Alaska State Public Health Laboratory

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation, a review of the laboratory's policies and procedures, manufacturer's instructions, and an interview with Technical Supervisor (TS) #1, the laboratory failed to follow the manufacturer's instructions for specimen stability and transport for 1 of 1 coolers containing patient specimens received from outside the facility. Findings Include: a. An observation on 07/20/2026 at 11:35 AM, in the accessioning area, revealed 5 bags containing patient specimens in a cooler with three cold packs that were cool to the touch. Staff did not document the specimen temperature at the time of receipt. b. A review of the laboratory's policy "Courier Services for Anchorage Lab Appendix C Description of Services" revealed specimens must be "protected from temperature extremes using cooler and ice packs ...Daily monitoring and documentation of the specimen temperatures are required." c. A review of the manufacturer's instructions "Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System" revealed "Specimen handling and storage ...Fresh specimens may be stored for up to seven days at 2 to 8C ...If longer storage is required, specimens should be stored frozen at -20C or below for 14 days ... It is the responsibility of the individual laboratory to use all available references and /or its own studies to determine specific stability criteria for its laboratory." d. A review of the laboratory's procedure "Gold Standard Diagnostic AIX1000 RPR Procedure" revealed "Specimen Handling ...Serum should be stored at 2-8C [degrees Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Celsius] for up to 7 days from draw. If a delay in testing is anticipated, store serum at 20C or below for up to 14 days." e. A review of the online Laboratory Test Directory revealed (sampling) "Syphilis Screen Rapid Plasma Reagin (RPR) ...Store refrigerated. Freeze sample if delay in testing is anticipated. Ship ambient temperature." The temperature range was not defined for refrigeration, frozen, or ambient conditions. f. During an interview on 07/20/2026 at 11:35 AM, TS#1 confirmed the transport temperatures were not documented by the laboratory, and daily monitoring is required per the laboratory's own policy. g. The laboratory received 60 patient specimens for various tests on 07/20/2026. A sample of the specimens reviewed included: i. Lab ID: 261980092SZ; Test: RPR ii. Lab ID: 261980143SZ; Test: RPR iii. Lab ID: 261980175SZ; Test: RPR 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 a review of the laboratory's procedures, the temperature chart, and an interview with Technical Supervisor (TS) #5, the laboratory failed to ensure that its defined room temperature range was consistent with its own written procedures for 4 of 12 days reviewed in July 2026. Findings Include: a. A review of the laboratory's procedure "Gold Standard Diagnostic AIX1000 RPR [Rapid Plasma Reagin] Procedure", authorized 07/09/2026, revealed "Quality control ...Room temperature needs to be between 20-25C [degrees Celsius] ...All reagents and specimens must be equilibrated to room temperature (20-25C) before a run is started ...Qualitative Test ... Remove specimens, reagents, and controls from the refrigerator and/or freezer and allow to equilibrate to room temperature, 20-25C." b. A review of the laboratory temperature chart revealed "Acceptable room temperature range: 19C+/- 5 C [14- 24C]." The defined range on the chart (14-24C) exceeded the defined range in the procedure (20-25C). Room temperatures were outside the range defined in the procedure (20-25C) on: Date: 07/02/2026, Temperature: 19.2C Date: 07/15/2026; Temperature: 19.8C Date: 07/16/2026; Temperature: 19.2C Date: 07/20/2026; Temperature: 19.3C c. During an interview on 07/20/2026 at 9:55 AM, TS#5, as listed on the CMS-209, confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of the manufacturer's instructions, direct observation, and an interview with Technical Supervisor (TS) #5, the laboratory failed to label 2 of 2 in- use Rapid Plasma Reagin (RPR) quality controls with open and expiration dates. Findings Include: a. A review of the manufacturer's instructions "Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System", revealed "5.0 Storage and Shelf Life of the Test kit and the Ready to Use Components ...Once opened, the reagents are good for a 90-day period, if kept refrigerated between runs." b. An observation on 07/20/2026 at 9:54 AM, in the laboratory, revealed 1 RPR Reactive and 1 RPR Non-Reactive quality control vial without an open or expiration date. Each vial had a single line marked on the lid. c. During an interview on 07/20 /2026 at 9:55 AM with TS#5, as listed on the CMS-209, stated the marking on the lid was to identify how many times the quality control was run from the vial and confirmed no open or expiration dates were on the vials. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. This STANDARD is not met as evidenced by: Based on an interview with General Supervisor (GS) #6 and a review of the laboratory's policies and procedures, the laboratory failed to have a maintenance procedure in place for 1 of 7 instruments. Findings Include: a. A review of the laboratory's QIAGEN EZ1 instrument maintenance policy revealed that the policy was for an affiliated laboratory with a different CLIA number. b. During an interview on 7/20/2026 at 11:43 AM, GS #5 stated the laboratory got the Qiagen EZ1 instrument in 2021 and confirmed there was no approved maintenance policy or procedure, signed by the laboratory director, for this CLIA number. 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 a review of the laboratory's procedures, patient test reports, and an interview with Technical Supervisor (TS) #1, the laboratory failed to include a test interpretation for 1 of 3 Syphilis Serology test results reviewed. Findings Include: a. A review of the laboratory procedure "FTA-ABS [Fluorescent Treponemal Antibody- -- 3 of 4 -- Absorption] Double Stain", authorized 07/08/2026, revealed "Report Comments ... Result ...Previous Positive FTA ...Comment ...FTA test not performed due to history of previously positive treponemal test. Clinical evaluation should be performed to identify current signs and symptoms or past history of infection. If recent exposure suspected and RPR [Rapid Plasma Reagin] titer is nonreactive, redraw RPR titer in 2- 4 weeks. Presumptive treatment is indicated if known exposure in last 90 days regardless of test results." b. A review of sampled patient test reports revealed no interpretation comments for FTA test results reported as "PREVIOUS POSITIVE". 1. Lab ID: 2619700066; FTA Final Result: PREVIOUS POSITIVE; Test Completed 07 /17/2026 9:29 [AM]. 2. Lab ID: 2618800090; FTA Final Result: PREVIOUS POSITIVE; Test Completed 07/13/2026 08:51 [AM]. c. During an interview on 07/20 /2026 at 10:00 AM and 11:10 AM, TS#1, as listed on the CMS-209, confirmed results reported as "FTA Final Results ...PREVIOUS POSITIVE" should include the comment listed in the procedure, and the laboratory reported 19 test results in 2024 and 170 test results in 2025. -- 4 of 4 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Supervisor (TS) during an onsite revisit conducted on January 8, 2024, the laboratory failed to train and ensure that each Testing Personnel (TP) performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed. Findings include: 1. In response to Dtag 2006, 5016, 5403, 5423, 5445, 6112, and 6114, deficiencies cited in the November 8, 2023 survey, the laboratory stated: "After the revised method has completed the review, Chemistry Staff will be trained on the new procedure. Training will be documented." 2. As of the onsite follow-up conducted on January 8, 2024, the laboratory maintained no documentation to indicate compliance with the statement above. 3. The onsite revisit on January 8, 2024, revealed that the laboratory failed to train TP in new policies and procedures created in response to the November 8, survey. 4. An interview with the TS confirmed on 01/08/2024 at 1:40 PM that training was not completed by the date stated in the response. 5. The laboratory reports perform 1,350 routine chemistry tests annually. 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 D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 laboratory 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 six individuals who are identified as technical supervisors (TS), of which three of the six are identified as general supervisors (GS) and all six are also testing personnel. 2. The two of the six individuals identified as TS had no competency assessments as testing personnel for the testing in which they perform. 3. Two of the six identified TS had a checklist of annual testing personnel competency completed which were not signed by the laboratory director. TS- (C) Start Date 6/17/2020 No six month competency performed. TS-(D) No annual competency 2019, 2020 4. Three of three testing personnel for the Toxicology laboratory had no annual competency's performed for 2019, 2020. The General Supervisor had performed assessments on all three (one on themselves) for 2020, which had not been reviewed or approved by the laboratory director. 5. The laboratory technical supervisor (A) confirmed the lack of competency assessments for Technical supervisors/General supervisors by interview on February 09, 2021 at 10:20 a.m. 6. The laboratory reports performing 283,025 patient samples annually. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(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 -- 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 rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory personnel on 02/08/2021, the laboratory failed to follow established written policies and procedures for each of the following, if applicable: Specimen storage and preservation, Conditions for specimen transportation. The findings include: 1. The laboratory utilizes the Fairbanks Public health laboratory's VTM media for SARS CoV-2 specimen transport to the public health labs from collection sites around the state. The validation study established the stability for SARS CoV-2 tests at 2-8 Celsius once inoculated for up to 7 day or frozen at -70 degrees. 2. On entrance to the laboratory facility on 02/08/2021, it was observed that a commercial cooler had been placed at the entrance reception area for specimens to be dropped off. Upon closer review it was noted that on the lid of the cooler a flyer was posted stating "do not close the lid". Inside the cooler was a cool pack and patient specimens. The cooler did not have a thermometer to monitor the temperature of the internal cooler space through out the day. 3. On 02/09/2021 at 08: 30 a.m. it was observed an individual carrying in two patient specimens and placing them into the cooler. Review of the cooler contents at 10:00 a.m. revealed the cooler now had over 30 patient samples awaiting testing. The laboratory has no policy or procedure for monitoring the temperatures of the cooler during the day as increased numbers of patient samples are placed in the open cooler over time. 4. The laboratory performs SARS CoV-2 testing on the Panther Aptima system on nasal swabs and Thermofisher MagMax Multiplex Real Time rt-PCR methodologies collected in the ASPHL VTM media validated for storage at 2-8 Celsius. The Laboratory had no documentation of specimen temperatures upon receipt to determine acceptability. 5. Upon interview with the department technical supervisors A, B,and C on 01/08/2021, it was revealed that the laboratory does not monitor and document the temperatures of patient VTM SARS CoV-2 specimens for acceptability upon receipt prior to testing. 6. The laboratory technical supervisors A,B, and C confirmed by interview on January 09, 2021 at 10:00 a.m. the lack of monitoring and documenting specimen temperature acceptability. 7. The laboratory reports performing 242,183 SARS CoV-2 molecular tests annually. D5805 TEST REPORT CFR(s): 493.1291(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: -- 2 of 3 -- Based on patient record review and interview with the laboratory Technical Supervisor B on 01/08/2021, the laboratory failed to ensure test report indicated the correct name and address of the laboratory location where the test was performed. The finding include: 1. A random patient record review from March 1, 2020 through February 02, 2021 revealed that patient testing performed on 06/13/2020 for lab ID 2016400258 had been reported as being performed at the Fairbanks Public Health laboratory. 2. The laboratory TS (B) and the Quality Assessment personnel confirmed that the specimen had been sent to the Anchorage laboratory due to reagent shortage at the Fairbanks location. The laboratory information system assigns the location automatically by the identification number. The number had not been reassigned prior to release of the patient report. 3. The laboratory Technical Supervisor (B) confirmed by interview on 02/09/2021 at 10:00 a.m. that the test had been performed at the Anchorage laboratory and the test report was not accurate. 4. The laboratory reports performing 283,025 patient specimens annually. -- 3 of 3 --