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1625 NORTH CAMPBELL AVENUE

TUCSON, AZ 85719

PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING

Tag No.: A0130

Based on review of hospital policies, documents (instructural/educational), staff and patient's representative interviews, it was determined that the hospital failed to provide information in a manner that the patient's representative could understand for one (1) of 1 patient in the Neonatal Intensive Care Unit (NICU), according to policy (Patient #10).

Findings include:

The hospital policy titled Patient Rights and Responsibilities (AD #3) requires: "...The patient (and family) has a right to...receive information in a manner he or she understands...."

The hospital policy titled Communicating with Persons with Limited English Proficiency (LEP) and Those Who are Deaf, Hard of Hearing, Blind, or Need Assistive Devises (PM #99), requires: "...The hospital respects the patient's right to receive information in a manner he or she understands...(the hospital) ensures that all vital documents are available in English and Spanish...."

The hospital provides all NICU patients the Newborn Intensive Care Unit P.O.P. (Patient Orientation Program) notebook. The Table of Contents includes:

Introduction
Medical - glossary, nursing care, respiratory
Nutrition and Growth - nutrition, lactation/breast feeding
Social work
Developmental Specialists - education, assessments
Your Baby's Story
Baby Going Home - NICP (Neonatal Intensive Care Program), car seats, pediatrician
Baby at Home
Resources for More Information
Photo Sleeves/Business Cards

The NICU staff adds additional information, relevant to the patient, throughout the course of hospitalization to keep the family/representative informed as to the patient's progress with goals. The notebook is provided to the parent/representative when the patient is discharged. The NICU nursing staff confirmed during interviews conducted on 12/17/14, that the notebook was not available in Spanish.

Patient (infant) #10 was admitted to the Newborn Intensive Care Unit (NICU) on 12/12/14, at 36 weeks gestation, thick meconium staining, and apgars 8/9. The patient was the mother's third infant.

The surveyor observed the infant's discharge on 12/17/14, and spoke with the infant's mother via the hospital's telephone based interpretation service. The conversation confirmed that the mother, who was the primary caregiver, was Spanish speaking only and did not speak or read English. The mother confirmed that the hospital did not provide the Newborn Intensive Care Unit POP notebook.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on review of Patient #34's medical record, interviews with staff, and review of policies and procedures, it was determined the hospital failed to determine Pt #34's capacity to make decisions and allow Pt #34 refuse treatment and leave the hospital.

Findings include:

The hospital policy titled, Title 36 Mental Health Services, policy PM 15, revised 07/10/14, required: "...Patients requiring emergency evaluations in accordance with Arizona Revised Statutes Title 36, Chapter 5, regarding involuntary mental health treatment...This policy/procedure is utilized only for patients with mental health disorders...Whenever an emergency evaluation is required for an inpatient, outpatient or Emergency Room patient who is a danger to himself/herself or others, a psychiatric consultation or Emergency Room evaluation should be requested. If based on the evaluation it is determined the patient requires level 1 admission and the patient declines, refuses, or is unable to consent to level 1 admission, follow the procedure an Application for Emergency Admission for Evaluation...."

Patient #34's history and physical exam dated 12/13/2014, 0522 hours, included: "... is a...male with a PMH (past medical history) of hepatocellular carcinoma secondary to hep (hepatitis) C...alcohol abuse, status post liver transplant, type 2 diabetes insulin-dependent, hypertension, asthma, coronary artery disease...On 12/11 (2014) patient left the hospital AMA...Patient returned for hospitalization, labs after he left AMA showed anemia with levels that required transfusion...."

On 12/13/14 at 1035, an internal medicine physician wrote an order for an inpatient consult for Adult Psychiatry.

On 12/13/14, at 1333, an internal medicine physician documented the following: "...Questionable whether the patient has decision-making capacity, our assessment is that he does not. Psychiatry consult was placed and pending. Would also appreciate recs (recommendations) for appropriate depression management, polysubstance abuse.... "

On 12/14/13 at 1034 the psychiatry initial consult note indicated: "...Assessment...At this time he is cooperative with his team and is not refusing any treatments. He has a history of leaving AMA. His thought process is slow and he is generally a poor historian; therefore, if he tries to leave, please place the patient on hold and re-consult psychiatry for the decision to leave AMA. At this time he does not appear to be an imminent DTS (danger to self) or DTO (danger to others)...."

On 12/14/14 at 1311, an internal medicine physician documented the following:
"...He expresses a desire to leave the hospital but it is uncertain whether he has capacity, or whether he understands the implications of his health problems...Finally psychiatry has been consulted regarding decisional capacity...."

On 12/15/14 at 1111, the internal medicine physician documented the following progress note: "...Patient seen by psych, he should not be permitted to leave AMA without urgent psych evaluation...."

On 12/16/14 at 1501, the internal medicine physician documented the following progress note: "...He expresses a desire to leave the hospital but it is uncertain whether he has capacity, or whether he understands the implications of his health problems ...."

On 12/17/14 at 1516, the internal medicine resident documented the following in a progress note: "...He expresses a desire to leave the hospital but it is uncertain whether he has capacity, or whether he understands the implications of his health problems...."

On 12/18/14 at 1900, the internal medicine resident documented: "...He left AMA on December 12, but was able to be brought back by EMS (emergency medical services) for his hematuria...He expresses a desire to leave the hospital, but it is uncertain whether he understands the implications of his health problems...."

On 12/18/14 at 1949, the internal medicine resident documented: "...patient wishing to leave AMA. Patient was informed that upon admission after last AMA departure from hospital he was placed on psychiatric old (sic) (hold), and that the psychiatrist would be required to clear him as having decisional capacity before he would be allowed to leave the hospital. He expressed understanding and reiterated his desire to leave. Attending and senior resident were both notified, and psychiatry was paged. Psychiatry resident and informed me that she would see the patient in the morning. The patient was informed that he would likely be held by security until psychiatry clear him in the morning...."

On 12/19/14 at 1013, the psychiatry resident noted in her " Psychiatry Initial Consult Note " the following: "...He does have capacity to sign out AMA, his plan is to return to his apartment where he resides with his ex-wife...."

According to documentation in the medical record the physicians requested a psych consult on 12/13/14, to determine if Pt #34 had the capacity to make decisions. No determination was documented by the psychiatry resident and they recommended another psych evaluation if the patient wanted to leave again. The patient expressed wanting to leave multiple times.

Decisional capacity was determined on 12/19/14, which was 5 days after the patient first requested to leave AMA. The determination concluded Pt #34 did have decisional capacity.

Patient #34 was not allowed to refuse treatment and leave AMA, even though he was allowed to sign the following informed consents:
1. Intravenous (IV) contrast for Magnetic Resonance Imaging (MRI) on 12/14/14;
2. Consent for Transfusion of Blood Products on 12/12/14 and 12/13/14;

The hospital failed to ensure Pt #34 ' s rights to refuse treatment.

Provider #4, Employee #8, and Employee #11, confirmed on 12/19/14, that the hospital did not follow their policy and procedure for psychiatric holds, and that Pt. #34 did not meet criteria for a psychiatric hold. They also confirmed the first psychiatric consult to determine decisional capacity failed to document their assessment of determination and directed staff to hold the patient and have a second psychiatric evaluation.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on review of hospital policy, medical records, and staff interviews, it was determined that the hospital failed to require nurses reassessed three (3) of four (4) patients post pain interventions (pain medication) to evaluate the effectiveness, according to policy (Patient #'s 24, 39 and 40).

Findings include:

The hospital policy titled Interpretation of Orders: Range Order Dosing, Duplication of Therapy (PM #68), requires: "...Ongoing patient assessments and measured outcomes will include...pain scale ratings...and/or the patient's verbal response to previous doses of medication...All approved adult pain scales will be based upon the 1-10 range to allow comparison...Monitoring - Observe for patient's response to medication...Assess the patient within 30 minutes for IV (intravenous) medication and 60 minutes for oral and IM (intramuscular) medications and document on the medical record...patient response will be documented in the medical administration record...document the patient taken for uncontrolled pain...in the patient progress note...."

Patient #24 was admitted on 11/29/14 with acute lymphoblastic leukemia, according to the medical record. Nurses documented pain management as follows:

12/18/14 at 0529: Morphine Sulfate (MS) 2 mg IV administered for pain 10/10 (on a scale of 0 - 10, 10 is the most severe pain). The patient's pain reassessment was 4/10 at 0816, which was 2.25 hours post medication administration. According to policy, pain reassessment should have been completed and documented, at 0600.

RN #130 confirmed during an interview conducted on 12/18/14, that the patient's pain was not reassessed according to policy.

12/18/14 at 0320: MS 2 mg IV administered for pain 6/10. Follow up reassessment was documented at 0520, which was 1.5 hours post administration. According to policy, pain reassessment should have been completed and documented, at 0550.

Patient #39 was admitted on 12/09/14 with endometrial cancer, according to the medical record. She underwent a total abdominal hysterectomy, with subsequent wound dehiscence. Nurses documented pain management as follows:

12/17/14 at 0600, patient # 39's pain was 6/10, and was documented but not addressed. Pain reassessed at 1513 was 7/10. At this time the patient was medicated with Oxycodone 5 mg. Documentation did not include/identity/describe or explain the lack of interventions (or that this level of pain was acceptable) for the pain that the patient reported at 0600, which was 8.25 hours later.

Patient #40 was admitted on 12/17/14 with a vertebral fracture, sepsis, and multiple comorbidities, according to the medical record. Nurses documented pain management as follows:

12/18/14 at 2025, Percocet 1 tablet was administered orally for pain 5/10. The patient's pain reassessment was 4/10 at 2230, which was 2 hours post medication administration. According to policy, the pain reassessment should have been assessed and documented at 2130.

RN #135 confirmed during an interview conducted on 12/18/14, that patient #'s 39 and 40 pain management were not documented according to policy.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on review of hospital policies, documents, Fresenius hemodialysis machine/Diasafe Plus filter manufacturers' requirements, and staff interviews, it was determined that the hospital failed to perform bacterial water quality testing on the hospital's seventeen (17) Fresenius 2008K2 hemodialysis machines, according to the manufacturer's requirements.

Findings include:

The hospital policy titled The University of Arizona Medical Center Infection Prevention Policy and Procedure...Department of Renal Dialysis (implemented 10/24/11), requires: "....AAMI (Association for the Advancement of Medical Instrumentation) standards will be followed for quality assurance for equipment used to treat, store, and distribute water in the dialysis unit...Microbiologic testing of dialysis machines...will be conducted according to established unit policy...."

The document titled AAMI (Association for the Advancement of Medical Instrumentation) Standards Dialysis 2013 provided by the staff during tour on 12/18/14, revealed: "...dialysis machines fitted with validated endotoxin-retentive filters, samples should be collected according to the filter manufacturer's instructions. If testing of any hemodialysis machine reveals a level of contamination above the action level, an investigation should be conducted. The investigation should be based on the presumption that other hemodialysis machines might also be contaminated. It should include a review of compliance with disinfection and sampling procedures and an evaluation of microbiological data for the previous three months to look for trends...."

The online AAMI article titled A Surveyor's Perspective: Water Quality for Hemodialysis (www.aami.org website) reviewed on 12/18/14, included: "...Expected Monitoring of the Water Treatment System: Chemical, Bacteriological, and Daily Testing...ensure that all machines are tested at least annually...."

The online 2008K2 Hemodialysis Machine Operator's Manual Rev. H., page 181 (www.fmcna.com website) reviewed on 12/19/14, requires: "...the use of the Diasafe Plus filter does not reduce the need for routine monitoring of the...bacterial water quality...."

The Diasafe Plus Dialysis Fluid Filter Instructions for Use (manufacturer's requirements), provided by the Dialysis BioMedical Tech on 12/18/14, requires: "...Attention must still be given to the...microbiological quality of water...."

According to the Dialysis Biomedical Technician (employee #132) and the Chief Dialysis Technician (employee #133), the hospital uses seventeen (17) Fresenius 2008K2 hemodialysis machines, all equipped with the Diasafe Plus filters. The Techs indicated that machine culturing is not required when operated with the Diasafe Plus filter.

The hospital did not have an "established unit policy" that identified how often the hemodialysis machines were microbiological tested.

The Dialysis Biomedical Technician (employee #132) and the Chief Dialysis Technician (employee #133) confirmed during interviews conducted on 12/18/14, that none of the 17 hemodialysis machines had been cultured in "several years".

INFECTION CONTROL PROFESSIONAL

Tag No.: A0748

Based on observations on tour, staff interviews, policies and procedures, the hospital's infection control officer failed to establish, document and implement policies that identified the process for cleaning/disinfection of the following multi-patient use items:
1. respiratory masks in the sleep lab;
2. seizure pads placed on patients ' beds;
3. electroencephalography electrodes (EEG); and
4. toys in the sleep lab area.

Findings include:

During a tour of the hospital on 12/19/14 at 1030-1230-hours the following items were identified.

1. During a tour of the hospital's sleep lab, respiratory masks were observed being re-used for multiple patients.

Employee #5 responsible for the sleep lab and reprocessing of the masks was unaware of the manufacturer's guidelines for reprocessing masks used for multiple patients. She confirmed the hospital did not have a policy based on the manufacturer's guidelines for reprocessing the respiratory masks.

2. During a tour of the EEG monitoring center, large blue pads were observed stacked on top of a wall cabinet. Approximately 10 pads were observed. The pads did not have any documentation on them that they had been cleaned/disinfected for the next patient's use. Staff present could not demonstrate verification that these pads had been cleaned.

Employee #11 confirmed on 12/19/14, later in the day, that the hospital did not have a policy and procedure established, documented and implemented for cleaning/disinfection of the seizure pads.

3. During a tour of the EEG monitoring center and sleep lab, EEG cables were observed hanging in both locations. The cables were not covered and were hanging on wall hooks in the EEG monitoring center adjacent to the door. Staff present could not verify that these cables had been cleaned/disinfected.

Employee #5 confirmed on 12/19/14, later in the day, that the hospital did not have a policy established, documented or implemented for the cleaning/disinfection of the EEG cables.

4. During the tour of the sleep lab area a cart on wheels was observed with toys. The toys had visible, dirt, debris and sticky material on them. The cart itself was observed to have a large build up of dust and spots on the outside of the cart. Staff present confirmed the toys are used for patients in the sleep lab.

Employee #5 confirmed on 12/19/14, later in the day, that the hospital did not have a policy established, documented or implemented for the cleaning/disinfection of the toys in the sleep lab.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on manufacturer's recommendations, hospital policy/procedure, observation and staff interview it was determined that the facility failed to provide and maintain a sanitary environment for the disinfection of non-critical environmental surfaces in the surgical suite as evidenced by:

1.) Failure to follow directions for use for disinfection of non-porous surfaces according to manufacturer's recommendations; and

2.) failure to follow the facility's Infection Control Program Policy PM 7.

Findings include:

1.) EnVerros SaniMaster 4 DIRECTION FOR USE requires: "...to disinfect inanimate, hard, non-porous surfaces apply solution...sprayer...so as to wet all surfaces...Allow to remain wet for 10 minutes...."

2.) The Infection Control Program Policy PM 7 requires: "...Non critical items will be cleaned according to the Medical Equipment Disinfectant Selection Table...."

The Medical Equipment Disinfectant Selection Table revealed: five (5) lines and four (4) columns. The table is labeled as follows: first line: examples of names of disinfectant; second line: activity as (bacterial, virucidal, fungicidal; third line: contact time; fourth line: for use on devices; fifth line protective equipment required. The four (4) separate columns are labeled with the following examples of disinfectants: column 1 (Clorox/PDI Bleach Wipes); column 2 (Alcohol) ; column 3 (Sanimaster IV/TB Coverage Spray); and column 4 (Sani-Cloths/ Super Sani-Cloths).

The above policy revealed: the Sanimaster 4 disinfectant has a contact time of 10 minutes; for use on these devices: floor, bedside table, bedpans, and protective equipment required: gloves.

Observations made in the surgical suite on 12/17/14 at 1130 hours, noted the Environmental Technician applying the disinfectant (SaniMaster 4) to a surgical bed. The surface of the bed was dry within 3 minutes, not within the required time frame of 10 minutes.

The Technician was asked by this surveyor "what is the contact time of the solution? " The Technician was unsure of the required wet time. The Technician was asked by the surveyor to reapply the solution; again the surface of the bed was dry within 3 minutes.

The Infection Preventionist confirmed during an interview conducted on 12/18/14 at 0830 hours, that the hospital follows the US Centers for Disease and Prevention (CDC) guideline as published in the American Journal of Infection Control 41 (2013) S36-S41. The research article " Disinfectants used for environmental disinfection and new room decontamination technology " reveals the following: " ...discusses a 1-minute contact time (ie, wet time) for low-level disinfection of noncritical environmental surfaces and patient care equipment. To get EPA clearance of the CDC Guideline, it was necessary to insert the sentences " By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action...there are no data that demonstrate improved infection prevention by a 10 minute contact time verses a 1-minute contact time.... "
The Quality Specialist confirmed during an interview conducted on 12/22/14 at 0900 hours that the facility does not use the 10 minute contact time for the disinfection of non-critical environmental surfaces.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, review of the medical record, interview with Staff RN and Attending Physician, patient # 37 had a skin prep with betadine to which this patient has a documented allergy.

Findings include:

Observation on 12/19/2014 at 0845 am, of a procedure to instill an epidural catheter pre-op for patient # 37, it was noted after a timeout had been called and completed prior to the procedure with all team members in attendance (employee # 127 and # 15,medical staff # 24 and # 25) , that the patient received a skin prep of betadine by medical staff # 25 which was documented in the medical record as an allergy. It was brought to the teams attention by Employee #127 that the patient was allergic to betadine. Identification that the patient was allergic to betadine was determined only after the surveyor requested to see the allergies for this patient which employee #127 pulled up on the Electronic Medical Record (EMR).

Employee # 15, employee # 127 and Medical staff #24 confirmed on 12/19/2014 at 0835 am, that betadine was applied to the patients back during the skin prep.

Employee # 127 confirmed that the allergy to betadine was documented in the medical record prior to the procedure being performed.