S60 administered Morphine 5 mg to Patient #31 on 11/09/12 at 1356 (1:56pm). Review of the PACU Notes revealed the following documentation by RN S60:

11/09/12 at 1400 (2:00pm) - Morphine 2.5 mg IVP for NRS (numerical pain rate score) 7 out of 10; refer to EMAR;

11/09/12 at 1410 (2:10pm) - Morphine 2.5 mg IVP for NRS 6 out of 10; refer to EMAR.

In a face-to-face interview on 11/14/12 at 11:20am, RN S60 indicated that she usually waited 5 minutes, and after evaluating the patient's pain level, she would administer the second dose of the pain medication if the pain assessment indicated a need for medication. After reviewing the medical record, S60 indicated that she administered 2.5 mg Morphine at 2:00pm and administered another 2.5 mg of Morphine 10 minutes later. S60 confirmed that there was no physician order for the time interval between doses of Morphine, and there was no clarification order obtained to specify the time interval to wait before administering additional doses of Morphine.

Patient #32

Review of Patient #32's medical record revealed that he was a [AGE] year old male who had an implant removal from the left clavicle, left distal tibia, and left lateral malleolus on 11/08/12.

Review of his Anesthesia PACU Orders revealed a verbal order was received on 11/08/12 at 8:36am by RN S34 to administer Dilaudid 0.5 mg IVP as needed for pain and may repeat to a maximum dose of 2 mg IVP and to administer Phenergan 6.25 mg IVP as needed for nausea and may repeat to a maximum dose of 12.5 mg IVP.

Further review revealed a verbal order was received by RN S62 (no documented evidence of the date or time that the order was received) to administer additional Phenergan in 6.25 mg IVP increments up to a total of another 12.5 mg. There was no documented evidence that the time interval to wait between doses had been addressed in either order, and there was no documented evidence of clarification of the verbal orders.

Review of Patient #32's Physician's Orders revealed a verbal order received by RN S33 on 11/08/12 at 12:30pm to administer Morphine Sulfate 2 mg IVP and titrate up to 10 mg for pain relief. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

Review of Patient #32's eMAR revealed he received 2 mg of Dilaudid on 11/08/12 at 9:19am and Morphine Sulfate 10 mg on 11/08/12 at 12:36pm. Review of the notes added to the eMAR revealed RN S34 administered Dilaudid 0.5 mg IVP on 11/08/12 at 9:19am for a pain score of 10, Dilaudid 0.5 mg IVP at 9:40am for a pain score of 10 out of 10, Dilaudid 0.5 mg IVP at 9:50am for pain of 7 out of 10, and Dilaudid 0.5 mg IVP at 10:15am for pain of 9.5 out of 10.

Review of Patient #32's Phase II Notes revealed RN S33 documented on 11/08/12 at 12:40pm Morphine Sulfate 2 mg IVP titrated Q (every) 5-10 minutes over 20 minutes to total 10 mg given as ordered. Further review revealed no documented evidence of the specific amount and the time that each dose of Morphine was administered.

In a face-to-face interview on 11/14/12 at 10:30am, RN S33 indicated that she called the anesthesiologist who gave her the order to administer Morphine. She further indicated that she did not document each time that she administered a dose of Morphine, but she gave 2 mg of Morphine every 5 to 10 minutes. S33 confirmed that there was no physician's order for the time interval to wait before administering each subsequent dose of Morphine. She indicated that she usually looks at the patient's response to the Morphine that was given and decides if additional Morphine was needed based on the patient's response.

In a face-to-face interview on 11/14/12 at 10:45am, RN S34 indicated that she reassessed a patient 5 minutes after administering pain medication IVP, asked the patient what his/her pain level was, and repeated the dose if necessary until she reached the maximum dose ordered. S34 confirmed that there was no physician order for the time interval to wait before administering additional doses of pain medication. She further indicated that the physician told the nurses to give the pain medication to the maximum dose.

Patient #33

Review of Patient #33's medical record revealed that he was a [AGE] year old male who had an excision of a scar and foreign body removal of his right cheek with a layered closure on 11/08/12.

Review of the Anesthesia PACU Orders dated 11/08/12 at 7:10am revealed an order for Morphine Sulfate as follows: a. For any pain score > (greater than) 5, or deemed intolerable by patient, give an IV bolus up to 2 to 3 mg; b. The above dose may be repeated PRN (as needed) as indicated by patient's pain score, or pain perception, for a maximum dose of up to 10 mg.

Further review revealed a verbal order was received by RN S61 (no documented evidence of the date or time that the verbal order was received) to administer Phenergan in 6.25 mg IVP increments as needed for nausea to total dose of 25 mg. There was no documented evidence that the time interval to wait between doses had been addressed in either order, and there was no documented evidence of clarification of the verbal orders.

Review of Patient #33's PACU Notes revealed an entry on 11/08/12 at 9:20am by RN S61 that she administered Morphine 3 mg IVP and Phenergan 6.25 mg IVP.

In a face-to-face interview on 11/14/12 at 2:45pm, RN S61 indicated that she decided whether to give Morphine 2 mg or 3 mg based on the patient's pain scale. She further indicated that if the pain was rated < (less than) 5, she would give 2 mg, and if the pain was rated >5, she would give 3 mg. She further indicated that she would also consider the patient's clinical picture [DIAGNOSES REDACTED]'s order for the time interval between doses of Phenergan, and that was why it said prn, in recovery it's different.

Patient #42

Review of Patient #42's medical record revealed that she was a [AGE] year old female who had a surgical procedure on 11/13/12.

Review of her Anesthesia PACU Orders revealed a verbal order was received by RN S34 on 11/13/12 at 10:38am to administer Dilaudid 0.5 mg IVP as needed for pain and may repeat to a maximum dose of 2 mg IVP.

Review of the Physician's Order Form (post op minor surgery orders) dated 11/13/12 (no documented evidence of the time the order was written and signed) revealed an order for Dilaudid 2 to 4 mg IM (intramuscular) every 3 hours as needed for pain and Percocet 5/325 1 or 2 by mouth every 3 hours as needed for pain. There was no documented evidence regarding what would determine if the nurse was to give the medication IM or orally. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

In a face-to-face interview on 11/13/12 at 11:10am, RN S34 indicated that the medication orders for Dilaudid were range orders and did not include an order for the time interval between doses.

In a face-to-face interview on 11/14/12 at 9:50am, Anesthesiologist S52 confirmed that the medication orders needed to be more specific and not open-ended.

In a face-to-face interview on 11/15/12 at 10:10am, Director of Pharmacy S32 indicated that the hospital policy allowed for a range in either dose or frequency but not both. She further indicated that it had been difficult for her to get policies for medication administration changed to require specific dose and frequency due to hospital politics. S32 confirmed that a nurse administering pain medication without a specific dose and time interval between doses ordered by the physician was practicing outside their scope of practice.

Review of the hospital policy titled Medication Administration: Pain Management/Anxiolytics, policy number NSG 4.15e, effective 08/16/11, and presented by Vice-President (VP) of Nursing S15 (at the off-site campus) as the current policy, revealed, in part, ...E. The order must state the drug name, dosage strength, and form, route of administration and frequency. ...

Procedure: A. Medication Administration

1. Range orders are acceptable, but should be limited to one variable within the order (i.e [that is] Morphine 2-4 mg IM every 4 hours PRN for pain or Morphine 4 mg IM every 4-6 hours PRN for pain.)

2. All nursing decisions when choosing dose ranges, routes, ordered drug types (i.e. Percocet PO and Morphine IV) and time intervals are made utilizing the parameters of the pain score as a guide...

Review of the hospital policy titled Written-New Physician Orders, policy number PH-92, revised 05/12, and presented as a current policy by Vice-President of Nursing S15 at the off-site campus, revealed, in part, ...Medication orders must clearly state the time interval between doses...

2) The hospital failed to ensure nursing staff clarified medication orders for completeness before administering medications with no specified route: Patient #1

Record review revealed Patient #1 was a female infant born on 8/26/12 and admitted on [DATE] for VSD (Ventricular Septal Defect), PDA ([DIAGNOSES REDACTED]) and PFO (Patent Foramen Ovale) closures, repair of [DIAGNOSES REDACTED] arch and end to end anastomosis of coarctation. Review of the Physician's Orders for Patient #1 revealed the following incomplete medication orders:

11/6/12 at 0600 (a.m.) - Vecuronium 0.4 (0.1 mg/kg) x 1 stat (immediately). (No route had been indicated by the physician).

11/6/12 at 1700 (5:00p.m.) - Clarification: Morphine 0.4 mg (milligram) (0.1 mg/kg/dose) q (every) 4 hours prn (as needed) pain. (No route had been indicated by the physician).

11/7/12 at 11:00 a.m. - Albumin 1 gm/kg (gram/kilogram) of 25% over 4 hours. (No route had been indicated by the physician).

Review of the medical record for Patient #1 revealed no clarification orders from the physician by the pharmacy or nursing staff for the routes of the above mentioned medications.

Review of the Medication Orders History w/ (with) Administrations record for Patient #1 revealed the pharmacy had indicated the routes of the above mentioned medications as IV (intravenous). The medications were all listed as having been administered IV.

In a face-to-face interview on 11/7/12 at 3:30 p.m. with PICU (Pediatric Intensive Care Unit) Manager S22, she verified the above mentioned medications for Patient #1 had been ordered without a route by the physician. S22 also verified although no clarification order was in the Patient #1 ' s chart, the medication administration record had a route of intravenous listed. S22 said if a medication order was incomplete, the pharmacy or nursing staff should have called the physician to clarify the route and placed a telephone order from the physician in the medical record.

In a face-to-face interview with CMO (Chief Medical Officer) S3, he verified the above mentioned medication orders for Patient #1 were incomplete because they did not include a route of administration.

In a face-to-face interview on 11/7/12 at 4:10 p.m. with Pharmacist S25, she said if a medication order was incomplete, the physician should have been notified and a telephone order with the clarification should have been placed in the patient ' s medical record. After reviewing the medical record for Patient #1, S25 verified the Vecuronium ordered on [DATE] at 6:00 a.m., the Morphine ordered on [DATE] at 1600, and the Albumin ordered on [DATE] at 11:00 a.m. had no route indicated on the physician's orders.

Patient #2 Medical record review for Patient #2 revealed she was a 5 year old female admitted on [DATE] following a MVA (motor vehicle accident). Further review revealed an incomplete physician's order for the following medication:

11/5/12 at 0620 (a.m.) - 250 ml (milliliter) NS (Normal Saline) bolus x 1 now. (No route had been indicated by the physician).

Review of the medication administration record for Patient #2 revealed the above mentioned Normal Saline Bolus had the route listed as intravenous. No clarification order by the physician for the correct route of administration was located in the medical record for Patient #2.

In a face-to-face interview on 11/7/12 at 4:15 p.m. with Pharmacist S25, she verified no clarification for the route of administration by the physician for the Normal Saline Bolus ordered on [DATE] at 6:20 a.m. could be located on Patient #2 ' s medical record. S25 also verified the normal saline had been administered by the nursing staff intravenously.

Patient #21 Review of the medical record for patient #21 reflected the patient was admitted on [DATE].

Further review reflected the patient had a diagnosis of [DIAGNOSES REDACTED][by mouth]. There was no documentation to reflect the frequency of the medication ordered. There was also no documentation to reflect a clarification order to include the frequency of the medication ordered.

Interview with S5, PI Coordinator confirmed there was no frequency noted on the physician order. S5 further confirmed the eMAR reflected the medication was ordered daily.

Patient # 41

Review of the medical record for Patient #41 revealed she was a female infant born on 10/31/12 admitted to the hospital for prematurity and possible sepsis. Further review of the Physician's Orders revealed the following incomplete medication orders:

10/11/12 at 0400 (a.m.) - Vitamin K 1 mg IM (intramuscular) or IV (intravenous). (No route had been circled by the physician to indicate the route).

10/14/12 at 11:05 a.m. - Normal Saline 12cc over 1 hour. (No route had been indicated by the physician).

Review of the medical record for Patient #41 revealed no clarification orders from the physician by the pharmacy or nursing staff for the routes of the Vitamin K ordered 10/11/12 at 4:00 a.m. or the Normal Saline ordered 10/14/12 at 11:05 a.m. Further review of the medical records revealed the pharmacy listed the route of the above mentioned medications for Patient #41 as intravenous on the medication administration record.

In a face-to-face interview on 11/8/12 at 1:45 p.m. with the Director of Women's and Children's services S28, she verified the above mentioned Vitamin K and Normal Saline ordered for Patient #41 did not include a route by the physician. S28 said the route indicated by the physician for the Vitamin K ordered on [DATE] at 4:00 a.m. should have been circled by the physician to indicate IM or IV. S28 also verified the pharmacy listed the routes of administration of the above mentioned medications as intravenous although no clarification of the orders could be located. S28 stated the physician was the only person who could order the routes of administration, not the pharmacy or nurses. S28 said it was not in a nurse's scope of practice to choose a medication route.

In a face-to-face interview on 11/8/12 at 3:25 p.m. with Pharmacist S30, he verified the Vitamin K ordered on [DATE] at 4:00 a.m. and the Normal Saline ordered on [DATE] at 11:05 a.m. did not have a route indicated by the physician. S30 also verified the orders for the Vitamin K and Normal Saline had not been clarified with the physician before a route was placed on the Medication Administration Record by the pharmacist and the medications administered by the nursing staff.

In a face-to-face interview on 11/9/12 at 9:00 a.m. with the Director of Pharmacy S32, she verified a complete physician ' s order would have included the medication name, the dose, the route, the duration, the frequency, any special instructions, and the physician's signature. S32 said if any of those items were missing from the order, it was incomplete and needed to be clarified.

Review of the hospital policy titled Medication Administration General, Policy No: NSG 4.15, revised 06/12 revealed in part:

B. All MARs (medication Administration Records) and electronic MARs will be checked against the physician orders ...

Procedure: A. Administration/Orders

1. Medications will be given as ordered by the authorized prescribing practitioner. When a concern about a medication, a dosage, and/or a route of administration the caregiver is to obtain clarification from the ordering practitioner.

2. The order must state the drug name, dosage strength and form, route of administration, and frequency.

3) The hospital failed to ensure nursing staff administered medications as ordered by the physician:

Patient #43

Review of Patient #43's medical record revealed that she was a [AGE] year old female admitted on [DATE] to the rehabilitation unit with a diagnosis of [DIAGNOSES REDACTED]

Review of the Physician's Order dated 11/06/12 at 1:00 p.m. revealed an order to transfuse 2 units of packed red blood cells each over 3-4 hours, and Lasix 40 mg. IV (Intravenous) after first unit of blood has been transfused. The physician's orders also revealed an order dated/timed 11/06/12 at 4:00 p.m. to transfuse blood when ready.

Review of Patient #43's medical record revealed that Unit #1 began at 1829 (6:29 p.m.) and was started by S48RN. Review of the nursing documentation and the BCTA (Bar-coded Transfusion Administration in Meditech) system revealed no documented evidence of when the first unit was competed. Further review of the record revealed Unit #2 began at 2310 (11:10 p.m.). Review of the medication administration record revealed the Lasix was administered on 11/07/12 at 12:43 a.m., 1 hour and 33 minutes after the second unit was started.

In a face-to-face interview on 11/13/12 at 11:00 a.m. S48RN stated she was the RN that started the first unit of blood on 11/06/12 at 6:29 p.m. S48 stated she was off duty at 7:00 p.m. and did not complete the transfusion process. After reviewing the BCTA system, she verified the completion time for both units had not been entered into the system. S48 verified the second unit of blood was started on 11/06/12 at 11:10 p.m. After reviewing the physician orders and the medication administration record, S48 verified the Lasix was not administered as ordered because it was administered 1 hour and 33 minutes after the second unit of blood was started, instead of after the first unit was completed.

Review of the hospital policy titled Medication Administration General, Policy No: NSG 4.15, revised 06/12 revealed in part:

B. All MARs (medication Administration Records) and electronic MARs will be checked against the physician orders....

Procedure: A. Administration/Orders

1. Medications will be given as ordered by the authorized prescribing practitioner....

Based on observations, interviews, and records review, the hospital failed to ensure that medical records were properly secured as evidenced by the hospital storing medical records on open shelving with no protection from water damage if the sprinkler system had been activated for 40,867 medical records at the off-site campus and 98,264 medical records at the main campus.

Findings:

An observation was made on 11/9/12 at 1:25 p.m. of the medical record department at the off-site campus. A sprinkler system was noted to be in the ceiling. There were 22 rows of shelves, which were 7 shelves high and approximately 9 feet deep that contained medical records. The shelves were open with no protection from water damage if the sprinkler system had been activated. Further observation revealed 10 open shelving units containing medical records.

In an interview on 11/9/12 at 1:35 p.m. with the off- site Manager of the Medical Records Department (S40), she said the medical record room at the off-site campus contained discharged patient records from 2011 to the present. She stated the records on the open shelving units had not been scanned into the computer and they were the only copies. When asked what she would do to protect the medical records if a fire broke out in the facility, S40 said she would evacuate the people. She said the facility had no policies for protection of medical records from water damage.

In an observation on 11/14/12 at 10:00 a.m. of the medical records department at the main campus, medical records were stored on open shelving units throughout the room. A sprinkler system was noted to be in the ceiling.

In an interview on 11/14/12 at 10:05 a.m. with the Director of Medical Records (S41), she stated the medical records department at the main campus contained discharged patient records from 2011 to the present. She verified there were no other copies of the medical records. S41 also stated the hospital had no system to protect the medical records from water damage if the sprinkler system had been activated.

Review of a document presented by the Director of Medical Records (S41) revealed the off-site campus contained approximately 40, 867 medical records on open shelving which was not protected from water damage if the sprinkler system had been activated. The main campus contained approximately 98, 264 medical records on open shelving which were not protected from water damage if the sprinkler system had been activated.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, records review, and interviews, the hospital failed to ensure that the pharmacy was administered according to hospital policies and accepted professional principles.

1) The hospital failed to develop and implement a system to ensure that physician orders for medications included a specific dose and frequency with the specific instructions for use as evidenced by having a hospital policy that allowed medication ranges to be ordered. This resulted in physician orders for medications with ranges in dose and no order for frequency between repeated dosing for 4 of 6 patients' records reviewed who had a surgical procedure (#31, #32, #33, #42) and for 1 of 6 Medical - Surgical records reviewed (#23) from a total of 44 sampled patients.

2) The hospital failed to maintain the PAR (number of vials to be maintained at all times) level of Dantrolene in the pharmacy at the off-site campus as required by hospital policy and to ensure that required items on the [DIAGNOSES REDACTED] Cart were not expired and available for patient use. The hospital pharmacy had 19 vials of Dantrolene available while the hospital policy required that 30 vials of dantrolene be maintained in the pharmacy at all times. The cart had expired lab collection tubes and an expired pediatric central venous catheter kit.

3) The hospital pharmacy failed to ensure medication orders were accurate and complete before creating medication administration records and dispensing medications for 4 ( #1, #2, #21, #41) of 44 sampled patients.

Findings:

1) Develop and implement a system to ensure that physician orders for medications included a specific dose and frequency with the specific instructions for use:

Patient #23

Review of the medical record for patient #23 reflected the patient was a [AGE] year old male who had diagnoses that include [DIAGNOSES REDACTED].

There was no documentation in the record to reflect a clarification order regarding the specific dose of medication to be administered. Interview with S19, Director of the Medical/Surgical unit on 11/14/12 at approximately 9:15 a.m. confirmed the above finding. S19 revealed the hospital was currently working on the policy for range orders.

Patient #31

Review of Patient #31's medical record revealed that she was a [AGE] year old female who had a Laparoscopic Cholecystectomy on 11/09/12. Review of her Anesthesia PACU (post anesthesia care unit) Orders revealed a verbal order was received by RN (registered nurse) S60 on 11/09/12 at 1350 (1:50pm) to give Morphine 2 to 3 mg (milligrams) IVP (intravenous push) as needed for pain to a maximum dose of 10 mg. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

Review of the e-MAR (electronic medication administration record) revealed that RN S60 administered Morphine 5 mg to Patient #31 on 11/09/12 at 1356 (1:56pm). Review of the PACU Notes revealed the following documentation by RN S60:

11/09/12 at 1400 (2:00pm) - Morphine 2.5 mg IVP for NRS (numerical pain rate score) 7 out of 10; refer to EMAR;

11/09/12 at 1410 (2:10pm) - Morphine 2.5 mg IVP for NRS 6 out of 10; refer to EMAR.

In a face-to-face interview on 11/14/12 at 11:20am, RN S60 indicated that she usually waited 5 minutes, and after evaluating the patient's pain level, she would administer the second dose of the pain medication if the pain assessment indicated a need for medication.

After reviewing the medical record, S60 indicated that she administered 2.5 mg Morphine at 2:00pm and administered another 2.5 mg of Morphine 10 minutes later. S60 confirmed that there was no physician order for the time interval between doses of Morphine, and there was no clarification order obtained to specify the time interval to wait before administering additional doses of Morphine.

Patient #32

Review of Patient #32's medical record revealed that he was a [AGE] year old male who had an implant removal from the left clavicle, left distal tibia, and left lateral malleolus on 11/08/12. Review of his Anesthesia PACU Orders revealed a verbal order was received on 11/08/12 at 8:36am by RN S34 to administer Dilaudid 0.5 mg IVP as needed for pain and may repeat to a maximum dose of 2 mg IVP and to administer Phenergan 6.25 mg IVP as needed for nausea and may repeat to a maximum dose of 12.5 mg IVP. Further review revealed a verbal order was received by RN S62 (no documented evidence of the date or time that the order was received) to administer additional Phenergan in 6.25 mg IVP increments up to a total of another 12.5 mg. There was no documented evidence that the time interval to wait between doses had been addressed in either order, and there was no documented evidence of clarification of the verbal orders.

Review of Patient #32's Physician's Orders revealed a verbal order received by RN S33 on 11/08/12 at 12:30pm to administer Morphine Sulfate 2 mg IVP and titrate up to 10 mg for pain relief. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

Review of Patient #32's eMAR revealed he received 2 mg of Dilaudid on 11/08/12 at 9:19am and Morphine Sulfate 10 mg on 11/08/12 at 12:36pm. Review of the notes added to the eMAR revealed RN S34 administered Dilaudid 0.5 mg IVP on 11/08/12 at 9:19am for a pain score of 10, Dilaudid 0.5 mg IVP at 9:40am for a pain score of 10 out of 10, Dilaudid 0.5 mg IVP at 9:50am for pain of 7 out of 10, and Dilaudid 0.5 mg IVP at 10:15am for pain of 9.5 out of 10.

Review of Patient #32's Phase II Notes revealed RN S33 documented on 11/08/12 at 12:40pm Morphine Sulfate 2 mg IVP titrated Q (every) 5-10 minutes over 20 minutes to total 10 mg given as ordered. Further review revealed no documented evidence of the specific amount and the time that each dose of Morphine was administered.

In a face-to-face interview on 11/14/12 at 10:30am, RN S33 indicated that she called the anesthesiologist who gave her the order to administer Morphine. She further indicated that she did not document each time that she administered a dose of Morphine, but she gave 2 mg of Morphine every 5 to 10 minutes. S33 confirmed that there was no physician's order for the time interval to wait before administering each subsequent dose of Morphine. She indicated that she usually looks at the patient's response to the Morphine that was given and decides if additional Morphine was needed based on the patient's response.

In a face-to-face interview on 11/14/12 at 10:45am, RN S34 indicated that she reassessed a patient 5 minutes after administering pain medication IVP, asked the patient what his/her pain level was, and repeated the dose if necessary until she reached the maximum dose ordered. S34 confirmed that there was no physician order for the time interval to wait before administering additional doses of pain medication. She further indicated that the physician told the nurses to give the pain medication to the maximum dose.

Patient #33

Review of Patient #33's medical record revealed that he was a [AGE] year old male who had an excision of a scar and foreign body removal of his right cheek with a layered closure on 11/08/12. Review of the Anesthesia PACU Orders dated 11/08/12 at 7:10am revealed an order for Morphine Sulfate as follows: a. For any pain score > (greater than) 5, or deemed intolerable by patient, give an IV bolus up to 2 to 3 mg; b. The above dose may be repeated PRN (as needed) as indicated by patient's pain score, or pain perception, for a maximum dose of up to 10 mg. Further review revealed a verbal order was received by RN S61 (no documented evidence of the date or time that the verbal order was received) to administer Phenergan in 6.25 mg IVP increments as needed for nausea to total dose of 25 mg.

Review of Patient #33's PACU Notes revealed an entry on 11/08/12 at 9:20am by RN S61 that she administered Morphine 3 mg IVP and Phenergan 6.25 mg IVP.

In a face-to-face interview on 11/14/12 at 2:45pm, RN S61 indicated that she decided whether to give Morphine 2 mg or 3 mg based on the patient's pain scale. She further indicated that if the pain was rated < (less than) 5, she would give 2 mg, and if the pain was rated >5, she would give 3 mg. She further indicated that she would also consider the patient's clinical picture [DIAGNOSES REDACTED]'s order for the time interval between doses of Phenergan, and that was why it said prn, in recovery it's different.

Patient #42

Review of Patient #42's medical record revealed that she was a [AGE] year old female who had a surgical procedure on 11/13/12. Review of her Anesthesia PACU Orders revealed a verbal order was received by RN S34 on 11/13/12 at 10:38am to administer Dilaudid 0.5 mg IVP as needed for pain and may repeat to a maximum dose of 2 mg IVP. Review of the Physician's Order Form (post op minor surgery orders) dated 11/13/12 (no documented evidence of the time the order was written and signed) revealed an order for Dilaudid 2 to 4 mg IM (intramuscular) every 3 hours as needed for pain and Percocet 5/325 1 or 2 by mouth every 3 hours as needed for pain. There was no documented evidence regarding what would determine if the nurse was to give the medication IM or orally. There was no documented evidence that the time interval to wait between doses had been addressed in the order, and there was no documented evidence of a clarification order.

In a face-to-face interview on 11/13/12 at 11:10am, RN S34 indicated that the medication orders for Dialudid were range orders and did not include an order for the time interval between doses.

In a face-to-face interview on 11/14/12 at 9:50am, Anesthesiologist S52 confirmed that the medication orders needed to be more specific and not open-ended.

In a face-to-face interview on 11/15/12 at 10:10am, Director of Pharmacy S32 indicated that the hospital policy allowed for a range in either dose or frequency but not both. She further indicated that it had been difficult for her to get policies for medication administration changed to require specific dose and frequency due to hospital politics. S32 confirmed that a nurse administering pain medication without a specific dose and time interval between doses ordered by the physician was practicing outside their scope of practice.

Review of the hospital policy titled Medication Administration: Pain Management/Anxiolytics, policy number NSG 4.15e, effective 08/16/11, and presented by Vice-President (VP) of Nursing S15 (at the off-site campus) as the current policy, revealed, in part, ...E. The order must state the drug name, dosage strength, and form, route of administration and frequency. ... Procedure: A. Medication Administration 1. Range orders are acceptable, but should be limited to one variable within the order (i.e [that is] Morphine 2-4 mg IM every 4 hours PRN for pain or Morphine 4 mg IM every 4-6 hours PRN for pain.) 2. All nursing decisions when choosing dose ranges, routes, ordered drug types (i.e. Percocet PO and Morphine IV) and time intervals are made utilizing the parameters of the pain score as a guide...

Review of the hospital policy titled Written-New Physician Orders, policy number PH-92, revised 05/12, and presented as a current policy by Vice-President of Nursing S15 at the off-site campus, revealed, in part, ...Medication orders must clearly state the time interval between doses...

2) [DIAGNOSES REDACTED] Cart:

Observation of the [DIAGNOSES REDACTED] Cart in the operating suite of the off-site campus on 11/13/12 at 10:00am revealed there were 12 vials of Dantrolene 20 mg. Further observation revealed there were 2 red top lab tubes (8.5 milliliters) and 2 green top lab tubes (3.0 milliliters) that had expired on ,d+[DATE]. Further observation revealed that one pediatric 2 lumen central venous catheter kit had expired on ,d+[DATE].

Observation of the [DIAGNOSES REDACTED] Check List for June 2012, July 2012, August 2012, September 2012, October 2012, and through 11/13/12 revealed that drawers 1, 2, 3, and 4 were initialed as stocked per policy.

In a face-to-face interview on 11/13/12 at 10:00am, RN Surgery Manager S65 indicated, after speaking with Pharmacist S30 at the off-site campus, that the pharmacy at the off-site campus had 19 vials of Dantrolene, rather than 30 vials as required by hospital policy.

In a face-to-face interview on 11/13/12 at 10:35am, Pharmacist S30 indicated that he had 19 vials of Dantrolene in the pharmacy. He further indicated, after reviewing the hospital policy, that he would take 6 vials of Dantrolene from the surgery [DIAGNOSES REDACTED] cart (policy required 6 vials to be kept on the individual cart) to make a total of 25 vials for the pharmacy. S30 indicated that he did not know that the hospital policy required that he have 30 vials of Dantrolene in the pharmacy at all times.

In a face-to-face interview on 11/13/12 at 10:00am, RN S66, Clinical Supervisor of Surgery at the off-site campus, confirmed that the blood tubes and pediatric central venous catheter kit were expired. He indicated that it was the responsibility of the anesthesia department to check the cart for expired items.

In a face-to-face interview on 11/13/12 at 2:20pm, Vice-President of Operations S27 indicated that the pharmacy policy was a system policy, and each pharmacy had to follow it regarding the maintenance of the PAR level of medications (meaning that the PAR level for Dantrolene had to be maintained at 30 vials in each pharmacy).

Review of the hospital policy titled [DIAGNOSES REDACTED], policy number NSG 4.19, reviewed 11/11, and presented by RN S66, Clinical Supervisor of Surgery at the off-site campus, as the current policy, revealed, in part, ...30 vials minimum of Dantrolene sodium will be stocked in the pharmacy at all times and 6 kept on each MH ([DIAGNOSES REDACTED]) cart... Review of page 8 of 8 of the policy revealed the [DIAGNOSES REDACTED] cart inventory list that revealed the following: drawer one was to include 6 red blood tubes and 4 green blood tubes; drawer two was to include a radial artery catheterization set 20 gauge and a radial artery catheterization set 22 gauge. Further review revealed a reference used for the policy was the AORN (association of operative registered nurses) Standards and recommended Practices, 2006.

Review of the AORN's Perioperative Standards and Recommended Practices, 2009 Edition, revealed that 36 vials of Dantrolene sodium 20 mg should be kept on the [DIAGNOSES REDACTED] cart.

3) The hospital pharmacy failed to ensure medication orders were accurate and complete before creating medication administration records and dispensing medications.

Patient #1 Record review revealed Patient #1 was a female infant born on 8/26/12 and admitted on [DATE] for VSD (Ventricular Septal Defect), PDA ([DIAGNOSES REDACTED]) and PFO (Patent Foramen Ovale) closures, repair of [DIAGNOSES REDACTED] arch and end to end anastomosis of coarctation. Review of the Physician ' s Orders for Patient #1 revealed the following incomplete medication orders:

11/6/12 at 0600 (a.m.) - Vecuronium 0.4 (0.1 mg/kg) x 1 stat (immediately). (No route had been indicated by the physician).

11/6/12 at 1700 (5:00p.m.) - Clarification: Morphine 0.4 mg (milligram) (0.1 mg/kg/dose) q (every) 4 hours prn (as needed) pain. (No route had been indicated by the physician).

11/7/12 at 11:00 a.m. - Albumin 1 gm/kg (gram/kilogram) of 25% over 4 hours. (No route had been indicated by the physician).

Review of the medical record for Patient #1 revealed no clarification orders from the physician by the pharmacy or nursing staff for the routes of the above mentioned medications.

Review of the Medication Orders History w/ (with) Administrations record for Patient #1 revealed the pharmacy had indicated the routes of the above mentioned medications as IV (intravenous). The medications were all listed as having been administered IV.

In a face-to-face interview on 11/7/12 at 3:30 p.m. with PICU (Pediatric Intensive Care Unit) Manager S22, she verified the above mentioned medications for Patient #1 had been ordered without a route by the physician. S22 also verified although no clarification order was in the Patient #1's chart, the medication administration record had a route of intravenous listed. S22 said if a medication order was incomplete, the pharmacy should have called the physician to clarify the route and placed a telephone order from the physician in the medical record.

In a face-to-face interview with CMO (Chief Medical Officer) S3, he verified the above mentioned medication orders for Patient #1 were incomplete because they did not include a route of administration.

In a face-to-face interview on 11/7/12 at 4:10 p.m. with Pharmacist S25, she said if a medication order was incomplete, the physician should have been notified and a telephone order with the clarification should have been placed in the patient's medical record. After reviewing the medical record for Patient #1, S25 verified the Vecuronium ordered on [DATE] at 6:00 a.m., the Morphine ordered on [DATE] at 1600, and the Albumin ordered on [DATE] at 11:00 a.m. had no route indicated on the physician's orders. S25 also verified no clarification of the orders had been done by the pharmacy. S25 stated she must have just assumed what the route should have been when making the medication administration record. S25 said no clarifying the routes was an error by the pharmacy.

Patient #2 Medical record review for Patient #2 revealed she was a 5 year old female admitted on [DATE] following a MVA (motor vehicle accident). Further review revealed an incomplete physician's order for the following medication:

11/5/12 at 0620 (a.m.) - 250 ml (milliliter) NS (Normal Saline) bolus x 1 now. (No route had been indicated by the physician).

Review of the medication administration record for Patient #2 revealed the above mentioned Normal Saline Bolus had the route listed as intravenous. No clarification order by the physician for the correct route of administration was located in the medical record for Patient #2.

In a face-to-face interview on 11/7/12 at 4:15 p.m. with Pharmacist S25, she verified no clarification for the route of administration by the physician could be located, but the route on the medication record for the NS ordered on [DATE] at 6:20 a.m. had been listed by the pharmacist as intravenous. S25 said listing the route without clarification was a mistake by the pharmacy.

Patient #21 Review of the medical record for patient #21 reflected the patient was admitted on [DATE]. Further review reflected the patient had a diagnosis of [DIAGNOSES REDACTED][by mouth]. There was no documentation to reflect the frequency of the medication ordered. There was also no documentation to reflect a clarification order to include the frequency of the medication ordered.

Interview with S5, PI Coordinator confirmed there was no frequency noted on the physician order. S5 further confirmed the eMAR reflected the medication was ordered daily.

Patient # 41 Review of the medical record for Patient #41 revealed she was a female infant born on 10/31/12 admitted to the hospital for prematurity and possible sepsis. Further review of the Physician's Orders revealed the following incomplete medication orders:

10/11/12 at 0400 (a.m.) - Vitamin K 1 mg IM (intramuscular) or IV (intravenous). (No route had been circled by the physician to indicate the route).

10/14/12 at 11:05 a.m. - Normal Saline 12cc over 1 hour. (No route had been indicated by the physician).

Review of the medical record for Patient #41 revealed no clarification orders from the physician by the pharmacy or nursing staff for the routes of the Vitamin K ordered on [DATE] at 4:00 a.m. or the Normal Saline ordered on [DATE] at 11:05 a.m. Further review of the medical records revealed the pharmacy listed the route of the above mentioned medications for Patient #41 as intravenous on the medication administration record.

In a face-to-face interview on 11/8/12 at 1:45 p.m. with the Director of Women's and Children's Services S28, she verified the above mentioned Vitamin K and Normal Saline ordered for Patient #41 did not include a route by the physician. S28 said the route indicated by the physician for the Vitamin K ordered on [DATE] at 4:00 a.m. should have been circled by the physician to indicate IM or IV. S28 also verified the pharmacy listed the routes of administration of the above mentioned medications as intravenous although no clarification of the orders could be located. S28 stated the physician was the only person who could order the routes of administration, not the pharmacy or nurses.

In a face-to-face interview on 11/8/12 at 3:25 p.m. with Pharmacist S30, he verified the Vitamin K ordered on [DATE] at 4:00 a.m. and the Normal Saline ordered on [DATE] at 11:05 a.m. did not have a route indicated by the physician. S30 also verified the orders for the Vitamin K and Normal Saline had not been clarified with the physician before a route was placed on the Medication Administration Record by the pharmacist and the medications administered by the nursing staff. S30 stated, The indication of the route of the medications was our error by the pharmacy because the pharmacists cannot order medication routes.

In a face-to-face interview on 11/9/12 at 9:00 a.m. with the Director of Pharmacy S32, she verified a complete physician's order would have included the medication name, the dose, the route, the duration, the frequency, any special instructions, and the physician's signature. S32 said if any of those items were missing from the order, it was incomplete and needed to be clarified. She said once the order had been clarified, a yellow/green sticker was placed into the patient's chart by the pharmacist with a telephone order for the physician to sign. S32 said the pharmacists were out of their scope of practice by assuming the route of medications when it was not indicated.

Review of the hospital policy titled Clarification of Orders, Policy No: PH-49, revised 05/12 revealed in part:

Policy - Orders that are incomplete, illegible, or otherwise unclear shall not be filled and shall be verified or clarified prior to dispensing.

Clarification of Drug Orders - If there is any question regarding a drug prescribed, dose, or strength (e.g. very high or very low), administration frequency, or dosage interval, a nurse or pharmacist shall contact the prescriber. Questionable orders shall be clarified prior to dispensing the medication.

Changes in Drug Orders - All changes in drug orders require the approval of an authorized prescriber.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records review and interviews, the hospital failed to ensure verbal orders were authenticated within 48 hours as per the hospital's policy and procedure for verbal orders for 5 of 38 records reviewed for physician signing and dating of verbal orders from a total sample of 44 patients (#6, #7, #8, #32, #33). Findings:

Review of the hospital's current policy and procedure dated July 16, 2012 and titled, VERBAL & TELEPHONE ORDERS reflected ....7. All verbal orders shall be signed within 48 hours......8. Physician signatures authenticating the verbal order must include the date and time the order was signed.....

Patient #6

Review of the medical record for patient #6 reflected telephone/verbal orders dated 10/31/12 at 0727 (7:27 a.m.) 10/31/12 at 2040 (8:40 p.m.); 10/31/12 at 2238 (10:38 p.m) and 11/5/12 at 8:30 p.m; Further review reflected the orders had not been authenticated, dated or timed by the physician/provider who had given the verbal order.

Patient #7

Review of the medical record for patient #7 reflected Telephone/Verbal orders dated 11/2/12 at 1020 (10:20 a.m.); 11/4/12 at 2213 (10:13 p.m.); 11/5/12 at 0500 (5:00 a.m.)and 11/5/12 at 0537 (5:37 a.m.). Further review reflected there was time noted to reflected when the orders were authenticated by the physician.

Patient #8

Review of the medical record for patient #8 reflected telephone/verbal orders dated 11/3/12 at 1146 (11:46 a.m.); 11/3/12 at 2035 (8:35 p.m.) and 11/4/12 at 1935 (7:35 p.m.). Further review reflected there was no date, time and/or physician's signature noted to reflect authentication of the orders by the ordering practitioner.

Patient #32

Review of Patient #32's medical record revealed that he was [AGE] year old male who had an implant removal from both the left clavicle and left leg, distal tibia, and lateral malleolus on 11/08/12. Review of the Anesthesia PACU (post anesthesia care unit) Orders revealed a verbal order was received on 11/08/12 at 8:36am for the administration of Dilaudid and Phenergan. There was no documented evidence that the verbal order had been signed by the physician within 48 hours as required by hospital policy (chart reviewed on 11/13/12). Further review revealed a verbal order was received by RN (registered nurse) S62 with no documented evidence of the date and time the order was received. There was no documented evidence that this verbal order had been signed by the physician as of 11/13/12 when the chart was reviewed.

Review of Patient #32's Physician's Order revealed a verbal order was received on 11/07/12 at 10:25am to cancel Ancef 1 gram intravenously and administer Ancef 2 grams intravenously on call to the operating room. There was no documented evidence that the verbal order had been signed by the physician within 48 hours as required by hospital policy (chart reviewed on 11/13/12). Further review revealed a verbal order was received on 11/08/12 at 12:30pm for Morphine Sulfate 2 mg to be administered intravenously up to 10 mg for pain relief. There was no documented evidence that the verbal order had been signed by the physician within 48 hours as required by hospital policy (chart reviewed on 11/13/12). Further review revealed a verbal order was received on 11/08/12 at 11:05am for Vicodin ES (extra strength) one tablet now for pain. There was no documented evidence that the verbal order had been signed by the physician within 48 hours as required by hospital policy (chart reviewed on 11/13/12).

Patient #33

Review of Patient #33's medical record revealed that he was a [AGE] year old male who had an excision of a scar and foreign body removal of his right cheek with a layered closure on 11/08/12. Review of the Anesthesia PACU Orders revealed a verbal order was received with no documented evidence of the date or time that the order was received for Phenergan to be administered for nausea. There was no documented evidence that this verbal order had been signed by the physician as of 11/13/12 when the chart was reviewed.

Interviews with S3, CMO and S5, PI Coordinator on 11/8/12 at approximately 10:45 a.m. revealed the current hospital's policy reflected that all verbal orders should be signed by the physician within 48 hours.

Based on record reviews and interviews, the hospital failed to provide patient safety and to control and distribute drugs and biologicals in accordance with applicable standards of practice as evidenced by not having a system in place for medication orders in non-emergency situations in the ED (Emergency Department) to be reviewed for appropriateness by a pharmacist before the first dose was dispensed. The pharmacy failed to review first dose medications in non- emergent cases in the ED for therapeutic appropriateness, therapeutic duplication, appropriateness of the drug, dose, frequency, route and method of administration, interactions, and other contraindications.

Findings:

In a face-to-face interview on 11/8/12 at 3:25 p.m. with off-site campus Pharmacist (S30), he stated that in the ED, the physician's orders are entered into the CPOE (Computerized Physician Order Entry) system. S30 said the computer only checked for allergic reactions with the patients and nothing else. S30 said if there was a drug interaction on the computer, the ED physician could override the warning. S30 said the hospital told him the pharmacist did not have to review first dose medications from the ED because the CPOE system would do it for them, but he did not know how the CPOE system worked. S30 also verified not all patients in the ED require emergency medication delivery.

In a face-to-face interview on 11/8/12 at 4:00 p.m. with Director of Patient Services in the ED (S21), she stated, It is 100% correct that every patient that comes through the ED is not an emergency case. S21 also verified that the CPOE system recommends dosages for patients, but the physician can order any dosage they wanted.

In a face-to-face interview on 11/8/12 at 4:00 p.m. with ED Physician (S31), she stated she entered medication orders for patients into the CPOE system. She verified and demonstrated on the computer how she could order any dose she wanted into the CPOE system, even if it was an incorrect dose. S31 stated the only monitoring the computer did for patient interactions was allergies. S31 also said she did not consider every case in the ED to be an emergency and all cases did not require emergency medications.

In a face-to-face interview on 11/13/12 at 8:45 a.m. with Vice President of Operations (S27), he stated the hospital did not have a policy differentiating a pharmacist performing a first dose review for ED patients versus patients in the rest of the hospital.

In a face-to-face interview on 11/13/12 at 9:00 a.m. with the Director of Pharmacy (S32), she stated she totally agreed that all cases in the ED were not emergencies and could see where not checking first dose medications was a problem. S32 stated she had been pushing for a pharmacist for the ED since she started at the hospital.

Review of the Policy titled Drug Therapy: Monitoring Effects of Drugs on Patients, Policy No: PH-44, Revised Date: 05/12 stated in part:

Review of New Orders

With the exception of emergency orders when time does not permit, a pharmacist shall review the patient's drug therapy (current drug regimen) prior to dispensing new orders for drugs to the patient.

Monitoring the Patient's Drug Regimen

Drug therapy monitoring shall include a review of the patient's drug regimen for:

-Potential interactions and contraindications.

- Allergies.

-Duplicate therapy (e.g. anti-infective, H-2 Antagonists & Proton-pump inhibitors).

- Interferences and incompatibilities.

- Unnecessary drugs.

- Excessive doses, dosage irregularities, and excessive lengths of use.

-Inadequate monitoring or lack of monitoring data.

-Absence of diagnosis or reason for the ordering of drug.

-As needed (PRN) orders administered every day.

-Other irregularities or departures from what is considered unusual or appropriate.

-Drug-Disease State Interaction of Potentiation/Reduction of Effects.

-Gender, Age, and Weight Restrictions.

Drug-Laboratory Interactions or Interferences.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, records review, and staff interviews, the hospital failed to ensure that patients under PEC (Physician Emergency Certificate) received care in a safe setting in the Emergency Department for 2 of 2 sampled PEC patients reviewed (#11, #19) from a total sample of 44 patients as evidenced by:

1) failing to implement the hospital policy titled, Suicidal Prevention Plan. The hospital failed to ensure that 1:1 (one-to-one) observation of PEC patients in the ED was performed as ordered by the physician and according to hospital policy. The RN (Registered Nurse) assigned untrained staff to monitor a PEC patient resulting in the elopement of Patient #11 from the Emergency Department (ED) on 10/13/12;

2) failing to ensure a level of observation was ordered by the physician for Patient #19 who had been PEC'd for suicidal ideations. The RN failed to assign the monitoring of Patient #19 to a staff member and relied on the patient's guardian to ensure the safety of the patient while in the ED and;

3) failing to ensure suicidal patients under PEC were provided a safe environment that did not afford the patient access to electric cords that could be a means of strangulation and plastic bags that could be a means of suffocation for Patients #11 and #19.

Findings:

1) Failing to implement the hospital policy titled, Suicidal Prevention Plan:

Patient #11

Review of Patient #11's medical record revealed the patient was a [AGE] year old male who (MDS) dated [DATE] at 1907 (7:07 p.m.) by ambulance with a chief complaint of change in mental status/neuro (Neurological) status. Review of the triage assessment at 1939 (7:39 p.m.) revealed the patient was having hallucinations and admitted to using LSD (Hallucinogenic Drug) and Ecstasy (Illegal drug with similar effects of hallucinogens and amphetamines).

Review of the Emergency Physician Record dated 10/13/12, with no time documented, revealed the chief complaint was agitated, hallucinations with onset 24 hours prior to arrival. The record revealed at 2130 (9:30 p.m.) the physician documented, Patient PEC'd on 1:1 observation, will be transferred to Psych at (main campus). Clinical Impression: Psychosis. Further review of the document revealed the following: 2230 (10:30 p.m.) Patient left room per RN. Premises searched by myself and staff. Unable to locate. Police notified. Missing person report filed.

Review of the physician's orders dated/timed 10/13/12 at 1913 (7:13 p.m.) revealed an order for Suicide Precautions and Elopement Precautions for Patient #11.

Review of the PEC dated/timed 10/13/12 at 2138 (9:38 p.m.) revealed Patient #11 was PEC'd due to being dangerous to self, gravely disabled, and unable to seek voluntary admission.

Review of the nursing documentation revealed a nursing assessment documented by S43RN at 1942 (7:42 p.m.) on 10/13/12. There was no documented evidence of suicide precautions or elopement precautions. Review of the Plan of Care developed by S43 on 10/13/12 at 1945 (7:45 p.m.) revealed no documented evidence of problems, interventions, or goals that addressed suicide precautions and elopement precautions.

Further review of the nursing documentation revealed the following:

Emergency notes - Patient with one to one observation per Medical/Nursing staff, entered by S42RN on 10/13/12 at 1915 (7:15 p.m.)....

Patient with one to one observation, entered by S42RN on 10/13/12 at 2100 (9:00 p.m.).

Patient seen exiting building on security camera from ambulance entrance wrapped in sheet. Security was notified of patient missing from room at 2205 (10:05 p.m.). (Local sheriff's department) deputy looking around parking lot for patient. All rooms in ER checked including both bathrooms. (S44 Unit Service Coordinator) Secretary was at patient bedside she looked up for a moment and when looked back patient was gone. Entered by S43RN on 10/13/12 at 2205 (10:05 p.m.) 911 called for assistance to locate patient, entered by S43RN on 10/13/12 at 2220 (10:20 p.m.).

There was no documented evidence that 1:1 observation of the patient by an assigned and dedicated staff member within arms reach of the patient was done, and there was no documentation of every 15 minute observations as required by hospital policy from 7:13 p.m. to 10:00 p.m. (when the patient was found to be missing).

Review of the Risk Occurrence Report for Patient #11 revealed the following:

Event Code: Elopement-Involuntary Admit, Patient was PEC'd and escaped for ER room.

Event Date: 10/13/12, Time: 2200 (10:00 p.m.), Shift: 7:00 p.m.-7:00 a.m.

Exact Location: Room a

Objective description event: Entered by (S43RN) Date: 10/14/12, Time: 2017 (8:17 p.m.) - Patient was PEC'd in Room a awaiting final transport orders, secretary watching patient standing in hall outside room, patient in red gown, belongings all checked and taken from room, patient had just been cleaned after spilling urine, linens all changed at 2130 (9:30 p.m.), family friend had just left patient bedside at that time. Patient noticed to be gone from room at 2205 (10:05 p.m.) when EMS (Emergency Medical Services) took another patient out of Room b at 2200 (10:00 p.m.) Upon checking with security, cameras saw patient leaving in red gown with sheet over him at 2157 (9:57 p.m.).....

Corrective Actions: (Left Blank)

In a face-to-face interview on 11/09/12 at 10:00 a.m., the ED Director of Patient Services, (S21) verified Patient #11 eloped from the ED on 10/13/12 while under a PEC with 1:1 observation ordered by the physician. S21 stated that the patient slipped out the ambulance entrance while a patient was being transported out the doorway. S21 stated the patient had a red gown on and had wrapped a sheet around himself when he eloped. After reviewing the patient's record, S21 verified the only documentation that 1:1 observation was implemented was at 2100 (9:00 p.m.). S21 verified that every 15 minute observations were not documented. S21 stated the ED was full at the time of the elopement and stated there were 10 patients in the 9-bed ED. S21 stated the elopement occurred on a Saturday night and there were 3 nurses working in the ED that night. S21 stated the USC (Unit Service Coordinator-Clerical) that was working that night was pulled from another unit. S21 stated that when a PEC patient is in the ED, the USC was assigned to observe the patient. When asked what had been done to prevent PEC'd patients from eloping, S21 stated the push plate which opened the ambulance door was changed to a key pad. S21 stated they had talked to security about monitoring and trying to increase staff, but it was not available at this time. S21 verified that the USC staff (S63USC and S64USC) had not received training in crisis prevention intervention techniques. S21 further indicated that only the nursing staff and security staff received training in crisis prevention intervention.

In a face-to-face interview on 11/13/12 at 9:05 a.m., S43RN verified that she was the ED Supervisor on 10/13/12 when Patient #11 eloped from the ED. S43 verified she had made the assignments for that shift. S43 stated there were 3 nurses working that night, S42RN, herself, and S69RN (pulled from another unit). S43RN verified the physician had ordered suicide and elopement precautions. S43 stated S44USC was pulled to the ED that night and stated she usually works as a secretary on the post partum unit. S43 verified S44USC was assigned to watch Patient #11. When asked if S44USC had received any training on working in the ED or providing supervision of PEC'd patients, S43RN stated, not that I know of. S43 stated the patient was in Room a and S44USC was standing outside the door to Room a to watch the patient. S43RN verified Room a was located at the end of a hallway and was not visible from the nurse's station. After reviewing the hospital policy for Suicide Prevention Plan, including the 1:1 observation directives, S43RN stated S44USC was outside the patient's room and not within arms reach of the patient. S43RN also verified the only documentation of patient supervision/observation was done in the electronic nursing documentation. S43 stated she was at the triage desk when she heard S42RN state the patient was gone. When asked if any ED procedures had been changed since the patient eloped, S43RN stated the ambulance entrance now had a key pad lock. S43 verified that the patient eloped by walking out this exit as ambulance personnel were transporting a patient out and verified the key pad lock would not have prevented that elopement. S43 stated they were trying to have more staff in the ED. S43RN stated they had training set up but verified no training had been done yet.

In a face-to-face interview on 11/13/12 at 12:55 p.m., S42RN verified he was assigned to Patient #11 on 10/13/12, 7 p.m. to 7 a.m. shift. S42 stated once the patient was PEC'd, the patient was put on observation. S42 stated he was observing the patient initially, and Ms. (S44 USC) was helping me. We were full. The patient was in Room a which is a private spot. S42RN stated he told S44USC, We need to watch him, keep an eye on him, observe him. S42 verified the physician ordered 1:1 observation, and stated he and S44USC were providing 1:1. S42RN verified he was responsible for the observation/monitoring of Patient #11. S42RN stated he had helped change the patient's bed, shortly before he left, but was unable to give the time this occurred. S42 stated when he returned to the patient's room, the patient was gone. S42RN stated he did not know where S44USC was at this time, but he did not have to walk around her to go into the patient's room. S42 stated he came out of the room and stated the patient was gone. S42RN stated S43RN then called the police and he (S42RN) went to look for the patient on the unit and outside. When asked what 1:1 monitoring and observation was, S42RN stated, 1:1 means someone watches at all times. S42 stated the primary nurse was responsible and stated he had asked S43 USC to watch the patient. S42 stated S43 was not in the room with the patient, she was either in the door or in the long hall. S42 stated he was not sure what S43's competencies were. After reviewing the patient's medical record and an entry of, Patient with one to one observation per Medical/Nursing Staff on 10/13/12 at 7:15 p.m., S42RN stated this means we were all watching. After review of the Suicide Prevention Plan policy, S42 was unable to explain if assigned and dedicated staff had provided observation of the patient within arms reach at all times. S42RN was unable to provide documentation of every 15 minute observations of Patient #11.

In a face-to-face interview on 11/13/12 at 2:04 p.m., S44USC verified she worked on the post-partum unit as the unit secretary and she was pulled to the ED on 10/13/12 for the 3:00 p.m. to 11:00 p.m. shift. S44 stated she was very seldom pulled to the ER, and she has only answered the telephone or entered charges in the past. S44USC stated S42RN asked her to keep an eye on the patient (#11) when he (S42RN) came out of the room. S44USC stated she stood outside the door of Room a. S44USC stated she was also assisting EMS staff with a patient in Room b, and was answering the telephone. S44 verified she had her back to Patient #11's room when she answered the telephone. S44 stated she was aware Patient #11 was under a PEC. S44 denied receiving any directions from the RN, and stated she only remembered being told to keep an eye on the patient. S44 stated she had never been assigned to monitor a PEC patient before 10/13/12. S44USC further stated she had not received any training on monitoring PEC patients, and had not received any training in crisis prevention intervention. S44USC also stated no one had asked her if she had training in monitoring PEC patients before assigning her to monitor Patient #11 on 10/13/12.

2) Failing to ensure a level of observation was ordered by the physician for Patient #19 who had been PEC'd for suicidal ideations:

Patient #19

Review of the patient's medical record revealed the patient was an [AGE] year old female who (MDS) dated [DATE] at 0957 (9:57 a.m.) ambulatory with a chief complaint of suicidal ideations, stating she wanted to stab herself.

Review of the initial nursing assessment revealed the patient had suicidal ideations, had a history of suicide attempts in the past, and voiced a plan (stab herself). The assessment also revealed, Patient states that she constantly has thoughts of suicide because she feels guilty about 'what she did' in the past. Review of the Psychiatric Related PoC (Plan of Care) revealed no documented evidence the RN had placed the patient on observation and monitoring, and no evidence the RN assigned patient observation and monitoring at any time during the patient's ED visit.

Review of the patient's record revealed a PEC was documented by S35 ED Physician and Director of Off-Site Campus ED on 11/12/12 at 10:40 a.m. The PEC revealed the patient complained of wants to stab myself, and patient currently suicidal-upset about her life. The PEC revealed immediate psychiatric treatment in a treatment facility was needed due to dangerous to self, gravely disabled, and unwilling, unable to seek voluntary admission.

Review of the physician orders dated 11/12/12 revealed no documented evidence of an order for the level of observation and monitoring of the patient.

Further review of the nursing documentation revealed on 11/12/12 at 10:44 a.m., S45RN documented the patient's guardian was at the bedside and was instructed and verbalized understanding that she needs to stay with patient at all times. Review of the record revealed the patient was transferred to the main campus by ambulance on 11/12/12 at 11:25 a.m. There was no documented evidence of every 15 minute monitoring and observation of the patient by the nursing staff from 10:09 a.m. when the RN assessed the patient as having suicidal ideations with a plan until 11:25 a.m. when the patient was transferred.

In a face-to-face interview with S45RN on 11/13/12 at 2:10 p.m., she verified she had worked with Patient #19 on 11/12/12. S45 stated the patient's guardian was with her and she had explained to her to stay with the patient. S45 stated no one staff member was assigned to the patient. S45 stated, I monitored her, I would look in on the patient when I went by the room. When asked what the observation level was for Patient #19, she explained the triage acuity level of 1-5. When asked to explain the observation levels for PEC'd patients, S45 stated she would have to read the policy, she was not familiar with it. When informed the hospital's Suicide Prevention Plan included Level 1, Level 2, and Level 3 observation levels with Level 3 being 1:1 observation, she verified she was not familiar with the observation levels.

In a face-to-face interview on 11/14/12 at 12:00 p.m. S35 Physician/Director of Off-Site Campus ED verified he was the ED physician when Patient #19 was seen on 11/12/12. S35 stated there should be an order for the level of supervision for suicidal/PEC patients. S35 stated when a patient says they are going to kill themselves, he liked Level 2 or Level 3. S35 stated Level 3 was the most critical and was 1:1 observation. S35 stated Level 2 is line of sight observation. S35 stated there should be a level of supervision ordered for all PEC'd patients. When asked if a level of supervision was ordered for Patient #19, he stated he did not remember ordering any supervision/observation for this patient. S35 stated the patient's guardian was with the patient. When asked if the presence of the guardian changed the hospital's policy for supervision of the patient, he stated no. After reviewing the patient's Emergency Physician Record and the electronic physician orders, S35 verified there was no order for a level of observation/supervision for Patient #19.

3) Failing to ensure suicidal patients under PEC were provided a safe environment that did not afford the patient access to electric cords that could be a means of strangulation and plastic bags that could be a means of suffocation for Patient #11 and #19:

On 11/08/12 at 8:40 a.m., observations were made of the off-site campus ED with S21, Director of ED Patient Services. S21 stated Room c and Room d were used for PEC'd patients. S21 stated the USC (Clerk) was pulled to observe PEC'd patients in the ED. S21 stated the RN staff and the Security Staff were trained in crisis prevention intervention and stated the hospital used CPI (Crisis Prevention Institute) for the training. S21 stated the USC staff were not trained in CPI. Observation of Room c and Room d revealed both were located across the hall from the nurse's station and both had glass walls on the front side with privacy curtains. Both rooms were observed to have cardiac monitors with a 3-4 foot electric cord. Both rooms were observed to have an Otoscope and Ophthalmoscope mounted on the wall with a 4-5 foot electric cord. S21 stated the electric cords for the cardiac monitor and the Otoscope/Ophthalmoscope could not be removed from the rooms.

Review of the ED record for Patient #11 (10/13/12) and Patient #19 (11/12/12) revealed both patients were placed in Room a and were PEC'd during the ED visit due to dangerous to self, gravely disabled, and unwilling/unable to seek voluntary admission. Review of the record for Patient #11 and #19 revealed no documented evidence that either patient was provided Level 1, Level 2, or Level 3 observation by the staff while in the ED.

On 11/14/12 at 12:05 p.m. an observation of Room a was made with S21, Director of ED Patient Services. Room a was observed to be located at the end of a hallway that extended from Room a to the main hallway and beside the nurse's station. Room b was also located on this hallway, but across from the nurse's station. Room a was not visible from the nurse's station. A privacy curtain was observed to hang in the door way of Room a. Electric cords from the cardiac monitor, Otoscope/Ophthalmoscope (4-5 feet), and a telephone line (4-5 feet) from the cardiac monitor to a wall outlet was observed. S21 verified none of these cords were removed from the room when a PEC'd patient was placed in the room. 2 garbage cans were observed in Room a with plastic liners. S21 stated the garbage can liners were not removed when a PEC patient was in the room. Also noted in Room a was a dispenser mounted on the wall with blue plastic bags inside and 9-10 inches of the plastic bag extending from the bottom of the dispenser. S21 stated these blue plastic bags were vomit bags and were not removed from the room when a PEC patient was in the room.

Review of the hospital policy titled Suicide Prevention Plan, policy number NSG 4.26, effective date February 2007, reviewed date 09/11, and provided as the current policy for supervision of PEC'd patients by the Director of ED Patient Services at the off-site campus (S21), revealed in part the following:

Purpose: The purpose of this policy is to ensure the safety and appropriate care of the patient with suicidal ideation and/or past suicide attempt. It is the responsibility of all (hospital name) personnel to adhere to this policy....

Staff Training and Education:

1. Upon hire, and prior to commencing work with patients, staff will be trained, oriented, and deemed competent in the following areas as appropriate to their job function and scope of practice. This training will occur at least annually thereafter: suicide screening and re-assessment as clinically indicated, high risk factors for suicide, monitoring a patient at high risk for suicide, suicide precautions, and prevention, patient safety and environmental rounds, discharge & suicide prevention patient education.

Suicide Risk Screening and Assessment:

1. ....Emergency Department Registered Nurses will only screen patients admitted to the ED with a primary focus/complaint of a behavioral issue(s) and/or if the RN has any clinical concerns for any patients presenting with risk for self-harm.

2. Any patient response of Yes to any of the interview questions on the Suicide Risk screening will identify the patient as at risk for suicide. These patients will be placed on suicide precautions, and the RN will assign patient observation monitoring immediately. A LIP (Licensed Independent Provider) order will be generated in order to gain further suicide risk assessment .... and determine an ongoing safety observation and monitoring level. Safe environment and patient safety guidelines will be documented and implemented to ensure the environment and patient will be safe....

3. For all patients identified as a risk for suicide, the LIP order initiated will define the level of patient observation and monitoring that will be continued....

Heightened Observations:

1. Patients who are screened/assessed to be at risk for suicidality will be placed on patient observation and monitoring as assigned by the RN and reassess after the.....assessment is completed. The patient may be placed on every 15 minute monitoring (Standard Observations), continuous visual or line of sight observation or on a one to one (1:1) observation status as outlined in the Level of Observation definitions below (Use the Monitoring Documentation form for all levels of observation)....

2. Level 1 = Standard Observation - Monitor and observe minimally every 15 minutes. Staff visually observes the patient at least every 15 minutes....

3. Level 2 = Line of Sight Observation - Line of sight at all times monitoring and observation. Continuous visual observations means that at no time is the patient out of the visual contact of a staff member....

4. Level 3 = 1:1 monitoring and observation. The patient is never to be out of arms reach of the assigned and dedicated staff member.... Hallmark guidelines for 1:1 observation: 1. The assessment supports 1:1 and the patient is reporting one of the following risk symptoms: a. Has attempted suicide attempt in the last 48 hours; b. Has displayed any self injurious behaviors in the last 8/12 (shift specific) hours; c. Is currently verbalizing suicidal ideation with a plan to harm self; d. Has command hallucinations to harm self; e. Verbalizing hopelessness....

Suicide Precautions:

1. Staff will closely observe and document rounds on the patient at least every 15 minutes or more often if heightened observations have been ordered....

7. Additional safety interventions are implemented for patients on suicide precautions upon the initial screening/assessment. These interventions include, but may not be limited to:

....Remove all potential ligatures (shoelaces, belts, cords) and sharps (glass, razors, brittle plastic) from the environment....

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interviews, the hospital failed to ensure that a registered nurse (RN) assigned the nursing care of each patient according to the patient's needs and the specialized qualifications and competence of the nursing staff. The RN assigned the observation of ED (Emergency Department) patients, who were under Physician Emergency Certificate (PEC) to USC (Unit Service Coordinator) staff who had not received training and orientation and had not been assessed for competency for 3 of 3 USC staff members' files reviewed for competency (S44USC, S63USC, S64USC). Findings:

On 11/08/12 at 8:40 a.m., observations were made of the off-site campus ED with S21, Director of ED Patient Services. S21 stated Rooms c and d were used for PEC'd patients. S21 stated the USC (Clerk) was pulled to observe PEC'd patients in the ED. S21 stated the RN staff and the Security Staff were trained in crisis prevention intervention and stated the hospital used CPI (Crisis Prevention Institute) for the training. S21 stated the USC staff were not trained in CPI. S21 stated there were 2 USCs (S63USC, S64USC) employed in the ED.

Patient #11

Review of the patient's medical record revealed the patient was a [AGE] year old male who (MDS) dated [DATE] at 1907 (7:07 p.m.) by ambulance with a chief complaint of change in mental status/neurological status.

Review of the patient's record revealed the physician had ordered suicide and elopement precautions on 10/13/12 at 7:13 p.m. and the patient was PEC'd on 10/13/12 at 9:38 p.m. for being dangerous to self, gravely disabled, and unable to seek voluntary admission.

Further review of the record revealed the patient eloped from the ED on 10/13/12 at 10:00 p.m. Review of the patient's record revealed S43RN and S42RN had documented entries in the patient's record on 10/13/12.

In a face-to-face interview on 11/13/12 at 9:05 a.m., S43RN verified she was the ED Supervisor on 10/13/12 when Patient #11 eloped from the ED. S43RN verified she had made the assignments for that shift. S43 verified the physician had ordered suicide and elopement precautions for Patient #11. S43RN stated S44USC was pulled to the ED that night and stated she usually works as a secretary on the post partum unit. S43RN verified S44USC was assigned to watch Patient #11. When asked if S44USC had received any training on working in the ED or providing observation/supervision of PEC'd patients, S43RN stated, not that I know of.

In a face-to-face interview on 11/13/12 at 12:55 p.m., S42RN verified he was assigned to Patient #11 on 10/13/12, 7:00 p.m. to 7:00 a.m. shift. S42 stated he told S44USC, We need to watch him, keep an eye on him, observe him. S42RN stated he was not sure what S43USC's competencies were.

In a face-to-face interview on 11/13/12 at 2:04 p.m., S44USC verified she worked on the post-partum unit as the unit secretary and she was pulled to the ED on 10/13/12 for the 3:00 p.m. to 11:00 p.m. shift. S44USC denied receiving any directions from S42RN, and stated she only remembered being told to keep an eye on the patient. S44USC stated she had never been assigned to monitor a PEC patient before 10/13/12. S44USC stated she had not received any training on monitoring PEC patients, and had not received any training in crisis prevention intervention. S44USC also stated no one had asked her if she had training in monitoring PEC patients before assigning her to monitor Patient #11.

Review of the personnel record for S44USC revealed no documented evidence of any orientation, or education and training, related to suicide precautions and prevention and the observation/monitoring of PEC patients from 02/06/01 to 09/12/12. There was no documented evidence S44USC was deemed competent to provide observation/monitoring of PEC/Suicidal patients. There also was no documented evidence of crisis prevention/intervention training. Review of the job description for S44USC revealed the position summary was as follows: Under the supervision of the assigned supervisor, coordinates and/or performs a variety of nonclinical and ancillary services of assigned patient care unit(s) including but not limited to housekeeping, maintenance, patient supply services, dietary, clerical support, and related unit support functions....

Review of the personnel record for S63USC revealed a date of hire of 07/25/06 and S63 was employed as a USC in the ED. Review of the education/training record for S63USC from 01/06/04 to 11/12/12 revealed no documented evidence of any orientation, or education and training, related to suicide precautions and prevention and the observation/monitoring of PEC patients. There was no documented evidence S63USC was deemed competent to provide observation/monitoring of PEC/Suicidal patients. There also was no documented evidence of crisis prevention/intervention training.

Review of the personnel record for S64USC revealed a date of hire of 10/13/09 and S64 was employed as a USC in the ED. Review of the education/training record for S64USC revealed no documented evidence of any orientation, or education and training, related to suicide precautions and prevention and the observation/monitoring of PEC patients. There was no documented evidence S64USC was deemed competent to provide observation/monitoring of PEC/Suicidal patients. There also was no documented evidence of crisis prevention/intervention training.

Review of the hospital policy titled, Suicide Prevention Plan, policy number NSG 4.26, effective date February 2007, reviewed date 09/11, and provided as current policy for supervision of PEC'd patients by the Director of ED Patient Services at the off-site campus (S21), revealed in part the following:

Purpose: The purpose of this policy is to ensure the safety and appropriate care of the patient with suicidal ideation and/or past suicide attempt. It is the responsibility of all (hospital name) personnel to adhere to this policy....

Staff Training and Education:

1. Upon hire, and prior to commencing work with patients, staff will be trained, oriented, and deemed competent in the following areas as appropriate to their job function and scope of practice. This training will occur at least annually thereafter: suicide screening and re-assessment as clinically indicated, high risk factors for suicide, monitoring a patient at high risk for suicide, suicide precautions, and prevention, patient safety and environmental rounds, discharge & suicide prevention patient education.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records review and staff interviews, the hospital failed to ensure blood transfusions were administered in accordance with approved medical staff policies and procedures for 1 of 4 sampled patient's record reviewed for blood transfusion (#43) from a total sample of 44 patients and 2 of 2 (R1, R2) random patients' records reviewed for blood transfusions from a total of 3 random patients.

The hospital failed to:

1) Obtain a complete informed consent for blood transfusion (R1, R2);

2) Monitor patients' vital signs during blood transfusion according to hospital policy (#43, R2);

3) Ensure blood transfusions were administered and monitored by the RN (Registered Nurse) (#43);

4) Ensure blood transfusion completion was entered into the electronic record according to hospital policy (#43);

5) Failed to ensure the rate of transfusion was ordered by the physician (R2).

Findings:

1) Obtain a complete informed consent for blood transfusion:

Patient R1

Review of Patient R1's medical record revealed that she was a [AGE] year old female admitted on [DATE] with a diagnosis of Pelvic Abscess. Review of the Physician's Order dated 08/17/12 at 9:00 p.m. revealed an order to transfuse 2 units of packed red blood cells now.

Review of the hospital's Patient Consent To Transfusion of Blood and Blood Components revealed that the patient's condition including the diagnosis and a description of the nature of the condition or ailment for which the transfusion was indicated and recommended was to be completed on the consent. Review of Patient R1's consent for transfusion revealed no documented evidence of her condition as evidenced by the blank being absent of writing.

In a face-to-face interview on 11/14/12 at 3:40 p.m., Vice-President of Nursing S15 at the off-site campus indicated that the place on the consent where the physician was to document the reason for the blood transfusion was left blank.

Patient R2

Review of Patient R2's medical record revealed that she was a [AGE] year old female admitted on [DATE] with diagnoses of early right-sided pneumonia, elevated temperature, and poor oral intake. Review of the Physician's Order dated 08/03/12 at 12:10pm revealed an order to transfuse 2 units of packed red blood cells.

Review of the hospital's Patient Consent To Transfusion of Blood and Blood Components revealed that the patient's condition including the diagnosis and a description of the nature of the condition or ailment for which the transfusion was indicated and recommended was to be completed on the consent. Review of Patient R2's consent for transfusion revealed no documented evidence of her condition as evidenced by the blank being absent of writing.

In a face-to-face interview on 11/14/12 at 3:30pm, Vice-President of Nursing S15 at the off-site campus indicated that the place on the consent where the physician was to document the reason for the blood transfusion was left blank.

2) Monitor patients' vital signs during blood transfusion according to hospital policy:

Patient #43

Review of Patient #43's medical record revealed that she was a [AGE] year old female admitted on [DATE] to the rehabilitation unit with a diagnosis of CVA (Stroke). Review of the Physician's Order dated 11/06/12 at 1:00 p.m. revealed an order to transfuse 2 units of packed red blood cells each over 3-4 hours. The physician's orders also revealed an order dated/timed 11/06/12 at 4:00 p.m. to transfuse blood when ready.

Review of the hospital policy revealed that a patient's vital signs (blood pressure, temperature, pulse respiration, pulse oximetry) were to be taken prior to initiating the transfusion, 15 minutes after the transfusion began, hourly during the transfusion, and at the conclusion of the transfusion.

Review of Patient #43's medical record revealed that Unit #1 began at 1829 (6:29 p.m.). Further review revealed that her vital signs were taken at 6:29 p.m. at the time the transfusion stared, at 6:32 p.m., 6:46 p.m., 7:00 p.m., 7:08 p.m., 8:28 p.m., and 10:28 p.m. . There was no documented evidence that Patient #43's vital signs were checked every hour during the transfusion (9:30 p.m.) or at the conclusion of the transfusion since there was no documentation of when the first unit was completed. Further review revealed Unit #2 began at 2310 (11:10 p.m.). The patient's vital signs were taken at 11:13 p.m., 11:38 p.m.(25 minutes later), 1:24 a.m., 2:18 a.m., and at 2:22 a.m.. There was no documented evidence that her vital signs were checked at 11:28 p.m. 15 minutes after the transfusion started, and there was no documented evidence the patient's vital signs were taken every hour (12:30 a.m.) as required by hospital policy. There was also no documented evidence that the patient's vital signs were taken at the completion of the transfusion, since there was no documentation of when the second unit was completed.

In a face-to-face interview on 11/13/12 at 11:00 a.m. S48RN stated she was the RN that started the first unit of blood on 11/06/12 at 6:29 p.m. S48 stated she was off duty at 7:00 p.m. and did not complete the transfusion process. After reviewing the BCTA (Bar-coded transfusion administration in Meditech) system, she verified the completion time for both units had not been entered into the system and she was unable to determine if post transfusion vital signs had been taken.

In a face-to-face interview on 11/14/12 at 2:00 p.m., Director of Women and Children Services S28 confirmed that vital signs were not documented every hour and at post transfusion for the first unit. S28 confirmed the vital signs were not taken 15 minutes after the second unit was started. S28 also verified the patient's vital signs were not take every hour and at post transfusion for the second unit of blood.

Patient R2

Review of Patient R2's medical record revealed that she was a [AGE] year old female admitted on [DATE] with diagnoses of early right-sided pneumonia, elevated temperature, and poor oral intake. Review of the Physician's Order dated 08/03/12 at 12:10pm revealed an order to transfuse 2 units of packed red blood cells.

Review of the hospital policy revealed that a patient's vital signs (blood pressure, temperature, pulse respiration, pulse oximetry) were to be taken prior to initiating the transfusion, 15 minutes after the transfusion began, hourly during the transfusion, and at the conclusion of the transfusion.

Review of Patient R2's medical record revealed that Unit #1 began at 1610 (4:10pm) and concluded at 1908 (7:08pm). Further review revealed that her vital signs were taken at 4:08pm prior to the transfusion starting, at 4:10pm at the start of the transfusion, and 4:30pm. There was no documented evidence that Patient R2's vital signs were checked at 4:25pm, 15 minutes after the start of the transfusion, as required by hospital policy. Further review revealed that her vital signs were taken at 4:35pm, 5:40pm, 5:43pm, 6:30pm, 6:37pm, 7:05pm, 7:07pm, and at 7:57pm when the second unit of blood was begun. There was no documented evidence that her vital signs were checked at 5:35pm as required by hospital policy (to be taken every hour).

In a face-to-face interview on 11/14/12 at 3:10pm, Director of Women and Children Services S28 confirmed that vital signs were not documented 15 minutes after the first blood transfusion was started.

3) Ensure blood transfusions were administered and monitored by the RN:

Patient #43

Review of Patient #43's medical record revealed that she was a [AGE] year old female admitted on [DATE] to the rehabilitation unit with a diagnosis of CVA (Stroke). Review of the Physician's Order dated 11/06/12 at 1:00 p.m. revealed an order to transfuse 2 units of packed red blood cells each over 3-4 hours. The physician's orders also revealed an order dated/timed 11/06/12 at 4:00 p.m. to transfuse blood when ready.

Review of Patient #43's medical record revealed that Unit #1 began at 1829 (6:29 p.m.) and was started by S48RN. Review of the nursing documentation and the BCTA system revealed no documented evidence that a RN monitored the transfusion of the 1st unit after 7:50 p.m. There also was no documented evidence of when the first unit was completed. Further review of the record revealed Unit #2 began at 2310 (11:10 p.m.). There was no documented evidence that the second unit was hung by an RN. There was no documented evidence that an RN monitored the patient during the transfusion of the second unit, and there was no documentation of when the second unit was completed. Further review of the medical record revealed all nursing entries in the electronic nursing record and the BCTA system in Meditech were made by S37LPN from 7:50 p.m. on 11/06/12 to 6:57 a.m. on 11/07/12.

In a face-to-face interview on 11/13/12 at 11:00 a.m. S48RN stated she was the RN that started the first unit of blood on 11/06/12 at 6:29 p.m. S48 stated she was off duty at 7:00 p.m. and did not complete the transfusion process. After reviewing the BCTA system, she verified the completion time for both units had not been entered into the system.

In a face-to-face interview on 11/14/12 at 2:15 p.m., the Vice President of Nursing at the off-site campus, S15 confirmed there was no documented evidence that an RN monitored the patient during the transfusions and there was no documented evidence that an RN hung the second unit of blood. S15 verified the only documentation of monitoring of the patient after 7:50 p.m. was by S37LPN. S15 confirmed the hospital policy indicated the RN was to hang/administer and monitor blood transfusions, and the RN could only delegate the vital signs to the LPN.

4) Ensure blood transfusion completion was entered into the electronic record according to hospital policy:

Patient #43

Review of Patient #43's medical record revealed that she was a [AGE] year old female admitted on [DATE] to the rehabilitation unit with a diagnosis of CVA (Stroke). Review of the Physician's Order dated 11/06/12 at 1:00 p.m. revealed an order to transfuse 2 units of packed red blood cells each over 3-4 hours. The physician's orders also revealed an order dated/timed 11/06/12 at 4:00 p.m. to transfuse blood when ready.

Review of Patient #43's medical record revealed that Unit #1 began at 1829 (6:29 p.m.) and was started by S48RN. There was no documented evidence of when the first unit was completed. Further review of the record revealed Unit #2 began at 2310 (11:10 p.m.). There was no documented evidence that the second unit was hung by an RN. There was no documented evidence of when the second unit was completed.

In a face-to-face interview on 11/13/12 at 11:00 a.m. S48RN stated she was the RN that started the first unit of blood on 11/06/12 at 6:29 p.m. S48 stated she was off duty at 7:00 p.m. and did not complete the transfusion process. After reviewing the BCTA system, she verified the completion time for both units had not been entered into the system.

In a face-to-face interview on 11/13/12 at 11:10 a.m. S50 Medical Technician from the Laboratory reviewed the BCTA system and verified the completion time on both units of blood transfused for Patient #43 had not been entered into the system.

In a face-to-face interview on 11/14/12 at 2:15 p.m., the Vice President of Nursing at the off-site campus, S15 confirmed there was no documented evidence of a completion time for either unit of blood for Patient #43. S15 verified the hospital policy indicating transfusion administration documentation that was started in BCTA needed to be completed in BCTA, and the completion times should have been entered.

5) Failed to ensure the rate of transfusion was ordered by the physician:

Patient R2

Review of Patient R2's medical record revealed that she was a [AGE] year old female admitted on [DATE] with diagnoses of early right-sided pneumonia, elevated temperature, and poor oral intake. Review of the Physician's Order dated 08/03/12 at 12:10pm revealed an order to transfuse 2 units of packed red blood cells. There was no documented evidence of an order by the physician for the rate at which the blood was to be transfused.

In a face-to-face interview on 11/14/12 at 4:15pm, Vice-President of Nursing S15 at the off-site campus confirmed that there was no order by the physician for the rate of transfusion.

Review of the hospital policy titled, Blood or Blood Product Administration, Policy number NSG.4.01, revised 02/12, and provided as current policy by S15 Vice President of Nursing at the off-site campus, revealed in part the following: 2. Blood and blood products must be hung and monitored by a Registered Nurse or physician. Vital signs may be delegated to the LPN, PCA, or MOA (Licensed Practical Nurse, Personal Care Assistant, Medical Office Assistant). 3. The physician must obtain the patient's consent prior to transfusion for blood or blood products. consent is required for any blood product that requires a type and cross match.... 6. Blood and blood products must be completely transfused within 4 hours of removal from refrigeration.... 8. Blood transfusion administration documentation that is initiated in BCTA (Bar-coded transfusion administration in Meditech) will need to be completed in BCTA....6. Obtain a baseline assessment of the patient: TPR (Temperature, Pulse, Respiration), B/P (Blood Pressure), pulse oximetry, check for rashes, breath sounds, heart tones, hydration status, color, history of blood transfusion/reaction and other parameters (CVP) (Central Venous Pressure) as indicated.... 19. Observe the patient continuously for the first 15 minutes of transfusion. TPR, B/P, pulse oximetry and other pertinent vital signs are taken prior to initiating the transfusion, after 15 minutes into the transfusion, hourly during transfusion and at the end of the transfusion. Documentation of the patient's pre, post and 15-minute vital signs on the transfusion tag is optional as long as these vitals are recorded in the patient's medical record.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observations, interviews, and record reviews, the hospital failed to ensure outdated or mislabeled drugs and biological were not available for patient use as evidenced by:

1) expired Dopamine and Epinephrine intravenous (IV) drips were connected to a patient's central line for 1 of 2 patients sampled in the Pediatric Intensive Care Unit (PICU) from a total of 44 sampled patients (#1);

2) opened medication vials with no patient identifier on the label were being stored on top of the medication cart in the Post-Anesthesia Care Unit (PACU).

Findings:

1) Expired Dopamine and Epinephrine drips connected to a patient's central line:

Record review revealed Patient #1 was a female infant born on 8/26/12 and admitted on [DATE] for VSD (Ventricular Septal Defect), PDA ([DIAGNOSES REDACTED]) and PFO (Patent Foramen Ovale) closures, repair of [DIAGNOSES REDACTED] arch and end to end anastomosis of coarctation.

An observation was made on 11/7/12 at 2:00 p.m. in the PICU. Two IV drips were at Patient #1's bedside on a tray on an IV pole. The drips were not infusing, but connected to Patient #1's central line by IV tubing. Observation of the labels on the medications revealed one syringe contained Dopamine (medication to increase blood pressure) 80 mg/48 ml (80 milligrams/48 milliliters) and the other syringe contained Epinephrine (medication to increase heart rate) 1.5 mg/50 ml. Both medications had an expiration date on the label of 11/6/12.

In an interview on 11/7/12 at 2:05 p.m. with Registered Nurse (RN) S24, he stated the Dopamine and Epinephrine drips were connected to the baby when she returned from surgery 2 days earlier but had not been infusing. S24 verified both drips had expired the previous day and should have been discarded and not attached to the Patient #1's central line.

In an interview on 11/7/12 at 2:05 p.m. with the PICU Manager (S22), she verified the Epinephrine and Dopamine drips should not have been connected to Patient #1's central line because they had expired on [DATE].

Review of the hospital policy titled Intravenous Access- Peripheral and Central Lines: General, Policy No: NSG 4.17, Revised 2/12 revealed in part:

d. Patients must have IV fluids on an IV/syringe pump.

g. All other fluids or medications prepared by pharmacy or nursing are changed every 24 hours.

k. Discard any IV fluids and tubing administration sets that have been discontinued from patients after 24 hours.

2) Opened medication vials with no patient identifier on the label were being stored on top of the medication cart in the Post-Anesthesia Care Unit (PACU):

In an observation on 11/14/12 at 2:55 p.m. in the PACU, 6 vials of medications were on top of a medication cart with no staff members present near the cart. A vial of Xylocaine (local anesthetic) 10mg/ml (milligrams/milliliter), a vial of Humalog insulin, and a vial Humulin R insulin (decreases glucose levels) were unopened. A vial of Lantus insulin 100u/ml (units/milliliter), a vial of Clindamycin (antibiotic) 300mg/2ml, and a vial of Humulin R insulin were opened. The 3 opened vials were observed to have no date on the label indicating when they had been opened and no initials of the person who opened the vials. Further observation revealed none of the 6 vials had a patient name on the medications.

In an interview on 11/14/12 with Peri-Operative Director (S20), she stated the vials of Xylocaine, Humalog insulin, Clindamycin, Lantus insulin, and 2 vials of Humulin R insulin were for overflow patients from the ICU (Intensive Care Unit). She stated they had been on top of the cart since Monday (11/12/11) and she was not even sure what patient they were for. S20 stated there were no drawers in the medication dispensing machine for the overflow patients, so the medications were left out to be used. S20 also verified no patient identifiers were on any of the medications. S20 said the medications should not have been left out and should have been discarded after the patients were discharged .

In an interview on 11/14/12 at 3:05 p.m. with Risk Management (S11), she verified the medications should not have been on top of the cart with no patient identifiers and the opened vials should have been labeled with the date of opening and the initials of who opened the vials.

Review of the Policy titled Medication Administration: Nursing Medication Management, Policy No: NSG 4.15a, Effective Date June 2012 revealed in part:

F ....Any medications that are not stored in the Pyxis Medstation (such as bulk or multidose drugs) must be secured within the medication preparation area; either behind locked doors or within an anchored, locked drug bin.

H. When a multidose vial is opened, the vial should be labeled with date and time and initials when opened and the date and time of expiration.

Based on observations and interviews, the hospital failed to ensure schedule II and schedule IV medications were locked within a secure area. Syringes containing Fentanyl Citrate and Phenobarbital were stored in an unlocked drawer of a plastic box in the supply room in the PICU (pediatric intensive care unit) that was accessible to the nursing staff, unit secretary, housekeeping staff, and the supply delivery staff. Findings:

An observation was made on 11/14/12 at 9:15 a.m. in the PICU of the supply room. The entry door to the supply room had a keypad for entry. Further observation revealed a plastic box inside the supply room which had rows of unlocked drawers containing patient medications. Inside the drawer for Patient R3 was a syringe with 250 mcg (micrograms) of Fentanyl Citrate (schedule II pain medication) and Phenobarbital (schedule IV medication) 7 mg (milligrams).

In an interview on 11/14/12 at 9:15 a.m. with Clinical Supervisor of PICU (S68), she verified the drawer for Patient R3 contained a Fentanyl drip and a Phenobarbital drip. S68 also verified the drawers in the plastic container were not locked. When asked who had access to the supply room, S68 stated the nursing staff, the unit secretary, housekeeping, and supply delivery staff. When asked if all of these people were monitored while in the supply room, S68 replied no.

In an interview on 11/14/12 at 9:45 a.m. with Pharmacy Director (S32), she stated the scheduled medication drips for the PICU were supposed to have been started on the patients immediately after delivery from the pharmacy. She said the Fentanyl and Phenobarbital drips for Patient R3 should have never been stored and certainly not in an unlocked cabinet. S32 further stated if drips are not started upon delivery to the unit, they are supposed to have been returned to the pharmacy department.

Review of the hospital policy titled HCA Medication Diversion Prevention Policy, No policy number listed, Effective Date: 3/1/2012 revealed in part:

Within HCA, DEA Controlled Dangerous Substances listed in Schedule II-V ...will be controlled along with state-mandated controlled substances ...

Controlled medications in patient care areas, pharmacy and/or designated storage areas are to be maintained in an automated dispensing cabinet (ADC) or locked in a substantially constructed cabinet (hereafter referred to as locked box that is stored in a locked area.

11. Patient specific controlled substances delivered to floor must be signed for by a nurse. Pharmacy technician will return signed form to pharmacist for reconciling. Medication signed for is for immediate administration and cannot be stored unsecured. If medication I not administered, medication must be returned to pharmacy immediately.

Based on interviews and records review, the hospital failed to have a system in place to accurately track and report medication errors to the hospital wide Quality Improvement (QI) Committee for 2 out of 2 campuses as evidenced by:

1) Relying on self-reporting of errors by the nursing staff as the only means of data collection for QI at 2 of 2 campuses (main campus and off-site campus).

2) Eighteen medication order errors being discovered by surveyors that were not recognized by the pharmacy department or self-reporting of medication errors for 10 of 44 sampled patients (#1, #2, #21, #23, #31, #32, #33, #41, #42, #43). (see tag A0405)

Findings:

1) Relying on self-reporting of errors by the nursing staff as the only means of data collection.

In an interview on 11/9/12 at 8:45 a.m. with Pharmacy Director (S32), she said the only system for data collection of medication errors used in Quality Improvement (QI) was self-reporting by the staff. S32 said when a nurse made a medication error, they were expected to self-report the error in the Meditech system. S32 said the medication error rate for both campuses was calculated by dividing the medications dispensed by the events reported monthly. She further said the current average medication error rate for both campuses was .0001 % (per cent). She said out of an estimated 135,000 medications dispensed, only 26-36 errors were reported. S32 stated, The error rate calculated for the hospital was not at all accurate. S32 verified other than self- reporting, no random chart audits or other means were used by the staff to collect accurate medication error data. S32 said she realized there was a problem with the accuracy of the medication error rate, but nothing had been put into place to more accurately track and trend the errors. S32 said when medications were overridden or omitted in the computerized medication dispensing system, the numbers were tabulated every month, but not included in the error rates in QI or listed as an occurrence in the Meditech system. S32 said self-reporting was non-punitive, but some people may have been afraid of repercussions. S32 said there was a definite problem with the collection of data for medication errors.

In an interview on 11/9/12 at 2:30 p.m. with Risk manager (S11), she verified that self-reporting of medication errors was not an accurate representation of the medication errors at the hospital.

In an interview on 11/15/12 at 3:35 p.m. with the Vice President of Quality (S58), she verified the only information used for tracking, trending and remediation of errors in QI was self-reporting of medication errors.

Review of the Policy titled Medication Error Reporting, Policy No: 3.21, Effective Date: August 2012 revealed in part:

B. A Medication Error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.

D. An occurrence report will be completed in Meditech when a medication error occurs.

2) Eighteen medication order errors being discovered by surveyors that were not recognized by the pharmacy department or self-reporting of medication errors. (see findings in tag A0405)

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on records review and interviews, the hospital failed to ensure that all patient medical record entries were dated, timed, and authenticated in accordance with the hospital's medical staff rules and regulations for 10 of 44 sampled patients (#1, #11, #19, #27, #28, #29, #30, #31, #41, #42). Findings:

Patient #1

Record review revealed Patient #1 was a female infant born on 8/26/12 and admitted on [DATE] for VSD (Ventricular Septal Defect), PDA ([DIAGNOSES REDACTED]) and PFO (Patent Foramen Ovale) closures, repair of [DIAGNOSES REDACTED] arch and end to end anastomosis of coarctation.

Review of the medical record for Patient #1 revealed a surgery note signed by the physician and dated 11/5/12. Further review revealed the document was not timed.

Patient #11

Review of the patient's record revealed the patient was a [AGE] year old male who presented to the Emergency Department (ED) on 10/13/12 at 7:07 p.m. by ambulance with a chief complaint of having hallucinations and use of LSD, Ecstasy (Hallucinogenic drugs). Review of the Emergency Physician Record revealed EMR (Electronic Medical Record) was documented in the space for Time Seen. There was no documented evidence on the Emergency Physician Record of the time the physician saw the patient and performed the evaluation of the patient.

Review of the electronic record revealed a Greeted date/time of 10/13/12 at 1910 (7:10 p.m.). There was no documented evidence of who entered the Greeted time, and there was no evidence of authentication of the Greeted time.

Patient #19

Review of the patient's record revealed the patient was an [AGE] year old female who (MDS) dated [DATE] at 9:57 a.m. ambulatory with a chief complaint of suicidal ideations. Review of the Emergency Physician Record revealed see EMR was documented in the space for Time Seen. There was no documented evidence on the Emergency Physician Record of the time the physician saw the patient and performed the evaluation of the patient.

Review of the electronic record revealed a Greeted date/time of 11/12/12 at 1008 (10:08 a.m.). There was no documented evidence of who entered the Greeted time, and there was no evidence of authentication of the Greeted time.

Patient #27

Review of the patient's record revealed the patient was a [AGE] year old male who (MDS) dated [DATE] at 12:06 a.m. by ambulance with a chief complaint of chest pain. Review of the Emergency Physician Record revealed EMR was documented in the space for Time Seen. There was no documented evidence on the Emergency Physician Record of the time the physician saw the patient and performed the evaluation of the patient.

Review of the electronic record revealed a Greeted date/time of 10/24/12 at 0017 (12:17 a.m.). There was no documented evidence of who entered the Greeted time, and there was no evidence of authentication of the Greeted time.

Patient #28

Review of the patient's record revealed the patient was a [AGE] year old female who (MDS) dated [DATE] at 4:43 p.m. by ambulance with a chief complaint of Alcohol intoxication. Review of the Emergency Physician Record revealed see EMR was documented in the space for Time Seen. There was no documented evidence on the Emergency Physician Record of the time the physician saw the patient and performed the evaluation of the patient.

Review of the electronic record revealed a Greeted date/time of 11/07/12 at 1645 (4:45 p.m.). There was no documented evidence of who entered the Greeted time, and there was no evidence of authentication of the Greeted time.

Patient #29

Review of the patient's record revealed the patient was a [AGE] year old female who (MDS) dated [DATE] at 5:19 p.m. by ambulatory with a chief complaint of right lower abdominal pain and possibly pregnant. Review of the Emergency Physician Record revealed see EMR was documented in the space for Time Seen. There was no documented evidence on the Emergency Physician Record of the time the physician saw the patient and performed the evaluation of the patient.

Review of the electronic record revealed a Greeted date/time of 11/02/12 at 1722 (5:22 p.m.). There was no documented evidence of who entered the Greeted time, and there was no evidence of authentication of the Greeted time.

In a face-to-face interview on 11/08/12 at 2:40 p.m., S21 Director of ED Patient Services stated the Greeted time in the electronic record was the time the ED physician saw the patient. S21 stated either the physician or nurse entered the Greeted time. S21 verified the electronic record did not include authentication of the Greeted time. S21 verified the Emergency Physician Records for Patient #11, #19, #27, #28, and #29 did not include the time the patients were seen by the physician.

Patient #30

Review of the medical record for Patient #30 revealed the patient was a 1 year, 9 month old male who had an Adenoidectomy on 11/09/12 as an outpatient. Review of the pre-operative physician's orders revealed the orders were signed and dated by the physician on 09/06/12. There was no documented evidence of the time the physician wrote the orders.

Further review of the physician's orders for Patient #30 revealed the post-operative orders were signed by the physician on 11/09/12. There was no documented evidence of the time the physician wrote the orders.

In a face-to-face interview on 11/09/12 at 9:45 a.m., S11 Risk Manager verified the above physician's orders were not timed by the physician.

Patient #31

Review of Patient #31's medical record revealed that she was a [AGE] year old female who had a Laparoscopic Cholecystectomy on 11/09/12. Review of the Physician's Order revealed an order was written to consult anesthesia for pre-operative orders and to draw blood work in the morning. There was no documented evidence of the date and time that the physician wrote the orders.

Patient # 41

Review of the medical record for Patient #41 revealed she was a female infant born on 10/31/12 admitted to the hospital for prematurity and possible sepsis.

Review of the progress notes for Patient #41 dated 10/28/12, 10/29/12, and 11/21/12 revealed a physician ' s signature, a date at the tops of the pages, and a time the document had been printed, but no time of authentication of the document by the physician.

Patient #42

Review of Patient #42's medical record revealed that she was a [AGE] year old female who had a surgical procedure on 11/13/12. Review of the Post Op Minor Surgery Orders dated 11/13/12 revealed no documented evidence of the time the orders were written by the physician.

In a face-to-face interview on 11/13/12 at 11:10am, RN S66, Clinical Supervisor of Surgery at the off-site campus, confirmed that the physician did not date and time the orders when he wrote the above orders.

Review of the hospital's Medical Staff Rules and Regulations, revised 07/23/12 and presented as the current rules and regulations by Vice-President of Nursing S15 at the off-site campus, revealed, in part, ...All clinical entries in the patient's record must be accurately dated and timed and individually authenticated. Authentication means to establish authorship by either approved electronic tag, or written signature as close to attestation statement as possible...

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interviews, the hospital failed to ensure that a registered nurse (RN) supervised and evaluated the nursing care for each patient.

1) The RN failed to ensure 1:1 (one-to-one) observation of PEC (Physician's Emergency Certificate) patients in the ED was performed as ordered by the physician and according to hospital policy for 2 of 2 sampled PEC patients reviewed out of a total sample of 44 patients (#11, #19). The RN failed to ensure Patient #11 was monitored by an assigned and dedicated staff member within arms reach of the patient. This resulted in the elopement of Patient #11 from the Emergency Department (ED) on 10/13/12. The RN failed to ensure a PEC'd suicidal patient (#19) was observed/monitored by a staff member, and relied on the patient's guardian to ensure the safety of the patient while in the ED.

2) The RN failed to assess and monitor patients during blood transfusions according to hospital policy for 1 (#43) of 4 sampled patients' records reviewed for blood transfusions from a total sample of 44 patients and 2 random patients' records reviewed for blood transfusions from a total of 3 random patients. The RN failed to monitor Patient #43 during the transfusion of 2 units of blood on 11/06/12 and 11/07/12.

3) The RN failed to ensure the patient's Aldrete Score (recovery room scoring system for patients) was assessed accurately as evidenced by the patient's circulation being assessed as a 2 rather than a 1 when using the policy for determining the Aldrete Score in PACU (post anesthesia care unit) for 1 of 6 surgical patients' records reviewed from a total of 44 sampled patients (#33).

Findings:

1) The RN failed to ensure 1:1 observation of PEC patients in the ED was performed as ordered by the physician and according to hospital policy:

Patient #11

Review of the patient's medical record revealed the patient was a [AGE] year old male who (MDS) dated [DATE] at 1907 (7:07 p.m.) by ambulance with a chief complaint of change in mental status/neurological status.

Review of the Emergency Physician Record dated 10/13/12 at 2130 (9:30 p.m.) revealed the physician documented, Patient PEC'd on 1:1 observation, will be transferred to Psych at (main campus). Clinical Impression: Psychosis. Further review of the document revealed the following: 2230 (10:30 p.m.) Patient left room per RN. Premises searched by myself and staff. Unable to locate. Police notified. Missing person report filed.

Review of the physician's orders dated/timed 10/13/12 at 1913 (7:13 p.m.) revealed an order for Suicide Precautions and Elopement Precautions.

Review of the PEC dated/timed 10/13/12 at 2138 (9:38 p.m.) revealed the patient was PEC'd due to being dangerous to self, gravely disabled, and unable to seek voluntary admission.

Further review of the nursing documentation revealed the following:

Emergency notes - Patient with one to one observation per Medical/Nursing staff, entered by S42RN on 10/13/12 at 1915 (7:15 p.m.)....

Patient with one to one observation, entered by S42RN on 10/13/12 at 2100 (9:00 p.m.).

Patient seen exiting building on security camera from ambulance entrance wrapped in sheet. Security was notified of patient missing from room at 2205 (10:05 p.m.). (Local sheriff's department) deputy looking around parking lot for patient. All rooms in ER checked including both bathrooms. (S44USC) Secretary was at patient bedside she looked up for a moment and when looked back patient was gone. Entered by S43RN on 10/13/12 at 2205 (10:05 p.m.) 911 called for assistance to locate patient, entered by S43RN on 10/13/12 at 2220 (10:20 p.m.).

There was no documented evidence that 1:1 observation of the patient by an assigned and dedicated staff member within arms reach of the patient was done, and there was no documentation of every 15 minute observations as the hospital policy directed from 7:13 p.m. to 10:00 p.m. (when the patient was found to be missing).

In a face-to-face interview on 11/09/12 at 10:00 a.m., the ED Director of Patient Services, S21 verified Patient #11 eloped from the ED on 10/13/12 while under a PEC with 1:1 observation ordered by the physician. S21 stated the patient slipped out the ambulance entrance while a patient was being transported out the doorway. After reviewing the patient's record, S21 verified the only documentation that 1:1 observation was implemented was one entry at 2100 (9:00 p.m.). S21 verified every 15 minute observations were not documented. S21 stated when a PEC patient is in the ED, the USC (Unit Service Coordinator-Clerical) was assigned to observe the patient. S21 stated the USC staff do not document patient observations. S21 verified the USC staff (S63USC and S64USC) had not received training in crisis prevention intervention techniques. S21 further indicated only the nursing staff and security staff received training in crisis prevention intervention.

In a face-to-face interview on 11/13/12 at 9:05 a.m., S43RN verified she was the ED Supervisor on 10/13/12 when Patient #11 eloped from the ED. S43RN verified she had made the assignments for that shift. S43 verified the physician had ordered suicide and elopement precautions for Patient #11. S43RN stated S44USC was pulled to the ED that night and stated she usually works as a secretary on the post partum unit. S43RN verified S44USC was assigned to watch Patient #11. S43RN stated the only documentation of observation would be in the nursing documentation and stated the USC did not document patient observations in the record. After reviewing the patient's record, S43 confirmed the above documentation was the only documentation of any observation and monitoring of Patient #11.

In a face-to-face interview on 11/13/12 at 12:55 p.m., S42RN verified he was assigned to Patient #11 on 10/13/12, 7:00 p.m. to 7:00 a.m. shift. S42 stated once the patient was PEC'd, the patient was put on observation. S42 stated he was observing the patient initially, and Ms. (S44 USC) was helping me. We were full. The patient was in a which is a private spot. S42RN stated he told S44USC, We need to watch him, keep an eye on him, observe him. S42 verified the physician ordered 1:1 observation, and stated he and S44USC were providing 1:1. S42RN verified he was responsible for the observation/monitoring of Patient #11. S42RN stated he had helped change the patient's bed, shortly before he left, but was unable to give the time this occurred. S42 stated when he returned to the patient's room, the patient was gone. S42RN stated he did not know where S44USC was at this time, but he did not have to walk around her to go into the patient's room. When asked what 1:1 monitoring and observation was, S42RN stated, 1:1 means someone watches at all times. S42 stated the primary nurse was responsible and stated he had asked S43USC to watch the patient. S42 stated S43USC was not in the room with the patient, she was either in the door or in the long hall. After reviewing the patient's medical record and an entry of, Patient with one to one observation per Medical/Nursing Staff on 10/13/12 at 7:15 p.m., S42RN stated this means we were all watching. After review of the Suicide Prevention Plan policy, S42 was unable to explain if assigned and dedicated staff had provided observation of the patient within arms reach at all times. S42RN was unable to provide documentation of every 15 minute observations of Patient #11 as directed per hospital policy.

In a face-to-face interview on 11/13/12 at 2:04 p.m., S44USC verified she worked on the post-partum unit as the unit secretary and she was pulled to the ED on 10/13/12 for the 3:00 p.m. to 11:00 p.m. shift. S44USC stated she was very seldom pulled to the ER, and she had only answered the telephone or entered charges in the past. S44USC stated S42RN asked her to keep an eye on the patient (#11) when he (S42RN) came out of the room. S44USC stated she stood outside the door of a. S44USC stated she was also assisting EMS staff with a patient in b, and was answering the telephone in the nurse's station. S44USC verified she had her back to Patient #11's room when she answered the telephone. S44USC stated she was aware Patient #11 was under a PEC. S44USC denied receiving any directions from S42RN, and stated she only remembered being told to keep an eye on the patient. S44USC stated she had never been assigned to monitor a PEC patient before 10/13/12. S44USC stated she had not received any training on monitoring PEC patients, and had not received any training in crisis prevention intervention. S44USC also stated no one had asked her if she had training in monitoring PEC patients before assigning her to monitor Patient #11.

Review of the hospital policy titled Suicide Prevention Plan, policy number NSG 4.26, effective date February 2007, reviewed date 09/11, and provided as current policy for supervision of PEC'd patients by the Director of ED Patient Services at the off-site campus (S21), revealed in part the following:

Purpose: The purpose of this policy is to ensure the safety and appropriate care of the patient with suicidal ideation and/or past suicide attempt. It is the responsibility of all (hospital name) personnel to adhere to this policy....

Suicide Risk Screening and Assessment:

1. ....Emergency Department Registered Nurses will only screen patients admitted to the ED with a primary focus/complaint of a behavioral issue(s) and/or if the RN has any clinical concerns for any patients presenting with risk for self-harm.

2. Any patient response of Yes to any of the interview questions on the Suicide Risk screening will identify the patient as at risk for suicide. These patients will be placed on suicide precautions, and the RN will assign patient observation monitoring immediately. A LIP (Licensed Independent Provider) order will be generated in order to gain further suicide risk assessment .... and determine an ongoing safety observation and monitoring level. Safe environment and patient safety guidelines will be documented and implemented to ensure the environment and patient will be safe....

3. For all patients identified as a risk for suicide, the LIP order initiated will define the level of patient observation and monitoring that will be continued....

Heightened Observations:

1. Patients who are screened/assessed to be at risk for suicidality will be placed on patient observation and monitoring as assigned by the RN and reassess after the.....assessment is completed. The patient may be placed on every 15 minute monitoring (Standard Observations), continuous visual or line of sight observation or on a one to one (1:1) observation status as outlined in the Level of Observation definitions below (Use the Monitoring Documentation form for all levels of observation)....

2. Level 1 = Standard Observation - Monitor and observe minimally every 15 minutes. Staff visually observes the patient at least every 15 minutes....

3. Level 2 = Line of Sight Observation - Line of sight at all times monitoring and observation. Continuous visual observations means that at no time is the patient out of the visual contact of a staff member....

4. Level 3 = 1:1 monitoring and observation. The patient is never to be out of arms reach of the assigned and dedicated staff member.... Hallmark guidelines for 1:1 observation: 1. The assessment supports 1:1 and the patient is reporting one of the following risk symptoms: a. Has attempted suicide attempt in the last 48 hours; b. Has displayed any self injurious behaviors in the last 8/12 (shift specific) hours; c. Is currently verbalizing suicidal ideation with a plan to harm self; d. Has command hallucinations to harm self; e. Verbalizing hopelessness....

Suicide Precautions:

1. Staff will closely observe and document rounds on the patient at least every 15 minutes or more often if heightened observations have been ordered....

2) The RN failed to assess and monitor patients during a blood transfusions according to hospital policy:

Patient #43

Review of Patient #43's medical record revealed that she was a [AGE] year old female admitted on [DATE] to the rehabilitation unit with a diagnosis of CVA (Stroke). Review of the Physician's Order dated 11/06/12 at 1:00 p.m. revealed an order to transfuse 2 units of packed red blood cells each over 3-4 hours. The physician's orders also revealed an order dated/timed 11/06/12 at 4:00 p.m. to transfuse blood when ready.

Review of Patient #43's medical record revealed that Unit #1 began at 1829 (6:29 p.m.) and was started by S48RN. Review of the nursing documentation and the BCTA system revealed no documented evidence that a RN monitored the transfusion of the 1st unit after 7:50 p.m. There also was no documented evidence of when the first unit was completed. Further review of the record revealed Unit #2 began at 2310 (11:10 p.m.). There was no documented evidence that the second unit was hung by an RN. There was no documented evidence that an RN monitored the patient during the transfusion of the second unit, and there was no documentation of when the second unit was completed. Further review of the medical record revealed all nursing entries in the electronic nursing record and the BCTA system in Meditech were made by S37LPN from 7:50 p.m. on 11/06/12 to 6:57 a.m. on 11/07/12.

In a face-to-face interview on 11/13/12 at 11:00 a.m. S48RN stated she was the RN that started the first unit of blood on 11/06/12 at 6:29 p.m. S48 stated she was off duty at 7:00 p.m. and did not complete the transfusion process. After reviewing the BCTA system, she verified the completion time for both units had not been entered into the system.

In a face-to-face interview on 11/14/12 at 2:15 p.m., the Vice President of Nursing at the off-site campus, S15 confirmed there was no documented evidence that an RN monitored the patient during the transfusions and there was no documented evidence that an RN hung the second unit of blood. S15 verified the only documentation of monitoring of the patient after 7:50 p.m. was by S37LPN. S15 confirmed the hospital policy indicated the RN was to hang/administer and monitor blood transfusions, and the RN could only delegate the vital signs to the LPN.

Review of the hospital policy titled, Blood or Blood Product Administration, Policy number NSG.4.01, revised 02/12, and provided as current policy by S15 Vice President of Nursing at the off-site campus, revealed in part the following: 2. Blood and blood products must be hung and monitored by a Registered Nurse or physician. Vital signs may be delegated to the LPN, PCA, or MOA (Licensed Practical Nurse, Personal Care Assistant, Medical Office Assistant).

3) The RN failed to ensure the patient's Aldrete Score (recovery room scoring system for patients) was assessed accurately:

Review of Patient #33's medical record revealed that he was a [AGE] year old male who had an excision of a scar and foreign body removal of his right cheek with a layered closure on 11/08/12. Further review revealed his pre-operative blood pressure was 106/78 (minus 20% [per cent] would be 84.8/62.4 - which was the lowest score on the Aldrete Score that would allow the circulation rate to remain at a score of 2).

Review of Patient #33's PACU Vital Signs revealed the following:

11/08/12 at 9:25am - 95/40

11/08/12 at 9:40am - 81/38

11/08/12 at 10:48am - 98/45

Review of Patient #33's PACU / Phase II Aldrete Score revealed his circulation was scored a 2 on 11/08/12 at 9:25am, 9:40am, and 10:50am while his blood pressure was more than 20% below his pre-operative blood pressure which required a score of 1 according to the Aldrete Score policy.

In a face-to-face interview on 11/14/12 at 2:45pm, RN S61 indicated that she did not notify the physician of Patient #33's low blood pressure, because she didn't perceive the blood pressure as a problem. S61 confirmed that she didn't rate Patient #33's Aldrete Score accurately if you're going by the specific numbers.

Review of the hospital policy titled Patient Discharge / Transfers?, policy number Nsg-PACU 1.12, reviewed 11/22/10, and presented as a current policy by Vice-President of Nursing of the off-site campus S15, revealed, in part, ...Recovery Room System ... Circulation BP (blood pressure) = (equals) 20% of preanesthetic level 2, BP = 20-50% of preanesthetic level 1, BP = 50% more of preanesthetic level 0...

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and interviews, the hospital failed to ensure that a pre-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia within 48 hours prior to surgery or a procedure requiring anesthesia for 2 of 6 patients' records reviewed who had anesthesia services from a total of 44 sampled patients (#32, #33). Findings:

Patient #32

Review of Patient #32's medical record revealed that he was a [AGE] year old male who had an implant removal from the left clavicle, left distal tibia, and left lateral malleolus on 11/08/12.

Review of Patient #32's Preanesthetic Evaluation revealed Anesthesiology Nurse Practitioner S70 performed the preanesthetic evaluation on 11/02/12, 6 days prior to the surgical procedure. Further review revealed the form was signed by an anesthesiologist with no documented evidence of the date and time the anesthesiologist reviewed and signed the preanesthetic evaluation.

Patient #33

Review of Patient #33's medical record revealed that he was a [AGE] year old male who had an excision of a scar and foreign body removal of his right cheek with a layered closure on 11/08/12.

Review of Patient #33's Preanesthetic Evaluation revealed Anesthesiology Nurse Practitioner S70 performed the preanesthetic evaluation on 11/02/12, 6 days prior to the surgical procedure. Further review revealed the form was signed by an anesthesiologist with no documented evidence of the date and time the anesthesiologist reviewed and signed the preanesthetic evaluation.

In a face-to-face interview on 11/14/12 at 9:50am, Head of Anesthesia at the off-site campus S52 indicated that the preanesthesia evaluation was done several days prior to the procedure. He further indicated that the anesthesiologist assessed the patient before the patient went to surgery. When asked about the patients' evaluations not having a date and time of the anesthesiologist's visit prior to surgery, S52 indicated is there a place for a date and time?. He further asked if the nurses had documented anything in the record to show that the anesthesiologist had visited the patient.

Review of the hospital policy titled Preanesthesia Assessment, policy number ANES 3.0, revised 11/19/10, and presented as the current policy by Vice-President of Nursing S15 at the off-site campus, revealed, in part, ...3. Preanesthesia patient assessment is performed before the operative procedure by a member of the anesthesia team (CRNA [certified registered nurse anesthetist] or anesthesia resident and staff anesthesiologist). The plan for anesthesia is discussed with the patient. The patient is reevaluated on the day of the procedure by the anesthesiologist. ... 8. The preoperative evaluation is written and documented in the patient's chart describing medical history, post anesthetic history, the physical examination, drug and alcohol history, allergies, laboratory results, ASA (American Society of Anesthesiologists) classification and the recommendations of any consultations. ... Requirements Prior To Induction of Anesthesia & (and) Operation ... (2) ... The anesthesiologist must document in the record a pre-anesthesia evaluation of the patient including pertinent information relative to the choice of anesthesia and the procedure anticipated, pertinent previous drug history, other pertinent anesthetic experiences, and any potential anesthetic problems. ... Immediately prior to induction, the patient is reassessed by the anesthesiologist and documented on the anesthesia record...

Based on review of the medical records, Anesthesia Policy and Procedures, and staff interviews, the hospital failed to complete and document a post anesthesia evaluation other than at the point of transfer from the operative area to the designated recovery area for 1 (#30) of 6 sampled surgical patients from a total sample of 44 patients. Findings:

Patient #30

Review of the medical record for Patient #30 revealed the patient was a 1 year, 9 month old male who had an Adenoidectomy on 11/09/12 as an outpatient.

Review of the Anesthesia Record dated 11/09/12 revealed the patient received general anesthesia starting at 6:54 a.m. the anesthesia stop time was documented as follows:

0727/0723 (7:27 a.m./7:23 a.m.). Review of the Post Anesthesia Evaluation revealed the evaluation was done on 11/09/12 at 0727 (7:27 a.m.) and was signed by S47CRNA (Certified Registered Nurse Anesthetist).

Further review of the Post Anesthesia Evaluation revealed the following:

Outpatient evaluations must be completed prior to discharge.

Respiratory Function: Respiratory Rate 21-24, 97-99% (Oxygen saturation)

Cardiovascular Function: 86/36 (Blood Pressure), Heart Rate 126.

Mental Status: Awake, alert.

Temperature: 97.6

Pain: none

Nausea and Vomiting: none

Postoperative hydration status: adequate

Other elements of concern or comments: none

Review of the PACU (Post Anesthesia Care Unit) dated/timed 11/09/12 at 7:23 a.m. and 7:30 a.m. revealed the patient was unresponsive and sedated. Review of an entry at 7:50 a.m. revealed the patient was awake and crying.

In a face-to-face interview on 11/13/12 at 10:10 a.m., S47CRNA stated 7:27 a.m. was the time he finished giving report to the PACU nurse. S47 verified he documented the Post Anesthesia Evaluation at this time. S47 stated he left the PACU at 7:27 a.m. to go to another case in surgery and stated, Outpatients are so fast. S47 stated the PACU nurse can call anesthesia if there are any problems. S47 stated if the patient had any complications, he (S47) would come back to PACU, evaluate the patient, and add another time to the Post Anesthesia Evaluation. S47 confirmed there was no other Post Anesthesia Evaluation of Patient #30 after 7:27 a.m.

Review of the hospital policy titled, The Patient is Monitored During the Post-procedure Period, Policy number: Anes 12.0, Last Reviewed: November 19, 2012, Originating Department/Committee: Anesthesiology, and provided as current policy by S11 Risk Manager, revealed in part the following: Post-Operative Care/Documentation: I. Purpose: To evaluate the patient's post-anesthetic status and to ascertain any potential complication related to anesthetic management. II Procedures: 1. All patients receiving anesthesia (other than local) will be evaluated subsequently to discharge from the post-anesthetic PACU. Generally, this will be within 48 hours postoperatively. The post-operative visits should be completed by an attending or resident physician anesthetist....

Based on observations, interviews, and record reviews, the hospital failed to meet the requirements of the Condition of Participation for Medical Records as evidenced by:

Failing to properly store over 139,000 medical records to protect them from water damage. (See findings tag A0438).

Based on interviews and records review, the hospital failed to develop an effective system for identifying errors in medication administration for Quality Improvement (QI) as evidenced by:

1) Relying on self-reporting of errors by the nursing staff as the only means of data collection at 2 of 2 campuses (main campus and off-site campus).

2) Eighteen medication order errors being discovered by surveyors that were not recognized by the pharmacy department or self-reporting of medication errors for 10 of 44 sampled patients (#1, #2, #21, #23, #31, #32, #33, #41, #42, #43). (see findings in tag A0405)

Findings:

1) Relying on self-reporting of errors by the nursing staff as the only means of data collection for QI.

In an interview on 11/9/12 at 8:45 a.m. with Pharmacy Director S32, she said the only system for data collection of medication errors used in Quality Improvement (QI) was self-reporting by the staff. S32 said when a nurse made a medication error, they were expected to self-report the error in the Meditech system. S32 said the medication error rate for both campuses was calculated by dividing the medications dispensed by the events reported monthly. She further said the current average medication error rate for both campuses was .0001 %. She said out of an estimated 135,000 medications dispensed, 26-36 errors were reported. S32 stated, The error rate calculated for the hospital was not at all accurate . S32 verified other than self- reporting, no random chart audits or other means were used by the staff to collect accurate medication error data. S32 said she realized there was a problem with the accuracy of the medication error rate, but nothing had been put into place to more accurately track and trend the errors. S32 said when medications were overridden in the computerized medication dispensing system, the numbers were tabulated every month, but not included in the error rates in QI or listed as an occurrence in the Meditech system. S32 said self-reporting was non-punitive, but some people may have been afraid of repercussions. S32 said there was a definite problem with the collection of data for medication errors.

In an interview on 11/9/12 at 2:30 p.m. with Risk manager S11, she verified that self-reporting of medication errors was not an accurate representation of the medication errors at the hospital.

In an interview at 11/15/12 at 3:35 p.m. with the Vice President of Quality S58, she verified the only information used for tracking, trending and remediation of errors in QI was self-reporting of medication errors.

2) Eighteen medication order errors being discovered by surveyors that were not recognized by the pharmacy department or self-reporting of medication errors for 10 of 44 sampled patients. (see tag A0405)

Based on observations, interviews, and record reviews, the hospital failed to meet the requirements of the Condition of Participation of Pharmaceutical Services as evidenced by:

1) Failing to develop and implement a system to ensure that physician orders for medications included a specific dose and frequency with the specific instructions for use as evidenced by having a hospital policy that allowed medication ranges to be ordered. This resulted in physician orders for medications with ranges in dose and no order for frequency between repeated dosing for 4 of 6 patients' records reviewed who had a surgical procedure (#31, #32, #33, #42) and for 1 of 6 Medical - Surgical records reviewed (#23) from a total of 44 sampled patients.

(Refer to tag A0491)

2) Failing to ensure medication orders were accurate and complete before creating medication administration records and dispensing medications for 4 ( #1, #2, #21, #41) of 44 sampled patients.

(Refer to tag A0491)

3) Failing to provide patient safety and to control and distribute drugs and biologicals in accordance with applicable standards of practice as evidenced by not having a system in place for medication orders in non-emergency situations in the ED (Emergency Department) to be reviewed for appropriateness by a pharmacist before the first dose was dispensed. The pharmacy failed to review first dose medications in non- emergent cases in the ED for therapeutic appropriateness, therapeutic duplication, appropriateness of the drug, dose, frequency, route and method of administration, interactions, and other contraindications. (Refer to tag A0500)

4) Failing to ensure schedule II and schedule IV medications were locked within a secure area. Syringes containing Fentanyl Citrate and Phenobarbital were stored in an unlocked drawer of a plastic box in the supply room in the PICU (pediatric intensive care unit) that was accessible to the nursing staff, unit secretary, housekeeping staff, and the supply delivery staff. (Refer to tag A0503)

5) Failing to have a system in place to accurately track and report medication errors to the hospital wide Quality Improvement Committee for 2 out of 2 campuses.

(Refer to tag A0508)