HCA Florida Osceola Hospital

Based on observation, interview and record review, the facility failed to ensure a sanitary environment by ensuring staff removed all sources of contamination from surgical instruments during the pre-wash phase of sterilization, and failed to monitor sterilized instruments after processing was completed to ensure there is no residue on the instruments prior to performing surgical procedures on patient in the operating room resulting in non-compliance with the Condition of Participation for Infection Control and an Immediate Jeopardy situation with the potential to affect any patient receiving a surgical procedure at the facility. The facility does approximately 400 surgical procedures per month and on 3/18/2013 there were 31 surgical procedures scheduled.

Findings:

During an observation on 3/18/2013 at 2 p.m., central sterile technician staff #L was cleaning instruments in the sink and preparing them for placement, in trays, in the instrument washer. One tray was observed to have some instruments with some red colored and other unknown materials still on the instruments. She was asked if she ensures the instruments are free of materials from the surgical procedures before she places in the instrument washing machine and she responded, No, not always. She said she soaks the instruments, and then the instrument washer should take care of the rest, and if anything was left, it would be identified prior to the wrapping. This observation and interview was witness by the assistant chief nursing officer (ACNO).

During a tour on 3/18/2013 at 2:20 p.m., the sterile instrument storage area was observed with multiple sterilized surgical trays and other sterile items stored on shelving units.

On 3/18/2013 at 2:30 p.m., a sterile tray was requested to be opened to inspect the instruments. The sterile processing department (SPD) supervisor was asked to select a tray that would not be needed immediately. She selected one tray labeled as a minor tray, and labeled as last processed on 3/18/2013. She stated the tray was either used today or over the weekend. She selected a Mayo Hegar 7 ? inch () and 6 ? (both instruments designed to hold a suture and needle during procedures) and both were wiped with a white cloth and both had a gray substance of an unknown origin. The gray residue was not visible to the eye on either instrument.

She then selected another tray labeled as a major hysterectomy tray, processed last on 3/15/2013, opened it and selected a Mayo Hegar 9, 7 1/4, and a Heaney needle holder. She wiped all of the instruments with a white cloth and all three instruments had a grey unknown residue found on the white cloth. Again, this gray residue was not visible to inspection.

During an interview on 3/18/2013 at 2:20 p.m., the SPD supervisor, employed at the hospital for the past 2 months, said currently there was no system in place to determine what patient, case, or doctor the instruments were used on last. When asked where she thinks the residue came from, she said it could be from the detergent concentration, the way the instruments were pre-cleaned, or it could be from the age of the instruments, they could be at their end of life cycle. She also said the needle holders have grooves and really require scrubbing when cleaned.

On 3/18/2013 at 3:10 p.m. during an observation of the instrument wrapping area, an interview was conducted with central sterile technician, staff #F who said he routinely wipes all plastic coated type handles and cords. However, he does not routinely wipe or check for any gray residue or any compromise on any of the metal instruments.

On 3/19/2013 at 4 p.m., the risk manager provided an email from the operating room educator dated 3/19/2013 at 1:02 p.m. from the repair agency for the instruments communicating the following information: The repair agency person stated that often the tungsten carbide inserts in the needle holders has to be replaced due to a) wear and tear; b) the water or detergents used; and c) the larger needles used can cause the softer tungsten carbide to shed small grey-black particles. Most often, it is found that it is the wear of the instrument since steel is harder composite than the tungsten carbide that grips the needle. The scored tungsten carbide in the inserts can after much use shed the fine grey-black particles found after being processed in SPD.

During an interview on 3/21/2013 at 1:40 p.m., operating room technician staff #N said she has been with the hospital for about 2 years. She said she has witness the gray residue on instruments during the past 2 years. She said on one occasion, she thought was last year, during a kidney/prostate case, she observed the surgeon's glove get wet, and the gray residue was visible on his gloves. When asked if the surgeon discarded the instrument, she responded no. She also said she had observed small bits of bone on Kerrison bone biting instruments used during spinal cases. She said she has always discarded these instruments and obtained others prior to patient contact. She said she would report these occurrences to the operating room manager and the charge nurse.

During an interview on 3/21/2013 at 1:50 p.m., the operating room manager, employed at the hospital for the past 11 years, confirmed there have been reports of dirty instruments in the past. She said when this happens, the instruments are discarded from the patient cases and re-processed.

During an interview on 3/21/2013 at 1:55 p.m., the operating room technician staff #M said he has been at the hospital for about 2 years. He said that he has never seen the gray residue but about 2 years ago when he first started, he was in the process of opening up the sterile instrument for a case and found tissue in a biopsy forceps instrument. He said he immediately removed all of the instruments and obtained all new sterile instruments for the case. He said about 1 year ago, he found bone fragments on a Tap 5.0 instrument and had to return it for re-processing. Yesterday (3/20/13), when opening the instruments for a surgical procedure, he inspected one of the cannulated (tube-like) instruments and visually saw debris. He wiped it with a Q-tip and found a reddish colored substance that he thought was possibly blood. He said he discarded all of these instruments and obtained others prior to patient contact. He said he reports these type incidents to the operating room manager or the charge nurse.

Both the operating room manager and the operating room technician staff #M said they felt there has been an improvement in the quality of instrument sterilization since a new sterile processing supervisor was hired about 2 months ago.

Review of the policy Decontamination of Instruments, dated as reviewed last 2/2012, states the policy purpose is:

To assure safe and efficient handling of used/contaminated instruments.

The policy is-All instruments removed from the sterile packaging will be cleaned and decontaminated as soon as possible after use.

The procedure states-d) All instruments need to be inspected before entering the automated washer for its need to be manually cleaned.

During an interview on 3/18/2013 at 3:15 p.m., the SPD supervisor said the Association for the Advancement of Medical Instrumentation is used for standards of practice related to instruments (ANSI/AAMI). Review of page 55, dated 2010 provided by the supervisor of SPD, showed the following rationale in the 7.5.1-General Considerations as follows: The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates, microorganisms, and potential pyrogens. The accepted standard for the degree for cleanliness is 'visibly clean.' Thorough cleaning and rinsing are vital to the effectiveness for subsequent microbicidal process used for decontamination, disinfection, and/or sterilization. The amount of residue that remains will vary depending on the conditions of use of the cleaning agents, the specific component materials of the reprocessed devices, and the methods used to reduce residuals before reuse. Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction....Adequate cleaning and rinsing should result in low bioburden, which is essential to the effectiveness of terminal sterilization and to the protection of patients form pyrogens.

During an interview on 3/18/2013 at 2:30 p.m., the sterile processing department (SPD) supervisor said that currently there was no routine preventative maintenance program in place related to surgical instruments.

During an interview on 3/19/2013 at 3:45 p.m., the chief nursing officer said she believes the last time the instrument maintenance company was at the facility was November of 2012.

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

Based on interview, record review and a review of hospital documentation, the hospital failed to ensure that it reported to CMS (Ceters for Medicare & Medicaid Services) each death that occurs within 24 hours after the patient has been removed from restraint in the form of full side rails with an exit seeing patient for 1 of 18 sampled patients (#1).

Findings:

A physician's note of 3/21/21 at 10:08 AM read, General appearance: chronically ill appearing, confused, alert, awake....Status post right TMA (Transmetatarsal amputation) and left BKA (below knee amputation) - surgical dressing clean dry and intact. Neuro/CNS (Central Nervous System): disoriented, alert. Psychiatry: abnl judgment/insight. A physician's note of 3/24/21 at 9:39 AM read, Patient over all stable clinically. Vitals stable. .... Remains confuse[d].

The hospital produced documentation from their Avasys Tele Sitter program covering 3/24/21. This system allows a Tele Sitter (or Patient Safety Attendant) to view a patient remotely through a camera and activate alerts if a patient exhibits behavior that could result in self-harm. It had been used with the patient since 3/17/21 at 2:04 AM. The entries, authored by Patient Safety Attendant (PSA) A, read:

1:04 PM: Confused/Disoriented/Restless/Fidgety.

1:09 PM: Getting out of bed.Tech interventions: activate alarm. Call Nurse/Tech.

1:40 PM: Confused/Disoriented. Reaching out of bed. Impulsive. Tech Intervention: Activate alarm. Call nurse/tech. Comment: Patient is actively trying to get out of bed and is hurting his surgery on his leg I called the supervisor... and said that patient needs sitter.

2:00 PM: Confused/disoriented. Reaching out of bed. Impulsive. Tech interventions: Activate alarm. Call nurse/tech.

2:58 PM: Confused/disoriented. Reaching out of bed. Pulling lines/tubes. Tech interventions: Activate alarm. Call nurse/tech.

3:04 PM: Patient got up out of bed and fell on the floor. I had the alarm on and was calling the nurses station (PTA C) went in to the room to check on the patient. Patient fell possibly hit his head in the fall. Time approximately 3:04 PM.

On 6/02/21 at 3:06 PM, the Director of Nursing stated that the Relief House Supervisor began looking into obtaining a live sitter at approximately 1:45 PM. She stated that after the patient's fall, they learned that the side rails had been raised, but they could not determine at what time they were raised or who raised them. They suspected that it was at some point after 2:30 PM. They determined that the side rails had been up at the time of the fall during the post-event review.

A computed tomography (CT scan) of the head/brain without contrast was ordered for the patient on 3/24/21 at 3:30 PM. The CT Head/Brain w/o (without) Cont (contrast) of 3/24/21 at 5:41 PM read, Impression: small to moderate acute left subdural hematoma with 3 MM (millimeter) of midline shift to the right.

A nurse's note of 3/24/21 at 6:39 PM read, Pt being transferred to higher level of care after falling out of bed and hitting head. An Advanced Practice Registered Nurse note of 3/25/21 at 12:01 AM read, Earlier today the patient had a fall that resulted in head strike....Grave prognosis. Patient now DNR (Do Not Resuscitate) and hospice to see. The patient was discharged to hospice care on 3/25/21. The patient died on [DATE] at 11:40 PM.

On 6/02/21 at 12:40 PM, Nurse Manager D from Surgical 2 unit stated that throughout the day of 3/24/21, prior to his fall, the bed alarm and TeleSitter alerted her and other staff to patient #1's attempts to get out of bed. She stated that she had entered his room at least 3 times in the morning.

On 6/03/21 at 10:45 AM, Registered Nurse (RN) B stated that during that day, the patient was actively and repeatedly trying to get out of bed.

On 6/02/21 at approximately 4:25 PM, Licesened Practical Nurse (LPN) E said she had been taking food to another patient when she heard the patient #1's alarm and subsequent fall. She stated she found the patient on the left side of his bed, somewhat on his side. She stated that all of the patient's bed siderails were up when she discovered the patient.

On 6/03/21 at 10:59 AM, Charge Nurse D stated she observed the patient periodically during the day moving his leg over the side of the bed.

On 6/03/21 at 11:17 AM, Patient Safety Attendant (TeleSitter) A stated that she observed full side rails just prior to the fall. She stated that she saw him on one occasion that day trying to get his right leg over the left side of the bed. She stated that in other instances, he would scoot to the bottom (foot) of the bed with arm assistance towards a gap at the foot of the bed, which was between the foot of the bed and the end of the lower side rail. She stated that the camera position faced the patient head-on, showing the entire bed. She stated that prior to the fall, she had noticed him scooting down and turned on the alarm. She stated that the patient got to a sitting position at the foot of the bed and then fell forward.

The hospital policy on restraints at the time of the fall, Patient Restraint/Seclusion - COG.COG.001 revealed the following: The hospital must report the following information to the CMS Regional Office. The hospital must report ....Each death known to the hospital that occurs within one week (days two through seven) after restraint or seclusion where it is reasonable to assume that use of restraint....Contributed directly or indirectly to a patient's death, regardless of the type(s) of restraint used on the patient during this time....Using side rails to prevent a patient from voluntarily getting out of bed would be considered a restraint....Disoriented patients may view a raised side rail as a barrier to climb over....or may scoot to the end of the bed to get around a raised side rail and exit the bed.

On 6/02/21 at 3:40 PM, the Vice President of Quality stated that a report of death in restraints was not reported to CMS as required.

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

Based on interview, record review and a review of facility documentation, the facility failed to ensure that a registered nurse (RN) evaluated the nursing care for each patient through the performance of thorough assessments in accordance with policy for 1 of 20 sampled patients (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient was admitted to the emergency room (ER) on 7/28/17 at 7:46 PM. A request for admission was made at 9:09 PM on 7/28/17. The patient was on the Cardiovascular Intensive Care Unit from 8/01/17 through 8/07/17.

A Nurse Practitioner note of 8/03/17 at 10:28 AM read, Extremities: decreased range of motion, left foot cyanosis, ischemic changes. This was the first mention in the record of any discrepancy regarding the patient's toes. A physician note of 8/03/17 at 11:57 AM read, New left toe discoloration noted this morning, possible janeway lesions as well. Left distal 1-3 toes are cold, and blue....Plan.... would appreciate recommendations of left lower extremity discoloration, likely attributable to septic emboli. Janeway lesions are one of the stigmata of infectious endocarditis. They are irregular, [DIAGNOSES REDACTED]tous, flat, painless macules on the palms, soles, thenar and hypothenar eminences of the hands, tips of the fingers, and plantar surfaces of the toes; they rarely present as a diffuse rash, and are very rare in clinical practice. (nih.gov).

The patient was on the Cardiovascular Step Down Unit as of 8/07/17.

The record revealed that nurses had assessed the patient during each shift from 8/03/17 through 8/08/17 for edema and peripheral pulses. During this time period, they did not document any abnormalities with respect to the patient's toes despite the mention of a significant abnormality by the Nurse Practitioner and physician on 8/03/17.

A nurse's note of 8/09/17 at 7:38 AM read, Noted slight bruising in both heels....left toes are blackish. Despite medical practitioners aware of a discrepancy with the patient's left foot as of 8/03/17, which, per the 8/09/17 nurse's note indicated had worsened, there was no evidence in the record that nursing had tracked the status of the toes from 8/03/17 through 8/08/17.

A review of facility policy Nursing Documentation read, Documentation will indicate that the patient met the defined parameters or documentation will describe variations from the defined parameters....Reassessment is also undertaken whenever a change in patient condition is identified. The lack of any nursing documentation from 8/03/17 through 8/08/17 regarding an outwardly visible decline in the status of the patient's toes, as first noted by medical practitioners on 8/03/17, indicated a lack of compliance with this policy which required documentation on variations from defined parameters. There was no evidence that thorough assessments that included the toes were performed by nurses from 8/03/17 through 8/08/17.

During an interview of the Risk Manager and Vice President of Quality on 10/17/17 at approximately 3 PM, they confirmed the findings.

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

Based on interview and record review, the facility failed to specify a discharge destination which would affect continuing care needs for 1 of 10 sampled patients (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient came to the emergency room on [DATE] at 3:45 PM and admitted on [DATE] at 8:55 PM.

The Agency for Health Care Administration document Instructions to Licensed Health Care Providers, signed by physician A on 5/03/17 read, Facility name: Family Care Home. This indicated the name of a facility that the patient was eventually sent to at discharge. This form had checks in boxes that indicated needs supervision for the following activities of daily living: ambulation; eating; and transferring. This form also had checks in boxes that indicated needs assistance for the following activities of daily living: bathing, dressing, self-care (grooming) and toileting. The document also read, Require 24-hour nursing or psychiatric care? Yes. 24 hour supervision. There was no documentation in the record after the completion of this form to indicate that all of the preceding mentioned services were no longer needed by the patient. Thus, the physician indicated that the patient needed the services that only a licensed Assisted Living Facility was authorized to provide in the State of Florida, upon discharge.

Physician A's orders of 5/04/17 at 9:41 AM read, Unconditional discharge. Regarding the meaning of this phrase, during an interview of the Risk Manager on 6/21/17 at 11 AM, she stated this meant that there were no stipulations to keep the patient in the hospital anymore. This order was acknowledged by nursing staff at 9:52 AM on 5/04/17. Under the heading of Discharge to:, the order document was blank. There was no documentation in the medical record that indicated any steps taken by nursing or case management staff to determine the actual destination which the physician had intended for the patient with his specific discharge order. As the order stood alone, it was unknown whether or not the physician wanted the patient to go home or to any other licensed health care facility. A document with the heading Discharge Instructions of 5/04/17 at 9:54 AM, initially signed by an advanced registered nurse practitioner (ARNP) B, and signed by physician A, who had signed the previously mentioned AHCA form on 5/04/17 at 2:29 PM, read, Discharge to: SNF [skilled nursing facility].

A Case Management note of 5/04/17 at 11:23 AM read, Call received from [a person at a senior resource organization that assists placing patients in facilities], who said that she secured a Family Care Home for patient.... Informed patient's sister, she is Okay with facility, assist with signing choice letter, placed in chart. The document Patient Choice Letter (undated) read, Used for patients selecting SNF, HHA [home health agency], hospice... services....Please acknowledge that you declined the list of home health agencies or skilled nursing facilities (initial).... I hereby choose to use Family Care Home in Orlando, FL. This form was signed by the patient. Nursing went over this form with the patient at 11:23 AM, after the discharge order had been written. Since this form indicated that it was intended for use in the discharge of patients to licensed entities of one form or another, it reflected an understanding that the patient was going to such a location, despite the lack of explicit physician orders in this regard. The patient left the facility at 12:51 PM on 5/04/17. The Family Care Home facility was not a licensed healthcare facility and was therefore not appropriate for addressing the continued needs of the patient as they had been written on the AHCA form on 5/03/17.

The Discharge Summary, dictated on 5/04/17 at 9:48 PM and signed by ARNP B and physician C read, Case Manager was involved for placement. Today, the patient was placed to a Family Care Home, therefore the patient was discharged .

Thus, a patient with documented post-discharge needs that could only be addressed by a licensed healthcare facility had a discharge order which did not specify any type of intended destination. The patient was subsequently transferred to a non-licensed facility.

On 6/21/17 at approximately 4:15 PM, the Risk Manager confirmed the findings.

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

Based on interview and record review, the facility failed to collaborate and coordinate a discharge plan for 1 of 10 sampled patients (#1).

Findings:

Patient #1 was admitted to the facility on [DATE]. He had a history of mental illness, homelessness, [DIAGNOSES REDACTED], indwelling urinary catheter and a powered wheelchair for ambulation. He was seen by psychiatric services on 1/03/17 for depression and medication recommendation. The recommendation was to collaborate with case manager for counseling therapy treatment in the community upon discharge.

The case management notes, dated 1/01/17, reflected that the manager was awaiting call back from a skilled nursing facility for patient placement. A case management progress note, dated 01/08/17, reflected that the patient was waiting for shelter placement. On 1/12/17, the note reflected that patient was discharged to a home in Ocala, Lake County.

A discharge summary by the physician, dated 1/10/17 at 4:05 PM, read, the patient was supposed to go into the hotel and now, the case manager found that the patient can be accepted in a facility which is more appropriate in Ocala area....So he will be sent to SNF [skilled nursing facility] and will be followed by his PCP [primary care physician] in 1 week.

An interview with the patient's case manager on 5/04/17 at 12 PM revealed that the patient was difficult to place. She stated that he was discharged to a boarding home near Ocala, Florida. She stated that he did not require placement in a SNF because he was independent with his activities of daily living, was able to self-catheterize, and had completed his intravenous antibiotics. The case manager stated that the patient was made aware of the placement to the boarding home. She could not say how the patient would follow-up with his PCP, and about the psychiatry recommendation for counseling treatments in the community, since he was transferred to Ocala.

A review of the Discharge Planning policy, approved 3/08/16, read, The patient ...is counseled by the interdisciplinary team to assure that the patient is: a. prepared for post hospital care, b. kept informed of the status or progress of the discharge plan, c. able to verbalize and or demonstrate the care needed and d. accepts the discharge plan.

Based on interview, record review and a review of facility documentation, the facility failed to ensure that the patient's right to access of information in the form of a complete medical record as requested was fulfilled for 5 of 5 sampled residents who had submitted post-discharge requests for complete records (#1, 11, 12, 13 & 14).

Findings:

Reviews of the records of patients #1, #11, #12, #13 and #14, in which requests were made for complete records after patient discharge revealed the following.

1. The request for patient #1's medical record indicated a request form dated 2/09/16 and resulted in 807 pages being provided.

2. The request for patient #11's medical record indicated a request form dated 3/22/16 and resulted in 38 pages being provided.

3. The request for patient #12's medical record indicated a request form dated 3/24/16 and resulted in 26 pages being provided.

4. The request for patient #13's medical record indicated a request form dated 3/17/16 and resulted in 19 pages being provided.

5. The request for patient #14's medical record indicated a request form dated 3/16/16 and resulted in 36 pages being provided.

During an interview of the Director of Health Information Management (HIM) on 4/01/17 at 10 AM, he stated that the actual amount of pages in the medical record for each patient was higher than the provided amounts as stated above. He provided documentation which showed that the total number of pages in each medical record were as follows:

for patient #1, it was 3,263, for patient #11, it was 159, for patient #12 it was 133, for patient#13, it was 610, and for patient #14, it was 285. He stated that he had learned that the staff member at their HealthPort vendor who was assigned to Osceola Regional Medical Center had been sending out abstracts instead of complete records when requests for complete records had been submitted. He stated that the vendor employee had been trained to do so by supervisory personnel. Thus, the requests that had been made for complete records of the above mentioned patients were not fulfilled.

During an interview of the Director of HIM at the above stated time, he confirmed the findings. During an interview of the Director of Quality on 4/01/16 at approximately 1:30 PM, she confirmed the findings.

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

Based on interview and record review, the facility failed to discharge a patient with a history of medication non-compliance and was designated by the court as being unable to handle his own heath concerns, including insulin administration, to a facility capable of providing continuing care for 1 of 10 sampled patients (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient was admitted to the facility on [DATE] at 1:40 AM.

The document Order Appointing Successor Plenary Guardian of Person and Property (Incapacitated person - no known advance directive), dated (as an order) on 7/13/15 read, (Person's name) is hereby appointed successor plenary guardian of the person and property of (Patient #1). Regarding the concept of an incapacitated status, an incapacitated person is an individual for whom a guardianship proceeding is initiated. Such a person has been determined by court as lacking the capacity to manage at least some of the property or to meet at least some of the essential health and safety requirements. An incapacitated person may not be able to make or communicate responsible personal decisions. S/he exhibits an inability to meet his/her own personal needs for medical care, nutrition, clothing, shelter, or safety. A plenary guardian is a person appointed by the court to exercise all delegable legal rights and powers of the adult ward after the court makes a finding of incapacity. Wards in plenary guardianships are, by definition, unable to care for themselves.

The History and Physical (H&P), dictated by the physician on 9/20/15 at 10:29 AM read, The patient also been leaving the ALF (Assisted Living Facility) facility without informing and found missing in the neighborhood. The patient also diabetic and noncompliant to his medications.... Very poor hygiene, neglected care.... Provisional diagnoses... Schizophrenia ... Diabetes mellitus... Plan... Discussed case manager to contact the ALF (assisted living facility) for ongoing need of treatment and collaboration for placement back once patient is stable....Collaboration with behavioral case management team needed for placement back to ALF. However, there were no specific physician orders in the record for ALF placement.

Another H&P, dictated by a different physician than the preceding one on 9/21/15 at 6:27 AM read, Continue inpatient psychiatric treatment....Continue sliding scale insulin for diabetes coverage....

A Case Management note of 9/28/15 at 11:19 AM read, Clinician called patient's guardian ... to inform her that patient is being discharged today. (The guardian) stated that reportedly patient is not allowed to return to the group home... he used to live at because staff said he walked out twice in the middle of the night, and administrator feels that patient needs a locked facility. Patient's guardian asked for assistance to find a safe facility for patient.

The physician discharged the patient on 9/28/15 at 11:44 AM. The order read, unconditional discharge. The orders did not specify discharge to any type of facility. There were no additional discharge orders in the patient's medical record. The actual discharge did not take place until 10/05/15.

A Case Management note of 9/28/15 at 2:26 PM read, Discharge planner called VA (Veterans Administration) Medical Center... and scheduled an appointment for Tuesday September 29, 2015 at 1 PM for the next level of care. Discharge packet including admission diagnosis, discharge diagnosis, med reconciliation, and patient notes were faxed to the next level of care for follow up. Patient aware and agreeable to this plan.

The document Patient Notes and Instructions, signed by the nurse educator and the patient on 9/28/15 at 3:51 PM read, Signature acknowledges that patient... has received these documents and verbalizes understanding....Oral medication for Type 2 diabetes. Later text indicated the patient required Levemer insulin, an injectable medication, at discharge.

The DC (discharge) Home Instruction was signed by the patient on 9/28/15 at 3:51 PM and read, Being transferred to another facility: N.... Follow-up appointments... Doctor... Tuesday September 29, 2015 at 1 PM.... VA Medical Center.

A nurse's note of 9/28/15 at 6:21 PM read, Patient was supposed to be discharged today, all paperwork and scripts prepared, awaiting for transportation. Social worker talked to guardian and said that patient was not leaving today; guardian wanted scripts to be faxed to her first, medication list given over the phone. On-call psychiatrist made aware, order given to hold discharge.

A Case Management note of 10/01/15 at 1 PM read, The treatment team met today with patient to discuss the plan of care. Patient reported waiting to hear on housing options for discharge. Patient was advised to follow up with discharge planner.

A Case Management note of 10/05/15 at 1:37 PM read, Discharge planner called legal guardian for patient... Discharge planner explained to guardian (patient #1) has been psych cleared and no longer meets criteria to remain here. Patient is not a danger to self or others and denies being suicidal and homicidal. (Guardian) is aware that patient was denied at numerous assisted living facilities due to patient's criminal record and inappropriate. (Guardian) has been made aware patient will be discharged to a local shelter. Patient is agreeable to this plan.

During an interview of the Case Manager on 11/17/15 at 2:30 PM, she stated that the guardian stated that she did not know what to do in the face of an inability to find an ALF or other facility. She stated that they had been trying to find ALFs or a VA (Veterans Administration) Medical foster home. She stated that the guardian had no specific requests for action and did not object to the final destination of a homeless shelter.

A Case Management note of 10/05/15 at 1:43 PM by the Case Manager read, Discharge planner called (another facility)... and scheduled an appointment for Tuesday October 6, 2015 at 8 AM for the next level of care. Discharge packet including admission diagnosis, discharge diagnosis, med reconciliation, and patient notes were faxed to the next level of care for follow up. Patient aware and agreeable to this plan.

A Discharge Summary, signed by the physician on 10/04/15 at 11:31 AM read, Discharge instructions. Discharge to: home.... Follow-up: As per discharge appointments.

A nurse's note of 10/05/15 at 2:16 PM read, Patient discharged at 2:12 PM with diagnosis of Schizophrenia and given scripts. AOX4 (alert and oriented times four), calm, cooperative, denies SI/HI, educated on follow up appointments, patient verbalized importance of compliance.

Regarding the need for injectable insulin, discharge medications included Levemir.

Thus, the insulin dependent patient with a documented history of medication non-compliance and a court-ordered designation which indicated the patient was unable to manage his own health concerns was discharged to a setting which was not capable of ensuring the administration of insulin medication according to physician discharge orders. This had the potential to result in adverse outcomes for the patient.

Based on interview, record review and a review of facility documentation, the facility failed to complete pressure sore assessments for 1 of 10 sampled patients (#1).

Findings:

Patient #1's nurse's note from 9/13/14 at 8 AM read, Tear. Location: Buttocks. Wound eval: open. A nurse's note from 9/15/14 at 9:35 AM read, Tear. Location: Buttocks. Wound eval: Open. Surround Tissue Eval: Red. Slight purplish. Wound bed: Black. Purple.... Dressing: Mepilex Boarder. Drainage amt.: small. Drainage type: serous..

Patient #1's Wound Care nurse's note of 9/15/15 at 5:34 PM read, New wound care nurse note for new skin problem/coccyx. Patient noted with linear deep tissue purple discoloration with open epidermis on sacral/coccyx.... Staff to notify family and PCP regarding new PU (pressure ulcer).

A review of facility policy Pressure Ulcer Prevention and Care Guidelines read, Measure wound size in centimeters. Measure length, width and depth. There was no evidence in the medical record that this directive was followed throughout the patient's stay with respect to the open wound buttocks site.

During an interview of the Director of Risk Management on 6/12/15 at approximately 5:15 PM, she confirmed the findings.

Based on interview and record review, the facility failed to ensure that topical medication patches were given according to physician's order for 1 of 10 sampled patients (#1).

Findings:

Patient #1's Medication Administration Record indicated that a topical Fentanyl Patch 50 MCG (micrograms)/HR (hour) for 72 hours, was applied on 9/19/14 at 10:04 AM. This was the last patch application, as it was cancelled through physician orders on 9/20/14. However, there was no documentation in the medical record from 9/20/14 forward of the removal and disposal of the 9/19/14 patch.

During an interview of the Director of Risk Management on 6/12/15 at approximately 5:15 PM, she confirmed the findings.

Based on interview, record review and a review of facility documentation, the facility failed to ensure that nutritional needs as understood through the interpretation of calorie counts were in accordance with orders for calorie counts being fulfilled for the practitioner's responsible for the care of patients for 1 of 10 sampled patients (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient was triaged in the emergency room (ER) at 6:54 PM on 7/16/14. A nurse's note of 7/16/14 indicated that the patient was transported to the floor at 9:40 PM.

Physician orders of 7/26/14 at 3:43 PM read, Calorie count times 2 days. This order would be in force through 7/28/14. A nurse's note of 7/28/14 at 9 AM read, On calorie count. Regarding the preceding two day order for a calorie count, there was no evidence in the medical record that this was performed.

A Case Management note of 7/28/14 at 3:50 PM read, Reviewed with ... CN (charge nurse) this morning who informed that ... MD (medical doctor) wants calorie count for 24 hrs before determination for peg tube. Physician orders of 7/28/14 at 4:53 PM read, Continue calorie count for another 24 hours. A physician note of 7/28/14 at 5:09 PM read, Spoke with (patient's spouse)....over the phone and explained patient's medical status.... explained that patient is on a calorie count as requested by gastroenterology.

A gastrointestinal physician note of 7/30/14 at 10:25 PM read, Plan: ... Continue calorie count. An Adult Nutrition Re-Assessment of 7/30/14 at 12:55 PM read, Calorie count underway... GI (Gastro Intestinal) recommends calorie count and soft meals. No C/S (consult) received for calorie count. RN and charge nurse indicated informal calorie count done on the floor for 24 hrs.... As with the prior orders of 7/26/14 for a calorie count, there was no evidence in the record that the 7/28/14 renewal of calorie count orders was followed.

A review of facility policy Calorie Count read, To provide a calorie count for patients when ordered by a Physician....The Dietician will be notified via the Meditech system of a physician ordered calorie count.... At the completion of the calorie count, the Dietician evaluates that patient's intake, documents the results in the patient 's electronic medical record and makes nutritional recommendations. This policy was not followed with respect to the orders.

During an interview of the Direct of Quality on 8/07/14 at 1:10 PM, she confirmed that the orders for calorie counts and the above mentioned policy were not followed.

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

Based on review of medical records, physician on-call schedule, Physician Consult Log, and hospital policy, and interviews,the hospital failed to maintain a list of physicians on its medical staff in a manner that best meets the needs of the hospital ' s patients who are receiving services required in accordance with the resources available to the hospital, including the availability of on-call physicians for 1 of 20 patients (#1).

Findings:

Review of the hospital policy EMTALA-Provision of On-Call Coverage, read in part, Purpose: to establish guidelines for the hospital ...and its personnel to be prospectively aware of which physicians, including specialists and sub-specialists, are available to provide additional medical evaluation and treatment necessary to stabilize individuals with emergency medical conditions in accordance with the resources available to the hospital as required the Emergency Medical Treatment and Labor Act (EMTALA) ....Policy: the hospital must maintain a list on its medical staff who have privileges at the hospital ....Physicians on the list must be available after the initial examination to provide treatment necessary to stabilize individuals with emergency medical conditions (EMC) who are receiving services in accordance with the resources available at the hospital ...Physicians' Responsibility:...when a physician is identified as being 'on-call' to the DED (dedicated emergency department) for a given specialty, is shall be that physician's duty and responsibility to assure....immediate availability, at least by phone, to the DED physician for his or her scheduled 'on-call' period, or to secure a qualified alternate if appropriate....arrival or response to the DED within a reasonable timeframe (generally, response by the physician is expected within 30 minutes)....

Review of the hospital policy EMTALA-Provision of On-Call Coverage, read, when a physician is identified as being 'on-call' to the DED (dedicated emergency department) for a given specialty, is shall be that physician's duty and responsibility to assure....immediate availability, at least by phone, to the DED physician for his or her scheduled 'on-call' period, or to secure a qualified alternate if appropriate. arrival or response to the DED within a reasonable timeframe (generally, response by the physician is expected within 30 minutes)....

Review of the Osceola Regional Medical Center Physician on call schedule was reviewed. The on-call schedule dated 8/18/2013 verified that a Neurosurgeon (physician who does surgery on the nervous system, especially the brain) was on call. Review of the medical record for patient #1 showed he was [AGE] years old, and (MDS) dated [DATE] at 10:36 p.m. after falling out of the bed at home. The record documented the chief complaint as, fell out of bed at home -Brain hemorrhage. The HPI read, Patient is a 69 y/o male who was found by his wife on the floor after falling out of bed, unresponsive. EMS was called to the house and state that patient has not returned to normal mentation. States patient has continued to vomit throughout transport but maintained good O2 saturation.

Patient #1 was seen by the emergency physician on 8/18/2013 at 10:38 p.m. and triaged at 10:44 p.m. Further review of the medical record indicated that a central line (intravenous line that is inserted in a large vein - typically the neck) was emergently placed. Oxygen was administered and patient #1 was also on cardiac and oxygen saturation monitoring. The patient was also placed on a ventilator (a method to mechanically assist or replace spontaneous breathing) to protect his airway. The patient's vital signs at 22:50 (10:50 p.m.) were: blood pressure 245/96 (normal range -110/70-130/85), pulse 49 (normal range 60-100). Review of the CT of the Head/Brain at 11:43 p.m., showed Large intraparenchymal hemorrhage (bleeding into the brain) as well as intraventricular hemorrhage (spaces in the brain that contain protective cerebral spinal Fluid) as described above with midline shift of approximately 1.6 cm. (centimeters) to the right ....

Additional notes in the medical record read in part, Spoke with family and of patient due to trying to contact Neurosurgery for over an hour and a half. Consultation:1 Consultant called: Neurosurgery; Requested call time: 23:41; Requested call date: 8/18/2013: Consultation: 2 - Consultant called: Transfer Center: Requested call time:0039; Requested call date 8/19/2013. Call returned: call returned (two (2) physicians from the receiving hospital that will accept patient #1 for transfer to their acute care hospital); Call return time:00:54; Consultant 0054: Spoke with Neurosurgeon (from the receiving hospital) who will consult once Pt (#1) arrives to the Hospital; 0100 spoke with physician ICU (intensive care unit) who accepts transfer to receiving hospital. Disposition: Alt (altered) Mental Status. Primary Impression: ICH (intracerebral hemorrhage) with shift. The transfer certification for patient # 1 was reviewed. The transfer form section titled, Reason for transfer revealed the box was checked as, On call physician refused or failed to respond within a reasonable time ...On call Physician name 'Physician's name was listed 2 hr (Hour)'.

Further review indicated that patient #1 was transferred to another major medical center by helicopter on 8/19/2013 at 1:50 a.m. because the on-call physician did not respond to phone calls. This was also verified by review of the Physician Consult Log.

Review of the Physician Consult Log dated 8/18/2013 revealed that the on-call neurosurgeon office phone number was called three (3) times. The times listed that the neurosurgeon was called at 11:20 p.m., 11:43 p.m. and 11:58 p.m., and messages were left with the answering service. The column of Physician Consult Log titled Call back time revealed Did not call. The facility failed to ensure that their on-call physician coverage policy was followed as evidenced by failing to ensure that physicians (neurosurgeon) on the list must be available after the initial examination to provide treatment necessary to stabilize individuals with an emergency medical condition who are receiving services in accordance with the resources available at the hospital for patient #1 on 8/18/2013.

Review of the medical record from the receiving hospital revealed patient #1 was admitted on [DATE] at 2:35 a.m. A CT Scan of the Head showed intraparenchymal hemorrhage with intraventricular extension 1.5 cm. and midline shift. The hospital's discharge summary read in part, The patient's family made the decision to move to comfort measures and the patient subsequently passed away.

During an interview on 9/12/2013 at 9:45 a.m., the vice-president of Quality and Risk said the facility investigation showed the physician said he did not get the phone call because his cell phone was not working. Staff did reach his answering service as a usual way of contact.

During a phone interview on 9/12/2013 at 3:20 p.m., the emergency room physician said he has been at the hospital for about 2 months. He said there were no problems with contacting specialists on-call and getting an appropriate response in the past.

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

Based on interview, record review and a review of facility medical staff by-laws, the facility failed to ensure the enforcement of its medical staff by-laws regarding the response times of physicians called for consultation for 1 of 10 sampled patients (#1).

Finding:

A review of the medical record of patient #1 was performed. The patient was admitted on [DATE] at 2:50 PM. A nurse's note of 5/09/13 at 10:45 PM read, Dr. ... consulted through answering service. Awaiting call back. Orders for a consult by Dr ... were entered on the computer at 10:47 PM on 5/09/13. Another nurse's note of 5/11/13 at 8:45 AM read, Placed call to Dr...re: consult and plan of care. Awaiting return call. A physician's consultation note for service on 5/11/13 was dictated by the physician on 5/13/13 at 8:27 PM.

Regarding physician responses to consultation requests, a review of Medical Staff Rules and Regulations revealed the following: The physician being consulted will evaluate the patient within 24 hours .... The facility was in violation of this requirement. The order had been placed on 5/09/13 at 10:47 PM and the patient was not seen by the consulting physician until 5/11/13, at an unknown point between 8:45 AM and 8:27 PM.

During an interview of the Director of Quality on 7/30/13 at approximately 4:30 PM, she confirmed the finding.

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

Based on interview and record review, the facility failed to ensure that orders for drugs in the form of controlled pain medications were documented in an accurate manner by the physician who signed them for 1 of 10 sampled patients (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient was admitted on [DATE] and discharged at 7:31 PM on 6/14/13. Discharge medications ordered by the physician included Percocet and Dilaudid. A photocopy of a script for Dilaudid and Percocet was found in the medical record. In the lower right corner of the script was the following text: Not valid for controlled substances. These two medications are controlled substances. Therefore, the patient would not have been able to fill the prescriptions as written.

During an interview of the Director of Quality on 7/30/13 at approximately 4:30 PM, she confirmed the finding.

Based on observation, interview and record review, the facility failed to ensure expired medications and supplies were not available for immediate patient use in the emergency department and on the pediatric and neonatal intensive care patient units in the emergency crash cart.

Findings:

During a tour of the emergency department fast track area on 5/06/13 at 11:05 a.m. observation of the Brasloe pediatric crash cart, used in respiratory and cardiac emergency situations, showed the following:

1. The outside of drawer #1 showed a label with a date of 5/01/13 as the date of the first drug expiring in the drawer. Review of the tray inside of the drawer showed the pharmacy tray had 4 vials of Lasix 4 milliliters, a diuretic medication, each with an expiration date of 5/01/13 and 1 vial of Nipride 2 milliliters, a medication used to increase blood pressure, with an expiration date of 5/01/13.

The Emergency Department (ED) manager confirmed the medications were expired.

During an interview on 5/06/13 with the ED manager, she said there were a total of 5 crash carts in the ED and they are to be checked by the staff every shift.

2. Observation of the Brasloe pediatric crash cart located in examination room #4 on 5/01/13 at 11:10 a.m. showed the following:

Pink/Red-Drawer #2 - 1 pediatric intravenous (IV) delivery module kit for starting an IV with an expiration date of 12/2012.

White-Drawer #5 - 1 pediatric intubation, used to place a breathing tube in the wind pipe, module kit with an expiration date of 3/2013.

Blue-Drawer #6 - 1 pediatric intravenous (IV) delivery module kit for starting an IV with an expiration date of 2/2012.

Orange-Drawer #8 - 1 pediatric intubation module kit with an expiration date of 3/2013.

Green-Drawer #9 - 1 pediatric Medtronic defibrillator electrode package with an expiration date of 1/28/2012.

All were on the cart and available for immediate patient use. The chief nursing officer (CNO) and the ED nurse manager were both present and confirmed the items were expired.

3. During a tour and observation on 5/06/13 at 12:53 p.m. of the obstetric supply room, one (1) female sterile urinary catheterization kit was opened and available for immediate patient use. The charge nurse confirmed the kit was opened and should have been removed.

4. During the toured on the 3rd floor pediatric unit on 5/07/13 at 10:45 a.m., observation of the Brasloe (pediatric) crash cart located in hallway on 5/07/2013 at 10:45 a.m. showed the following:

Pink/Red-Drawer #2 - 1 pediatric IV delivery module kit for starting an IV with an expiration date of 10/2012.

Purple-Drawer #3 - 1 pediatric IV delivery module kit for starting an IV with an expiration date of 11/2012 and 1 pediatric intubation module kit with an expiration date of 1/2013.

Yellow-Drawer #4 - 1 pediatric intubation module kit with an expiration date of 3/2013.

White-Drawer #5 - 1 pediatric intubation module kit with an expiration date of 3/2013 and 1 trocar #20 French catheter, used for chest tube placement, with an expiration of 11/2012.

Blue-Drawer #6 - 1 pediatric intubation module kit with an expiration date of 3/2013 and 1 trocar #32 French catheter, used for chest tube placement, with an expiration of 11/2012.

Orange #7 - pediatric IV delivery module kit for starting an IV with an expiration date of 10/2012, 1 pediatric intubation module kit with an expiration date of 3/2013, 1 trocar #32 French catheter with an expiration of 11/2012, and 1 #28 French trocar catheter with an expiration date of 4/2013.

Green-Drawer #8 - pediatric IV delivery module kit for starting an IV with an expiration date of 5/2012, 1 pediatric intubation module kit with an expiration date of 3/2013, and 1 trocar #32 French catheter with an expiration of 12/2012.

Review of the pediatric crash cart check list log showed the cart as checked daily during the month of May 2013.

During an interview on 5/07/2013 at 11 a.m., the registered nurse (RN) director of the pediatric department said the cart was just checked yesterday. The CNO was present during this observation and confirmed the expired supplies. All items were on the cart and available for immediate patient use.

5. During a tour of the neonatal intensive care unit (NICU) on 5/07/13 at 11:10 a.m., the pediatric crash cart was found to have the following expired supplies available for immediate patient use:

3 arterial blood sample syringes with an expiration of 3/2013 and 1 Provent arterial blood sampling kit with an expiration of 2/2013.

During an interview on 5/07/2013 at 11:10 a.m., the RN said the crash cart was just rechecked yesterday for outdated supplies and medications.

During an interview on 5/09/13 at 10:45 a.m., the pharmacy director said the process for changing out the crash carts is as follows: the cart is brought to the pharmacy and the medications are removed, the cart is then taken to the central supply area and the supplies are checked and the cart is then returned to the pharmacy for the medication tray replacements and locked and it is then ready for use.

Review of the policy Code Cart Monitoring and Maintenance, revised 2/2013, read, All Code Carts shall be checked by the individual departments in which they are located....the first to expire cards shall be checked monthly to ensure that there are no expired items in the Code Cart in the event that the cart has not been used. It is the responsibility of the personnel assigned to complete this checklist and notify either Materials Management or Pharmacy of any expired/missing items.

Based on observation and interview, the facility failed to ensure 1 of 2 Caesarian section rooms, 1 of 4 cardiac catheterization labs, and 3 of 18 intensive care rooms were clean and sanitary.

Findings:

1. Observation on 5/07/13 at 2:20 p.m. of the cardiac catheterization lab Electro-physiology room (any of the 4 labs can be used for all procedures) found the following: an anesthesia cart with the top dusty and in need of cleaning, the top of the overhead light is dusty and in need of cleaning, and the top of cardiac monitoring screens are dusty and in need of cleaning. The registered nurse (RN) said the room was last used on 5/01/13. When asked when the rooms are terminally cleaned, the she said it is wiped down prior to use, but only the surfaces, and the tops of the lights and monitors would not be cleaned until after the procedure was completed. The chief nursing officer (CNO) and the cardiac catheter lab director were both present and confirmed the dusty findings.

During an interview on 5/07/13 at 2:45 p. m. the RN Quality nurse for the cardiac catheterization lab said she said currently monitors the areas for cleanliness, but does not document any of it.

2. During a tour of the 2 operating rooms in the obstetrics department used for Caesarian sections (C-sections), room #1 had dust on the top of the Pxyis machine and the top of the anesthesia drug cart was in need of cleaning.

During an interview on 5/06/13 at 3:10 p.m., staff confirmed the dust on top of the equipment and said the room was last used on 5/01/13. The CNO was present during the C-section room observations.

Review of the policy High Dusting, dated as reviewed 11/15/12, read, High dusting items in areas above normal hand shall....be done by EVS (environmental service) associates as an integral part of the cleaning process....The procedure includes the following items to be cleaned - wall mounted TV sets, tops of over-bed light fixtures, tops of examination light fixtures, and any other items that need to be dusted above normal hand reach.

During an interview on 5/08/13 at 3:30 p.m., the infection control officer said she or her assistant make environmental rounds in all areas of the hospital. She said she or her assistant were last in the labor and delivery area on 10/31/12 and in the cardiac catheterization area on 9/07/12 and 4/23/13 for environmental rounding.

3. On 5/08/13 starting approximately at 9:30 a.m., tour of the Intensive Care Unit (ICU) accompanied by the nurse manager, the charge nurse and the director of Medical/Surgical/PCU (Progressive Care Unit), revealed the following:

In room 249, there was visible dust on top of the cardiopulmonary monitor. When the monitor was wiped with a finger, the dust easily came off.

In room 250, there was visible dried matter on the left frame of the bed near the head of bed site. There was also dried matter on the frame and wheelbase cover on the left side. The nurse manager touched the material and it was definitely dried onto the frame.

In room 252, there was visible dust on top of the ventilator being used by the patient. It was easily removed by a swipe of a hand.

In all incidences described above, the nurse manager confirmed the findings.

Based on observation, interview and record review, the facility failed to ensure policies and procedures related to ensuring a sanitary environment within the operating rooms were enforced.

Findings:

1. During an observation on 3/18/2013 at 2 p.m., central sterile technician staff #L was cleaning instruments in the sink and preparing them for placement, in trays, in the instrument washer. One tray had some instruments with some red colored and other unknown material still on the instruments. She was asked if she ensures the instruments are free of materials from the surgical procedures before she places in the instrument washing machine and she responded, No, not always. She said she soaks the instruments, and then the instrument washer should take care of the rest, and if anything was left, it would be identified prior to the wrapping. This observation and interview was witness by the assistant chief nursing officer (ACNO).

During a tour on 3/18/2013 at 2:20 p.m., the sterile instrument storage area was observed with multiple sterilized surgical trays and other sterile items stored on shelving units.

On 3/18/2013 at 2:30 p.m., a sterile tray was requested to be opened to inspect the instruments. The sterile processing department (SPD) supervisor was asked to select a tray that would not be needed immediately. She selected one tray labeled as a minor tray, and labeled as last processed on 3/18/2013. She stated the tray was either used today or over the weekend. She selected a Mayo Hegar 7 ? inch () and 6 ? (both instruments designed to hold a suture and needle during procedures) and both were wiped with a white cloth and both had a gray substance of an unknown origin. The gray residue was not visible to the eye on either instrument.

She then selected another tray labeled as a major hysterectomy tray, processed last on 3/15/2013, opened it and selected a Mayo Hegar 9, 7 1/4, and a Heaney needle holder and wiped all of the instruments with a white cloth and all three instruments had a grey unknown residue found on the white cloth. Again, this gray residue is not visible to inspection.

During an interview on 3/18/2013 at 2:20 p.m., the SPD supervisor, employed for the past 2 months, said that currently there was no system in place to determine what patient, case, or doctor the instruments were used on last. When asked where she thinks the residue came from, she said it could be from the detergent concentration, the way the instruments were pre-cleaned, or it could be from the age of the instruments, they could be at their end of life cycle. She also said the needle holders have grooves and really require scrubbing when cleaned.

On 3/18/2013 at 3:10 p.m. during an observation of the instrument wrapping area, an interview was conducted with central sterile technician #F who said he routinely wipes all plastic coated type handles and cords. However, he does not routinely wipe or check for any gray residue or any compromise on any of the metal instruments.

During an interview on 3/21/2013 at 1:40 p.m., operating room technician #N said she has been with the hospital for about 2 years. She said she has witness the gray residue on instruments during the past 2 years. She said on one occasion, she thought it was last year, during a kidney/prostate case, she observed the surgeon's glove get wet, and the gray residue was visible on his gloves. When asked if the surgeon discarded the instrument, she responded no. She also said, she had observed small bits of bone on Kerrison bone biting instruments used during spinal cases. She said she has always discarded these instruments and obtained others prior to patient contact. She said she would report these occurrences to the operating room manager and the charge nurse.

During an interview on 3/21/2013 at 1:50 p.m., the operating room manager for the past 11 years, confirmed there have been reports of dirty instruments in the past. She said, when this happens, the instruments are discarded from the patient cases and re-processed.

During an interview on 3/21/2013 at 1:55 p.m., operating room technician #M said he has been at the hospital for about 2 years. He said he has never seen the gray residue, but about 2 years ago when he first started, he was in the process of opening up the sterile instrument for a case and found tissue in a biopsy forceps instrument. He said he immediately removed all of the instruments and obtained all new sterile instruments for the case. He said about 1 year ago, he found bone fragments on a Tap 5.0 instrument and had to return it for re-processing. Yesterday, when opening the instruments for a surgical procedure, he inspected one of the cannulated (tube-like) instruments and visually saw debris. He wiped it with a Q-tip and found a reddish colored substance, he thought was possibly blood. He said he discarded all of these instruments and obtained others prior to patient contact. He said he reports these type incidents to the operating room manager or the charge nurse.

Both the operating room manager and operating room technician #M said they felt there was an improvement in the quality of instrument sterilization since a new sterile processing supervisor was hired about 2 months ago.

Review of the policy Decontamination of Instruments dated as reviewed last 2/2012, states the policy purpose is: To assure safe and efficient handling of used/contaminated instruments. The policy is, All instruments removed from the sterile packaging will be cleaned and decontaminated as soon as possible after use. It read, All instruments need to be inspected before entering the automated washer for its need to be manually cleaned.

During an interview on 3/18/2013 at 3:15 p.m., the SPD supervisor said the Association for the Advancement of Medical Instrumentation is used for standards of practice related to instruments (ANSI/AAMI). Review of page 55, dated 2010 provided by the supervisor of SPD showed the following rationale in the 7.5.1-General Considerations as follows: The purpose of cleaning and rinsing is to remove all visible debris from an item and to reduce the number of particulates, microorganisms, and potential pyrogens. The accepted standard for the degree for cleanliness is 'visibly clean'. Thorough cleaning and rinsing are vital to the effectiveness for subsequent microbicidal process used for decontamination, disinfection, and/or sterilization. The amount of residue that remains will vary depending on the conditions of use of the cleaning agents, the specific component materials of the reprocessed devices, and the methods used to reduce residuals before reuse. Any organic material or residual cleaning agents remaining on an item can inactivate chemical disinfectants or sterilants as well as protect microorganisms from destruction....Adequate cleaning and rinsing should result in low bioburden, which is essential to the effectiveness of terminal sterilization and to the protection of patients form pyrogens.

2. During an observation on 3/18/2013 at 3 p.m. in operating room (OR) #6, the anesthesia locked cart top drawer was found to have 1 opened single dose 10 milliliter (ml) vial of normal saline, opened, unlabeled, and undated with an unknown amount remaining. Also 1 opened glycopyrrolate 5 milliliters (ml.) multi-dose vial opened, unlabeled, and undated with an unknown amount remaining. The anesthesia machine unlocked cart top drawer was found to have 1 bottle of Forane 100 ml. and 1 bottle of Sevoflurane 250 ml. Both were opened, unlabeled, and undated with an unknown amount remaining.

During an interview on 3/18/2013 at 3 p.m. the anesthesiologist said the vials should have been discarded after the surgical case was completed. During an interview on 3/18/2013 at 3:05 p.m., the supervisor of SPD confirmed operating room #6 was last used and the surgical case completed today at 10:30 a.m.

3. During an observation on 3/18/2013 at 3:20 p.m. in operating room (OR) #1, the anesthesia locked medication cart top drawer was found to have:

1 Atropine Sulfate 1 milligrams (mg.)/ml. abbojet (a pre-filled system of medications) available for immediate patient use with and expiration date of 2/01/2013 opened, unlabeled, and undated with an unknown amount remaining

The anesthesia machine unlocked cart top drawer had one bottle of Forane 100 ml. opened, unlabeled, and undated with an unknown amount remaining

One bottle of Suprane 240 ml., both , 2 bottles of Sevoflurane 250 ml., one was unopened and one was opened, unlabeled, and undated with an unknown amount remaining.

One 50 ml. vial of 8.4 % Sodium Bicarbonate and 1-50 ml IV bag of Potassium Chloride both opened, unlabeled, and undated with an unknown amount remaining.

On 3/18/2013 at 3:20 p.m., the supervisor of SPD said that the operating room #6 was last used and the surgical case completed today at 2:08 p.m.

4. During an observation on 3/18/2013 at 3:35 p.m. in OR #9 which is used for heart surgical cases, the anesthesia machine top drawer was found to be unlocked, accessible to unauthorized personnel

One expired abbojet Epinephrine 1:10,000/10 ml. available for immediate patient use with an expiration date of 3/01/2013

One bottle of Sevoflurane 250 ml.

Two bottles of Suprane 240 ml. (1 opened and 1-unopened)

Two Lidocaine 5 ml. 2% abbojets 2%

Three 10 ml. epinephrine 10 ml. unopened vials

One bottle of Nitroglycerin 50 mg.

None of the opened medications were labeled, dated, or timed.

5. Observation of the anesthesia medication cart on 3/18/2013 at 3:35 p.m. in OR #9 found it unlocked and unattended, leaving it available for access by unauthorized personnel.

The top drawer had one opened 20 ounce bottle of diet Pepsi

One 100 ml. bag of expired Epinephrine mix (1 mg./100 ml.) labeled available for immediate patient use with an expiration date of 3/07/2013 at 11 p.m.

One opened and engaged Epinephrine 1 mg. abbojet was found, and it was unknown if it was used for a patient. The operating room manager was asked if she could make a determination if the medication had been used on a patient, and she said no she would not know if it was used or when it was opened, since it was not labeled with a date and time.

A total of 3 opened, unlabeled abbojets were found in this drawer.

One 10 ml. syringe was found with a label identifying the medication as Epinephrine, but there was no strength, and it was undated and untimed.

One 100 ml. intravenous (IV) bag was found with a label of Phenylephrine but there was no strength or amount of additive, and it was undated and untimed.

The unlocked drawer also had the following medications available to unauthorized personnel:

Five vials of Heparin 10 ml.

One Esmolol 10 ml. vial

One Neostigmine 10 ml. vial

Two Phyenylephrine 1 mg. single dose vials

One Glycopyrate 5 ml. vial

One Lidocaine 5 ml. vial

One Succinylcholine 10 ml. vial

One Aminocaprocic Acid 20 ml. vial

During an interview on 3/18/2013 at 3:30 p.m., the supervisor of SPD confirmed operating room #9 was last used and the surgical case completed today at 1:30 p.m.

During an interview on 3/18/2013 at 3:30 p.m., the OR manager said the housekeeping staff have access to the operating rooms after cases are completed to terminally clean all rooms and would have access to the unlocked medication items in the anesthesia machine drawers.

During the above observations and interviews, the assistant chief nursing officer, infection control nurse, and operating room manager were all present to confirm the findings.

Review of the policy Single/Multi-Dose Vials and Containers (excludes anesthesia gases), dated as last revised on 1/2012 showed the scope of the policy. It read, This document is intended for all health care professionals in patient care areas, including procedural and operating rooms....Products labeled as multi-dose vials, i.e., glycopyrrolate, lidocaine, etc. and as multi-use containers, i.e. inhalers, ointments/creams, and drops, etc. are to be limited to use for a single patient and then discarded. These items should NOT accompany the patient upon transfer outside of the procedural or operating room areas and must be discarded. As with multiple dose vials, single dose vials, i.e. esmolol, ephedrine, metroprolol, etc. are to be limited for a single patient and then discarded. Use on a second or subsequent patient is not permissible.

During an interview on 3/21/2013 at 2 p.m., the infection control nurse confirmed the facility's current policy showed all multi-dose vials (except insulin) are to be treated as single-dose vials.

Review of the policy Medication management, dated as reviewed last on 1/2011, read for Storage of Medications, Inpatient Medications that All patient care areas are equipped with automatic dispensing medication (ADM), locked medication room, or locked medication cabinet for medication storage....Monthly inspections are performed by pharmacy personnel who will check for outdated and improperly stored medication, facility-wide. Outdated or unusable medications are stored in bins marked for this class of medication and are properly disposed of by the facility's disposal contractor.... Multiple dose vials are labeled with the date, time, and initials when opened. Shelf life shall be according to the manufacturer's recommendation.

Review of the policy Medication Safety, dated as last reviewed on 5/2012, read, Any solution/medication found in the invasive procedure area without a label shall be discarded. If there is any doubt as to the strength or identity of a medication/solution, it shall be discarded....Anesthesia providers shall follow the same procedure of labeling all medications drawn up for use....

During an interview on 3/21/2013 at 1:20 p.m., the OR manager said the anesthesia medication carts should not have any medications left in them. After the completion of the procedure, the medications are to be returned to the pharmacy or to the Pxyis machine.

During an interview on 3/19/2013 at 12:50 p.m., staff H, a cardiac surgeon, was asked if he allows beverages in the operating room during procedures, responded no and was disappointed to find out about the Pepsi found in the anesthesia medication cart.

Review of the policy Food Consumption, dated as revised last on 1/2013 read that Food consumption shall be allowed only in designated areas....No eating or drinking allowed in the work place, on nursing units, or in any area where there are patients, in any areas where pharmaceuticals are prepared, or in any area where laboratory tests are performed.

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

Based on interview and record review, the facility failed to ensure that drugs which belonged to the patient and were allowed for use were administered in accordance with the orders of the practitioner responsible for the patient's care, accepted standards of practice, Federal law and approved policies and procedures for 1 of 10 sampled patients (#1)

Findings:

A review of the medical record of patient #1 was performed. The patient was admitted to the Clinical Decision Unit of the hospital at 01:51 AM on 9/21/12. Physician orders of 9/21/12 at 6 AM read, Felbamate Q6hr (every six hours) . . . . Pt (patient) own meds. Physician orders of 9/21/12 at 11:42 AM read, Med - nonformulary & Pt own med . . . . Felbatol (1200 MG) 2 tablets BID (twice a day). Felbatol is an ant-seizure medication.

The History & Physical, dictated on 9/21/12 at 1:22 PM, read, Present medications . . . . Albuterol sulfate . . . Advair . . . Felbamate . . . Phenytoin . . . . Continue all home medications as dictated above.

The record revealed that Felbatol was administered on 9/21/12 and 9/22/12 as ordered. A nurse's note on 9/22/12 at 12:45 PM read, Received pt to medical floor. Thus, the patient had left the Clinical Decision Unit at this time.

A nurse's note on 9/23/12 at 10 PM read, Pt's (patient's) own med, Felbatol, not available to be given. A review of the Medication Administration Record confirmed this statement as it revealed that this medication was not given at any time during 9/23/12. A nurse's note on 9/24/12 at 11:02 AM (the next day) read, Pts seizure medication found in CDU (Clinical Decision Unit) and brought up to med room, med given to pt as per MD (Medical Doctor) orders. This medication had been ordered on [DATE]. Thus, orders had not been followed as written on 9/23/12.

A review of facility policy Medication Management Plan revealed the following: Medication shall be administered by licensed personnel in accordance with Florida laws and regulations governing such acts. This includes . . . . nurses proper licensed and certified to administer medication in their respective professional area. Since the patient had not received Felbatol on 9/23/12, the nurse did not comply with Federal regulations 482.23(c)(1) which specify that medications be administered to patients per physician order.

During an interview of the Director of Quality at approximately 5 PM she confirmed the preceding.

Based on interview, record review and a review of facility documentation, the facility failed to ensure that staff did not specify or otherwise limit the selection of qualified home health care providers that were available to the patient at discharge for 1 of 10 sampled patients (#7).

Findings:

Facility policy Discharge Planning read, When the patient needs home health services ... the Case Manager provides the patient or persons acting on his/her behalf with a list of Medicare certified providers who service the geographic area in which the patient resides. The patient's choice is documented on the Patient Choice form and placed in the Medical Record.

Examination of the Patient Choice form revealed the following text: You have the right to select any provider to provide the care ordered/recommended by your physician. This is your choice.

A review of the medical record of patient #7 revealed physician orders of 2/01/12 at 1:39 PM for Home with home health. A Case Management note of 2/01/12 at 5:38 PM read, Also HHC (home health care) order. Spoke with pt (patient). Stated that she has not had hhc in past and therefore, is okay with cm (case manager) selecting from rotating list for HHC and DME (durable medical equipment). Agreeable to Phoenix HHC. Faxed referral to Phoenix. There was no evidence in the record indicating that the patient was presented with a list of agencies from which she could choose and make a selection. As stated above, it was the case manager who selected or specified an agency. There was no evidence of a completion of a Patient Choice form, as required in facility policy (below).

An interview was performed with the Director of Case Management on 5/03/12 at approximately 9:30 AM. She stated that patients are asked if they have a current or recent Home Health Agency with whom they would like to return. If they don't, they are provided with a list of available agencies and asked to select from one of them. Once a decision is made, they are asked to sign a form which attests to their choice. She stated that their practice is to not pick agencies for the patient. The final decision is that of the patient.

During an interview of the Quality Manager on 5/03/12 at approximately 4:15 PM, she confirmed the finding.

Based on interview and record review, the facility failed to obtain timely cardiac marker laboratory services for 1 of 10 sampled patients entering the facility emergency department (ED) with complaints of chest pain (#1).

Findings:

Record review of patient # 1's record revealed the patient entered the ED on 3/15/12 at 2:17 p.m. complaining of chest pain and a history of myocardial infarction.

Physician orders revealed electronic documentation on 3/15/12 at 2:31 p.m. for a troponin level for diagnostic purposes. The record documented an elevated troponin level on 3/15/12 at 3:42 p.m.

Review of the facility ED policy CARDIAC MARKERS/CARDIAC ENZYMES #EMS.003.2 revealed: PURPOSE: To more quickly and accurately identify the patient having an MI. POLICY: Patients who present with chest pain will have cardiac markers drawn on arrival as ordered by MD. PROCEDURE # 4: Cardiac markers are performed in the ED, results available in 10 minutes.

Interview with the director of nursing and the ED manager related the facility was over capacity on 3/15/12 and was in surge plan as the hospital had no open beds and the ED census was over capacity at 55. (ED census 25). They further related the facility was doing the best they could considering the overcapacity problems and were prioritizing by condition of the patient. Patient #1's troponin levels should have been performed immediately as ordered at 2:31 p.m. and were unable to explain the delay of patient #1's initial troponin level dated/timed as 3/15/12 at 3:42 p.m.

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

Based on interview and record review, the facility failed to ensure compliance with the delineated responsibilities for patient care, as stated in policy, for 1 of 10 sampled patients who required a full assessment prior to discharge (#1).

Findings:

A review of the medical record of patient #1 was performed. The patient was admitted on [DATE]. A nurse's note of 12/20/11 at 7:31 AM mentioned the presence of a pressure ulcer on the left buttock which was being treated with Mediplex. A nursing note of 12/24/11 indicated the presence of a pressure ulcer on the right buttock and that a dressing was in use.

A final nursing assessment was performed at 8 AM on 12/28/11. However, this did not include the two pressure sores, as mentioned above. The medical record had not indicated that the pressure sores had resolved by discharge. Thus, the assessment, which was a patient care responsibility, was not complete. The lack of a complete assessment was not in compliance with policy (see below).

A Case Management note of 12/28/11 at 10:33 AM read, Call received from ... at Consulate (a skilled nursing facility) that bed is available today. Arrangements made for pt to be transported to (room number). The patient was discharged at 11:48 AM.

A review of facility policy 2011 Plan for Assessment/Reassessment revealed the following: Patients in the Medical Surgical Units are reassessed, at a minimum, every 12 hours, with change in patient condition and prior to transfer or discharge.

The preceding was confirmed during an interview of the Quality Manager at approximately 4 PM.

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

Based on record review, observation and interview, the facility failed to ensure the physician orders were obtained and included the type of restraint to be used prior to ongoing application for 2 of 5 patients with restraints (#3 & 4).

Findings:

Review of policy-Restraints (COP.R.1), revision date 1/10/2010 showed: #5 An order for restraint must be obtained from an LIP/physician who is responsible for the care of the patient prior to the application of restraint. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release.

During a tour and observation of the second floor intensive care unit on 11/07/2011 at 11:33 a.m., patient #3 is observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient #3, [AGE], admitted on [DATE] with a diagnosis of respiratory failure/exacerbation of asthma, showed the patient was in wrist restraints from 11/02/2011 to present. There are physician orders; however, the type of restraint is not specified for the use of the restraints on 11/02/2011, 11/04/2011, 11/05/2011 and 11/06/2011.

During an interview on 11/07/2011 at 11:45 a.m. the nursing manager (staff I) confirmed the physician orders only stated to restrain the right and left upper extremity, but does not state the type of restraint to be used.

During a tour and observation of the second floor cardiovascular intensive care unit on 11/07/2011 at 12:05 p.m., patient #4 is observed in bed and at rest.

Medical record review for patient #4, [AGE], admitted on [DATE] with a diagnosis of chest pain, showed the patient was in wrist restraints from 10/21/2011 to 10/24/2011. There is no type of restraint specified in the physician order for the use of the restraints on 10/21/2011, 10/22/2011, and 10/24/2011.

During an interview on 11/07/2011 at 12:45 p.m. registered charge nurse (staff L) confirmed the patient was in restraints from 10/21/2011 to 10/24/2011 and confirmed the physician orders only states to restrain the right and left upper extremity, but does not state the type of restraint to be used.

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

Based on record review, observation, and interview, the facility failed to ensure signed physician orders were obtained prior to ongoing application for 2 of 5 patients with restraints (#3 & 4).

Findings:

Review of policy-Restraints (COP.R.1), revision date 1/10/2010 showed: #5 An order for restraint must be obtained from an LIP/physician who is responsible for the care of the patient prior to the application of restraint. The order must specify clinical justification for the restraint, the date and time ordered, the duration of use, the type of restraint to be used and behavior-based criteria for release.

During a tour and observation of the second floor intensive care unit on 11/07/2011 at 11:33 a.m., patient #3 was observed in bed, at rest, intubated (a tube into the lung for breathing) with mechanical ventilation, and restrained with bilateral soft wrist restraints.

Medical record review for patient # 3, [AGE], admitted on [DATE] with a diagnosis of respiratory failure/exacerbation of asthma, showed the patient was in wrist restraints from 11/02/2011 to present. There were no signed physician orders for the use of the restraints on 11/02/2011 and 11/06/2011.

On 11/07/2011 at 11:45 a.m. the nursing manager (staff I) and the RN order specialist (staff G) both confirmed the physician orders are not signed on 11/02/2011 and the order for 11/06/2011 was missing entirely.

During a tour and observation of the second floor cardiovascular intensive care unit on 11/07/2011 at 12:05 p.m., patient #4 is observed in bed and at rest. Registered charge nurse (staff L) said patient #4 was in restraint earlier in his stay, but is not in restraints at this time.

Medical record review for patient #4, [AGE], admitted on [DATE] with a diagnosis of chest pain, showed the patient was in wrist restraints from 10/21/2011 to 10/24/2011. There were no signed physician orders for the use of the restraints on 110/21/2011 and 10/22/2011.

During an interview on 11/07/2011 at 12:45 p.m. registered charge nurse and the RN order specialist both confirmed the physician orders were not signed on 10/21/2011 and the order for 10/22/2011 was missing entirely.

Based on interview and record review, the facility failed to credential one Advanced Registered Nurse Practitioner (ARNP staff CC) through the medical staff credentialing process prior to allowing access to patient care areas.

Findings:

File review for Advanced Registered Nurse Practitioner (ARNP staff CC) showed a hire date of 09/23/2011 with no documentation of temporary privileges or approval by medical staff. Review of time recording record for staff cc showed she worked on 09/21, 09/22, 09/23, 09/26, 09/27, 09/30, 10/03, 10/04, 10/05, 10/10, 10/11, 10/12, 10/13, 10/14, 10/17, 10/24, 10/25, 10/26, 10/31, 11/01, 11/02, 11/07, and 11/08/2011 (8 hour shifts).

During an interview on 11/08/2011 at 11:57 a.m., the director of the medical staff office (staff P) said staff CC is in the credentialing process, however, since she is a facility employee approval by the medical staff is not required. When asked about other ARNP privilege requirements, staff P said if an ARNP was privately employed by a physician, the ARNP would not be permitted to work until the credentialing process was completed. Staff P said ARNP staff CC is currently in orientation with another ARNP and on the patient care units.

Review of the Medical Staff Bylaws, dated revised in 11/2010, defines ARNP as an advanced practice professional in Article I, section 2, and defines the appointment process for an advanced practice professional in Article V, section 10 as The advanced practice professional, as defined in Article I, section 2, shall include but not be limited to Physicists, Psychologists, Physician Assistants, Nurse Practitioners, Midwives, and Nurse Anesthetists, who shall be deemed to meet a specific service within the hospital, and physicians who are seeking limited clinical privileges.

During an interview on 11/09/2011 at 2:45 p.m., both the director of Human Resources and Vice President of Quality and Risk confirmed there were two different processes for credentialing employed and non-employed ARNPs.

Based on observation, interview and record review, the facility failed to ensure expired, opened, and unlabeled medications were not readily available for patient use in the surgical department.

Findings:

The facility has a total of 9 operating rooms, 1 cysto room, and 2 endoscopy rooms.

Review of the policy Medication Shelf Life, revision date of 7/10, read Policy #1-All medications at ORMC shall be monitored for expiration dates. #3-It is the responsibility of all personnel who dispense, handle, or otherwise work with medications at ORMC to remove the deteriorated, discolored, inappropriately labeled, and/or expired drugs from their respective areas and return them to Pharmacy for proper disposition. #5-All opened vials will be given no greater than a 28 day expiration

During a tour of the surgical department on 11/07/2011 beginning at 2:10 p.m., the following medications were found:

1. Endoscopy room #2-Anesthesia cart, drawer #1- 1-10 milliliter (ml.) vial Esmolol 100 milligrams (mg.) (a medication used to slow the heart) unknown amount with no open date. The vial did not state if it is single or multi-use. 2- 5 ml. single dose vials of Metroprolol 5 mg. with no open date. 1-container, single dose, of Original nasal spray with an expiration date of 08/2011. 1-100 ml. bag of Normal Saline 0.9 % mixed with phenylephrine 100 mg. undated as to the date and time of mixing. 1-10 ml. syringe with Ephedrine 5 mg./ml. mixed on 11/02/2011. 1-10 ml. syringe labeled with 100 mg. of Phenylephrine dated as 11/01/2011. Endoscopy room anesthesia cart #2 was last used on 11/07/2011.

2. Endoscopy room #1 anesthesia cart was found in the storage room and drawer #1 had 1-multidose 5 ml vial of glycopyrrolate found opened and unlabeled with date. 1-single dose Ventolin inhaler opened and unlabeled for date. Endoscopy room anesthesia cart #1 was last used on 11/03/2011.

3. Operating room #4 anesthesia cart, drawer #1-1-container of Original nasal spray with no open date. 1-single dose Ventolin inhaler opened and unlabeled for date. 1-240 ml bottle (with an unknown quantity remaining) of Suprane (an inhaled anesthesia) with no opened date.

During an interview on 11/07/2011 at about 2:30 p.m., the anesthesia technician stated the entire bottle of Suprane is usually emptied in one day, but confirmed the bottle found was not labeled.

4. Operating room #8 anesthesia cart, drawer #1-1-240 ml. bottle (with an unknown quantity remaining) of Suprane (an inhaled anesthesia) with no opened date.

5. Sub sterile room between operating rooms #8 and #9 has a refrigerator containing Bacitracin 50,000 units for intra-muscular injection, one with an expiration date of 6/2011, and one with an expiration date of 9/11/2011. The interim chief nursing officer confirmed the dates of expiration.

During an interview on 11/08/2011 at 10:30 a.m., MD anesthesiologist said single dose medications are to be disposed of after each case, and the anesthesia technician was responsible for checking for expired medications when stocking the carts.

Based on observation, interview and record review, the facility failed to maintain operating room floors, failed to maintain operating room equipment, failed to ensure outdated supplies are not available for immediate patient use, and failed to maintain furniture in the obstetrical department to promote a sanitary environment.

Findings:

The facility has a total of 9 operating rooms and 1 cysto room.

Review of the policy Environmental Cleaning, revision date of 9/11, read #19 OR rooms are terminally cleaned on a rotating schedule-a. OR table is taken apart (pads and radio-lucent supports), cleaned and inspected for debris. i. Entire floor space shall be mopped. #20 All other areas and equipment shall be cleaned according to an established schedule to include: a. ducts and filters and c. ventilation and heating grills.

1. During a tour of the surgical department on 11/07/2011 at 2:45 p.m., the table and arm board pad in operating room #1 had several dime size areas with the outer covering of the pad worn away exposing the inner core mesh area of the foam. Also, there was adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the inner foam of the mattress absorbs fluids and the leftover tape may have prior case body fluids adhering under or on the tape surfaces.

2. Operating room #3 is found to have a large area approximately 12 inches by 12 inches, covered with small quarter size areas split with the outer covering of the pad worn away exposing the inner core mesh area of the foam. Also, there was adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the inner foam of the mattress absorbs fluids and the leftover tape may have prior case body fluids under or on the tape surfaces. The air return was dusty and in need of cleaning. The floor had tape stuck to ii and was black in color as if someone has repeatedly walked on the tape.

During an interview on 11/07/2011 at 2:50 p.m., the operating room nurse manager confirmed the hole in the mattress pads and the dirty tape on the floor. She stated room #3 was terminally cleaned last on 11/04/2011 and room #3 was last used on 11/07/2011 for two laparoscopic (a scope into the abdomen) gall bladder removals.

3. Operating room #4 had tape stuck to the floor and was black in color as if someone has repeatedly walked on the tape. The air return was dusty and in need of cleaning. The interim chief nursing officer stated room #4 was terminally cleaned last on 11/04/2011.

During an interview on 11/07/2011 at 2:55 p.m., the operating room housekeeper said his regular flooring cleaning machine has been broken the past few weeks. The housekeeper also said maintenance is responsible for cleaning the air ducts. The interim chief nursing officer stated a new floor machine is on order.

4. Operating room #8 had adhesive tape left over from a prior surgical case on several areas of the mattress. This prohibits the cleaning of the pad because the leftover tape may have prior case body fluids under or on the tape surfaces.

Review of the form 2011 Hazard Surveillance Survey last conducted on 08/2011 for the operating rooms did not show any survey activity specifically related to individual operating rooms.

During an interview on 11/09/2011 at 1:45 p.m., the infection control officer said she tries to round in areas on a quarterly basis, but did not always go in to all of the operating rooms, because they may be in use. The infection control officer said she was not aware of the broken floor cleaning machine. She also said she depends on other staff to keep of informed of any infection control issues in their areas.

Review of the policy In-House Sterilization Shelf Life, Sterile Storage and Handling, last revision date of 02/03, states in Procedure: 1. Shelf Life of Sterile Products. A. Shelf Life is event related with regard to packaging manufacturer's recommendation. B. Products that degrade over time and have a manufacturer expiration date will be adhered to.

5. During a tour on 11/07/2011 at 10:30 a.m., the crash cart on the second floor intermediate care unit had a CVP dressing tray on the top of the cart with an expiration date of 04/2008. The cart was last checked on 11/06/2011.

6. During a tour of the facility obstetrical department on 11/07/11 at about 2:15 p.m., a chair was observed in a patient room 349 which had multiple tears in the seat cushion. During an interview with the Nurse Manager for the floor at that time, she agreed the cushion was in need of repair.

Based on observation, interview and record review, the facility failed to enforce the infection control policy related to contact isolation, affecting 1 sampled patient (#2).

Findings:

Review of the policy-Isolation Policy, last revision date of 3/07, read Contact Precautions: Don gown and gloves upon entry into the patient room and After personal protective equipment (PPE) removal ensure that clothing and skin do not contact potentially contaminated environmental surfaces that could result in possible transfer of micro-organisms to other patients or environmental surfaces.

1. During a tour of the second floor intermediate care unit on 11/07/2011 at 10:30 a.m., a visitor was observed in a room with a sign designating the room to be a contact isolation patient. The visitor had gloves on, but no gown. The visitor handled patient items, assisted the patient (#2) with a drink, and touched the patient's environment with his clothing.

The charge nurse spoke with the visitor and said the visitor said this was the first time he has not put a gown on when entering the room. The charge nurse confirmed the visitor should have put a gown on.

Review of the medical record showed patient #2 had a positive nasal culture on 10/29/2011 for Methicillin Resistant Staphylococcus Aureus (MRSA) resistant to most antibiotics.

2. During a tour of the second floor intensive care unit on 11/07/2011 at 11:25 a.m., a staff registered nurse (RN) was observed in a room with a sign designating the room to be a contact isolation patient. The staff nurse caring for the patient and did not wear a gown or gloves. The charge nurse present during the observation, confirmed the staff should be wearing a gown and gloves.

The charge nurse said the patient had a prior positive culture and was being cultured again, but the culture is not back yet. She also said the staff should have worn the gown and gloves until the culture results were returned.

Based on record review and interview, the facility failed to credential 4 registered nurse first assistants (RNFAs) (staff Y, Z, AA, & BB) through the medical staff credentialing process prior to allowing their services assisting with patient surgical procedures in the operating rooms.

Findings:

The facility had four RNFAs recorded as employed and providing services at the facility, two (AA & BB) were employed by the facility and two were physician employed.

During an interview on 11/08/2011 at 2:25 p.m., the director of the medical staff office said all of the RNFAs go through a process by an outside source for the collection of the items required for credentialing. The outside source then turns the data over to the medical staff office; however, the RNFAs were not appointed or granted privileges through the medical staff office.

Review of the Medical Staff Bylaws, dated revised in 11/2010, did not define a RNFA as an advanced practice professional in Article I, section 2, and did not define the appointment process for a RNFA.

Review of the two employed RNFA who worked during the month of October 2011, showed RNFA staff AA and BB each worked 20 days in October 2011.

Review of the Medical Staff Bylaws, dated 11/2010, showed no requirement for RNFA to be credentialed by the medical staff.

During an interview on 11/09/2011 at 2:45 p.m., both the director of Human Resources and Vice President of Quality and Risk confirmed there were two different processes for credentialing employed and non-employed RNFAs.

Based on observations, interviews, and record reviews, the facility:

Failed to ensure that the medical staff was accountable for the quality of care provided to patients as evidenced in failure to insure that any individual providing patient care services is a member of the medical staff (refer to A-0049);

Failed to insure that evidence of current licensure, current training and professional education were available, maintained, and reviewed for 2 of 11 facility staff; representing themselves as either physicians or physician assistants (PAs), records reviewed. (Staff A & B) (refer to A-0341);

Failed to to protect patients right to confidentiality of medical record during emergency department (ED) visits to the hospital (refer to A-0147); and

Failed to protect patients right to privacy during emergency department (ED) visits to the hospital. (refer to A-0143).

The effect of these systemic practices resulted in the hospital's failure to have a consistent practice(s) related to assuring that any individual providing or representing themselves to provide patient care services was a member of the medical staff and the facility is found to be out of compliance with 42 CFR 482.12 - Condition of Participation: Governing Body.

Based on record review and interview, the facility failed to ensure that the medical staff was accountable for the quality of care provided to patients as evidenced in failure to insure that any individual providing patient care services is a member of the medical staff.

Findings:

Staff A (A), a seventeen year old, posed as an observer, a physician assistant (PA), PA student from 08/20/2011 to 08/28/2011, in the emergency department (ED) of the facility (on the night shift).

During an interview with the Chief Nursing Officer (CNO) on 09/07/2011 at 10 a.m., it was confirmed the facility was made aware of that A was in the ED posing as a PA student.

Interviews on 09/07/2011 at 10:15 a.m. and 09/08/2011 at 4:55 p.m. with ED physician (staff F), it was confirmed he met A on 08/08/2011 in the ED. A asked him if he could come to the ED as an observer and shadow him. He stated he told A to contact the ED Medical Director (staff C) for permission. He also asked A to write the Medical Director a note. He informed A that he would have to get clearance through the Medical Staff Office. He stated he had conversation with the Medical Director on 08/12/2011 and that both he and the Medical Director had told A to get the clearance and paperwork from the Medical Staff Office. He stated A was first observed in the ED on the night shift on 08/20/2011. He confirmed that A had a facility badge which indicated A worked for Surgical Management, a physician group, with a second badge which hung below the main badge with large letters PA. He stated that all clinical staff in the ED such as physicians, PAs, and registered nurses had the second badge with MD, PA, or RN in large letters. The badges described were observed on clinical staff in the ED during the interview. He stated A told him he had the clearance but confirmed he did not ask for the clearance form and that A did not present the clearance. He stated A observed in the ED on 08/20, 08/21, 08/25, 08/26, and 08/27/2011 on the night shift. He stated that when A was with him, he observed and did not provide patient care. He did confirm A could observe care provide by ED staff and observe what staff was documenting in the patient record. He stated that he told A to work with the PAs in the ED on 08/25/2011 because he felt they could provide more information to A. He stated he was not present with A when A was with the ED PAs.

During interviews on 09/07/2011 at 5 p.m. and on 09/08/2011 at 3:20 p.m. with staff C, the Medical Director of the ED, he stated he had met with A during the week of 08/12/2011. He stated A was requesting to do a clinical PA rotation. He stated he told A the ED no longer provided PA clinical rotations, but agreed to allow a one (1) day observation with physician F. He confirmed he told A to get clearance from the Medical Staff Office. He also confirmed he had not received any clearance from the Medical Staff Office.

Review of the credentialing files for PA student, staff A, did not show a credential file, and did not have a verification letter or notice related to an approval by the medical staff.

During an interview with the Director of Medical Staff Service on 09/08/2011 at 11:40 a.m., she confirmed that she had never met A and that the Medical Staff office had not received a request from A. She did confirm that the badges for the medical staff, including medical doctors (MDs) and PAs were made in the Human Resources (HR)department. She confirmed that sometimes medical staff go to HR on their own. She stated that when that happens, the HR staff call the Medical Staff office for confirmation of their credentials. She stated that although this was the practice, there was no written policy for the practice. She could not provide any evidence documenting when it occurred.

During interview with members of the HR department, including the Vice President of HR (staff S), an HR generalist (staff Q), and HR Assistant (staff R), it was confirmed that A had received a courtesy badge when he stated working in the medical office located on the facility campus. The VP of HR confirmed that the facility provided the courtesy badges to allow physicians' office staff access to the hospital. She could not provide a policy concerning the practice and confirmed no background check or verification was completed on the staff who were not employed by the facility. The HR Generalist (staff Q) stated A came to HR on 08/24/2011 and asked to have his badge changed. She checked the system and found his name. She stated the original badge stated his name and under it Surgical Management, which was the office practice where he worked. He told her he had a new position, PA. She confirmed she made the change in the system. She stated she was interrupted and did not print the badge. The HR Assistant (staff R) stated she did print the badge. She stated that it was the practice to give the second badge with the large letters PA to anyone receiving a PA badge but she could not recall if she gave him the second badge. The Vice President, Generalist, and Assistant all confirmed it was their practice to call the Medical Staff Office to verify credentials for PAs. They confirmed there was not a written policy concerning the phone verification, and that they did not document when they did call. Both the HR Generalist and the HR Assistant confirmed they did not call when they gave A the badge.

During an interview on 09/07/ at 6:15 p.m., ED PA (staff E) said staff A was in the ED during the week of August 24th 2011. He confirmed A had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirmed A had examined patients, assessed breath sounds, assisted in restraining a combative patient, and assisted in holding a pediatric patient who was being sutured. Staff E did confirm A had access to patient demographic and clinical information by watching other staff members enter information in patient records.

During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse, staff N, said the first time he saw PA student A, was on 08/26/2011 at around 7 p.m. The ED charge nurse said A had access to view patient information and personal health information on screen while shadowing another staff member. The ED charge nurse also said A would also have had access to patient demographic information sheets and patient stickers. The ED charge nurse said he witnessed A performing ear examinations, eye examinations, neurological examinations, and listening to patients' lungs for breath sounds.

During a phone interview on 09/08/2011 at 1:45 p.m., the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.

During an interview on 09/09/11 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients A may have interacted with during the times he was present in the ED.

Based on observations, interviews, and record reviews, the facility:

Failed to inform two patients and/or patient representative of the patient's rights related to An Important Message from Medicare within two days of admission (refer to A-0117);

Failed to provide patient's with notification of the hospital grievance process (refer to A-0121);

Failed to provide one patient response to a filed grievance in a timely manner (refer to A-0122);

Failed to provide one patient with advanced directive assistance (refer to A-0131);

Failed to protect patients right to privacy during emergency department (ED) visits to the hospital. (refer to A-0143); and

Failed to to protect patients right to confidentiality of medical record during emergency department (ED) visits to the hospital (refer to A-0147);

The severity and effect of these systemic practices resulted in the hospital's failure to have a consistent practice(s) related to patient's rights throughout the hospital and the facility is found to be out of compliance with 42 CFR 482.51 - Condition of Participation: Patient Rights.

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

Based on observation, interview, and record review, the facility failed to ensure two of seven Medicare patients (#12 & 17) signed and received a copy of the An Important Message from Medicare document within two days of admission.

Findings included:

1. Patient #12, [AGE], was admitted on [DATE] with pneumonia. Review of the medical record documented the patient did not sign the document An Important Message from Medicare (MI) until 09/07/2011, six days after admission.

During an interview on 09/07/2011 at 10:35 a.m., the licensed practical nurse (LPN) said that normally the Medicare notification is signed and a copy is placed on the front of the patient's medical record. This is done by the registration department.

During an interview on 09/07/2011 at 11:30 a.m., the registered nurse (RN) case manager (staff KK) said case management provides the copy of the Medicare Important Message two days prior to the patient being discharged , not within two days of admission, has the patient sign, and places a copy on the medical record.

2. Patient #17, [AGE], was admitted on [DATE] for open heart surgery. Review of the medical record showed no copy of the An Important Message from Medicare within two days of admission. On 09/09/2011 at 11 a.m., the director of registration, staff DD, reviewed the electronic record, finding an entry of some unknown type of documentation dated 09/07/2011 but could not locate a signed copy of the An Important Message from Medicare in the patient's medical record. Staff DD said it is the responsibility of the registration coordinator to get the signed during the registration process.

During an interview on 09/07/2011 at 12:30 p.m., the registration coordinator said all patients sign the consent, receive patient right's packets, MI information sheet, and are asked about advanced directives at the time of admission. All signed copies are placed on the medical record. The process was changed, but not recently. The last change in process was about two years ago.

Based on record review and interview, the facility failed to provide patient's with notification of the hospital grievance process.

Findings included:

Review of the Patient Information Guide given to patients in the registration department at the time of admission showed on page nine the instructions for filing a complaint the following, If you have a complaint regarding your care, please discuss it with the staff member most directly involved in your care. If you are unable to resolve it at this level then you may talk or write to the department director or follow the hospital grievance process. The patient information guide did not show any information explaining the hospital grievance process.

Review of the policy Patient Grievance, dated as revised 08/2008, read that the procedure is as follows, Patients and/or patients' representative are provided with information, at the time of admission about the Grievance process.

During an interview on 09/07/2011 at 12:40 p.m., the Patient Access supervisor (staff NN) said she was not sure where the written notice is located, A lot of times the patients come back to the registration department and complain about care and services. Staff NN said she then refers the patient to the patient advocate.

Based on record review and policy, the facility failed to provide 1 of 5 patients response to a filed grievance in a timely manner (#20).

Findings included:

Review of the grievance filed by the husband of patient #20 showed a grievance filed on 08/17/2011 related to the patient complaining about an unknown observer during a cardiac catheterization procedure. Review of the letter of response to the patient showed it was dated 09/07/2011, twenty-one days later. The facility grievance policy read that response is expected to be within seven days.

Review of the policy Patient Grievance, dated as revised 08/2008, read, A written response will be provided on average a timeframe of 7 days when possible . . . . respond to the patient or their representative, upon receiving the grievance, to let them know that the complaint is being addressed and they will receive a follow up response once the investigation is concluded. Every effort will be made to respond within 7 days.

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

Based on record review and interview, the facility failed to provide 1 of 7 patients with advanced directive assistance in a timely manner (#13).

Findings included:

Review of the policy Advanced Directives, dated as revised 08/2008, read that the procedure for a patient who desires to execute an advanced directive and asks for forms is to, contact the Patient Advocate or Risk Manager. The patient Advocate or Risk Manager will provide the patient with a copy of the health Care Advanced Directives pamphlet provided by the State of Florida Agency for Health Care.

Patient #13, [AGE], was admitted on [DATE] with pneumonia. Review of the medical record review showed the patient has been in the hospital since 08/26/2011 and there is documentation patient #13 does not have an advanced directive. On 08/26/2011, the medical record read that the patient requested information for an advanced directive.

During an interview on 09/07/2011 at 11 a.m., the patient nurse advocated confirmed the medical record showed the patient's request for additional information related to advanced directives on 08/26/2011 but she has not yet consulted with the patient or family. The patient nurse advocate said she usually sees patients within one day of admission, but this patient had not been seen yet.

Based on interview and record review, the facility failed to protect patients right to privacy during emergency department (ED) visits to the hospital.

Findings included:

Staff A, a seventeen year old, posed as an observer, a physician assistant (PA) or PA student, from 08/20/2011 to 08/28/2011, in the ED of the hospital on the night shift. It is unknown how many patients he might have had contact with prior to discovery.

During an interview on 09/09/2011 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients staff A might have interacted with during the times he was present in the ED.

During an interview on 09/07/2011 at 6:15 p.m. ED PA (staff E) said staff A was in the ED during the week of August 24th 2011. He confirmed staff A had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirmed staff A had examined patients, assessed breath sounds, assisted in restraining a combative patient, and assisted in holding a pediatric patient who was being sutured. Staff E did confirm staff A had access to patient demographic and clinical health information by watching other staff members enter information in patient records.

During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse (staff N) said the first time he saw staff A was on 08/26/2011 at around 7 p.m. The ED charge nurse said staff A had access to view patient health information and personal information on screen while shadowing another staff member. ED charge nurse also said staff A would also have had access to patient demographic information sheets and patient stickers. ED charge nurse said he witnessed staff A performing ear examinations, eye examinations, neurological examinations, and listening to patients' lungs for breath sounds.

During a phone interview on 09/08/2011 at 1:45 p.m., the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.

Review of the credentialing files for staff A did not show a credential file and did not contain a verification letter or notice related to an approval by the medical staff.

Based on interview and record review, the facility failed to protect patient's right to confidentiality of medical record during emergency department (ED) visits to the hospital.

Findings included:

Staff A, a seventeen year old, posed as an observer, a physician assistant (PA) or PA student, from 08/20/2011 to 08/28/2011, in the ED of the hospital on the night shift. It was unknown how many patients he may have had contact with prior to discovery.

During an interview on 09/09/2011 at 2:55 p.m., the chief nursing officer (staff X) said the facility ED sees approximately 200 patients a day. The facility is still in the process of trying to gather information and determine how many patients staff A might have interacted with during the times he was present in the ED.

During an interview on 09/07/2011 at 6:15 p.m., ED PA (staff E), confirmed that Staff A was in the ED during the week of August 24th 2011. He confirmed staff member A had presented himself as a PA student and wore a facility name badge identifying himself as a PA. He confirm staff member A had access to patient demographic and clinical information by watching other staff members enter information in patient records. He stated he did not observe staff member A enter information in the electronic records, but was observed to be writing information in a personnel notebook.

During an interview on 09/08/2011 at 9:30 a.m. registered ED charge nurse, staff N, said the first time he saw staff A was on 08/26/2011 at around 7 p.m. The ED charge nurse said staff A had access to view patient medical information and personal information the computer screen while shadowing another staff member. Staff N also said staff A would have also had access to patient demographic information sheets and patient stickers.

Review of the medical record face (demographic) sheet showed the document would have a patient's social security number, date of birth, address, phone number, and insurance specific information included. The patient sticker has the patient's name, date of birth, and age included.

During a phone interview on 09/08/2011 at 1:45 p.m. the chief of medical staff said students would not be allowed to make documentation entries in the medical record, but are allowed access to read the medical record. Students are allowed to touch patients for examinations and assessment purposes.

Review of the credentialing files for staff A did not show a credential file and did not contain a verification letter or notice related to an approval to be a hospital observer or physician assistant or physician assistant student by the medical staff or staff A.

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

Based on record review and interview, the facility failed to insure that evidence of current licensure, current training and professional education were available, maintained, and reviewed for 2 of 11 facility staff representing themselves as either physicians or physician assistants (PAs) (staff A & B).

Findings:

Review of medical staff credentials did not provide evidence of ACLS certification for physician B from 02/23/2010 through 05/12/2010. The physician's privileges include requirement for current ACLS certification.

Interview with the Director of Medical Staff Services on 09/09/2011 at 11 a.m. confirmed that the privileges required ACLS and that the certification had expired on [DATE] and was not renewed until 05/12/2010.

During and interviews on 09/07/2011 at 5 p.m. and 09/08/2011 at 3:20 p.m. with Staff C, the Medical Director of the ED, he stated he had met with staff A during the week of 08/12/2011. He stated staff A was requesting to do a clinical PA rotation. He stated he told staff A the ED no longer provide PA clinical rotations, but agreed to allow a one (1) day observation with physician F. He confirmed he told staff A to get clearance from the Medical Staff Office. He also confirmed he had not received any clearance from the Medical Staff Office.

Review of the credentialing files for staff A did not show a credential file, and did not contain a verification letter or notice related to an approval by the medical staff. During an interview with the Director of Medical Staff Service on 09/08/2011 at 11:40 a.m., she confirmed that she had never met staff A and that the Medical Staff office had not received a request from staff A. She did confirm that the badges for the medical staff, including medical doctors (MDs) and PA S were made in the Human Resources (HR) Department. She confirmed that sometimes medical staff go to HR on their own. She stated that when that happens the HR staff call the Medical Staff office for confirmation of the credentials. She stated that although this was the practice there was no written policy for the practice. She could not provide any evidence documenting when it occurred.

Interviews on 09/07/2011 at 10:15 a.m. and 09/08/2011 at 4:55 p.m. with ED physician F; confirmed he met staff A on 08/08/2011 in the ED. Staff A asked him if he could come to the ED as an observer and shadow him. He stated he told staff A to contact the ED Medical Director (staff C) to get permission. He also asked staff A to write the Medical Director a note. He informed staff A that he would have to get clearance through the Medical Staff Office. He stated he had conversation with the Medical Director on 08/12/2011 and that both he and the Medical Director had told staff A to get the clearance and paperwork from the Medical Staff Office. He stated staff A first observed in the ED on the night shift on 08/20/2011. He confirmed that staff A had a facility badge which indicated staff A worked for Surgical Management, a physician group, with a second badge which hung below the main badge with large letters PA. He stated that all clinical staff in the ED such as physicians, PAs, and registered nurses had the second badge with MD, PA, or RN in large letters. The badges described were observed on clinical staff in the ED during the interview. He stated staff A told him he had the clearance but confirmed he did not ask for the clearance from and that staff A did not present the clearance. He stated staff A observed in the ED on 08/20, 08/21, 08/25, 08/26, and 08/27 2011 on the night shift. He stated that when staff A was with him he observed and provide no patient care. He did confirm staff A could observe care provide by ED staff and observe what staff were documenting in the patient record. He stated that he told staff A to work with the PAs in the ED on 08/25/2011 because he felt they could provide more information to staff A. He stated he was not with staff A when staff A was with the ED PAs.

Review of records and interview failed to confirm Staff A was involved in any invasive care.

Record review and interview confirmed A provided cardiopulmonary resuscitation (CPR) on one patient. Patient #2 arrived in the ED on 08/25/2011 at 3:04 p.m. She arrived by ambulance with CPR in progress. The record reflected that she had taken over 30 Hydrocodone pills. CPR was continued in the ED and she was successfully resuscitated at 3:12 p.m. with rhythm of Sinus Tach 136, B/P 68/43 was continued on ventilator. Between 3:34 and 7:19 p.m., the patient ' s heart rate was between 100 and 120, and was between B/P 88/60 to 100/62.

At 7:19 p.m., she went into ventricular fibrillation (V-Fib), and CPR was initiated. The patient was successfully resuscitated at 7:32 p.m. with Sinus Tachycardia. The vital signs from 7:32 p.m. until transferred to floor at 9:10 p.m. were Sinus Tachycardia 101-105 and B/P 87/40-113/68. The patient expired the next day 09/26/2011 at 5:30 p.m. The hematology consultation ' s clinical impression was Hydrocodone overdose, liver failure, coagulopathy, and severe anemia. She was critically ill with extremely poor prognosis.

There were no clinical issues with either case, care documented was consistent with current standards of practice. Interview with CNO 09/09/11 at 10 p.m. confirmed the records were accurate and the policies were operational.

During interview on 09/15/2011 at 9:15 a.m., physician SS, an ED physician, stated he recalled staff A was in the ED on the night of 08/25/2011, most of the time with PA staff D. Other than the code involving patient #2, he did not observe staff A providing any patient care. He confirmed staff A provided CPR during the Code on patient #2 on 08/25/2011. He stated that staff A was performing CPR correctly and that when he, staff SS assessed the pulse with a Doppler, the CPR was producing an effective femoral pulse.

During interview on 09/07/2011 at 7 p.m., staff Z, an ED nurse, stated he confirmed the police record that CPR was performed by staff A. A second interview was requested but the staff was unavailable.

A second interview on 09/15/2011 at 7:15 a.m. confirmed patient #2 was in the ED when he, staff Z came on duty at 7 p.m. on 08/25/2011. Staff Z was not assigned to patient #2 but went to the room when the respiratory therapist called him about 7:15 p.m. The patient had experienced a second cardiac arrest. Staff Z started CPR. Staff A relieved him at about 7:20 p.m. He stated that staff A continued CPR until the patient was successfully resuscitated.

During interview by phone on 09/15/2011 at 11 a.m. Staff VV, a respiratory therapist, confirmed staff A performed CPR on patient 2. Had no other contact with A .

During interview by phone on 09/15/2011 at 11:30 a.m., Staff D, an ED PA, confirmed staff A was in the ED on 3 nights. She confirmed he shadowed her and that when shadowing her, he watched her examine patients. She confirmed staff A had a hospital badge identifying him as a PA. She said staff A was also with MD staff F and PA staff E. She stated she did not observe staff A provide and care or complete any patient examinations.

Interview at 11:45 a.m. on 09/15/2011 with staff X, CNO, and staff W, the Director of Quality, confirmed that the facility did not have any evidence that staff A was certified in CPR.

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

Based on record review, the facility failed to ensure that all drugs were administered under supervision of nursing in accordance with state laws which require physician orders for administration in one of eight sampled patients. (#1)

Findings:

A review of the medical record of patient #1 was performed. The patient (MDS) dated [DATE] at 11:18 AM, whereupon he received a rapid initial assessment. The subjective assessment was stated as: Chest pain, SOB (shortness of breath), cough X 1 month. Denies fever. The Objective assessment read: NAD (no acute distress) noted at pres, EKG done in triage office. From this point through 2:12 PM the patient remained in the lobby and received two additional assessments during the intervening time period.

A Triage Reassessment at 2:12 PM read: Pt states his pain is fluctuating BTW (between) 2-4, pt states he has nitro. RN advised pt to take a nitro and advise on his pain. ... NAD noted. ... Pulse: 65; Respirations 14; Blood pressure 148/93; SPO2: 99. ... Pain /Discomfort Severity: 4. Condition: worsened; Disposition: Moved to treatment area. Nitro, short for nitroglycerin, is a medication used to relieve acute chest pain. Therefore, as this entry was written, the patient was advised by the nurse to perform an action involving a medication. This action was beyond the purview of the nurse, as there was no physician orders to do such.

Nursing note on 1/22/11 at 2:14 PM read: Pt taking a 0.4 mg nitro at pres will monitor. A nursing note at 2:24 PM read: After 1st nitro pain dropped to a 2 but about 1 min later pt pain up to 4. Pt taking 3rd nitro. NAD noted. As with the first nitroglycerin administration, there was no evidence of any physician orders or involvement with these second and third administrations.

The act of advising a patient to take a medication once they are under their care, without physician orders for such, is a violation of standard nursing practices as ordained by State of Florida law.