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

ABRAZO CENTRAL CAMPUS 2000 WEST BETHANY HOME ROAD PHOENIX, AZ 85015 Dec. 6, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on review of hospital policies/procedures, Medical Staff Bylaws Rules and Regulations, medical records, documents, committee meeting minutes, and interviews, it was determined the hospital failed to comply with the provisions for the Governing Body requiring accountability for the quality of care, as demonstrated by the failure to identify, prioritize, evaluate, and execute corrective actions related to overall hospital management, quality assurance improvement processes, patient health/safety deficiencies specific to the provisions of nursing, medical staff, and pharmaceutical services, and failure to ensure the Chief Executive Officer (CEO) was accountable for managing the hospital.

The Governing Body failed to assume responsibility for all hospital operations as determined by non-compliance with the following regulations:

A057 Chief Executive Officer: The CEO did not identify and implement appropriate actions related to deficient medical staff, pharmaceutical, and nursing practices; did not require that hospital-wide Quality Assurance/Performance Improvement (QAPI) activities included specific activities intended to identify and address patient health and safety practices; did not ensure leadership at all levels i:e: 16 of 51 (30%) management positions were filled with interim directors; and did not demonstrate accountability to the Governing Body for deficient hospital processes.

The Governing Body failed to demonstrate active involvement and decision making related to the AzHH campus.

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.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on review of hospital policies/procedures, Medical Staff Bylaws, medical records, committee meeting minutes, documents, and staff interviews, it was determined that the CEO, appointed by the Governing Body, did not assume responsibility for managing both hospital campuses.

Findings include:

The CEO failed to:

1. identify and implement appropriate actions related to deficient medical staff, pharmacy, and nursing practices. Reference tags A0338, A0385, and A0490;

2. require that hospital-wide Quality Assurance/Performance Improvement (QAPI) activities included specific activities intended to identify and address patient health and safety practices. Reference tag A0263; and

3. ensure leadership and stability at all levels i:e: 16 of 51 (30%) management positions (both campuses inclusive) were filled with interim (non-permanent) directors, according to the Organizational Charts provided on 11/27/12 and 12/06/12.

Key interim positions included: CEO, Chief Nursing Officer (CNO), Assistant Director of Nursing (ADON), Chief Operating Officer (COO), Chief Medical Officer (CMO), Med/Surg/Telemetry Director, Women's Services Director, Imaging Services and Cath Lab Nursing Director, Critical Care Unit (CCU) Director, Emergency Department, Same Day Surgery and Wound Care Clinical Director, Environment of Care (EOC) Director, Surgical Services Clinical Director, Pharmacy Director, Laboratory Director, and Director of Quality and Risk.

The above listed members of the hospital's management confirmed numerous changes in leadership (ongoing from 11/2010 to current), during interviews conducted 11/27/12 through 12/06/12.
VIOLATION: QAPI Tag No: A0263
Based on review of hospital policies/procedures, documents, personnel files, 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 to improve health and safety outcomes, as demonstrated by the:

1. failure to require the Root Cause Analysis (RCA) conducted in 05/12 identified opportunities for improvement related to patient safety, by addressing RN #42's incompetencies and unsafe nursing practices that were documented in the personnel file prior to the sentinel event (Reference tag A0397 Patient Care Assignments regarding RN #42);

2. failure to require the QAPI process implemented corrective action of identified hospital-wide practices that were consistently reported at less than required benchmarks for Employee Health, Progressive Care Unit (PCU), and the Operating Room (surgical services); and

3. failure to require the Quality Plan identified and took action for all hospital services impacting health outcomes to prevent and reduce medical errors.

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.

Findings include:

1. The root cause analysis (RCA) conducted for a Sentinel Event in 05/12 did not identify opportunities for improvement regarding sharing information/communication included in RN #42's personnel file that confirmed incompetencies and unsafe nursing practices that the hospital documented prior to the Sentinel Event, that impacted the health and safety of the patient.

2. The hospital's Performance Improvement Plan, requires: "...The purpose of the Performance Improvement Plan...is to provide guidance for improving organization performance functions and to ensure that the organization designs processes well and systematically monitors and analyzes performance activities with the goal of improving patient outcomes...All Medical Staff departments and all hospital clinical and support services participate in planning, designing, measuring, analyzing and implementing opportunities to improve care and organizational performance...."

The Quality Performance Improvement Scoreboard (AzHH campus) reported:

Employee Health Compliance with tuberculosis (TB) Vaccine: Benchmark: 100% (all samples):

07/2012 - 80%
08/2012 - 36%
09/2012 - 72%
10/2012 - 35%

Progressive Care Unit (PCU) Compliance with Skin Assessment (each shift): Benchmark: 95% (22 samples):

08/2012 - 92%
09/2012 - 89% "...back of the flow sheet form...getting missed...."
10/2012 - 90%

Operating Room (OR) Compliance with Start Times (within 10 minutes): Benchmark: 80% (30 samples):

08/2012 - 60%
09/2012 - 67% "...variety of reasons...we can only keep trying...."
10/2012 - 44%

QAPI activities did not analyze, identify, and implement corrective actions intended to improve hospital performance, related to indicators reported below acceptable benchmarks.

The interim Quality Manager indicated during an interview conducted on 12/05/12, that the QAPI committee was in the process of developing action plans, however could not provide documentation that demonstrated committee guidance.

3. Reference tag A0353: regarding the failure to require physicians write complete medication and titration orders; and failure to require physicians signed restraint orders within 24 hours, per protocol;

Reference tag A0392: regarding the failure to require staff competencies be evaluated by appropriate management personnel; failure to require the wound care nurse demonstrate competencies; and failure to require patients' assignments be based on acuities;

Reference tag A0395: regarding the failure to document assessments and sedation levels; failure to document wound descriptions/treatment and obtain wound care; failure to require complete medication orders prior to administration; failure to notify the ordering physician of possible conflicting medication orders; failure to notify physicians of critical lab values; failure to require physicians' orders for restraints and to document assessments; and failure to complete required documentation of the Procedure Safety Checklist for surgical patients;

Reference tag A0396: regarding the failure to develop and implement nursing care plans;

Reference tag A0397: regarding the failure to assign patient care according to the competencies and skills of the staff;

Reference tag A0405: regarding the failure to to identify incomplete titration medication orders and obtain clarification prior to administration; and failure to require Propofol titrated drip be administered according to the physician's order;

Reference tag A0490: regarding the failure to require complete physicians orders for Nicardipine drip; failure to require complete physicians orders for titrated medications; and

Reference tag A0508; regarding the failure to require the hospital demonstrate an organized system for investigating, reporting, analyzing medication occurrences, and recommending actions for improvement.
VIOLATION: MEDICAL STAFF Tag No: A0338
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 to assume responsibility for patient safety related to ensuring complete orders, as determined by the following:

A0353 Medical Staff Bylaws: 1) The medical staff did not document complete medication orders to include dose, route, dilution, rate, stop/start dose, or titration instructions for 4 of 4 patients; and 2) did not sign restraint orders within 24 hours for 2 of 2 patients according to Medical Staff Bylaws Rules and Regulations.

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.
VIOLATION: MEDICAL STAFF BYLAWS Tag No: A0353
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of physician orders, medical staff bylaws, rules, regulations and staff interviews, it was determined the Medical Staff failed to enforce their bylaws requiring complete physicians' orders, as demonstrated by the:

1. failure to require physicians write complete medication and titration orders that included minimum and maximum dosing, titration increments, and specific parameters for blood pressure or sedation levels, for 4 of 4 patients (Patients #2, 7, 8 and 15); and

2. failure to require physicians signed restraint orders within 24 hours (Patients #1 and 2) according to Medical Staff Bylaws Rules and Regulations.

Findings include:

1. The Medical Staff Bylaws, Rules and Regulations (approved 04/26/11), require: "...The practitioner's orders must be written clearly, legibly and completely. Orders which are...improperly written will not be carried out until rewritten...."

Reference tag A0501 Pharmacist Responsibilities Item #1: failure to require complete orders for titrated medications for Patients #2, 7, 8 and 15.

2. The Medical Staff Bylaws, Rules and Regulations (approved 04/26/11), require: "...Restraint orders (verbal or telephone), must be signed with (sic) 24 hours. Failure to do so shall be brought to the attention of the practitioner, and Chairman of the appropriate Department...."

Patient #1 was admitted on [DATE] with an altered level of consciousness, electrolyte imbalance, and history of previous cerebral vascular accidents (CVA's). The medical record revealed the following:

04/13/11 at 0300: Nursing documented on the 24 Hour Restraint Non-Violent Flowsheet that the patient required restraints, documented the clinical justification that the patient was pulling at invasive tubes/devices, and that restraints were required for patient safety.

04/15/11: The physician signed an untimed restraint order, however the medical record confirmed that the patient was not restrained on 04/15/11.

04/16/11: Restraints in place at 0700 continuously through 04/19/11 at 1500.

04/17/11 and 04/18/11: The physician signed untimed restraint orders.

Patient #2 was admitted on [DATE] with peripheral vascular disease requiring endovascular intervention and angiogram. Additional procedures were required when the patient lost pulses in both feet. She was discharged to a long term acute care facility on 03/28/12. The medical record revealed the following:

03/24/12 at 0600: Nursing documented on the 24 Hour Restraint Non-Violent Flowsheet that the patient required restraints, and documented the clinical justification that the patient was pulling at invasive tubes/devices. Nursing documented a physician's telephone order for restraints. The physician (#2) signed the order on 03/31/12, which was 7 days post telephone order.

03/31/12: Physician #2 signed a blank restraint order form, which was 2 days post patient discharge.

The Director of ICU confirmed during an onsite interview that physicians did not sign restraint orders within 24 hours, as required by the Medical Staff Bylaws Rules and Regulations.
VIOLATION: NURSING SERVICES Tag No: A0385
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 by failing to identify, prioritize, evaluate and execute corrective actions related to deficient medication administration practices, develop and implement effective care plans, and ensure staffing assignments are made according to the patients' health care needs and staff competencies.

The hospital failed to assume responsibility for Nursing Services as determined by non-compliance with the following regulations:

A0392 Staffing and Delivery of Care: Staffing schedules did not take into consideration the numbers and acuities of patients, and staff competencies;

A0395 RN Supervision of Care: Nursing did not document assessments and sedation levels for patients receiving titrated sedation medication; did not document wound descriptions/treatment and require wound care consultations per policy; did not require complete physicians' orders for titrated medication prior to administration; did not notify the physician that the patient was administered Propofol and Precedex concurrently; did not document notifying the physician of critical lab values; did not require physician's orders for restraints and document assessments for restrained patients; and did not complete required documentation of the Procedure Safety Checklist;

A0396 Nursing Care Plan: Nursing did not develop and implement nursing care plans that identified patients' needs, interventions, and goals;

A0397 Patient Care Assignments: Nursing leadership did not consider and require nursing competencies when RN #42 was assigned to a patient (identified in the Root Cause Analysis report) but failed to assess and take action, which contributed to the patient's death; and failing to require RN #74 had documented competencies to pull Patient #2's arterial sheath that subsequently resulted in emergency surgery; and

A0405 Preparation and Administration of Drugs: Nursing did not clarify physicians' incomplete orders prior to administering patients' medication.

The cumulative effect of these systemic deficient practices resulted in the hospital's failure to meet the requirements for the Condition of Participation for Nursing Services.
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
Based on review of hospital policies/procedures, Organizational Chart, personnel files, and staff interviews, it was determined that nursing leadership failed to require RNs, Anesthesia Techs, Surgical Techs, and Sterile Processing Techs had competencies evaluated by appropriate management personnel, and that RN-to-patient assignments were made according to an acuity plan, per policy, as demonstrated by the:

1. failure to require Surgical Services staff (RNs, Anesthesia Tech, Surgical Techs, and Sterile Processing Techs) competencies were evaluated by appropriate management personnel;

2. failure to require Wound Care Nurse #28 demonstrated competencies prior to providing services; and

3. failure to require patient assignments were based on patients' acuities, and according to the scope of practice, competence, and experience of staff caring for the patients.

Findings include:

1. The hospital policy titled Competency of Staff #HR003 (last review 10/10), requires: "...Department Director, or designee, in conjunction with the Education Coordinator, will complete periodic competency assessments and validations of staff to include a review of...ability to perform specific responsibilities defined in their job description...competencies as defined in the department/unit specific structure standards or policy and procedure manuals...Competency testing will be conducted on an annual basis...Competency validations may include: skill demonstration, cognitive testing, oral verbal evaluations, and/or peer review...."

The Performance Evaluation Job Duty Competencies form requires the following ratings: 1 (needs improvement) through 5 (exceeds expectations). Competency Assessments require the following ratings: 1 (needs instruction) to 5 (able to teach).

Radiology Tech (RT) #4 is the Director of Radiology, Central Scheduling, Wound Care, Day Surgery, and Business Manager of Surgical Services, according to the hospital's Organizational Chart. RT #4 provided documentation of only 2 of her Job Descriptions as follows: Director of Radiology (signed 11/2011), and Clinical Director (signed 07/27/12).

The hospital's interim CEO conducted and signed RT #4's Performance Evaluation on 10/29/12, as follows: Job Duties scored "5" in all 6 categories, and Competencies scored "4" - "5" and verified by "DO" (direct observation) in all 8 categories, as follows:

Critical Thinking
Safe Environment
Infection Prevention
Computer Usage
Communication
Department Environment/Operations
Leadership
Management Skills

RT #4 conducted, documented, and signed Performance Evaluations and Job Duty Competencies for clinical staff members, as follows:

RN #3 Charge Nurse: Performance Evaluation: scored "5" in 18 categories, without competency verification, that included the following:

Assesses patient's physical, psychosocial...safety/risk...discharge planning
Determines nursing diagnosis
Individualizes patient's plan of care
Implements nursing and medical orders
Assists physicians with special tests and procedures
Recognizes...changes in patient condition...intervenes to prevent further deteriorization (sic)
Collaborates with physician to develop new plan of care
Initiates and performs life support measures effectively during emergency/crisis situations
Coordinates multidisciplinary team...for...patient's care and discharge needs
Documents patient care assessments...interventions
Makes assignments, delegates and supervises care provided by...RNs, LPNs
Adherence to...professional practice standards, laws, and regulations

Competency Assessment scored "5" in each of 10 categories, with no documentation of competency verification as follows:

Critical thinking
Assessment
Plan of Care
Safe Environment
Infection Prevention
Communication/Continuum of Care
Leadership
Fall Prevention
Computer Usage
Department Environment/Operations

Competency Assessment by Department (Surgery): scored "5" in each of 10 categories, with no documentation of competency verification as follows:

Surgical Patient Care
Pain Management
Medication Administration
Skills and Procedures
Conscious Sedation
Intravenous (IV) Therapy
Specimen Collection
Blood Transfusion
Wound/Pressure Ulcer Prevention
Restraints

RN #35 Operating Room Nurse scored either "3", "4" or "5" in all categories on her Performance Evaluation and Competency Assessment, and no competency verification.

RT #4 signed the evaluations and competencies on 10/26/12.

Anesthesia Tech #16: Performance Evaluation scored "3" - "5" in all 14 categories, with no competencies verified, as follows:

Set up of anesthesia equipment
Follows laser operating procedures
Set up of arterial lines, blood warmers...cell savers
Assist physicians with...epidural, spinal, regional blocks and difficult intubations

Job Competencies: scored "3" - "5" in all 7 categories, with no competencies verified, as follows:

Critical thinking
Safe Environment
Infection Prevention
Teamwork
Skills and Procedures
Department Environment/Operations

RT #4 signed the evaluation on 10/23/12.

Central Sterile Technician (Instrument Tech) #21: Job Duties scored "3" in all 12 categories, with no competencies verified, as follows:

Decontaminates, cleans and processes items according to established standards
Utilizes equipment in the sterile processing environment according to manufacture's guidelines
Maintains power equipment
Performs sterility assurance testing
Complete documentation of the sterilization process

Competencies: scored "3" in all 7 categories, with no competencies verified, as follows:

Critical Thinking
Safe Environment
Infection Prevention
Computer Usage
Communication
Department Environment/Operations
Teamwork

RT #4 signed the evaluation on 10/23/12.

Certified Surgical Technician #36: Job Duties scored "4" - "5" with no competencies verified, in 11 categories that included the following:

Conducts and documents sponge, instrument and needle counts
Working knowledge of current surgical scrub technology and medical terminology
Coordinates with circulating nurse

Competencies: scored "4" - "5" in all 8 categories, with no competencies verified, as follows:

Critical Thinking
Safe Environment
Infection Prevention
Communication/Continuum of Care
Teamwork
Skills and Procedures
Specimen Collection
Department Environment/Operations

RT #4 signed the evaluation on 11/06/12

Surgical Technician (non-certified) #37: Job Duties scored "3" - "5" in 12 categories with no competencies verification, that included the following:

Coordinates with circulating nurse
Recognizes, intervenes and reports...changes in the patient's status
Working knowledge of current surgical scrub technology

Competencies: scored "3" - "5" in all 8 categories, with no competencies verification, as follows:

Critical Thinking
Safe Environment
Infection Prevention
Communication/Continuum of Care
Teamwork
Skills and Procedures
Specimen Collection
Department Environment/Operations

RT #4 signed the evaluation on 10/24/12.

RT #4 is not qualified to assess the skills/competencies of a Registered Nurse, Central Sterile Technician, Anesthesia Technician or Surgical Technicians. RT #4 indicated during an interview conducted on 11/28/12, that she was waiting for the new Associate Director of Nursing (ADON) to begin employment to approve the evaluations.

2. The hospital policy titled Job Description: Registered Nurse #2305 (last revised 01/11), requires: "...Required Certification/License...Wound Care...Wound-Ostomy Certification or Training in Wound Care and/or Ostomy Care...."

Wound Care RN #28's hire date was 09/12/11. The nurse's personnel file did not contain evidence of Wound-Ostomy certification or training in wound care and/or Ostomy care.

The 90-Day Orientation Competency Profile - Wound RN requires: "...This checklist must be completed and reviewed at the end of the 90-day evaluation...."

The checklist instructions required the following documentation:

Self Assessment...1 = unfamiliar...2 = need practice....3 = competent.

Validation Method (VM):

1 = direct observation/Skills return demonstration
2 = Education: In-service/Continuing Education
3 = Review: Appropriate Answer or reasons. Chart Review/Simulated Situation/Case Study Lecture
4 = Exam Self Study/Written Exam/Post Test

Performance Level (PL):

1 = Novice...needs instruction...performs with assistance
2 = Intermediate: performs independently
3 = Expert: acts as department resource, able to teach/teaching observed

Instructions on the form to the evaluator indicated: "...If results are noted as 'novice' or evaluator believes staff needs additional guidance, list what will be done to increase the employees knowledge and proficiency...."

RN #28 documented a self-assessment and "Standard/Skill/Knowledge" as follows: Equipment Management i:e: rental beds, wound VACs (vacuums): score "2"(need practice)

RN #28 scored the following as "1" (unfamiliar):

Application of wound vacuum
Attends wound vac class/reviews
Chart review re: house acquired pressure ulcers
Participates in: wound related process, orders, case management, physician staff training, product evaluation
Participates in Case Management
Prepares documentation re: placement of discharge/other durable medical equipment
Participates in: Ostomy staff training, product review, patient education
Participates in: diabetes staff training, product review, patient education
Aseptic technique during wound care

The Evaluator/Preceptor/Re-Evaluator's Assessment, performed by the Wound Care RN evaluator, did not document comments or Action Plans, although signed: "...I agree that this complete checklist accurately reflects the abilities of the employee regarding the listed competencies..." on 10/05/11, which was 30 days post hire and 60 days prior to the required 90 day evaluation period. RN #28 signed: "...I agree that this completed checklist accurately reflects my abilities regarding the listed competencies..." on 10/05/11.

The Evaluator documented on 10/16/12 that RN #28 had "all current certifications."

The Orientation/Competency Skills List follow up dated 11/14/11, required the nurse's self assessment, and documentation of Evaluation - Validation. RN #28 assessed herself as follows:

Score "1" (have performed) for the following:

Places sterile supplies required for dressing removal on over-bed table
Removes old compression bandage and old dressing material used as primary dressing and disposes of materials in appropriate container
Assess and measures wound areas
Uses sterile normal saline to cleanse debris from wound area
Cleanses and dries wound with sterile 4 x 4 gauze
Observes color of the wound
Observes odor of wound
Assesses level of moisture in wound
Evaluate laboratory results
Appropriately documents findings
Administers topical, oral, intramuscular and intravenous medications as ordered

Scored "5" (have performed but needs additional experience) as follows:

Assess wound drainage: type/odor/color
Assess peri-wound area
Measure length and width of wound
Measure depth of wound
Assess wound for tunneling

The Evaluator documented her initials but did not document the following required Evaluation - Validation codes/comments:

P = per review
D = demonstration
S = simulation
W = written test
O = oral exam
Ob = observation
C = chart check/documentation
Ca = case study + post test

The Evaluator documented her assessment of RN #28's skills as follows:

Competencies: scored "4" - "5" in all 7 categories, with no documentation of competency verification, as follows:

Patient Care: demonstrates systematic skin and wound assessment
Skills and Procedures
Fall Prevention
Restraints
Infection Prevention
Safe Environment
Leadership

Competency Assessment by Department: scored "4" - "5" in all 2 categories, with no documentation of competency verification, as follows:

Wound /Pressure Ulcer Prevention:

Completes total skin assessment
Identifies risk for pressure ulcers and wounds
Assist staff with the prevention, identification, staffing and care of the pressure ulcers and wounds.

Ostomy Care:

Demonstrates accurate (sic) of the patient with an Ostomy
Assist staff with the care of the Ostomy.

The Evaluator documented: "...(RN #28) was new to the wound care department with little knowledge in the field...she has improved greatly...."

RN Educator #18 confirmed no documentation that verified the required competencies for Wound Care RN #28, during the personnel file review and interview conducted on 12/04/12.

3. The hospital policy titled Nursing: Scope of Practice, Delegation, and Supervision #1899 (effective 10/2010), requires: "...Patient assignment will be based on patient acuity, scope of practice, competence, and the experience of staff caring for them...."

The hospital policy titled Staffing By Acuity and Patient Classification #1348 (last review 02/12), requires: "...patient acuity levels are updated every shift...the level of care is identified through the implementation of the patient acuity worksheet...."

The hospital policy titled Staffing by Acuity System (Patient Classification System) #PC002 (last review 10/10), requires: "...The (hospital) uses a system to identify patients' acuity levels...This information is used to determine safe and appropriate staffing levels for patients...On admission and transfer, and following assessment...verify that the acuity assigned in the computer is correct...complete the Acuity Level Form. This form is provided to the Directors for their review...."

Progressive Care Unit (PCU) Director and interim Intensive Care Unit (ICU) Director #8, House Supervisor RN #38, and Staff RN #40, confirmed the following during interviews conducted on 11/30/12:

1. The acuity plan was not implemented.
2. Staffing was based on nurse-to-patient ratios.
3. Acuities were not assigned.
4. The Acuity Level Form was not used.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, medical records, laboratory reports, and interviews, it was determined that the registered nurses failed to assess patients and evaluate their needs, document nursing interventions, and notify physicians of medication discrepancies and critical laboratory results, per policy, as demonstrated by the:

1. failure to document assessments and sedation levels, per policy, for 4 of 4 patients (pts.) receiving titrated sedation medications (Pts #2, 7, 8 and 15);

2. failure to document wound descriptions/treatments and obtain wound care consultations, per policy, for 3 of 3 (Pts #1, 9 and 13);

3. failure to require complete medication orders prior to administration for 3 of 3 patients receiving titrated drip medications (Pts #2, 7 and 8);

4. failure to notify the ordering physician that 1 of 1 patients was administered Propofol and Precedex together for 16 hours from 03/21/12 through 03/22/12, and that Precedex was administered for greater than 24 hours (Pt #2);

5. failure to notify the ordering physician of critical lab values for 2 of 2 patients, per policy (Pts #2 and 13);

6. failure to require physician's restraint orders, and document assessments for 2 of 2 restrained patients, per policy (Pts #1 and 2); and

7. failure to complete required documentation of the Procedure Safety Checklist (items 1 - 20) for 2 of 4 surgical patients prior to admission to the surgical holding area (Pts #10 and 11).

Findings include:

The hospital policy titled Continuous IV (intravenous) Sedation & Neuro Blockade Medications (effective 05/01/11), requires: "...Scope: All patients at both campuses...Physician's order is required for continuous sedation and mechanical ventilation...trained staff may adjust medication dose to achieve...sedative goal...Sedation score and vital signs are monitored and documented every 15 minutes for one hour, every 30 minutes for the next hour, then every hour thereafter after initiation, with each rate change, or when weaning from continuous sedation. Discontinue sedation on a daily basis until patient is able to follow commands or becomes agitated or uncomfortable...."

The hospital document titled ICU (intensive care unit) Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients, dated 01/12, requires: "...Patient Monitoring...Assess Ramsey and pain scores hourly and adjust drugs as needed...If patient does NOT meet criteria for use of the PREFERRED benzodiazepine based sedation protocol, select & check ONE of the regimens/medications listed below to maintain a goal Modified Ramsey Score of (practitioner to list)...Propofol...CONTINUOUS infusion...Dexmedetomidine (Precedex) CONTINUOUS infusion: Use can continue after extubation as long as the total duration does not exceed 24 hours...."

The hospital policy titled Titrating Medications requires: "...Clinical staff must assess the patient when titrating medications to detect potential problems as early as possible...." The form titled ICU Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients requires: "...assess Ramsey...hourly...."

Hospital policies required different monitoring interval instructions for nursing personnel, as follows: PBH nursing personnel were to document hourly sedation levels according to the ICU Manager, and AZHH nursing personnel were to document sedation levels every 4 hours according to the ICU Director.

1. Patient #2 was admitted on [DATE] with peripheral vascular disease requiring endovascular intervention and angiogram that were performed on 03/14/12. Two additional procedures were subsequently performed after the patient lost pulses in both feet, as follows:

03/15/12 at 0330: Physician order: "...Propofol drip for sedation, Ramsey 3 - 4...." Nursing initiated the drip at 0340. The first Modified Ramsey Scale Score was documented at 2230, which was 19 hours after the drip was initiated. The patient continued on Propofol through 03/20/12 at 0830. Nursing documented sedation levels every 4 hours, despite rate changes.

03/20/12 at 1135: Physician order: "...Precedex gtt (drip) IV titrate for comfort...." Nursing initiated the sedation drip at noon on 03/20/12. The first Ramsey score was documented at 1830 hours, which was 6 hours after the sedation was initiated. The score was "1." The next score documented was 4 hours later and remained "1." Four hours later the Ramsey score was documented "3." The nurse did not clarify the physician's order which did not include parameters for the desired sedation level.

03/21/12 at 1640: Physician order: "...Propofol drip keep comfortable tonight...." Nursing initiated the drip at 1700, and administered Precedex in conjunction with Propofol. Documentation on the Sedation Vacation With Response area in the medical record revealed: "...03/21/12 (from) 1800 - 1830...Propofol restarted, then Precedex started at low dose because pt. still restless even (with) Propofol on...." Nursing documented the Modified Ramsey Sedation Score every 4 hours as "3" - "4." Nursing documentation indicated the patient was on Precedex from 03/20/12 at 1830 through 03/22/12 at 1030 hours which exceeded the 24 hour maximum required by protocol.

03/23/12 at 0930: Physician order: "...(change) Propofol to Precedex gtt...." Nursing documented "done" on the right hand side of the page, however, did not document that Precedex was initiated on the required Ramsey Scale With Ventilator Bundle Flowsheet on 03/23/12.

Patient #7 was admitted on [DATE] with bacterial endocarditis involving the mitral valve, requiring a valve replacement on 11/23/12. The medical record revealed the following:

11/24/12 at 1040: Physician order: "...Propofol IV drip as needed for sedation...."

11/27/12 Physician order (untimed): "...Precedex drip for sedation...."

Nursing did not clarify the physicians' orders, and documented the patient's Ramsey score approximately every 4 hours.

Patient #8 was admitted on [DATE] for a coronary artery bypass (open heart surgery). The surveyor's review of the medical record on post operative day #1, revealed the following:

11/28/12 at 1100: Physician order: "...Precedex gtt PRN (as necessary)...."

Nursing did not clarify the physician's order, nor documented the sedation level on the Ramsey Scale With Ventilator Bundle Flowsheet. No documentation was identified for the Ramsey score achieved by nursing with the administration of Precedex initiated on 11/28/12 at 1115.

The Director of ICU confirmed during an interview conducted on 11/28/12 at 1445, that nursing was documenting the Ramsey Scores every 4 hours and that she was unaware of the monitoring requirements stated in the policy titled Continuous IV Sedation & Neuro Blockade Medications. The Director of ICU verified that nursing did not document Ramsey scores for Patient #8 during the Precedex infusion.

The Region Vice President of Quality, and the Interim CEO explained during interviews conducted on 11/29/12 at 0830, that the Medical Executive Committee adopted titration drip protocols/order sets that were intended to be implemented at the AzHH campus, however, the protocols were never implemented.

Patient #15 was admitted on [DATE] status post cerebral vascular accident (CVA), with renal insufficiency, hypertension, aphasia and bleeding status post temporary portacaval anastomosis (TPA). The ICU physician ordered a Dexmedetomidine (Precedex) Drip on 12/3/12 at 1315 to provide sedation while the patient was mechanically ventilated.

Nursing did not document hourly Ramsey Scores when the patient was on a continuous drip, as follows: 12/3/12 at 2100, 2200 and 2300, and 12/4/12 at 0100, 0200, 0400, and 2200.

The PBH ICU Nurse Manager confirmed during an interview conducted on 12/05/12, that the nursing staff did not follow hospital policy to consistently monitor/assess Pt #15's hourly Ramsey scores.

2. The hospital policy titled AZHH: Skin and Wound Care requires: "...Any wound ulcer at Stage II or greater must be documented with a photo...Assessments...on admission and...every shift...Every patient's skin will be assessed and re-scored every shift and the score will be documented on the Patient Care Flowsheet...For any patient identified as moderate risk, a Braden Scale of 13 - 14, the Registered Nurse will institute Early Skin Care Management Measures...according to the patient's individual needs. The Registered Nurse will initiate an order from the physician for a Wound Care Clinic consult as appropriate...High Risk Skin Care Management...Turn patient every two hours and record on the Patient Care Flowsheet...."

The hospital document titled When Should You Order A Wound Consult, requires: "...Anytime a patient is admitted with a pressure ulcer or a wound...Anytime a patient develops a pressure ulcer or a wound...Anytime a patient has an order for a wound VAC (vacuum)...."

Patient #1 was admitted on [DATE], and discharged to a long term acute care facility on 04/19/11. The reason for admission was documented as altered level of consciousness, secondary to electrolyte imbalances and history of multiple cerebrovascular accidents. The patient required restraints for pulling on medically necessary devices (tubes). The Emergency Department (ED) physician documented the following on admission: "...Skin: 1 (degree) sacral decubitus...."

Nursing documented the following:

04/12/11 at 1330: Admission Wound 1...skin tear, stage II...right forearm.
04/13/11 no dayshift assessment documented.
04/13/11 at 1840: Skin intact.
04/14/11 (no time): Skin intact.
04/14/11 at 1820: Skin intact.
04/15/11 at 0700: Duoderm coccyx area.
04/15/11 no second shift assessment documented.
04/16/11 at 0700: Alevyn on buttocks clean and dry, Stage II.
04/16/11 no second shift assessment documented.
04/17/11 at 0700: Sacral breakdown, Alevyn patch.
04/17/11 no second shift assessment documented.
04/18/11 at 0648: Sacral wound - alevyn.
04/18/11 at 1830: Bilateral groin punctures - slow ooze, dressing applied.
04/19/11 at 0630: Sacral wound with duoderm. Bilateral groin punctures, open to air.

Nursing did not document turning the patient every 2 hours, per policy, on the following days:
04/13/11, 04/14/11 and 04/19/12.

The Director of ICU confirmed during an interview conducted on 11/28/12, that nursing documentation regarding the pressure ulcer was not consistent, did not contain descriptions or wound measurements, did not identify if the patient was turned every 2 hours, per policy, nor if the nurse requested a wound consult.

Patient #9 was admitted on [DATE] for a and thrombectomy of the left leg. The patient received a split thickness graft on 11/26/12. The surveyor reviewed the medical record with the Director of ICU, and the primary care nurse assigned to the patient, on 11/29/12. Both confirmed that the patient required a wound VAC from 11/07/11 through 11/11/12, and that nursing had physician's orders for wet-to-dry dressing changes after the wound VAC was discontinued and until the skin graft was placed on 11/26/12. The medical record revealed that nursing did not document a description of the wound with measurements, did not obtain a wound consult, and did not photograph the wound, per policy.

Patient #13 was admitted on [DATE] at 2200 with an infected peritoneal dialysis catheter site and multiple painful abdominal wounds, according to the medical record. Nursing documented complete wound descriptions including site, staging, drainage, and odor on admission. There were no physician's orders for wound care.

11/26/12 at 0200, the physician ordered: "...Silvadene cream to open ulcers...." (remainder of order illegible) and documented: "...stage 2 wounds to abd (abdomen)...cleansed site and applied Silvadene - will request wound care nurse...." At 0700: "...multiple abdominal wounds - necrotic - silvadene applied...."

Nursing documentation 11/24/12 through 11/29/12 did not include complete wound descriptions for size, color, drainage, odor, and treatment. In addition, there was no documentation to confirm a wound care nurse consult was requested.

RN #40 confirmed that she was the patient's assigned nurse, during an interview conducted on 11/30/12. RN #40 indicated that the patient's wounds were infected, there were no physician's orders for treatment, and that she ordered a wound care consultation (at 1350). The medical record however confirmed the Silvadene order. RN #40 stated that she was unaware of the order, and confirmed no documentation that Silvadene was applied 11/27/12 to 11/30/12.

Patient #13's wounds were not documented according to hospital policy, and not treated according to physician's order.

3. Patients #2, 7 and 8: Reference Tag 0501 Pharmacist Responsibilities, findings #2.

4. Patient #2: Reference Tag 0501 Pharmacist Responsibilities, findings #1. In addition, the medical record revealed the following:

03/20/12 at 1135, the Physician ordered: "...Precedex gtt IV titrate for comfort...." Nursing initiated the drip at noon on 03/20/12.

03/21/12 at 1640, the Physician ordered: "...Propofol drip keep comfortable tonight...." Nursing initiated the drip at 1700. According to documentation on the Ramsey Scale With Ventilator Bundle Flowsheet, nursing administered Precedex in conjunction with the Propofol. Sedation Vacation With Response documentation included: "...03/21/12 (from) 1800 - 1830 Propofol restarted, then Precedex is started at low dose because pt. still restless even (with) Propofol on...." Nursing documented the Modified Ramsey Sedation Score every 4 hours as "3" - "4." Documentation indicated the patient was on Precedex from 03/20/12 at 1830 through 03/22/12 at 1030. This exceeded the 24 hour maximum, required by protocol. In addition, the protocol indicated that only 1 sedation medication be administered.

Nursing did not clarify the duplicate medication orders, did not notify physicians that Precedex and Propofol were administered together, and that Precedex was administered for over 24 hours.

5. The hospital policy titled Critical Diagnostic Values or Interpretations: Reporting of, requires: "...Notify responsible physician of critical values or findings as soon as possible for further orders...Consider initiating the Chain of Command when having difficulty notifying the patient's physician for further instruction/orders or if the patient's clinical condition is deteriorating or when unable to notify within 1 hour time from when result was reported...Read Back of critical diagnostic result/finding...Date and time report was received...Notification of physician...."

The Director of ICU indicated during an interview conducted on 11/29/12, that nursing is expected to utilize a sticker titled Critical Lab or Diagnostic Test Results that is placed in the physician's order section of the medical record. Nursing personnel are required to document the sticker with the reported critical lab value(s) and physician notification.

Patient #2's medical record revealed Critical Lab or Diagnostic Test Results stickers as follows:

03/16/12: Lab reported a critical value of pH 7.252 for arterial blood gas. Nursing did not document that the physician was notified.

03/17/12 at 1730: Lab reported a critical value of "PT" (Prothrombin time) 76.5 (normal 9.5-11.5) and "INR" (International Normalized Ratio) 7.85 (normal 0.80-1.20). Nursing did not document that the physician was notified.

Laboratory reports for arterial blood gases from 03/15/12 through 03/17/12 revealed the following:

0315/12 at 0240: pH 7.056 (critical low CL), PCO2 85.0 (critical high CH)
03/15/12 at 0300: pH 7.089 (CL), PCO2 76.7 (CH)
03/15/12 at 0330: pH 7.189 (CL)
03/15/12 at 0445: pH 7.207 (CL)
03/15/12 at 2245: pH 7.271 (CL)

The Director of ICU confirmed during an interview conducted onsite, that the above critical lab values were not documented on the Critical Lab or Diagnostic Test Results stickers in the the medical record. She confirmed the requirement that nursing utilize the stickers for physician communication.

Patient #13's medical record revealed the following: The lab reported a critical low Sodium value of 125 on 11/30/12 at 0535. There was no documented evidence, as of 11/30/12 at 1300, that nursing notified the physician.

6. The hospital policy titled Restraints and Seclusion in the Acute Care Setting, requires: "...Restraint orders may be given, written or verbally obtained by phone...order is limited to one calendar day for one episode of restraint...Evaluation, Assessment/Reassessment, and Monitoring during the Restraint or Seclusion...Minimally every two (2) hours unless more frequent monitoring of the patient is determined to be necessary...."

The hospital policy titled Physician Orders: Accepting, Transcribing, and Signing Off, requires: "...Verbal orders are accepted after writing and then verifying the order by reading back the written order to the physician...prior to implementation...Written orders are dated, timed, and signed by the practitioner receiving the order...Verbal/Telephone orders will be documented with V.O. or T.O. preceding documentation of the ordering practitioners name and licensed staff receiving the order...."

Patient #1 was admitted on [DATE] with an altered level of consciousness, electrolyte imbalance and history of previous CVA's. The medical record revealed the following:

04/13/11 at 0300: nursing documented on the 24 Hour Restraint Non-Violent Flowsheet, that the patient required restraints, documented the clinical justification that the patient was pulling at invasive tubes/devices, and that restraints were needed for patient safety.

The physician's Restraint Order Form was initiated on 04/13/11 at 0300. The handwriting for the nursing date/time was the same handwriting for the physician's date/time. The Director of ICU confirmed during an interview and medical record review conducted on 11/29/12, that she could not determine if the nurse obtained a verbal telephone order or if the physician wrote the order. If nursing obtained a verbal order the nurse obtaining the order did not sign his/her name, credentials, and the physician's name, according to hospital policy for a telephone order.

The restraints were removed on 04/14/11 at 1200 (noon). The physician signed an untimed restraint order on 04/15/11, however, there was no documentation that the patient was in restraints on 04/15/11. The restraints were re-applied on 04/16/11 at 0700, however the next order for restraints was obtained on 04/16/11 at 2100 hours. Nursing personnel restrained the patient for 14 hours without an order. The patient remained in restraints from 04/16/11 at 0700 hours continuously through 04/19/11 at 1500 hours.

The restraint order on 04/18/11 indicated "Nurse to document when RESTRAINTS INITIATED: Date: 04/18/11 Time: 0600...." The physician's signature is present without a date or time. The Director of ICU confirmed she could not determine if this was a telephone/verbal order obtained by nursing, since nursing did not document his/her name, credentials, and physician's name on the order sheet.

Patient #2 was admitted on [DATE] with peripheral vascular disease requiring an endovascular intervention and angiogram and additional procedures. The medical record revealed the following:

03/26/12 at 0600: nursing documented on the 24 Hour Restrain Non-Violent Flowsheet that the patient required restraints and documented the clinical justification as the patient pulling at invasive tubes/devices. Nursing did not document assessments every 2 hours from 1700 on 03/26/12 through 0500 on 03/27/12. In addition, nursing did not document the restraints were removed during that timeframe.

The Director of ICU confirmed the findings during an interview conducted on 11/29/12.

7. The hospital form titled Procedural Quality Checklist/Procedure Safety Checklist, requires: "...Patient may not be sent to holding area unless all items 1 - 20 are checked 'yes'...." The form has a column for N/A, however, directions on this form include "if N/A check yes."

Patient #10 was admitted on [DATE] for a right leg angiogram, angioplasty, arthrectomy and stent. Review of the medical record conducted with the Director of ICU on 11/29/12, confirmed the following orders were in the medical record:

11/28/12: Pre-Operative Vascular/Endoscopy Orders...UA w/reflex to microscopic and culture if indicated...ECG (if not done within 1 week)...."

The Director of ICU on 11/29/12, confirmed the following items were not checked:

Item #11: Ordered lab results in medical record EKG (electrocardiogram) CXR (Chest x-ray)

Item #12: Urinalysis results in medical record HCG (human chorionic gonanatrophin (on female patients less than [AGE] years old (If NA check Yes)

Item #19: Patient voided prior to procedure

The Director of ICU confirmed the items were blank. She confirmed the EKG in the medical record was not within the required 1 week timeframe ordered by the physician, and no urinalysis report was in the medical record. She explained that it is required that nurses complete the Procedure Safety Checklist on the nursing unit prior to sending patients to the surgery holding area.

Patient #11 was admitted on [DATE] for a cardiac catheterization. Review of the medical record conducted with the Director of ICU on 11/29/12, revealed the following items were not checked:

Item #15: Pre-Procedural Teaching Completed including steps to prevent surgical site infections and wrong site surgery-Patient/family given written education specific to procedure

Item #16. Patient understands measures taken to prevent adverse events in surgery including steps to prevent surgical site infections and wrong site surgery

Item #17: Vital signs: Time: (left blank) B/P (blood pressure) (blank) Pulse (blank) Resp (respirations) (blank) Temp (temperature) (blank) SPO2 (Saturation of oxygen) (blank)

Item #19: Patient voided prior to procedure

Item #20: Pre-op Meds sent with patient. Specify Antibiotic: (blank)

Patient # 11 had a second procedure in the EP (Electro Physiology) Lab on 11/29/12 requiring another Procedure Safety Checklist. The following items were not checked:

Item #3: Face sheet on chart/addressograph labels in medical record

Item #4: Patient identification verified using 2 patient identifiers

Item #5: Identification band on patient and legible. Specify location: (blank)

Item #9: History and Physical in medical record (within 7 days of procedure and updated day of procedure)

Item #11: Ordered lab results in medical record EKG, CXR

Item #12: Urinalysis results in medical record HCG on female patients less than [AGE] years old (If NA check Yes)

Item #13: Jewelry removed. Specify item(s) removed and disposition

Item #19: Patient voided prior to procedure

The Director of ICU confirmed the unchecked items, and confirmed that the policy requires the Procedure Safety Checklist be completed on the nursing unit prior to sending patients to the surgery holding area.
VIOLATION: NURSING CARE PLAN Tag No: A0396
Based on review of hospital policies, medical records, and staff interviews, it was determined that the hospital failed to have a system to develop Nursing Care Plans that identified patients' nursing care needs, nursing interventions, updates and revisions to the care plan, described goals, and ensured nursing care plans were revised as patients' needs changed.

Findings include:

The Director of PCU/Interim ICU Director, and the Interim Director of Quality stated during interviews conducted on 12/05/12, that nursing care plans were developed according to the following 2 policies: Plan for Patient Care #1836 (effective 01/10), and Standards of Care - Patient Care Unit #PC105 (last revised 03/07).

The Directors identified the Clinical Path Plan forms in medical records as the care plans used by the AzHH campus. The form resembled a checklist of nursing tasks, was not individualized, and only indicated the type of procedure the patient had, or type of problem the patient was admitted with.

Neither policy identified how nursing care plans were developed to include nursing interventions in response to patients' identified nursing care needs, responses to interventions, or described goals.
VIOLATION: PATIENT CARE ASSIGMENTS Tag No: A0397
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of a sentinel event, personnel files, policies, procedures, and staff interviews, it was determined nursing leadership did not assign patient care according to competencies and skills of RN #42 and RN #74, as evidenced by:

1. RN #42 failed to assess a patient after a pacer and internal cardiac defibrillator were implanted when the patient's cardiac monitor showed pacer spikes without capture, resulting in the death of the patient; and

2. RN #74 failed to have documented competencies for pulling arterial/venous sheaths as required. Patient #2 lost pulses in the leg after the sheath was removed requiring emergent surgery for an open thrombectomy and patch of the left common femoral artery.

Findings include:

The hospital policy titled AZHH: Competency of Staff, required: "...Department Director, or designee, in conjunction with the Education Coordinator, will complete periodic competency assessments and validations of staff to include a review of...Their ability to perform specific responsibilities defined in their job description...Their competencies as defined in the department/unit-specific structure standards or policy and procedure manuals...Each Director is responsible for identifying educational needs pertaining to orientation, inservice, continuing education, and credentialing for the staff...."

1. RN #42 was hired to the hospital corporation's internal nursing pool on 06/09/09. She remained in the internal nursing pool and transferred to a permanent position on 03/04/12 at this hospital. The following is a time line of documentation in RN #42's personnel file:

01/19/10, written warning for failing to wash hands pre and post patient contact;

01/21/10, written warning for changing a physician's order without contacting the physician. Documentation explained that a patient had a computerized tomograph (CT) with contrast ordered on [DATE]. When the patient went for the test she told the technician she was allergic to contrast dye and the test was not performed. The technician called the nurse caring for the patient (RN #42) and explained the patient's allergy. The nurse said she would call the physician. The next day the patient went for the CT scan again and no new order was in the medical record. The technician called RN #42 who then wrote the word "out" after the word "with", changing the order to read "with out" contrast. The ordering physician confirmed he was not called by RN #42. This information was sent to RN #42's unit director;

03/23/10, verbal warning for failure to perform proper hand hygiene pre and post patient contact;

08/26/10, shift evaluation indicated RN #42 did not meet (NM) expectations for:

Presentation/Dress Code; Adapts to unit routines and role expectations;
Performs nursing interventions and treatments in a timely and safe manner;
Utilizes appropriate resources for problem solving;
Demonstrates positive interpersonal skills with patients, family, and health care team; Performance deficiencies identified: On personal e-mail; frequent complaints from staff RN #42 is rude; Makes a negative work environment. Signed by Nursing Supervisor;

08/26/10, shift evaluation included: "(RN #42) is very rude always whenever we approach. She looks very untidy she always not (sic) an approchable (sic) person. Signed by RN co-worker;

10/01/10, written individual performance improvement plan: "...Written Warning...RN inserted an Intravenous (IV) line on the Right Arm of a patient. This right arm had a deep vein thrombosis...(RN #42) inserted the IV without review of the patient's condition...Further Action To Be Taken...Further corrective action including termination of employment...." Signed by the Director of the hospital's corporation internal nursing pool;

10/15/10, written individual performance plan: "...Final Written Warning...IV (intravenous) Amiodarone and TPN (total parenteral nutrition)/Lipid discontinued prior to sending the patient to dialysis...Further Action To Be Taken...Further corrective action including termination of employment..." signed by the Director of the hospital's corporation internal nursing pool;

11/13/10, shift evaluation included: "...(RN #42) continues to be rude at times...when going to lunch does not report off. Nurses ask her to tell them about her pts. and she states 'No' and leaves..." signed by co-worker;

07/06/11, Performance Evaluation: indicated the employee met or exceeded expectations in all areas. The Competency Assessment by Position scored as "met expectations" for the following areas: "...Patient Care: Consistently provides quality, safe...care in developmentally and culturally appropriate manner...Demonstrates critical thinking...Initiates, monitors and maintains intravenous therapy in accordance with hospital policy...Ensures personal clinical competency for...skills and procedures...standards of care...Infection Prevention...."

03/12/12, RN #42 requested transfer for a permanent position at this hospital;

RN license statement included: "...There has been past disciplinary action taken against this person within the past 10 years...For information about this action, call (number)....";

05/07/12, verbal counseling: "...(RN #42) was off unit in excess of one hour for break. Verbal counseling given and copy of hospital policy provided..." signed by Resource Nurse;

05/08/12, Sentinel Event occurred with RN #42 which resulted in the death of a patient;

05/12/12, e-mail from co-worker who relayed information to the Director of ICU, that RN #42 was a "Do Not Return" (DNR) at another corporation hospital. She was not sure if this was faxed to the (internal pool name). Additional information included: "...she (RN #42) told me she has had difficulty working in this setting...she is not strong on her rhythms (cardiac) and seems unsure of herself. Specifically she has never mixed any cardiac drips, worked in an ICU (intensive care unit) setting or taken a critical care class. Thought you should know. I also mentioned this to (name of Resource Nurse)....";

05/21/12, individual performance improvement plan: "...Written Warning...(RN #42) was found sleeping in a patient empty room while on duty on 05/07/12. She was off the floor for 1.5 hours during this time. She also failed to comply with the department's protocol for patient care regarding telemetry monitoring, routine print out of rhythm strips and interpretation. Failure to recognize and appropriate (sic) patient cardiac rhythms more than one occasion (Sinus rhythm vs. A(atrial) - Fib). She also failed to carry out physicians orders accordingly and failed to practice read back process to clarify telephone orders...State the employees action plan for performance improvement...Employee must follow hospital policies at all times..." signed by the Director of ICU; and

06/13/12, Termination: "...(RN #42) was found sleeping in a patient empty room while on duty on 06/03/12. She was off the floor for 1 hour during this time. IV pump in patient room (number) was alarming and Heparin drip was empty. PCP (patient care provider) assigned in the Pod went looking for (RN #42)...found (RN #42) sleeping in room (number). (RN #42) then told the PCP to just turn off the pump and that she will be right out...."

The Director of ICU in an interview on 12/05/12 at 1505 hours, explained that she did not have prior knowledge of RN #42's verbal and written counselings documented in the personnel file. She assumed when she received the application for RN #42 that all the criteria required were met by the candidate. She explained she did not verify competencies, the competencies were verified by the internal pool agency. When asked why RN #42 was allowed to work after the Sentinel Event, she conveyed the hospital was waiting on the report from the monitoring company to verify the monitor was functioning properly. No additional monitoring or training was provided for RN #42.

In summary, RN #42 had multiple verbal and written counselings with no interventions by the nursing leadership prior to a Sentinel Event resulting in the death of a patient on 05/08/12. RN #42 was allowed to continue working after the Sentinel Event until 06/13/12. The RN had written counseling on 05/21/12. The performance improvement plans implemented by nursing leadership included review of policies and procedures only. No monitoring or verification of competencies was conducted at this hospital. Furthermore, the hospital did not identify during the root cause analysis that RN #42 had multiple verbal and written counselings prior to the sentinel event. The hospital did not identify opportunities for training or interventions for RN #42.

2. RN #74 was hired in 03/04. Documentation in her personnel file included annual competencies for 03/11, which included a written test for "Femoral Sheath Removal." Question #1 asked which personnel are authorized to remove femoral arterial/venous sheaths and RN #74 answered correctly, "Any RN who has demonstrated competency." RN #74 did not have documented demonstrated competency. The RN Educator confirmed on 11/28/12, that RN #74 did not have the required Sheath Removal competencies documented or demonstrated.

RN #74 was caring for Patient #2. Patient #2 was admitted [DATE] with peripheral vascular disease requiring an endovascular intervention and angiogram performed on 03/14/12. Two additional procedures were performed after the first as a result of the patient losing pulses in both feet. RN #74 received Pt #2 after the first procedure on 03/14/12, at 1055. The patient had a left common femoral artery sheath left in place after the procedure. At 1640 RN #74 documented removing the arterial sheath and holding manual pressure. The last recorded dorsalis pedal (DP) and posterior tibial (PT) pulses were at 1430 prior to sheath removal. RN #74 did not document pulses or neurovascular status after pulling the sheath at 1640. At 2100, nursing documented the patient developed a hematoma in the left groin, subsequently losing pulses distally in the left foot. The patient required emergent surgery for an open thrombectomy and a patch to repair to the left common femoral artery.

According to the hospital document titled Vascular Closure Site Assessment Competency Form the following is required: "...RN assesses the peripheral vascular and neurovascular status of the affected extremity after arterial sheath every 15 min X 4, every 30 min X 2, every 60 min X 4, including assessment of presence or absence of bruit and pain...." The RN Educator confirmed that RN #74 did not have this competency documented. The Director of ICU confirmed that RN #74 did not document pulses and neurovascular assessments as required after pulling the sheath.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review hospital policies/procedures, medical records, policies/procedures, and staff interviews, it was determined that nursing services failed to administer medications according to physicians' complete orders, as demonstrated by:

1. failure to identify incomplete titration medication orders and obtain clarification prior to administration for 4 of 4 patients receiving titrated medications (Pts #2, 7, 8 and 15); and

2. failure to require Propofol titration drip was initiated at the starting dose ordered by the physician (Pt #22).

Findings include:

The hospital policy titled Continuous IV Sedation & Neuro Blockade Medications, effective: 05/01/11, revealed: "...Scope: All patients at both campuses of Phoenix Baptist Hospital...Physician's order is required for continuous sedation and mechanical ventilation...staff may adjust medication dose to achieve the patient's sedative goal...Sedation score and vital signs are monitored and documented every 15 minutes for one hour, every 30 minutes for the next hour, then every hour thereafter after initiation, with each rate change, or when weaning from continuous sedation. Discontinue sedation on a daily basis until patient is able to follow commands or becomes agitated or uncomfortable...."

The hospital document titled ICU Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients, dated 01/12, revealed: "...Patient Monitoring...Assess Ramsey and pain scores hourly and adjust drugs as needed...."

The hospital policy titled Titrating Medications, effective 08/12, required: "...Orders for medications that require titration must include the desired rate the prescriber desires for the patient...Based on a physician's order, titration increments may vary depending on the patient's clinical status, comorbid conditions and other factors...A dose limit (maximum and minimum limits) at which the physician must be called for each titrated medication must be set if appropriate...The Pharmacist will contact the prescriber to obtain dose limits...Orders received for titrated medications without dose limits...will not be prepared or dispensed...."

The hospital policy titled Ordering and Administration of Medications, revealed: "...Titrating orders...titrated per a hospital approved protocol...."
Patient #2 was admitted on [DATE] with peripheral vascular disease requiring an endovascular intervention and angiogram performed on 03/14/12. Two additional procedures were performed after the first as a result of the patient losing pulses in both feet. The following incomplete physician orders were identified in the medical record. None of the orders contained clarification:

03/15/12, 0330: "...Propofol drip for sedation, Ramsey 3 - 4...."
03/16/12, 1535: "...Milrinone (Primacor) gtt start @ 0.375 mcg/kg/min...."
03/16/12, 1745: "...Epi gtt 1-2 mcg/min...."
03/16/12, 1800: "...Dopamine, start @ 5 mg/kg/min...."
03/16/12, 1855: "...wean Dopamine + Primacor gtts off. May use Vasopressin gtt to keep MAP (greater than) 65...."
03/16/12, 2300: "...Vasopressin 0.04 units/min may titrate (down) for MAP (greater than) 65...Wean Phenylephrine if able after Vasopressin started...."
03/18/12, 1730: "...Metoprolol 2.5 mg IV prn HR (greater than or equal to) 120 if SBP (greater than or equal to) 110...."
03/20/12, 1135: "...Precedex gtt IV titrate for comfort...."
03/21/12, 1640: "...Propofol drip keep comfortable tonight...."
03/22/12, 0930: "...Fentanyl 100/mg (illegible) IV drip...."
03/23/12 0930: "...(change) Propofol to Precedex gtt...."

The medical record was reviewed with the Director of ICU on 11/28/12. When asked if the above orders were complete she confirmed the orders were complete and explained their patients can be very unstable, so to have an order that tells a nurse how often to titrate and amount with which to titrate, would not work for their patients. When asked about the sedative level of "comfort" ordered, which is not on the Modified Ramsey Scale, she agreed "comfort" could be subjective, but that the nurses know what the physicians want. She confirmed nursing administered the medications in the orders above. The Director confirmed there were no policy, procedure or protocols for the titration of drips.

The Regional Director of Pharmacy reviewed the above orders on 11/30/12, and confirmed the above orders were not complete and should have been clarified. He explained sedation orders needed a sedation level ordered (Modified Ramsey Score), a minimum, maximum dose, titration increments and frequency. Hemodynamic titration orders need hemodynamic parameters desired, minimum, maximum, titration increments and frequency. He explained the hospital has a policy and procedure for titration medications and medication administration which addresses complete orders.

Patient #7 was admitted on [DATE] with bacterial endocarditis involving the mitral valve, requiring a valve replacement on 11/23/12. The following incomplete medication titration orders were identified in the medical record. None of the orders were clarified prior to administration:

11/24/12, 1040: "...Propofol IV drip as needed for sedation...."
11/27/12, (order not timed): "...precedex drip for sedation...."
11/25/12, 0940: "...Keep SBP (greater than) 100...can restart vaso/levo as needed...."
11/28/12, 1445: "...Start Neo drip to keep SBP (greater than) 100 IV now, prn...."

Patient #7's medical record was reviewed with the Director of ICU on 11/29/12. The Director of ICU confirmed the above orders were incomplete, nursing did not clarify the orders, and nursing administered the medications as ordered.

Patient #8 was admitted on [DATE] for a coronary artery bypass graph. The medical record was reviewed on post op day 1. The following incomplete titration order was identified in the medical record. The order was not clarified and nursing administered the medication:

11/28/12, 1100: "...Precedex gtt prn...."

Patient #15 was admitted on [DATE] s/p CVA, Kidney Insufficiency, Hypertension, Aphasia and Bleed s/p TPA. The ICU physician ordered a Dexmedetomidine (Precedex) Drip on 12/3/12 at 1315 to provide sedation to the patient while on a mechanical ventilator.

The policy and procedure titled Titrating Medications revealed: "...Clinical staff must assess the patient when titrating medications to detect potential problems as early as possible.

The form titled ICU Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients revealed: "...patient monitoring...assess Ramsey and pain scores hourly and adjust drugs as needed...."

The medical record identified missing documentation of the Ramsey Score on the following dates and times: 12/03/12 -2100, 2200, 2300, 12/4/12 - 0100, 0200, 0400, and 2200.

An interview with the Director of ICU was conducted on 11/29/12, during a tour of the ICU and telemetry pods. The Director of ICU confirmed the order was incomplete, and that nursing did not clarify the order prior to administration.

The Intensive Care Unit (ICU) Nurse Manager confirmed during an interview conducted on 12/5/12, that the nursing staff did not follow hospital policy and consistently monitor/assess hourly Ramsey scores for Patient #15 on Precedex.

The Director of Pharmacy for the AZHH campus was interviewed on 11/29/12. He was asked if the above orders were complete and would pharmacy fill the order and place the medication on the medication administration record (MAR). He explained he would put the medications on the MAR so the nurses could get the medication and would tell the nurses to contact the physician to clarify the titration orders. He explained pharmacy only calls the physician if there are dosing questions. He confirmed the hospital did not have a policy or protocol for titrating medications for this campus. He did agree the order for Metoprolol (Pt #2) on 03/18/12 at 1730 was incomplete as it did not have a frequency for administration. He added the pharmacy would not have put this medication on the MAR without clarification. When shown the MAR with the prn Metoprolol entered by pharmacy with the frequency of "see MAR for frequency," he explained that they must have wanted to enter the medication so the nurses could get to it in the Pxysis machine. He was questioned regarding the notations in the MAR for the titration drips that read "Titrate Per Protocol," however he offered no explanation.

The Region Vice President of Quality, and the Interim CEO were interviewed on 11/29/12 at 0830. They explained that the Medical Executive Committee had adopted titration drip protocols and those protocols were supposed to be implemented at AzHH, however, were not implemented.

2. Patient #22 was admitted to the intensive care unit with a C-1 fracture, odontoid process fracture, cervical contusion, and left wrist fracture. The patient was intubated and placed on Propofol to control behaviors of pulling at tubes and lines.

Hospital policy titled Ordering and Administration of Medications, revealed: "...Titrating orders...titrated per a hospital approved protocol...."
The policy titled ICU Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients, revealed: "...Initial dosing: 5 micrograms/kg/minute, then titrate by 5 micrograms/kg/minute every 5 minutes to desired Modified Ramsey Score...Maximum dose...not to exceed 50...."
The Physician ordered Propofol on 12/03/12 at 0015 per the ICU Protocol.
Patient #22's Medication Administration Record (MAR) revealed nursing initiated the Propofol infusion on 12/03/12 at 0015 at 40 mcg/kg/minute.
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
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 Pharmaceutical Services as demonstrated by the failure to identify, prioritize, evaluate and execute corrective actions related to deficient medication practices specific to the provisions of pharmaceutical services.

A0501 Pharmacist Supervision of Services: failure to require complete physicians orders prior to dispensing patients' medications for Nicardipine drip for Patient #15; and failure to require complete physicians' order for titrated medications dispensed for Patients #2, 7 and 8; and

A0508 Reporting Adverse Events: failure to adopt and implement an organized system for investigating, reporting, analyzing medication occurrences and recommending actions for improvement that identified patients' medications that were dispensed despite physicians' incomplete 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 Pharmaceutical Services.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of hospital policies/procedures, medical records, and staff interviews, it was determined the Pharmacist failed to require complete physicians orders prior to dispensing patients' medications, as demonstrated by the:

1. failure to require complete physician's orders for Nicardipine drip to identify starting and maximum doses for Patient #15; and

2. failure to require complete physicians' orders for titrated medications for Patients #2, 7 and 8.

Findings include:

1. The hospital policy titled Titrating Medications, requires: "...orders for medications that require titration must include the desired state the prescriber desires for the patient (i.e. titrate medication to achieve B/P of (physician's order)...a dose limit (maximum and minimum) at which the physician must be called for each medication titration must be set...dose limits must be clearly communicated...dose limits for titrated medications must be included on any preprinted orders, clinical practice guidelines or written protocols for titrated medications...."

The Hemodynamic Medication Protocol form requires: "...Titrate to maintain Systolic Blood Pressure 140 -160 mmHg or (physician's order) mmHg with...Nicardipine...initiate infusion at 5 mg/ hour and titrate in increments of 2.5 mg every 15 minutes until goal blood pressure or a maximum of 15 mg/hour is achieved...."

Patient #15's medical record revealed the physician's order on 11/29/12 at 1700: "...25 mg in D 5 250 ml dextrose Nicardipine drip protocol...Cardene GTT titrate to maintain SBP (systolic blood pressure) <160 mg/Hg...." The order did not identify a starting dose, nor a maximum titrating dose.

The Intensive Care Unit (ICU) Nurse Manager PBH confirmed during an interview conducted on 12/05/12, the order was incomplete and did not identify an initial or maximum dose.

2. The hospital policy titled Continuous IV Sedation & Neuro Blockade Medications, effective: 05/01/11, required: "...Scope: All patients at both campuses of Phoenix Baptist Hospital...Physician's order is required for continuous sedation and mechanical ventilation...staff may adjust medication dose to achieve the patient's sedative goal...Sedation score and vital signs are monitored and documented every 15 minutes for one hour, every 30 minutes for the next hour, then every hour thereafter after initiation, with each rate change, or when weaning from continuous sedation. Discontinue sedation on a daily basis until patient is able to follow commands or becomes agitated or uncomfortable...."

The hospital document titled ICU Protocol for Propofol or Dexmedetomidine Use in Mechanically Ventilated Patients, dated 01/12, revealed: "...Patient Monitoring...Assess Ramsey and pain scores hourly and adjust drugs as needed...."

The hospital policy titled Titrating Medications, effective 08/12, required: "...Orders for medications that require titration must include the desired state the prescriber desires for the patient...Based on a physician's order, titration increments may vary depending on the patient's clinical status, comorbid conditions and other factors...A dose limit (maximum and minimum limits) at which the physician must be called for each titrated medication must be set...The Pharmacist will contact the prescriber to obtain dose limits...Orders received for titrated medications without dose limits...will not be prepared or dispensed...."

The hospital policy titled Ordering and Administration of Medications requires: "...Titrating orders...per a hospital approved protocol...."
Patient #2 was admitted on [DATE] with peripheral vascular disease requiring an endovascular intervention and angiogram performed on 03/14/12. Two additional procedures were performed after the first as a result of the patient losing pulses in both feet.

The following incomplete physician titration orders were identified in the medical record. None of the orders included clarification:

03/16/12, 1535: "...Milrinone (Primacor) gtt start @ 0.375 mcg/kg/min...."
03/16/12, 1745: "...Epi gtt 1-2 mcg/min...."
03/16/12, 1800: "...Dopamine, start @ 5 mg/kg/min...."
03/16/12, 1855: "...wean Dopamine + Primacor gtts off. May use Vasopressin gtt to keep MAP (greater than) 65...."
03/16/12, 2300: "...Vasopressin 0.04 units/min may titrate (down) for MAP (greater than) 65...Wean Phenylephrine if able after Vasopressin started...."
03/18/12, 1730: "Metoprolol 2.5 mg IV PRN (as needed) HR (heart rate) (greater than or equal to)120 of if SBP (greater than or equal to)...."
03/20/12, 1135: "...Precedex gtt IV titrate for comfort...."
03/21/12, 1640: "...Propofol drip keep comfortable tonight...."
03/22/12, 0930: "...Fentanyl 100/mg (illegible) IV drip...."
03/23/12, 0930: "...(change) Propofol to Precedex gtt...."

The Director of ICU reviewed the medical record on 11/28/12. When asked if the above orders were complete she confirmed the orders were complete and explained their patients can be very unstable, so to have an order that tells a nurse how often to titrate and amount with which to titrate, would not work for their patients. When asked about the sedative level of "comfort" ordered, which is not on the Modified Ramsey Scale, she stated "comfort" could be subjective to the nurses, but that the nurses know what the physicians want. She confirmed nursing administered the medications ordered. The Director confirmed there were no policy, procedure or protocols for the titration of drips.

Patient #7 was admitted on [DATE] with bacterial endocarditis involving the mitral valve requiring a valve replacement on 11/23/12. The following incomplete medication titration orders were identified in the medical record. None of the orders were clarified prior to administration:

11/24/12, 1040: "...Propofol IV drip as needed for sedation...."
11/27/12, (no time order time): "...precedex drip for sedation...."
11/25/12, 0940: "...Keep SBP (greater than) 100...can restart vaso/levo as needed...."
11/28/12, 1445: "...Start Neo drip to keep SBP (greater than) 100 IV now, prn...."

The Director of ICU reviewed Patient #7's medical record on 11/29/12. The Director of ICU confirmed the orders were incomplete and amended her previous statement, by confirming nursing did not clarify the orders prior to administering the medications.

Patient #8 was admitted on [DATE] for a coronary artery bypass graph. The medical record was reviewed on post op day 1. The following incomplete titration order was identified in the medical record. The order was not clarified prior to administering the medication: 11/28/12, 1100: "...Precedex gtt prn...."

The Director of ICU confirmed during an interview and tour of the ICU and telemetry pods conducted on 11/29/12, that the order was incomplete and amended her previous statement, by confirming nursing did not clarify the orders prior to administering the medications.

The Director of Pharmacy for AZHH was interviewed on 11/29/12. He was asked if the above orders were complete and would pharmacy fill the order and place the medication on the medication administration record (MAR). He explained he would put the medications on the MAR so the nurses could get the medication and would call the nurses to contact the physician to clarify the titration orders. He explained pharmacy only calls the physician if there's dosing questions. He confirmed the hospital did not have a policy or protocol for titrating medications for this campus. He did agree the order for Metoprolol (Pt #2) on 03/18/12 at 1730 hours was incomplete as it did not have a frequency for administration. He added the pharmacy would not have put this medication on the MAR without clarification. When shown the MAR with the prn Metoprolol entered by pharmacy with the frequency of "see MAR for frequency," he offered an explanation that they must have wanted to enter the medication so the nurses could get to it in the Pxysis machine. He was questioned regarding the notations in the MAR's for the titration drips that read "Titrate Per Protocol," however offered no explanation.

The Regional Director of Pharmacy reviewed the above orders on 11/30/12 and confirmed the orders were not complete and should have been clarified. He explained sedation orders needed a sedation level ordered (Modified Ramsey Score), a minimum, maximum dose, titration increments and frequency. Hemodynamic titration orders need hemodynamic parameters desired, minimum, maximum, titration increments and frequency. He explained the hospital has a policy and procedure for titrated medications, and medication administration which addresses complete orders.

The Region Vice President of Quality, and the Interim CEO explained during interviews conducted on 11/29/12 at 0830, that the Medical Executive Committee adopted titration drip protocols. Those protocols were supposed to be implemented at the AzHH campus, however, were not implemented.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on review of hospital data, Patient Care Services Meeting Minutes, Regional Pharmacy & Therapeutics (P &T) Meeting Minutes, Medication Safety Committee Meeting Minutes, and staff interviews, it was determined the hospital failed to demonstrate an organized system for investigating, reporting, analyzing medication occurrences, and recommending actions for improvement.

Findings include:

The Regional Pharmacy Director indicated the following during interviews conducted on 12/04/12 and 12/05/12:

The Regional P&T Committee represents both hospital campuses. Individual campuses do not operate their own P&T committees.

The Patient Care Services (PCS) Committees currently discuss medication occurrences. The PCS Meeting Minutes were reviewed by the Regional Pharmacy Director who reported that medication errors were last reported as numbers only, in April of 2012 on the dashboard spreadsheet.

The Regional P&T Committee Meeting Minutes, dated 01/03/12, included the following: "...Medication Occurrence Reporting...(Name) presented the medication occurrences from July to September 2011. Major trends are seen in the categories of delays, near misses, and processing errors. Dr. (Name) led a discussion of the need to create formal action plans centered around the analysis of medication occupancies...Action: (Names) to meet and discuss next steps...Develop spreadsheet for action plans...."

The Regional P&T Committee recognized in March 2012, the need for a Medication Safety Committee. The Medication Safety Committee met for the first time on 05/11/12 and identified the purpose was "to provide process improvement guidance/education regarding medication management." According to meeting minutes dated 06/08/12, one of the first items of focus was identified as "Medication Occurrences," and the committee agreed to report to the P&T on a quarterly basis.

No reports from the Medication Safety Committee have been submitted to the Regional P&T Committee as of 12/05/12. The hospital has not reported Medication Occurrences to the Medical Executive Committee for 8 months, except to report aggregate regional numbers for all corporation hospitals. The hospital could not demonstrate an organized system for investigating, reporting, analyzing medication occurrences and recommending actions for improvement.

The Regional P&T committee meeting minutes dated 01/12 through 09/12 (current) for both PBH and AzHH campuses, revealed no discussion of medication occurrences, and no trending or tracking of med errors.