HospitalInspections.org

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Based on document review and interview, the hospital failed to establish a formal quality assurance plan specific to compounded sterile products (CSPs) as required by USP 797.
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Failure to develop a formal quality assurance plan for compounded sterile products risks patient safety from the hospital's inability to identify problems and make corrections in the hospital's sterile compounding program.
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Reference: U.S. Pharmacopoeia Convention (USP) General Chapter 797, 2016.
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Findings:
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1. The USP 797 (Effective June 1, 2008) under the section titled "Quality Assurance (QA) Program" read in part: "A provider of CSPs shall have in place a formal QA program intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. . .Characteristics of a QA program include the following: 1. Formalization in writing; 2. Consideration of all aspects of the preparations and dispensing of products as described in this chapter, including environmental testing and verification results; 3. Description of specific monitoring and evaluation activities; 5. Identification of appropriate follow-up mechanisms when action limits or thresholds are exceeded; and 6. Delineation of the individuals responsible for each aspect of the QA program. . . In general, the selection of indicators and effectiveness of the overall QA program is reassessed on an annual basis."
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2. On 8/1/2016 between 1:00 PM and 2:00 PM, Investigator #1 interviewed the Pharmacy Director of Operations (Staff Member #1) about the quality assurance (QA) program. The investigator asked if there was a formal written document that described and outlined all the key elements of the program as required by USP 797. Staff Member #1 acknowledged there was not a comprehensive unifying document that identified the program's structure, scope, responsibilities, goals and objectives as required by USP 797. Along with hospital policies and procedures related to sterile compounding, Staff Member #1 presented a document containing sterile compounding metrics that are reported to the hospital quality oversight council as evidence of an ongoing QA program.
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Based on document review, interview, and review of hospital policies and procedures, the hospital failed to ensure staff followed its policy when performing sterility testing for batch prepared compounded sterile products (CSPs) when utilizing "extended beyond use" dating.
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Failure to follow prescribed processes and requirements for batch prepared CSPs put patients at potential risk for receiving medications with compromised sterility, integrity, or stability.
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Reference: U.S. Pharmacopoeia Convention (USP) General Chapter 797, 2016.
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Findings:
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1. The hospital policy and procedure titled "IV Admixture Service: Sterility Testing for Batch Prepared Compounded Sterile Products (CSPs)" (Reviewed 10/2015) read in part: "Sterility testing will be performed under the following circumstances: When extended beyond use dating is used. . .For Compounded Sterile Preparations (CSPs) Utilizing Beyond Use Dating: A complete test consists of one sample in Trypticase-Soy Broth (TSB) and one sample in Alternative Fluid Thioglycolate (FTG). . .4. ThioMS TM PROCEDURE: . . . Tamper-seal the sample vial and incubate at controlled room temperature (20 o C. to 25 o C). . . 5. SteriMSTM PROCEDURE: . . . Tamper-seal the sample vial and place in incubator at 30 Degrees C. to 35 Degrees C. . . 6. INTERPRETATION OF RESULTS: Document the verification of the temperature results daily on the ExtenDate Batch Sterility Test Log. Examine the sample(s) at 1, 3, 7 and 14 days. Document the result (Pass or Fail) on the Compounded Sterile Product Sterility Log."
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2. On 8/1/2016 at 9:00 AM, Investigator #1 reviewed the ExtenDate Batch Sterility Test Logs for years 2014, 2015, and 2016 with the Director of Operations (Staff Member #1) and Director of Purchasing & Specialty Pharmacy Services (Staff Member #2) and noted the following:
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a. Document review for 2014 indicated that 25 of 26 batch sterility test logs had some aspect of monitoring noncompliance. There were entries that had documented temperatures outside of the recommended range and there were entries that had missing documentation. Eleven of 26 batch sterility test logs had no incubator temperature measurements recorded for any aspect of the 14-day monitoring period.
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b. Document review for 2015 indicated that 19 of 19 batch sterility test logs had some aspect of monitoring noncompliance. There were entries that had documented temperatures out of the recommended range and there were entries that had missing documentation. Seventeen of 19 batch sterility test logs had room temperature incubation measurements out of the recommended test range (20-25o Celsius) varying from 18 to 19o Celsius (C).
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c. Document review for 2016 indicated that 6 of 7 batch sterility test logs had room temperature incubation measurements out of the recommended test range (20-25o C) varying from 15 to 18o C.
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3. On 8/4/2016 at 9:00 AM, Investigator #1 interviewed the Inpatient Pharmacy Manager (Staff Member #3) about sterility testing procedures for batch prepared CSPs when staff utilize "beyond use dating". Staff Member #3 acknowledged that historically the lead pharmacy technician reviewed the test logs but not to the detail required. S/he stated a supervising pharmacist would now review them. S/he indicated the sterility test log sheet was in the process of revision. Staff Member #3 informed the investigator that two weeks ago, pharmacy staff identified that an incubator thermometer was not working properly and was under reporting the temperature by 5o C. Two additional thermometers have now replaced the defective thermometer.
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