HospitalInspections.org

Based on observation, interview, and record review, the hospital failed to document evidence of actions or interventions implemented to address the compounding of sterile preparations when the compounding sterile room was decertified as evidenced by:

1. Chemotherapeutic agents (used in cancer treatment) were compounded in an environment that was not set up for hazardous drug compounding according to facility adopted USP 797 standards (United States Pharmacopoeia chapter describing conditions and practices for compounding sterile drugs). This failure had the potential of exposing staff and patients to harmful effects of chemotherapeutic agents. (Refer to A 501)


2. Medium risk compounded sterile preparation (CSP, risk assigned in USP 797 according to the corresponding probability of contamination) including intrathecal (injected into the space between the spinal cord and the protective sheath surrounding the spinal cord) CSPs were compounded in an environment designated by the hospital as a low risk compounding environment. This failure had the potential of causing infection of the central nervous system including fatal meningitis due to contamination. (Refer to A 501)

Findings:

1. An observation on 12/17/15, at 8:40 AM, of the inpatient pharmacy, revealed a sterile intravenous (IV: inside the vein) compounding room. The IV room was separated from the main pharmacy area with plastic curtains. The IV room was further divided into three parts using plastic curtains, the ante area (to prepare for compounding including garbing), the buffer area (where actual compounding equipment was located), and a smaller room for compounding hazardous chemotherapeutic agents. A pharmacy technician was observed compounding CSPs in the BSC (biological safety cabinet, equipment for compounding hazardous CSPs).

In a concurrent interview with the Pharmacist in Charge (PIC), she stated that the hospital pharmacy followed USP 797 standards. The PIC confirmed that the hazardous compounding was taking place in a BSC in a non-certified and non-pressurized room. The PIC stated that the BSC was not vented to the outside. The PIC confirmed that the IV rooms were not certified by the certification company and the pharmacy was only certified to compound low risk CSPs with a 12 hour BUD (beyond use date) as a segregated compounding area.

Review of the IV room certification reports dated 5/2015 and 11/2015 indicated, "Pharmacy IV Room areas currently do not pass USP 797/state board sterile compounding room requirements, due to lack of positive/negative room pressure, HEPA filtered fresh air supply requirements, and classified air cleanliness requirements."

Review of the hospital policy "Sterile Products: Aseptic processing and Product Preparation," review date 9/2015, indicated, "Beyond Use Dating will be assigned to all drug products based on manufacturer's recommendations or in accordance with standards for sterility testing found in USP 797."

USP 797 indicated that the BSC for compounding hazardous drugs must be placed in an ISO Class 7 (measure of air cleanliness) room that is physically separated from other preparation areas, and optimally has no less than 0.01-inch water column negative pressure to the adjacent positive pressure ISO Class 7 anteroom, thus providing inward airflow to the buffer room to contain any airborne drug.

During an interview with the PIC, on 12/17/15, at 12:15 PM, the PIC stated 190 chemotherapeutic CSPs were compounded in 10/2015 and 115 in 11/2015. The PIC stated that the hospital Chief Operating Officer and the Medical Director were notified that the chemotherapeutic compounding area was not in compliance with USP 797 as the BSC was not vented to the outside, it was not a negative pressure room, and the room was not ISO certified.

During an interview on 12/17/15, at 2:45 PM, with the Director of Pharmacy (DOP) and PIC, they stated that they did not track or look for any quality indicators for patients receiving compounded chemotherapeutic agents. They confirmed that no additional quality measures were put in place after the IV room was decertified in 5/2015.

Review of Pharmacy and Therapeutics Committee (the hospital committee responsible for developing written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing, and use of drugs in the hospital, for patient safety decision making) minutes for 8/2014 indicated a State Board of Pharmacy Inspection recommending a separate negative pressure room for compounding chemo CSPs with a hood vented to the outside for protection of patients and employees.

2. On 12/17/15, at 8:40 AM, a tour of the inpatient pharmacy revealed a sterile IV compounding room with a vertical laminar airflow hood (LAH, equipment for compounding CSPs). In a concurrent interview, the PIC confirmed that the IV room was not certified and was designated for low risk 12 hour BUD compounding per USP 797 standards.

Review of USP 797 indicated, "Low-Risk Level CSPs with 12-Hour or Less BUD-If the ...laminar airflow workbench (LAFW) or a biological safety cabinet (BSC) that cannot be located within an ISO Class 7 (see Table 1) buffer area, then only low-risk level non-hazardous and radiopharmaceutical CSPs pursuant to a physician's order for a specific patient may be prepared ..."

Review of the IV room certification reports dated 5/2015 and 11/2015 indicated, "Pharmacy IV Room areas currently do not pass USP 797/state board sterile compounding room requirements, due to lack of positive/negative room pressure, HEPA filtered fresh air supply requirements, and classified air cleanliness requirements."

In an interview on 12/17/15, at 9 AM, the PIC stated that the pharmacy compounded medium risk intrathecal (IT) amphotericin (anti-fungal drug used for valley fever). The PIC stated that once the IV room was no longer certified (5/2015) most of the medium risk CSPs were outsourced to an outside compounding facility but were unable to outsource IT amphotericin.

Review of the Pharmacy and Therapeutics committee minutes for 7/2015 indicated, "Currently all IV compounding has 12 hour expiration and medium risk compounding are being outsourced."

Review of the hospital compounding policies indicated that they had not been updated after the decertification of the IV room and the lack of ISO 7 and 8 certification. The hospital policy "Sterile Products: Aseptic Processing and Product Preparation," review date 9/2015, indicated, "The LAH is located in a buffer area which is ISO Class 7 ... An ISO Class 8 anteroom is immediately adjacent to the buffer room."

Review of the hospital policy "Sterile Products: General Information," effective 8/2015, indicated, "A sterile products room adjoins the pharmacy and consisted of an anteroom in which air quality is ISO Class 8 or better and a buffer area with ISO Class 7 or better air quality."

Review of an email communicated between the State Board of Pharmacy and the hospital Medical Director indicated that the hospital was aware that IT amphotericin CSP was a medium risk CSP.

Review of the patient roster for the IT amphotericin administration indicated that since 6/24/15 until 12/10/15, a total of 313 doses of IT amphotericin were administered.

During an interview on 12/17/15, at 11:27 AM, the DOP stated that from mid-January 2015 until 10/2015, IT amphotericin was compounded at patient bedside as an immediate use product.

Review of USP 797 indicated that immediate use CSPs pertain to low risk CSPs only.

During an interview on 12/17/15 at 2:45 PM, with the DOP and PIC, they stated that they did not track or look for any quality indicators for patients receiving compounded IT amphotericin. They confirmed that no additional quality measures were put in place after the IV room was decertified in 5/2015.

Based on observation, interview, and document review, the hospital failed to develop and implement procedures for the provision of pharmaceutical services that ensures patient safety as evidenced by:

1. Single dose containers of IV (intravenous, injected through the vein) medications were opened and reused for up to 24 hours for multiple newborn or pediatric patients. This failure had the potential of exposing newborn babies to serious infections due to contamination. (Refer to A 501)

2. Chemotherapeutic agents (used in cancer treatment) were compounded in an environment that was not set up for hazardous drug compounding according to the hospital adopted USP 797 standards (United States Pharmacopoeia chapter describing conditions and practices for compounding sterile drugs). This failure had the potential of exposing staff and patients to harmful effects of chemotherapeutic agents. (Refer to A 501)

3. Medium risk compounded sterile preparation, (CSP, risk assigned in USP 797 according to the corresponding probability of contamination) including intrathecal (injected into the space between the spinal cord and the protective sheath surrounding the spinal cord) CSPs were compounded in an environment designated by the hospital as a low risk compounding environment. This failure had the potential of causing infection of the central nervous system including fatal meningitis due to contamination. (Refer to A 501)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the Conditions of Participation: Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to ensure pharmaceutical sterile (germ free) compounding (mixing) services were provided in a safe manner as evidenced by:

1. Single dose containers of IV (intravenous, injected through the vein) medications were opened and reused for up to 24 hours for multiple newborn or pediatric patients. This failure had the potential of exposing newborn babies to serious infections due to contamination.

2. Chemotherapeutic agents (used in cancer treatment) were compounded in an environment that was not set up for hazardous drug compounding according to hospital adopted USP 797 standards (United States Pharmacopoeia chapter describing conditions and practices for compounding sterile drugs). This failure had the potential of exposing staff and patients to harmful effects of chemotherapeutic agents.

3. Medium risk compounded sterile preparation, (CSP, risk assigned in USP 797 according to the corresponding probability of contamination) including intrathecal (injected into the space between the spinal cord and the protective sheath surrounding the spinal cord) CSPs were compounded in an environment designated by the hospital as a low risk compounding environment. This failure had the potential of causing infection of the central nervous system including fatal meningitis due to contamination.

Findings:

1. On 12/17/15, at 8:40 AM, a tour of the inpatient pharmacy revealed a sterile IV compounding room. The room was separated from the general pharmacy by plastic curtains. Inspection of the refrigerator in the IV room showed a plastic bin containing opened and spiked (punctured with a spike to allow subsequent dose withdrawals) IV bags and syringes.

The opened and spiked IV bags included:

-Vancomycin (antibiotic) 500 milligrams (mg) 100 milliliter (ml) single dose container with a BUD (beyond use date after which a product should not be used) of 12/18/15 at 8 AM.
-Penicillin G Potassium (antibiotic) 2,000,000 units 50 ml single dose container with a BUD of 12/18/15 at 8 AM.
-Cefipime (antibiotic) 1 gram single dose vial mixed in 0.9% sodium chloride (saline solution) 50 ml mini bag with a BUD of 12/18/15 at 8 AM.
-Metoclopramide (for stomach reflux) preservative free injection compounded by the hospital pharmacy with a BUD of 12/17/15 at 8 PM.

Stored at room temperature included:

-Heparin (blood thinner) preservative free 0.5 units/ml in 0.45 % sodium chloride 100 ml IV bag compounded by the pharmacy on 12/16/15 with a BUD of 12/17/15 at 7 AM.

During a concurrent interview with the Pharmacist in Charge (PIC), the PIC stated that once the single dose containers of IV drugs were spiked and used in the ISO 5 (measure of air quality) environment, the remainder of the solution left in the IV bag or syringe was given a BUD of 24 hours and stored in the fridge for use for subsequent doses mainly for NICU (neonatal intensive care unit) and pediatric patients. The PIC confirmed that the above listed solutions were single dose containers.

Review of hospital policy "Sterile Products: Aseptic processing and Product preparation," review date 9/2015 indicated, "Beyond Use Dating will be assigned to all drug products based on manufacturer's recommendations or in accordance with standards for sterility testing found in USP 797 and risk levels whichever is shorter ...A single-dose container (not an ampule) must be used entirely or discarded: ...Within six hours if needle-punctured or opened in an ISO Class 5 environment."

Review of USP 797 indicated "SINGLE-DOSE...CONTAINERS...Beyond-use time of 6 hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry."

During an interview on 12/17/15, at 3 PM, the Infection Control Nurse (ICN) stated that the single dose containers do not contain preservatives and should not be stored for reuse.

The Centers for Medicare and Medicaid Services (CMS) issued a survey and certification letter dated 6/15/12: Ref: S&C: 12-35-ALL indicating, "SUBJECT: Safe Use of Single Dose/Single Use Medications to Prevent Healthcare-associated Infections. Administering drugs from one SDV (single dose vial) to multiple patients without adhering to USP <797> standards is not acceptable under CMS infection control regulations: Medications in SDVs typically lack antimicrobial preservatives. According to the Centers for Disease Control and Prevention (CDC), ongoing outbreaks provide evidence that medications from SDVs can become contaminated and serve as a source of infection when they are used inappropriately."

2. On 12/17/15, at 8:40 AM, a tour of the inpatient pharmacy revealed a sterile IV compounding room. The IV room was separated from the main pharmacy area with plastic curtains. The IV room was further divided into three parts using plastic curtains, the ante area (to prepare for compounding including putting on special clothes), the buffer area (where actual compounding equipment was located), and a smaller room for compounding hazardous chemotherapeutic agents. A pharmacy technician was observed compounding CSPs in the BSC (biological safety cabinet, equipment for compounding hazardous CSPs).

In a concurrent interview, the PIC stated that the hospital pharmacy followed USP 797 standards. The PIC confirmed that the hazardous compounding was taking place in a BSC in a non-certified and non-pressurized room. The PIC stated that the BSC was not vented to the outside. The PIC confirmed that the IV rooms were not certified by the certification company and the pharmacy was only certified to compound low risk CSPs with a 12 hour BUD as a segregated compounding area.

Review of the IV room certification reports dated 5/2015 and 11/2015, indicated, "Pharmacy IV Room areas currently do not pass USP 797/state board sterile compounding room requirements, due to lack of positive/negative room pressure, HEPA filtered fresh air supply requirements and classified air cleanliness requirements."

USP 797 indicated that the BSC for compounding hazardous drugs must be placed in an ISO Class 7 (measure of air cleanliness) room that is physically separated from other preparation areas, and optimally has no less than 0.01-inch water column negative pressure to the adjacent positive pressure ISO Class 7 anteroom, thus providing inward airflow to the buffer room to contain any airborne drug.

During an interview on 12/17/15, at 12:15 PM, the PIC stated 190 chemotherapeutic CSPs were compounded in 10/2015 and 115 in 11/2015. The PIC stated that the hospital Chief Operating Officer and the Medical Director were notified that the chemotherapeutic compounding area was not in compliance with USP 797 as the BSC was not vented to the outside, it was not a negative pressure room, and the room was not ISO certified.

Review of the Pharmacy and Therapeutics Committee (the hospital committee responsible for developing written policies and procedures for establishment of safe and effective systems for procurement, storage, distribution, dispensing and use of drugs in the hospital, for patient safety decision making) minutes for 8/2014 indicated a State Board of Pharmacy Inspection recommending a separate negative pressure room for compounding chemotherapeutic CSPs with a hood vented to the outside for protection of patients and employees.

3. On 12/17/15, at 8:40 AM, a tour of the inpatient pharmacy revealed a sterile IV compounding room with a vertical laminar airflow hood (LAH, equipment for compounding CSPs). In a concurrent interview, the PIC confirmed that the IV room was not certified and was designated for low risk 12 hour BUD compounding per USP 797 standards.

Review of the USP 797 indicated, "Low-Risk Level CSPs with 12-Hour or Less BUD-If the ... laminar airflow workbench (LAFW) or a biological safety cabinet (BSC) that cannot be located within an ISO Class 7 (see Table 1) buffer area, then only low-risk level nonhazardous and radiopharmaceutical CSPs pursuant to a physician's order for a specific patient may be prepared ..."

Review of IV room certification reports dated 5/2015 and 11/2015 indicated, "Pharmacy IV Room areas currently do not pass USP 797/ state board sterile compounding room requirements, due to lack of positive/negative room pressure, HEPA filtered fresh air supply requirements and classified air cleanliness requirements."

In an interview on 12/17/15, at 9 AM, the PIC stated that the pharmacy compounded medium risk intrathecal (IT) amphotericin (anti-fungal drug used for valley fever). The PIC stated that once the IV room was no longer certified (5/2015), most of the medium risk CSPs were outsourced to an outside compounding facility but were unable to outsource IT amphotericin.

Review of Pharmacy and Therapeutics committee minutes for 7/2015 indicated, "Currently all IV compounding has 12 hour expiration and medium risk compounding are being outsourced."

Review of hospital compounding policies indicated that they had not been updated after the decertification of the IV room and the lack of ISO 7 and 8 certification. The hospital policy "Sterile Products: Aseptic Processing and Product Preparation," review date 9/2015, indicated, "The LAH is located in a buffer area which is ISO Class 7 ... An ISO Class 8 anteroom is immediately adjacent to the buffer room."

Review of hospital policy "Sterile Products: General Information," effective 8/2015, indicated, "A sterile products room adjoins the pharmacy and consisted of an anteroom in which air quality is ISO Class 8 or better and a buffer area with ISO Class 7 or better air quality."

Review of an email communicated between the State Board of Pharmacy and the hospital Medical Director indicated that the hospital was aware that IT amphotericin CSP was a medium risk CSP.

Review of the patient roster for the IT amphotericin administration indicated that since 6/24/15 till 12/10/15 a total of 313 IT amphotericin's were administered.

During an interview on 12/17/15, at 11:27 AM, the Director of Pharmacy stated that from mid-January 2015 until 10/2015, IT amphotericin was compounded at the patient bedside as an immediate use product.

Review of USP 797 indicated that immediate use CSPs pertain to low risk CSPs only.