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Based on review of the governing body/corporate bylaws, Banner Health Quality Plan, meeting minutes, and interview, it was determined that the hospital failed to comply with the provisions of the Governing Body, that require the Governing body to assume legal responsibility for the hospital as a separately certified institution. The hospital's governing body bylaws did not demonstrate that the Care Management and Quality Committee, had sole legal responsibility for this hospital. The hospital shared a single governance with multiple Banner owned/operated facilities, and separately certified hospitals.

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

Findings include:

Employee # 7 confirmed on 11/02/10 at 1245 hours, the hospital is a separately licensed hospital and they don't have facility boards, but instead have a coporate board. S/he confirmed they have corporate governing body, not a separate governing body.

The hospital provided the Governing Body bylaws for this hospital, titled Fourteenth Amended and Restated Corporate Bylaws of Banner Health, Adopted June 14, 2008, which included: "...Article III Board of Directors...the Board of Directors shall have the authority to establish medical staff membership requirements for the medical staffs of the facilities owned or leased by this corporation in addition to such requirements as may be set forth in the medical staff bylaws of such facilities...Article VI Committees...Standing Committees...The standing committees of the corporation...Care Management and Quality Committee...Duties and Delegated Responsibilities...shall have the following duties and delegated responsibilities:...Review and make recommendations to the Board regarding a systemwide quality plan...Evaluate and make recommendations to the Board concerning healthcare technologies...Evaluate and make recommendations to the Board with respect to ethical implications relating to the activities and services of the corporation...Duties of the Medical Staff...Investigating and making recommendations to the board, acting through the Care Management and Quality Committee (including through the Medical Staff Subcommittee) on all matters and activities pertaining to the medical staff members, including applications for initial appointment, reappointment and clinical privileges; assignments to departments and staff categories; denial, curtailment, limitation or revocation of medical staff membership or privileges...Medical Staff Bylaws and Medical Staff and Department Rules and Regulations...the Board (acting as a whole, and not through a committee) reserves the right to amend or supplement a Medical Staff Bylaws...."

The hospital was asked to provide the Governing Body meeting minutes. Employee # 7 identified that the Governing Body meeting minutes were at the corporate office and s/he would request the minutes. S/he provided the Care Management and Quality Care Committee as the Governing Body meeting minutes, dated Friday, September 24, 2010, for review. The minutes are titled, DRAFT Banner Health--Banner Baywood Medical Center Care Management and Quality Meeting.

According to the Governing Body Bylaws the Care Management and Quality Meetings are standing committees that review, evaluate and make recommendations to the Board of Directors and are not the governing authority for the hospital.

Review of the Banner Health Quality Plan, effective 01/21/2008, required: "...Quality Authority/Responsibility...Governance...The BH (Banner Health) Board of Directors has the ultimate responsibility and accountability for quality of care and services provided by BH...."

Based on review of policy/procedure, medical records, and interview, it was determined the hospital failed to obtain patient's advance health care directives per hospital policy and/or document discussion of advance directives and related information given to the patient per hospital policy as evidenced by:

1. failure to document discussion of Advance Directives and related information with the patient per hospital policy for 3 of 4 patients who did not have Advance Directives (Pt's #29, #42, & #43); and

2. failure to document efforts to obtain a current copy of Advance Directives per hospital policy for 3 of 5 patients whose medical record contained documentation that the patient had an Advance Directive (Pt's #39, #41, & #46, ).

Findings include:

Review of the hospital's policy/procedure titled Advance (Health Care) Directives revealed: "...During the admission assessment, document discussion of Advance Directives and related information given to the patient in the 'Advance Directives' section of the Adult Health Profile. (ADMITTING NURSE)...If the Patient has an existing Advance directive that is not part of the medical record, make reasonable efforts to obtain a current copy...These efforts will be documented on the health Profile...."

1. Pt #29 was admitted to a hospital unit on 11/1/10. The Adult Health Profile contained documentation that the patient did not have an Advance Directive. The space to document whether the patient received the brochure regarding Advance Directives was blank. The medical record did not contain documentation of discussion regarding Advance Directives or related information. It did not contain documentation that the patient declined discussion.

Pt #42 was admitted on 11/1/10. The Adult Health Profile contained documentation that the patient did not have an Advance Directive. The space to document whether the patient received the brochure regarding Advance Directives was blank. The medical record contained no documentation of discussion regarding Advance Directives or related information. It did not contain documentation that the patient declined discussion.

Pt #43 was admitted on 10/31/10. The Adult Health Profile contained documentation that the patient did not have an Advance Directive. The space to document whetner the patient received the brochure regarding Advance Directives was blank. The medical record contained no documentation of discussion regarding Advance Directives or related information. It did not contain documentation that the patient declined discussion.

2. Pt #39 was admitted on 12/29/09. The Adult Health Profile contained documentation that the patient had Advance Directives (Living Will and Medical Durable Power of Attorney.) The space to document the location of the Advance Directives was blank. The medical record did not contain documentation of efforts to obtain copies.

Pt # 41 was admitted on 10/30/10. The Adult Health Profile contained documentation that the patient had Advance Directives (Living Will and Medical Durable Power of Attorney.) The space to document the location of the Advance Directives was blank. The medical record did not contain documentation of efforts to obtain copies.

Pt #46 was admitted on 10/28/10. The Adult Health Profile contained documentation that the patient had Advance Directives (Living Will and Medical Durable Power of Attorney.) the space to document the location of the Advance Directives was blank. The medical record did not contain documentation of efforts to obtain copies.

On 11/3/10, Employee #1, a Quality Specialist, confirmed that the required documentation regarding Advance Directives was incomplete.

Based on review of policy/procedure and medical record, it was determined the hospital failed to prohibit the use of a chemical restraint order on an as needed basis for 1 of 1 patient where a drug was used as a restraint in a Non Violent Situation (Pt # 52).

Findings include:

Review of the hospital policy/procedure titled Restraint use in Non Violent Situations revealed: "...Use of Drug as a Restraint: Medication used as a restriction to manage the patient's behavior or restrict movement and is not a standard treatment or dosage for the patient's condition...Use of a 'PRN' order for restraint use is not acceptable...."

Pt #52 is a 92-year-old who was admitted on 7/21/10 with a presenting complaint of shortness of breath. A physician documented that the patient's past medical history included diabetes. The pt was admitted via the ED when s/he was found to have hypoxia, with an oxygen saturation of 86%. The physician documented the following in the History and Physical: "...Plan...pulmonary edema...started on Lasix...cardiology consult...Questionable pneumonia...started on IV clindamycin and azithromycin...Hyponatremia...could be due to the hydrochlorothiazide that the patient takes at home...Diabetes...."

The medical record contained no documented evidence that the patient had been on any medications related to behavior prior to admission to the hospital that would indicate that Haldol was a standard treatment for the patient.

Pt #52's medical record contained a physician's order recorded on 7/22/10 at 2138 for: "...Haldol 2mg IV (intravenous) q6h (every 6 hours) prn...." The medical record also contained a physician's telephone order for: "...Acute Med/Surg Restraint...Restrain with Soft restraints (limb holders)...noted at 2221 by an RN.

On 7/22/10, at 2230, a nurse documented initiation of Chemical Restraint and Mechanical Restraint and documented: "...order obtained 2138...." The nurse documented: "...Pt behavior/response: Sleeping...."

The medical record contained documentation that the patient remained with all four side rails elevated and soft restraints on both arms from 7/22/10 at 2230 until 7/23/10, at 1747 when the mechanical restraints were discontinued.

A nurse documented that the patient received Haldol 2mg IV on 7/22/10 at 2230; on 7/23/10 at 0453, 1031, and 1609.

Based on review of physician credential files, medical records, hospital documents, and interview, it was determined the hospital failed to specify in policy the training requirements for physicians authorized to order restraint or seclusion in 2 of 2 physicians (physician #16 & 17.)

Findings include:

Physician credential files for Physicians #16 & #17 contained no specific documentation of training related to restraint and/or seclusion. Pt #50's medical record contained an order from Physician #17 for Nonviolent Restraint. Pt #49's medical record contained an order from Physician #16 for physical resraints for Nonviolent Behavior.

On 11/5/10, Employee #62, Director, Medical Staff Services, and Employee #7, Quality Specialist, confirmed that the hospital had no policy specifying the training requirements for physicians authorized to order restraint or seclusion. Employee #62 provided a document signed by each physician (#16 & #17). This document contained the following statement: "...I further acknowledge that I am responsible for knowing the contents of the Medical Staff Bylaws and Rules and Regulations and of the Hospital Policies and that I agree to be bound by same...." Employee #62 stated that all physicians with hospital privileges sign this document.

Review of Medical Staff Bylaws and Rules and Regulations revealed that neither document contained a specific statement related to training requirements for physicians authorized to order restraint or seclusion.

Based on review of policies/procedures, medical records, and interview with staff, it was determined the hospital failed to assure that 4 of 4 patients, restrained for violent behavior, had a face-to-face evaluation, within one hour of a restraint, which included: the patient's; immediate situation; reaction to the intervention; medical and behavioral condition; and need to continue or terminate the restraint, as required by hospital policy. (Pts #27, #35, #53 & #54.)

Findings include:

The hospital policy titled Restraint Use in Violent Situations, required: "...Initiation of restraint...Perform a face-to-face evaluation of the patient as soon as possible, but no later than 1 hour after the initiation of violent restraint or seclusion...Include in the evaluation...The patient's immediate situation...reaction to the intervention...medical and behavioral condition...The need to continue or terminate the restraint or seclusion...."

Patient #27 arrived in the emergency department (ED) on 07/20/10, at 0148 hours. Nursing documented the chief complaint as: "...Pt...to ED...for evaluation of erratic behavior at home per EMS (emergency medical system). EMS reports Pt's girlfriend called 911. This Pt arrived to ED accompanied by Mesa PD (police department) in handcuffs...."

Nursing obtained two violent restraint orders at 0150 and 0550 hours on 07/20/10. The ED physician documented a physical examination at 0709. The examination did not include that the patient was restrained, the patient's reaction to the restraint intervention; and the need to continue or terminate the restraints as required by hospital policy.

Patient # 35 arrived in the ED on 10/26/10 at 1531 hours with a chief complaint documented as: "...Patient found unresponsive at storage unit per EMS. Patient aroused with sternal rub. Became combative with EMS and they restrained him...." The ED physician ordered violent restraints at 1633 hours. Documentation by the ED physician for the 1 hour face-to-face assessment did not include the patient's reaction to the restraint intervention or the need to continue or terminate the restraint as required by hospital policy.

Quality Specialist (employee #6) confirmed on 11/05/10 at 1200 hours, that the ED physicians did not document all elements of the 1 hour face-to-face evaluations.

Pt #53 was admitted to the ICU (Intensive Care Unit) via the ED on 10/31/10 at 0044. A physician documented that s/he saw the patient in the ED on 10/30/10 at 1835. The physician entered an order for "Restraint Violent" on 10/30/10 at 1907. A nurse documented initiation of Chemical and Mechanical Restraints on 10/30/10 at 1850 and documented: "...Reason: Agitation/restlessness; Danger of hurting self/others...Little or no understanding of the risks of refusing treatment/intervention...Pt is in immediate danger of hurting self/others (Violent Behavior)...Removing lines, dressing equipment...Pt behavior/response: Verbally aggressive...Physically aggressive towards object...Physically aggressive towards person...Physically aggressive towards self...Restless/agitated/anxious...Verbally threatening towards others...."

The medical record contained documentation that indicated the patient remained in Velcro restraints on all four extremities until 10/30/10 at 2107. The ED physician documented a history and physical examination performed at 1905. This documentation contained no mention of restraints, the patient's reaction to the intervention, and/or the need to continue or terminate the restraints as required in a face-to-face evaluation per policy.

Pt #54 was admitted on 12/29/09. On 1/2/10, at 1107 a nurse documented a physician's telephone order for restraints: "...Place soft restraint for combative behavior...." A nurse documented initiation of Mechanical Restraints (soft restraints to both arms) at 1100 and documented: "...Reason: Agitation/restlessness...Danger of hurting self/others...pt in immediate danger of hurting self/others (Violent Behavior)...Pt behavior/response: Verbally aggressive...Physically aggressive towards person...."

The medical record contained documentation that indicated the patient remained in restraints until 1215. A psychologist documented an evaluation for "re-eval for competency" at 1245. This evaluation did not contain required elements of the 1 hour face-to-face evaluation. An MD entered a progress note at 1300 which did not contain the required elements of the 1 hour face-to-face evaluation.

On 11/12/10, Employee #1, a Quality Specialist confirmed that the medical records of Pt
#53 and #54 did not contain the required 1 hour face-to-face evaluation.

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

1. failure of a registered nurse (RN) to document supervision and evaluation of nursing care for patients assigned to licensed practical nurses (LPNs) for 4 of 4 patients (Pts # 34, 36, 37, and 38); and

2. failure of a registered nurse to assess 2 of 2 patients as required by the alcohol withdrawal protocol (Pts #46 & 47).

Findings include:

1. The hospital policy titled, RN Scope of Practice, Delegation and Supervision, required: "...The initial and ongoing plan/strategy of care is completed by the RN...The plan/strategy of care is evaluated at least once a shift by the RN...Evaluate the patient's response and the performance of the LPN/supervised personnel to whom tasks are delegated...."

The hospital policy titled, Assessment and Reassessment of Patients Policy, required: "...A registered nurse assesses, plans, directs, implements, and evaluates nursing services provided to a patient...."

On 11/04/10 at 1130 hours the Senior RN Manager (employee #16) on 4 South explained that LPN's are supervised by the Senior RN Managers. S/he will assess a patient if the LPN comes and asks the RN to do so. S/he said that s/he does not automatically go in and assess the LPN's patients unless the LPN requests. On 11/04/10 (employee #3) explained that the supervising RNs document that they agree with the LPN in the medical record to demonstrate oversight.

According to staff assignment documents for 11/03/10, for the 0700-1900 day shift indicated that LPN (employee #17) was assigned to the following patients, Pt's #34, 36, 37, and 38.

Patient #34 was assigned to LPN (Employee #17) on 11/03/10, for the day shift 0700-1900 hours. Review of the documentation in the medical record for that day revealed that the LPN completed the Adult Physical Assessment at 0932 hours. The Clinical RN Manager supervising the LPN documented the following at 1226 hours, six hours before the end of the shift: "...I have reviewed the LPN's documentation, including assessments, medications, careplans, and all pt. documents and I am in agreement...." The RN did not document his/her own assessment of the patient; completion of the patient's ongoing care plan; and/or evaluation of the patient's response to care for this shift as required by policy.

Patient #36 was assigned to LPN (Employee #17) on 11/03/10, for the day shift 0700-1900 hours. Review of the documentation in the medical record for that day revealed that the LPN completed Adult Physical Assessments at 0802, 1200, and 1623 hours. The Clinical RN Manager supervising the LPN documented the following at 1221 hours, six hours before the end of the shift: "...I have reviewed the LPN's documentation, including assessments, medications, careplans, and all pt. documents and I am in agreement...." The RN did not document his/her own assessment of the patient; completion of the patient's ongoing care plan; and/or evaluation of the patient's response to care for this shift as required by policy.

Patient #37 was assigned to LPN (Employee #17) on 11/03/10, for the day shift 0700-1900 hours. Review of the documentation in the medical record for that day revealed that the LPN completed Adult Physical Assessments at 0815 and 1220 hours. The Clinical RN Manager supervising the LPN documented the following at 1221 hours, six hours before the end of the shift: "...I have reviewed the LPN's documentation, including assessments, medications, careplans, and all pt. documents and I am in agreement...." The RN did not document his/her own assessment of the patient; completion of the patient's ongoing care plan; and/or evaluation of the patient's response to care for this shift as required by policy.

Patient #38 was assigned to LPN (Employee #17) on 11/03/10, for the day shift 0700-1900 hours. Review of the documentation in the medical record for that day revealed that the LPN completed Adult Physical Assessments at 0903 and 1245 hours. The Clinical RN Manager supervising the LPN documented the following at 1221 hours, six hours before the end of the shift: "...I have reviewed the LPN's documentation, including assessments, medications, careplans, and all pt. documents and I am in agreement...". The RN did not document his/her own assessment of the patient; completion of the patient's ongoing care plan; and/or evaluation of the patient's response to care for this shift as required by policy.

Quality Specialist (employee #1) reviewed patients 34, 36, 37, 38, and confirmed the above documentation and findings on 11/05/10 at 1008 hours.

2. Review of hospital document titled Alcohol Withdrawal Protocol Standing Orders revealed: "...Implement Alcohol Withdrawal Severity Assessment and Intervention Scale...Monitor alcohol withdrawal severity score every 2-4 hours while awake, every 4-6 hours while sleeping...Severity Score...0-5...Lorazepam Dose...0mg... Severity Score...6-7...Lorazepam Dose...2mg IV or PO (by mouth)...Severity Score...8-9...Lorazepam Dose...3mg IV...Severity Score...10-11...Lorazepam Dose...4mg IV...Severity Score...
>12...Lorazepam Dose...5mg IV...Reassess the withdrawal severity scores 15-30 minutes after the initial dose and give another dose of lorazepam based on above...if score 6 or greater and respiratory rate is at least 12 per minute...Continue to assess 15-30 minutes after each dose...."

Pt #46 was admitted on 10/28/10. The patient was placed on the Alcohol Withdrawal Protocol per physician order at 0639. At 0655, an RN recorded the patient's severity score as 10 and administered 4mg of Lorazepam at 0700. The RN reassessed the patient's severity score at 0810 (required reassessment time was 0715-0730.)

On 10/31/10, at 1000, an RN recorded the patient's severity score as 10 and administered 4mg of Lorazepam at 1039. The RN reassessed the patient's severity score at 1200 (required reassessment time was 1054-1109.)

Pt #47 was admitted on 10/31/10. The patient was placed on the Alcohol Withdrawal Protocol per physician order at 2151. On 11/1/10, at 0800, an RN recorded the patient's severity score as 7 and administered 2mg of Lorazepam. The RN reassessed the patient's severity score at 1130 (required reassessment time was 0815-0830.) At 1430, an RN recorded the patient's severity score as 6 and administered 2mg of Lorazepam. The RN reassessed the patient's severity score at 1800 (required reassessment time was 1445-1500.

On 11/3/10, employee #58, a Pharmacist, and employee #1, Quality Specialist, confirmed that the nurses did not complete assessments as required per Alcohol Withdrawal Protocol.

Based on review of hospital documents, medical record, and interview, it was determined the hospital failed to require that drugs are administered in accordance with a physician's order for 1 of 2 patients on the Alcohol Withdrawal Protocol (Pt #46).

Findings include:

Cross reference Tag (A0404) #2 for information regarding the Alcohol Withdrawal Protocol Standing Orders.

Pt #46 was admitted on 10/28/10 and placed on the Alcohol Withdrawal Protocol on 10/29/10 at 0639. On 10/31/10, at 0800, an RN recorded the patient's severity score as 4 and administered 1mg of Lorazepam. The nurse recorded on the Alcohol Withdrawal Protocol Documentation Record "...per pt's request...." The patient should have received no medication per protocol. In addition, the medical record did not contain a physician's order for Lorazepam other than according to the protocol.

On 11/1/10, at 0245, an RN recorded the patient's severity score as 2 and administered 2mg of Lorazepam. The nurse recorded on the Alcohol Withdrawal Protocol Documentation Record "per pt. request 'Feeling Anxious'...." The patient should have received no medication per protocol. The medical record did not contain a physician's order for Lorazepam other than according to the protocol.

On 11/3/10, employee #58, a Pharmacist, and employee #1, a Quality Specialist, confirmed that the nurse did not administer medication according to the physician's orders and that the medical record did not contain an order for Lorazepam other than according to the Alcohol Withdrawal Protocol.

Based on review of hospital policies and procedures, manufacturer's written guidelines, log books, nationally accepted standards, and interviews with staff, it was determined the hospital failed to follow sterilization procedures according to acceptable standards of practice.

Findings include:

Review of hospital policy and procedure, "STERILIZATION IN THE OPERATING ROOM" revealed: "...Select exposure time according to manufacturer's recommended time and item to be sterilized...."

Review of "AMSCO EAGLE CENTURY SERIES GRAVITY AND PREVACUUM STERILIZERS OPERATING INSTRUCTIONS" revealed: "...Factory-set cycles and cycle values for flash are sterilize time of 10 minutes and dry time of 1 minute...."

Review of "STERILIZATION RECORD" revealed: "...On 10/26/10 at 0648 hours, Physician #18 instruments were run with a cycle of 10 minutes of sterilize time and 1 minute of dry time....on 11/2/10 at 0808 hours, Physician #18 instrument was run for a cycle of 10 minutes of sterilize time and 1 minute of dry time...on 11/2/10 at 0930 hours, Physician #18 instruments were run with a cycle of 10 minutes of sterilize time and 1 minute of dry time...on 11/2/10 at 1508 hours, Physician #18 instruments were run with a cycle of 10 minutes of sterilize time and 1 minute of dry time...."

According to 2010 Edition of "AORN PERIOPERATIVE STANDARDS AND RECOMMENDED PRACTICES FOR INPATIENT AND AMBULATORY SETTING" revealed: "...Use of flash sterilization should be kept to minimum...."

The Director of Operating Room and Orthopedics verified on 11/2/10 at 1030 hours that Physician #18's instruments had been flashed at 0808 hours. She stated that the hospital has offered to purchase another instrument set for this physician but he continues to request that his instruments be flashed between his cases.