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Based on review of governing body meeting minutes, medical staff bylaws, rules, regulations, credential files, hospital documents, contracted services, and interview with staff, it was determined that the hospital failed to have an effective governing body responsible for the conduct of the hospital, as evidenced by:

A0049:
failing to monitor and evaluate the clinical activities of each licensed independent practitioner with privileges to work in the psychiatric acute care unit (PACU) in order to promote maintenance of quality performance and coordinate the conduct and findings of client care monitoring activities (Physicians #s 1, 2, 4, 5, and 7);

failing to maintain surveillance of enforcement of policies and rules and regulations relating to completion, preparation, forms, availability of records, and review and evaluate records to determine they properly describe the conditions and progress of the client and are sufficiently complete, for all practitioners with privileges in the PACU (Physicians #1, 2, 4, 5, and 7);

failing to require the PACU licensed independent practitioners maintained a certificate to dispense medications independently for 4 of 4 physicians reviewed (Physicians #'s 1, 2, 3, and 4);

failing to require the PACU Medical Chair (Physician #3) maintained privileges as defined in Article V of the medical staff bylaws;

failing to require the medical staff reported to the governing body peer review/chart reviews for all psychiatric acute care unit (PACU) providers; and

A0084:
the governing body failing to require contracted services were evaluated to ensure services were performed in a safe and effective manner, as evidenced by, evaluations of the dietician, laboratory and pharmacy were not reported to the governing body.

Additionally, the hospital shared a governing body with all areas of service and all locations of The Guidance Center including, outpatient services, child and family services in Flagstaff and Williams, Substance abuse outpatient services, psychiatry and medication services, community living services, Inverrary House (Level II Behavioral Health Residential Facility), Title 36 services, inpatient services, and the psychiatric acute care unit.

Findings include:

Review of the governing body meeting minutes for 02/10/11, revealed the minutes discussed all services and reported data as an aggregate for many items. For example, the form titled Data Summary FY09-10, included data from all services and reported an overall compliance rate for each item, however, individual scores for the PACU were not reported. Peer review reports included all physicians at all areas and did not provide the PACU scores individually in the areas scored.

The governing body received aggregate data for all areas of service and locations.

The Chief Executive Officer confirmed in an interview that governing body meeting minutes included all services and locations, not just the PACU information.

The cumulative effect of these deficient practices resulted in the hospital's failure to meet the requirements of the Condition of Participation (COP) for the Governing Body.

Based on review of the medical staff bylaws, rules, regulations, credential files, governing body meeting minutes, and interview with staff, it was determined the governing body failed to ensure the medical staff was accountable for the quality of care provided as evidenced by:

1. failing to monitor and evaluate the clinical activities of each licensed independent practitioner with privileges to work in the psychiatric acute care unit (PACU) in order to promote maintenance of quality performance and coordinate the conduct and findings of client care monitoring activities (Physicians #s 1, 2, 4, 5, and 7);

2. failing to maintain surveillance of enforcement of policies and rules and regulations relating to completion, preparation, forms, availability of records, and review and evaluate records to determine they properly describe the conditions and progress of the client and are sufficiently complete, for all practitioners with privileges in the PACU (Physicians #1, 2, 4, 5, and 7);

3. failing to require the PACU licensed independent practitioners maintained a certificate to dispense medications independently for 4 of 4 physicians reviewed (Physicians #'s 1, 2, 3, and 4);

4. failing to require the PACU Medical Chair (Physician #3) maintained privileges as defined in Article V of the medical staff bylaws.

5. failing to require the medical staff reported to the governing body peer review/chart reviews for all psychiatric acute care unit (PACU) providers.

Findings include:

1. See A-0353 #1

2. See A-0353 #2

3. See A-0353 #3

4. Review of the Bylaws of the Licensed Independent Practitioners Staff of the Guidance Center, revised 10/10, required: "...Monitoring Activities...Maintain and forward documentation of monitoring activities...."

The Medical Director stated on 04/06/11, the medical staff reports peer review/chart reviews to the Quality Committee, however, data submitted on physicians is an aggregate for all physicians, who work in all services areas at three different locations. The peer review/chart review data for the PACU physicians was commingled and one could not discern the PACU physician's quality of care issues, nor were all physicians who worked in the PACU evaluated for care provided in the PACU.

Based on review of contracted services, governing body meeting minutes, and interview with staff, it was determined the governing body failed to require contracted services were evaluated to ensure services were performed in a safe and effective manner, as evidenced by, evaluations of the dietician, laboratory and pharmacy were not reported to the governing body.

Findings include:

According to the Quality Director the hospital had 5 services provided under contract for the hospital. These were for Coconino County Title 36; Flagstaff Medical Center; Pharmacy; Sonora Quest Laboratory; and Registered Dietician services. Evaluations of the services were requested for review.

The Director of Nursing (DON) collects data for the laboratory and pharmacy. The DON confirmed in an interview on 04/06/11, that she has not reported any evaluations of these contracted services to any committee.

The governing body meeting minutes were reviewed, evaluations of contracted services had not been reported. The Chief Executive Officer confirmed on 04/07/11, that contract evaluations have not been reported to the governing body.

Based on review of documentation provided by the hospital, direct observation, review of hospital policies/procedures, and medical records, and interviews, it was determined the hospital failed to protect and promote each patient's rights as evidenced by:

(A144) failure to provide care to patients in a safe setting;

(A166) failure to require that the use of restraint or seclusion be in accordance with a written modification to the patient's plan of care;

(A179) failure to require that a patient restrained and/or secluded for the management of violent or self-destructive behavior is seen face to face within one hour after the initiation of the intervention to evaluate the patient's medical and behavioral condition;

(A182) failure to require that a trained registered nurse who conducts the face to face evaluation of a patient after a restraint and/or seclusion required for the management of violent or self-destructive behavior consults the LIP who is responsible for the care of the patient as soon as possible after the completion of the 1 hour face to face evaluation;

(A205) failure to require documentation of competency to evaluate a patient's medical and/or behavioral condition of RN's completing the one hour face to face evaluation of a patient who requires seclusion and/or restraint for the management of violent or self-destructive behavior; and

(A214) failure to require that the hospital policy/procedure accurately reflect the CMS requirements with regard to reporting patient deaths associated with the use of seclusion or restraint.

The cumulative effect of these systemic problems resulted in the hospital's failure to meet the requirements of the Condition of Participation for Patient Rights.

Based on review of documentation, direct observation, and interview, it was determined that the hospital failed to protect the patients' right to receive care in a safe setting as evidenced by:

1. failure to provide an environment that is free of fixtures and surfaces conducive to patient suicide for 1 of 1 patient who committed suicide in the hospital (Pt #1); and

2. failure to provide a patient care environment that is free of fixtures, surfaces, and equipment conducive to patient injury, self-injury, or suicide for all patients admitted to the unit.

Findings include:

1. Review of a written statement completed by BHS #1, dated 3/22/11 at 0656 revealed: "...I was performing morning 0600 hrs. vital signs checks on all clients when at 0610 hrs. I knocked on (Pt #1's) door and got no answer so I then proceeded and noticed his bathroom light was on but the door had been tied shut with a rag. I immediately called for help and (BHS #2) assisted me in getting the door open immediately. We both noted (Pt #1) had used rags and torn bedsheets to hang himself in his shower, we immediately removed (Pt #1) from the shower and placed him in the hallway lying down. I noticed he had rigor mortis, levidity, (sic) and was cold to the touch. Also noticed marks around his neck and checked for pulse and breath sounds, he had no pulse and wasn't breathing. I decided to not begin CPR (Cardio Pulmonary Resuscitation) due to time that had passed by of this event happening but I did call for gloves & AED (Automatic External Defibrillator) just in case. 911 was then dialed...."

During tour of the PAC on 3/30/2011, Pt #1's bathroom in Room M 3, was observed to contain several safety hazards for a patient who may be self-injurious and/or suicidal: exposed toilet pipes; door handles (inside and outside); two cupboard door handles; pipes under the sink, inside the unlocked cupboard; exposed door hinges inside the bathroom; shower door handle; and shower faucet handle. In addition, the patient bedroom itself contained several safety hazards for a self-injurious and/or suicidal patient: two handles on the window frame; bedroom door handle; four wooden slats where drawers had been removed; two ceiling vent covers with metal slats. All of these items could provide the surface for an individual to harm himself/herself by hanging.

On 3/30/11, the DON confirmed that Pt #1 had tied the bathroom door shut by looping a towel or sheet fabric between the door handle and the cupboard handles. In addition, Pt #1 had committed suicide by hanging himself from the shower faucet handle.

The Director of Risk Management confirmed during interview on 3/30/11, that the facility had no documentation of the facility's action taken to prevent a similar incident. None of the environmental hazards which the patient had utilized to secure the closed bathroom door or to hang himself had been altered by 4/7/11, date of the survey.

2. The survey team directly observed the following environmental safety hazards while on site from 3/30/11 through 4/1/11 and from 4/4/11 through 4/7/11:

Eight semi-private patient rooms with Bathrooms, each containing:
Exposed toilet plumbing pipes
Under-sink plumbing pipes, located inside unlocked bathroom cupboard sinks
Bathroom cupboard handles
Two ceiling vent covers with metal slats
Shower door handle
Shower faucet handle
Bathroom door handles (inside and outside)
Bedroom door handle
Two handles on window frames
Hinges inside bathroom door
Four wooden slats exposed after removal of drawers

Bathroom adjacent to observation room contained:
Exposed toilet and sink plumbing pipes
Soap dispenser (risk of patient ingestion)
Toilet plunger in a plastic bag (plastic bag presents risk of suffocation)

Handicap bathroom (utilized by some patients without supervision) contained:
Grab rails at the sink
Exposed sink and toilet plumbing pipes.
Hand-held shower hose
Grab rails around the inside of the shower

All of the above items/risks identified provide surface for an individual to harm themselves by hanging unless otherwise specified.

Hallway leading to bathroom outside seclusion/observation rooms contained:
Seven crutches
Five walkers
Two bed frames
One mattress
One wheelchair
One bedside commode
One bath chair
One electrical power cord (approximately 10 ft long)
One wood crate with magazines
One five-gallon bucket of salt (used for snow/ice)

The items listed above were stored in the hallway leading to the bathroom used by patients who require care in the observation/seclusion rooms. They present safety hazards for anyone attempting to walk through the hallway, especially an agitated patient who my require an escort to the bathroom.

In addition, a hole, approximately 4" in diameter, was located in the wall beneath the window in Room M3. The hole appeared to have been the result of a patient's damage to the property. The DON stated, on 3/30/11, that the last two patients occupying the room had not caused the damage. The hole in the wall presents a patient safety hazard.

A similar hole was located just inside the door to the PAC unit, presenting another patient safety hazard.

Based on review of policy/procedure, medical records and interview, it was determined that the hospital failed to require that the use of restraint or seclusion must be in accordance with a written modification to the patient's plan of care for 3 of 3 patients restrained and/or secluded for management of violent and/or self destructive behavior (Pt's #2, #3, & #18).

Findings include:

Review of the hospital policy titled Seclusion (Locked), Physical Restraint and Chemical Restraint-Inpatient Programs revealed: "...Physical restraints are: Any manual method, physical device, material. or equipment attached or adjacent to the body, that s/he cannot easily remove that restricts freedom of movement or access to one's body. This includes any 'takedown'...All seclusion and restraints are used in accordance with the client's plan of care...."

Review of the hospital form titled: Psychiatric Acute Care (800) Seclusion or Restraint Physician's Orders revealed a section titled Provider Orders For: Locked Seclusion...Mechanical Soft Restraints...Pharmacological Restraint...Brief Physical Hold...." The provider is to indicate by placing a mark in a box, which method is selected.

Pt #2 was admitted on 1/27/11 with Bipolar disorder, severe mania with psychosis. Pt #2's medical record contained documentation that s/he was restrained by "Brief Physical Holds" twelve times between 1/27/11 and 2/10/11; s/he was restrained by "Pharmacological Restraint" four times between 1/27/11 and 2/7/11; and s/he was placed in "Locked Seclusion" ten times between 1/29/11 and 2/10/11. Pt #2's treatment plan contained no mention of seclusion and/or restraint.

Pt #3 was admitted involuntarily on 10/09/10. On 10/13/10, s/he was restrained with a "Brief Physical Hold." Pt #3's treatment plan contained no mention of restraint.

Pt #18 was admitted involuntarily on 12/21/10. On 1/24/11 s/he was restrained with a "Brief Physical Hold." Pt. #18's treatment plan contained no mention of restraint.

The DON confirmed during an interview on 4/6/11, that the treatment plans of Pt's #2, #3, & #18 contained no mention of these patient's requiring seclusion and/or restraint.

Based on review of hospital policy/procedure, medical records, hospital documents, and interview, it was determined that the hospital failed to require that a patient restrained and/or secluded for the management of violent or self-destructive behavior is seen face to face within one hour after the initiation of the intervention to evaluate the patient's medical and behavioral condition for 3 of 3 patients (Pt #2, #3, & #18).

Findings include:

Review of the hospital's policy titled Seclusion (Locked), Physical Restraint and Chemical Restraint-Inpatient Programs revealed: "...A physician or licensed nurse practitioner will see the client face to face and will complete and document an assessment of the client within an hour of the initiation of the Seclusion or Restraint order...."

Review of the form titled Psychiatric Acute Care Unit/Face to Face Assessment "From" (sic) revealed: "...2. What medical history/issues does the consumer have?...." This section includes items that the individual conducting the assessment is to mark: "...a. Is the consumer medically compromised?...Yes...No...If 'Yes' check all that apply: Morbid Obesity...Recent Vomiting...History of Seizures...Spinal Injury...Pregnancy...Known history of cardiac disease...Known history of respiratory disease...Other (specify)...b. Is there increased risk of injury because of medical history?...

3. What behavioral history does the consumer have: (Past S/R (Seclusion/Restraint; hx (history) of abuse or trauma etc.)...

4. Mental Status...." This section includes items that the individual conducting the assessment is to mark: "...A/O X 3 (Alert & Oriented to person, place, & time)...X4 (situation)...Repeat 3 objects...yes...no...Recall after 5 min...yes...no...Able to name 3/3 objects...2/3 objects...1/3 objects...a. Is Consumer able to understand the situation and criteria for discontinuing the Seclusion or Restraint...5. Did the consumer receive any injuries during the seclusion or restraint?...yes...no...If yes explain:...."

The form does not contain space or a section for an individual to document the patient's current medical condition, including a current review of systems and/or physical assessment and/or assessment or description of pertinent lab results, medications etc. The form does not contain space for documentation of the patient's current behavior or behavioral condition beyond the specific choices listed above.

Pt #2 was admitted on 1/27/11 with Bipolar disorder, severe mania with psychosis. Pt #2's medical record contained documentation that s/he was restrained by "Brief Physical Holds" twelve times between 1/27/11 and 2/10/11; s/he was restrained by "Pharmacological Restraint" four times between 1/27/11 and 2/7/11; and s/he was placed in "Locked Seclusion" ten times between 1/29/11 and 2/10/11.

Pt #2's medical record contained documentation of a face to face assessment completed by an RN within one hour of each of the patient's episodes of restraint and/or seclusion. These assessments were recorded on the Psychiatric Acute Care Unit/Face to Face Assessment Form. None of the one hour face to face assessments included documentation of evaluation of the Pt #2's medical or behavioral condition at the time of the assessment. In addition, the RN's completing the face to face assessments did not document the patient's medical and/or behavioral condition elsewhere in Pt #2's medical record.

Pt #3 was admitted involuntarily on 10/09/10. On 10/13/10, s/he was restrained with a "Brief Physical Hold." Pt #3's medical record contained documentation of a face to face assessment completed by an RN within one hour of the initiation of the physical hold. This assessment was documented on the Psychiatric Acute Care Unit Face to Face Assessment Form. The documentation did not include evaluation of Pt #3's medical and/or behavioral condition at the time of the assessment.

Pt # 18 was admitted involuntarily on 12/21/10. On 1/24/11 s/he was restrained with a "Brief Physical Hold." Pt #18's medical record contained documentation of a face to face assessment completed by an RN within one hour of the initiation of the physical hole. This assessment was documented on the Psychiatric Acute Care Unit Face to Face Assessment Form. The documentation did not include evaluation of Pt #18's medical and/or behavioral condition at the time of the assessment.

The DON confirmed, during an interview on 4/6/11, that the RN one hour face to face assessments of Pt's #2, #3, #18 did not include evaluation of the patients' medical and/or behavioral condition at the time of the assessments. In addition, she confirmed that the practice of utilizing an RN to conduct the one hour face to face assessments is not consistent with the hospital's policy.

Based on review of hospital policy/procedure, medical records and interview, it was determined that the hospital failed to require that registered nurse who conducts the face to face evaluation of a patient after a restraint and/or seclusion required for the management of violent or self-destructive behavior consults the LIP who is responsible for the care of the patient as soon as possible after the completion of the 1 hour face to face evaluation.

Findings include:

Review of the hospital's policy/procedure titled Seclusion (Locked), Physical Restraint and Chemical Restraint-Inpatient Programs revealed that it does not contain information regarding the ability of a trained RN to complete the face to face evaluation, or the requirement for the trained RN to consult the LIP who is responsible for the care of the patient.

Cross reference Tag (A0179) for information regarding Pt's #2, #3, & #18.

The medical records of Pt's #2, #3, & #18 did not contain documentation that the RN conducting the patients' one hour face to face evaluations contacted the patients' LIP's who were responsible for the patients' care as soon as possible after the completion of the one hour face to face evaluation.

The DON confirmed during an interview on 4/6/11, that the RN's who complete the one hour face to face evaluations do not routinely contact the patients' LIP's after a face to face evaluation, unless the LIP happens to be present on the unit at the time of the evaluation.

Based on review of hospital policy/procedure, personnel documents, and interview, it was determined that the Competency Checklist utilized by the hospital to document RN competency in completing the one hour face to face evaluation of a patient who requires seclusion and/or restraint for the management of violent or self-destructive behavior does not include documentation of RN competency to evaluate a patient's medical and/or behavioral condition.

Findings include:

Review of the hospital's policy/procedure titled Seclusion (Locked), Physical Restraint and Chemical Restraint-Inpatient Programs revealed the policy/procedure does not contain information regarding the ability of a trained RN to complete the face to face evaluation or the training necessary for an RN to be able to complete the one hour face to face evaluation.

Review of medical records of Pt's #2, #3, & #18 revealed that RN's #5, #9, & #18 completed documentation of one hour face to face evaluations. Review of the RN's training documentation provided by the DON revealed a form titled RN Face to Face Assessment Competency Checklist. Checklists were completed for RN's #5, #9, & #18 and signed by the Director of Nursing as the Instructor. The Competency Checklist does not include documentation that the nurse demonstrated competency in completing an assessment of a patient's medical condition including review of systems and/or physical assessment; nor does it include documentation that the nurse demonstrated competency in evaluating a patient's behavioral condition. The documentation did not include the content of the training.

The DON confirmed on 4/6/11 that the RN's conducting the one hour face to face evaluations are not completing assessments of the patients' medical condition and/or behavioral condition.

Based on review of hospital policy/procedure and interview, it was determined that the hospital's policy/procedure related to Death Reporting Requirements was incomplete.

Findings include:

Review of the hospital policy/procedure titled Seclusion (Locked), Physical Restraint and Chemical Restraint-Inpatient Programs revealed: "...Any death which occurs while the client is in seclusion, must be reported to Medicare (CMS)...Any death which occurs while the client is in seclusion, must be reported to Medicare (CMS)...."

The hospital policy/procedure did not contain requirements to report a patient's death that occurs within 24 hours after the patient has been removed from restraint or seclusion. In addition, the hospital policy/procedure did not contain requirements to report a patient's death that occurs within one week after restraint or seclusion where it is reasonable to assume that the use of restraint or placement in seclusion contributed a patient's death.

The DON confirmed during interview on 4/6/11, that the hospital policy/procedure related to Death Reporting Requirements was incomplete.

Based on review of hospital documents, patient #1's medical record, incident report, and interview with staff, it was determined the hospital failed to identify and set priorities that affected patient safety as evidenced by:

1. the failure to identify potential environmental safety risks during a failure, mode, effect, and criticality analysis (FEMCA) conducted 10/2010 and implement changes; and

2. the failure to identify that nursing staff was not routinely conducting 15" visual observation of patients with physician orders for 15" visual checks; that competency of BHS nursing staff was documented; and BHS nursing staff were being oriented to specific hospital policies/procedures related to patient safety.

Findings Include:

1. Review of the report titled Proactive Risk Assessment The Guidance Center Psychiatric Acute Care Unit Environmental Safety F.M.E.C.A., dated 10/10, included: "...This FMECA will be focusing on the Potential Failure Modes that would create danger or gaps in care that could lead to PACU (psychiatric acute care unit) consumers (patients) being able to cause injuries to themselves or others...Safety Committee has taken a proactive approach and is attempting to correct these issues that could cause problems in the future. The committee will attempt to correct these issues before someone gets hurt...The Safety Committee identified 12 potential Safety Issues for this project...1. Shower doors could be broken and used for self harm...2. The corners of doors could be used for self injury...3. Door handles could be used for self injury...4. Hand sanitizer could be used inappropriately...5. furniture could be used for self injury...6. The courtyard environment could be unsafe...7. Light fixtures could be used for self harm...8. Electrical outlets could be used for self harm...9. Loose drawers could be used for self harm...10. Window frames could be used for self harm...11. Plastic corner guards could be broken and used as weapons...12. Consumers could use objects like pens as weapons...The team members had the opportunity to brainstorm and think of any Potential Failure Modes that each issue could possibility (sic) cause to our consumers, staff, or event the facility itself...."

The hospital then scored and ranked each item identified. After this the hospital assigned a Failure Mode Category: "...1. Issues that have already been addressed...2. Issues that will be addressed through a change in process...3. Issues that will be addressed through additional staff training...4. Issues that the team will not be attempting to correct at this time...."

Of the 12 items identified 5 items were identified to be changed and all others would not be attempted to correct at this time.

The Safety Committee did not identify potential risk issues identified by the survey team while onsite 03/30-31/11, and 04/04-07/11.

Cross reference A0144, Item #2.

On 03/22/11, Patient #1 was found at 0610, in his bathroom where he had tied the bathroom door shut by using a towel or other fabric to tie the door handle to the cupboard door handles. He was found hanging from the shower faucet handle and was pronounced dead at approximately 0627.

The hospital conducted a FMECA in October 2010 and did not correct or identify risk factors associated with the death of Patient #1 who successfully hung himself on 03/22/11.

2. Cross reference Tags 0395 #4 and 0397 #2.

Based on review of governing body meeting minutes, FEMCA report, hospital documents, and interview with staff, it was determined the hospital failed to ensure the governing body, medical staff, and administrative officials were accountable for ensuring patient safety as evidenced by, failing to identify potential environmental safety risks during a failure, mode, effect, and criticality analysis (FEMCA) conducted 10/2010, implement changes and report to the governing board.

Findings include:

Review of the governing body meeting minutes for 02/10/11, revealed that the board received the Environment of Care Quality Report titled Second Quarter (EOC) Safety Report 2010-2011. The report contained the following information regarding the FEMCA: "...PACU Environmental Safety FMECA: The project focused on the concerns of safety on the TGC PACU and whether anything in the PACU environment could be harmful or used for self harm...."

No other information was provided to the governing board regarding the FEMCA.

On 04/06/11, the Director of Quality provided the governing body meeting minutes for 02/10/11 with attachments and confirmed this is what the board was provided for the meeting.

Cross reference A0144, Item #2 and A0285 #1.

Based on review of the medical staff bylaws, rules and regulations, review of provider credential files, and interviews with staff, it was determined the hospital failed to ensure the organized medical staff operated under their bylaws and were responsible for the quality of care provided to patients, as evidenced by:

A0353:
failing to monitor and evaluate the clinical activities of each licensed independent practitioner with privileges to work in the psychiatric acute care unit (PACU) in order to promote maintenance of quality performance and coordinate the conduct and findings of client care monitoring activities (Physicians #s 1, 2, 4, 5, and 7);

failing to maintain surveillance of enforcement of policies and rules and regulations relating to completion, preparation, forms, availability of records, and review and evaluate records to determine they properly describe the conditions and progress of the client and are sufficiently complete, for all practitioners with privileges in the PACU (Physicians #1, 2, 4, 5, and 7);

failing to require the PACU licensed independent practitioners maintained a certificate to dispense medications independently for 4 of 4 physicians reviewed (Physicians #'s 1, 2, 3, and 4); and

failing to require the PACU Medical Chair (Physician #3) maintained privileges as defined in Article V of the medical staff bylaws.

A0364:
the medical staff did not define a mechanism for documenting permission to perform an autopsy and a system to notify the attending practitioner when an autopsy is performed.

These deficient practices resulted in the hospital's failure to meet the requirements of the Condition of Participation (COP) for the Medical Staff.

Based on review of the medical staff bylaws, rules and regulations, review of provider credential files, and interviews with staff, it was determined the hospital failed to enforce its bylaws as evidenced by:

1. failing to monitor and evaluate the clinical activities of each licensed independent practitioner with privileges to work in the psychiatric acute care unit (PACU) in order to promote maintenance of quality performance and coordinate the conduct and findings of client care monitoring activities (Physicians #s 1, 2, 4, 5, and 7);

2. failing to maintain surveillance of enforcement of policies and rules and regulations relating to completion, preparation, forms, availability of records, and review and evaluate records to determine they properly describe the conditions and progress of the client and are sufficiently complete, for all practitioners with privileges in the PACU (Physicians #1, 2, 4, 5, and 7);

3. failing to require the PACU licensed independent practitioners maintained a certificate to dispense medications independently for 4 of 4 physicians reviewed (Physicians #'s 1, 2, 3, and 4); and

4. failing to require the PACU Medical Chair (Physician #3) maintained privileges as defined in Article V of the medical staff bylaws.

Findings include:

1. Review of the Bylaws of the Licensed Independent Practitioners Staff of the Guidance Center, revised 10/10, required: "...Purpose and Responsibilities...To monitor and evaluate the clinical activities of each Licensed Independent Practitioner in order to promote maintenance of quality performance...Monitoring Activities...Adopt plans, modify, coordinate the conduct and findings of client care monitoring activities...."

The Quality Director confirmed during an interview on 04/06/11, that only 2 providers were currently reviewed for peer review/chart reviews. She explained the person who obtains medical records for review only chooses the 2 providers that work full time in the PACU for review and never pulls the other practitioners PACU medical records for review.

The Medical Director confirmed during an interview on 04/06/11, that 2 providers work full time in the PACU (Providers # 3 and 6) and the other providers will take call for the PACU.

2. Review of the Bylaws of the Licensed Independent Practitioners Staff of the Guidance Center, revised 10/10, required: "...Monitoring Activities...Review and evaluate records to determine that they properly describe the conditions and progress of the client and are sufficiently complete so as to facilitate continuity of care and communications between those providing client care services...Develop, review, enforce and maintain surveillance of enforcement of Policies and Rules, and Regulations relating to completion, confidentiality, preparation, format, forms, filing, storage, destruction and availability of records...."

The Quality Director confirmed during an interview on 04/06/11, that only 2 providers were currently reviewed for peer review/chart reviews. She explained the person who obtains medical records for review only chooses the 2 providers that work full time in the PACU for review and never pulls the other practitioners PACU medical records for review.

3. Review of the Bylaws of the Licensed Independent Practitioners Staff of the Guidance Center, revised 10/10, required: "...Definitions...Licensed Independent Practitioner means any Physician, Nurse Practitioner, Physician Assistant, or Licensed Psychologist who is privileged to provide diagnostic, therapeutic or medical services and, excepting Psychology staff, maintains a DEA License to prescribe and dispense medications independently for TGC (The Guidance Center)...."

Review of 4 of 4 physician credential files (Physician #1, 2, 3 and 4) revealed none of the physicians had a certificate to dispense medications from the hospital for use by the patient outside the hospital.

During interviews with nurse # 19 on 04/05/11 and 04/06/11, he explained that when a patient is discharged over the weekend and the hospital pharmacy is closed the discharging physician will send prescription medications home with the patient and the medications that are sent home with the patient are taken out of the emergency supply medication stock.

Review of credential files for 4 of 4 physicians #1, 2, 3, and 4, did not contain a dispensing certificate from a licensing medical board.

4. Review of the Bylaws of the Licensed Independent Practitioners Staff of the Guidance Center, revised 10/10, required: "...Responsibilities of Staff Membership...Agree to abide by the Licensed Independent Practitioners Staff By-Laws, Rules and Regulations, and Policies and procedures of TGC, including all pertinent provisions of state and federal laws...Agree to apply for and maintain privileges as defined in Article V...."

Review of the Medical Chair for the PACU revealed the physician's privileges expired 01/15/11. The physician was currently practicing at the hospital. The Director of Human Resources, responsible for the credential files, confirmed on 04/06/11, that the physician's privileges had expired.

Based on review of the medical staff bylaws, rules and regulations and interview with staff, it was determined the medical staff did not define a mechanism for documenting permission to perform an autopsy and a system to notify the attending practitioner when an autopsy is performed.

Findings include:

Review of the medical staff bylaws, rules and regulations did not define permission to obtain an autopsy, nor a system to notify the attending practitioner when an autopsy is performed.

The Quality Director confirmed on 04/06/11, the medical staff bylaws did not include autopsies.

Based on review of hospital policies/procedures, medical records, interviews, review of documents provided by the hospital, personnel files,and direct observation, it was determined that the hospital failed to provide an organized nursing service 24-hours per day with an adequate number of registered nurses and competent nursing staff to assess patients' care needs and deliver, assign and supervise the care required by each patient as evidenced by:

(A395) failure to require that a registered nurse supervise and evaluate the nursing care of each patient;

(A396) failure to ensure that the nursing staff develops and keeps current, a nursing care plan for each patient;

(A397) failure to require that a registered nurse assign nursing care of each patient to other personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff; and

(A404) failure to follow accepted standards of practice for medication administration and require that medications be administered in accordance with a physician's order.

The cumulative effect of these systemic problems resulted in the hospital's failure to provide an adequate, organized nursing service.

Based on review of hospital policies/procedures, medical records, interviews, review of documents provided by the hospital and direct observation, it was determined that the hospital failed to require that a registered nurse supervise and evaluate the nursing care of each patient as evidenced by:

1. failure to implement physicians' orders for 2 of 2 patients; one of which required transfer to a higher level of care;

2. failure to assess patients' response to medication per policy for 1 of 1 patient who received medication via a "now" order (Pt #1) and 3 of 3 patients who received medication via prn (as needed) orders (Pts #6, #7, & #12);

3. failure to monitor admission of a patient, including collection of assessment data by observation, inspection, auscultation, and/or palpation per policy for 1 of 1 patient (Pt #1);

4. failure to supervise and evaluate the observation of a patient who was high risk for suicide as required by physician's order for 1 of 1 patient (Pt #1);

5. failure to complete patient rounds, assessing patient location and health status per policy for 1 of 1 patient (Pt #1);

6. failure to assess a patient and initiate appropriate action during a medical emergency per policy; and

7. failure to locate emergency resuscitation equipment for emergency patient care.

Findings include:

1. Review of the hospital policy titled Documentation revealed: "...A flow sheet is utilized for vital statistic information...Each client's medical record is legal proof of the quality of care provided by the Psychiatric Acute health team members...Vital statistics...is recorded on a graphic sheet to enhance trending of the recorded behavior...Documentation of care is synonymous with care itself...."

Review of the hospital policy titled Shift Guidelines revealed: "...The charge nurse is accountable for staff team members completing all tasks assigned on the shift...assigning specific tasks, i.e., assessments/vitals...ensure all Consumers have been charted on in the treatment record for the shift as well as any other significant documentation needs and corresponding paperwork completed...."

Review of the hospital policy titled Medical Emergencies revealed: "...A progress note shall be written by the staff with first-hand knowledge of the situation fully describing the situation...and a nursing assessment completed by nursing staff if appropriate, including the persons notified and how the consumer was transported to receive emergency services...."

Pt #8's medical record contained physician's orders, dated 12/18/10 @ 1800: "...O2 3L (Oxygen at 3 Liters hold until 90% is maintained then 2 liters of 02. Vitals q 1 hr (every hour) until stable...." Physician 's Orders, dated 12/18/10 @ 2205 revealed: "...Send to ED (Emergency Department) due to unstable VS (vital signs)...."

Review of Nursing Progress Notes by RN #17 revealed: "...He became irritable and belligerent after lunch, c/o screaming repeatively (sic) and yanking on doors. Able to sit in chair with constant supervision and redirection from several staff but would not stop screaming repeatively (sic). Given PRN (as needed) medication which was eventually effective after about 1.5 hours and he fell asleep. Vitals were taken and O (sic) @ at 80% so 3L 02 started via nasal cannuli (sic) with vital checks q hour. Resting in room snooring (sic)...."

Review of Nursing Progress Notes by RN #16 revealed: "...After shift change his BP were (sic) 66/40. Legs were elevated and rechecked pressure was 92/74 with manual cuff. O2 ranged between 85-95%. Apneic breathing. Was transitioned to 02 mask at 5L. Maintained >90%. He removed the mask himself and 02 sats dropped to 71%. Reverted to cannula after several unsuccessful attempts to leave mask in place. Would occasionally mumble, open eyes briefly or take his mask off but otherwise was unresponsive. At 2130 B/p was 90/52 and 91/56 and at 2215 was 94/64. Tachycardic throughout this time, ranging between 101-125. Physician consulted multiple times. Received order to send to ED at 2205. 911 called. Physician stated he gave report to ED physician and charge RN. Paramedics arrived at 2220 and transported him to ED. Med sheets given to paramedic...."

Pt #8's medical record did not contain documentation of hourly vital signs. The Director of Nursing confirmed during an interview conducted on 4/5/11 @ 2:55 pm, that nursing staff did not document hourly vital signs in Pt #8's medical record as ordered by physician.

Patient #10 was admitted 12/2/10 @ 1925. Review of Patient # 10's Physician's Orders, dated 12/3/10 @ 1200 revealed: "...to Hold all medications. Full VS/O2 q 1 h today...." Physician's orders dated 12/3/10 @1710 revealed: "...vital signs q4 h until evaluated on 12/4/10...."

RN #9 documented Nurses Notes on 12/3/10 @ 5:54pm: "...Aroused for his 7 am medications. Medications were found in his room during room check. (Patient) was listless, observed weaving when he walked, drowsy, slurred speech, difficulty answering questions...Medications have been held...Vital signs to be measured q hour, orders later in the day decrease frequency to q4 hours...."

A physician documented on 12/4/10, at 1036: "...Once admitted he took several different pills of Valium, Flexeril, Xanax. He soon became very sedated was taken off the OWL(Opiate Withdrawal) and monitored. He continues to sleep on couch and in day room. He was seen briefly on his own and reports some serious sedation. His vitals were not recorded today...."

Pt #10 's medical record did not contain documentation of q 1 hour vital signs on 12/3/10 from 1200 to 1710 or documentation of vital signs every 4 hours on 12/3/10 from 1710 until 12/4/10 when re-assessed by the Physician's Assistant.

The Director of Nursing confirmed during an interview conducted on 4/5/11 @ 3:50 pm that Pt #10's medical record did not contain documentation of the hourly and every four hour vital signs from 1200 on 12/3/10 until 12/4/10 as ordered by physician.

2. Review of the facility policy titled American Nurses Association Psychiatric-Mental Health Nursing Scope and Standards of Practice revealed: "...The Psychiatric-Mental Health Registered Nurse:...Assess patient's response to biological interventions based on current knowledge of pharmacological agents' intended actions, interactive effects, potential untoward effects, and therapeutic doses...."

Pt #1's medical record contained a physician's telephone order documented by RN #4 on 3/21/11 at 2250: "...Ativan (lorazepam) 2 mg po 1 x now for (increased) anxiety...."

An RN charted, on 3/21/11 at 2300, on a form titled Medication Notes: "...Ativan 2mg po now x 1 for anxiety...."

RN #4 documented in his/her night shift note which s/he completed at 0600, that the patient "...became tearful at 2300 and verbalized his anxiety and inability to sleep because of his recent trauma on 3/19/2011...empathized with client. orders were received to give medication to minimize client's anxiety...was observed more relaxed, appreciative to staff and returned to his room. Sleep note...remained in his room eyes closed throughout the night without incident...Breathing noted even, regular and unlabored...."

RN # 4 recorded administration of the Ativan 2mg po at 2300 on 3/21/11. The medical record contained no documentation of the nurse's assessment of the patient's response to the medication.

The DON confirmed, during an interview on 4/1/2011, that the RN did not document assessment of the patient after administration of the Ativan.

Review of the hospital policy titled General Guidelines For Medication Administration required: "...When PRN (as needed) medications are administered; the following is to be documented...Results noted from giving the dose and the time...."

Review of the PRN medication administration notes revealed the following:

Patient #6:
Received a total of 7 PRN medications from 04/01/11 through 04/04/11. Three of the 7 medications did not have the results noted.

Patient #7:
Received a total of 22 PRN medications from 04/01/11 through 04/04/11. Ten of the 22 medications did not have the results noted.

Patient #12:
Received a total of 5 PRN medications from 04/04/11 through 04/05/11. Four of the 5 medications did not have the results noted.

DON reviewed and verified the findings on 04/05/11.

3. Pt #1 was admitted on 3/21/10, after a suicide attempt. RN #14 recorded verbal admission orders received from Physician #2 on 3/21/11, at 1310.

Review of the hospital policy titled Shift Guidelines (0700-1930) revealed: "...RN Charge Nurse Responsibilities...Monitor admission of all new Consumers to the Psychiatric Acute Care Unit, this process includes the following: "...Collect assessment data by: Interview, observation, inspection, auscultation, palpation, and report to team and record data on the Nursing Admission Assessment in the consumer's record...."

RN #14 documented the Admission Nursing Assessment for Pt #1 on 3/21/2011, at 4:05. This assessment contained the following information:

"...time of Arrival 3:30 PM...Collateral Information: Received report from crisis...Presenting Problem...Reason for admission: Csr (Consumer) agrees that he became traumatized and depressed after this assault but he politely declines to elaborate, stating that he really does not want to talk about it at this time...Patient's Goal for Stay: 'Just let me out of here so I can be with my family'...Oriented to time, place, and person? Yes...Memory: Yes...Impaired (blank)...." The RN selected "depressed" for mood and entered "0" in the space for the patient's rating of depression on a scale of 1-10 with 10 being suicidal/hopeless. The RN marked "no" in the space for suicidal thoughts. The RN selected "yes" by the question: "Have you been physically or sexually abused," however the space for description was blank. In the section titled Medical Nursing Focus, the RN recorded: "...some injuries from assault...." However, the RN recorded no description or assessment of injuries.

4. RN #14 recorded verbal admission orders, in Pt #1's medical record, received from Physician #2 at 1310, on 3/21/2011. The admission orders contained an order for: "...Safety Precautions:...1:3 Q (every) 15 min. visual checks...."

During a telephone interview conducted on 3/31/11, Physician #2 confirmed that s/he admitted the patient and determined that the patient was a high suicide risk. However, since the patient wasn't expressing immediate intent to harm himself at the time of his admission, visual checks conducted by staff every 15" would be an appropriate level of observation.

Review of the hospital's policy titled Consumer Observation revealed: "...Consumers who may be not be known to the staff or may have a minimum risk of injury may be placed on 1:3 observations or every 15 minute checks. This is documented on the PAC Individual Client Observation record indicating the clients whereabouts every 15 minutes through out the day. This is placed in the consumers chart at the end of the 24 hour period...."

Pt #1's medical record contained a form titled The Guidance Center/Psychiatric Acute Care Individual Client Observation Record. The form contained spaces for staff to record the patient's location every 15", using codes. Staff records his/her initials next to each entry. "S" designated "...Sleeping in Room...." The form was dated 3/22/2011, and the first entry was written at 0000. The letter "S" was recorded every 15" from 0000 through 0500. Behavioral Health Specialist (BHS) #1 recorded entries from 0000 through 0030, and BHS #3 recorded entries from 0045 through 0500.

Review of documentation of staff interviews conducted by the Director of Nursing (DON) revealed: "...3/31/11...Spoke with (Employee #22) regarding what he trains BHS (Behavioral Health Specialist) staff on in regards to consumer observations...He stated his understanding is that...1:3 observations every 15 minutes staff 'need to know where the consumer is'....Spoke with (BHS #3) who said he didn't really remember exactly what was covered in his unit orientation...He reviewed the observation forms but was unclear as to what exactly he was documenting and why...initialing on the observation form...thought it indicated that the consumer was in their room or in the day room...

Review of the Assignment Sheet for Night Shift, 3/21/2011, revealed that BHS #3 was assigned to "Chair" from 2000-2100, 2100-2200, 2200-2300, 0100-0200, 0300-0400, 0500-0600.

On 3/31/11, the DON confirmed that no 15" checks were documented for Pt #1 from the time of his admission on 3/21/11 at 1530, until 3/22/11 at 0000, and after 0500 on 3/22/11. When asked how BHS #3 could be assigned to "Chair" and complete the 15" checks of the patient, s/he explained that the staff assigned to the "Chair" are responsible to watch the hall to ensure that patients aren't entering each other's rooms. In addition, s/he confirmed that it is possible that the staff did not enter Pt #1's room during the night to complete the 15" checks, since the staff was concerned regarding the patient getting his sleep. She confirmed that the nursing staff did not follow the physician's order for q 15 min visual checks.

5. Review of the facility policy titled Shift Guidelines (1099-0700) revealed: "...RN Charge Nurse Responsibilities...Complete rounds of the unit, assessing consumers' locations and health status...Rounds are to be done by the nurse at lease (sic) every two hours...."

Review of documentation of staff interviews conducted by the DON regarding Pt #1 revealed a written statement, dated 3/23/11, from RN #5 (the Charge Nurse on 3/21/11 night shift) who was assigned to Pt #1: "...He came out of his room at 2200...stating that he could not sleep...he went over in detail stating 'I can still feel the hand cuffs on me'...he was fearful for him self and his family I encouraged him to stay in the day room. He stated 'I just need to be with my family I don't think being here will help me'...He asked if I could get him anything to help him sleep...I called the on call provider and received an order for 2 mg of Ativan, @ 2250...He than (sic) stayed awake and spoke to the medication nurse for several minutes...returned to his room...at 0500 per BHS report he was seen in his bed by staff. I was told to call 911 at 0611...I was informed that BHS staff had gone to get 0600 vitals and found that (pt) had tied the bathroom door shut with a towel and hung himself with a sheet by the handle of the shower. EMT's arrived and FPD (Name of Police Department) consumer was pronounced at 0633...."

The medical record contained no documentation that the RN assessed the patient's location and health status during the shift per policy or documentation that an RN conducted patient rounds every two hours per policy.

The DON confirmed, during an interview on 4/1/2011, that the RN did not document assessment and evaluation of the care of Pt #1 during the night shift.

6. Review of the facility policy titled Medical Emergencies revealed: "...In the event that a physician is unavailable, a registered nurse will be responsible for assessing the consumer...and initiating the appropriate action according to policies and procedures for the Psychiatric Acute Care Unit...First Aid and/or CPR procedures will be initiated immediately upon discovery of an urgent or emergency situation by paging a 'Code Blue'...Resuscitative services and life-sustaining treatment will be maintained by The Guidance Center staff until the arrival of 911 emergency personnel...A Progress Note shall be written by the staff with first-hand knowledge of the situation fully describing the situation, immediate First Aid or CPR intervention by staff, and a nursing assessment completed by nursing staff if appropriate, including the persons notified and how the consumer was transported to receive emergency services...."

Review of the facility policy titled Emergency Procedures and Protocols for the PAC revealed: "...Institute cardiopulmonary resuscitation when respiration and pulse cease in a client...AED machine initiation...Institute and maintain ventilation using airway adjuncts and/or Ambu bag to maintain adequate airway...."

Review of the facility policy titled Shift Guidelines (1900-0700) revealed: "...The charge nurse is accountable for staff team members completing all tasks assigned on the shift...Assess the number and level of personnel needed to provide consumer care on the unit and collaborate with Director of Nursing in adjusting staffing assignments. Complete the assignment sheet...Ensure all consumers have been charted on in the treatment record for the shift as well as any other significant documentation needs...Provide direct clinical supervision to Behavioral Health Specialists...Check emergency equipment and equipment log and ensure procedure completion monthly...."

Review of the Assignment Sheet for 3/21/11, night shift, revealed that RN #5 was the Charge Nurse and was assigned to Pt #1. BHS #3 was also assigned to Pt #1.

Review of Pt #1's medical record revealed that it did not contain documentation by nursing personnel who were responsible for the patient's care during the night shift commencing on 3/21/2011 at 1900, that he was found with no pulse or respirations. RN #4 recorded a note, entered into the computer at 0600 on 3/22/2011, that the patient "...remained in his room eyes closed throughout the night without incident...."

The DON completed a late entry into the medical record on 3/22/2011, at 8015: "...After nurse had final approved her shift note. Consumer was found during VS (Vital Signs) in the shower deceased having tied torn fabric around the shower knob and his neck. He had tied fabric around the door handle to prevent entry as well. EMS was notified...."

Review of documentation of staff interviews conducted by the Director of Nursing (DON) revealed a written statement completed by BHS #1, dated 3/22/11 at 0656: "...I was performing morning 0600 hrs. vital signs checks on all clients when at 0610 hrs. I knocked on...door and got no answer so I then proceeded and noticed his bathroom light was on but the door had been tied shut with a rag. I immediately called for help and (BHS #2) assisted me in getting the door open immediately. We both noted...had used rags and torn bedsheets to hang himself in his shower, we immediately removed...from the shower and placed him in the hallway lying down. I noticed he had rigor mortis, levidity (sic), and was cold to the touch. Also noticed marks around his neck and checked for pulse and breath sounds, he had no pulse and wasn't breathing. I decided to not begin CPR (Cardio Pulmonary Resuscitation) due to time that had passed by of this event happening but I did call for gloves & AED (Automatic External Defibrillator) just in case. 911 was then dialed...."

Review of a written statement completed by BHS #2, dated 3/22/11, revealed: "...At approximately 6:00 a.m. (BHS #1) called urgently for my help...We entered the bathroom and found...sitting in the shower with a torn towel wrapped around his neck and around the shower handle...We quickly went to...and called his name and shook him. We released the towel and pulled...out of the shower and into the hallway. We inspected...felt for a pulse, both radial and carotid, and looked and listened for breathing. There was no pulse and he was not breathing. We then waited for 911 responders to arrive...."

Review of a written statement completed by BHS #3, dated 3/23/11, revealed: "...Last time I saw him was at 5:00 am when I did a hall check...I was called out of the nurses station by (BHS #1) to come help after he had found him. I got there and helped (BHS #2 & BHS #1) move him into the hallway. The Police/Paramedics arrived just after...."

Review of a written statement completed by RN #5, dated 3/23/11, revealed: "...at 0500 per BHS report he was seen in his bed by staff. I was told to call 911 at 0611...I was informed that BHS staff had gone to get 0600 vitals and found that...had tied the bathroom door shut with a towel and hung himself with a sheet by the handle of the shower. EMT's arrived and FPD consumer was pronounced at 0633 am...."

The DON confirmed during interview on 4/1/11, that neither of the two RN's working during the night shift on 3/21/11, assessed the patient when the BHS's discovered him; that an RN did not supervise and evaluate the care of the patient provided by the BHS's; and that none of the staff initiated CPR per facility policy.

7. The hospital policy titled Emergency Procedures and Protocols for the PAC, #PAC NR-120, required: "...The PAC staff who have been trained in CPR may perform the following emergency procedures...Institute and maintain ventilation using airway adjuncts and/or Ambu bag to maintain adequate airway...."

During a tour of the psychiatric acute care unit (PACU) on 04/04/11, at 1405 hours, the two registered nurses (RNs) working were asked to locate an Ambu-bag. They could not locate the Ambu-bag.

The Director of Nursing (DON) was present on the unit with the Surveyor when the RN's could not locate the Ambu-bag, and she was also unable to locate the Ambu-bag.

Based on review of hospital policy/procedure, medical record, and interview, it was determined that the hospital failed to ensure that the nursing staff developed and kept current, a nursing care plan for 1 of 1 patient who committed suicide while in the hospital (Pt #1).

Findings include:

Review of the hospital policy titled American Nurses Association Psychiatric-Mental health Nursing Scope and Standards of Practice revealed: "...Planning...The Psychiatric-Mental health Registered Nurse develops a plan that prescribes strategies and alternatives to attain expected outcomes...Prioritizes elements of the plan based on the assessment of the patient's level of risk for potential harm to self or others and safety needs...."

Review of Pt #1's treatment plan revealed: "...Goal 1.1 Stable Emotional/Behavioral Functioning...By taking credit for his actions, not blaming others for his situation, and realizing that his decisions have and do affect his life, it is clear that...accepts responsibility...Problem 1 Emotional/Behavioral...Psychosocial events and other conditions in...life are causing him to have severe depression and, lately, suicidal ideations, and are identified as being in need of change...Goal 1.1 The goal is for...to achieve stable emotional and behavioral functioning through attending therapeutic groups and utilizing the coping mechanisms learned there, and by adhering to a medication regime if prescribed...Objective 1.1.1: Reduce Depression...Current objective:...will rate depression at 5 or below by 3/23/11. Next objective:...will rate depression at 3 or below by 3/25/11...Completion objective:...will report that depression has ceased or is at a manageable baseline by 3/27/11...."

The DON confirmed during interview on 4/1/11, that the patient's care plan did not address specific needs related to providing for his safety due to his suicide attempt following a recent trauma.

Based on review of hospital policy/procedure, hospital documents, personnel files, and interview, it was determined that the hospital failed to require that a registered nurse assign nursing care of each patient to other personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff as evidenced by:

1. failure to require that an RN assign nursing care of patients and that assignments are based on patients' needs; and

2. failure to require that staff assigned to provide nursing care to patients have demonstrated competence to perform their patient care responsibilities and received orientation to policies/procedures necessary to perform their patient care responsibilities.

Findings include:

1. Review of the facility policy titled Nursing Staffing Plan for Client Care revealed: "...Staffing goals are developed based on identified individual hospital needs. These six goals are to: Ensure that each client receives the nursing care required based on individual needs...The staffing schedules are reviewed and adjusted prior to the beginning of each shift...to meet defined client needs and unusual occurrences. Acuity is reviewed each shift...." Patient acuity is determined by a Client Classification System as follows: Each client is classified by either Client Type 1, 2, or 3...." The Staffing Plan includes descriptors for each Client Type. Criteria Points designated for each category of Client Type include: Type 1 = 8.5 points; Type 2 = 5.5 points; and Type 3 = 4.0 points. The number of Clients in each Client Type is multiplied by the Criteria Points and then divided by 12 (the number of hours per shift). The final number is the number of staff needed for the shift.

The DON confirmed, during an interview on 4/1/11, that the staffing/acuity plan does not include a method that establishes the types of nursing personnel required to staff the 16 bed PAC to meet the patient's needs.

RN #18, the Charge Nurse on 4/1/2011, described, during an interview on 4/1/2011, that the Unit Secretary on the day shift completes the acuity designation for each patient and records it on a document titled PAC Acuity Evaluation. The Unit Secretary explained that s/he completes this process at approximately 1200 and it is used primarily to justify the staffing for the current shift (not to determine staffing for the next shift). S/he then files the PAC Acuity Evaluation in a notebook and informs the Charge Nurse of the results. RN #18 also stated that the BHS's divide the patients and determine their own patient assignments. S/he stated that the BHS's are aware of their own skills and experience with regard to other assignments such as groups.

Review of the Assignment Sheet for the Day Shift (0700 - 1930) on 4/1/2011 revealed that, at 0845, it contained no patient assignments for the two RN's working on the unit. The Assignment Sheet contained 9 patient names, with 3 patients assigned to each BHS. RN #18, the Charge Nurse, stated during interview on 4/1/11, that s/he completes the RN's patient assignments after 1015 when the "Board Rounds" meeting is completed. He explained that the "Board Rounds" meeting includes the members of the patients' treatment team and each patient's treatment is reviewed during the meeting. The patient assignments for the RN's designate which patients the RN's chart on. Both RN's are responsible for all of the patients until the "Board Rounds" meeting is concluded.

Review of the Assignment Sheet for the night shift on 3/21/11 revealed that BHS #3 was assigned: "...Other Duties: Acuity...."

The DON confirmed, during an interview on 4/1/11, that the acuity plan has not been connected with patient assignments and that the BHS's will frequently determine their assignments.

2. Review of the Assignment Sheet for the Night Shift on 3/21/11, revealed that BHS #3 was assigned to Pt #1. Review of Pt #1's medical record revealed that BHS #3 documented 15" checks of the patient from 0045 through 0500 on 3/22/11. Review of a written statement dated 3/23/11 and signed by BHS #3, revealed that s/he assisted in moving the patient from the shower to the hallway after the patient was found hanging in the shower. BHS #3 did not initiate CPR.

Review of BHS #3's personnel file revealed that s/he completed high school, was hired on 12/6/10, and had no previous behavioral health work experience.

In addition, BHS #3's personnel file contained a document titled Job Functions, Competencies and Evaluative Criteria. This document contained a section titled General and Job-Specific Clinical Competencies which included: "...Able to recognize, prevent and respond to a situation in which a client may be a danger to self or others...." A column indicating level of competency contained the #2 which a legend defined as "...Has demonstrated competence in this area...." A column indicating the method of determining competency contained the numbers 3 & 5 which were defined as "...Visual Observation/Chart Documentation & Test (Paper and Pencil or Online)...." The document was unsigned with no indication of the identity of the individual verifying BHS #3's competency. In addition, BHS #3's personnel file did not contain documentation that s/he was oriented to the facility's policy/procedures titled Emergency Procedures and Protocols for the PAC, Medical Emergencies, Consumer Observation, or Shift Guidelines (1900-0700).

Review of Pt #1's medical record revealed that BHS #1 documented 15" checks of the Pt #1 on 3/22/11 from 0000 through 0030. Review of a written statement dated 3/22/11 at 0656 and signed by BHS #1, revealed that BHS #1 discovered Pt #1 on 3/22/11 after the patient had hung himself from the shower faucet handle. BHS #1 assisted in moving the patient from the shower to the hallway and did not initiate CPR.

Review of BHS #1's personnel file revealed that he completed high school, was hired on 3/7/11 and had no previous behavioral health work experience. His personnel file did not contain a job description. In addition, BHS #1's personnel file did not contain documentation of competency, skills, or knowledge related to a behavioral health client. His file did not contain documentation of orientation to the facility's policy/procedures titled Emergency Procedures and Protocols for the PAC, Medical Emergencies, Consumer Observation, or Shift Guidelines (1900-0700).

Review of the Assignment Sheet for night shift 3/21/11, revealed that BHS #2 was working on that shift.

Review of a written statement dated 3/22/11 and signed by BHS #2 revealed that s/he assisted BHS #1 & #3 in moving Pt #1 from the shower to the hallway after the patient was found hanging in the shower. BHS #2 did not initiate CPR. Review of BHS #2's personnel file revealed that he was hired 11/16/09, and had no previous behavioral health work experience. His personnel file contained no documentation of orientation to the facility's policy/procedures titled Emergency Procedures and Protocols for the PAC, Medical Emergencies, Consumer Observation, or Shift Guidelines (1900-0700).

The DON confirmed during interview on 4/1/11, that the personnel files of BHS #1, #2, & #3 did not contain documentation of orientation to policies/procedures necessary for the performance of their duties. S/he also confirmed that the competency statements for BHS #3 were not signed by an individual to verify the BHS's competency, and that BHS #1's personnel file contained no documentation of competency.

Based on review of hospital policies/procedures, patients' records, observation and staff interviews, it was determined the hospital failed to follow accepted standards of practice for medication administration and require that medications be administered in accordance with a physician's order for 3 of 3 patients (Patients #7, 8, and 14 ), one instance which lead to a transfer to a higher level of care (Patient # 8).

Findings include:

The hospital policy titled General Guidelines for Medication Administration (MAR) required: "...Medications are administered with written orders of the attending/ prescribing LIP (Licensed Independent Practitioner)...Medications are administered at the time they are prepared. Medications are not pre-poured...Consumers are identified before medication is administered utilizing two (2) of the four (4) patient identifiers listed: 1. Call the Consumer by name. 2. The Consumer's identification band. 3. Ask the Consumer their birthday compare to their BMIS number on the MAR. 4. If necessary, verify Consumer identification with Guidance Center personnel...Medication supplied for one Consumer is never administered to another Consumer...."

The hospital policy titled Shift Guidelines (0700-1930) required: "...RN Charge Nurse Responsibilities...Safely administer or delegate the administration of medications according to Guidance Center Policies and Procedures as delineated in the Medication Management Policies. The medication nurse is responsible to check doctor's orders, Consumer medication records and assure all prior and current orders have been correctly noted, signed and dated...."

The hospital policy titled Shift Guidelines (1900-0700) required: "...RN Charge Nurse Responsibilities...Safely administer or delegate the administration of medications according to Guidance Center Policies and Procedures as delineated in the Medication Management Policies. The medication nurse is responsible to check doctor's orders, Consumer medication records and assure all prior and current orders have been correctly noted, signed and dated...Check all physicians' orders for completeness and accuracy for prior 24 hours. Check medication administration records for the PAC, unit to insure all orders are accurately transcribed...."

On 3/31/11 @ 0850, direct observation of the medication room revealed pre-poured patient medications in souffle' medication cups. The six (6) souffle' medication cups were marked with the patients' first names and contained loose pills in each cup. RN # 9 stated during an interview conducted on 03/31/11, that s/he had pre-poured the medications after change of shift report at approximately 7:30 am.

Direct observation of medication administration on 3/31/11 @ 0900, revealed that RN #9 started to administer medication to Pt #14 from the pre-poured medication cups. Pt #7's name was written on the cup that RN #9 was giving to Pt #14. As RN #9 verbally listed the names of the medications to Pt #14, Pt #14 corrected RN #9, stating that s/he did not take the medication that the RN had named. RN #9 then changed the souffle cups and handed Pt #14 the cup with his name on it, containing the correct medication.

Review of Pt #7's medical record revealed that it contained the following physician's medication orders:

3/28/11: "...Morphine Sulfate continuous (MS Contin) 30 mg PO Q 8 HRS (by mouth every 8 hours) for pain/back/leg...." 3/29/11: "...change timing of scheduled MS Contin to TID (three times a day)...." 3/29/11: "...may receive prn Morphine IR (Immediate Release) at the same time as scheduled extended release...." 3/31/11: "...MS Contin (IR) 15 mg PO may have with scheduled MS Contin TID 30 mg PO...."

Direct observation of medication administration on 3/31/11, revealed that RN #9 administered 2 tablets of Morphine Sulfate (IR) 15 mg to Pt #7 @0850. RN #9 had pre-poured these tablets in the souffle' cup prior to patient # 7 coming to the medication window. RN #9 documented on Pt #7's medical record administration of MS Contin 30 mg @ 0800 on 3/31/11.

Nurse # 9 confirmed during an interview conducted on 03/31/11, that s/he administered 15 mg IR tablets to Pt #7, stating that the 30mg MS Contin tablets were not available from the pharmacy.

Direct observation of medication administration on 3/31/11, at 1230, revealed that Nurse # 9 administered 3 tabs of Morphine Sulfate 15 mg IR to patient #7. RN #9 documented on patient #7's medical record administration of MS Contin 30 mg @ 1300 on 3/31/11 and Ms Contin (IR) 15 mg PO TID with scheduled Morphine @ 1225 on 3/31/11.

Nurse # 9 confirmed during an interview conducted on 03/31/11, that s/he administered three 15 mg IR tablets, stating that the 30mg MS Contin tablets were not available from the pharmacy.

Physician Assistant #6, documented in Pt #7's medical record at 8:00 PM on 3/31/11: "...MAR reviewed with (patient) and medications, dosages, and times clarified. (Patient) does appear somewhat sedated today...."

The Clinical Pharmacist confirmed during an interview conducted on 4/5/11 @ 330pm that MS Contin (CR) and Morphine Sulfate (IR) are two different medications. One is controlled release and one is Immediate Release.

The Director of Nursing confirmed during an interview conducted on 4/6/11 @0900, that RN #9 did not follow the physician's order.

Review of Pt #8's medical record revealed that it contained the following physician's orders:

12/18/10 @1230: "...Ativan (lorazepam) 2 mg PO q 4-6 hours PRN agitation, Haldol 5 mg PO q 4-6 hours PRN agitation..." 12/18/10 @ 1530: "... Haldol 5 mg PO, Ativan (lorazepam) 2 mg PO + Cogentin 2 mg PO X 1 now...." 12/18/10 @ 1615: "...Haldol 5 mg PO, Ativan (lorazepam) 2 mg Po + Cogentin 2 mg PO X 1 now...." 12/18/10 @ 1800: "...O2 3L hold until 90% is maintained then 2 liters of 02. Vitals q 1 hr until stable...." 12/18/10 @ 2205: "...Send to ED due to unstable VS...."

The Medication Administration Record (MAR) for Patient # 8 contained the following entries with time of administration:
"...Haldol 5 mg PO, Ativan 2 mg PO, Cogentin 2 mg PO X 1 now @1420...
Haldol 5 mg PO, Ativan 2 mg PO @1530...
Haldol 5 mg PO, Ativan 2 mg PO, Cogentin 2 mg PO X 1 now @ 1550...
Haldol 5 mg PO, Ativan 2 mg PO,Cogentin 2 mg PO @1615...."

The medical record did not contain a physician's order for the Haldol, Ativan, and Cogentin listed above on the MAR as a "X 1" order when administered at 1420.

Review of Nursing Progress Notes for Patient # 8 by RN #17 revealed: "... He became irritable and belligerent after lunch, c/o screaming repeatively (sic) and yanking on doors. Able to sit in chair with constant supervision and redirection from several staff but would not stop screaming repeatively (sic). Given PRN medication which was eventually effective after about 1.5 hours and he fell asleep. Vitals were taken and O (sic) @ at 80% so 3L 02 started via nasal cannuli (sic) with vital checks q hour. Resting in room snooring (sic)...."

Review of Nursing Progress Notes for Patient # 8 by RN #16 revealed: "...After shift change his BP were 66/40. Legs were elevated and rechecked pressure was 92/74 with manual cuff. O2 ranged between 85-95%. Apneic breathing. Was transitioned to 02mask at 5L. Maintained >90%. He removed the mask himself and 02 sats dropped to 71%. Reverted to cannula after several unsuccessful attempts to leave mask in place. Would occasionally mumble, open eyes briefly or take his mask off but otherwise was unresponsive. At 2130 B/p was 90/52 and 91/56 and at 2215 was 94/64. Tachycardic throughout this time, ranging between 101-125. Physician consulted multiple times. Received order to send to ED (Emergency Department) at 2205. 911 called. Physician stated he gave report to ED physician and charge RN. Paramedics arrived at 2220 and transported him to ED. Med sheets given to paramedic...."

The Clinical Pharmacist confirmed during an interview conducted on 4/5/11 @ 3:25pm, that the nursing staff did not have a corresponding physician's order for the "...Haldol 5 mg PO, Ativan 2 mg PO, Cogentin 2 mg PO X 1 now given @1420...."

The Director of Nursing confirmed during an interview conducted on 4/5/11 @ 2:55pm, that the nursing staff administered medication without an order. S/he also confirmed that medications were reviewed at the time of review of the incident (since the patient was transferred to a higher level of care) but nothing was documented.