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 Dec. 22, 2016
VIOLATION: GOVERNING BODY Tag No: C0241
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Based on document review, the facility failed to ensure that the medical staff bylaws were approved by the governing body.

Failure to do so created risk to the effectiveness and adequacy of the bylaws for the needs of patients being served.

Findings:

1. In review of a document titled, "Medical Staff Bylaws Peace Island Medical Center", it was noted that the medical staff bylaws were not signed as approved by the governing body.

2. In review of PeaceHealth Peace Island Medical Center Governing Board Meeting Minutes from August 20, 2012, the Governing Board provisionally approved (with input into the final draft) the medical staff bylaws. Documentation could not be located by facility staff indicating that the final input was adopted by the medical staff and subsequently that there was final approval by the Governing Board.
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VIOLATION: POLICIES - DRUG MANAGEMENT Tag No: C0276
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Item #1 - Sterile Compounding Environment and Practices

Based on interview, observation and record review, the facility failed to demonstrate that the sterile compounding practices, including low volume hazardous drug compounding, were managed in adherence to USP 797 standards.

Failure to do so created risk to medication safety and patient harm.

Reference: 2016 USPC Official, 8/1/2016 - 11/30/2016 <797>, Pharmaceutical Compounding - Sterile Preparations

Findings:

A. Pharmacists' Interpretation of Cleanroom Performance Standards for Sterile Compounding

1. a. In review of reports titled, "Cleanroom Certification and Biological Sampling Report" (December 16, 2015 and June 1, 2016; on page 3 of 22 and 3 of 24, respectively) it stated that the negative pressure test readings recorded as "PASS" at the measurement site in the hazardous drug compounding room. However, the report did not address the fact that there were not continuous pressure reading instruments to ensure required pressurization for the entire room. (The readings determined as "PASS" by the certification contractor were not reflective of the entire HDC compounding environment.)

b. The pressure measurement test results listed for the "Ante Room" and "IV Room" (non-hazardous drug room) were recorded as "Fail" status.

c. In review of the above referenced certification reports it indicated that the "IV Room", "Ante Room" and "Chemo Room" test results on "Air Changes per Hour" was "N/A" and the Pass/Fail criteria was "N/A". The section for "Additional Testing/Comments "did not include any related information. Therefore, the test results could not be interpreted.

d. In review of the above referenced certification reports it indicated that the "IV Room", "Ante Room" and "Chemo Room" test results on "HEPA Leak" (HEPA filter leak) was "N/A" and the Pass/Fail criteria was "N/A". The section for "Additional Testing/Comments" did not include any related information. Therefore, the test results could not be interpreted.

2. a. On 11/29/2016 at 10:30 AM, the surveyor interviewed the Lead Pharmacist (Staff Member #1) about the air flow for the hazardous drug compounding (HDC) room. S/he stated that the room pressure was "negative" and that the room was "compliant".

b. On 11/29/2016 at 12:45 PM, the surveyor and technical advisor interviewed the Lead Pharmacist (Staff Member #1) about the HEPA filter tests. S/he understood that the current HEPA filter were not adequate and that new HEPA filters (with access ports) were due to be placed in the near future so that measurements could be taken. The current HEPA filter were re-placed in May 2016 (but without measurement access ports) and were thought to be adequate at that time.

c. On 11/29/2016 at 11:45 AM, the surveyor and technical advisor interviewed the Lead Pharmacist (Staff Member #1) about her/his understanding of the requirement for air changes per hour required for a sterile compounding ISO 7 environment. S/he stated s/he did not know the requirement and did not know whether the sterile compounding environment met the standard.

d. On 11/29/2016 at 2:00 PM in an interview with an onsite pharmacist trainer (from another facility) (Staff Member #2), s/he stated that she understood that, to date, the HDC room was not compliant with USP 797 standards.

e. On 11/30/2016 at 3:30 PM, the Director of Pharmacy (Staff Member #6) stated that prior to 2015, s/he did not know that the facility's pharmacy space was not USP 797 compliant. On 12/1/2016 at 12:45 PM, s/he stated that s/he had requested remodeling of the space in March 2015 for USP 797 compliance.

B. Pressure Differential Monitoring

Based on observation, the facility did not ensure that there was continuous pressure differential monitoring at prescribed locations.

Failure to do so created risk for improper air purity for the type of sterile compounding environment.

Findings:

During a tour of the pharmacy on 11/30/2016 at 8:30 AM, the technical advisor and surveyor noted that there were no pressure gauges for continuous monitoring and daily recording of the air pressure differential between the anteroom and the general pharmacy; and between the hazardous drug compounding buffer area and the anteroom. Lack of monitoring in relation to the anteroom space could also potentially negatively impact the air quality in the non-hazardous segregated compounding area as well.

This finding was confirmed at the time with the Lead Pharmacist (Staff Member #1).

C. HEPA Filters in the Sterile Compounding Space

During a tour of the pharmacy on 11/30/2016 at 8:30 AM, the technical advisor noted that there were HEPA filters in the anteroom and hazardous drug compounding room. However, the filters were not configured with ports for required testing for leaks (impaired function) despite being reordered more than one time.

D. Air Changes Per Hour

According reports titled, "Cleanroom Certification and Biological Sampling Report" (December 16, 2015 and June 1, 2016; on page 3 of 22 and 3 of 24, respectively), the information related to air change was rated as "N/A". The adequacy of the changes could not be determined accordingly.

E. Hood Location with the Sterile Compounding Rooms

During a tour of the pharmacy on 11/30/2016 at 8:30 AM, the technical advisor noted that the hoods located in the HD and NHD compounding space were located up against the wall in a manner that prevented required routine cleaning to the back of the hoods and adjacent wall surfaces.

At that time, the technical advisor observed the pharmacy technician (Staff Member #3) garbed (gown, hat, mask, shoes covers) and cleaning the HD compounding area. Due to the hood location, the pharmacy technician did not clean the areas behind the hood or on the adjacent wall area.

F. Cleanable Surfaces in the Anteroom and Sterile Compounding Areas

On 11/29/16 at 11:30 AM the technical advisor noted that the light fixtures were not flush mounted and sealed to the ceiling and that the ceiling tiles were not sealed.

G. Storage of Hazardous Drugs (HDs)

On 11/29/2016 at 11:45 AM the surveyor and technical advisor interviewed the Lead Pharmacist (Staff Member #1) about where the HDs were stored. S/he stated that they were stored in two locations; in the main pharmacy refrigerator co-mingled with biological products and inside the upper cabinets (regular casework) located in the anteroom (serving both the NHD and HD sterile compounding areas).

When asked why they were stored in that manner, s/he stated that options for separate and adequate storage were not available at that time.

H. Training/Competency for Compounding Practice

1. In review of facility training documents, the following was noted: all onsite pharmacy staff (Staff Members #1, 3, 7 and 8) had completed a consent to handling/acknowledging the risk of hazardous drugs. Per their signatures, they agreed to undergo training related to hazardous drug preparation for patients. Those documents were all signed between 10/27 to 10/31/2016. However, follow-up training documents were not available to date.

2. On 11/29/16 at 10:30 AM, the surveyor interviewed the Lead Pharmacist (Staff Member #1) about staff training for USP 797. S/he stated that in early October 2016 s/he arranged for onsite training to begin that day (11/29/2016) about ensuring USP 797 practices. A trainer (from another facility) was onsite that day as planned to initiate the training process (not completed on that day).

When asked if any other training had occurred within the past year, s/he stated that as the Lead Pharmacist that she was scheduled to attend a national training course in March 2017 and had completed 15 hours pre-requisite training in preparation for the course. S/he could not identify other training specific to USP 797 that s/he and/or other pharmacy staff had attended in the past year.

I. Gloves for Handling Hazardous Drugs (HDs)

On 11/29/2016 at 4:15 PM the technical advisor and surveyor observed the Pharmacy Technician (Staff Member #3) open the medication refrigerator and remove a HD while wearing gloves.

At that time, the technical advisor asked about the glove type used after observing retrieval from the nearby cart. The gloves were non-sterile (appropriate) protective gloves but were not chemotherapy rated.

J. Location of Required Supplies for Sterile Compounding

Based on observation, the facility failed to ensure that supply placement needed to perform sterile compounding was adequate.

Failure to so created risk for cross-contamination of sterile procedures.

Findings:

On 11/30/2016 at 11:30 AM, in observation of a pharmacy technician's (Staff Member #3) preparation for sterile compounding while located outside of the sterile compounding space, the technician carried a gown, gloves, mask and cap into the anteroom for future use. Those supplies for sterile compounding were located outside of the compounding space.

At the same observation time, the technician placed alcohol-based hand sanitizer with persistent antimicrobial activity into her/his cupped palm for use after entry to the anteroom, but prior to donning protective gear. The source location of the hand cleanser was 15 -20 feet away from the sterile compounding space. Additionally, s/he did not have access to alcohol-based hand sanitizer with persistent antimicrobial activity in the sterile compounding environment for use just prior to donning sterile gloves.

Item #2 - Sink for Routine Hand Washing

Based on observation and interview, the facility did not provide a sink in the Pharmacy for staff routine hand washing.

Failure to do so created a risk for inadequate hand hygiene which may contribute to diminished quality of patient medications and/or patient harm.

1. On 11/30/2016 at 11:00 AM during a tour of the pharmacy, the surveyor noted that there was not a sink located in the pharmacy for routine hand washing.

2. a. In a follow-up interview that day at 12:00 PM with the Lead Pharmacist (Staff Member #1) s/he stated that s/he exited the pharmacy for routine handwashing and used a sink located at a nearby nurses' station.

b. On 12/01/2016 at 8:45 AM the surveyor interviewed a pharmacy technician (Staff Member #3) about where s/he washed her/his hands in pharmacy. S/he stated that s/he used the sink located in the anteroom of the sterile compounding area. This sink location required staff to don protective garb for routine access in that location. (The sink located in the anteroom of the sterile compounding room was situated for procedural hand hygiene prior to sterile compounding). Additionally, the location of that sink created exposure to HD compounds due to design limitations.

Item #3 - Medication Security

Based on observation, record review and interview, the facility failed to ensure that adequate processes were in place to ensure medication security, availability and quality.

Failure to do so created risk that availability to safe medications may be impaired.

A. After-Hours Pharmacy Access

1. In review of facility policy titled, "Access After Pharmacy Hours" (Policy # MC-ANC; Effective 12/01-2014) under the "Policy" section it referenced WAC 246-873-050, "Absence of a pharmacist". Item #2 stated, "One registered nurse supervisor in any given shift may have access to the pharmacy and remove drugs from there".

2. On 11/30/2016 at 11:45 AM, the surveyor and technical advisor toured the Emergency Department and interviewed the Emergency Department charge nurse (Staff Member #6), who also served as the nursing supervisor at that time. S/he stated that there were 2 keys available for after-hours pharmacy access. S/he showed that one key was located on the charge nurse key ring and the other key was located in a locked medication storage tower.

When asked about the rationale for 2 keys, s/he stated that a nurse might leave the facility with one of the keys and the other key was for back-up access. The surveyor and technical advisor discussed with the nurse that this created an opportunity for 2 nurses at a time to access the pharmacy when the policy stated that only one nurse may access during the described time period.

B. Crash Cart Security in an Intermittently Unstaffed Patient Care Area

1. In review of facility policy titled, "Verifying Code Carts" (Document #304.387.38; Reviewed 4/13/2016) item #2 stated, "In areas that are not open on a continuous basis, code carts will be checked every day during operational times." The policy did not address emergency cart overall security.

2. During a tour of the facility, the surveyor and technical advised observed a crash cart located on the medical-surgical unit in the nurses' station. However, there were no patients located on the medical surgical unit during the investigation time period and there were no hospital staff assigned to that area for patient care.

3. On 11/30/2016 at 11:00 AM the surveyor and technical advisor interviewed the hospital maintenance specialist (Staff Member #9) about public access in the hospital and after hours. S/he confirmed that during "business hours" (until 6:30 PM) there was public access to the unstaffed area where the emergency crash cart was located on the medical-surgical unit.

S/he also confirmed that even though there was an after-hours "garage door" closure in a hallway that prevented access from one part of the hospital to the other, a public elevator allowed for after-hours public access to the unstaffed unit and emergency crash cart.

Item #4 - Pharmacy Staff Evaluations

Based on record review and interview, the facility did not ensure that 2 of 2 pharmacy staff were evaluated by a supervising pharmacist at the hospital.

Failure to do so created risk that staff competency was not adequately determined.

Findings:

1. In review of personnel record of a pharmacy technician (Staff Member #2) and a per diem pharmacist (Staff Member #10), it was determined that their evaluations were not documented as completed by the Director of Pharmacy/designee who worked at the faciity. They were completed by a pharmacist who worked at a different hospital.

2. On 11/29/2016 at 2:00 PM during an interview with the Pharmacist Lead (Staff Member #1), s/he stated that Pharmacy Director was on site about 3 times per year.

In a follow-up interview with the Director of Pharmacy (Staff Member #6) on 12/1/2016 between 12:00 PM and 3:00 PM, s/he stated that s/he gave input into the evaluation comments of the above noted staff members but that the evaluation was completed under the name of different hospital's pharmacy manager because of the configuration of the human resource computer system.

3. In review of the job description titled, "Director, Pharmacy Services" (Modified 8/23/2016) item #7 stated, "Directs recruitment, training, development and evaluation of staff."

In review of the onsite lead pharmacist's (Staff Member #1) job description (modified 8/10/2016) under item #10 it identified responsibility to supervise and train pharmacy technicians, as well as (under item #11) pharmacy interns and externs. However, evaluation of competency was not specifically listed in the job description for oversight of pharmacists or pharmacy technicians.
VIOLATION: POLICIES - MED ERRORS & ADRS Tag No: C0277
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Based on document review and interview, the facility failed to ensure processes were followed for adverse drug event analysis.

Failure to do so created risk that medication errors were not adequately identified and/or evaluated for affected and future patients

1. In review of facility policy titled, "Adverse Drug event (ADE) Reporting Program Policy" (Document #304.333.1, Reviewed 4/14/2014) on page 2 under item 4.1 it stated, "All EIRs [electronic incident reports] involving medications will be sent to the Pharmacy Director for initial review. They will see all medication and ADR's [adverse drug event] related incidents, and review them for trends and issues utilizing the pharmacy ADE program. They will document their analysis. . ."

2. On 11/30/2016 at 2:45 PM the surveyor reviewed a document titled, "Quality and Patient Safety Plan-Critical Access, Appendix C- Measurement Monitoring and Analysis" with the Director of Pharmacy (Staff Member #6). On page 20 it identified the quality measures throughout the hospital, including medication safety measures. The person listed as responsible for medication quality improvement was the "Director of Pharmacy".

When the Director was asked if s/he was aware that s/he was responsible for those quality activities, s/he stated no. The activities listed on the above document under the purview of the Director of Pharmacy (or designee) did not include analyzing hospital medication errors.

3. In review of the content of the minutes of the facility Pharmacy and Therapeutics Report (included in the monthly Medical Staff Meetings) from April 13, 2016 to November 2016, there was limited information about pharmacy activities, except in October. In October, there was a report of 5 adverse drug events that occurred from May to August. There was no final analysis of the adequacy of the findings.

4. On 11/29/2106 at 2:00 PM the surveyor interviewed the Lead Pharmacist (Staff Member #1) about analysis of patient medication errors for quality improvements. S/he stated that recently began to review each event to determine the root cause of medication errors on a case by case basis. S/he stated s/he shared that data at the Pharmacy and Therapeutics Report (part of the Medical Staff Meeting). However, data was not analyzed at the hospital level and reported to the Quality Improvement program at that time.

5. In review of the job description (modified 8/23/2016) of the Pharmacy Director (Staff Member #6) item #5 stated, "Participates as an active member of the Pharmacy and Therapeutics Committee and assures that all medication related processes, policies and practices are reviewed and communicated".

6. On 11/30/2016 at 3:00 PM, the Director of the Pharmacy (Staff Member #6) confirmed that s/he did not participate in the facility Pharmacy and Therapeutics Report meetings or discussions and was not aware of their content.
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VIOLATION: POLICIES - INFECTION CONTROL Tag No: C0278
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Item #1 - Hand Hygiene

Based on review of policy and procedure and observation, the facility failed to demonstrate that 1 of 1 nurses adhered to hand hygiene standards in the flow of direct patient care.

Failure to do so created risk for transmission of infection to patients, visitors and facility personnel.

Findings:

1. In review of facility policy titled, "Standard Precautions" (Document #101.82.1; revised 9/24/2014) on page 1 under "Hand Hygiene", it stated that "Hand Hygiene is the single most important measure to reduce the risk of transmitting microorganisms" and then refers staff to a link to Mosby's hand hygiene nursing skills". In review of that document on page 2, it identified when a nurse should use an alcohol based hand rub for routinely decontaminating hands if not visibly soiled and requiring hand washing.

Those criteria included, but were not limited to, "Before having patient contact"; "Before putting on clean or sterile gloves"; "After contact with patient intact skin"; "When moving from a contaminated body site to a clean body site during care"; "After contact with inanimate objects . . .in the immediate vicinity of a patient"; and "After removing gloves".

2. On 12/20/2106 between 10:15 and 10:45 AM the surveyor observed a RN (Staff Member #11) provide care to an inpatient (Patient #1) who was admitted for treatment with a diagnosis of pneumonia. The following omissions in hand hygiene with an alcohol based hand rub were noted:

-The RN exited the room after patient contact, without hand hygiene, to obtain nebulizer equipment from a supply area.

-Then the RN re-entered the room (no hand hygiene), opened nebulizer packaging, scanned medication for inhaled administration and gave the device/medication to the patient.

-Then right afterwards the RN did not clean hands prior to clean glove placement, a blood draw from the patient's intravenous (IV) site with a syringe and ablood draw into a tube for processing.

-Later the RN entered the medication room and removed medications from the drug storage machine drawers without recent prior hand hygiene; then answered the phone in the medications room and later continued with removing medications after handling the phone.

-Later in the medication room the RN positioned a 1 liter bag of IV fluids between her/his shoulder and face while draining the fluid through the tubing into the sink. The bag was then handled with ungloved hands. Then the nurse entered the patient's room and, without hand hygiene, touched the patient to re-position the oxygen sensor on her/his right pointer finger.

-Later the RN exited the room and returned and without prior hand hygiene, put on another pair of gloves used the computer and administered oral medications to the patient. With the same gloves the RN handled the IV port (clean site after contact with inanimate objects in the room).

-With the same gloves the RN exited the room and obtained a clean gown for the patient.

-Then the nurse re-entered the room and, after hand hygiene, helped the patient back to bed (after the patient used the bathroom) and to put on a new gown and then the RN hooked up the patient's IV to a heparin lock site (clean site) without prior hand hygiene.

-Then after patient contact the RN exited the room without hand hygiene and went to the nutrition room. Hand hygiene was performed there and a new pair of clean gloves were placed on. Food and a food thermometer (general use) were prepared/handled. During that time period the RN handled a phone for a call.

-Then the RN re-entered the patient's room (no hand hygiene) to deliver food from the nutrition room and then removed clean gloves and did not perform hand hygiene after glove removal.

Item #2 - Blood product handling and testing in the Emergency Department

Based on observation and review of policy and procedure, the facility failed to establish a procedure to prevent possible blood product environmental contamination related to lab testing located at the Emergency Department staff work station.

Failure to do so created risk for possible transmission of infection.

Findings:

1. In review of facility policy titled, "Point of Care Testing: Breathalyzer, Clinitest, Gastroccult, Hemoccult, Nitrazine, Urine Chemstrip, Urine HCG" (Document #304.387.55; Reviewed 5/14/2015) it described the purpose as providing staff guidelines accurately screen bodily fluids. It did not address infection prevention measures except that "Gloves are worn when conducting tests."

Another policy titled, "Laboratory Ordering, Drawing, Redrawing Procedures" (Document #304.387.54; Reviewed 5/14/2015) described specimen collection and reporting procedures. It did not address infection prevention measures.

Both policies applied to the facility's patient care and laboratory staff.

2. On 12/20/2106 between 10:30 and 10:45 AM the surveyor observed a RN (Staff Member #11) provide care to an inpatient (Patient #1) who was admitted for treatment with a diagnosis of pneumonia. The RN drew blood for a purple top tube in the patient's room. Then the RN carried the tube (in the same gloved hand used to draw the blood in the patient's room) to the back counter of the main workstation to the Emergency Department's testing equipment.

The RN placed the tube of blood (not located in a plastic bag) directly on the counter surface (no barrier) and then opened the tube, removed a small volume of blood with a pipet and transferred that portion into a tray for eventual placement into the testing device. After completion the nurse removed her/his gloves and performed handwashing at the sink. However, the work area surface of the counter was not cleaned before the nurse took a patient related phone call.

3. On 12/21/2016 at 11:00 PM in a follow-up discussion with the Infection Preventionist (Staff Member #11), s/he acknowledged that the above referenced procedures did not address environmental containment and/or cleaning related to blood (including microscopic) product handling in the testing process.

Item #3 - Cleaning of Patient Fruits and Vegetables

Based on observation and review of policy and procedure, the facility failed to ensure the proper concentration of an antimicrobial fresh fruit and vegetable treatment rinse.

Failure to do so created risk for microbial contamination and foodborne illness.

Findings:

1. In review of facility policy titled, "Washing of Fresh Fruits for Patient Consumption Procedure": (Document # 304.98.10, reviewed 8/1/2016) item #1 stated, "All fresh fruits will be washed with Victory brand food safe vegetable wash prior to serving to patients". The procedure further described holding the fruit under the wash hose for 90 seconds.

2. During a tour of the nutrition room nursing unit, the surveyor noted that instructions were posted on the refrigerator for use of a wash product (same as in the above policy) for a minimum of 30 seconds. The instructions also stated to "Periodically check wash solution for proper amount" of antimicrobial product. . . "Use test paper or test kit supplied. Recommend concentration is between 60 ppm and 80 ppm peracetic acid." At that time the surveyor requested recent information about the concentration of the product.

3. On 12/21/2016 at 11:30 the Infection Preventionist (Staff Member #12) confirmed that testing strips were not onsite at the facility and that staff testing of the peracetic acid solution concentration had not been occurring. The testing strips were ordered (not yet arrived) after the omission was identified.
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VIOLATION: NURSING SERVICES - CARE PLANS Tag No: C0298
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Based on record review and interview, the facility did not demonstrate that nursing care plans were developed and kept current on each patient in 5 of 5 inpatient medical records.

Failure to do so created risk that the quality of nursing care of patients could not be ensured.

Findings:

1. In review of facility policy, "CareConnect Patient's Plan of Care" (Policy #NSG-3900, effective 8/01/2015) item 1.4 stated under "POLICY ", "A registered nurse utilizes the nursing process to develop and keep current a plan of care for each patient that is interdisciplinary in nature." Under "General Requirements" item 1.2 stated, "Evidence of an individualized plan of care is contained within each patient's medical record." Item 2.7 stated that stated the care plan model, "Develops realistic, understandable and achievable goals ..."

2. During review of the medical records of Patients #1-5, there was not evidence that nursing care plans had been developed (or subsequently updated) to achieve patient goals.

3. During an interview on 12/21/2016 at 3:00 PM, a RN indicated that the medical record system did not contain an individualized nursing care plan (based on outcomes of assessments and interventions).

In a follow-up interview later that day at 4:30 PM with the Director of Clinical Operations (Staff Member #13) , s/he stated that routine documentation in the medical record was considered evidence of care planning.