HospitalInspections.org

Based on review of meeting minutes and interviews, it was determined that the hospital failed to comply with the provisions of the Governing Body, that require the Governing body to assume responsibility for the hospital as a separately certified institution, and holding it accountable for the quality of care, as demonstrated by the hospital's failure to maintain a separate governing body to ensure focus on the hospital's individual issues. The hospital shared a single governance with multiple Banner owned/operated facilities, and separately certified hospitals.

This deficient practice resulted in the hospital's failure to meet the requirements of the Condition of Participation (COP) for the Governing Body.

Findings include:

The hospital's administration/management confirmed during the entrance conference conducted on 09/20/10, that Banner Thunderbird Medical Center is separately certified and licensed from other Banner-based hospitals/entities. The surveyor requested the most recent minutes related to Banner Thunderbird Medical Center. The following were provided:

The "Banner Health Care Management and Quality Committee" 03/12/10, was called to order at 1412, and adjourned at 1700. This 16 page report revealed the following:

1. Discussion regarding Research at Banner Health Research Institute, Alzheimer's Institute, Sun Health Research Institute, MD Anderson Cancer Center Research.
2. Banner North Colorado Medical Center (for 9 of 16 pages).
3. Care Management Update for Banner Del E Webb, Baywood, and Estrella Medical Centers.
4. 4 th Quarter (4 Q) 2009 Sentinel events.
5. Home Care Board report.
6. Banner Lassen Medical Center Policies.
7. Medical Staff subcommittee minutes 12/10/09 through 03/10 "pertaining to appointments and reappointments for all of Banners hospitals."
8. Care Management and Quality Reports 4 Q 2009 (36 entities listed).
9. Peer review Improvement subcommittee report related to all Banner facilities.
10. Quality Report Banner Surgery Centers, included 11 entities.
11. Annual Incident Report.
12. Nursing Acuity Plan "...staffing needs for all acute and critical areas...."
13. Annual Grievance Report.

The "Regular Session of the Board of Directors Meeting of Banner Health" 03/13/10, was called to order at 0930 and adjourned at 1045. This 15 page report revealed the following issues:

1. Home care documents and Banner Lassen Medical Center policies.
2. Committee reports and action items: finances, mention of Banner Good Samaritan Medical Center (related to cardiac devices).
3. Care management and Quality Committee: documentation related to Banner Health Research Institute, and Banner Alzheimer Institute.
4. Peer review council summary re: Banner Baywood, and Banner Gateway. Annual Quality report for the ambulatory surgery centers.
5. North Colorado Medical Center (9 of the 15 pages).
6. East Morgan Community Hospital, and Banner Ironwood Medical Center.

The "Banner Health Care Management and Quality Committee" meeting minutes 06/12/10, were not provided for review.

The "Regular Session of the Board of Directors Meeting of Banner Health" (DRAFT) 06/12/10, was called to order at 1130, and adjourned at 1205. The following was revealed:

1. Audit committee (financial).
2. Care Management and Quality Committee. Included Banner Del E Webb Medical Center. "The committee received reports from the medical staff subcommittee with respect to each Banner hospital...The Committee had also received and carefully reviewed for each facility the Sentinel Event report and the Qualify Indicators report...."
3. Approval of Interim Chief Executive Officer of Community Hospital in Wyoming, discussion of Home Health agencies related to McKee Medical Center, North Colorado Medical Center, and Banner Mesa Medical Center.

The "Care Management and Quality Committee Agenda" (Draft) provided on 09/24/10 for the meeting scheduled for 09/24/10, from 1415 - 1700, revealed: Care Management and Quality Reports 2 Q for Non-Hospital business lines and Acute Medical/Surgical Hospital. Hospital specific reports for 23 Banner owned and operated entities. In addition, the minutes revealed: "...the recommendation of the Medical Executive Committee...shall be adopted and approved and recommended for final approval by the Board of Directors of Banner Health...."

The agenda for the Governing Body/Board of Directors meeting scheduled for 09/25/10, was requested daily from 09/20/10 through 09/24/10. The Director of Quality stated on 09/24/10, that the agenda was not available ("still waiting").

The meeting minutes confirmed that multiple separately certified hospitals, were discussed at the same times, at the same meetings, and did not focus on Thunderbird Medical Center's specific issues, as a separately certified hospital.

Based on review of a medical record, observations, interviews with staff and medical staff bylaws, it was determined that for 1 of 1 patient (Pt #13) reviewed for restraint for violent behaviors, and 2 of 2 patients (Pts #10 and 11) reviewed for "resume orders," the medical staff failed to enforce its bylaws as evidenced by:

1. failing to require a face-to-face evaluation within 1 hour of restraint, and documenting the patient's reaction to the intervention, the medical and behavioral condition, and the need to continue or terminate restraint; and

2. a physician failed to renew the violent restraint within in the timeline specified for violent restraint of an adult; and

3. physicians failed to write new orders for 2 of 2 patients (Pt. #10 and 11) post procedure.

Findings include:

The RN Clinical Manager for ICU (Personal #37), was interviewed regarding PT #13's medical record on 10/13/10 at 1100 hours through 1430 hours.

1. The hospital's medical staff rules and regulations, dated 02/11/10, required: "...Restraints For Violent or Self-Destructive Behavior and/or Seclusion...must perform face-to-face patient assessment within one hour of initiation of the restraint and/or seclusion...The assessment musts (sic) be conducted to evaluate the patient's immediate situation, reaction to the intervention, medical and behavioral condition, and the need to continue or terminate restraint or seclusion...."

Review of Pt #13's medical record revealed the following orders for restraints:

09/27/10, 2053 hours: "...Order Details...Violent Behavior..." ordered by the e-ICU (the e-ICU is an offsite area with computers and video equipment that the physicians can see the patient via video television, but not face to face in person) physician. The e-ICU physician's progress note on 09/27/10 at 2052 hours, included: "...Plan...PATIENT VIOLENT; TRIED TO KICK NURSE AND SITTER. SO I WILL ORDER 4 POINT RESTRAINTS...."

The medical record did not contain a face-to-face assessment within 1 hour of initiating the intervention, and include documentation of the required elements listed in the medical staff bylaws, rules and regulations.

09/29/10, 0121 hours: "...Order Details...Physical, Violent Behavior..." ordered by the e-ICU physician. The e-ICU physician's progress note addendum on 09/29/10 at 0123 hours, included: "...Pt has been displaying violent behavior toward the staff and has successfully torn through soft wrist restraints. I have reordered leather wrist restraints for pt's and staff's safety...."

The medical record did not contain a face-to-face assessment within 1 hour of initiating the intervention, and include documentation of the required elements listed in the medical staff bylaws, rules and regulations.

09/29/10, 0914 hours: "...Order Details...Physical, Violent Behavior..." ordered by physician # 14. The next physician documentation was in a progress note by physician #14 at 1213 hours.

The medical record did not contain a face-to-face assessment within 1 hour of initiating the intervention, and include documentation of the required elements listed in the medical staff bylaws, rules and regulations.

The RN Clinical Manager for ICU confirmed the findings on 10/13/10, during the medical record review.

2. The hospitals's medical staff rules and regulations, dated 02/11/10, required: "...Restraints For Violent or Self-Destructive Behavior and/or Seclusion...An order is required before initiating each episode of restraint...and must be renewed within specific time...."

The hospital's policy titled Restraint Use in Violent Situations required: "...Each order for restraint or seclusion in violent situations must state the maximum duration of the restrain (sic)
or seclusion according to the following limits...Every four hours for patients age 18 and older...."

The violent restraint order on 09/29/10, at 0121 hours was not renewed within the 4 hour time requirement.

The RN Clinical Manager for ICU confirmed the findings on 10/13/10, during the medical record review.

3. The hospital's Medical Staff Bylaws required: "...New orders must be generated after a surgical procedure...."

Patient #10's physician ordered on 09/21/10 at 1936, "...Please resume all pre-op meds, diet and other orders...."

Patient #11's physician ordered on 09/27/10 at 1546, "...resume pre-op diet and meds...."

The physicians did not write new orders for Pts #10 and 11, post procedure, as the Bylaws require.

Based on review of hospital policies and procedures, medical record, observations during tours, and interviews with staff, it was determined a registered nurse failed to evaluate the nursing care for 1 of 1 patient (Pt #13) in the intensive care unit (ICU) with an Ativan infusion, Precedex infusion, clinical indications for alcohol withdrawal (CIWA) scoring and medication, restraints for violent and non-violent behaviors; and a documented assessment of 1 of 1 patient's skin/wound (Pt. #38) in the Emergency Department (ED), as evidenced by:

1. nursing did not clarify the lorazepam infusion order, and titrated the medication without an order which included the desired parameters to achieve specified by the physician (Pt #13);

2. nursing did not clarify the Precedex titration order, and titrated the medication without an order which included the desired parameters to achieve specified by the physician (Pt #13);

3. nursing did not assess the Clinical Institute for Withdrawal of Alcohol (CIWA) per protocol and administer medications (Pt #13);

4. nursing did not obtain, from a physician, an order, which specified criteria when restraints for violent behavior could be discontinued (Pt #13); and

5. nursing did not document a wound/skin description, for 1 of 1 patients admitted to the Emergency Department (ED) with scrotal cellulitis and gangrene (Pt #18).

Findings include:

The hospital's policy titled Medication Orders, reviewed 08/13/2009, included: "...Taper/Titrate Orders:...Adjust dose and/or flow rate to achieve desired parameters specified by the physician...."

The hospital's policy titled Medication Range Orders, reviewed 05/08/2008, included: "...Open ended orders such as 'titrate to comfort' are not permitted...."

A tour of the ICU was conducted on 09/28/10 at 0900 hours. Patient #13 was selected for review. Registered nurse (RN) #32 caring for the patient was interviewed. The patient was admitted on 09/25/10, with the diagnoses of: acute alcohol withdrawal; acute pancreatitis; hepatitis; and hyponatremia.

The RN Clinical Manager for ICU (Personal #37), was interviewed regarding PT #13's medical record on 10/13/10 at 1100 hours through 1430 hours.

PATIENT #13:

1. RN #32 showed the Surveyor the Ativan infusion order in the computer, the order read: "09/27/10...1922 hours...lorazepam...Order Details: 1 mg/hr, IV For mechanical ventilation sedation use. (Note: Pt # 13 was not on the ventilator) Sum the PRN use over the first 6 hour period, divide by 6 and add to current infusion rate as the new rate. Call physician for any further needed increases. D5W, 100, ml, 09/27/10 19:22 MST (mountain standard time), Yes, 1-4 mg Titrate, 100, 1, 2...." RN #32 was asked if that was the complete order and s/he verified that was the order. S/he could not articulate if, or how often the infusion could be titrated, what was the maximum amount that could be given, and s/he said they would call the physician. S/he could not explain why the order included the verbiage "For mechanical ventilation sedation use."

S/he was asked about the above lorazepam order dated 09/27/10 at 1922 hours, and the first lorazepam infusion order (identical) on 09/26/10 at 0729 hours. Specifically, s/he was asked what the order meant and how should the lorazepam be infusing. S/he initially said this order was "tied to the CIWA scale," however, after researching in the medication administration record (MAR) and the nursing flowsheets, s/he said the lorazepam was an infusion not tied to the CIWA. S/he was then asked what rate would the infusion be running at on 09/27/10, at 1922 hours. S/he explained s/he would added up the last lorazepam doses for the rate. S/he was asked to explain why the order indicated "IV For mechanical ventilation sedation use" and s/he said that the medication would be for a ventilated patient that needed sedation. S/he was asked if the patient was on a ventilator and after review of the record, s/he confirmed that Pt #13 was never on a ventilator the entire hospital stay. S/he found a note by nursing in the MAR written by the nurse starting the lorazepam infusion on 09/26/10, at 0830 hours, which indicated the doctor wanted the infusion to run 0.5miligrams (mg) / hour (h). The infusion was started at 0.5 mg/h. The clinical manager could not explain why the order indicated to start the infusion at 1.0 mg/hour and there was no order written by nursing or providers to start the infusion at 0.5 mg/h.

Review of the MAR and nursing flowsheet documentation for the lorazepam infusion rates indicated the following rates were administered:
09/26/10;
0830, 0.5 mg/h
2000, 1mg/h

09/27/10;
1700, 2mg/h
1800, 3mg/h
2000, 4mg/h

09/28/10;
0100, 3mg/h
0900, 2mg/h
2000, 6mg/h
2200, 1mg/h

09/29/10;
0900, 0.5mg/h
1000, OFF

Review of the physician progress notes for Pt #13 revealed the following: "...09/28/10, 2216 (hours), Called by RN regarding pt's ativan (lorazepam) infusion. Currently the infusion is running at 6mg/h. (patient) will awaken with vigorous tactile stimulation and mumble but he appears to be over-narcotized at the current rate. I have asked the RN to decrease the drip to 1 mg/hour...." The physician did not enter a new lorazepam infusion order at this time.

The ICU RN Clinical Manager confirmed the above orders for lorazepam were not complete, and needed to be clarified and needed a medication effect specified by the physician if the medication was to be titrated.

2. Review of the MAR and the patient's medication orders revealed the following order from the e-ICU on 09/26/10, 2100 hours, for Precedex: "...dexmedetomidine (Precedex infusion) 50 ml (milliliters) Every Bag...) mcg/kg initial bolus then, Start infusion at 0.2 mcg/kg/hr, Titrate 0.2 to 0.7 mcg/kg/hr IV. Give initial bolus over 10 minutes...Order Comment: NOTE: no bolus...FINAL CONC (concentration)=4 MCG/ML...NOT TO EXCEED 24HR...."

The following rate ranges for the Precedex were recorded:
09/26/10;
2117, 0.2 micrograms (mcg) per kilogram (kg) per hour (h)
2120, 0.3 mcg/kg/h
2131, 0.4 mcg/kg/h
2145, 0.5 mcg/kg/h
2200, 0.7 mcg/kg/h
2300, 0.7 mcg/kg/h

09/27/10;
0000, 0.5 mcg/kg/h
0300, 0.4 mcg/kg/h
1800, 0.7 mcg/kg/h

The 0.7 mcg/kg/h rate continued through 09/27/10 and 09/28/10 until 09/29/10 at 0812 when it was stopped.

The patient received the Precedex infusion from 09/26/10 at 2117 hours through 09/29/10 at 0812 hours, for a total of approximately 59 hours, which exceeded the 24 hour time reference in the order.

The manufacturer's insert from Hospira Inc. for Precedex included: "...Indications and Usage...Administer Precedex by continuous infusion not to exceed 24 hours...Warnings and Precautions...Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy...Use in Specific Populations...Hepatic impairment: Dose reduction should be considered...Dosage and Administration...Dosing Guidelines...Precedex in not indicated for infusions lasting longer than 24 hours...."

The hospital's Doctor of Pharmacy (PharmD) (Personnel #15) was interviewed about the Precedex titration order. S/he confirmed the order did not specify the desired effect that nursing was to achieve.

Personnel #15 confirmed the Precedex order for titration did not include to adjust the dose and/or flow rate to achieve desired parameters specified by the physician.

The ICU RN Clinical Manager confirmed the above order for Precedex was not complete, needed to be clarified, and needed the physician to specify the desired parameters to achieve.

3. The patient was placed on the Clinical Indication for Withdrawal of Alcohol (CIWA) protocol and scoring on 09/25/10, at 1350 hours. The order read: "...Use and document with the Clinical Institute Withdrawal Assessment (CIWA-AR) form. Doses of benzodiazepines should be based on this scale. Continue to reassess and medicate based on the CIWA result at the interval recommended...." The order included the following protocol: "If CIWA score is 5 to 7, repeat assessment Q (every) 4H (hours) and medicate according to CIWA-AR scale...If CIWA score is 8 to 11, repeat assessment Q2H and medicate according to CIWA-AR scale...If CIWA score (greater than) 11, repeat assessment Q1H and medicate according to CIWA-AR scale...." The computer order set has the option for oral and intravenous benzodiazepine prophylaxis. Pt #13 had both options ordered for the CIWA protocol. "...Diazepam...5 mg P.O. (orally), Tab (tablet), Q4H, PRN, Alcohol Withdrawal Symptoms, IF CIWA SCORE 5 to 7...Diazepam...10 mg P.O., Tab, Q2H, PRN Alcohol Withdrawal Symptoms, IF CIWA SCORE 8 to 11...Diazepam 20 mg P.O., Tab, Q1H, PRN, IF CIWA SCORE (greater than) 11...Lorazepam...2 mg IV...Q4H, PRN Alcohol Withdrawal Symptoms IF NPO AND CIWA SCORE 5 to 7...Lorazepam 2 mg IV Q2H, PRN, IF NPO AND CIWA SCORE 8 to 11...Lorazepam 2 mg IV Q1H, PRN, IF NPO AND CIWA SCORE < (greater than) 11...."

Review of the CIWA scoring for Pt #13 on 09/28/10, revealed that nursing documented a CIWA score of 29 at 0846 and the next documented CIWA was approximately 24 hours later on 09/29/10 at 0730 hours. The score at that time was 12. Nursing did not score the patient for alcohol withdrawal symptoms every hour according to the protocol for a score greater than 11 and did not administer any medication according to the CIWA protocol, until 1719 hours. Nursing did not administer the required 20 mg of Valium orally per protocol.

The RN Clinical Manager confirmed nursing should have scored the CIWA again in 1 hour and medicated according to the protocol.

4. The hospital's policy titled Restraint Use in Violent Situations required: "...Discontinue restraints based on criteria identified in provider orders...."

Review of Pt #13's medical record contained the following orders for violent restraints:

09/27/10, 2053 hours: "...Order Details...Violent Behavior..." ordered by the e-ICU physician.

09/29/10, 0121 hours: "...Order Details...Physical, Violent Behavior..." ordered by the e-ICU physician.

09/29/10, 0914 hours: "...Order Details...Physical, Violent Behavior..." ordered by physician #14.

The orders did not contain criteria for discontinuing the restraints as required by policy and nursing did not clarify or obtain the criteria.

The RN Clinical Manager for ICU confirmed the findings on 10/13/10, during the medical record review.

5. Patient #18, presented to the Emergency Department (ED) on 09/12/10 at 1516, 24 hours post discharge from the inpatient unit, for evaluation and treatment of suspected scrotal wound/cellulitis. The ED nurse documented, "...awaiting MD to assess scrotum, see wound assessment flow sheet...." The patient was admitted directly to the operating room, at 1740, for excision of necrosis.

RN #31 confirmed that there was no documented wound description, or "wound assessment flow sheet" during the record review and interview conducted on 10/01/10 at 1330.

Based on review of hospital policies and procedures, medical record, observations during tours, and interviews with staff, it was determined that nursing administered a lorazepam infusion and Precedex titration infusion for 1 of 1 patients reviewed (Pt #13) without a complete order as evidenced by:

1. nursing titrated the lorazepam infusion medication without an order which included the desired parameters to achieve specified by the physician in an order; and

2. nursing titrated the Precedex infusion medication without an order which included the desired parameters to achieve specified by the physician in an order.

Findings include:

See Citation 0395: 482.23(b)(3) Nursing Services, 1.and 2.

Based on review of hospital policies and procedures, manufacturer's written guidelines, log books, observations during tour, and interviews with staff, it was determined the hospital failed to follow sterilization procedures according to acceptable standards of practice, as evidenced by failing to:

1. run and document a Sterrad CycleSure biological indicator (BI) control for the Sterrad sterilizer and document the BI results required at 24 and 48 hours;

2. run a control test from the same lot number as the processed Attest Rapid 5 Steam Test biological indicators (BI's) for the steam sterilizers; and

3. document the lot numbers for the Attest Rapid 5 Steam Test BI's.

Findings include:

1. The hospital's policy titled Perioperative Services: Biological Surveillance Program for Sterilization Process required: "...The Sterrad units are monitored daily with biological indicators...Manufacturer's written instructions are followed for testing and incubation...CSPD (Central Sterile Processing Department) gas plasma (Sterrad) sterilizer...Create control vial...Verify that control vial and all test vials are of the same lot number...Run test with first load of the day...Follow manufacturer's written instructions for handling of sterilized vials and incubation...Procedural Documentation: Forms: Logbooks--Sterrad...complete all indicated areas...."

The CSPD Manager provided a copy of the Sterrad CycleSure 24 Biological Indicator (BI)
manufacturer' written instructions which required: "...Use of Controls...Use a positive control with each Sterrad CycleSure 24 BI. Crush an unprocessed Sterrad CycleSure 24 vial and place in the same incubator used for the processed CycleSure 24 vial. The positive control should be from the same lot of CycleSure 24 as the processed biological indicator...Readout of Results...Observe each vial for color change from purple to yellow and/or for turbidity of the media. Record results after 24 hours but prior to 72 hours of incubation...."

During the tour of CSPD the biological indicators, used to verify sterilization of instruments, were observed in incubators on 09/24/10 at 1230 hours.

The #5 Sterrad BI incubator was observed with 4 BI's. The BI's lot #'s were 050101. No control vial was present in the incubator.

The log for the #5 Sterrad incubator was reviewed with the Manager of CSPD on 09/24/10, at 1230 hours, s/he confirmed the following:
1. the log did not contain documentation of a positive control for the tests remaining in the incubator;
2. twenty-four (24) hour results were not logged for the following tests, 09/22/10, 1320 hours, 09/22/10, 0500 hours, 09/23/10, 0525 hours;
3. forty-eight (48) hour results were not logged for the following tests, 09/21/10, 0905 hours, and 09/22/10, 0804 hours.
4. it is a requirement of the hospital to document the 24 hour and 48 hour results in the spaces provided on the hospital's log.

2. The hospital's policy titled Perioperative Services: Biological Surveillance Program for Sterilization Process required: "...Procedure...the steam sterilizers are monitored with biological indicators...Manufacturer's written instructions are followed for testing and incubation...Surgery steam sterilizers...create control vial...verify the control is from the same lot number...Forms: Logbooks--Steam sterilizers...complete all indicated areas...."

The CSPD Manager provided the Attest Rapid 5 Steam-Pack manufacturer's written instructions, which required: "...Incubate at least one unprocessed Attest biological indicator (positive control) in each Attest auto-reader every day a processed Attest biological indicator is incubated. The positive control should be from the same lot number as the processed Attest biological indicator in the incubator...."

During the tour of CSPD on 09/24/10 at 1230 hours, the steam sterilizer incubator contained a control BI in well 12 labeled 09/14/10, lot #2012-06. Three processed BI's were incubating in wells 7, 8,and 9, with lot #'s 2012-04. The processed BI tests and control were not from the same lot number as required by the manufacturer's written instructions.

3. The form used by the hospital to log the Attest Rapid 5-Steam Pack did not have an area for lot numbers to be recorded. The Surveyor could not determine the control and tests BI's had been conducted from the same lot numbers.

The CSPD Manager confirmed the above findings on 09/24/10 at 1230 hours.