HospitalInspections.org

.
Based on observation, interview and document review, the Critical Access Hospital's Governing Body failed to implement and administer hospital pharmacy policies to ensure patients received quality health care in a safe environment.

Failure to provide oversight and monitoring of Pharmacy services puts patients at risk of harm from substandard care and non-compliance with state law and practice standards.

Findings Included:

1. The Governing Body failed to ensure that the hospital met the requirements for the provision of hospital services specific to Pharmaceutical Services.

2. The Governing Body failed to ensure that the hospital sustained correction of deficiencies identified in Pharmacy Services during a previous Federal survey completed in November 2016.

Due to the cumulative effect of deficiencies detailed under the Conditions of Participation at 42 CFR 485.635 Provision of Services, the Condition of Participation for Organizational Structure was NOT MET.

Cross-reference: Tags C0270
.

.
Based on observation, interview, and document review, the Critical Access Hospital failed to meet the requirements for the Condition of Participation for Provision of Services.

Failure to meet established service requirements and responsibilities for Pharmacy services impaired the hospital's ability to provide quality care in a safe environment.

Findings included:

The hospital pharmacy failed to maintain intravenous supplies in a way that ensured their integrity and quality.

The hospital pharmacy failed to maintain security of medications in the automated drug-dispensing machine(Pyxis).

The hospital pharmacy failed to review medication orders of all medications prior to dispensing to patients outside of emergent use.

The hospital pharmacy failed to develop and implement policies and procedures to ensure the safe administration of intravenous (IV) medications and admixtures.


Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 485.635 Provision of Services was NOT MET.

Cross Reference: C0276

.

.
Based on observation, interview, and document review, the Critical Access Hospital failed to ensure that hospital staff protected the overwrap of IV fluids, (Item #1), safeguarded the security of controlled medications, (Item #2), provided a prospective medication review for safe patient handling (Item #3), and performed sterile compounding according to the safety standards (Item #4).

Failure to protect patients from unusable intravenous fluids, failure to safeguard the security of controlled substances, failure to provide prospective review of medications to prevent errors and adverse medication interactions, and failure to protect patients from unsafe sterile compounding of medications, risks drug diversion, patient harm and or patient demise.

Findings included:

Item #1- Intravenous supplies

1. On 06/11/19 at 3:00 PM, Surveyor #8 toured the Emergency Department(ED) with a Registered Nurse (RN) Manager (Staff #802). The observation showed room #5's crash cart drawers with 2 unusable 1,000 liters bags of Normal Saline intravenous (IV) with torn overwraps. The overwrap had no date marking on it.

2. Staff #802 stated that the IV's don't fit in the smaller drawers and staff may not be aware of the problem when squeezing the IV into the drawers.

3. On 06/13/19 at 1:15 PM, Surveyor #8 toured the Emergency Department with the RN Nurse Manager, (Staff #802). In the medication room on a supply cart, the observation showed two (2) 0.9% NaCL 100ml Baxter IV bags in an opened overwrap container. The opened overwrap of the IV bags were not marked with the open date or the beyond use date

4. At the time of the observation, Staff #802 stated that she was not aware of the need to mark the date when the overwrap was opened but that she would update the policy and inform staff.

Item #2- Medication Security

1. On 06/13/19 at 1:25 PM, Surveyor #8 toured the ED medication room with the RN Manager, (Staff #802). The observation showed 3 keys hanging on the inside of the first cupboard in the med room. The keys opened the back of the automated drug-dispensing machine (Pyxis) providing access to all the medication drawers including those with controlled substances.

2. At the time of the observation, Staff #802 stated that she believed the keys are stored in the cupboard to be available to maintenance staff. Staff #802 removed the keys and stated that staff should store them in the main pharmacy for safety reasons.

Item #3-Medication Review

1. Document review of the hospital policy titled, "Pharmacy Manager," no policy number, effective date 10/16/13 showed the Pharmacy is responsible for the final check for quality and accuracy of all medications dispensed from the pharmacy including medications in the Pyxis' and compounded products.

2. On 06/12/19 at 1:30 PM, Surveyor #8 reviewed emergency department medication errors for the previous 12 months. The review showed:

a. On 05/20/19, an ED Patient (Patient #805) received 1mg hydromorphone, (strong narcotic used to relieve pain) via Pyxis override. There was no order entered into the Pyxis for the medication and the patient had a documented allergy to the hydromorphone.

b. On 05/10/19, the adult ED Patient (Patient #802) received an incorrect dose of an antibiotic (Vancomycin).

c. On 05/07/18, ED Patient #804 received the medication Morphine (strong narcotic used to relieve pain). The electronic medical record showed the patient had a history of an allergy to morphine with a reaction of hives.

3. On 06/12/19 at 3:30 PM, Surveyor #8 and the RN Nurse Manager (Staff #802) reviewed the ED medication error documentation. Staff #802 stated that the Pharmacist does not review the medications in the ED prior to dispensing to the patient or following medication administration. Staff #802 stated that a pharmacy medication review would be helpful the patients and decrease risk of medication errors.

Item #4-Sterile Compounding

Reference: United States Pharmacopeia (USP) - General Chapter 797 - "Sterile Compounding - Sterile Preparation" (Revised April 2016)

1. Document review of the hospital policy titled, "Compounding Sterile Preparations," no policy number, effective date 11/16, showed sterile compounding at Summit Pacific Medical Center is to be done in the compounding aseptic isolator, located in a designated area near the pharmacy department. When pharmacy services are unavailable, immediate-use medication preparations may be prepared in the ED and Acute Care units. Any employee [the nursing staff] preparing a compounded sterile preparation, will prepare the medication in the compounding aseptic isolator.

2. On 06/11/19 at 12:00 PM, Surveyor #8 and the Acute Care Manager (Staff #801) observed the admixing process of an IV antibiotic in the acute care medication room. The observation showed a Registered Nurse (RN) (Staff #803) combining an antibiotic concentrate (Ancef) into a 1000 liter of Dextrose. The staff member performed the admixing above the medication counter that had tape and tape residue on the counter.

3. At the time of the observation, Surveyor #8 asked Staff #801 about the mixing of medications in the med room. The Acute Care Manager (Staff #801) stated that the Pharmacist has the nursing staff mix the medications they need.

4. On 06/13/19 at 1:25 PM, Surveyor #8 toured the ED medication room with the RN Nurse Manager, (Staff #802). Staff #802 stated that the ER nurses mix "Low and Medium Risk" medications (risk level is based on the likelihood of contamination of compounded sterile preparations with microorganisms, spores etc.) in the med room or sometimes at the patient bedside when ordered by the doctor. Staff #802 stated not all of the RN's have training in USP 797.

5. On 06/13/19 at 4:10 PM, Surveyor #8 received a copy of the certificate of training, dated 2/21/19, for the Lead Pharmacist that read, "Sterile Product Preparation Training and Certificate Program - LOW RISK" [medication preparations]. Surveyor #8 asked if there was a Training and Certificate Program to provide training on Medium-Risk medications. The Pharmacist (Staff #804) stated "No, the 'Sterile Product Preparation Training and Certificate Program - LOW RISK' was the most recent".

.
Based on observation, document review, and interview, the Critical Access hospital staff failed to implement policies and procedures to prevent infections by failing to properly document date and read-times for biologic indicators used for testing the efficacy of steam sterilization (Item #1), failing to disinfect equipment between patients in the Emergency Department (ED) (Item #2), failing to maintain sanitary conditions in the hospital's medication room (Item #3), and failing to implement a water management plan that is in compliance with Washington Administrative Code 246-290 for Group A Public Water Supplies (Item #4).

Failure to implement policies and procedures to prevent infections puts patients, staff, and visitors at risk of harm from exposure to communicable diseases.

Findings included:

Item #1 - Biologic indicators

On 06/12/19 at 9:30 AM, Surveyor #4 toured the area used for sterile processing. During the tour, the surveyor reviewed the logbook documenting results of biologic indicator used to test the efficacy of the steam sterilizer. The observation showed that the staff marked the outcome of the indicator and the control, but failed to mark the date and the read time of the indicator.

At the time of the observation, the surveyor asked the sterile processing technician (Staff #401) about the required incubation time for the biologic indicator. She stated that the hospital uses an indicator with a 24-hour read time and that she reads the indicator on the following day when she comes in to work, but acknowledged that she didn't document the date and time of the reading.

Item #2- Equipment cleaning between patients

1. On 06/11/19 at 2:20 PM, Surveyor #8 observed the room turnover following the care for Patient #801 in the ED triage room. The observation showed that as one staff wheeled Patient #801 out of Triage and into the ED hallway, the other staff was bringing in the next patient from the waiting room. Hospital staff failed to disinfect patient care supplies in the room before admitting the next patient.

2. On 06/11/19 at 2:20 PM, Surveyor #8 interviewed The ED Nurse Manager (Staff #802) stated that it is the hospital policy to disinfect patient care items such as the blood pressure cuff, between patients and that the staff had forgotten.

Item #3- Medication rooms

1. Document review of the hospital policy titled, "Medication Administration," no policy number, revised 12/16, showed that unless the tablet splitter is single use, the tablet splitter must be cleaned of all pill residue in between patient use.

2. On 06/11/19 at 10:00 AM, Surveyor #8 toured the medication room for the acute care-swing bed area with the Registered Nurse Manager (RN) (Staff #801.) The observation showed tape residue on the counter surface, making the surface un-cleanable for preparing medications.

3. On 06/11/19 at 10:10 AM, Staff #801 stated that the staff haven't been able to remove the residue but that they are to wipe the surface with alcohol prior to preparing medications.

4. On 06/11/19 at 2:00 PM, Surveyor #8 observed a plastic device that breaks pills (pill splitter) on the counter with white residue on the cutting surface.

At the time of the observation, the ED Nurse Manager (Staff #802 ) stated that the staff are supposed to clean the pill splitter after use. Staff #802 acknowledged the staff have not cleaned the device.

Item #4- Water Management Plan

Reference: CMS (Quality, Safety and Oversight) Memo #QSO-17-30- Hospitals/CAHs/NHs, DATE: June 02, 2017 REVISED 07.06.2018
Facilities must have water management plans and documentation that, at a minimum, ensure each facility mintains compliance with other applicable Federal, State and local requirements.

Reference: WAC 246-290-020 Applicability.
(2) The rules of this chapter shall apply to all Group A public water systems except those systems meeting all of the following conditions:
(a) Consists only of distribution and/or storage facilities and does not have any source or treatment facilities;
(b) Obtains all water from, but is not owned by, a public water system where the rules of this chapter apply;
(c) Does not sell water directly to any person; and
(d) Is not a passenger-conveying carrier in interstate commerce.Washington State Department of Health,

1. Document review of the Environmental Public Health Office of Drinking Water Document #DOH 331-488, dated January 2014, stated that, "If you regularly treat the municipal supply to your building, you are an active public water system with important legal obligations." The document defines "treatment" as adjustment of the pH of the incoming municipal supply or addition of chemicals or compounds (such as chlorine, chlorine dioxide, a corrosion inhibitor, copper or silver ions).

Document review of hospital's water management plan provided by Liquitech, a third party vendor, showed that the facility implemented the use of Copper silver ionization (CSI) as a supplemental treatment for their incoming municipal water supply to control the risk of Legionella and other waterborne pathogens within the hospital's water system.

2. On 06/12/19 at 12:10 PM, Surveyor #4 interviewed the Facility Manager (Staff #402) about implementation of the water management plan. He stated that the hospital was using CSI, which they did not consider an addictive, as they were not adding any product to the incoming municipal water.


35594