HospitalInspections.org

The hospital must have pharmaceutical services that meet the needs of the patients. The facility failed to ensure the following:

1) On November 15, 2017, at 2:30 PM, the hospital's IV compounding room certification testing was reviewed. IV room certification was performed on November 6, 2017, almost 7 months after the previous testing on April 10, 2017.
(Refer to A-501)

2) During a tour of the hospital pharmacy on November 14, 2017, at 10:00 AM, the pharmacy IV compounding room was inspected. Observed to be placed on the far wall from the entry door were two laminar air flow workbenches (LAFW - pharmacy equipment used to prepare IV medications). On the wall to the left of the LAFWs, bolted to the wall and floor, was a BSC. The BSC was approximately 3 feet from the nearest LAFW.
(Refer to A-501)

3) A review of the IV compounding log was done on November 16, 2017. Hazardous drug IV medications prepared from October 15, 2017 to November 11, 2017 were reviewed. Ninety-eight (98) hazardous drugs were prepared on 12 different days during that time period (October 16, 17, 20, 23, 24, 27, 30, 31, and November 3, 6, 7, and 10).
(Refer to A-501)

4) During an interview with the DOP & VPPS on November 14, 2017, at 3:35 PM, the DOP and VPPS confirmed that the IV compounding room was a segregated compounding room according to USP <797>.
(Refer to A-501).

The cumulative effect of these systemic deficient practices resulted in the failure of the facility to deliver care in compliance with the Condition of Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to ensure the safety of intravenous (IV, directly into a vein) compounded (mixed) sterile (germ free) preparations (CSP) as evidenced by:

1) The hospital failed to complete IV room certifications in a period no less than every 6 months. Not completing a certification within a 6 month period increases the risk for the IV compounding room to be contaminated for a longer period of time. IV medications prepared in a contaminated IV compounding room may become contaminated. Administering contaminated IV medications to patients increases the risk for serious infections or death.

2) The hospital failed to ensure that hazardous drugs (chemotherapy - medications used to treat cancer) were prepared in a separate room from other non-hazardous drug preparation areas. The hospital prepared hazardous drugs in the same IV compounding room as non-hazardous drugs, potentially contaminating non-hazardous drugs with hazardous toxic substances. Exposing patients to IV medications that have been contaminated with toxic substances increases the risk for serious harm.

3) The hospital failed to ensure not more than a minimum number of hazardous IV medications were prepared in a segregated (separated) compounding area with negative pressure. The hospital prepared more than a low volume of hazardous drugs. Preparing more than a low volume of hazardous drugs in a IV compounding room without negative pressure increases the risk for exposing hospital personnel to toxic substances.

4) The hospital failed to ensure that only low-risk compounding was performed in the IV compounding room. The hospital prepared total parenteral nutrition (TPN - IV medication with multiple ingredients that is considered more than low-risk compounding) IV compound medications in the segregated compounding area. Preparing more than low-risk medications in the segregated compounding area increases the risk for contaminated IV medications. Contaminated IV medications can lead to significant patient harm or death.

These deficient findings had the potential to affect the health and safety of 153 patients in the hospital.

Findings:


1) On November 15, 2017, at 2:30 PM, the hospital's IV compounding room certification testing was reviewed. IV room certification was performed on November 6, 2017, almost 7 months after the previous testing on April 10, 2017.

During a concurrent interview with the Director of Pharmacy (DOP) and Senior Regional Vice President of Pharmacy Services (VPPS), the DOP confirmed that the certification of the IV compounding room was done on November 6, 2017, more than 6 months after the previous testing.

A review of USP <797>, under the section "ENVIRONMENTAL NONVIABLE PARTICLE TESTING PROGRAM", the guideline states, "Certification that each ISO (classification used to measure sterility) classified area...is within established guidelines shall be performed no less than every 6 months."

On November 17, 2017, hospital policy and procedure regarding sterile compounding was reviewed. The policy titled "Compounding Sterile Preparations (CSP)", undated with no policy number placed on it, under the section "Environmental Monitoring - Engineering Control Performance Verification", the policy states, "Primary Engineering Controls (PEC - the term used to describe equipment used to prepare sterile compound medications; sometimes referred to as "hoods") ...are certified by a qualified individual no less than every 6 months ...). In addition, the policy, under the section Viable Air Sampling, states, "Air sampling ...is performed by properly trained individuals at least every 6 months as part of the re-certification process."

2) During a tour of the hospital pharmacy on November 14, 2017, at 10:00 AM, the pharmacy IV compounding room was inspected. Observed to be placed on the far wall from the entry door were two laminar air flow workbenches (LAFW - pharmacy equipment used to prepare IV medications). On the wall to the left of the LAFWs, bolted to the wall and floor, was a BSC. The BSC was approximately 3 feet from the nearest LAFW.

During a concurrent interview, the DOP confirmed that hazardous drugs were prepared in the BSC and non-hazardous drugs were prepared in the LAFWs.

A review of USP <797>, under the section "HAZARDOUS DRUGS AS CSPs", the guideline states, "All hazardous drugs shall be prepared in a BSC or a CACI (Compounding Aseptic Containment Isolator - special pharmacy equipment used to prepare IV medications) that meets or exceeds the standards for CACI in this chapter. The...BSC or CACI shall be placed in an ISO Class 7 (classification of a sterile environment) area that is physically separated (i.e., a different area from other preparation areas)...to adjacent positive pressure ISO Class 7...or better ante-areas."

On November 17, 2017, hospital policy and procedure regarding sterile compounding was reviewed. The policy titled "Compounding Sterile Preparations (CSP)", undated with no policy number placed on it, under the section "Hazardous Drugs as CSPs", the policy states, "Hazardous drugs are prepared in a BSC ...or CACI that meets the specified requirements, that is physically separated and optimally has not less than 0.01-inch water column negative pressure to adjacent positive pressure ISO Class 7 (a classification of area sterility or cleanliness) or better ante-areas ...".

Another hospital policy titled "Hazardous Drugs", undated with no policy number, was reviewed. Under the section "Preparation/Compounding", the policy states, "The C-SEC (Containment Secondary Engineering Control - equipment the hospital uses to prepare hazardous drugs, previous referred to as a BSC) used for sterile and non-sterile compounding is: a. Externally vented b. Physically separated (i.e. different room from other preparation areas) c Has an appropriate air exchange d. Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas".

3) A review of the IV compounding log was done on November 16, 2017. Hazardous drug IV medications prepared from October 15, 2017 to November 11, 2017 were reviewed. Ninety-eight (98) hazardous drugs were prepared on 12 different days during that time period (October 16, 17, 20, 23, 24, 27, 30, 31, and November 3, 6, 7, and 10).

During an interview with the Director of Pharmacy (DOP) and Senior Regional Vice President of Pharmacy Services (VPPS) on November 14, 2017, at 3:35 PM, the DOP confirmed that the IV compounding room containing the BSC where hazardous drugs are prepared was a positive pressure room. The DOP confirmed that the pharmacy used CSTDs (closed-system vial-transfer devices: vial-transfer systems that allow no venting or exposure of hazardous substance to the environment). The DOP also confirmed that the hospital pharmacy was preparing more than a low volume of hazardous drugs.

A review of USP <797>, under the section "HAZARDOUS DRUGS AS CSPs", the guideline states, "When closed-system vial-transfer devices (CSTDs) (i.e., vial-transfer systems that allow no venting or exposure of hazardous substance to the environment) are used, they shall be used within the ISO Class 5 (see Table 1) environment of a BSC or CACI. The use of a CSTD is preferred because of their inherent closed system process. In facilities that prepare a low volume of hazardous drugs, the use of two tiers of containment (e.g., CSTD within a BSC or CACI that is located in a non-negative pressure room) is acceptable."

On November 17, 2017, hospital policy and procedure regarding sterile compounding was reviewed. The policy titled "Compounding Sterile Preparations (CSP)", undated with no policy number placed on it, under the section "Hazardous Drugs as CSPs", the policy states, "Hazardous drugs are prepared in a BSC ...or CACI that meets the specified requirements, that is physically separated and optimally has not less than 0.01-inch water column negative pressure to adjacent positive pressure ISO Class 7 (a classification of area sterility or cleanliness) or better ante-areas ...".

Another hospital policy titled "Hazardous Drugs", undated with no policy number, was reviewed. Under the section "Preparation/Compounding", the policy states, "The C-SEC (Containment Secondary Engineering Control - equipment the hospital uses to prepare hazardous drugs, previous referred to as a BSC) used for sterile and non-sterile compounding is: a. Externally vented b. Physically separated (i.e. different room from other preparation areas) c Has an appropriate air exchange d. Negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas".

4) During an interview with the DOP & VPPS on November 14, 2017, at 3:35 PM, the DOP and VPPS confirmed that the IV compounding room was a segregated compounding room according to USP <797>.

A review of USP <797>, under the section "Glossary", USP <797> defines a segregated compounding area as, "A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding."

On November 16, 2017, the hospital pharmacy IV compounding log was reviewed. Noted to be prepared by the pharmacy were TPN medications, some of which were prepared for NICU (Neonatal Intensive Care Unit) patients.

During the interview with the DOP on November 14, 2017, at 3:35 PM, the DOP confirmed that TPNs were considered medium-risk according to USP <797>. The DOP stated that the hospital was currently in contract negotiations with an outsource pharmacy supplier to prepare TPN medications for their patients.