HospitalInspections.org

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Based on observation, interview and document review, the surveyors determined that the hospital failed to ensure that policies and procedures addressed the appropriate level of supervision during the sterile compounding process; storage of cleaning supplies; and correction of deficiencies related to equipment quality identified during two previous failed inspections.
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Failure to meet the minimum pharmaceutical requirements for testing, equipment maintenance and supervision of staff resulted in an unsafe health care environment.
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Findings include:
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Due to the scope and severity of deficiencies detailed under 42 CFR 482.25 Condition of Participation Pharmaceutical Services, the Condition of Participation of Governing Body was NOT MET.
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Reference: Tag A 490, 42 CFR 482.25 Pharmaceutical Services Condition of Participation

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Based on interview, observation, document review, clinical record reviews and review of policies and procedures, the hospital failed to correct equipment deficiencies identified during previous state surveys. The hospital also failed to adhere to standards of practice for safe preparation of sterile medications.
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Failure to maintain equipment and meet the minimum requirements for safe medication preparation placed all patients at risk for medication errors and/or receiving contaminated drugs and biologicals.
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Findings include:
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1. Review of documentation from the Pharmacy Quality Assurance Commission revealed the hospital was made aware of problems with the hospital physical standards in a report dated May 2014, regarding LAFW used in the hospital in-patient pharmacy. The findings indicated the hoods had rust, dust, debris and discoloration behind a grate located at the back of one of the hoods. The hospital received a second report in June 2014 that referenced the same findings related to LAFW in the hospital in-patient pharmacy. At the time of this investigation, the hospital had not fully corrected the problems identified in the two previous reports.
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Reference: A501
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2. The hospital failed to ensure that medications were stored separately from hazardous cleaning solution in multiple drug storage areas.
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Reference: A491
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3. The hospital did not comply with State and Federal laws related to maintaining clean surfaces and testing of the environment during dynamic conditions when an LAFW is in use.
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Reference: A501
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4. The hospital failed to ensure supervision of pharmacy personnel during the compounding of sterile medications including hazardous medications and intravenous admixtures to ensure safe preparation consistent with State and Federal laws.
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Reference: A501

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Based on observation and review of hospital policy and procedure, the hospital failed to ensure that medications were stored separately from hazardous cleaning solution in multiple drug storage areas.
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Failure to ensure medications are stored separately from cleaning supplies puts patients at risk of receiving medications with compromised sterility or with compounding errors.
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Findings include:
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Between 10/1/2015 and 10/2/2015, Surveyors reviewed the following policy:
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1. The hospital policy titled " IV Admixture Service: Cleaning and Disinfecting of the Pharmacy IV Areas " " [Section 10] Cleaning equipment and supplies " , read in part: " 1. Shall be stored in a designated area to ensure segregation from compounding supplies."
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2. On 10/1/2015 at 11:42 am, Surveyors #1 and #2, in the company of Pharmacists #1 and #2, observed that the hospital stored a disinfectant (Peridox) in a plastic storage bag in a refrigerator that also contained multiple bags of intravenous infusion solutions. The surveyors observed the storage of disinfectant in this manner, in the following medication refrigerator locations:
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a. The satellite pharmacy
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b. The hospital operating room

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Based on observation, interview and record review, the hospital failed to ensure supervision of pharmacy personnel during the compounding of sterile medications, including hazardous medications and intravenous admixtures. The hospital also failed to maintain compliance with State and Federal laws for safe preparation of drugs and biological including procedures to ensure accuracy of compounded medications and maintenance of the compounding rooms and equipment.
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Item #1 - Supervision:

Findings include:

1. On 10/1/2015 and 10/2/2015, surveyors reviewed the following policy:

Facility Policy titled "IV Admixture Service" . Under "Staffing", the policy describes the roles of the IV admixture staff. The policy included, "IV Pharmacist-The IV Admixture Service is under the immediate supervision of a registered pharmacist at all times. The pharmacist is to "oversee storage and handling of drugs in the IV admixture areas."

2. On 10/1/2015 and 10/2/2015, Surveyors #1 and #2, accompanied by hospital pharmacists #1 and #2, toured the hospital in-patient pharmacy and the oncology pharmacy. During the tour of these areas, the surveyors observed the following:

a. On 10/1/2015 at 12:00 p.m. in the In-patient pharmacy, the surveyors observed pharmacist technician #1 compounding an intravenous infusion without the appropriate level of supervision by a pharmacist.

b. On 10/1/2015 at 3:15 p.m. in the Oncology pharmacy, the surveyors observed oncology pharmacist technician #2 compounding multiple sterile hazardous drugs without the appropriate level of supervision by a pharmacist.

c. On 10/1/2015 and 10/2/2015, Surveyors #1 and #2 interviewed Pharmacists #1 and #2. During the interview, the pharmacists indicated that they are only engaged in the final checking of the completed sterile products after compounding, and not at each stage of the compounding process as required by state law.

The pharmacists went on to explain that chemotherapy orders are reviewed by 2 prescribers, 2 pharmacists, and 2 licensed nursing staff before the order can be verified and a label will print.

After a label prints, pharmacist technicians pull the required stock including hazardous drugs, to compound the product. A system is not in place for pharmacists to verify that the product removed from stock is the correct product. Pharmacist technicians then compound the sterile product without supervision by a pharmacist. Pharmacist verification is limited to ensuring the completed compounded sterile product is the correct drug on the product and label.

When questioned by the surveyors, oncology and hospital in-patient pharmacy staff members explained that pharmacists rarely enter the compounding area to directly observe technique or verify the compounding process. The oncology and main pharmacy areas are constructed so that it is impossible to observe active compounding without entering the compounding area.

The surveyors asked how a pharmacist could verify what is actually in the compounded sterile product without performing visual verification of the selection or measurement of the products. Pharmacist #1 and #2 explained that they have to trust that the pharmacy technician correctly selected the product, used appropriate technique during compounding, correctly added the appropriate amount of product to the IV bag, correctly labeled the IV bag, and correctly placed the products used in the compounding of the product in a bin for the pharmacist's final verification.

References
RCW 18.64.257(2) "Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products."

USP 797: "Written procedures for double-checking compounding accuracy shall be followed for every CSP during preparation and immediately prior to release. The double-check system should meet state regulations and include label accuracy and accuracy of the addition of all drug products or ingredients used to prepare the finished product and their volumes or quantities.

The used additive containers and, for those additives for which the entire container was not expended, the syringes used to measure the additive should be quarantined with the final products until the final product check is completed. Compounding personnel shall visually confirm that ingredients measured in syringes match the written order being compounded. Preferably, a person other than the compounder can verify that correct volumes of correct ingredients were measured to make each CSP " .

WAC 246-878-100(2) "Components for drug product compounding shall be accurately weighed, measured, or subdivided as appropriate. These operations should be checked and rechecked by the compounding pharmacist at each stage of the process to ensure that each weight or measure is correct as stated in the written compounding procedures."


Item #2 - Maintenance of compounding rooms and equipment:

Findings include:

1. On 10/1/2015 at 1:00 p.m. with Pharmacist #2, the surveyors observed pharmacist technician #3 in the hospital inpatient main compounding area during the preparation of sterile compounded medications. During the observation, the surveyors noted that the primary engineering control (the LAFW) used in the main compounding area contained visible rust, debris, and the HEPA filter was stained and discolored.

Rust was visible along the entire back edge of the laminar flow hood where the filter screen panel meets the compounding deck. The surveyors observed rust, dust and debris on the inside of the front edge air return slots. There was visible rust and peeling paint on the pre-filter grates. Environmental sampling reports did not indicate that environmental testing had been performed on any of the rusted or discolored areas.

The laminar flow hood utilized in the main compounding area contained a sticker indicating a manufacture date of 1986. Surveyors asked Hospital Pharmacist #1 about the longevity of the Laminar Air Flow Hoods and s/he responded that the expectation was 10-15 years. The survey team requested the maintenance information, but the hospital did not provide it.

During the exit conference on 10/2/2015, hospital staff told surveyors #1, #2, #3 and #4, that the LAFW was to be replaced that day.

2. At 10/1/2015 at 3:15 p.m., during the observation of the oncology pharmacist technician #2, a non-garbed pharmacy staff member entered the negatively pressured hazardous drug Oncology buffer room, wearing only foot covers and not the required gown, mask, hair and face cover. The individual entered the room for a brief period and then exited.

References:
RCW 18.64.257(2) Any medicinal products that are compounded for patient administration or distribution to a licensed practitioner for patient use or administration shall, at a minimum, meet the standards of the official United States pharmacopeia as it applies to nonsterile products and sterile administered products.

USP 797: "Each compounding facility shall ensure that each source of ISO Class 5
environment (Cleanroom with a low level of environmental pollutants such as dust, airborne microbes, particles and chemical vapors) for exposure of critical sites and sterilization by filtration is properly located, operated, maintained, monitored, and verified."

"Surfaces and essential furniture in buffer rooms or zones and clean rooms shall be nonporous, smooth, non-shedding, impermeable, cleanable, and resistant to disinfectant."

"Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they are easily cleaned and disinfected."

WAC 246-878-080 (1) : Equipment used in the compounding of drug products shall be of appropriate design, appropriate capacity, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Equipment used in the compounding of drug products shall be suitable composition so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond that desired.
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USP 797: Revision Bulletin <797> (page 29) Pharmaceutical Compounding-Sterile Preparations Personnel Cleansing and Garbing " stated in part: " After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks, a hand cleansing procedure shall be performed by removing debris from underneath fingernails using a nail cleaner under running warm water followed by vigorous hand washing. Hands and forearms shall be washed to the elbows for at least 30 seconds with soap (either nonantimicrobial or antimicrobial) and water while in the ante-area ...Hands and forearms to the elbows will be completely dried using either lint-free disposable towels or an electronic hand dryer. After completion of hand washing, a non-shedding gown with sleeves that fit snugly around the wrists and enclosed at the neck is donned. Gowns designated for buffer area use shall be worn, and preferably, they should be disposable.

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Item #3 - Testing:

Findings include:

During the survey, the surveyors reviewed documentation related to the particle count testing of compounding aseptic isolators (CAI), LAFW and compounding rooms. The contracted testing agency noted that CAI testing was performed during static, non-operational, conditions. Interviews with pharmacist technicians #4, #6, #8 and #9 from the Roosevelt site, Intensive care unit, and pharmacy technicians from Pavilion operating rooms #1 and #2, who were present during the CAI testing, confirmed the static condition test.

Documentation of the LAFW and clean room testing indicated the tests had been performed under dynamic conditions. However, an interview with pharmacist technician #5, who observed the testing agency's studies, indicated that the LAFW testing occurred when s/he was in the room, but not using the LAFW being tested.

Pharmacist #4 commented that the next routine environmental testing would be performed during dynamic conditions and isolator testing equipment leads would be routed through trash receptacle ports.

Reference:
USP 797: " The nature of the activities conducted in a supporting clean area determines its classification. The FDA recommends that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards under dynamic conditions. "

RCW 18.64.270 requires pharmacopoeia standards be met when compounding sterile products. This stipulates, in part, that when sterile drug compounding activities occur they must be done so in environments which support certain particulate count thresholds. The particle counts in areas of direct compounding must be verified " ...under dynamic operating conditions ... " and the placement of non-isolator type devices must be verified to be in " ...Class 10,000 (ISO 7) standards under dynamic conditions ... "

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