Wyoming Public Health Laboratory

Summary Statement of Deficiencies D0000 Federal jurisdiction recertification survey with standard level deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation of the Serology laboratory, review of reagent and quality control package inserts, review of Serology temperature recording chart, and interviews with the Serology General Supervisor and the Quality Assurance Coordinator, the laboratory failed to ensure the storage temperature ranges were within the manufacturer's specifications for storage for 40 of 40 boxes of Diasorin test reagents and 22 of 22 Diasorin quality control kits used with the Liaison XL instrument located in room number 1398. Findings included: 1. An observation during a tour of the laboratory, room number 1398, on 04/30/2025 at 9:10 AM, revealed the following Diasorin items stored in the VWR refrigerator (serial number 10701284): Test Reagents QuantiFERON, Lot # 137287, Quantity 21 Mumps, Lot # 163044A, Quantity 2 Measles, Lot # 159051, Quantity 2 Varicella Zoster, Lot # 392005, Quantity 2 Rubella, Lot # 306023, Quantity 2 Hepatitis B Core, Lot # 265014, Quantity 3 Hepatitis B Surface Antigen, Lot # 277046, Quantity 2 Hepatitis B Antibody, Lot # 271025, Quantity 3 Hepatitis C Antibody, Lot # 279036, Quantity 3 Quality Control QuantiFERON, Lot # 137309A, Quantity 4 Mumps, Lot # 164047A, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Quantity 2 Measles, Lot # 160036, Quantity 2 Varicella Zoster, Lot # 393004, Quantity 1 Rubella, Lot # 009043A, Quantity 2 Hepatitis B Core, Lot # 266010, Quantity 3 Hepatitis B Surface Antigen, Lot # 278032, Quantity 3 Hepatitis B Antibody, Lot # 272013, Quantity 3 Hepatitis C Antibody, Lot # 280033, Quantity 2 a. Each test reagent and quality control kit indicated on the box container, a storage temperature requirement of 2 - 8C. 2. A review of the manufacturer's package inserts for the test reagents and quality control material stated a storage temperature requirement of 2 - 8C. 3. A review of the Serology temperature recording chart revealed a temperature range of 1 - 5C +/- 1C for the VWR refrigerator (serial number 10701284). 4. A review of Serology temperature recording charts from 04/01/2023 to 04/30/2025, revealed 2 out of 760 days the refrigerator temperature was recorded as follows: Date Temperature 10/18/2023 1.6 C 04/02/2024 1.0 C 5. An interview on 04 /30/2025 at 9:15 AM with the Serology General Supervisor confirmed that the laboratory failed to define specified temperature requirements for the storage of Diasorin test reagents and quality control material in the VWR refrigerator, serial number 1070284. 6. An interview on 04/30/2025 at 11:55 AM with the Quality Assurance Coordinator confirmed that 2 out of 760 days, the recorded temperature for the VWR refrigerator (serial number 10701284) was outside the manufacturer's specified storage temperature range of 2 - 8C. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of patient test reports, and interview with the Laboratory Director, the laboratory failed to include test results on the patient test reports with multiplex SARS COV-2 (FLU SC2) Multiplex Assay for 2 of 2 months reviewed (February and March) 2025: 1. In review of the laboratory's policy CMS.491 PHL CDC Influenza SARS-COV-2 (Flu SC2) Multiplex Assay shows a table on pg 16. The table indicates the following: INFA + report positive for Influenza A inf B + report positive for Influeza B SC2 + report positive for Covid -19 INFA - INFB - SC2 - report negative. 2. In review of the following patient test reports, the laboratory did not put the final results (positive or negative) on the patient test reports for Influenza virus A, Influenza Virus B, and SARS-COV-2. a. patient 30361 report 2/10/2025. b. patient 102809 report 3/10/2025. 3. In interview with the laboratory director on 5/1/2025 at 1222, confirmed the results weren't on the test reports only the interpretation. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a direct observation and an interview with microbiology General Supervisor, the laboratory failed to ensure that the REMEL Bactidrop Oxidase reagent was not used past the expiration date. The laboratory performed 34 Oxidase tests with the expired reagent from 08/13/2022 to 11/17/2022. Findings include: 1. A direct observation of the microbiology BSL2 hood revealed one (1) open box of single use vials of REMEL Bactidrop Oxidase reagent, lot number 202384, with an expiration date of 08/13/2022, was being used for bacterial culture identification on patient culture specimens. 2. An interview with the General Supervisor on 11/17/2022, at approximately 3:10 PM, confirmed the REMEL Bactidrop Oxidase reagent was expired and was used for patient testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on a record review and an interview with the Laboratory Director, the laboratory failed to have a system in place to document the comparison of six (6) Applied Biosystems 7500 Fast Dx instruments used for the CDC Multiplex Assay for Influenza A, B, and SARS-CoV-2 testing at least twice a year since September of 2020. The laboratory performed approximately 50,000 tests per year. Findings include: 1. A review of the laboratory's quality assurance records revealed that the laboratory failed to have a system in place to evaluate the CDC Multiplex Assay for Influenza A, B, and SARS-CoV-2 patient test results using 6 Applied Biosystems 7500 Fast Dx instruments. 2. An interview with the Laboratory Director on 11/17 /2022, at approximately 2:30 PM, confirmed the laboratory failed to have a system that twice a year evaluates the relationship between 6 Applied Biosystems 7500 Fast Dx instruments used for patient testing. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on a review of the laboratory's bacteriology culture worksheets and an interview with the microbiology General Supervisor, the laboratory failed to document or have a system in place to ensure the bacteriology culture worksheets included the dates and testing personnel for each step of bacterial organism identification process, from media inoculation through organism isolation and identification since the last survey performed on 11/3/2020. The laboratory performed approximately 1500 bacteriology culture tests per year. Findings include: 1. Review of the laboratory's bacteriology culture worksheets revealed the laboratory failed to document the dates and the identity of the testing personnel who performed each step in the organism isolation and identification process since the last survey performed on 11/3/2020. 2. An interview with the microbiology General Supervisor on 11/17/2022, at 3:30 PM, confirmed the laboratory's culture worksheets did not include the identity of the testing personnel and the dates of each testing step. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the extraction room for PCR COVID-19 testing, lack of temperature and humidity documentation, Qiagen manufacturer's insert, and interview with the laboratory director (LD), the laboratory failed to monitor and document the temperature and humidity of the extraction room used for PCR COVID-19 testing. Findings: 1. Observation of the extraction room for the PCR COVID-19 testing, revealed the laboratory failed to monitor and document the temperature and humidity since March 4, 2020. 2. Review of the Qiagen manufacturer's product insert revealed that operating conditions must be in a temperature range of 18 to 28 degrees Celsius and a relative humidity of 15 to 75 percent (noncondensing). 3. Interview with the LD on November 3, 2020 at 3:00 PM confirmed the laboratory failed to monitor and document the room temperature and humidity in the extraction room for PCR COVID- 19 testing. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency documentation and staff interview, the technical consultant failed to have a competency evaluation performed prior to performing evaluations on other staff members in 1 of 1 years evaluated. Findings include: 1. Review of competency documentation revealed the Technical Supervisor was hired on March 1, 2018, and performed competency evaluations on testing personnel prior to being assessed for competency. 2. In an interview conducted on November 14, 2018 at approximately 11:00 AM, the Laboratory Manager confirmed the technical supervisor hired on March 1, 2018 had not been assessed for competency but did perform competency assessments on other employees. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on review of the test method procedures and staff interview, the current laboratory director failed to approve all test method procedures. Findings include: 1. Review of the procedure manual in Bacteriology revealed the current laboratory director failed to approve 3 of 7 test method procedures. 2. Review of the procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- manual in Immunology revealed the current laboratory director failed to approve 1 of 11 test method procedures. 3. In an interview conducted on 11/15/2018 at approximately 12:00, the Laboratory Administrator and Technical Supervisor stated they were unaware these procedure were not signed by the current laboratory director. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of competency documentation and staff interview, the laboratory failed to perform annual competency evaluations on 3 of 14 employees in 2017. Findings include: 1. Review of competency documentation revealed 3 employees had not received their annual competency evaluation in 2017 in Immunology. For each of these three employees, the 2016 competency was performed in November 2016. Competency was next performed and documented on these employees in February 2018. 2. In an interview conducted on November 14, 2018 at approximately 2:00 PM, the Technical Supervisor confirmed competency evaluations were not performed on three employees in 2017. -- 2 of 2 --