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.

YAVAPAI REGIONAL MEDICAL CENTER 1003 WILLOW CREEK ROAD PRESCOTT, AZ 86301 Sept. 15, 2017
VIOLATION: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT Tag No: A0308
Based on review of the hospital's policy and procedure, hospital documents, and staff interview, it was determined that the hospital failed to comply with the provisions of the Quality Assurance and Performance Improvement (QAPI) program to include that the Governing Body failed to ensue that the QAPI program/plan was developed and documented. This deficient practice poses a significant risk for patient's health and safety if the hospital's Governing Body cannot ensure that the QAPI program/plan is developed to include the complexity of the hospital's organization and services, including all departments and services.

Findings include:

The hospital policy titled "Quality Assessment Process Improvement Plan Policy" Corporate Policy (date approved 12/11/2015) lists the "...purpose, scope, standards, responsibilities...." of a QAPI, but does not detail the program specific to each hospital (West and East campus) or the six (6) hospital-based entities for 2017.

The Director of Quality/Risk Management confirmed in an interview conducted 9/13/2017 that no 2017 QAPI program/plan was available. The only document provided by the hospital when the QAPI program/plan was requested, was the "Quality Assessment Process Improvement Plan Policy", Corporate Policy (date approved 12/11/2015).
VIOLATION: PATIENT RIGHTS: GRIEVANCES Tag No: A0118
Based on review of the hospital's policies and procedures, hospital documents, medical records and staff interview, it was determined that the hospital failed to comply with the hospital's policy related to Grievance Complaints for 4 of 4 patients. (Patients #38, #39, #40, and #41)

Failure to ensure the staff adhere to the facility grievance policy poses a high potential risk for violation of patient rights.

Findings include:

Hospital policy titled "Patient-Family Grievance Complaints Policy' revealed: "...DEFINITIONS:...A patient or patient representative concern/ issue: -A concern that can be resolved at the time of the concern by either staff present or staff who can quickly be present (i.e., nursing, administration, nursing supervisor)
-A verbal communication after discharge that addresses patient care issues that would routinely have been handled by staff if the communication had occurred during the hospital visit.
-Information obtained from patient satisfaction surveys are usually not considered grievances.
-Billing issues are usually NOT considered grievances...

A patient or patient representative grievance/complaint: -A formal or informal written or verbal complaint that is made to the hospital by a patient or patient's representative, regarding patient's care and the complaint cannot be resolved at the time of the complaint by the staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution.
-All verbal or written complaints regarding abuse, neglect, patient harm or hospital compliance with CMS CMS requirements are considered grievances.
-Medicare beneficiary billing complaint related to rights and limitations.
-Any written complaint (including email or fax) is always a grievance.
-When an identified patient attaches a written complain on a patient satisfaction survey and requests resolution OR does not request resolution, but the hospital would usually treat as a complaint.
-Whenever the patient or patient's representative requests their complaint to be handled as a grievance OR when patient requests a response from the hospital...."

Patient # 38

Hospital document revealed the Nursing Director of the East Campus (EC) #19 received a discharge alert phone call from patient #38 on 7/17/2017.

The patient's message revealed: "...he is not happy with Hospitalist who cared for him. He is not understanding the diagnosis on his chart that says 'acute kidney injury'...he did not injure his kidney and he wants his chart corrected. (The patient) said Hospitalist made him NPO and the nurses kept calling him to try to get a diet order...he told them i needed to be NPO...physician later came to see patient and admitted that he was wrong and he could have something to eat. The patient is under the impression the physician didn't know what he was doing and wants to talk with someone who can address his medical concern about the acute kidney injury being documented in his MR...."

The hospital document revealed on 9/1/17 12:36: "...Still waiting a response from (name of Internal Medicine Physician #16)...."

Director of Quality/Risk confirmed in an interview conducted on 09/15/17, that this concern was referred to the Director of the Hospitalist Group (name of Internal Medicine Physician #16) for review and the Director of Quality/Risk also confirmed, they are still waiting a response from the Director of Hospitalist Group.

Director of Quality/Risk confirmed during an interview on 9/15/17, regarding the above patient's allegations were categorized as a concern/issue and not as complaint/grievance.

However, according to the hospital's policy titled "Patient-Family Grievance Complaints Policy' this patient care and complaint could not be resolved at the time by staff present and these allegations required an investigation and resolution.

The hospital failed to provide documentation of proper investigation and resolution.

Patient # 40

Hospital document revealed a phone call received on 8/2/2017, regarding the behavior of RN #57, who cared for patient #40 on 7/17/17.

The allegations were: "...that (name of RN #57) was disrespectful to the patient and made patient feel like an inconvenience...(the patient was) struggling with breastfeeding and...(the nurse) was not helpful and had a bad attitude, rough personality...."

The hospital document revealed: "...Apologized for experience and ensured him his concerns would be addressed...Will council (sic) RN...."

Director of Quality/Risk confirmed during an interview on 9/15/17, regarding the above patient's allegations were categorized as a concern/issue and not as complaint/grievance.

However, according to the hospital's policy titled 'Patient-Family Grievance Complaints Policy' this patient care and complaint could not be resolved at the time by staff present and these allegations required an investigation and resolution.

The hospital failed to provide documentation of investigation and resolution for the patient or education/counsel of the nurse.

Patient # 39

Hospital document revealed a follow up phone call on 8/10/17, from patient #39, regarding an emergency room visit on 7/28/17.

The allegations were: "...she should have had additional testing x-rays or CT or something and...the nurse checked on her once in the 4 hours she was there...."

The hospital document revealed that the target nurse (RN #58) was interviewed and stated: "...he had been in the patient's room multiple times providing care...."

Director of Quality/ Risk confirmed during an interview on 9/15/17, regarding the above patient's allegations were categorized as a concern/issue and not as complaint/grievance.

However, according to the hospital's policy titled 'Patient-Family Grievance Complaints Policy' this patient care and complaint could not be resolved at the time by staff present, these allegations had to be referred to other staff (including nursing and medical staff) and required an investigation and resolution.

The hospital failed to provide documentation of further investigation and resolution for the patient or education/counsel of the nurse.

Patient # 41

Hospital document revealed, this hospital received a complaint on 4/12/2017, regarding patient #41 care during her emergency room visit on 12/12/2016.

Hospital document revealed Emergency Department Clinical Coordinator RN #3 documented on 4/13/2017 at 15:32: "...Reviewed...This is already being followed by the QI office...."

Hospital document revealed Director of Quality/Risk documented on 4/12/17 at 12:56: "...will refer to (name of Emergency Medicine MD #15) for review since this is regarding the EC Medical Director...5/22/2017 at 14:12...Received review from (name of MD #15)...This patient was treated appropriately...."

On 5/22/2017, a letter was mailed to the complainant providing updated conclusion regarding the resolutions of the complaint.

Hospital policy titled 'Patient-Family Grievance Complaints Policy' requires: "...Grievances that can not be resolved by staff present will be referred to the appropriate department for review investigation, and written response. Although most grievances will be able to be resolved within seven days...The majority of all grievances should be resolved and followed up within 30 days...All grievances require a written response to the grievant...."

Director of Quality/Risk acknowledged during an interview on 9/15/17, she was aware the letter was sent out after the 30 day timeframe. She confirmed that often there is a delay in response, because they need to wait on physicians' response.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on review of medical record, hospital document and interviews, the Department determined the administrator failed to require documentation that patients received information informing them of their Rights for 12 of 12 medical records from the 2 provider based entities (MED5739 and MED6539).

Failure to require staff maintain documentation related to informing patients of their rights poses a potential risk of patients not being notified of their rights as required. (Patient's #'s 63 through 74).

Findings include:

Hospital document titled "Conditions of Service"- number 14 Federal and State Requirements revealed:
A. Do you have an advance directive?
B. Are you providing us with a copy?
C. Do you have any changes from this copy?
D. Do you wish assistance in creating an Advance Directive?
E. Do you have a Medical Power of Attorney?
F. Were you offered a copy of the Patient Care Partnership (Patient Rights and Responsibilities)?

A yes or no response is required for all the above questions.

A signature is required by the patient or legal representative acknowledging they received a copy of the Patient Care Partnership.

Review of patient charts contained no documentation to confirm patients received their Patient Rights in two (2) single group licensed entities effecting 12 patients (Patient #'s 63 through 74).

The Infection Control Manager, confirmed during an interview on 9/12/2017, that the facility did not provide and/or document that the above patients received their Patient Rights.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on review of hospital policies and procedures, hospital documents, medical record, and interview, it was determined the hospital failed to ensure that one of one [1] patient was protected from a potential unsafe situation when the patient, identified as not oriented to time, situation, place, confused and a risk for a fall, eloped from the hospital and was found approximately 1 mile away by community citizens. Failure to maintain a patient with documented altered mental status in a safe environment, while a patient in the hospital arena, poses a high potential serious risk to a patient's health and safety/adverse outcomes, if the hospital cannot provide a safe environment for patients. (Patient # 1)

Findings include:

Review of the policy and procedure titled ""Patient and Family-Centered Care Nursing Model Operating Practice" reads: "Direct Care RN...responsible for providing for all aspects of patient and family-centered care to assigned patients including...assessments...nursing interventions...activity of daily living...."

Review of the policy and procedure titled "Interdisciplinary Plan of Care (IPOC): Inpatient Policy reads: "Care planning for inpatient care and discharge needs starts upon admission...to facilitate the care of the patient...nursing is required to develop and update an individualized plan of care that will include...problems...interventions...appropriate to the patient's needs...each shift the RN reviews the IPOC and updates as needed...."

Document review of "Patient Care Partnership" (Patient Rights and Responsibilities) provided to patients on admission reads "...Rights of Every Patient...the right to be free from all forms of abuse or harassment, neglect...."

Review of the electronic medical record for Patient #1 identified the following nursing documented entries: "...04/18/2017 (1900-1959) bed alarm on, ambulate with assistance...(2000-2059) high risk for falls...04/19/2017 (0700-0759) high risk for falls, ambulate with assistance...(1630) confused...(1900-1959) bed alarm on, high risk for falls, confused...(2200) confused...04/20/2017 (0000-0059) confused...(0300-0359) bed alarm on, high risk for falls, ambulate with assistance...(0500) not oriented to situation...not oriented to time...forgetful...(0700-0759) bed alarm on, high risk for falls, ambulate with assistance...(0800-0859) not oriented to place, not oriented to situation, not oriented to time, confused...."

Additional electronic medical record nursing documentation review, revealed that Patient #1 was reported missing from the unit on 04/20/2017 at approximately 1430. There is no nursing documentation that staff responded to a bed alarm.

Electronic medical record review of the nursing IPOC revealed that between the date range of 04/18/2017 and 04/20/2017, there was no documentation regarding the patient's confusion or safety interventions to include: bed alarm, ambulating with assistance or high risk for falls.

Electronic medical record documentation by MD #5 on 04/20/2017 at 1729 revealed: "...presented on 4/20 with Altered Mental Status (AMS) after leaving the hospital and walking to the local Wal-Mart and cemetery...suspect secondary to medication...."

RN Clinical Coordinator #59 confirmed during an interview conducted 09/11/2017, the above nursing documentation was in the electronic medical record and that the documentation confirmed the patient was confused, was high risk for falls, required assistance with ambulation and that the patient's bed alarm was on. Additionally, RN Clinical Coordinator #59 confirmed during an interview conducted 09/13/2017 that the above IPOC did not list confusion, high risk for falls, ambulation with assistance or use of the bed alarm. It was confirmed that Impaired Mental Status was an option for adding to the IPOC, but that it had not been added.

MD #7 confirmed during an interview conducted 09/12/2017, that the patient left the hospital without knowledge and was found by a community citizen approximately 1 mile from the hospital. The Prescott City Police Department was notified and escorted the patient back to the hospital. It was also confirmed that the patient had an altered mental status for several days due to the accumulation of pain medications post surgical procedure. MD #7 revealed that the patient did not leave AMA (Against Medical Advice).

RN #32 confirmed during an interview conducted 09/13/2017, that when it was identified that Patient #1 was not on the unit, that the charge nurse was notified. Additionally, it was confirmed that the patient's wife notified the nurse prior to the patient leaving the unit, voicing concern of the patient's mental status. Documentation of speaking with the wife and notification of the charge nurse was confirmed in the nursing notes.

RN Charge Nurse #33 confirmed during an interview conducted 09/11/2017, that after being notified of the patient's absence on the unit, that hospital security was notified. Additionally, the Prescott Police Department was called to report the patient was missing. RN Charge Nurse #33 revealed that together with RN Clinical Coordinator #59, they went to the hospital lobby to meet with the patient's family.

Director of Support Services #21 confirmed during an interview conducted 09/03/2017, the procedures required by the security guards when they are notified that a patient is missing person. It was revealed that all incidences regarding security are personally reviewed, but that the incident report filed specific to Patient #1, read that the patient left AMA, and these are only reviewed to ensure that there was no injury to hospital staff, patients or visitors. If there has been no injury, then the incident report requires no further action.

Director of Quality Risk Management #22 confirmed during an interview conducted 09/12/2017, that Patient #1 did not leave the hospital AMA. Additionally it was confirmed, that a patient leaving the hospital having an altered mental status, would be an elopement and that the hospital does not have a policy specific to elopement.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
Based on review of the hospital's policies and procedures, hospital documents, medical records and staff interview, it was determined that the administrator failed to ensure that medical staff complied with the hospital's restraint policy policy for 2 of 2 patients (Patient #33 and #34) that required a face to face evaluation within one (1) hour after the initiation of restraints.

Failure to conduct a face to face evaluation within [1] hour of initiation of restraints poses a high potential risk for patient safety if restrained patients are not properly evaluated by a medical staff, once restraints have been initiated.

Findings include:

Hospital policy titled 'Restraints ad Seclusion Policy' revealed: "...When restraints or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be evaluated face-to-face- within 1 hour after the initiation of the intervention by a Physician or other LIP (Licensed Individual Practitioner). The evaluation must include:
a. The patient's immediate situation;
b. The patient's reaction to the intervention;
c. The patient's medical and behavioral condition; and
d. The need to continue or terminate the restraint or seclusion...."

Patient # 33

Patient #33's medical record revealed the following information: an emergency room (ER) visit on 7/1/2017 at 2:46 PM with a diagnosis of Methamphetamine abuse, Polysubstance abuse and Seizure. This patient presented via EMS ( Emergency Medical Services) with seizure, with onset prior to arrival. Postictal symptoms that were reported as a result of the seizures including combative and violent confusion. The patient presented with a mild abrasion on left scalp, and was initially unable to give any medical history. Target patient #33 was reported to have had a seizure disorder. He was restrained for violent behavior.

Per patient's medical record: "...Notes: the patient was initially agitated and confused and combative, (sic) he is improved after. Rest and initial treatment with Ativan...."

Medical record revealed that on 7/1/17 at 14:49 (upon arrival), a restraint order was placed by ED Physician #13.

ED RN #4 confirmed during separate interviews on 9/12/17 and 9/13/17, that the restraint order was initiated at 14:49.

On 7/1/17 at 18:36, a Face to Face Evaluation was performed by ED Physician #13 revealing a description of the patient's immediate situation: "...Psychotic Symptoms posing harm to self or others, Violent behavior posing harm to self or others...."

ED Physician #13 confirmed during an interview on 9/14/17 at 0930 hours, that he was aware that a face to face evaluation had to completed within 1 hour.

ED Physician #13 failed to perform a face to face evaluation of patient #33 within 1 hour of initiation of restraints.

Patient # 34

Patient #34's medical record revealed the following information: an emergency room visit on 7/30/2017 at 09:20 AM with diagnosis of Alcohol intoxication. The patient was found in the back of a vehicle with friends, and reported that he had been drinking up until 3:30 in the morning. He fell at one point and hit his face on the ground. The patient presented by EMS, and was combative and aggressive on the scene. The patient was uncooperative and unable to give a medical history at the time of assessment due to his altered mental status. Restraints were initiated for violent behavior.

Medical record for pt # 34 revealed: "...Reexamination/Reevaluation: Patient urinated on the ground. We were unable to get urine sample at this time. The patient was eventually is sedated (sic) and both physically and chemically restrained with Ativan and 4 point restraints given his agitation and combativeness...."

It is documented in the medical record that target patient #34 was already in restraints on 7/30/17 at 10:15 AM with restraint location documented as: "...Wrist Bilateral, Ankle Bilateral, Torso...."

Medical record revealed that on 7/30/17 at 11:29 AM a restraint order was placed by ED Physician #14.

Hospital policy titled 'Restraints ad Seclusion Policy' revealed: "...11. The decision to initiate restraint or seclusion can be made in an emergency by a trained RN: (sic) a physician or LIP order is obtained as soon as possible after initiation of restraint...."

Clinical Coordinator RN #3 and ED RN #4 confirmed during separate interviews on 9/12/17 and 9/13/17, that a nurse can initiate a restraint order if patient behavior poses a risk for patient or others, but a restraint order has to be obtained as soon as possible. Both confirmed that the order was placed approximately 75 minutes after the initiation of restraints.

On 7/30/17 at 12:28 PM, a face to face Evaluation was performed by ED Physician #14 revealing a description of the patient's immediate situation: "...Violent behavior posing harm to self or others, (sic) Threatening violent behavior posing harm to self or others...."

ED Physician #14 confirmed during an interview on 9/14/17 at 1330 hours, that she completed a face to face evaluation within 1 hour of ordering the restraint.

ED physician #14 failed to perform a face to face evaluation within 1 hour after the initiation of restraints.

Clinical Coordinator RN #3 and ED RN #4 confirmed the above information regarding both patients (Patient #33 and #34).
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on review of policies and procedures, documentation and interview with staff, it was determined that the hospital failed to ensure that the Quality Assessment Process Improvement (QAPI) Plan assessed and evaluated the quality of the hospital services, and effectiveness of data reported from the Safety Committee.

Failure to assess and evaluate the quality of the hospital services and effectiveness of data reported poses a high risk if the hospital does not ensure/validate that the data reported reflect the current situation.

Findings include:

Review of facility policy titled "Biomed Policies and Procedures/Medical Equipment Management Program" revealed: "...All incoming clinical equipment shall 1) be inspected by Biomed for safety and functionality before initial use or 2) be provided with current inspection documentation by manufacturer or 3rd party vendor...added to the medical equipment inventory list and placed on a computerized inspection schedule...with an inspection frequency of at least annually thereafter...All equipment not included in the program shall be inspected per 'Environmental Area Testing Procedures'...on an annual basis...during one of the two scheduled PM months for the area in which they are located...Biomed performance standards compliance (90% PM completion rate) is reported to the Safety Committee on quarterly basis in the equipment management reports...Biomed shall on an annual basis make written report to the Safety committee summarizing the performance and effectiveness of the Medical Equipment Management Program...."

Review of facility policy titled "Cleaning and Disinfecting of Hospital Equipment" revealed: "...All medical equipment used in patient care shall be kept clean and in proper working condition...after cleaning/disinfecting, the medical equipment will be taken to Biomed Department for system checking prior to returning to patient use...."

Review of facility document titled "BioMed YRMC Growth and BioMed Tech Shortage" submitted to the Facilities Director on 02/17 revealed: "...YRMC and its offsite buildings would greatly benefit from the addition of an additional BioMed tech to help meet the growing equipment maintenance needs...One tech on the East Campus (EC) is responsible for maintaining 1089 pieces of medical equipment in the Hospital, Del Webb and the PC offices...3.5 techs on the West Campus (WC) are responsible for maintaining 1906 pieces of medical equipment in the Main Hospital, Pendleton, PC offices including Bagdad and Chino Valley...Other hospitals perform PM inspections on all of their patient equipment annually...The BioMed techs are very proactive with their equipment inspection schedules...Equipment is inspected Quarterly, Semi-annually and Annually, depending on how critical the equipment is. More frequent inspections on equipment is important to insure patient and staff safety and patient satisfaction...."

Review of facility documents titled "Safety Committee Medical Equipment Management Program Exception Report" revealed the following:

10/12/16 EC PM completion rate 1st quarter: 95% 2nd quarter: 92% 3rd quarter: 94%

02/01/17 Annual Evaluation Report: With the exception of PM Completion Rate, all Q.I. indicators were above minimum thresholds for the year.
04/12/17 EC PM completion rate 1st quarter: 94%

07/12/17 EC PM completion rate 1st quarter: 94% 2nd quarter: 95%

Review of facility documents titled "YRMC Quality/Patient Safety Council" meeting minutes revealed the following:

01/05/17 No discussion related to BioMed Engineering.

02/02/17 No discussion related to BioMed Engineering.

04/06/17 Facilities: Service requests and PMs being graphed and determining how received.

05/04/17 No discussion related to BioMed Engineering.

07/06/17 No discussion related to BioMed Engineering.

Employee # 17 confirmed during interview on 9/13/17 at 15:20, that the performance standards for BioMed Engineering is a 90% PM completion rate which is reported to the Safety Committee on a quarterly basis. S/he relayed that the East Campus is currently staffed with one BioMed tech, with recent approval to hire a second tech. Employee # 17 relayed that more focus is placed on keeping the PMs on the West Campus current as that campus has a higher level of acuity of patients. S/he also relayed that more focus is concentrated on the PMs for vital patient equipment such as anesthesia machines and defibrillators.

Employees # 17, # 20 and #21 acknowledged during interview on 9/14/17 at 14:00, that the "Safety Committee Medical Equipment Management Program Exception Report" dated 07/12/17, revealed a 95% EC PM completion rate. They relayed that the 95% completion rate may have been combined information from the East and West Campuses. If the PM data from the WC was included, it would have reflected incorrect data on the East Campus (EC).

A conference call was conducted on 09/14/17 at 16:30, between the Department and the following employees from the East and West Campuses: Employees # 1, # 22, # 28, #26, # 27. The nature of the conference call was to inform the facility management that there was currently multiple patient equipment in high risk areas with no preventive maintenance completed, which posed a risk to patient's health and safety.

Chief Executive Officer (CEO) and Chief Administrative Officer (CAO) confirmed during an interview conducted on 9/15/2017, that they were in agreement that the data reported to the Safety Committee did not reflect the actual data regarding the completion of the preventative maintenance.

Both confirmed during the same above interview that the data regarding the preventative maintenance was overlooked.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on review of the hospital's policy and procedure, hospital documents, and staff interview, it was determined that the hospital failed to comply with the provisions of the Quality Assurance and Performance Improvement (QAPI) program to include that the Governing Body and Quality Improvement Committee (CQI) failed to ensure that the QAPI program/plan was reviewed annually. This deficient practice poses a significant risk for patient's health and safety, when the hospital's Governing Body and CQI Committees failed to ensure that quality improvement , quality assessment, quality of care and performance improvement projects are evaluated annually.

Findings include:

The hospital policy titled "Quality Assessment Process Improvement Plan Policy" Corporate Policy (date approved 12/11/2015) requires "...The Board of Directors and CQI Steering Committee share the responsibility for the annual review and approval of the Quality Assurance Process Improvement Plan...." of a QAPI, but does not detail the actual program specific to each hospital (West and East campus) or the six (6) hospital-based entities for 2017.

Review of the following Yavapai Regional Medical Center (YRMC) Board Meeting (Governing Body) minutes revealed no approval of a QAPI program/plan for 2017:

September 26, 2016
October 24, 2016
December 12, 2016
January 23, 2017
February 27, 2017
March 27, 2017
April 27, 2017
May 22, 2017
June 26, 2017
July 24, 2017
August 28, 2017

Review of the following Yavapai Regional Medical Center (YRMC) Board of Trustees Quality Improvement Committee (CQI)Meeting minutes revealed no approval of a QAPI program/plan for 2017:

August 11, 2016
October 18, 2016
December 8, 2016
February 9, 2017
April 13, 2017
June 8, 2017
August 10, 2017

The Director of Quality/Risk Management confirmed in an interview conducted 9/13/2017 that no 2017 QAPI program/plan was sent to the Quality Improvement Committee (CQI) or to the Governing Body for approval.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on observation on tour, review of policies and procedures, documentation and interview with staff, it was determined that the hospital failed to maintain preventative maintenance of medical equipment to ensure an acceptable level of safety and quality as evidenced by:

(A0700) The hospital failed to ensure that various types of medical equipment, located throughout the hospital was tested and calibrated according to facility policies and procedures. Failure to inspect, test and maintain medical equipment with annual preventative maintenance poses a high potential risk to patient's health and safety if the facility does not ensure that the equipment is properly tested and calibrated.

The hospital failed to inspect, test, and maintain the medical equipment to ensure their safety, availability and reliability.

The cumulative effect of this systemic practice resulted in the inability of the hospital to meet the requirement for the Condition of Participation: Physical Environment.
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on observation on tour, review of policies and procedures, documentation and interview with staff, it was determined that the hospital failed to ensure that various types of medical equipment, located throughout the hospital was tested and calibrated according to facility policies and procedures. Failure to inspect, test and maintain medical equipment with annual preventative maintenance poses a high potential risk to patient's health and safety if the facility does not ensure that the equipment is properly tested and calibrated.

Findings include:

Direct observation during tour of the Pre-op, PACU, and 3 Operating Rooms (OR) with RN # 18, Director, on 09/13/17 identified that the following equipment had expired preventative maintenance (PM) stickers, indicating that the equipment had not been recently tested /calibrated:

Accuvein, expired 1/16. Quantity: 1
Air Pal , expired 1/16. Quantity: 1
Air Pal, expired 7/16. Quantity: 1
Alternating Leg Pressure, expired 9/15. Quantity: 1
Alternating Leg Pressure, expired 7/16. Quantity: 1
Aquamantys system, expired 7/16. Quantity: 1
Dyonics Power, expired 7/16. Quantity: 1
Dyonics Power II Control System, expired 7/16. Quantity: 1
Electra Cell Saver, expired 7/16. Quantity: 1
Ethicon Endo-Surgery, expired 7/16. Quantity: 1
Hotline Fluid Warmer, expired 1/16. Quantity: 1
Hotline Fluid Warmer, expired 7/16. Quantity: 2
Intellivue Blood Pressure Monitor, no PM sticker. Quantity: 1
IntraTemp Saline Warmer, expired 7/16. Quantity: 1
LEEP System 1000, expired 7/16. Quantity: 1
Luxtec Model 9300xsp, expired 7/16. Quantity: 2
Neoprobe Gamma Detection System, expired 7/16. Quantity: 1
Novasure Hologic, expired 7/16. Quantity: 1
Olympus TC-E400, no PM sticker. Quantity: 1
Sigma Spectrum, expired 6/16. Quantity: 1
Spider 2 Arm Positioner, expired 7/16. Quantity: 1
Stryker Instrument Driver, expired 7/16. Quantity: 1
Stryker TPS System, expired 7/16. Quantity: 1
Temp Probe, no PM sticker. Quantity: 1
Ultrasound Sonosite, expired 8/16. Quantity: 1
Valley Lab Cautery Machine, expired 7/16. Quantity: 2
Valley Lab FT10 Energy Platform, expired 7/16. Quantity: 1
Versapoint Gynecare, expired 7/16. Quantity: 1
Welch Allyn Blood Pressure Monitor, expired 12/15. Quantity: 1
Welch Allyn 'Biomed Loaner' Blood Pressure Monitor, expired 8/16. Quantity: 1
Welch Allyn Sure Temp Plus, expired 7/15. Quantity: 1

Direct observation during tour of the Physical Therapy Department on 09/13/17 identified that the following equipment had expired preventative maintenance (PM) stickers, indicating that the equipment had not been recently tested /calibrated:

CPM Machine, expired 6/16. Quantity: 1
Physical Therapy Table, expired 10/15. Quantity: 1

Direct observation during tour of the ICU on 09/14/17 identified that the following equipment had expired preventative maintenance (PM) stickers, indicating that the equipment had not been recently tested /calibrated:

5 of 5 wall mounted Welch Allyn Otoscope/Ophthalmoscopes with PM's that expired 10/15 were identified in ICU rooms 2002, 2004, 2005, 2006 and 2007.

Direct observation during tour of the Family Birthing Center on 09/15/17 with RN # 2 identified that the following equipment had expired maintenance (PM) stickers, indicating that the equipment had not been recently tested /calibrated:

Sigma Scaletronix, expired 5/16. Quantity: 1
Exam Light, no PM sticker. Quantity: 3
Scaletronix Pediatric Scale 4802, expired 4/16. Quantity: 1
Symphony Medela machine, expired 10/15. Quantity: 1
Adult Patient Weight Scale, no PM sticker. Quantity: 1
Neonatal Transilluminator Venoscope II, expired 9/15. Quantity: 1
Seca Scale, expired 4/15. Quantity: 1
Taylor CCN Diaper Scale, no PM sticker. Quantity: 2
Olympic hand held Bili-Meter, expired 4/15. Quantity: 1
Oxygen Blender, no PM sticker. Quantity: 1
Teledyne Oxygen Monitor, expired 5/16. Quantity: 1
Spectrum "104", expired 3/16. Quantity: 1
Precision Medical Blender Air-Oxygen, no PM sticker. Quantity: 1

Review of facility policy titled "Biomed Policies and Procedures/Medical Equipment Management Program" revealed: "...All incoming clinical equipment shall 1) be inspected by Biomed for safety and functionality before initial use or 2) be provided with current inspection documentation by manufacturer or 3rd party vendor...added to the medical equipment inventory list and placed on a computerized inspection schedule...with an inspection frequency of at least annually thereafter...All equipment not included in the program shall be inspected per 'Environmental Area Testing Procedures'...on an annual basis...during one of the two scheduled PM months for the area in which they are located...Biomed performance standards compliance (90% PM completion rate) is reported to the Safety Committee on quarterly basis in the equipment management reports...Biomed shall on an annual basis make written report to the Safety committee summarizing the performance and effectiveness of the Medical Equipment Management Program...."

Review of facility policy titled "Cleaning and Disinfecting of Hospital Equipment" revealed: "...All medical equipment used in patient care shall be kept clean and in proper working condition...after cleaning/disinfecting, the medical equipment will be taken to Biomed Department for system checking prior to returning to patient use...."

Review of facility document titled "BioMed YRMC Growth and BioMed Tech Shortage" submitted to the Facilities Director on 02/2017 revealed: "...YRMC and its offsite buildings would greatly benefit from the addition of an additional BioMed tech to help meet the growing equipment maintenance needs...One tech on the East Campus (EC) is responsible for maintaining 1089 pieces of medical equipment in the Hospital, Del Webb and the PC offices...3.5 techs on the West Campus (WC) are responsible for maintaining 1906 pieces of medical equipment in the Main Hospital, Pendleton, PC offices including Bagdad and Chino Valley...Other hospitals perform PM inspections on all of their patient equipment annually...The BioMed techs are very proactive with their equipment inspection schedules...Equipment is inspected Quarterly, Semi-annually and Annually, depending on how critical the equipment is. More frequent inspections on equipment is important to insure patient and staff safety and patient satisfaction...."

Review of facility documents titled "Safety Committee Medical Equipment Management Program Exception Report" revealed the following:
10/12/16 EC PM completion rate 1st quarter: 95% 2nd quarter: 92% 3rd quarter: 94%

02/01/17 Annual Evaluation Report: With the exception of PM Completion Rate, all Q.I. indicators were above minimum thresholds for the year.

04/12/17 EC PM completion rate 1st quarter: 94%

07/12/17 EC PM completion rate 1st quarter: 94% 2nd quarter: 95%

Review of facility documents titled "YRMC Quality/Patient Safety Council" meeting minutes revealed the following:

01/05/17 No discussion related to BioMed Engineering.

02/02/17 No discussion related to BioMed Engineering.

04/06/17 Facilities: Service requests and PMs being graphed and determining how received.

05/04/17 No discussion related to BioMed Engineering.

7/06/17 No discussion related to BioMed Engineering.

Employee # 17 confirmed during interview on 9/13/17 at 15:20, that the performance standards for BioMed Engineering is a 90% PM completion rate which is reported to the Safety Committee on a quarterly basis. S/he relayed that the East Campus is currently staffed with one BioMed tech, with recent approval to hire a second tech. Employee # 17 relayed that more focus is placed on keeping the PMs on the West Campus current as that campus has a higher level of acuity of patients. S/he also relayed that more focus is concentrated on the PMs for vital patient equipment such as anesthesia machines and defibrillators.

Employees # 17, # 20 and #21 acknowledged during interview on 9/14/17 at 14:00, that the "Safety Committee Medical Equipment Management Program Exception Report" dated 07/12/17 revealed a 95% EC PM completion rate. They relayed that the 95% completion rate may have been combined information from the East and West Campuses. If the PM data from the WC was included, it would have reflected incorrect data on the East Campus (EC).

A conference call was conducted on 09/14/17 at 16:30, between the Department and the following employees from the East and West Campuses: Employees # 1, # 22, # 28, #26, # 27. The nature of the conference call was to inform the facility management that there was currently multiple patient equipment in high risk areas with no preventive maintenance completed, which posed a risk to patient's health and safety.