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.

PEACEHEALTH PEACE ISLAND MEDICAL CENTER 1117 SPRING STREET FRIDAY HARBOR, WA 98250 March 7, 2018
VIOLATION: NURSING SERVICES Tag No: C1048
Based on interview, it was determined that the hospital had failed to assure that a Registered Nurse (RN) evaluated the nursing care for each patient. The hospital's failure to do so potentially placed patients at risk for unmet nursing care needs.

Findings include:

Based on interview, it was determined that the hospital failed to assure that the nursing care of all patients was evaluated by a Registered Nurse. The hospital's failure to do so potentially placed patients at risk for nursing care from personnel not qualified to provide care to patients and potentially placed patients at risk for unmet care needs.

Findings include:

On March 5, 2018, hospital leadership was presented with a list of document requests. One of the requests was for documentation that described how the hospital assured that the nursing care of each patient was evaluated by a Registered Nurse.

On March 7, 2018, Regulatory and Accreditation staff acknowledged that there was no documentation that described that requirement.
VIOLATION: NURSING SERVICES Tag No: C1049
Based on interviews, review of medical records and review of hospital documents, it was determined that the hospital failed to assure that all drugs, biological's and intravenous medications were administered by or under the supervision of a Registered Nurse or a physician. The hospital's failure to do so potentially placed all patients of the hospital at risk for drugs, biological's and intravenous medications administered by unqualified personnel.

Findings include:

Patient #1
Patient #1 had been been rescued in the field and brought to the ED by Emergency Medical Services (EMS) personnel. The patient had been unconscious and in critical condition.

On 03/06/2018, at 2:30 PM, the Director of the Emergency Department (ED) stated that s/he was aware of alleged issues regarding the care of Patient #1, and had conducted a review of the patient's care.

The Director stated that s/he had interviewed one of the medics involved in the rescue and transport of Patient #1, and the medic had reported that s/he used her/his own medications in the ED. The Director stated that s/he had directed EMS personnel that they were not to provide medications, equipment or care services when in the ED. The Director stated that s/he had asked the Medical Director of the EMS to review the case and address some of the ED Director's concerns, but had not received a response to that request.

The Director stated that s/he believed the EMS personnel were emotionally involved in the rescue of Patient #1, and if someone had provided medication to the patient in the ED, it was a "one time situation".

Review of the medical record for Patient #1 revealed 4 pages of what appeared to be hand-written medication administration notes. Medications apparently administered included ketamine (a medication used for anesthesia), succs (possibly meaning succinylcholine, a medication used to cause paralysis for anesthesia purposes), dopamine (medication used for the treatment of hypotensive shock) and others.

The 4 pages were dated and timed, and included vital signs, but the pages were not signed. There was no notation of who had ordered the medications and not all medications had a route. There were no corresponding physician medication orders.

The medication documentation was reviewed with the Director of Clinical Services, who was a Registered Nurse, and who acknowledged that it was not possible to determine who had ordered the medications or who had administered the medications. S/he stated that hand-written notes were utilized when the electronic medical record (EMR) was not working, but the correct protocol was to then transcribe the hand-written notes into the EMR, which had not been done.
VIOLATION: EMERGENCY SERVICES Tag No: C0880
CONDITION NOT MET:
Based on interviews, review of the hospital's policies and procedures and document review, it was determined that the hospital failed to ensure that the emergency care needs of inpatients and outpatients were met.

As evidenced in the findings detailed throughout this report, the cumulative effect of these systemic problems resulted in the hospital failure to identify the qualifications necessary for physicians to practice in the Emergency Department (ED), failure to establish the necessary policies and procedures for care of patients in the ED, as described in the Federal Conditions of Participation and the hospital's scope of practice, failure to identify nursing standards for nursing practice in the ED, failure to identify and define the scope of diagnostic and/or therapeutic respiratory services offered by the hospital, failure to integrate emergency services into the hospital-wide quality program and failure to develop and implement accurate policies and procedures regarding the use of verbal orders.

Findings include:

EMERGENCY DEPARTMENT PHYSICIANS
On 03/06/2018 at 2:30 PM, the Emergency Department (ED) Medical Director stated that s/he had been a physician since 1991, worked in this ED since 2012 and was board-certified in Emergency Medicine. S/he stated that, as ED Medical Director s/he required that physicians who worked in the hospital's ED were required to be residency-trained and board-certified in Emergency Medicine.

On 03/07/2018 at 10:25 AM, I interviewed a second ED physician. S/he stated that s/he had been a physician since 1984, worked in the Friday Harbor ED since it opened and was board-certified in Emergency Medicine.

The position description for "Physician", did not describe qualifications regarding education beyond "graduation from an accredited school of medicine...successful completion of a US or Canadian Internship/Resident and fell owship (if required Program in area of specialty..." The document was undated and unsigned.

Position description for "MD/Medical Director PIMC - ER" listed required education as "graduation from an accredited school of medicine". Required license/certification was "licensed to practice as a physician in the State Board Certified (sic)". The document was undated and unsigned.

Position description for "Medical Director for PIMC Trauma Services" listed qualifications as 1.)Unrestricted license to practice medicine in the State of Washington
2.) Federal DEA number
3. ) Medical Staff membership and appropriate clinical privileges at PIMC
4.) Board Certified in Emergency Medicine
The document was undated and unsigned.

The Regulatory and Accreditation (RA) staff was asked to provide documentation that the medical staff had defined who was qualified to provide care in the ED. The "PeaceIsland Medical Center Friday Harbor, Washington Medical Staff Bylaws" dated February 17, 2017, were provided and portions were reviewed with the RA staff, who confirmed that the information was not contained in the bylaws or elsewhere that could be found.

POLICIES AND PROCEDURES REGARDING CARE IN THE EMERGENCY DEPARTMENT
On 03/05/2018, the hospital was presented with a list of requested documents, including "all policies and procedures related to care in the ED, including triage of patients, medical screening examinations, care and evaluation of pregnant/laboring patients and who has been determined qualified to perform each".

The hospital provided some policies and procedures, identified under Tag 0272, but was unable to provide policies and procedures for the care of patients with chest paint, seizures, alcohol/substance abuse, STEMI [ST-Elevation Myocardial Infarction (STEMI) which is a serious type of heart attack] or URI/SOB [upper respiratory infection/shortness of breath], all of which were identified in the ED Scope of Services as the patient needs for which the ED could provide care.

On 03/07/2018, at 1:45 PM, the Director of Clinical Services (DCS) confirmed that the hospital did not have policies and procedures to guide care in the above-described instances.

The policy and procedure "Triage" nsg-1037, did not identify which personnel were qualified to perform triage. The policy and procedure stated: "SCOPE This Procedure applies to all Peace Island Medical Center Emergency Department caregivers providing Triage to patients". The document did not specify which "caregivers" were qualified to do so.

During the same interview, the DCS stated that the hospital used ENA [Emergency Nurse Association] standards and ESI [Emergency Severity Index] guidance in the ED. The DCS confirmed that documentation reviewed did not refer nurses to those standards or guidance.

No policy and procedure was provided regarding medical screening examinations (MSE) and/or who was qualified to perform a MSE.

STANDARDS FOR NURSING CARE IN THE ED
The policies and procedures provided regarding care in the ED were reviewed, as were the were the 4 standing orders provided: "Nurse Initiated Standing Orders: Clinical Guidelines', "ED Seizure Standing Orders", "ED Altered Mental Status Standing Orders" and ED Chest Pain Standing Orders", as was the protocol "ED Adult Dyspnea Protocol".

The "Emergency Department Nursing Care Standard (NCS)" was reviewed and was found to lack directives on the qualifications of the nurses who worked in the ED, and which nurses were qualified to implement the standing orders or protocols. The document showed that the document was effective as of "03/01/16", "last review: 03-01-16" and the "next review: 03-01-17".

On 03/07/2018, at 1:45 PM, the Director of Clinical Services (DCS), who was a Registered Nurse, stated that the ED nurses adhered to the Emergency Nurse Association standards. The DCS confirmed that the hospital had not identified the nursing care standards to be followed. The DCS confirmed that the hospital had not identified in writing who was qualified to initiate the standing orders or the protocol.

VERBAL ORDERS
On March 5, 2018, the hospital was presented with a list of requested documents, including "policy and procedure that describes who may give and who may receive medication orders..."

Two documents regarding verbal orders were provided.

The first document was "Order Management Procedure" # 900.2.106. The procedure stated
"6.3 Verbal Orders
6.3.1 Verbal orders are strongly discouraged due to the potential for miscommunication...
6.3.2 The following roles may accept medical orders as appropriate to their role and scope of practice..." and listed 14 roles/disciplines who were determined appropriate to take verbal orders.

The second document was "Peace Island Medical Center Rules, Regulations Medical Staff Services", and was noted to be approved 10/26/12. No other dates were found on the document. The document stated:
" SECTION 5 ORDERS...D Verbal Orders
1. All verbal orders can be accepted and transcribed by..." and listed 15 disciplines. Not all disciplines were instructed to accept verbal orders within their scope of practice. The disciplines that had no restrictions written were:
-Medical Staff Member
-Registered Nurse
-Licensed Practical Nurse
-Physicians Assistants
-Therapeutic Recreation specialists...

2. Verbal orders shall be signed, dated and timed by the person taking the order, along with the name of the practitioner who dictates the order. Verbal orders shall be signed by the ordering practitioner or his alternate within 48 hours..."

Ref. citation written at Tag 0297

RESPIRATORY SERVICES
On 03/05/2018, the hospital was presented with a list of requested documents, including "Position description for respiratory care services, including job description, licensure requirements, education, training and experience and what types of respiratory care they may perform..."

On 03/07/2018, ED Registered Nurse (RN) #1 stated that Emergency Medical Services (EMS) personnel did not provide any care to patients in the ED. S/he stated that the RNs did not extubate patients or provide ventilatory management to patients because that was outside of the scope of RN practice. S/he stated that the hospital did not employ respiratory therapists, so when patients required extubation or ventilatory management, the physicians provided that care.

On 03/07/2018, at 1:45 PM, the DCS confirmed that the hospital did not have a respiratory care service. S/he also confirmed that no policies and procedures were available that gave guidance to RNs or physicians regarding role and scope of respiratory services for patients.

BLOOD AND BLOOD PRODUCTS
On March 5, 2018, the hospital was presented with a list of requested documents, including "Documentation that describes how the hospital accesses blood and blood products".

A policy - 900.2.103 and a procedure 900.2.104 - were provided. The policy stated "POLICY: It is the policy of PeaceHealth that PeaceHealth caregivers follow all established policy and procedures to ensure that blood transfusions are given in a safe and appropriate manner..." The policy referenced the procedure.

The procedure stated:
"PURPOSE The purpose of this procedure is to outline the safe and appropriate administration of blood and/or blood products...
...PROCEDURE 2. Patient and Blood Unit Identification Prior to Administration...by two authorized individuals...
...3. Verifying Patient and Blood Unit Identification
3.1 Two authorized individuals...
...3.2 One of the authorized individuals initiating the blood/blood product administration must be one of those participating in verification and safety checks..."

The DCS and the Safety and Accreditation staff both stated throughout the 3-day onsite investigation that the PeaceHealth organization used the term "caregivers" to mean any employee of the organization, including non-clinicians.

On 03/07/2018, the DCS confirmed that the blood/blood products policy and procedure did not identify which personnel were "authorized" to verify or administer blood/blood products. S/he stated that the hospital practice is to have either 2 RNs or a RN and a physician participate in the procedure.

QUALITY ASSURANCE/PROCESS IMPROVEMENT (QAPI)
On 03/05/2018, the hospital was presented with a list of requested documents, including "documentation of any quality improvement initiatives related to care and services in the ED".

On 03/06/2018 at 8:30 AM, the Regulatory and Accreditation staff was asked to identify personnel responsible for the QAPI process at the hospital, and s/he identified Staff #3.

On 03/065/2018 at 12:05 PM, Staff #3 confirmed that s/he was the quality specialist for the hospital and stated that s/he had been in the role since 2016. S/he stated that RN #1 was leading the project regarding trauma in-house, which was the only formalized initiative in place.

Staff #3 stated that the project had been in place since 2016. S/he stated that the first level review of medical records for trauma patients was done by RN #1. S/he stated that the second level of review was done by a physician. Staff #3 stated that the trauma initiative for this hospital was the same across all PeaceHealth hospitals.

Staff #3 stated that s/he was not a clinician and her/his qualifications to perform and lead a quality initiative were that s/he held a certificate in Health Care Quality.

On 03/07/2018 at 9 AM, RN #1 stated that s/he reviewed "every ED patient record" for those who "meet criteria". The RN was unable to describe the audit criteria used for the medical record review or provide the written guidelines for implementation of the QAPI plan regarding that review. S/he stated that s/he met with the DCS and the ED Medical director and they look for "patterns and trends".

RN #1 provided the completed, hand-written tool for chart review for September 2018 (sic) October 2018 (sic) and November 2018 (sic). S/he stated that she had already "talked to" those whose practice or documentation did not meet criteria. S/he stated that s/he had completed the medical record review for December 2017 through February 2018, but those results were hand-written and had not been entered into a database as yet. S/he acknowledged that it would not be possible to track or trend data that was not entered.

When asked how s/he interacted and communicated with Staff #3, s/he stated that s/he did not know who that person was and was not involved with her/him.

On 03/07/2018, at 1:45 PM, the DCS stated that the hospital could not provide the last 3 months of data on the trauma initative being conducted.
VIOLATION: PROVISION OF SERVICES Tag No: C1004
CONDITION NOT MET:
Based on interview, review of the hospital's policies and procedures and document review, it was determined that the hospital failed to ensure that policies and procedures were developed to meet the needs of patients identified in the hospital's Scope of Services for the Emergency Department (ED) and safe and appropriate nursing care throughout the hospital.

As evidenced in the findings detailed throughout this report, the cumulative effect of these systemic problems resulted in the hospital failing to develop and implement policies and procedures to assure the consistent implementation of necessary, and potentially life-saving, care in the ED and to assure safe and appropriate nursing care throughout the hospital.

Reference citations at:
Tag 0272 - Patient Care Policies
Tag 0294 - Nursing Services - RNs assign nursing care of patients
Tag 0296 - Nursing Services - RNs supervise nursing care of patients
Tag 0297 - Nursing Services - RNs evaluate nursing care of patients
VIOLATION: PATIENT CARE POLICIES Tag No: C1008
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and review of hospital policies and procedures (P&Ps) it was determined that the hospital failed to assure that all policies and procedures were developed with the advice of members of the CAHs professional healthcare staff, including one or more physicians, and were reviewed at least annually. The hospital's failure to do so potentially resulted in hospital staff using outdated/incomplete information and direction related to care and services of all patients.

Findings include:

Thirty-five (35) P&Ps were reviewed.

Of the 35 P&Ps reviewed, 31 did not include evidence that a physician had been involved with the development of the policies and procedures, although several included evidence that physicians had been involved in subsequent P&P reviews.

The P&Ps which did not include evidence of physician involvement in P&P development were:
-Secured Medication in Locked Emergency Department Cart
-Medication Administration Policy
-Narcotic and Controlled Substance Security and Documentation Policy
-Medication Waste Disposal
-High Alert Medications Policy
-Drug Product Recall
-Drug Product Evaluation and Selection Policy
-Drug Formulary
-Automated Floor Stock Device (Pyxis Medication station)
-Access After Pharmacy Hours
-Order Management Policy
-Blood and Blood Product Administration Procedure
-Blood and Blood Product Administration Policy
-Shift Change/Transition of Care Policy - Front page of policy stated "approved by Medical Executive Committee" (undated), second page stated original approval by Director of Clinical Services on 11/01/12 with subsequent review/revisions by Medical Executive Committee on 10/12/16
-Monitoring of Medication and Chronic Conditions
-Policy and Procedure Development (adm - 0640)
-Policy and Procedure Development (adm - 0851)
-Holding Patients Requiring DMHP Outreach Policy (225.3.102)
-Holding Patients Requiring DMHP Outreach Policy (225.3.103)
-Domestic Violence Screening Policy
-Screening Brief Intervention and Referral to Treatment (SBIRT)
-Triage
-Management of the OB Patient in the Emergency Department Policy
-Admission and Assessment of the Newborn
-Trauma Quality Improvement Plan
-Orthopedic Trauma
-C-Spine Procedure for Trauma Patients
-Trauma Team Roles and Activation
-Trauma Transfer In/Out
-Telephone Advice Policy
-Trauma Quality Improvement Plan


Of the 35 P&Ps reviewed, the 18 which did not include evidence that the P&Ps had been reviewed at least annually were:
-Secured Medication in Locked Emergency Department Cart - Original version 10/01/2013, next reviewed 8/26/2015
-Narcotic and Controlled Substance Security and Documentation Policy - Original version 11/01/2012, next reviewed 10/19/2015
-Narcotic and Controlled Substance Security and Documentation Policy - Original version 11/01/2012, next reviewed 10/19/2015
-Medication Waste Disposal - Original version 11/01/2012, next reviewed 11/05/2014
-High Alert Medications Policy - Original version 11/01/2012, next reviewed 3/20/2014. Last review on 2/28/2017
-Drug Product Recall - Original version 11/01/2012, next reviewed 11/04/2014. Last reviewed 2/28/2017
-Drug Formulary - Original version 11/01/2012, next reviewed 11/04/2014
-Automated Floor Stock Device (Pyxis Medication station) - Original version 5/13/2013, next reviewed 3/09/2015
-Monitoring of Medication and Chronic Conditions - Original version 11/01/2012, next reviewed 11/04/2014
-Policy and Procedure Development (adm - 0640) Approved by System Leadership Group on 2/11/2016. Next review scheduled for 2/11/2019
-Policy and Procedure Development (adm - 0851) Approved by System Leadership Group on 2/11/2016. Next review scheduled for 2/11/2019
-Holding Patients Requiring DMHP Outreach Policy (225.3.102). Original approval by Clinical Services Director on 11/1/2012, effective 7/02/17, Medical Executive Committee revision on 7/12/2017, next review set for 7/12/2018
-Holding Patients Requiring DMHP Outreach Policy (225.3.103). Original approval by Clinical Services Director on 11/1/2012, effective 7/02/17, Medical Executive Committee revision on 7/12/2017, next review set for 7/12/2018
-Domestic Violence Screening Policy. Original approval by Director of Clinical Services on 11/01/2012, effective 3/20/2015, subsequent reviews by Medical Executive Committee on 12/14/2016 and 12/08/2017
-Management of the OB Patient in the Emergency Department Policy. Original approval by Director of Clinical Services on 11/24/2014, next review/revision by Medical Executive Committee on 1/11/2017 and 1/10/2018
-[DIAGNOSES REDACTED] Screening and Interventions in the Neonate Procedure. Original approval by Director of Clinical Services on 11/01/2013. Next, and only, review/revision by Medical Executive Committee on 7/20/2017
-Telephone Advice Policy - Original approval by the Director of Clinical Services on 11/01/2012. Next, and only, review/revision by Medical Executive Committee on 7/20/2017
-Trauma Quality Improvement Plan - Original approval on 11/07/2012, next review on 10/2014

The above policies and procedures were reviewed/discussed with the Director of Pharmacy/hospital pharmacist/Director of Clinical Services.
VIOLATION: NURSING SERVICES Tag No: C1046
Based on interview, it was determined that the hospital failed to assure that the nursing care of all patients was provided, or assigned, by a Registered Nurse. The hospital's failure to do so potentially placed patients at risk for nursing care from personnel not qualified to provide care to patients and/or having unmet care needs.

Findings include:

On March 5, 2018, hospital leadership was presented with a list of document requests. One of the requests was for documentation that described how the hospital assured that the nursing care of each patient was assigned by a Registered Nurse.

On March 7, 2018, Regulatory and Accreditation staff acknowledged that there was no documentation that described that requirement.