HospitalInspections.org

Based on review of hospital policies/procedures, Governing Body Rules and Regulations, medical records, documents, meeting minutes, and interviews, it was determined the hospital failed to comply with the provisions of the Governing Body, that require accountability for the quality of care, as demonstrated by:

A0115 Patient Rights: failure to require complaint/grievance investigations included corrective action(s) and monitoring, and failure to provide complainants accurate contact information for the state health department (A0118); failure to maintain patients free from restraints imposed as a means of discipline or staff convenience (A0154); failure to require complete physicians' restraint orders (A0168); failure to require physician orientation for hospital policies/procedures regarding restraints/seclusion (A0176); failure to document face-to-face medical and behavioral evaluations within 1 hour after restrains were initiated (A0184).

A0263 Quality Assurance and Performance Improvement (QAPI): failure to require adverse occurrences and unanticipated outcome events, were identified and analyzed to ensure corrective action(s) were implemented and monitored for effectiveness; failure to identify and address incomplete physicians' medication orders; failure to require follow up interventions for issues identified in root case analysis (RCA)s (A0265); failure to demonstrate what or how information is processed to identify performance improvement opportunities related to Occurrence reports; failure to demonstrate that restraint trending reports were accurate and determine performance measures based on the results; failure to demonstrate complaint/grievance reports identified performance improvement activities (A0267); failure to analyze adverse patient events.

A0313 Executive Responsibilities: failure to identify priorities for improved patient safety, and address, and monitor process improvements for effectiveness; failure of the Pharmacy and Therapeutics committee, as part of the Quality program, to identify and address incomplete physicians' medication orders; failure to identify that physicians did not maintain documentation of restraint orientation; failure to verify that Directors and Administration addressed complaints/grievances with appropriate responses; failure to require RCAs identified process improvement opportunities; failure to investigate and process Occurrence reports to identify process improvement opportunities.

A0338 Medical Staff: failure to formulate specific rules and regulations for the Departments of Surgery and Medicine; failure to require complete physicians' medication orders; failure to formulate department specific rules and regulations, and document complete medication orders; failure to formulate specific rules and regulations for the Departments of Surgery and Medicine; failure to document complete medication orders.

A0385 Nursing Services: failure to require patients' medications were administered according to complete physicians' orders; failure to require complete and accurate medical record documentation for all care provided; failure to require complete physicians', prior to administering medications.

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

Based on review of hospital policies/procedures, medical records, documents, and interviews, it was determined that the hospital failed to comply with the Provisions of Patient Rights, that require complete documentation of complaints/grievances investigations including follow up actions, require complete physicians' orders for restraints, and require physician orientation regarding patient restraints, as demonstrated by:

A0118: failure to require complete documentation of complaints/grievances investigations and follow up actions; failure to provide patients the correct contact information for filing grievances with the state health department;

A0154: failure to maintain the patient free from restraints imposed as a means of discipline or staff convenience, for 1 of 6 restrained patients;

A0168: failure to require complete physicians' orders for 5 of 6 restrained patients;

A0176: failure to require physician orientation for hospital policies/procedures regarding restraints/seclusion; and

A0184: failure to document face-to-face medical and behavioral evaluations within 1 hour after restraints were initiated, for 5 of 5 patients.

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

Based on review of hospital policies/procedures, documents, medical records, and interviews, it was determined that the hospital failed to comply with the provisions of Quality Assurance Performance Improvement (QAPI) to identify and address processes that improve health outcomes, as demonstrated by:

A0265: failure to monitor patient restraints, fully investigate and document occurrence reports; failure to require nursing administered medications according to complete physicians' orders;

A0267: failure to require adverse events reports were analyzed to identify performance improvement opportunities; and

A0313: failure to identify and address priorities to improve patient safety; and failure to require process improvements were evaluated for effectiveness.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Quality Assurance Performance Improvement.

Based on review of Medical Staff Bylaws, Rules and Regulations, medical records, and interviews, it was determined the hospital failed to comply with the provisions of the Medical Staff, as demonstrated by:

A0353: failure to formulate specific rules and regulations for the Departments of Surgery and Medicine; and failure to document complete medication orders.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for the Medical Staff.

Based on review of hospital policies/procedures, documents, medical records, and interviews, it was determined that the hospital failed to comply with the provisions of Nursing Services for documenting restraints and medication administration per complete physicians' orders, as demonstrated by:

A0404: failure to require complete physicians' orders before administering patients' medications.

The cumulative effect of this systemic deficient practice resulted in the hospital's failure to meet the requirements for the Condition of Participation for Nursing Services.

Based on review of hospital policies/procedures, complaint/grievance documents, and interviews, it was determined that the hospital failed to document their grievance process for 6 of 6 patient complaints/grievances, and failed to require all patients/complainants were provided accurate state health department contact information for filing grievances, as demonstrated by:

1. failure to require complete documentation verifying complete investigations for 6 of 6 closed complaints/grievances: (Patients #13, 14, 20, 21, 22, 23);

2. failure to the provide patients/public accurate contact information for the state health department in the event the hospital did not or could not resolve a dispute; and

3. failure to periodically present complaint/grievance data to the Governing Body.

Findings include:

1. The policy titled Patient Complaints and Grievances #PCS.098 (approved 04/10) requires: "...Patient complaints are processed as grievances under the following circumstances...Verbal complaints that cannot be resolved by staff present, or are postponed for later resolution, or are referred to staff for later resolution, investigation, or further action...Written complaints about patient care (includes e-mails and faxes)...Patients (including patient families...)...Quality Risk Manager...will generate a written response to a grievance...The complaint, interventions and follow up correspondence to the complainant will be documented in the Midas (computer) system...Risk Manager will...investigate and preserve for reference and use the information obtained from medical records review, interviews and other applicable potential evidentially data...."

The Annual Review of Performance Improvement Activities and Reports dated 12/01/10, indicated, "...55 patients...presented complaints and grievances with 105 issues. Each...addressed by appropriate response...Complaints and grievances...addressed by...Directors and administration...."

The DQM provided closed complaint/grievance investigations including all related documentation, on 12/02/10 at 0950, as follows:

Patient #13: complainant's letter, dated 09/17/10, regarding multiple allegations referencing the 07/10 inpatient admission. The VP of Clinical Services confirmed during an interview conducted on 12/02/10 at 1100, that s/he spoke directly with the complainant, however did not document the discussion or any follow up activity.

Patient #14: the VP of Clinical Services confirmed during an interview conducted on 12/02/10 at 1100, that s/he spoke directly with the complainant (telephone complaint), and that the ED Medical Director and the Director of Radiology also spoke with the complainant, however did not document the discussions and follow up activity.

Patient #20: complainant's letter dated 09/10, referenced allegations related to nursing and physician services, during an ED visit on 04/08. Documentation did not verify what information was obtained from the medical record, and/or interviews conducted.

Patient #21: complainant's letter dated 09/10, referenced outpatient services on 07/10. Documentation did not verify what information was obtained from the medical record, and/or interviews conducted.

Patient #22: complainant's letter was not dated, but referenced ED nursing services. Documentation did not verify what information was obtained from the medical record, and/or interviews conducted.

Patient #23: complainant's letter dated 04/10, referenced physician issues related to the 01/10 hospitalization. Documentation did not confirm what information was obtained from the medical record, and/or interviews conducted.

The CEO, VP of Quality, VP of Clinical Services, and the DQM, confirmed during interviews conducted on 12/02/10 at 1615, that complaint/grievance investigations were incompletely documented, and did not demonstrate how the investigations were conducted to determine what processes were considered for corrective action, monitoring performed, and what if any follow up processes were determined and implemented.

2. The policy titled Patient Complaints and Grievances #PCS.098 (approved 04/10) requires: "...All patients are advised of the telephone number for the Department of Health Hotline should they prefer to utilize that mechanism for problem resolution...."

The Patient Admission Packet, provided for review on 11/20/10, contained the "Nondiscrimination Policy," related to civil rights and disabilities. The policy references the Department of Health Services general phone number, however, the Department does not review civil rights and disability complaints. Complaints of this nature are referred to the Attorney General's Office. In addition, there is no "hotline."

The hospital does not provide the correct Department of Health Services Office of Medical Facilities Licensing contact information, for reporting complaints/grievances related to hospital practices.

3. The policy titled Patient Complaints and Grievances #PCS.098 (approved 04/10) requires: "...Executive team...periodically reports trends to the Governing Body...Risk Management will collect, maintain and distribute appropriate statistical data to...Medical Staff and Hospital departments and committees, as well as the Governing Body...." The policy did not define "periodically."

Governing Body meeting minutes for the past 12 months (the hospital was initially Medicare certified 10/09), reviewed on 11/30/10, revealed no complaint/grievance related discussions. The DQM and the VP of Clinical Services provided the Annual Review of Performance Improvement Activities and Reports on 12/01/10, and stated that the report was scheduled for presentation to the Governing Body meeting scheduled that evening (12/01/10). The hospital did not provide the Governing Body complaint/grievance related data, prior to the Complaint Validation survey initiated on 11/29/10.

Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to maintain 1 of 1 patient, free of restraints imposed as a means of discipline or staff convenience (Patient #6).

Findings include:

The policy titled Restraint and Seclusion (approved 09/09) requires: "...Restraint:...any...method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to freely move...arms, legs, body or head...."

Patient #6, presented to the ED on 10/27/10, at 2040. ED RN #1 documented the patient was "alert but uncooperative...resistant to go home," disrobed, urinated on the floor, and "refused to get dressed...refused to leave the room." The police reported that the patient was unresponsive and "tied in a wheelchair" when officers arrived at the ED on 10/28/10, to assume custody for an unrelated warrant.

The DQM stated during an interview conducted on 11/29/10: "...the patient was not in restraints...the sheet around the patient tied to the wheelchair was not a restraint - it was to keep the patient from falling (out of the wheelchair...(RN #1) used the sheet because the patient was sliding out of the wheelchair...the patient had the capacity and capability of making decisions...."

ED Charge RN #4 stated during an interview conducted on 12/02/10 at 0707: "...the patient always seemed appropriate...there was a sheet around the chest because (s/he) was intentionally arching and not staying in the chair...it wasn't a restraint because it wasn't tied...."

Nursing failed to document, in the medical record, that the patient was restrained in the wheelchair. In addition, there was no physician order, nor documentation that the patient was advised of the restraint. The hospital failed to identify that the sheet restraining the patient in the wheelchair, was applied for the staffs' convenience, to control/confine the patient.

Based on review of hospital policies/procedures, medical records, and interviews, it was determined that the hospital failed to require complete physicians' orders for 5 of 6 patients in restraints (Patients #5, 6, 7, 8 and 9).

Findings include:

The policy titled Restraint Policy (approved 09/09) requires: "...A Licensed Independent Practitioner (LIP) order is required prior to or immediately following the application of all restraints...order must include:..date and time the order was received...type of restraint...reason...duration...."

Patient #5, presented to the ED on 10/01/10 at 0325, with vomiting x 2 weeks. The physician ordered, "Soft restraints x 4 for pt. (patient) safety." The order did not include the type of restraint, reason, or duration.

Patient #6, presented to the ED on 10/27/10 at 2040, with abdominal pain. The police reported that when officers arrived at the ED to take custody of the patient, s/he was unresponsive and "tied" in a wheelchair. RN #4 stated that the patient was in the wheelchair from approximately 0200 to 0230. ED Physician #2 confirmed during the record review and interview conducted on 12/01/10 at 0708, no restraint orders, and that s/he was unaware the patient was restrained.

Patient #7, presented to the ED on 05/25/10 at 1020, combative and agitated, with diagnosed drug overdose. The physician ordered, "restraints - soft." The order did not include what type of restraints, reason, or timeframes.

Patient #8, presented to the ED on 09/27/10 at 2108, with diagnosed alcohol intoxication. The physician ordered, "soft wrist restraints x 24 (hours) med/surg (medical/surgical)." The order did not include the reason.

The policy titled Care of Patients on Correctional/Legal Restraints #PCS.026, requires: "...all patients under legal/correctional restrictions...be guarded at all times by the custodial agency...."

Patient #9, was handcuffed when escorted by sheriff's deputies to the ED on 05/30/10 at 2320, for "attempted suicide by cop." The physician ordered "handcuffs" at 2330. The officers left the ED at 0015, leaving one of the patient's wrists handcuffed to the gurney. The order did not include the reason, duration, and did not clarify if 1 or 2 wrists were to be restrained. In addition, the hospital does not employ handcuffs, and the patient was not guarded while under legal/correctional restrictions.

The DQM and VP of Clinical Services confirmed the incomplete orders during interviews conducted on 12/01/10.

Based on review of hospital policies/procedures, physicians' credential files, and interviews, it was determined that 6 of 6 physicians did not have documentation verifying restraint orientation (Physicians #1, 2, 3, 4, 5, and 6).

Findings include:

The policy titled Restraint and Seclusion (approved 09/09) requires: "...physicians...must have a working knowledge of hospital policy regarding restraint...will receive orientation on the Restraint Policy and Procedure...and annually thereafter...."
The DQM provided the "Physician Orientation Checklist," on 11/30/10 at 0800, that included: Admission Orders, Charting Requirements, Physician Communication, Blood and Radiology Readings, Pain Management, Policy Review, and Medical Screening Evaluation. The checklist did not include restraint orientation.
Six of 6 physicians' credential files contained no documentation of restraint orientation: Physicians #1, 2, 3, 4, 5, and 6. The Medical Staff Services Director confirmed during an interview conducted on 11/29/10 at 1400, that the physicians' orientation packet does not include restraints.

Based on review of hospital policies/procedures, medical records, and interviews, it was determined the hospital failed to require face-to-face medical and behavioral evaluations within 1 hour of initiation, in order to evaluate the patients' condition and response to restraints, for patients 3 of 5 patients restrained for violent or self-destructive behavior (Patients #5, 8, and 9).

Findings include:

The policy titled Restraint Policy (approved 09/29/09) requires: "...Violent or Self Destructive Behavior: Patient is aggressive, combative and has the potential to harm self, other patients or staff...Within 1 hour of application of restraint, a physician, a licensed independent practitioner, physician's assistant or qualified RN...must perform a face-to-face evaluation of the patient and the need for restraint...must be documented in the patient's medical record...must include:...patient's immediate situation--behavior...reaction to restraint...medical and behavioral condition...need to continue or terminate the restraint...."

Patient #5, presented to the ED on 10/01/10, with vomiting x 2 weeks and diagnosed alcohol withdrawal. Nursing documented, "...agitated...confused...visual and auditory hallucinations...." The Restraints Used For Violent or Self-Destructive Behavior form in the medical record included the physician's order at 0545, "...soft restraints x 4...." Nursing initiated restraints at 0620, and discontinued them at 1930. The Medical Surgical Restraint Flow Sheet in the medical record indicated the patient was assessed every 1 - 3 hours. There was no documentation of a face-to-face evaluation conducted within 1 hour of restraint initiation.

Patient #8, presented to the ED on 09/26/10 at 2108. The RN documented, "confused...uncooperative...agitated...combative...kicking...." The patient was placed in soft Medical/Surgical restraints, per physician's order at 2120.

Patient #9, presented to the ED on 05/30/10 at 2326, with suicidal ideation and agitation. The ED physician documented an evaluation, noted that the patient arrived in handcuffs with police, and ordered handcuffs and chemical restraints for violent self-destructive behavior, at 2330. The physician documented at midnight, "...sleeping...1230: denies SI, HI (homicidal ideation)..." and indicated that the patient was medically cleared for psychiatric intervention.

RN #14 confirmed during the record review and interview conducted on 12/01/10 at 0900, that documentation did not confirm the restraint was placed for violent behavior, a face-to-face evaluation was conducted 1 hour after restraints were initiated.

Nursing documented that the police restrained the patient with handcuffs to the gurney, at 2330, and administering the following medications: Geodon 20 mg IM at 2330, and Valium 2 mg IM at 2335 and 2350. ED CN and VP of Clinical Services confirmed during interviews conducted on 12/01/10 at 1000, that the hospital "never" uses handcuffs as a restraint, unless the officer applying the handcuffs remains with the patient.

The VP of Clinical Services confirmed during an interview on 11/31/10 at 1030, that the physicians failed to perform and document the 1 hour face-to-face evaluation for patients restrained for violent self-destructive behavior.

Based on review of Medical Staff Bylaws Rules Regulations, medical records, and interviews, it was determined that the Medical Staff failed to formulate department specific rules and regulations, and document complete medication orders, as demonstrated by:

1. failure to formulate specific rules and regulations for the Departments of Surgery and Medicine; and

2. failure to document complete medication orders in 6 of 19 medical records (Patients #1, 2, 3, 5, 8, and 12).

Findings include:

1. The Bylaws of the Medical Staff Article V Section 5.1 Organization of Department requires: "...There shall be two Departments: the Department of Medicine and the Department of Surgery...Each Department shall formulate such rules, regulations, procedures and policies as are necessary to fulfill the functions and responsibilities of the Department and Department Chief...."

The VP of Quality confirmed during an interview conducted on 12/02/10 at 1300, that the Departments of Medicine and Surgery have not formulated any specific rules or regulations.

2. The Rules and Regulations of the Medical Staff require: "...A medication or biological administered to the patient including; the name, strength, dosage, amount, and route of administration...."

The VP of Clinical Services and the Intensive Care Unit (ICU) Director RN #18, stated during interviews conducted on 12/2/10 at 1415, that the hospital had no written protocols or order sets addressing titratable medications, and stated, "...physicians do not need to document a start dose or dosing parameters...."

Physicians' medication orders were incomplete, did not identify the starting dose, loading dose, initial rate, titration rate with time interval, maximum dose, reason or goal, and "banana bag" orders did not identify the ingredients, as follows:

Patient #1:
08/27/10 (1750) "Start Levophed gtt (drip) if SBP (systolic blood pressure) (less than) 80...titrate to keep SBP (greater than) 100."

Patient #2:
09/10/10 (1930) "Vasopressin to keep SBP greater than 100...Versed drip (and) Fentanyl drip for sedation"
09/10/10 (0200) "Start Neosynephrine gtt keep SBP greater than 100"
09/10/10 (1500) "Dopamine 5 mcg/min IV (intravenous) titrate to SBP greater than 90...Versed 5 mg/ml gtt IV titrate to RH (sedation scale) 2 - 3...Fentanyl 100 mcg IV gtt titrate to RH 2 - 3...Levophed 8 mcg/min IV titrate to SBP greater than 90"

Patient #3:
09/27/10 (untimed) "Epinephrine IV 5 mcg/min. titrate syt (systolic) BP greater than 100"
09/29/10 (0954) "Dopamine drip - titrate for BP (increase)"

Patient #5:
10/01/10 (0330) "Banana bag over 1 (hour)...Ativan 2 mg IVP (intravenous push) may titrate for ETOH (alcohol) withdrawal symptoms"
10/01/10 (0535) "Ativan 4 mg IV Q (every) 15 min until vitals stable"
10/01/10 (0615) "Ativan 6 mg IVP Q 15 minutes until shaking/confusions ceases"
10/01/10 (0745) "(increase) Ativan to 8 mg/IVP Q 15 minutes until mania resolves"

Patient #8:
09/27/10 (2120) "Banana bag over 1 (hour)"

Patient #12:
11/27/10 (0810) "IV Dopamine 2 - 4 mic (micrograms). Don't titrate"

The VP of Clinical Services and the ICU Director RN #19, subsequently confirmed during the medical records reviews and interviews conducted on 12/01/10 and 12/02/10, that the orders were incomplete.

Based on review of hospital policies/procedures, personnel files, and interviews, it was determined the hospital failed to require that 4 of 4 ED RNs maintained documentation of orientation and/or competencies, specific to emergency services (RNs #1, 2, 4, and 11).

Findings include:

The hospital policy titled General Orientation (approved 07/20/09) requires: "...Each new employee shall be given an orientation to the department/area for which they are hired...During...orientation...Department Director will review and document specific competencies required...."

The hospital policy titled Staffing by Acuity System #PCS.000, requires: "...Agency personnel must complete the Department Orientation Skills Checklist in a timely manner...."

RN #1's personnel file revealed s/he was hired through a temporary (temp) placement agency on 07/22/10. The file contained a self-assessment of competencies completed for the temp agency. There was no resume or other confirmation of work history, and no documentation of ED orientation or competencies, specific to Hualapia Mountain Medical Center.

RNs #2, 4, and 11's, personnel files contained no documentation of ED competencies.

The Director of Human Resources confirmed the personnel files did not verify ED competencies, during an interview conducted on 12/01/10.

Based on review of hospital policies/procedures, medical records, documents, and interviews, it was determined that the hospital's QAPI program failed to identify and monitor restraints, investigate occurrence and grievance reports, ensure nursing administered medications according to complete physicians' orders, ensure staff competency, and failed to address issues identified in RCAs to include measurable improvements that impact health outcomes, as demonstrated by:

1. failure to identify and monitor patient restraints;

2. failure to require documentation that demonstrates the steps taken to investigate occurrence reports, suggest/require corrective actions, perform monitoring, and ensure follow up, for 5 of 5 reports (Patients #3, 15, 16, 18, and 19);

3. failure to require nursing administered medications according to complete physicians' orders; and

4. failure to require follow up interventions for issues identified in 3 of 3 RCAs.

Findings include:

1. Refer to A0154, A0168, and A0184.

2. The policy titled Occurrence Reporting Policy #PCS.00 (approved 07/09) requires: "...collecting information for unexpected events or circumstances not consistent with the routine operations of the hospital...filling out the form completely...Occurrence Report...immediately sent to...Team Leader or Resource Nurse for review and follow up...forwarded...Risk Manager...If...submitted via RDE (intranet computer system)...report will go directly to the Risk Manager who will assign to the appropriate Team Leader/Director...Risk Manager to compile an Occurrence Report...."

Patient #3, was admitted on 11/03/10, with diagnosed hyperglycemia, according to the medical record. The Risk Management Worksheet dated 11/04/10, indicated that Insulin Lantus ordered at bedtime, was given in the morning in error. The worksheet indicated: "...Response: A medication error was reported to pharmacy. Patient was monitored for any adverse reaction due to wrong timing of medication administration. New Grad (graduate) staff was given a short education by...preceptor about the 5 Rs (rights) of medication administration...Outcome: no adverse outcome requiring T (treatment)...Status: closed." There was no documentation to determine how the error was investigated.

Patient #15, presented to the ED on 10/27/10 with chest pain, according to documentation. The Risk Management worksheet revealed: "...Outcomes: not defined...Status: closed...Comments:...signed out AMA (against medical advice)...." There was no documentation to verify an investigation was conducted to determine why the patient left, or if remedial action was necessary to discourage future occurrences.

Patient #16's medical record indicated that the patient was admitted on 09/21/10, with reported chest pain. The Risk Management Worksheet dated 09/22/10, revealed that the physician's order for venous doppler studies was not performed because "radiology too busy." The worksheet indicated that an unidentified personnel was "working with the Director of Imaging and the Medical Director of Imaging" to explore alternatives to improve the process, such as, "...If it is a STAT order, the nurse and/or charge nurse will follow up if results are not received in a timely manner...Outcome: follow up...." There was no documentation to confirm what caused the delay, what follow up or remedial action was identified, no documentation of "follow up."

Patient #18, was admitted on 11/16/10, with an urinary tract infection and discharged 11/23/10, according to the medical record. The Risk Management Worksheet dated 11/18/10, revealed: "...on floor...helped up and back to bed...RN assessed...called...MD...Pt. has small open area on back of...head with some bleeding. MD aware. Will watch and monitor...moved closer to nurses station...." The worksheet indicated, "...Outcome: unknown at this time...Status: closed...." Documentation did not identify the steps taken to investigate the incident to include why the incident occurred, and what follow up action was determined regarding the patient's injuries.

Patient #19's medical record indicated that the patient presented to the ED on 11/28/10 at 1733, with chest pain and cough. The patient was triaged at 1733, seen by the physician at 1750, and eloped at 1815. The Risk Management Worksheet dated 11/28/10, revealed: "...Complaint: chest pain...Type: Behavior related...Outcomes: no known adverse outcome...Comments:...left...prior to medication or receiving Rx's (prescriptions) or instructions...Multiple attempts to contact pt...but unable to leave message...." Documentation did not identify the personnel initiating and signing off the report, nor if the incident was reviewed, and who reviewed it. There was no documentation to confirm the event was investigated, and what corrective actions, if any, were taken.

3. The QAPI process did not identify and address nurses administering patient medications with incomplete physician orders: Refer to A0404

4. The policy titled Sentinel Event #PCS (approved 09/09) requires: "...event that has resulted in an unanticipated death...not related to the natural course of the...illness or underlying condition...(the hospital) will identify and respond...thorough and credible root case analysis (RCA), implementation of improvements to reduce risk, and monitoring of the effectiveness of those improvements...The PI/RM (Performance Improvement/Risk Management) Coordinator...is responsible...events will be investigated using a...root cause analysis method..Action Plan will be developed...will identify...strategies...to reduce the risk of similar events occurring in the future...plan will address responsibility for implementation, oversight, pilot testing...time lines, and strategies for measuring the effectiveness of the actions...."

The "Framework for a Root Cause Analysis and Action Plan" form requires: "...For each of the findings identified in the analysis as needing an action, indicate the planned action expected, implementation date and associated measure of effectiveness...Identify where the improvements will be implemented...."

Three of 3 RCAs identified Risk Reduction Strategies (action items) and Measure of Effectiveness (MOE) comments, as follows:

RCA #2: unsterilized endoscope (09/10):

Action Item #1: "Observe the process"
MOE: "based on the new design"
Action Item #2: "Counsel employee"
MOE: "monitor performance"

RCA #3: moderate sedation: elderly (03/10):

Action Item #1: "Revise sedation policy"
MOE: "question staff on policy location, information...10 cases/month"
Action Item #2: :Develop department orientation and physician orientation manuals with key policies"
MOE: "N/A" (not applicable).
Action Item #3: "Employees...need to pass a moderate sedation competency"
MOE: "Audit employee competency - 100% of employees and 100% compliance"
Action Item #4: "Chain of command...included in Emergency physician orientation"
MOE: "ED Medical Director will instruct 100% of the ED physicians and maintain a record"
Action Item #5: "Discuss...whether all ED physicians should have moderate sedation privileges"
MOE: "...will monitor the credentialing/privileging files for 100% compliance"
Action #6: "Investigate if ED cardiac monitors can print vital signs"
MOE: "N/A"
Action #7: "Present...to Medical Executive Committee (MEC)"
MOE: "N/A"

RCA#4: medication overdose (12/09):

Action Item #1: "Re-education and policy development...making the physical environment safe"
MOE: nothing listed
Action Item #2: "Develop de-escalation program and train staff"
MOE: nothing listed
Action Item #3: "Investigate, develop and educate security staff on a 1:1 monitor program"
MOE: nothing documented
Action Item #4: "Use property list...when personal possessions are removed"
MOE: nothing listed
Action Item #5: "...get call bell adapters"
MOE: nothing listed
Action Item #6: "...documentation class"
MOE: nothing listed

Three (3) of 3 RCAs were not dated, or signed, action items did not include the action expected, dates and associated MOEs were not documented, no documentation to identify where improvements would be implemented, no documentation to conclude proposed or implemented improvements reduced risks, and no documented monitoring for effectiveness. The Action Plan(s) did not identify strategies to reduce the risk of similar events re-occurring, and who was responsible for implementation, over-sight, pilot testing, and time lines.

The VP of Clinical Services confirmed during an interview conducted on 12/01/10, that the RCAs lacked documentation required by policy.

Based on review of hospital policies/procedures, documents, and interviews, it was determined that the hospital failed to require adverse event and trending reports were analyzed, processed, and performance improvement activities were identified, as demonstrated by:

1. the hospital did not demonstrate how Occurrence reports were processed to identify performance improvement opportunities;

2. the hospital did not confirm that Encounter Focus trending reports (for restraints) verified the collected information, or identify what performance improvement measures were determined; and

3. the hospital did not confirm that Complaint/Grievance reports were processed to identify performance improvement opportunities.

Findings include:

The DQM provided the following data reports, during interviews conducted 11/20/10 through 12/01/10:

1. The policy titled Occurrence Reporting Policy #PCS.00 (approved 07/09) requires: "...Risk Manager to compile an Occurrence Report...If an incident has occurred that may have caused patient harm...."

The policy titled Sentinel Event #PCS (approved 09/09) requires: "...identification, reporting, analysis, and prevention of sentinel events...response includes implementation of improvements to reduce risk... monitoring...effectiveness of those improvements...Action Plan will...identify...strategies...to reduce the risk of similar events occurring in the future...will address responsibility for implementation, oversight, pilot testing...time lines...measuring the effectiveness...."

The Occurrence Report trending data for closed investigations dated 09/10, 10/10, and 11/10, revealed 11 indicators and 105 outcomes, as follows:

No adverse outcome requiring treatment: 15
No known adverse outcome: 38
No known injury: 6
"Other:" 10
Unknown at this time: 10
"Not defined:" 6
None, no adverse effect: 10
Skin breakdown: 1
"Follow up:" 5
Abrasions: 1
No outcome indicated: 3

There was no documentation provided for review, to confirm what or how the findings were processed, to identify performance improvement opportunities.

2. Encounter Focus Summary for Restraints report, dated 10/15/09 through 10/31/10, indicated 13 records for patients in restraints were audited for the following required documentation:

Shift
Staff member name
Category: non-violent/violent self-destructive
Reason
Ordering Caregiver
Ordering Provider name
MD notified timely
Face-to-face patient evaluation conducted
Attending physician notified
Order renewed timely
Criteria to end restraints
Type of restraint
Description of restraint
Individuals sustaining injury
Staff sustaining injury
Clinical justification
Alternatives
Physical assessment
Care Plan modified
Family notified
Flow sheet initiated
Pt. expired in restraints in past 24 hours

There was no documentation provided for review, to confirm what or how the findings were verified/validated, processed, to identify performance improvement opportunities.

3. Patient Relations (complaint/grievance) reports dated 10/09 through 10/10, indicated a total of 111 allegations for the following 13 categories:

Accommodations
Billing
Departmental
Environment
Food/Dietary
Human Relations
Nursing
Patient
Physician
Quality of Care
Staff
Timeliness
Regulatory

There was no documentation provided for review, to indicate what performance improvement activities were identified and implemented.

The VP of Quality confirmed during an interview conducted on 12/02/10, that the Quality Assessment data did not confirm the processes identified, and performance measures implemented.

Based on review of hospital policies/procedures, QAPI documents, and interviews, it was determined that the QAPI program failed to identify priorities for improved patient safety, and address, and monitor process improvements for effectiveness, as demonstrated by:

1. failure of the Pharmacy and Therapeutics committee, as part of the Quality program, to identify and address incomplete physicians' medication orders;

2. failure to identify that physicians did not maintain documentation of restraint orientation;

3. failure to verify that Directors and Administration addressed complaints/grievances with appropriate responses;

4. failure to require RCAs identified process improvement opportunities; and

5. failure to investigate and process Occurrence reports to identify process improvement opportunities.

Findings include:

The Quality Management Plan 2010 requires: "...Organizational Leadership...Leaders are able to describe how data are used to create...quality and patient safety...Priorities are established...Intensified assessment is initiated when statistical analysis identifies significant and undesirable variations in performance with sentinel events, patterns and/or trends...Key responsibilities of the Governing Board include:...Recommending strategic direction and assessing, prioritizing and operationalizing the performance improvement/risk/safety activities...Key Responsibilities of Administration include:...identification and analysis of the Sentinel Event...and other events that require intense analysis...."

Refer to A0118, A0176, A0265, and A0404.

Based on review of Medical Staff Rules and Regulations, medical records, and interviews, it was determined the nursing staff failed to require complete physicians' orders for 6 of 19 patients, prior to administering medications (Patients #1, 2, 3, 5, 8 and 12).

Findings include:

The VP of Clinical Services and ICU Director RN #19, reviewed the medical records and confirmed during interviews conducted on 12/2/10 at 1415, that the hospital had no written protocols or order sets addressing titratable medications, and stated: "...it's not in writing...physicians do not need to document a start dose or dosing parameters...ICU nurses are expected to know how to titrate medications by virtue of their training...."

The Rules and Regulations of the Medical Staff require: "...medical record should contain...medication or biological administered to the patient including:...name, strength, dosage, amount...route of administration...."

Nurses documented, without clarification, administering medication according to physicians' incomplete orders, that did not identify the route, starting dose, loading dose, initial rate, titration rate with time interval, maximum dose, and reason or goal, as follows:

Patient #1:
08/27/10 (1750) "Start Levophed gtt (drip) if SBP (systolic blood press) (less than) 80...titrate to keep SBP (greater than) 100"

Patient #2:
09/10/10 (1930) "Vasopressin to keep SBP greater than 100...Versed drip (and) Fentanyl drip for sedation." 09/10/10 (0200) "Start Neosynephrine gtt keep SBP greater than 100"
09/10/10 (1500) "Dopamine 5 mcg/min IV titrate to SBP greater than 90...Versed 5 mg/ml gtt IV titrate to RH (sedation scale) 2 - 3...Fentanyl 100 mcg IV gtt titrate to RH 2 - 3...Levophed 8 mcg/min IV titrate to SBP greater than 90"

Patient #3:
09/27/10 (untimed) "Epinephrine IV 5 mcg/min. titrate syt BP greater than 100"
09/29/10 (0954) "Dopamine drip - titrate for BP (increase)." Nursing documented, "1930 - 0700...(Dopamine) 2 mcg" administered.

Patient #5:
10/01/10 (0330) "Banana bag over 1 (hour)...Ativan 2 mg IVP may titrate for ETOH withdrawal symptoms"
10/01/10 (0535) "Ativan 4 mg IV Q 15 min until vitals stable"
10/01/10 (0615) "Ativan 6 mg IVP Q 15 minutes until shaking/confusion ceases"
10/01/10 (0745) "(increase) Ativan to 8 mg/IVP Q 15 minutes until mania resolves"

Patient #8:
09/27/10 (2120) "Banana bag over 1 (hour)"

Patient #12:
11/27/10 (0810) "IV Dopamine 2 - 4 mic (micrograms). Don't titrate"

Nurses administered medications without identifying, and clarifying, incomplete physicians' orders.