CMS-HCA-Houston-Healthcare-West

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

Based on record review, and interview the facility failed to ensure that registered nurses failed to assess and elevate patients for potential skin breakdown in three out of seven patients admitted through the emergency department (Patient, ID#1,2, 8).

Findings Include:

Record review of three patients (ID#1,2, 8) who were admitted on [DATE] and 01/30/2021 from the emergency department. The documentation revealed the patient had no skin issues and skin was Intact. The nursing staff did not implement the facility's Skin Risk Nursing Protocol for patients at risk for skin breakdown.

Record review of the emergency department (ED) noted dated 01/23/2021 revealed patient (ID#1) an 83 year- old- female, who was admitted for respiratory distress and it was documented that her skin was intact. A wound care assessment was triggered on 01/28/2021 for this patient who had bilateral hips and sacral area open with scar tissue, and bilateral feet were noted to have with multiple diffuse areas of deep tissue injury and pressure injury.

Record review of the ED noted dated 01/22/2020 revealed patient (ID# 2) an [AGE]-year-old male, who was admitted with acute hypoxic respiratory failure secondary to pneumonia. The documentation revealed the patient had no skin issues and skin was Intact. The skin risk assessment was completed 01/24/2021, posterior sacrum, stage III. The first wound order was noted on 01/26/21 @1513 for silver alginate dressing to a open wound.

Record review of the ED noted dated 01/30/2021 revealed patient (ID# 8) an [AGE]-year-old male, who was admitted from the ED for aspiration pneumonia, anoxic [DIAGNOSES REDACTED]. The documentation also revealed the patients was intact skin and no other skin integrity issues were found. Four days later, 02/03/2021 the wound care nurse was consulted and documented the wound.

Interview with nurse (ID# 57) on 02/12/2021 at 1145, who stated we chart by exception, and it is easier to chart what is pertinent to the patient, especially in the ED. The ED staff documents the chief complaint, that is why they are not addressing the patient's skin at admission. The system stages the wound for the nursing the staff. If it is not documented, it is not done.

Interview with wound care nurse (ID# 65) at 02/12/2021 at 1040 who stated, we go by the physicians note and make recommendations about the wound. We are just asking staff to write what they see.

Record review of the facility policy Clinical Practice Guidelines for Skin Alterations dated 01/2020 stated the Purpose To ensure all patients will be properly screened for the presence of skin alterations (also known as wounds, ulcers, injuries) and for risk of, or presence of pressure injuries.

The Adult Skin Risk Nursing Protocol, stated should the adult patient be at risk for any of the risk factors within the Adult Skin Risk Assessment, the Adult skin risk Nursing Protocol is to be implemented.

Show Text of Violation

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

Based on record review and policy review, the nurses did not follow their policy and procedure related to addressing potential issues related to the patient's diagnosis in the intermediate care unit and the intensive care unit in seven (7) out of 11 patients (Patient ID # 12,13,14,16, 17, 19, 20)

Findings Included:

Record review of the facility policy dated 07/2014, Multidisciplinary Plan of Care Documentation that stated:

The initial responsibility for the assessment of the inpatient's care and educational needs rest with the Registered Nurse (R.N.)

Subsequent reassessments, made at least every 24 hours by a RN, or finding from consults made to nursing or other specialties may result in additional changes to the Plan of Care.

Record review of the facility policy Documentation Standards for ICU (Intensive Care Unit) dated 04/2015. The policy stated, ICU nurse will prioritize the care plan at least once a shift

Record review of five out of eight patients in the intermediate care unit revealed the nurses were not documenting the patients' needs within the nursing care plans.

1. Patient ID# 12, [AGE]-year-old female admitted with arteriosclerosis, had a bypass graft and was also a diabetic. The nurses did not address her history diabetes within their plan or care.

2. Patient ID# 13, a 50-year male admitted for chest pain, who was admitted for a right bundle branch block received a cardiac catheterization and was scheduled for coronary bypass. The nurses did not address the emotional issues related to his impending lifestyle change with his plan of care.

3. Patient ID# 14, a [AGE]-year-old female admitted for chest pain with a history of diabetes, hypertension, and stroke. The nurses did not address her history of diabetes or nutritional teaching in the plan of care.

4. Patient ID# 16, a [AGE]-year-old female admitted for congestive heart failure and pedal edema. The nurses did not address potential for skin breakdown in the plan of care.

5. Patient ID# 17, a [AGE]-year-old male who was admitted for acute coronary syndrome. Discharge was pending, related to a low oxygen saturation. He also obese and had a history of smoking two packs of cigarettes per day for the last 15 years. The nurses did not address nutrition or smoking cessation with the patient within the plan of care.

Record review of the two (2) patient out of three (3) patients in the surgical intensive care unit revealed the nurses were not addressing the patients' needs within the nursing plan of care.

1. Patient ID# 19, a [AGE]-year-old male who was admitted with arteriosclerosis to the right lower extremity. He had a right femoral popliteal bypass with an infected graft, no pulses in his right foot, pending a right foot amputation.

Interview with the staff nurse (ID #59) stated the patient was quite upset and depressed about the possible amputation. The nurses did not address the patients emotional state within the plan of care.

2. Patient ID# 20, a [AGE]-year-old female patient who was admitted for osteo[DIAGNOSES REDACTED] of the left foot. She had a previous right leg amputation and would be receiving a left leg ampution due to gangrene. Emotional support and a change of lifestyle were not addressed in the nurse's plan of care for patient (ID#20).

Interview with staff nurse (ID# 59) stated on 12/12/2020 at 1130, stated

Absolutely, we should be addressing these issues.

Show Text of Violation

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

Based on record review and interview, the governing body failed to ensure the facility followed its Policy and Procedures, Medical Staff Bylaws and Rules and Regulations.

The facility failed to treat 1 of 15 the patient (Patient ID #22) with respect and dignity and to respond in a prompt and reasonable time for requested service.

Findings:

Review of current Rules, Bylaws & Policy and Procedures:

Review on August 14, 2018 at 2:30 p.m. of the facility's 2015 Medical Staff Rules and Regulations Last revision January 2014 read in part ...B. Enforcement and Discipline: The Rules and Regulations are intended to be the policy of the Medical Staff as proposed and approved by the Departments, the Medical Executive Committee and the Board of Trustees. The Medical Executive Committee shall have the authority to ensure that the Rules and Regulations are enforced in the best interest of the patient. F. 8) Each member of the staff shall name another member of the staff as an alternate to be called to attend his patients in an emergency when the attending practitioner is not available or until the attending practitioner can be present. In case of a medical emergency the designated alternate shall be called. In case the alternate is not available, the CEO (or designee) or the Chief of Staff shall have the authority to call any other member of the Staff to attend to the patient.

Review on August 14, 2018 at 2:30 p.m. of the current faculty's Bylaws of the Medical Staff 2014. 1.3 Purpose and responsibilities of the Medical Staff are: 1.3.1 To provide a formal organizational structure through which the Medical Staff shall carry out it responsibilities and govern the professional activities of its members .....to provide mechanisms for accountability of the Medical Staff. 2.2.6 Be available on a continuous basis, either personally or by arranging appropriate coverage to respond to the needs of inpatients and Emergency Department patients in a prompt, efficient and conscientious manner. ((Appropriate coverage means coverage by another member of the Medical Staff with specialty-specific privileges equivalent to the Practitioner for whom he or she is providing coverage.) The Practitioner must document that he or she is willing and able to: 2.2.61. Respond within 15 minutes, via phone, to STAT pages from the Hospital and respond within 30 minutes, via phone, to all other pages; 2.2.6.2 Appear in person to attend patient within 30 minutes when requested to do so by the Practitioner caring for the patient at the Hospital.

Review on August 14, 2018 at 2:30 p.m. of the current Policy and Procedure titled Patient Rights, Policy ID: 23, Last Revised: 06/2016 reads in part ...Patient Rights: (facility) respects the dignity and pride of each individual we serve. Every patient has the right to have his/her rights respected ...Considerate and Respectful Care: To receive ethical, high-quality, safe and professional care without discrimination. To be free from all forms of abuse and harassment. To be treated with consideration, respect ...Decision Making and Notification: To request or refuse treatment. To a prompt and reasonable response to ...requests for service. Protective Services: To expect emergency procedures to be carried out without unnecessary delay....

Review on August 14, 2018 at 2:30 p.m. of the current facility's Policy and Procedure titled Scope of Service - Emergency Services, PolicyStat ID: 63, Last Approved 08/2016 reads in part .... Policy: The Emergency Service Plan for the Provision of Patient Care Services has been designated to support and promote improvements and innovation in the delivery of care to patients in accordance with the Hospital Plan for the Provision of Patient Care Services. Types of Services: Activities and services provided by the Emergency Services included but are not limited to ....5. Consideration shall be given to the psychological and social needs of the patients in a crisis situation. 7. Consideration shall be given to the patient's family in a crisis situation.

Review on August 14, 2918 at 2:30 p.m. of the current facility's Policy and Procedure titled, Chain of Command for Register and Licensed Practitioners, - Conflict Resolution - Admission, Treatment or discharge of a Patient. PolicyStat ID: 55, Last Revised: 03/2015 states in part .... Purpose; 1. To provide guidelines for registered or licensed practitioners should a conflict arise in the admission, treatment or discharge of a patient. 2. To provide Guidelines for register or licensed practitioners to request intervention or consultation regarding physician orders or patient care. Procedure: 1. At all times during the resolution process, care will be provided to the patient following appropriate and uncontested physician orders and standards of care. Procedure: V. If the concern is still not resolved, the House Supervisor/Leadership will notify the Chief Nursing Officer (CNO), or in his/her absence, the Administrator on-call. The CNO or Administrator on-call will contact the ordering physician to resolve the concern. VI. If the concern remains unresolved, the CNO or Administrator on-call will notify the Chief of Staff/Department Chairman for the ordering physician/Medical Director for the Unit regarding the unsolved situation. Risk Management is available for consult upon request

Patient # 21

Complaint # TX 488 reads in part ....... when the dead fetus was delivered at home, the parents returned to the ED (emergency department) for the mom to lay on a gurney in the ED for 7 hours with a dead baby between her legs. The mom begged to have the cord cut, but the ER MD wouldn't and the OB MD couldn't be reached.

Record review of medical records for admitted [DATE] reviewed on 08/13/2018 reads in part ....

ER Visit 6/15/18 - Arrival Time: 8:49 a.m. brought by HFD (Houston fire department) for abdominal pain and vaginal bleeding, was told she had a miscarriage last night in ER. On arrival, Pt noted to have delivered fetus with moderate amount of bleeding. Physician ID #74 made aware. Pain 7/10.

Physician Note - Emergency Department: 6/15/2018 (Physician ID#74) - 32 y/o 13 weeks pregnant, presents to ED with c/o vaginal bleeding that began this morning at 8:15 a.m. Patient states she went to the restroom this morning and a gush of fluid and bright red blood came out of her vagina. Reports she partially delivered the fetus and had 2 episodes of vaginal discharge in route to ED. Note she was here yesterday and advised she may have a miscarriage and saw her OB, Physician ID #70 four days ago.

Partial delivered fetus, however, cord is still intact internally.

deceased fetus present and umbilical cord still attached internally.

Primary Impression - incomplete miscarriage

Disposition Decision - admit Physician ID #70, OB/GYN, request time 6/15/18 @ 0906. Admission Accepts - Yes 6/15/2018 at 0920. Called Physician ID #70 information given, will see patient. Advised to give patient: l liter NS (normal Saline (0920), Zofran (0910), Hemabate (used to treat bleeding after childbirth and cramping (0921), Lomotil (drug used to treat diarrhea) (0929), Tylenol (0921), Hemabate 2nd dose (1459)

10:05 am - Patient having more pain so will give her stronger pain meds. Tylenol is not helping. Morphine 4 mg IV

Disposition: Admit 6th floor, Room 612

ER Nurse notes: 6/15/2018 Arrival time 8:49 am discharged ED Department 3:30 p.m.

10:08 a.m. - (Employee ID # 75 Charge RN) Per L&D nurse, Physician ID #70 wants patient admitted to 5th floor/medsurg.

11:30 a.m. - (Employee ID #76 RN ER primary nurse) Physician ID #70 called at this time in regards to when he will come to see the patient as patient and family are concerned and upset. Physician ID #70 is currently in emergency surgery as well as a procedure scheduled. Charge Nurse Employee ID #75 and ER Physician ID #74 notified of patient's concerns. Awaiting physician at this time.

1:16 p.m. - (Employee RN ID #76) Family still concerned at this time. They want the baby and placenta removed from the room, but placenta is still intact. Physician ID #70 to remove, discussed with family, awaiting Physician ID #70 at this time.

1:56 p.m. - (Employee RN ID #76) Physician ID #70 at bedside at this time.

2:45 p.m. - (Employee RN ID #76) Fetus sent to pathology at this time.

2:57 p.m. - (Employee RN ID #76) Report faxed to 6th floor at this time, Russel confirmed.

3:40 p.m. - (Employee RN ID #76) Patient transferred to 6th floor via stretcher, IV, tech and RN.

OB/GYN Physician ID #70 notes:

6/15/18 at 2:29 p.m. - [AGE]-year-old presented to the ER for the second time in 24 hours for complaints of cramping and pelvic pressure. Patient passed the fetus in the ER and I was called while in surgery. Order given for Hemabate IM q 4 hrs. After surgery I went down to see patient. Placenta still in place but protruding 1 cm thru os. Patient otherwise appears stable. Patient has been afebrile on all readings in the ER. Plan - Reviewed findings and associated risk of expectant management vs suction D & C. Patient voiced understanding and wishes to continue with Hemabate every 4 hours for now.

Interview with Emergency Physician Employee ID #74 on 8/14/18 at 1:20 p.m. stated he personally called and spoke with OB/GYN Physician ID #70 and told him of the incomplete miscarriage with everything still connected and need evacuation. Physician ID #70 did not tell me he was delayed; said he was coming. Physician #70 did not tell me he was in surgery and did not come in for a long time. The patient and husband was very upset about the delay. I went back and talked to husband and he wanted a different OB doctor. Patient wanted a different OB. Physician ID #70 does not have cross cover with any MD practice. The OB doctors do not cover each other's patients. Patients usually go up to L & D for delivery of placenta, never seen a delay like this, the patients are usually seen within one hour. Physician ID #74 was asked why the ER doctor did not cut cord on the fetus. Physician ID #74 replied that he had never done an aborted fetus like that and stated if it was a live birth we cut the cord, but a partial abortion we do not cut the cord. When asked what he would have done different Physician ID #74 stated, looking back I would have expedited the case with the house supervisor, better communication and have doctor cross coverage information.

Interview on 8/13/2018 at 4:25 p.m. OB/GYN Physician Employee ID #70 regarding 32-year-old, Patient ID #22 admitted on [DATE], who was 13 weeks pregnant and presented to the ED with vaginal bleeding and a partial delivered fetus. He stated ER doctor should have cut the cord. I was in surgery for four hours. The family was very upset the placenta was still inside of her and the fetus was still attached for four hours. The cord was clamped. The placenta was delivered and I sent her home the next day. Physician ID #70 was asked if he would do anything different and he stated The ER doctor should have cut the cord instead of leaving it there for 4 hours. I was in surgery.

Interview on 8/13/2018 at 4:40 p.m. with OB/GYN Division Medical Director Doctor Employee ID #57 was asked if he was aware of the Patient's ID #22 complaint about lying on a gurney with a dead fetus still attached to her placenta for over 5 hours. Employee ID #57 stated that should have never happened, the ER physician could have cut the cord a long time before that. Employee ID #57 stated they could of called someone else.

Interview on 8/9/18 at 2:10 p.m. Employee ID #54 CNO (Chief Nursing Officer) revealed:

Concerning fetal demise, incomplete abortion or miscarriage we do not put those patients that have lost a baby on the labor and delivery unit with other crying babies or active L&D patients. Those patients go to medical/surgical floor and stay in a different area rather than L & D. OB/GYN Physician ID #70 had requested patient be admitted to 5th floor med/surg unit. There were no beds on the 5th floor so she was admitted to 6th floor medical surgical unit. The staff were not really familiar with post-partum delivery of a placenta and were afraid it was a large clot and called for a rapid response for a physician to come evaluate the patient.

Employee ID #54 confirmed the staff should have expedited the delay of the physician arrival with patient ID #22 with the hospital supervisor and up to administration. It was wrong of them to leave her miscarried fetus in bed with her for over 5 hours. She stated that should of never happened. CNO stated that patient ID #22 was not treated with respect and dignity nor compassion. CNO stated that both Physician #70 and #74 had been reported and the case has gone to the peer review committee.

CNO Employee ID #54 stated that emergency room RN Employee ID #76 was the patient's primary nurse. Employee ID #76 had escalated the issues to both ER Physician ID #74 and ER Charge Nurse Employee ID#75 who notified the Administrator on call at the time. Employee ID #77 was the night shift manager on duty when the patient was transferred to the 6th floor. He spoke to the Administrator on Call about the issue and was told that the Administrator had spoken to OB/GYN Physician #70 personally about the issue.

Show Text of Violation

Based on observation, interview, and record review, the facility failed to ensure a safe safe environment for 1 of 12 current patients ( Patient # 1). The facility failed to:

* Ensure Patient #1's bathroom was free of ligature risks.

* Monitor Patient # 1 per physician order ( 1:1; Line of Sight).

Findings include:

Ligature risk:

Observation on 05-17-18 at 10:00 a.m. revealed Patient # 1 in room 320. Interview with RN Director #6 at the time of observation, she stated this patient had been admitted during the night after attempting suicide; she had been placed on suicide precautions.

Further observation revealed Patient # 1 awake, lying in bed; both of her wrists were bandaged. There were no staff or visitors in room. A call light cord was observed in this patient's bathroom. The call light pull consisted of a white cord (approximately 15 inches long) with a plastic red portion (approximately 6 inches long) attached to the bottom of the white cord. Interview with RN # 6 at the time of observation, she stated the call light cord should have been rolled up and secured. It was a ligature risk.

Interview on 5/17/18 at 12:30 p.m.. with RN Director # 6 she stated all of the bathroom call lights had been cut short. She further stated the facility maintenance director informed her the call lights were breakaway cords at 30 pounds. They had been tested when installed but he was unable to locate documentation of the testing.

Record review of facility policy titled: Suicide Prevention Plan dated 8/2017, read: ...Suicide Precautions ...5. Additional safety interventions are implemented for patients on suicide precautions ...These interventions include ...Nurse call cords will be secured ...

Patient Monitoring:

Record review of Patient # 1's physician orders, dated 5/17/18 (time 0425) read: Observation: every 15 minutes; Line of sight; 1:1 .

Observations of Patient # 1 on 05-17-18 at 10:00 a.m.; 10:45 a.m. and 11:15 a.m. revealed her to be lying in bed, alone in room: no staff; no visitors...

Record review of Patient # 1's Behavioral Health Patient Monitoring form, dated -5-17-18, had the following types of Precautions indicated at the top of the form (by check mark): Standard (q [every] 15); Suicide; and Fall; Line of Sight and 1:1 (monitoring) were not checked.

Record review of facility policy titled: Suicide Prevention Plan, dated 8/2017, read: ...Heightened Observations: 1:1 Monitoring: The patient is NEVER to be out of arms reach of the assigned and dedicated staff member (facility bolding & capitalization) ...Line of Sight Observation: monitoring and observation. Continuous observation means that at no time is the patient out of the visual contact of a staff member ...

Record review of facility Senior Program Patient Information Handbook, read: Patient Rights ... (3) The right to an....environment that ensures protection from harm ...

Show Text of Violation

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

Based on record review and interview the facility failed to respond in writing to a family member who complained to the facility that their father died because of poor quality of care during his hospital admission.

The facility failed to implement their grievance policy which require the facility respond in writing to grievances. Citing one (1) Patient named in a complaint, Patient #1.

Findings:

Review of complaint Narrative dated 10/17/2016 revealed information Patient # 1 was admitted on [DATE] and died at the hospital on [DATE]. Ther complainant alleged during the one month Patient # 1 was admitted in the hospital the incompetence and negligence of the Doctors, Nurses and Hospital Staff succesfully killed the patient on January 14, 2016.

The Complainant alleged the family met with the Hospital to get answers to their concerns but did not get any answers.

Review of the facility's complaint /Grievance logs for January 26, 2016 through November 10, 2016 revealed no documentation of the family's complaints or information on the family meeting conducted on 1/26/2016.

During an interview on 11/10/2016 at 11:15 am with the Chief Nursing Officer (CNO) she stated the family did have concerns regarding the care of Patient #1 and the circumstance of his death. The CNO stated the facility did not consider it to be a grievance so no letter was sent to the complainant.

According to the CNO the complaints by the family were not documented in the facility's

Complaint/Grievance System.

Review of the facility's Complaint/Grievance Policy and Procedure dated May 2016 revealed the following information:

To allow all patients and/or their representatives their right to voice complaints and/or grievances about his or her care, and to have those complaints reviewed and, when possible, resolved.

Complaints or grievances that are reported directly to Administration will be entered into Resolvv and forwarded to the appropriate member of the Leadership team.

The Director/Manager handling the complaint enter the findings and actions taken under event response in Resolvv, noting whether or not there was resolution.

If the complaint is not promptly resolved, the complaint then becomes a grievance and is noted as such in Resolvv.

Following review and investigation of grievances, the Risk Manager is responsible for ensuring that a written notice of the hospital's determination regarding the grievance is communicated to the patient or the patient's representative in a language and manner the patient or the patient's representative.

The written response will contain the following elements: name of the hospital, hospital contact

person, steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion of the grievance process.

Show Text of Violation

Based on observation, interview, and record review the facility failed to implement an effective system to control the transmission of infections and communicable disease. The facility failed to ensure:

* A Registered Nurse (RN) utilized appropriate hand hygiene prior to inserting an intravenous (IV) catheter on 2 sampled patients (Patient # 5, # 6).

*Two (2) RNs donned appropriate personal protective equipment (PPE) when providing direct care to a patient on Contact Isolation Precautions (Patient # 5)

* Operating room (OR) surfaces and equipment were maintained in a manner to allow appropriate cleaning and disinfecting.

* OR staff donned appropriate hair covering during surgery (Patient # 4).

* Linen was stored and transported in a manner to prevent contamination.

Findings include:

TX # 662

Hand Hygiene:

Patient # 6:

Observation in the Day Surgery Unit on 08-07-15 at 9:50 a.m. RN # 6 prepared to insert an IV catheter into Patient # 6 prior to her surgery. RN # 6 failed to perform hand hygiene prior to donning gloves. RN # 6 proceeded to insert the IV catheter into Patient #6's left hand.

He was unable to open the Biohazard sharps container. RN # 6 left the room while wearing the contaminated exam gloves. He went into an empty patient room and opened the biohazard container and disposed of the IV catheter needle. RN # 6 was still wearing the contaminated gloves.

Patient # 5:

Observation in the Day Surgery Unit on 08-07-15 at 12:30 p.m. RN # 6 prepared to insert an IV catheter into Patient # 5 prior to her surgery. RN # 6 failed to perform hand hygiene prior to donning gloves. RN # 5 proceeded to insert the IV catheter into Patient #5's left hand.

Interview immediately after this observation with Quality Manager # 4, she stated hand hygiene is required before / after donning gloves and before an invasive procedure.

Review of facility policy titled Hand Hygiene, revised date 12/13, read: ...Procedure...ll. Hand Hygiene is indicated:...before donning gloves...when inserting peripheral vascular catheters...

PPE : Contact Precautions

Observation in the Day Surgery Unit on 08-07-15 at 12:20 p.m. RN # 6 entered Patient# 5's room to investigate a sounding alarm ( bed alarm). RN # 6 remained in the room to insert an IV catheter. Further observation revealed a sign posted on the outside of Patient #5's room that read CONTACT PRECAUTIONS.

RN # 7 entered the room to assist RN # 6 with repositioning the patient. She donned gloves and came into contact with Patient # 5's bed linen when repositioning her.

During an interview with RN # 7 when she exited the room, she was asked if she was aware this patient was on Contact precautions? RN #7 then observed the sign on Patient # 5's door and said I did not see the sign; I should have been wearing a gown.

Interview on 08-07-15 at 12: 35 p.m. with RN # 6 while he remained in Patient # 5's room, he was asked if he was aware this patient was on Contact Precautions? RN # 6 said Yes, she is on Contact precautions for MRSA (Methicillin-Resistant Staphylococcus Aureus) of the wound. RN #6 was not wearing a gown. After he exited the room, RN # 6 was asked by the unit manager to change his scrubs and wear appropriate PPE when caring for patients placed on Contact Precautions.

Review of facility policy titled Isolation Plan, revised date 12/13, read: ... Fundamentals of Transmission-Based Precautions:...B. Contact Precautions:...3. Personal Protective Equipment:...b. Gowns will be worn whenever anticipating that clothing will have direct contact with the patient or potentially contaminated environment surfaces..or equipment in close proximity to the patient...

OR Surfaces and Equipment: Cleaning & Disinfecting:

Observation on 08-07-15 at 1:00 p.m. in OR # 3 revealed one of the walls had non-intact drywall/sheetrock. In addition, the paint around the OR door frame was peeled and chipped in multiple areas.

Further observation in OR # 3 revealed an IV pole stand and an equipment cart with rust on the bases.

The non-intact wall and the rusted areas were not able to be appropriately cleaned and disinfected.

Review of facility policy titled Operating Room Cleaning Checklist,undated, read: The Operating Room should be cleaned before the first case of the day, between each case and at the end of the day Terminal cleaning...Terminal cleaning: 1. Disinfect all of the following...b.push plates and door handles..l. All furniture & equipment...2. Spot clean walls... Review of facility Surgery Rooms Terminal Cleaning Log Sheet, read: ...4. High dust ( damp-disinfect) vents and equipment...6. Wash disinfect walls, ledges...13. Inspect work area...and report anything in need of repair..

Hair Covering in OR

Observation on 08-07-15 at 1:00 p.m. in OR # 3 revealed OR preparing Patient # 4 for a excision of soft tissue mass and bone-left hallux. Patient # 4 was given general anesthesia.

Observation of three (3) male OR personnel in the room: Surgeon DPM # 9; MD anesthesiologist #11; and MD anesthesiologist (resident) # 10 revealed they were not wearing acceptable hair coverings. All three were wearing skull caps with hair visible and uncovered at the nape of the neck. Two of the 3 had beards that were not covered,

Review of facility policy titled Surgical Attire in the Operating Room,revised date 05/13, read: Policy: All personnel entering the restricted areas of the surgical suites must be in proper OR attire...All possible head and facial hair including sideburns and neckline must be covered in the semi-restricted and restricted areas of the surgical suite...

Review of correspondence (regarding OR Attire) from Region VI. CMS (Centers for Medicare & Medicaid) dated 04-24-14, read: ...Head coverings should completely cover the hair, scalp, and facial hair. Skull caps are not permissible since it fails to contain the side hair above and in front of the ears and hair at the nape of the neck...

Storage and Transport of Linen:

Observation in the Day Surgery Unit on 08-07-15 at 9:10 a.m. revealed an uncovered pillow and patient gown stored on top of a rolling linen cart. Continued observation revealed a wire cart on wheels that contained multiple patient gowns. This cart was covered with a bedsheet and located in a high traffic area easily accessible to visitors. Interview at the time of observation with manager RN # 14, she stated this linen could be contaminated as the bedsheet was not impermeable.

Continued observation in the Day Surgery Unit on 08-07-15 at 9:20 a.m. revealed RN # 7 holding a stack of clean linen directly against her scrub uniform as she entered a patient's room. Interview at the time of observation with manager RN # 14, she stated linen should not be held against RNs uniform as it becomes contaminated. RN # 14 said she would speak to this nurse regarding this practice.

Review of facility policy titled Infection Control-Linen Service, revised date 03/05, read: V....An extra supply of linen should be stored on shelves in clean linen room on nursling unit. Linen should not be stored on bottom shelves and shelving units must have solid bottoms...

Show Text of Violation

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

Based on interview and record review, the facility failed to ensure protection of the rights of two (2) of five sampled discharged ER patients.

Two(2) sampled patients ( Patient # 6, # 8 ) were informed by nursing staff they had holds and could not leave the unit or hospital.

Findings include:

TX # 957

Patient # 6

Review of complaint intake # TX 957 read: ... a Physician Assistant (PA) said 'you can walk right out the door.' I said OK and proceeded to do so. A nurse called security and told me to stop. I asked why, she responded: 'You know you have a hold on you can't leave.' ... Using threat of force to keep someone in an area is...illegal...

Review of Patient # 6's clinical record revealed he was [AGE] years old and voluntarily admitted to the emergency room (ER) on 06-21-14 at 5:48 p.m.with diagnosis of attempted suicide. On 06-21-14 at 8:28 p.m.. Registered Nurse # 13 documented : pt. highly agitated and attempting to elope. Pt aggressively came out of room and stated 'I'm leaving and you can't stop me. I'm leaving.' Pt. grabbed his bag from counter and was attempting to throw this bag at staff. Code Grey was called to room. Pt screaming and acting violently. Pt redirected to his room and was told that he is in a hold and cannot leave due to hold.

Patient # 8

Review of the clinical record of Patient # 8 revealed he was a [AGE] year old male admitted to the ER on 06-21-14 at 2:40 p.m. with diagnosis of suicidal ideation. On 06-22-14 at 8:04 p.m.. Registered Nurse # 13 documented : pt. up and about in unit...pt informed that he is on hold and that he is prohibited from leaving the unit at this time...

Interview on 09-12-14 at 3:10 p.m. with Behavioral Health Director ID # 5 she stated in the ER there was no such thing as a HOLD. A patient could be under an Emergency Detention Warrant or under the custody of law enforcement and be legally held. Other that these circumstances in the ER, patients have a right to leave at any time. If leaving against medical advice (AMA) the patient would be informed of the treatment recommended and risks of refusal. The patient would be asked to sign the AMA form prior to leaving the ER.

On 09-12-14 at approximately 2:15 p.m., four (4) Registered Nurses (RN) in the ER were interviewed. All four (4) RNs appropriately described the process for admission of a patient who had attempted suicide or had suicidal ideation. All four (4) correctly verbalized patient safety factors including environmental and appropriate observation / monitoring levels.

Continued interviews with the RNs in the ER revealed inconsistencies in their understanding of patient rights related to holding. The RNs stated the following:

RN # 8: ...I believe we can legally keep a patient here for 24 hours; I am not sure..

RN # 9: ...We have a legal responsibility for patient safety.... If a patient tried to leave and we feel it is unsafe, we would call Security and inform the doctor. The doctor would then decide if it was OK to let them go or force them to stay..

RN # 11: ... If a patient wanted to leave and we felt it was unsafe for them...we would tell them 'you can't leave' and call security...but we don't hold them...

Interview on 09-12-14 at 3:45 p.m. with ER Director # 12, she acknowledged there were opportunities for clarifying ER nursing staff understanding of patient rights with respect to leaving the ER or being placed on a hold.

Record review of facility policy titled Patient Rights and Responsibilities, revised date 6/13, read: ...D Right of the patient ...to make informed heath care treatment decision...4. Request or refuse treatment to the extent permitted by law and to be informed of the medical consequences of such refusal. Patients are given information regarding their right to accept/refuse treatment, and the right to informed consent, upon admission...

Show Text of Violation

Based on record review and interview, the facility failed to conduct a thorough investigation of a grievance and inform the complainant of the findings for 1 of 1 patient (#16) as evidenced by:

-The facility investigation failed to discover that a DNR had been noted in the ED.

-No steps were taken to ensure the incident did not happen again.

-The complainant was not notified by mail of the results of the investigation.

Findings include:

Record review of Patient #16's closed electronic medical record revealed she was admitted to the Emergency Department (ED) on 4/8/14 at 9:16 a.m. She had fallen at home with pain in her left hip and left ankle. She was triaged at 9:18 a.m. and a Detail Assessment was done at 9.24 a.m. by RN #64. In the Detail Assessment there was a notation that read, Are there cultural, religious, language, developmental or behavioral factors to consider in planning care: Yes. Describe: DNR (Do Not Resusitate).

On 4/8/14 at 12:04 p.m.ED physician #69 wrote an order to make the patient a Full Code.

Record review of Patient #16's Physician's Clinical note dated 4/8/14 at 5:55 p.m. by her Attending Physician #70 who wrote this note, Patient seen in ER (emergency room ) and evaluated, has DNR status as per daughter and they do not want intubation. Patient's medical record reviewed and I discussed with daughter. Patient stopped all her medications 3 weeks ago and may have given up... RN #68 was the patient's nurse at this time.

Record review of Patient #16's Physician's Orders revealed no order for DNR from the ED.

Further review of Patient #16's closed medical record revealed she was admitted to ICU on 4/9/14 at approximately 7:00 p.m. with diagnoses of diabetic ketoacidosis and hypotension. She was a Full Code. On 4/11/14 at 5:15 a.m. there was a Code Blue Record and the patient was resusitated, intubated and put on a ventalator.

Interview on 7/17/14 at 11:00 a.m. with RN #58 in the ED, she was asked what the procedure was if a patient came in the ED with a DNR. She said the facility did not accept an Out-of-Hospital DNR if there was time to get a facility DNR. As soon as the nurse knew of a DNR, she was to get the hospital form and have the patient or family member and physician sign it. Then the physician should put an order in the electronic system for a DNR. Once the order was in the computer, then the nurse would place a purple band on the patient's wrist. She said there was no sticker to place on the chart like in ICU (Intensive Care Unit). She said there was no hand off sheet from shift to shift. A verbal report was given at the computer.

Interview on 7/17/14 at 2:00 p.m. with Risk Manager RN #61, she said that when she got the complaint from Patient #16's family member on 4/15/14, the concern was that there was no communication between the ED and ICU about a DNR. RN #61 said that she did not find any DNR in the ED notes and that the patient had an order for a full code. She said the ED Manager RN #59 had tried to contact the complainant several times by phone without a response. She said she had sent three letters asking for the complainant to call her, but did not get a response. She said she quit trying because she thought the complainant may not have wanted to be reminded of her loss. She said she attended a conference on Team STEPPS in June 2014 which was about communications. She said she wanted to initiate the concepts at the hospital to improve communication between units as a response to the complaint. She said she had not initiated anything at this time. She said she did not know if the ED Manager or Director had provided any in-services for their staff on obtaining DNR orders.

Interview on 7/18/14 at 9:00 a.m. with ED Manager RN #59, she said there was no where in the ED computerized system that prompted information about a DNR. When she was asked about the notation made in Patient #16's Detailed Assessment, she said that had to be typed in by the nurse. The ED Director RN #54 was present at this time and said the nurse should have gotten an order from a physician for a DNR and a purple band should have been put on the patient. Risk Manager RN #61 was present at this time and said she had not seen the DNR in Patient #16's ED record when she did her investigation. She was going on the complainants words that a DNR had been discussed.

Record review of Risk Manager RN#61's investigation information revealed a copy of the Code Blue Record, a copy of the Clinical Note by Attending Physician #70, an EKG strip dated 4/8/14, an admisssion order by Physician #70 dated 4/8/14 at 6:17 p.m., and the ED notes. She had a hand written note by the DNR section of the ED notes that the surveyor had found the notation. There were three letters in the investigation file dated 4/16/14, 4/23/14, and 5/6/14. The first two letters stated the facility was in the process of investigating their concerns. The last letter stated, Our emergency department management team has attempted to contact you by phone to discuss your concerns, and left my name and call back information. As of today, I have not heard back from you. All three letters were written by RN #61 and gave her call back information. None of the letters gave any information about the investigation, i.e. steps taken, the results of the grievance process, and the date of completion.

Record review of the facility's Policy and Procedure for Complaint and Grievance Resolution for Patients and Customers dated 3/99 and revised/reviewed on 5/13 revealed the following:

To allow all patients and/or their representatives their right to voice complaints and/or grievances about his or her care, and to have those complaints reviewed and, when possible, resolved....

PROCEDURE...

III. The person receiving the complaint will log the complaint into Resolvv (complaint tracking system). Resolvv will electronically notify the Department Director/Manager. The Risk Manager is responsible for reviewing all complaints and for management of Resolvv...

V. The Director/Manager handling the complaint will complete the investigation, follow up with the patient, and enter the findings and actions taken under event response in Resolvv, noting whether or not there was resolution...

VI. The Risk Manager reviews all complaints and grievances and works collaboratively with Department Directors/Managers to ensure that a thorough investigation is conducted and the grievances are resolved timely.

VII. The Hospital will respond to the substance of each grievance while identifying, investigating, and resolving any deeper, systemic problems indicated by the grievance...

XI. some grievances may require more extensive investigation and will be resolved as quickly as possible but within 21 days. The patient will be sent a follow up letter....

X...A. The written response will contain the following elements: name of the hospital, hospital contact person, steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion of the grievance process.

Interview on 7/18/14 at 1:45 p.m. with Director of Quality RN #60, she said the incident with Patient #16 receiving CPR and being intubated and put on a ventilator was not necessarily a sentinal event, but was serious and the facility took it very seriously. The Director of Quality RN #60 was given the concerns that nothing had been done to resolve the grievance. By the time of exit on 7/18/14 at 3:30 p.m., no further information was provided.

Show Text of Violation

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

Based on record review and interview, the facility failed to comply with advance directives for 1 of 5 patients (#16) with DNR (Do Not Resuscitate) as evidenced by:

-There was a notation in Patient #12's ED Detail Assessment on 4/8/14 at 9:24 a.m. of a DNR

-The Attending Physician #70 made a progress note dated 4/8/14 at 5:55 p.m. that Patient #12 had a DNR and the family did not want her intubated. No order was written.

-Patient #12 was admitted on [DATE] with a Full Code order.

-Patient #12 was given CPR on 4/11/14 in ICU, intubated and put on a ventilator.

Findings include:

Record review of Patient #16's closed electronic medical record revealed she was admitted to the Emergency Department (ED) on 4/8/14 at 9:16 a.m. She had fallen at home with pain in her left hip and left ankle. She was triaged at 9:18 a.m. and a Detail Assessment was done at 9:24 a.m. by RN #64. In the Detail Assessment there was a notation that read, Are there cultural, religious, language, developmental or behavioral factors to consider in planning care: Yes. Describe: DNR (Do Not Resuscitate).

On 4/8/14 at 12:04 p.m. ED Physician #69 wrote an order to make the patient a Full Code.

Record review of Patient #16's Physician's Clinical note dated 4/8/14 at 5:55 p.m. by her Attending Physician #70 who wrote this note, Patient seen in ER (emergency room ) and evaluated, has DNR status as per daughter and they do not want intubation. Patient's medical record reviewed and I discussed with daughter. Patient stopped all her medications 3 weeks ago and may have given up... RN #68 was the patient's nurse at this time.

Record review of Patient #16's Physician's Orders revealed no order for DNR from the ED.

Further review of Patient #16's closed medical record revealed she was admitted to ICU on 4/9/14 at approximately 7:00 p.m. with diagnoses of diabetic ketoacidosis and hypotension. She was a Full Code. On 4/11/14 at 5:15 a.m. there was a Code Blue Record and the patient was resuscitated, intubated and put on a ventilator.

Interview on 7/17/14 at 11:00 a.m. with RN #58 in the ED, she was asked what the procedure was if a patient came in the ED with a DNR. She said the facility did not accept an Out-of-Hospital DNR if there was time to get a facility DNR. As soon as the nurse knew of a DNR, she was to get the hospital form and have the patient or family member and physician sign it. Then the physician should put an order in the electronic system for a DNR. Once the order was in the computer, then the nurse would place a purple band on the patient's wrist. She said there was no sticker to place on the chart like in ICU (Intensive Care Unit). She said there was no hand off sheet from shift to shift. A verbal report was given at the computer.

Interview on 7/17/14 at 2:00 p.m. with Risk Manager RN #61, she said that when she got the complaint from Patient #16's family member, the concern was that there was no communication between the ED and ICU about a DNR. RN #61 said that she did not find any DNR in the ED notes and that the patient had an order for a full code. She said she attended a conference on Team STEPPS in June 2014 which was about communications. She said she wanted to initiate the concepts at the hospital to improve communication between units as a response to the complaint.

Phone interview on 7/17/14 at 2:30 p.m. with Physician #70, he said when he talked to Patient #16's daughter in the ED about a DNR, he believed a nurse was present. He did not know the name of the nurse.

Interview on 7/18/14 at 9:00 a.m. with ED Manager RN #59, she said there was no where in the ED computerized system that prompted information about a DNR. When she was asked about the notation made in Patient #16's Detailed Assessment, she said that had to be typed in by the nurse. The ED Director RN #54 was present at this time and said the nurse should have gotten an order from a physician for a DNR and a purple band should have been put on the patient. Risk Manager RN #61 was present at this time and said she had not seen the DNR in Patient #16's ED record when she did her investigation. She was going on the complainant's words that a DNR had been discussed.

Record review of the facility's Policy and Procedure for DNR Orders and Comfort Care dated 12/01 and revised/reviewed on 4/13 revealed the following:

IV. The physician has an ethical obligation to honor the resuscitation preferences expressed by the patient or the patient's surrogate...

VI. ORDERS

A. Do Not Resuscitate orders (DNR): In accordance with West Houston Medical Center's commitment to provide appropriate care to its patients, cardiopulmonary resuscitation is attempted whenever a patient suffers a cardiopulmonary arrest unless a DNR Order has been written in the patient's chart by the physician....

PROCEDURE...

II. Nursing responsibility: The patient's primary care RN must review the DNR order, sign off on the order and affix a purple armband to the patient, signifying the DNR status....

Interview on 7/18/14 at 1:45 p.m. with Director of Quality RN #60, she said that Attending Physician #70 should have written the order when he talked to the patient and family on 4/8/14 at 5:55 p.m. When she was asked if it was also the RN's responsibility to get the order for DNR, when she became aware of one, and put on a purple arm band, RN #60 said it would be.

Show Text of Violation

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

Based on record review and interview, the facility failed to ensure nursing staff provided DNR (Do Not Resuscitate) orders, DNR arm bands, and monitored 7 of 9 patients (#s 16, 11, 13, 14, 15, 8 and 10) in the Emergency Department and ICU (Intensive Care Unit) as evidenced by:

-Patient #16 was not given an order for DNR when it was noted on 4/8/14 at 9:24 a.m. and again at 5:55 p.m. CPR was initiated on 4/11/14 and the patient was intubated and put on a ventilator.

-Patients #11 and #14 were admitted to the ED with DNRs, but had no documentation that a purple arm band was applied.

-Patient #13 was admitted to ICU on 6/28/14 from ED as a Full Code. A DNR was ordered on [DATE] at 1:30 p.m. There was no documentation that a purple arm band had been applied.

-Patient #15 was admitted to ICU where a DNR order was written on 5/20/14 at 11:42. a.m. There was no documentation that a purple arm band had been applied.

-Patients #16, #8, #10, and #11 were not monitored in the ED per protocol.

Findings included:

DNR

Patient #16

Record review of Patient #16's closed electronic medical record revealed she was admitted to the Emergency Department (ED) on 4/8/14 at 9:16 a.m. She had fallen at home with pain in her left hip and left ankle. She was triaged at 9:18 a.m. and a Detail Assessment was done at 9:24 a.m. by RN #64. In the Detail Assessment there was a notation that read, Are there cultural, religious, language, developmental or behavioral factors to consider in planning care: Yes. Describe: DNR (Do Not Resuscitate).

On 4/8/14 at 12:04 p.m. ED Physician #69 wrote an order to make the patient a Full Code.

Record review of Patient #16's Physician's Clinical note dated 4/8/14 at 5:55 p.m. by her Attending Physician #70 who wrote this note, Patient seen in ER (emergency room ) and evaluated, has DNR status as per daughter and they do not want intubation. Patient's medical record reviewed and I discussed with daughter. Patient stopped all her medications 3 weeks ago and may have given up... RN #68 was the patient's nurse at this time.

Record review of Patient #16's Physician's Orders revealed no order for DNR from the ED.

Further review of Patient #16's closed medical record revealed she was admitted to ICU on 4/9/14 at approximately 7:00 p.m. with diagnoses of diabetic ketoacidosis and hypotension. She was a Full Code. On 4/11/14 at 5:15 a.m. there was a Code Blue Record and the patient was resuscitated, intubated and put on a ventilator.

Interview on 7/17/14 at 11:00 a.m. with RN #58 in the ED, she said she had worked at the facility for 1 1/2 months. She was asked what the procedure was if a patient came in the ED with a DNR. She said the facility did not accept an Out-of-Hospital DNR if there was time to get a facility DNR. As soon as the nurse knew of a DNR, she was to get the hospital form and have the patient or family member and physician sign it. Then the physician should put an order in the electronic system for a DNR. Once the order was in the computer, then the nurse would place a purple band on the patient's wrist. She said there was no sticker to place on the chart like in ICU (Intensive Care Unit). She said there was no hand off sheet from shift to shift. A verbal report was given at the computer.

Interview on 7/17/14 at 1:30 p.m. with ED Director RN #54, she said she had a skills check for her staff that included DNR. She said all the staff did training on line during orientation on Code of Conduct that included DNR and Patient Rights.

Record review of the facility's Code of Conduct booklet (no date) revealed the following on page 8:

Patients are provided information regarding their right to make advance directives regarding treatment decisions, financial considerations and the designation of surrogate healthcare decision-makers. Patient advance directives or resuscitative measures are honored within the limits of the law and our organization's mission, philosophy, values, and capabilities.

Phone interview on 7/17/14 at 2:30 p.m. with Physician #70, he said when he talked to Patient #16's daughter in the ED about a DNR, he believed a nurse was present. He did not know the name of the nurse.

Interview on 7/18/14 at 9:00 a.m. with ED Manager RN #59, she said there was no where in the ED computerized system that prompted information about a DNR. When she was asked about the notation made in Patient #16's Detailed Assessment, she said that had to be typed in by the nurse. The ED Director RN #54 was present at this time and said the nurse should have gotten an order from a physician for a DNR and a purple band should have been put on the patient. She said RN #64 had been hired in January 2014 and had been given information on DNR through a skills check the same as RN #58 who knew what to do.

Record review of the facility's Policy and Procedure for DNR Orders and Comfort Care dated 12/01 and revised/reviewed on 4/13 revealed the following:

IV. The physician has an ethical obligation to honor the resuscitation preferences expressed by the patient or the patient's surrogate...

VI. ORDERS

A. Do Not Resuscitate orders (DNR): In accordance with West Houston Medical Center's commitment to provide appropriate care to its patients, cardiopulmonary resuscitation is attempted whenever a patient suffers a cardiopulmonary arrest unless a DNR Order has been written in the patient's chart by the physician....

PROCEDURE...

II. Nursing responsibility: The patient's primary care RN must review the DNR order, sign off on the order and affix a purple armband to the patient, signifying the DNR status....

Record review of the following ED RN's records and training revealed the following:

RN #64 - Date of Hire (DOH) 1/6/14

Code of Conduct training 1/6/14. No documented training for DNR

RN #68 - DOH - 6/17/13

Rapid Regulatory Compliance:...Advanced Directives, 6/1/14, 6/25/13

Code of Conduct - 3/11/13

Patient #11

Record review of Patient #11's closed electronic record revealed he was admitted on [DATE] at 5:19 a.m. with a fall at a nursing home with a fractured left hip. He was assessed as a Level 3. He was admitted to the hospital. He had a DNR order in the computer on 4/9/14 at 7:05 p.m. There was no documentation in the ED notes that a purple band had been applied.

Patient #13

Record review of Patient #13's closed electronic record revealed she was admitted on [DATE] at 5:26 p.m. with acute respiratory failure. She was admitted to ICU at 6:58 p.m. with a Full Code. On 7/3/14 at 1:30 p.m. a DNR order was written. There was no documentation that a purple arm band had been applied.

Patient #14

Record review of Patient #14's closed electronic record revealed she was admitted on [DATE] at 5:48 p.m. with pneumonia. She had a notation in her ED notes of a DNR. There was a physician's order for DNR. She was admitted to ICU (Intensive Care Unit). There was no notation in the ED notes or ICU notes that a purple arm band had been applied.

Patient #15

Record review of Patient #15's closed electronic record revealed she was admitted on [DATE] at 6:31 p.m. She was a full code. She was admitted to ICU on 5/19/14 apporximately an hour later. On 5/20/14 at 9:00 a.m. the patient was intubated and put on a ventilator. A DNR was signed by a family member and an order placed in the electronic record at 11:42 a.m. There was no documentation that the purple arm band had been applied.

Interview on 7/18/14 at 11:00 a.m. with ED Manager RN #59, she verified there was no documentation that a purple arm band had been applied to the patients with DNRs admitted to the ED. She said documentation would show the staff followed procedures.

Interview on 7/18/14 at 1:45 p.m. with Director of Quality RN #60, she said that Attending Physician #70 should have written the order when he talked to the patient and family on 4/8/14 at 5:55 p.m. When she was asked if it was also the RN's responsibility to get the order for DNR when she became aware of one, and put on a purple arm band, RN #60 said it would be. When she was informed there was no documentation of arm bands being applied for patients with DNRs, she said the facility did not document when other bands were applied, so would not document when the purple one was applied.

Record review of an ICU record revealed a notation on the electronic record to note if the allergy band was on, Yes or No. Review of Patient #14 ED record dated 5/19/14 revealed the following under Patient Safety Parameters: Allergy and Patient Identification Bands in Place and Validated.

Interview on 7/18/14 at 3:30 p.m. with CNO (Chief Nursing Officer) #51, she said she would expect to see that the arm band had been applied in the nurses' notes.

Monitoring Vital Signs

Further review of Patient #16's ED notes on 4/8/14 revealed the following:

- From 12 noon to 5 p.m. (5 hours) there was no documentation of vital signs being taken or assessed.

-At 5 p.m. the patient's blood pressure was 78/62. Up until then the systolic (top number) blood pressure (BP) had been in the 120s and 90s. There was no documentation that the lower BP was assessed or addressed.

-From 5 p.m. to 12 midnight (7 hours) there was no documentation of vital signs being taken or assessed.

Patient #16 was assessed to be at Level 3 for care.

Patient #8

Record review of Patient #8's closed electronic record revealed she was admitted on [DATE] at 5:03 p.m. with diagnosis of unwitnessed fall with shoulder and chest pain. She was assessed as a Level 3. Review of her vital signs revealed they were documented as follows:

5:03 p.m. to 2:11 a.m. (9 hours), to 6:30 a.m. (4 hours), to 10:24 a.m. (4 hours), to 2:07 p.m. (3.5 hours), to 5:09 p.m. (3 hours), to 9:00 p.m. discharge (4 hours).

Patient #10

Record review of Patient #10's closed electronic record revealed she was admitted on [DATE] at 11:50 p.m. with shortness of breath for three days. On oxygen at home and sent to the ED by her physician. She was assessed as a Level 3. Review of her vital signs (VS) revealed they were documented as follows:

11:50 p.m. to 7:37 a.m. on 4/9/14 the vital signs were taken every one to two hours.

From 7:37 to 12:00 p.m. (4.5 hours), to 3:06 p.m. (3 hours).

From 3:06 p.m. to 9:00 p.m. the VS were taken every 1 to 2.5 hours.

From 9:00 p.m. to 1:01 a.m. (4 hours)

From 1:01 a.m. to 9:07 a.m. the VS were taken every 1 to 2.5 hours.

From 9:07 a.m. to 12:04 p.m. (3 hours), to 5:05 p.m. (5 hours), to 8:20 p.m. when left department (3 hours).

Patient #11

Record review of Patient #11's closed electronic record revealed he was admitted on [DATE] at 5:19 a.m. with a fall at a nursing home with a fractured left hip. He was assessed as a Level 3. Review of his VS revealed they were documented as follows:

From 5:19 a.m. to 3:45 p.m. the VS were taken every 1 to 2.5 hours.

From 3:45 p.m. to 9:30 p.m. when he was discharged from the department (4 hours 45 minutes).

During an interview on 7/18/14 at 9:05 p.m. with ED Director RN #54 and ED Manager RN #59, they verified there were no vital signs documented for the times above. RN #54 said the hospital corporation had identified problems with charting and had initiated a report she could monitor on charting. She said she rolled out the educational tool for charting reassessments in February 2014 and was now monitoring documentation. She said if she found any problems she would do a one on one retraining for that staff. She said vital signs were taken per the assessment level of the patient from 1 to 5. Level 1 was resuscitation, Level 2 was critical, Level 3 was not as critical, but needed many resources, and Level 4 and 5 required less resources and were not critical. She said vital signs were taken according to their Level. Level 1 would be continuously, Level 2 would be a minimum of hourly, Level 3 would be a minimum of every 2 hours, Level 4 would be every 4 hours and Level 5 would be at a minimum on admission and at disposition

Show Text of Violation

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

Based on observation, interview and record review the facility's Governing Body failed to effectively monitor contract dialysis services to ensure medical devices used to dialyze patients were safe for use;

(b) The Governing Body failed to ensure dialyzers on an Urgent Medical Device Recall list were not used on facility's patients;

(c) The facility failed to ensure the recalled dialyzers and outdated blood collection tubes were not available for continued use by the Contract Dialysis Service at there facility.

(d) The facility failed to ensure the recalled dialyzers and outdated blood collection tubes were not available for continued use by the Contract Dialysis Service at there facility.

This failed practice had the potential for causing harm to all patients that used the the recalled dialyzers. Citing 22 of 24 sampled patients #s 1-22 and random observations on the Acute Dialysis Unit.

Findings:

Observation at the hospital on [DATE] at 11:15 am on the Acute Dialysis care unit revealed Staff (G) who stated her job title was Transporter was stocking a cupboard shelf with Revaclear (R) dialyzers. The staff was asked if the cupboard was the storage for supplies in use, and she replied yes. She further stated supplies were stocked so that the older ones were used first.

Observation revealed a small quantity of Revaclear Max dialyzers on the supply cupboard shelf.

According to Staff (J) Registered Nurse who was present at the time of the observation, the unit chiefly use Revaclear Regular (R) Dialyzers but there were a few physicians who occasionally order the Revaclear Max.

During an interview on 5/27/2014 at 11:30 am in the Acute Dialysis Unit with Staff (B) who identified herself as the Group Administrator for the Contract Dialysis Service ,she was asked if she had knowledge of a recent recall on some Revaclear Dialyzers. Staff (B) stated she received an email with the dialyzer recall information on 4/14/2014 and they had no dialyzers with the recall numbers in stock. When asked, the Administrator presented a copy of the recall letter to the Surveyor.

Review of the Recall Notice presented revealed there was a letter and an attachment with lot numbers of Revaclear and Revaclear Max Dialyzers that were on the recall list. The letter and list revealed the following information:

Urgent: Medical Device Recall ...Reference OPL-2014-01...April 14,2014

Revaclear / Revaclear Max Dialyzers

Dear Customer,

Gambro is sending you this communication to advise you of the possibility of internal blood leaks occurring in certain Lots of Revaclear / Revaclear Max dialyzers distributed during the recent winter months (December 2013 - March 2014). This can be caused if a dialyzer case is handled roughly during transportation while simultaneously being exposed to freezing temperatures. The impact shock origination from rough handling may cause damage to a frozen membrane which could result in an internal blood leak.

If fibers are damaged in the dialyzer, minute amounts of blood could pass into the dialysate. When this happens during a treatment, the Dialysis Machine will automatically stop the blood pump and trigger a Blood Leak Alarm, thereby avoiding any blood loss.

Consecutive use of dialyzers with damaged fibers on the same patient in combination with not returning the blood in the circuit to the patient may lead to an accumulation of blood loss that could require the administration of adequate solution to compensate for the blood loss.

Gambro takes its responsibilities to its customers and their patients very seriously and, in response to this situation, requests that you take the following actions:

? If you have any remaining Revaclear / Revaclear Max dialyzers from the lots listed on the following page in your inventory, please remove them from inventory and place them in quarantine for collection and replacement.

? Provide the request information in the attached Customer Reply Form and return it to Gambro Regulatory Affairs department as indicated on the Customer Reply Form.

? Bring this notice to the attention of all who need to know or be aware of within your facility, and to any third party to which any products from the affected lots may have been transferred.

? Maintain awareness of this notice internally until all actions have been completed within your facility.

If you take the actions recommended in this notice, there is no risk of any harm to the patient.

The List dated 4/14/2014, had the following information :

Gambro has determined that single cases of the following lots of Revaclear and /or Revaclear Max dialyzers may be affected. Revaclear Max Lot # C 0701 was listed.

Inspection on 5/27/2014 at 11: 25 am in the Acute dialysis unit of lot numbers and expiration dates on randomly selected dialyzers and other supplies in the supply cupboard revealed eleven (11) Revaclear Max Dialyzers with the lot # C 0701 listed on the Urgent: Medical Device Recall list-- Reference OPL-2014-01 dated April 14, 2014 was in the unit's supply cupboard amongst supplies that were available for use.

Further observation at that time revealed a carton containing 100 unopened Buffered Sodium Citrate blood collecting tubes in the cupboard had an expiration date of April ,2014.

The recalled dialyzers and expired blood collection tubes were brought to the attention of Staff (Q) the facility's Director of Quality who was present on the Dialysis Unit during the inspection.

During an interview on 5/27/2014 at 11:45 am with the Staff (B) Group Administrator of the contracted dialysis service regarding the recall information, she was asked if the dialysis staff were informed of the recall notice , she stated no because she was informed by their Area Manager on 4/16/2014 that none of the recalled dialyzers were in their stock. The Area Administrator stated none of the staff at the hospital physically checked to verify that there were no recalled dialyzers in their stock.

During an interview on 5/27/2014 at 12:12 pm with Staff (Q) the facility's Quality Director who was present on the Acute Dialysis Unit regarding the facility's knowledge of the recall dialyzers, she stated the facility was not notified by the contract agency that there was a recall notification.

.

Review of a list of patients who had hemodialysis treatment in the facility after the recall notice was released April 14, 2014, revealed the following information :

During the months of April, 2014 and May 2014 a total of thirty-one (31) dialyzers with the Lot number C 0701 on the medical device recall list was used in the facility to hemodialyze twenty-two (22) patients as late as May 20,2014, more than a month after the facility received the recall notice.

Review of the clinical records revealed multiple patients were dialyzed with the recalled dialyzers on more than one occasion.

The usage of the recall dialyzers is broken down as follows:

Between April 16, 2014 and April 30,2014 a total of nineteen (19) Revaclear Max Dialyzers Lot # C 0710 were used to hemodialyze a total of fourteen (15 ) patients.

Between May 1,2014 and May 20,2014 a total of twelve (12) Revaclear Max Dialyzer with the recall lot number C 0701 was used on seven (7) patients.

The number of Patient who had the recalled dialyzers used for their hemodialysis treatment on multiple days were as follows:

Patient (# 1) two dialyzers,

Patient (# 3) two dialyzers,

Patient (# 9) three dialyzers,

Patient (#4) , three dialyzers

Patient (# 8) two dialyzers,

Patient # 16 two dialyzers, and

Patient # 18 two dialyzers.

Review of the facility's Dialysis Contract effective July 7, 2013 revealed the listed responsibilities of the contract service to the facility did not include a responsibility to inform the facility when there was a recall notification on the equipment/supplies that the Contract service purchased.

Review of the facility's Bylaws of the Board of Trustees dated 2011 that was presented during the investigation revealed information that: The Hospital shall retain overall responsibility and authority for services furnished under a contract.

Show Text of Violation

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

Based on observation, interview and record review the facility failed to have systems in place to prevent medical errors and maintain patient safety;

(c) The facility's Quality Assurance Performance Improvement (QAPI) Program failed to have systems in place that informs the hospital when there is a Recall on medical equipment/supplies purchased by all Contracted Services in the facility .Dialyzers on an Urgent Medical Device Recall list were used on multiple facility's patients and were made available for continued use by the Contract Dialysis Service without the facility's staff having knowledge of the recall.

This failed practice had the potential for wide spread harm to the facility's patients who receive care through contract service. Citing 22 of 24 sampled patients #s 1-22 and random observations on the Acute Dialysis Unit.

Findings:

Observation at the hospital on [DATE] at 11:15 am on the Acute Dialysis care unit revealed Staff (G) who stated her job title was Transporter was stocking a cupboard shelf with Revaclear.. (R) dialyzers. The staff was asked if the cupboard was the storage for supplies in use, and , she replied yes. She further stated supplies were stocked so that the older ones were used first.