The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ARROWHEAD REGIONAL MEDICAL CENTER 400 NORTH PEPPER AVENUE COLTON, CA 92324 March 3, 2016
VIOLATION: SUPERVISION OF CONTRACT STAFF Tag No: A0398
Based on interview and record review, the facility failed to implement its policy and procedure when there was no documented evidence Registered Nurse (RN 3), a contracted licensed personnel, completed an orientation checklist and acknowledgement form. This had the potential to result in delivery of unsafe and ineffective care, without the proper orientation, affecting the overall health and safety of the patients receiving the care in the unit.

Findings:


During a concurrent interview and record review of the Registered Nurse (RN 3's) personnel file on March 2, 2016 at 3:10 PM, House Supervisor (HS) confirmed there was no documented evidence of a signed completed "Orientation and Safety Resource Booklet" acknowledgment. HS stated the House Supervisor was supposed to ensure RN 3 acknowledged and submitted this at the end of the shift of the first day of the contracted shift worked.

A review of the facility's policy and procedure POLICY NO. 313.00 Issue 7 titled "CONTRACT/REGISTRY AGENCY PERSONNEL," revealed, "...PROCEDURE...IV...B. Initial Screening Guidelines...3. A record for each nurse utilized from the registry incorporates:...b. Completed orientation checklist and acknowledgement form (s)..."
VIOLATION: ORGANIZATION AND STAFFING Tag No: A0432
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure the Medical Records Department workforce, who had access to the facility's information or facilities and the patient's clinical records, were adequate and were screened accordingly when:

1. Four out of six Medical Record department contracted personnel files, who were hired under contracted services, were incomplete and were not up-to-date of kept current.


2. There was no documented evidence the quality of contracted services, who provided personnel service to the Medical Records department, were evaluated accordingly.


These failures had the potential to result in provision of ineffective services by the contracting agency staff in a universe of 358 patients.

Findings:

1. During an interview and a concurrent review of the employees' files on March 2, 2016 at 2:35 PM, Staff Analyst (SA) and Human Resources Officer II (HR II) confirmed the following contracted personnel files were incomplete and were not current as follows:

1A. For Health Information Management (HIM) Consultant - Date of Hire (DOH) was December 17, 2014 and was a contracted personnel under Contracted Services 2. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.
c. A signed job description on file.
d. An updated copy of a certificate of membership of American Health Information Management Association (AHIMA). The copy on file revealed HIM Consultant's membership expired on [DATE].

A review of the Medical Records Manager position description, Class Code , revealed, "POSITION QUALIFICATIONS Minimum Education: Must be a Registered Records Administrator (RHIA) or an Accredited Records Technician (RHIT), and must be accredited or registered with the American Medical Records Association and maintain requirements for membership..."


1B. For Medical Coder I (MC 1) - The DOH was not specified and was a contracted personnel under Contracted Services 1. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

1C. For Copy Service Representative (CSR) - DOH was October 13, 2015 and was a contracted personnel under Contracted Services 3. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

1D. For CSR Supervisor - DOH was December 7, 2015 and was a contracted personnel under Contracted Services 3. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

During an interview on March 3, 2016 at 9:10 AM, SA confirmed the HR department did not have a complete and current contracted personnel files because these employees were "contracted" (hired under contracted services). SA stated each department manager of the respective department, was responsible to ensure all of their contracted employees, had been properly screened. SA stated the Human Resources (HR) department did not have MC 1 in the system and did not have his personnel file.

During an interview on March 3, 2016 at 9:35 AM, SA stated the facility contracted directly with HIM Consultant under Contract Services 2 and HIM Consultant was not in the HR department's system. There was no documented evidence HIM Consultant's contract agreement underwent HR Board of Review.

During an interview on March 3, 2016 at 10:30 AM, Assistant Health Information Manager (Assistant HIM) stated the contracts indicated they were supposed to send "qualified staff" members. Assistant HIM Manager stated, "We're assuming they send qualified people" and that the screenings were conducted based on the contract agreement.

During a phone interview on March 3, 2016 at 4 PM, HIM Consultant stated she started working for the facility as a consultant and mentored the previous HIM Manager, who left on February 9, 2016. HIM Consultant stated she was not aware and was involved in the hiring process of the contracted personnel of the Medical Records Department. HIM Consultant stated her "understanding" was that HR department was involved in the hiring process of all new employees, including the contracted personnel. HIM Consultant stated her hours or schedule to come to the facility were Tuesdays and Thursdays or as needed. All of her hours were titled as a "consultant" and her duties had been in the "realm of management."

A review of the facility's policy and procedure (P&P) POLICY NO. 700.03 Issue 3 titled "WORKFORCE SECURITY REQUIREMENTS," revealed, "PROCEDURES...Workforce Screening... Each department manager/chairperson and system/application owner is responsible to ensure that all workforce members and persons have been properly screened and have received security clearance prior to being granted access to (name of hospital) information and/or resources ...Screening requirements for workforce members include but are not limited to: Criminal background ad credit check ...Verification of references and employment history..."

During an interview and a concurrent review of the employee's files on March 2, 2016 at 3:30 PM, Employee Health Nurse (EHN) confirmed Employee Health Department (EHD) did not have the health files for the contracted personnels HIM Consultant, MC 1, CSR, and CSE Supervisor. EHN confirmed there was no documented evidence of a Tuberculosis (an infectious disease usually caused by bacteria generally affecting the lungs) screening for them. EHN stated the Medical Records Department Manager should have contacted EHN department regarding the employment of these contracted personnel.

During an interview on March 3, 2016 at 10 AM, Assistant HIM Manager stated EHN department should have the contracted personnel health files. Assistant HIM Manager acknowldeged there was no oversight by the Medical Records department to ensure contracted personnel underwent the hiring process accordingly, and that complete and current personnel files were maintained for the contracted personnel.


A review of the facility's P&P, POLICY NO.220.01 Issue 3 titled "PRE-EMPLOYMENT MEDICAL EVALUATION," revealed, "POLICY... Pre-employment medical evaluations are required of all applicants being considered for positions with (name of hospital)... PROCEDURES 1. The HR Department will contact the hiring Department Manager/Supervisor upon receiving approval to proceed with the hiring process after the results from the criminal background check process...3. Required Health Screenings at the Medical Center for its new employees: A. Tuberculosis... All persons must be screened for evidence of exposure to Tuberculosis during the orientation process and at least annually thereafter..."


During an interview on March 3, 2016 at 3:25 PM, Chief Nursing Officer (CNO) acknowledged the Quality Assurance Performance Improvement (QAPI) committee failed to identify there was no oversight by the Medical Records department to ensure contracted employees hired under contracted providers service providers, underwent the hiring process accordingly and that the contracted personnel files were maintained complete and current.

A review of the facility's P&P, POLICY NO. 110.24 Issue 6 "CONTRACT SERVICES-REVIEW AND MANAGEMENT OF," revealed, "POLICY...It is the policy of (name of hospital) to ensure that it maintains compliance with the terms of agreements to which it enters into. PROCEDURES ...3. It is the responsibility of the Department Manager to review the contract in its entirety. The Department Manager will be responsible for monitoring and maintaining all "Vendor/Contractor" obligations as defined in the agreement;...5. The Department Manager will request Vendor/Contractor to provide (name of hospital) with verification of required licenses, certifications, etc. as stated in the contract. The Department Manager will be responsible for requesting all updated information/documentation as necessary...10. QAPI - Department Managers will evaluate their patient care related contracts (i.e. registry staff and radiology services) on a quarterly basis. The Evaluation will be a rating of the performance and quality of the service provided. If and Contracted Services did not meet expectations a corrective action plan will be required. Results of the Contracted Services evaluations will be sent to the Hospital Compliance Department for tracking and reported annually at the Quality Management Committee meeting..."


2. During an interview and a concurrent review of the contracted personnel files on March 3, 2016 at 9:10 AM, SA confirmed the Human Resources (HR) department did not have a complete and current personnel files for Health Information Management (HIM) Consultant, Medical Coder (MC 1), Copy Specialist Representative (CSR) and CSR Supervisor, because these employees were "contracted" (hired under contracted services). SA stated each department manager of the respective department, was responsible to ensure all of their contracted personnel, had been properly screened and had complete and current personnel files. SA stated MC 1 and HIM consultant were not in the HR system.

During an interview on March 3, 2016 at 10:30 AM, Assistant Health Information Manager (Assistant HIM) stated the contracts with Contracted Service 1 for MC 1, and Contracted Service 3 for CSR and CSR Supervisor, indicated they were supposed to send "qualified staff" members. Assistant HIM Manager stated, "We're assuming they send qualified people" and that the screenings were conducted based on the contract agreement.


An interview with Assistant Health Information Management (HIM) Manager and a concurrent review of the agreements with Contracted Services 1 and Contracted Services 2, who provided personnel to Medical Records Department, was conducted on March 3, 2016 at 3:45 PM. During the interview, Assistant HIM Manager acknowledged the managers of the departments were responsible in reviewing the contracted services agreements. Assistant HIM Manager confirmed there was no documented evidence Contracted Service 1 and Contracted Service 2 were reviewed to ensure to ensure they maintained its compliance with the terms of agreements to which it enters to, and that it meets the expectations of the facility. Assistant HIM Manager also confirmed there was no oversight by the Medical Records department to ensure the contracted personnel underwent the hiring process accordingly, and their personnel files were complete and current.

During an interview on March 3, 2016 at 9:35 AM, SA stated the facility contracted directly with HIM Consultant under Contract Services 2. There was no documented evidence HIM Consultant underwent HR Board of Review.


During a phone interview on March 3, 2016 at 4 PM, HIM Consultant stated she started working for the facility as a consultant and mentored the previous HIM Manager, who left on February 9, 2016. HIM Consultant stated she was not involved in the hiring process of contracted employees of the Medical Records Department and was not aware of the employees that were contracted. HIM Consultant stated her "understanding" was that HR was involved in the hiring process of all new employees including the contracted employees. HIM Consultant stated her hours or schedule to come to the facility were Tuesdays and Thursdays or as needed. All her hours were titled as a "consultant" and her duties had been in the "realm of management."

A review of the facility's policy and procedure POLICY NO. 110.24 Issue 6 "CONTRACT SERVICES-REVIEW AND MANAGEMENT OF," revealed, "POLICY...It is the policy of (name of hospital) to ensure that it maintains compliance with the terms of agreements to which it enters into. PROCEDURES ...3. It is the responsibility of the Department Manager to review the contract in its entirety. The Department Manager will be responsible for monitoring and maintaining all "Vendor/Contractor" obligations as defined in the agreement; ... 5. The Department Manager will request Vendor/Contractor to provide (name of hospital) with verification of required licenses, certifications, etc. as stated in the contract. The Department Manager will be responsible for requesting all updated information/documentation as necessary...10. QAPI - Department Managers will evaluate their patient care related contracts (i.e. registry staff and radiology services) on a quarterly basis. The Evaluation will be a rating of the performance and quality of the service provided. If and Contracted Services did not meet expectations a corrective action plan will be required. Results of the Contracted Services evaluations will be sent to the Hospital Compliance Department for tracking and reported annually at the Quality Management Committee meeting..."
VIOLATION: GOVERNING BODY Tag No: A0043
Based on interview, observation and record review, the governing body failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Program was collecting data on types and frequencies of nursing assessments performed in the behavioral health unit (BHU) Triage area. This resulted in patients in the BHU (Behavioral Health Unit) not being assessed more frequently by licensed nursing staff as compared to other hospital nursing units/departments. The governing body failed to assure that entries to the medical record were accurate and documented by the person(s) making the observation. This resulted in the hospital being unable to assure that every 15 minutes safety checks were completed as per hospital policy. These deficient practices resulted in a patient (Patient 13) with no recognized medical problems, found dead in the BHU triage unit, 7 hours from the last documented nursing assessment of the patient.

Findings:

1. The governing body failed to assure that the QAPI program maintained a hospital-wide, data driven process as pertains to nursing assessments in the BHU triage area. (Refer to A-0263)

2. The governing body failed to assure that the nursing service was organized in a way that would provide nursing assessments in the BHU consistent with other units of the hospital, and as needed to maximize patient safety. (Refer to A-0395-IJ).

3. The governing body failed to assure that all entries in the medical record were documented by the person(s) making the observation. Nursing Assistants would sometimes document observations for each other. (Refer to A-0432)

4. The governing body failed to ensure the quality of contracted services, who provide personnel staff services to the Medical Records Department, were evaluated by the hospital. (Refer to A-083)


The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure the provision of quality health care in a safe environment, which created noncompliance with the Condition of Participation: Governing Body in a universe of 358 patients.
VIOLATION: CONTRACTED SERVICES Tag No: A0083
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interview and record review, the facility failed to ensure the Medical Records Department's contracted workforce, who had access to the facility's information or facility's patient's clinical records, had completed pre-employment screening evaluations by the hospital as evidence by:

1. Four of six Medical Record department contracted personnel files, who were hired under a contracted agency, were found incomplete and were not kept current by the hospital.

2. There was no documented evidence the quality of contracted services by the Medical Records department, were being evaluated by the hospital's Quality Assurance and Improvement Program.

These failures had the potential to result in provision of ineffective services by contracting agency's employees provided to the hospital in a universe of 358 patients.

Findings:

1. During an interview and a concurrent review of the employees' files on March 2, 2016 at 2:35 PM, Staff Analyst (SA) and Human Resources Officer II (HR II) confirmed the following contracted personnel files were incomplete and were not kept current as evidence by:

1A. The personnel file for the Health Information Management (HIM) Consultant - Date of Hire (DOH) was December 17, 2014 and was a contracted personnel under Contracted Services 2. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.
c. A signed job description on file.
d. An updated copy of a certificate of membership of American Health Information Management Association (AHIMA). The copy on file revealed HIM Consultant's membership expired on [DATE].

A review of the Medical Records Manager position description, Class Code , revealed, "POSITION QUALIFICATIONS Minimum Education: Must be a Registered Records Administrator (RHIA) or an Accredited Records Technician (RHIT), and must be accredited or registered with the American Medical Records Association and maintain requirements for membership..."


1B. For Medical Coder I (MC 1) - The DOH was not specified and was a contracted personnel under Contracted Services 1. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

1C. For Copy Service Representative (CSR) - DOH was October 13, 2015 and was a contracted personnel under Contracted Services 3. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

1D. For CSR Supervisor - DOH was December 7, 2015 and was a contracted personnel under Contracted Services 3. There was no documented evidence of:
a. A criminal background screen.
b. A verification of references and employment history.

During an interview on March 3, 2016 at 9:10 AM, the SA confirmed that the HR department did not have a complete and current contracted personnel files because these employees were "contracted" (hired under contracted services of an outside agency). The SA stated each department manager of the respective department, was responsible to ensure all of their contracted employees, had been properly screened. SA stated the Human Resources (HR) department did not have MC 1 in the system and did not have his personnel file.

During an interview on March 3, 2016 at 9:35 AM, SA stated the facility contracted directly with HIM Consultant under Contract Services 2 and HIM Consultant was not in the HR department's system. There was no documented evidence HIM Consultant's contract agreement underwent the hospital's HR Board of Review.

During an interview on March 3, 2016 at 10:30 AM, Assistant Health Information Manager (Assistant HIM) stated the contracts indicated they were supposed to send "qualified staff" members. Assistant HIM Manager stated, "We're assuming they send qualified people" and that the screenings were conducted based on the contract agreement.

During a phone interview on March 3, 2016 at 4 PM, HIM Consultant stated she started working for the facility as a consultant and mentored the previous HIM Manager, who left on February 9, 2016. HIM Consultant stated she was not aware and was involved in the hiring process of the contracted personnel of the Medical Records Department. HIM Consultant stated her "understanding" was that HR department was involved in the hiring process of all new employees, including the contracted personnel. HIM Consultant stated her hours or schedule to come to the facility were Tuesdays and Thursdays or as needed. All of her hours were titled as a "consultant" and her duties had been in the "realm of management."

A review of the facility's policy and procedure (P&P) POLICY NO. 700.03 Issue 3 titled "WORKFORCE SECURITY REQUIREMENTS," revealed, "PROCEDURES...Workforce Screening... Each department manager/chairperson and system/application owner is responsible to ensure that all workforce members and persons have been properly screened and have received security clearance prior to being granted access to (name of hospital) information and/or resources ...Screening requirements for workforce members include but are not limited to: Criminal background ad credit check ...Verification of references and employment history..."

During an interview and a concurrent review of the employee's files on March 2, 2016 at 3:30 PM, Employee Health Nurse (EHN) confirmed Employee Health Department (EHD) did not have the health files for the contracted personnels HIM Consultant, MC 1, CSR, and CSE Supervisor. EHN confirmed there was no documented evidence of a Tuberculosis (an infectious disease usually caused by bacteria generally affecting the lungs) screening for them. EHN stated the Medical Records Department Manager should have contacted EHN department regarding the employment of these contracted personnel.

During an interview on March 3, 2016 at 10 AM, Assistant HIM Manager stated EHN department should have the contracted personnel health files. Assistant HIM Manager acknowldeged there was no oversight by the Medical Records department to ensure contracted personnel underwent the hiring process criteria/procedure accordingly, and that the hospital kept completed and kept current and up-to-date personnel files were being maintained for the contracted personnel hired by the hospital.

A review of the facility's P&P, POLICY NO.220.01 Issue 3 titled "PRE-EMPLOYMENT MEDICAL EVALUATION," revealed, "POLICY... Pre-employment medical evaluations are required of all applicants being considered for positions with (name of hospital)... PROCEDURES 1. The HR Department will contact the hiring Department Manager/Supervisor upon receiving approval to proceed with the hiring process after the results from the criminal background check process...3. Required Health Screenings at the Medical Center for its new employees: A. Tuberculosis... All persons must be screened for evidence of exposure to Tuberculosis during the orientation process and at least annually thereafter..."

During an interview on March 3, 2016 at 3:25 PM, Chief Nursing Officer (CNO) acknowledged the Quality Assurance Performance Improvement (QAPI) committee failed to identify there was no oversight by the Medical Records department to ensure contracted employees hired under contracted providers service providers, underwent the hiring process accordingly and that the contracted personnel files were maintained complete and current.

A review of the facility's P&P, POLICY NO. 110.24 Issue 6 "CONTRACT SERVICES-REVIEW AND MANAGEMENT OF," revealed, "POLICY...It is the policy of (name of hospital) to ensure that it maintains compliance with the terms of agreements to which it enters into. PROCEDURES ...3. It is the responsibility of the Department Manager to review the contract in its entirety. The Department Manager will be responsible for monitoring and maintaining all "Vendor/Contractor" obligations as defined in the agreement;...5. The Department Manager will request Vendor/Contractor to provide (name of hospital) with verification of required licenses, certifications, etc. as stated in the contract. The Department Manager will be responsible for requesting all updated information/documentation as necessary...10. QAPI - Department Managers will evaluate their patient care related contracts (i.e. registry staff and radiology services) on a quarterly basis. The Evaluation will be a rating of the performance and quality of the service provided. If and Contracted Services did not meet expectations a corrective action plan will be required. Results of the Contracted Services evaluations will be sent to the Hospital Compliance Department for tracking and reported annually at the Quality Management Committee meeting..."

2. During an interview and a concurrent review of the contracted personnel files on March 3, 2016 at 9:10 AM, SA confirmed the Human Resources (HR) department did not have a complete and current up-to-date personnel files for Health Information Management (HIM) Consultant, Medical Coder (MC 1), Copy Specialist Representative (CSR) and CSR Supervisor, because these employees were "contracted" (hired under contracted services). SA stated each department manager of the respective department, was responsible to ensure all of their contracted personnel, had been properly screened and had complete and current personnel files. SA stated MC 1 and HIM consultant were not in the HR system.

During an interview on March 3, 2016 at 10:30 AM, Assistant Health Information Manager (Assistant HIM) stated the contracts with Contracted Service 1 for MC 1, and Contracted Service 3 for CSR and CSR Supervisor, indicated they were supposed to send "qualified staff" members. Assistant HIM Manager stated, "We're assuming they send qualified people" and that the screenings were conducted based on the contract agreement.


An interview with Assistant Health Information Management (HIM) Manager and a concurrent review of the agreements with Contracted Services 1 and Contracted Services 2, who provided personnel to Medical Records Department, was conducted on March 3, 2016 at 3:45 PM. During the interview, Assistant HIM Manager acknowledged the managers of the departments were responsible in reviewing the contracted services agreements. Assistant HIM Manager confirmed there was no documented evidence Contracted Service 1 and Contracted Service 2 were reviewed to ensure to ensure they maintained its compliance with the terms of agreements to which it enters to, and that it meets the expectations of the facility. Assistant HIM Manager also confirmed there was no oversight by the Medical Records department to ensure the contracted personnel underwent the hiring process accordingly, and their personnel files were complete and current.

During an interview on March 3, 2016 at 9:35 AM, SA stated the facility contracted directly with HIM Consultant under Contract Services 2. There was no documented evidence HIM Consultant underwent HR Board of Review.


During a phone interview on March 3, 2016 at 4 PM, HIM Consultant stated she started working for the facility as a consultant and mentored the previous HIM Manager, who left on February 9, 2016. HIM Consultant stated she was not involved in the hiring process of contracted employees of the Medical Records Department and was not aware of the employees that were contracted. HIM Consultant stated her "understanding" was that HR was involved in the hiring process of all new employees including the contracted employees. HIM Consultant stated her hours or schedule to come to the facility were Tuesdays and Thursdays or as needed. All her hours were titled as a "consultant" and her duties had been in the "realm of management."

A review of the facility's policy and procedure POLICY NO. 110.24 Issue 6 "CONTRACT SERVICES-REVIEW AND MANAGEMENT OF," revealed, "POLICY...It is the policy of (name of hospital) to ensure that it maintains compliance with the terms of agreements to which it enters into. PROCEDURES ...3. It is the responsibility of the Department Manager to review the contract in its entirety. The Department Manager will be responsible for monitoring and maintaining all "Vendor/Contractor" obligations as defined in the agreement; ... 5. The Department Manager will request Vendor/Contractor to provide (name of hospital) with verification of required licenses, certifications, etc. as stated in the contract. The Department Manager will be responsible for requesting all updated information/documentation as necessary...10. QAPI - Department Managers will evaluate their patient care related contracts (i.e. registry staff and radiology services) on a quarterly basis. The Evaluation will be a rating of the performance and quality of the service provided. If and Contracted Services did not meet expectations a corrective action plan will be required. Results of the Contracted Services evaluations will be sent to the Hospital Compliance Department for tracking and reported annually at the Quality Management Committee meeting..."
VIOLATION: QAPI Tag No: A0263
The hospital failed to ensure the Condition of Participation: CFR 482.21 Quality Assessment and Performance Improvement Program was met by failing to develop, implement and maintain an effective on-going hospital wide data quality assessment and performance improvement program as evidenced by the following:

1. Failed to collect data on types and frequencies of nursing assessments performed in the Behavioral Health Unit, and implement preventive and corrective actions following an unexplained/unobserved patient (Patient 13) death in the Behavioral Health Unit Emergency Department triage area. (Refer to A-0283)

2a. Failed to identify the assessment procedure being used by licensed staff in the Behavioral Health Unit, was completed in a timely manner. (Refer to A-0286)

b. Failed to identify entries to the medical record were accurate and documented by the person(s) making the observation.(Refer to A-0286)

3. Failed to ensure the Medical Records Department's workforce, who had access to the facility's information or facilities and the patient's clinical records, were adequately screened accordingly when four out of six Medical Record department contracted personnel files, who were hired under contracted services, were incomplete and were not current. (Refer to A-0432)

4. There was no documented evidence the quality of contracted services, who provide personnel services to the Medical Records department, were evaluated accordingly. (Refer to A-083)

5. Failed to fensure that license nursing staff evaluated the nursing care of patients in the Behavioral Health Unit in a timely manner and ensure that documentation of a patients activities are done by the person making the observation. (Refer to A-395-IJ)

The cumulative effect of these systemic practices resulted in the failure of the hospital to ensure the provision of quality health care in a safe environment, which created noncompliance with the Condition of Participation: Quality Assessment and Performance Improvement Program in a universe of 358 patients.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review, the facility failed to implement preventive and corrective actions following an unexplained/unobserved patient (Patient 13) death in the Behavioral Health Unit (BHU) Emergency Department (ED) triage area. This failure created the potential for patient harm to occur.

Findings:

1a. During a record review, conducted on March 1, 2016, documentation revealed Patient 13 voluntarily presented on December 3, 2015 at 10:39 AM, with complaints of auditory hallucinations. The patient received a medical screening examination by the BHU ED triage physician and was declared "Medically clear for BHU."

On March 1, 2016 at 8:05 AM, an interview was conducted with Registered Nurse (RN) 1. RN 1 stated he was asked to assist with the transfer of Patient 13 to an inpatient room. At 8:50 PM, RN 1 stated when he entered Patient 13's room he found him unresponsive, not breathing, with no pulse, CPR was initiated and a code blue was called.

A review of the ED physician's "Code Note," dated December 4, 2015 revealed the following documentation:

"....Two rescuer CPR being performed. Upon evaluation of the patient there were no carotid pulses (neck veins) appreciated (present), no spontaneous breaths, patient had fixed pupils with no corneal reflex. Patient's jaw was clenched, patient cold to touch....No signs of life appreciated....Patient had signs of rigor." Patient 13 was pronounced dead at 9:07 PM.

A review of nursing notes, revealed the last documented nursing note was done on December 4, 2015 at 1:45 PM. No other documentation by licensed staff could be located until the time of the code blue, approximately 7 hours later.

On March 3, 2016 at 10:43 AM, an interview was conducted with RN 2, who worked the 7 PM to 7 AM shift and was assigned to Patient 13 on the evening of December 4, 2015. During the interview, RN 2 was asked if he had completed an assessment of Patient 13 prior to his being discovered unresponsive at 8:50 PM, RN 2 stated, "I did not." As the interview continued, RN 2 was asked when assessments of patients in the BHU ED triage area were done, RN 2 stated, "We do assessments of patients within the 12 hour shift," further stating he (Patient 13) wasn't due."

As the interview continued, RN 2 was asked when he first comes on duty and gets his patient assignment, if he performs an assessment or observation of his patients, RN 2 replied, "No, we don't do that."

On February 29, 2016 at 10 AM, a tour of the BHU ED triage area was conducted with the Assistant Hospital Administrator of the BHU (AHA/BHU) and the Medical Director of the BHU in attendance. At 10:50 AM, the AHA/BHU stated that since the time of the patient's death (December 4, 2015), changes had been made regarding the timeframe of nursing assessments being completed. The AHA/BHU stated that licensed staff were conducting nursing assessments of patients within four (4) hours from the start of their shift. The AHA/BHU was asked when the assessment process changed, however the AHA/BHU did not reply.

On March 1, 2016, a policy and procedure (P & P) on nursing assessments was requested. A BHU P & P titled "Nursing Assessment Process," last approval date of 6/11, under the "Components" section, in effect at the time of Patient 13's death revealed the following:

"A. Assessment ..... The initial assessment begins upon admission and completed within four hours of admission, is documented on the Patient Data Base. Reassessments are documented on flowsheets and in the PIE (plan, implement, evaluate) Note every 12 hours."

On March 1, 2016, at 2:05 PM, an interview was conducted with the Interim Associate Hospital Administrator (IAHA). The IAHA was asked if the P & P provided, was the same P & P in effect at the time of Patient 13's death, the IAHA stated, "Yes."

On March 3, 2016 at 3:30 PM, an interview was conducted with the Chief Nursing Officer (CNO) of the facility. The CNO was asked if prior to the patient's death if she was aware that nursing staff in the BHU, were not conducting assessments/observations of the patient assigned to them in a timely manner, the CNO stated, "I was not aware."

b. During a record review, conducted on March 1, 2016, documentation revealed Patient 13 voluntarily presented to the Behavioral Health Unit (BHU) Emergency Department (ED) triage area on December 3, 2015 at 10:39 AM, with complaints of auditory hallucinations.

Further review of the patient's clinical record revealed the patient was classified as a "Priority: 2."

On March 1, 2016, at 9 AM an interview was conducted with the Nurse Manager (NM) of the BHU ED triage area, who confirmed that Patient 13 was a "Priority: 2," and fell into the category of "Routine - Status."

A review of the BHU policy and procedure (P & P) titled "Psychiatric Triage Policy," Policy NO. 734.01, under the "Procedure" section documentation revealed the following:

"J. ....Patients assigned and/or ordered a specific observation will be monitored as follows:

3. Routine - Status: Patients in BH Triage admitted and/or transfer to inpatient unit or other facility. Patients are assigned rooms, and required standard inpatient Q (every) 15-minute observation monitoring."

On March 1, 2016 at 10 AM, an interview was conducted with Nursing Assistant (NA) 1. NA 1 noted to have the most documentation on Patient 13's Q15-minute observation record from the 3 PM to 11 PM shift on December 4, 2015, was asked if she could recall the last time she could say for certain that she knew Patient 13 was alive, NA 1 stated, "Before 2000 (8 PM), I remember the patient snoring and moving."

As the interview continued, NA 1 was asked if she recalled anything about the patient from 8 PM to 9 PM other than the patient sleeping, as documented by her with her initials (meaning done) on the Q15-minute observation sheet. NA 1 stated, "It wasn't necessarily me who saw the patient during that time, because we work so closely, my co-worker could have told me that they saw the patient and I wrote it down." NA 1 was was asked if she knew that she could only legally document if she made the observation herself, NA 1 responded, "We were taught to work together."

On February 29, 2016 at 10 AM, a tour of the BHU ED triage area was conducted with the Assistant Hospital Administrator of the BHU (AHA/BHU) and the Medical Director of the BHU in attendance. At 10:55 AM, the Medical Director of the BHU stated, "The Q15-minute observation sheet is a patient locator." The AHA/BHU stated, along the way other items were added to the sheet such as the patient's activity, "It used to be two (2) sheets condensed into one (1).

c. On February 29, 2016, at 10 AM, a tour of the Behavioral Health Unit (BHU) Emergency Department (ED) triage area was conducted with the Assistant Hospital Administrator (AHA) of the BHU and the Medical Director of the BHU. During the tour, the AHA/BHU was asked if he could provide the survey team with a copy of the surveillance video for the hours prior to the death of Patient 13 on December 4, 2015. The AHA/BHU stated that immediately following the patient's death, the BHU management team was able to view the video footage from the computers at the nursing station and made a CD copy of the entire day (December 4, 2015) but only a few hours the morning of December 4, 2015 recorded.

The AHA/BHU further stated the surveillance system was old and needed to be upgraded within the BHU. The AHA/BHU was asked if security or anyone else other than BHU management had access to the video recordings, the AHA/BHU stated, "No."






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VIOLATION: PATIENT SAFETY Tag No: A0286
Based on observations and interview, the hospital's Quality Assessment and Performance Improvement (QAPI) program, failed to identify, measure and track adverse patient events as evidenced by:

1. Failed to identify the assessment procedure for patients by licensed staff in the Behavioral Health Unit (BHU).

2. Failed to identify that documented observations were documented by the person who made the actual observation.

These failures created the potential for patients to receive poor quality health care services, may have resulted in the unexplained/unobserved death of a patient in the BHU ED triage area.

Findings:

1. On March 3, 2016 at 11:20 AM, a meeting was held with members of the QAPI committee.

The committee members were asked if they were aware that patients in the BHU ED triage area were not conducting assessments/observations of the patient assigned to them in in timely manner. Committee members stated they were not aware until the survey team identified the issue.

2. A meeting was held on March 3, 2016 at 11:20 AM, with members of the QAPI committee.

During the meeting, committee members were asked if they were aware that staff in the BHU ED triage area were documenting observations that they did not actually observe. Committee members stated they were not aware untile the survey team identified the issue.
VIOLATION: NURSING SERVICES Tag No: A0385
The hospital failed to ensure the Condition of Participation: CFR 482.23 Nursing Services was met by failing to:

1a. Ensure Registered Nurse's supervised and evaluated the nursing care of patients in a timely manner. (Refer to A-0395)

b. Failed to ensure documentation on the Q (every) 15-minute observation sheet was only done by the person who made the actual observation. (Refer to A-0395)

2. Failed to ensure non-employee licensed nurses adhered to policies and procedues of the hospital. (Refer to A-0398)

The cumulative effect of these systemic practices resulted in the failure of the hospital to deliver care in compliance with the Condition of Participation: Nursing Services in a universe of 85 patients in the Behavioral Health Unit Triage area. This deficient practice created the potential to cause serious harm or death to other patients.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on interview and record review, the facility failed to ensure all licensed staff (Registered Nurse/RN) supervised and evaluated the nursing care of Patient 13 and all other patients in the Behavioral Health Unit (BHU-psychiatric unit) Emergency Department (ED) triage (evaluate) area in a timely manner. This failure created the potential to have contributed to the death of a patient (Patient 13) in the BHU ED triage area, who had not been assessed (evaluated)/observed for seven (7) hours by licensed staff. The facility failed to ensure documentation of a patient activity is to be done by the person making the actual observation. This failure created the potential to have contributed to the death of a patient (Patient 13).

Findings:

1. During a record review, conducted on March 1, 2016, documentation revealed Patient 13 voluntarily presented on December 3, 2015 at 10:39 AM, with complaints of auditory hallucinations (hearing voices). The patient received a medical screening examination by the BHU ED triage physician and was declared "Medically clear for BHU."

Continued record review revealed Patient 13 remained in the BHU ED triage unit while awaiting an inpatient bed to become available.

A review of the BHU ED nursing notes dated December 4, 2015 at 21:15 (9:15 PM) revealed the following:

"At 2050 (8:50 PM-RN 1) was preparing to transfer Patient 13 to 1 BHN for admission. At 2055 when RN 1 attempted to wake him for transfer, patient was unresponsive, not breathing with no pulse, CPR (cardiopulmonary resuscitation) initiated immediately and code blue (emergency) was called. Crash cart (emergency cart)brought in by staff and code team from ER (emergency room ) arrived a few minutes after code was initiated."

On March 3, 2016 at 10:43 AM, an interview was conducted with Registered Nurse (RN) 2, who worked the 7 PM to 7 AM shift and was assigned to Patient 13 on the evening of December 4, 2015. During the interview, RN 2 was asked if he had completed an assessment of Patient 13 prior to his being discovered unresponsive at 8:50 PM, RN 2 stated, "I did not." RN 2 was asked when were assessments of patients in the BHU ED triage area done, RN 2 stated, "We do assessments of patients within the 12 hour shift, he (Patient 13) wasn't due."

RN 2 was asked if he recalled conducting an assessment or observation of his assigned patients at the beginning of his shift on December 4, 2015, RN 2 stated, "The Charge RN does walking rounds (walk around unit and receives a verbal report of the condition/status of patients) with the off-going Charge RN and they make sure everyone is safe."

RN 2 was then asked when he gets an assignment when he first comes on duty if he performs an assessment or observation of his patients, RN 2 replied, "No, we don't do that." RN 2 stated, "We do them when they are due, the assessments are done every 12 hours."

On March 1, 2016 at 9:03 AM, an interview was conducted with the Charge RN (CRN 1) on duty the night of Patient 13's death. CRN 1 was asked what walking rounds with the off-going CRN consisted of, CRN 1 stated, "I check if the patient is physically here, like a head count."

On February 29, 2016 at 10:45 AM, an interview was conducted with the Director of the BHU, who stated, "Nursing assessments are not done at the beginning of the shift, unless indicated." As the interview continued the BHU Director stated, "Patient 13 was not in need of an assessment by the nurse, he was not due until 1:45 AM." A review of nursing notes revealed the last documented assessment by a licensed staff was completed on December 4, 2015 at 1:45 PM.

On March 1, 2016, a BHU Nursing Assessment policy and procedure (P & P) was requested. At 2:05 PM, a review of the P & P titled "Nursing Assessment Process," last approval date of 6/11, under the "Components" section, in effect at the time of Patient 13's death revealed the following:

"A. Assessment ..... The initial assessment begins upon admission and completed within four hours of admission, is documented on the Patient Data Base. Reassessments are documented on flowsheets and in the PIE (plan, implement, evaluate) Note every 12 hours."

On March 1, 2016 at 2:05 PM, an interview was conducted with the Interim Associate Hospital Administrator (IAHA). The IAHA was asked if the P & P provided, was the same P & P in effect at the time of Patient 13's death, the IAHA stated, "Yes."

On March 3, 2016 at 3:30 PM, an interview was conducted with the Chief Nursing Officer (CNO). The CNO was asked if she was aware that nursing staff in the BHU, were not conducting assessments/observations of the patient assigned to them in a timely manner, the CNO stated, "I was not."

On March 1, 2016 at 5:43 PM, an Immediate Jeopardy was called in the presence of the Hospital Director, the Director of Behavioral Health Unit, the Chief Nursing Executive, the Interim Associate Hospital Administrator, and the Chief Medical Officer. The Immediate Jeopardy situation resulted due to the facility's failure to conduct nursing assessments (evaluation) of patients in the BHU within a timely manner. This failure created the potential to have contributed to the death of a patient in the BHU, who had not been assessed/observed for seven (7) hours by licensed staff.

On March 3, 2015 at 11:12 AM, the Immediate Jeopardy was lifted following the acceptance of an acceptable and validated plan of correction. Present during the abatement was the Hospital Director, the Interim Associate Hospital Administrator, the Chief Nursing Officer and the Chief Medical Officer.

2. A review of the clinical record for Patient 13, indicated the patient voluntarily presented to the Behavioral Health Unit (BHU) Emergency Department (ED) triage area on December 3, 2015 at 10:39 AM, with complaints of auditory hallucinations. Patient 13 received a medical screening examination by the BHU ED triage physician and was determined that the patient needed inpatient psychiatric treatment and was declared "Medically clear for BHU."

Review of Patient 13's clinical record revealed the patient remained in the BHU ED triage area for a total of 34 hours until an inpatient bed became available. On December 4, 2015 at 8:50 PM, Registered Nurse (RN) 1, found Patient 13 unresponsive, not breathing, no pulse, and in rigor (body stiff), cardiopulmonary resuscitation (CPR) was initiated and a code blue (emergent situation requiring immediate help) was called. The patient was pronounced dead at 9:07 PM, by the ED doctor who responded to the code.

A review of the ED physician's "Code Note (documentation by the physician regarding the event)," dated December 4, 2015 revealed the following documentation:

"....Two rescuer CPR (1 staff providing chest compressions and another staff assisting with airway/breaths) being performed. Upon evaluation of the patient there were no carotid pulses (neck veins) appreciated (present), no spontaneous breaths, patient had fixed pupils with no corneal reflex. Patient's jaw was clenched, patient cold to touch....No signs of life appreciated....Patient had signs of rigor."

A review of the "ED Summary Report," dated December 3, 2015 revealed documentation that the patient was deemed a "Priority: 2."

On March 1, 2016, at 9 AM an interview was conducted with the Nurse Manager (NM) of the BHU ED triage area, who confirmed that Patient 13 was a "Priority: 2," and fell into the category of "Routine - Status."

A review of the BHU policy and procedure (P & P) titled "Psychiatric Triage Policy," Policy NO. 734.01, under the "Procedure" section documentation revealed the following:

"J. ....Patients assigned and/or ordered a specific observation will be monitored as follows:

3. Routine - Status: Patients in BH Triage admitted and/or transfer to inpatient unit or other facility. Patients are assigned rooms, and required standard inpatient Q (every) 15-minute observation (performed by a licensed and non-licensed staff) monitoring."

A review of the Q15-minute observation record ("Non-Admit Activity Flow Sheet) dated December 4, 2015, indicated Patient 13 was asleep from 12 PM to 9 PM. No other activity was documented during this time frame.

On March 1, 2016 at 10 AM, an interview was conducted with Nursing Assistant (NA) 1. NA 1 noted to have the most documentation on Patient 13's Q15-minute observation record from the 3 PM to 11 PM shift on December 4, 2015, was asked if she could recall the last time she could say for certain that she knew Patient 13 was alive, NA 1 stated, "Before 2000 (8 PM), I remember the patient snoring and moving."

NA 1 was asked if she recalled anything about the patient from 8 PM to 9 PM other than the patient sleeping, as documented by her with her initials (meaning done) on the Q15-minute observation sheet. NA 1 stated, "It wasn't necessarily me who saw the patient the last time, because we work so closely, my co-worker could have told me that they saw the patient and I wrote it down." NA 1 was asked if she knew that she could only legally document if she made the observation herself, NA 1 responded, "We were taught to work together."

On March 3, 2016 at 10:43 AM, an interview was conducted with Registered Nurse (RN) 2, who worked the 7 PM to 7 AM shift and was assigned to Patient 13 on the evening of December 4, 2015. RN 2 was asked if he was aware that the NA's were documentating observations that they did not actually observe, RN 2, stated, "I did not."