HospitalInspections.org

Based on observations, interviews, and record review, the hospital failed to inform the Department (California Department of Public Health) and failed to obtain prior approval from local licensing agency prior to the use of an upgraded sterile (germ-free) compounding area (an area designated to prepare germ-free intravenous medications) in the pharmacy area.
This deficient practice had the potential for the facility to use an area that did not meet standards and increase the possibility for facility acquired infections.

Findings:

On 9/4/2019 at approximately 3 PM, the hospital presented a copy of a CDPH HS200 form (an application for facilities seeking approval for new or remodeling of existing licensed space), signed by the hospital's president and dated on 11/12/2018. During a concurrent interview, the director of pharmacy confirmed that the upgraded compounding area in the pharmacy had been re-commissioned, and currently in use, prior to 11/12/2018.

On 9/4/2019 at approximately 4 PM, during a tour of the pharmacy, the survey team observed through a glass door and window that a pharmacy staff was working in the sterile compounding area (also called IV room).

On 9/6/2019 at approximately 10:50 AM, during an interview and concurrent review of a project task list, or timeline, presented by the hospital, the chief operation officer (COO or operations executive) indicated the compounding pharmacy upgrade project involved many phases as listed on the timeline. The COO further indicated that line item 10 on the task list, "Sequence #1 and #2 combined" and finished on 12/2/2016, referred to the demolition of the IV room ceiling fixture and the installation of the air ducts. Referring to the line item 12, "Start of segregating compounding" started on 12/19/2016, the director of pharmacy indicated that was the recommission of the compounding area.

Based on interview and document review, the hospital failed to ensure its quality improvement committee effectively oversaw and integrated the sterile compounding process into its surveillance plan to ensure adherence to the minimum requirement and standard of practice.
This deficient practice could lead to unsafe preparation of intravenous (IV) medication that may or may not have affected patient safety.

Findings:

A review of the hospital's quality improvement committee minutes of 2018 and 2019 indicated a similar report of the IV room (a common term for a sterile, or germ-free, compounding area designated to prepare sterile IV medications) construction progress. The minutes did not indicate discussion of IV room closures and other issues that affected the sterile compounding process in the past 15 months. Under the surveillance plan of the minutes, there was no evidence that the committee discussed the past positive results from the environmental sampling tests conducted in the IV room. (Refer to 501)

On 9/6/2019 at around 3:50 PM during an interview, the chief operation officer (COO or operations executive) indicated that the quality improvement committee was not aware that the pharmacy prepared medium-risk level compounded sterile products (CSPs) for immediate use during IV room downtimes. The COO also confirmed the committee did not have a hospital-wide program to evaluate the sterile compounding process.

§482.25 Condition of Participation: Pharmaceutical Services, this condition is NOT MET.

Based on observation, interviews, and record reviews, the hospital failed to ensure a safe and effective pharmaceutical service process that met the needs of their patients, as evidenced by:

1. The hospital failed to obtain approval prior to the use of an upgraded sterile (germ-free) compounding area (an area designated to prepare germ-free intravenous medications, also called the IV room) in the inpatient pharmacy. This IV room had undergone services including, but not limited to, the demolition and installation of new air ducts and ceiling fixtures. (Refer to A 22)

2. The hospital failed to recertify the aforementioned IV room prior to the re-commission of its use. The aforementioned IV room was decommissioned twice in 2018 to accommodate facility services (included but not limited to the switch of air handling unit in June 2018 and the repair of pipe leakage in October 2018), yet, there was no evidence that the hospital had recertified the IV room to ensure it met the minimum practice and quality standards. (Refer to 501)

3. The hospital failed to ensure medium-risk level preparations would not be compounded as immediate-use CSPs. (Refer to A 501)

4. The hospital failed to ensure the pharmacy personnel in the IV room prepared sterile IV medications with proper aseptic technique and garbing requirement following their policies and procedures that were in accordance with acceptable standards of practice. (Refer to 501)

5. The hospital failed to ensure its quality improvement committee adequate oversight, by means of integrating the sterile compounding process into its surveillance plan, had been documented to ensure adherence to the minimum requirement and standard of practice. (Refer to A 283, 501)

6. The hospital failed to ensure labels on dispensed medication would be completed and intact. The hospital also failed to ensure open and undated medications would not be available for use. (Refer to A 505)

The cumulative effects of these deficient practices resulted in the hospital's inability to provide sterile compounding products in a safe and effective manner in accordance with the Condition of Participation for Pharmaceutical Services, that may or may not have impacted patient safety.

Based on observation, interviews, and record reviews, the hospital failed to ensure a safe and effective sterile (germ-free) compounding process (a process of making sterile intravenous medications) that meets the needs of all patients requiring intravenous (IV, route of administration through a vein) medications, as evidenced by:

1. The hospital failed to ensure the sterile compounding area (common known as the IV room, an area designated to prepare germ-free intravenous medications) would be re-certified to meet the minimum standard of practice and quality standards, prior to re-commission of its use. This IV room had been decommissioned twice in 2018 to accommodate facility services (included but not limited to the switch of air handling unit in June 2018 and the repair of pipe leakage in October 2018).

2. Medium-risk level preparations were compounded as immediate-use CSPs.

3. The hospital failed to ensure the pharmacy personnel in the IV room followed proper garbing requirement as per policies and procedures or in accordance with acceptable standards of practice.

These deficient practices had a potential for patients requiring IV medications be exposed to avoidable contamination that may or may not have affected the safety or health of its patients.

Findings:
1. On 9/4/2019 at approximately 3 PM, during an interview, the Director of Pharmacy (DOP) indicated the hospital decommissioned, or closed, the IV room from 6/25/2018 to 7/7/2018 for service to the air handling system, specifically disconnected the air handling from the old system and then connected to a newly installed air handling unit.

A review of the hospital's project task list, or timeline, indicated the facility services done to the IV room included the removal of cabinets during the time period mentioned above.

On 9/6/2019 at 9:45 AM during an interview and concurrent documents review, the director of plant operation indicated that between 10/3/2018 to 10/7/2018, there was service request to remove and re-patch a piece of dry wall approximately measured six (6) feet by 3 feet, and to fix a pipe leakage inside the wall in the IV ante room.

A review of the hospital policy and procedure last reviewed on 9/14/2018, Compounding Sterile Products, indicated " ... The pharmacy department operates the compounding sterile service from the main pharmacy IV room, ... in accordance with the FDA, USP and California Board of Pharmacy guidelines, to the highest quality standards for sterility and content."

On 9/6/2019 at approximately 10:05 AM, during an interview in the presence of the director of risk management (DORM) and the director of accreditation (DOA), and a concurrent review of the USP 797 (USP, the sterile compounding standards issued by the United States Pharmacopoeia; the USP 797 chapter describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded), the infection control specialist (ICS) indicated the facility services done in the IV room, such as the removal of cabinets and re-patching of the drywall, might change the environment within the IV room. During a concurrent interview, the DOP, ICS, DORM, and DOA, confirmed that the hospital did not request recertification of the IV room in July 2018 and in October 2018 after the services done in the IV room. In both occasions, the IV room was re-commissioned without USP 797 compliance testing and certification.

2. On 9/4/2019 at approximately 3 PM, during an interview, the director of pharmacy (DOP) indicated that while the IV room was out of commission (6/25/2018 to 7/7/2018, and 10/3/2018 to 10/7/2018), the pharmacy prepared certain IV medications on a counter top located just outside of the IV room for immediate use (within one hour from preparation to the start of administration) and enlisted a sister hospital to prepared other IV medications.

A review of the IV medication compounding records during the aforementioned time periods (while the IV room was out of commission) indicated 618 compounded sterile products (CSPs) were made on the counter top between 6/25/2018 to 7/7/2018 and 10 of 618 were "banana" IV fluid bag (IV fluid containing a mix of vitamins and minerals); between 10/3/2018 to 10/7/2018, there were 120 CSPs made on the counter top and 13 of 120 were "banana" IV fluid bags.

On 9/5/2019 at approximately 4:10 PM, during an interview and a concurrent review of USP 797, the DOP indicated the master formula used for the "banana" IV fluid bag called for four (4) additives and transferred with four (4) entries via syringes to the final container bag.

A review of the USP 797 indicated " ... Immediate-use CSPs ... compounding process involves simple transfer of not more than three (3)... sterile, nonhazardous products ... and not more than two (2) entries into any one (1) container ... of sterile infusion solution ..." During a concurrent interview, the DOP indicated those 23 "banana" IV fluid bags were incorrectly made as immediate use CSP while the IV room was out of commission.

A review of the hospital policy and procedure last reviewed on 9/14/2018, Compounding Sterile Products, did not indicate the policy and/or procedure on immediate use CSP, as well as no protocol denoted in the event when the IV room was out of commission.

3. On 9/4/2019 at approximately 4 PM, during a tour of the pharmacy, the survey team observed through a glass door and window that a pharmacy staff was working in the sterile compounding area (also called IV room) by a counter with many IV bags. Shortly after, the pharmacy staff had the mask hanging around the chin. During a concurrent interview, the director of pharmacy (DOP) identified the aforementioned pharmacy staff as a pharmacy technician. The DOP described this pharmacy technician had pulled the mask to the chin area, exposing the nose and mouth, while in the ante area, before crossing the demarcation line from the clean area toward the doffing area of the IV room. The DOP indicated the technician did not keep the mask on (covering the nose and mouth) until the technician crossed the red demarcation line into the doffing area.

On 9/6/2019 at approximately 2:45 PM, during an observation in the pharmacy area with the director of accreditation and the director of pharmacy (DOP), a pharmacy staff donned hair cover, mask, and shoe covers, crossed the demarcation line into the IV ante room area, and started handling labels and IV bags by a steel top work bench located at the far end of the ante room. During a concurrent interview, DOP confirmed that the pharmacy technician was not donning gloves or gown. The DOP proceeded to signal the pharmacy technician to put on gloves and gown.

A review of the hospital policy and procedure last reviewed on 9/14/2018, Compounding Sterile Products, indicated " ... Personnel in the clean room area must wear a low shedding coverall, head cover, facemask, and shoe covers." However, this policy did not denote the procedure on the proper doffing of personal protective equipment (PPE, such as hair cover, mask, gown, gloves, and shoe covers).

Based on observation, interview and record review, the facility failed to ensure that drugs that are opened and undated or had labels taken off are not available for patient's use.

This deficient practice had the potential for patients to use expired, or incorrect medications/drugs during their hospital stay.

Findings:

1. In the medication refrigerator in the ICU floor, Vancomycin 250 mg /5 ml oral solution was observed that had a label with patient name however there was no DUE date/time printed on it.
Zosyn 3.37 gm IV and Vancomycin Injectable USP 750 mg/150 ml in 5% Dextrose, were observed and had residual label marks from a label that had been removed.

There were two (2) individual plastic cassette drawers that had debris and dust and were broken that contained IV Medications (intravenous medications).

2. In the Pharmacy Area, there were open and undated medications were observed:
- Cefepime For Injectable 2 gm vial
- Two (2) vials of Hydrogen Peroxide with red tape on the top of the cap
- Calcipotriene Topical with red tape on top of the cap
- Two (2) containers of Povidone Iodine with red tape on top of the cap

A review of the facility policy, number 15459 titled, "Storage of Drugs and Fluids, Pharmacy", indicated that pharmacy storage areas are inspected monthly to assure proper drug storage conditions, and to remove expired, contaminated or deteriorated drugs from stocks.

During an interview with the Pharmacy Director, at the time of observation, the Pharmacy Director stated that open and undated medication, with red tape on top of the cap and the labels taken off should be discarded and not available for patient use.

During an interview with Pharmacy Director at the time of observation, the Pharmacy Director stated that since the Pharmacy Department was not aware of who took off the labels, the medications should be discarded.

A review of the facility policy, number 15459 titled, "Storage of Drugs and Fluids, Pharmacy" indicated that drugs shall not be kept in pharmacy stock beyond their expiration dated and no contaminated or deteriorated drugs shall/ be available for use. The policy also indicated that it is to inspect for basic cleanliness and document all actions taken.

Based on observation, interview and record review, the facility failed to ensure the facility policy that relates to infection control was implemented to control infections and spread of communicable diseases.
This deficient practice had the potential for the spread of infection.

Findings:

On survey days September 4 to 6, 2019, at various times, during provision of care observation, the following was observed:

1. Patient 1 in room 5115 had four (4) visitors in the room. Three (3) of the four (4) visitors was wearing gowns and one (1) was not wearing a gown. When the visitor recognized that the staff members and the evaluator noticed her not wearing a gown, she covered herself with a blanket.

During an interview at the time of observation, the ICU Manager (intensive care unit Manager), stated the visitor should be wearing a gown since the patient was in contact isolation. There was a contact isolation posting by the patient's door.

A review of the Physician Face Sheet for Patient 1, indicated the patient was admitted to the facility on 9/1/19, with the initial diagnosis of hypotension. On 9/3/19, a physician order for continuous contact precautions for MRSA (methicillin resistance staphylococcus aureus, a bacterium that causes infections in different parts of the body) in the nares.

A review of facility policy number 17489, titled "Isolation Procedures", indicated visitors should be instructed by the nursing department on the importance of proper hygiene and the usage of masks and gowns when indicated.

2. A review of the physician's face sheet forPatient 2 indicated Patient 2 was admitted to the facility on September 3, 2019, with a diagnosis of abdominal pain and cirrhosis. The patient was observed lying in bed. There was no sign/posting to indicate the patient was on isolation.

The physician order for Patient 2, dated September 4, 2019, indicated continuous Contact Plus Isolation for possible Clostridium diffecile infection (an intestional bacterial infection), with additional risk factors.

During an interview with the Telemetry Manager at the time of observation, the Telemetry Manager stated there should be a sign/posting of the patient being on isolation precautions.

The facility policy number 17489, titled "Isolation Procedures", indicated that appropriate signs will be posted by nursing outside the patient's room indicating the type of isolation. The sign will be discarded by the housekeeper after completion of terminal cleaning.

3 (a).There were two (2) individual plastic cassette drawers that contained IV (intravenous medications) that had debris and dust and were broken.

(b) The sink where the Cactus Waste Container (discarded narcotic waste) was located, patient supplies such as paper cups, specimen tubes and a pill crusher were stored underneath the cactus waste container. The potential for cross contamination was imminent.

During an interview with the ICU Manager at the time of observation, the ICU Manager stated the waste container is considered dirty and the supplies used for patient are considered clean.

Review of the facility policy number 15459, titled "Storage of Drugs and Fluids, Pharmacy", indicated drugs shall not be kept in pharmacy stock beyond their expiration dated and no contaminated or deteriorated drugs shall/be available for use. The policy indicated the facility it is to inspect for basic cleanliness and document all actions taken.

4. In the hallway by ICU area, an EVS cart was noted to contain a container of Sani Wipes with the lid open.

During an interview, a member of the EVS (environmental staff) stated the lid should be kept closed when not in use. When the cloths dry up, it is no longer good to use to disinfect the surfaces.

Upon closer look of the Manufacturer's Label of the Sani Wipe ( Bleach Germicidal Disposable Wipes) indicated "Tightly close lid between use to maintain moisture."