Alaska State Virology Laboratory

Summary Statement of Deficiencies D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on document review of College of American Pathologist (CAP) proficiency testing (PT) for immunology analytes Hepatitis B core antigen (Anti-HBc) and Hepatitis B surface antigen (HBsAg) and interview with the Technical Supervisor (TS), the laboratory failed to submit 2023 second (B) event PT results for immunology analytes. Findings include: 1. A review of CAP 2023 Event B revealed that the laboratory failed to submit the 2023 Immunology Event B PT results within the time frame specified by CAP for scoring, which resulted in unsatisfactory performance and a score of 0. Event Analyte Score 2023-B Anti-HBc 0 2023-B HBsAg 0 2. Interview with the TS confirmed on 01/10/2024 at 2:00 pm that the PT was not returned to CAP in time for scoring. 3. The laboratory reports performing 25,020 immunology tests annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 3 -- Based on document review and interview with the laboratory director (LD), the laboratory failed to ensure Quality Assessment (QA) review of the staff competency assessment forms. Findings include: 1. Policy review of "Performing Competency Assessments for CLIA Personnel" states, "The QA officer must review the forms annually and sign/date at the top of the form." 2. A review of 17 of 17 competency Assessment forms for 2022 and 70 of 70 for 2023 had not been reviewed by the QA officer. 3. An interview with the LD confirmed on 1/10/2024 at 11:30 am that the QA officer did not review the competency assessment forms. 4. The laboratory reports performing 42,515 tests annually. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, document review, and interview with the Technical Supervisor (TS), the laboratory failed to ensure annual pipette calibrations were performed for the year 2023. Findings include: 1. A tour of the laboratory on 01/10/2023 at 03:20 pm Reagent Prep Room 206B, Specimen Prep Room 206C, and Specimen Prep Room 210C revealed that 14 of 14 observed pipettes had expired calibrations of October 2023. 2. A document review of the "Updated Pipette Inventory" revealed that all pipettes were due for calibration. S/N Due D0301178A 09/19/2023 C011130741 09/19 /2023 Media Prep (Room 202) S/N Due H0801028A 10/13/2023 L0507975A 10/14 /2023 C011158586 10/13/2023 Main Lab (Room 206) - Rabies S/N Due J39073D 09 /19/2023 2220209 11/29/2023 014662C 09/19/2023 Main Lab (Room 206) - Geenius S/N Due A0402643A 09/23/2023 H13848D 09/19/2023 318850 09/19/2023 O14556C 09/19/2023 Main Lab (Room 206) - Immunology S/N Due 3919809 09/19/2023 3747039 09/19/2023 O14537C 09/19/2023 G33944C 09/23/2023 Reagent Prep (Room 206B) S/N Due C011161342 10/13/2023 K0921195A 10/14/2023 D0300667A 10/13/2023 Specimen Prep (Room 206C) S/N Due K0916534A 09/19/2023 K0920398A 10/13/2023 L0936138A 10/14/2023 C011160803 10/14/2023 K0921334A 09/23/2023 C044371274 10/13/2023 Sequencing (Room 211A2) - Bench S/N Due D0301139A 09/19/2023 K0916531A 09/19/2023 C011130722 09/19/2023 C017341829 11/22/2023 3762639 09/19/2023 Sequencing (Room 211A2) - Main BSC S/N Due C011160796 09/23/2023 C044416428 11/22/2023 Sequencing Special Path (Room 211A2B) S/N Due J0901405A 09/19/2023 K0921300A 09/23/2023 C214835551 09/23/2023 Kingfisher (Room 211A3) S/N Due F0879328A 09/19/2023 C011130725 09/19/2023 B1107810A 10/13/2023 C044416153 09/23/2023 J1149125T 11/22/2023 Reagent Prep (Room 210D) S/N Due K0916511A 10/13/2023 C0303417A 10/14/2023 K0921321A 10/14/2023 J1149162T 10/14/2023 Specimen Prep (Room 210C) S/N Due C011161328 11/21/2023 H08033068 11/21/2023 L0936223A 10/14/2023 K0920166A 09/19/2023 K0916201A 09/23/2023 G0301167A 09/23/2023 C017341849 10/14/2023 C048594468 11/22/2023 Amplification Room (210B) S/N Due C011161662 11/21/2023 C0303369A 10/14 -- 2 of 3 -- /2023 F0300048A 11/18/2023 B1105192A 10/14/2023 3. An interview with the TS confirmed on 1/10/2024 at 4:15 pm that pipette calibrations were not performed for the year 2023. 4. The laboratory reports performing 42,515 tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a surveyor's review of the patient test reports and an interview with the technical supervisor (TS#1), the laboratory failed to include pertinent reference intervals, normal or expected values on the final test reports. Findings: 1. A review of final test reports for the following tests revealed that no normal or expected values were available on the final test reports for: a. HIV 1/2 b. VZV IgG c. Hepatitis C Virus 2. An interview conducted on June 27, 2022 at approximately 12:30 PM with TS #1 assigned to the Virology and General Immunology sections, confirmed that the final reports for all analytes do not include reference intervals, normal or expected values. 3. The laboratory reports performing approximately 72, 450 patient samples annually. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on the lack of documentation and an interview with the laboratory director and the technical supervisor (TS#1) it was determined that the laboratory did not have a Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- policy or documentation of notification of results when imminent life-threatening conditions, panic or alert values are obtained. Findings: 1. A review of the Quality Assurance policy revealed that the laboratory failed to establish a policy or process to address how imminent life-threatening conditions, panic or alert values are reported and documented. 2. An interview conducted on June 27, 2022 at approximately 5:30 PM with the Laboratory Director and TS#1, confirmed that the laboratory did not have a policy to identify which results would be considered significant and require immediate notification to the authorized provider or individual. 3. The laboratory reports performing approximately 72, 450 patient samples annually. D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the -- 2 of 3 -- factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on a review of personnel records and an interview with the technical supervisor (TS#1) assigned to the Virology and General Immunology sections, two testing personnel did not meet the educational qualifications and training requirements to perform high complexity testing. Findings: 1. A review of diplomas and transcripts revealed that the two of ten testing personnel listed on the CMS 209 as testing personnel (TP) for Virology and General Immunology did not meet the minimum educational and training requirements to perform high complexity testing. 2. A further review of TP #1's transcripts revealed that the TP did not have a qualifying degree or the number of semester hours required to perform high complexity testing in any specialty. 3. A further review of TP #3's transcripts revealed that the individual had a Bachelor's of Arts degree and although the appropriate number of semester hours had been met, the TP did not have 3 months of documented training in Virology and General Immunology. 4. An interview conducted on June 27, 2022 at approximately 9: 10 AM with TS#1 confirmed that TP #1 and 3 did not meet the requirements to perform high complexity testing in the specialties of Virology and General Immunology. -- 3 of 3 --

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 the CMS-209 personnel report form and interview with the laboratory manager on 02/11/2021 the laboratory failed to establish and follow written policies and procedures to assess employee competency annually. Findings include: 1. The laboratory's CMS-209 personnel form identified seven individuals who are designated as General supervisors, of which six of the seven are testing personnel and three of the seven are designated as technical supervisors. 2. Review of personnel competency records revealed that 3 of 3 technical supervisors, and seven of seven general supervisors, did not have annual competencies performed to assess their competency for those responsibilities as Technical supervisor or General supervisors and the additional responsibilities as delegated by the laboratory director for 2019 and 2020. 3. The laboratory manger confirmed the lack of competency assessments for Technical supervisors/General supervisors by interview on February 11, 2021 at 10:20 a.m. 4. The laboratory reports performing 284,000 patient samples annually. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and 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 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager on 02/11/2021, the laboratory failed to follow established written policies and procedures for each of the following,specimen storage and preservation, conditions for specimen transportation. Findings include: 1. The laboratory had established it's VTM media stability for SARS CoV-2 storage and transport to be at 2-8 degrees Celsius once inoculated or frozen at -70 degrees. 2. During the tour of the laboratory's receiving processing area, it was observed that the laboratory did not take the temperatures of the of the samples upon receipt. 3. The laboratory failed follow their established information for use, of their own VTM media by monitoring and documenting the temperatures of patient VTM SARS CoV-2 specimens for acceptability upon receipt prior to testing. 4. The laboratory manager confirmed by interview on January 11, 2021 at 5:00 p.m. the lack of monitoring and documenting specimen temperature acceptability. 5. The laboratory reports performing 210,000 SARS CoV-2 molecular tests annually. . -- 2 of 2 --