Vermont Dept Of Health Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was performed on 07/22/25 through 07/24/25. Standard-level deficiencies cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the laboratory's written procedure, testing worksheets, and interview with general supervisor #12 (GS #12), the laboratory failed to follow its written procedure for one of one lot change for the antigen needle used for syphilis testing. Findings included: 1. Review of the laboratory's written procedure titled "Procedure for the Rapid Plasma Reagin (RPR) Test for Syphilis" section, "6.4 Antigen Dispensing Needle" stated, "6.4.1 The antigen-dispensing needle is checked after a new needle or new lot of antigen is put into use.". 2. Review of the "Syphilis RPR Run Worksheets" revealed no evidence of an antigen-dispensing needle check for one of one antigen lot number 4033530. 3. In an interview on 07/23/25 at 10:30 am, GS #12 confirmed the 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 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 -- information required for proper use. This STANDARD is not met as evidenced by: I. Based on observation and interview with staff, the laboratory failed to label laboratory prepared media tubes with the name of the media, storage requirements, preparation and expiration dates for two of two media. Findings included: 1. During a tour of the Bacteriology Laboratory (Room 220A) on July 24, 2025, at approximately 10:30am, the following laboratory prepared media was observed in Refrigerator SP1395: a. A test tube rack with a label on the front on the rack with the following: "TSI Slants.. A Procedure pH 7.36 ...Preparation Date 4/1/2 (QC PASSED sticker covered the remaining date)..Expiration Date 10/1/2 (QC PASSED sticker covered the reaming date)..Prepared By" (written initials were not legible) ... Storage Room ... Refrig. The rack contained unlabeled tubes of media. b. A test tube rack with a label on the front on the rack with the following: Motility Test Medium ...pH 7.27.. Preparation Date 4/11/25 ...Expiration Date 10/1/25 ...Prepared By (written initials were not legible) ... Storage Room ... Refrig. The rack contained unlabeled tubes with media. 2. During interview on July 24, 2025, at approximately 10:30am, the laboratory's Quality Assurance staff confirmed the above findings. 47272 II. Based on the laboratory's written procedure, observation, and interview with technical supervisor #7 (TS #7), the laboratory failed to document the expiration date for two of two bottles of L-Ascorbic Acid. Findings included: 1. Review of the laboratory's written procedure titled, "Cyanide in Blood By Headspace GC/MSD" section, "1.2 Identification of the Method" stated, "Cyanide in whole blood is analyzed at the Vermont Department of Health Laboratory (VDHL) using static headspace sampling on an Agilent 5977B mass spectrometer coupled with 8890 gas chromatograph and a Gerstel Robotic PRO MultiPurpose Sampler (MPS) system. ... ... L-ascorbic acid is used to prevent the conversion of the thiocyanate (SCN-) in blood to HCN. ....." 2. Observation on 07/23/25 at 09:30 am in the Chemical Threat Organic Laboratory revealed no expiration dates for two bottles of two containers of Fisher Chemical L- Ascorbic Acid bottles (Lot#213733 and Lot# 235732). 3. In an interview on 07/23/25 at 09:35 am, TS#7 confirmed the findings. Word Key: HCN = Hydrogen Cyanide III. Based on the laboratory's written procedure, direct observation, and interview with general supervisor #12 (GS #12), the laboratory failed to document the expiration date for one of one container of Sulfuric Acid. Findings included: 1. Review of the laboratory's written procedure titled, "Enzyme-linked Immunoassay for Qualitative Detection of Antibody to Hepatitis C Virus (Anti-HCV) in Human Serum stated the following: a. Section, "4.7. Materials" stated, "4N H2SO4, Fisher Scientific 500 mL bottle, Catalog # SA818-500" b. Section, "4.8. ELISA Procedure" stated, "s. Add 50 ? L of 4N sulfuric acid (H2SO4) to all wells, including 1A. Ensure proper mixing taking care to avoid splashing." 2. Observation on 07/23/25 at 10:05 am revealed no expiration date documented on one container of Sulfuric Acid (lot# 244182). 3. In an interview on 07/23/25 at 10:10 am, GS#12 confirmed the findings. Word Key: ELISA = Enzyme-linked Immunoassay L= Microliter D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(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. (b)(2)(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 -- 2 of 4 -- testing is conducted. This STANDARD is not met as evidenced by: Based on review of laboratory documents and staff interview, the laboratory failed to calibrate the timers on the centrifuges in the Mycobacteriology and Parasitology laboratories for 2 of 2 years. Findings included: I. Mycobacteriology Laboratory a. Review of the laboratory's procedure "Mycobacteriology Procedure Manual, Version: 9.0, P-MIC-002", page 10 revealed the following : "g. Centrifuge the tube at 3800xG for 15 minutes, using aerosol-free sealed centrifuge cups". b. Review of the laboratory's "Centrifuge Verification Worksheet" for the Mycobacteriology Laboratory /BLS 3 (Biosafety Level 3) found two centrifuges in use. Rotunda 35 R serial number 0002079-04-00 located in room 2404 and Eppendorf serial number 54240N647015 located in room 2401 B. The documentation provided did not include calibration of the centrifuges' timers. c. The surveyor requested and was not provided documentation of the two centrifuges' timer calibration for 2 of 2 years (2023 and 2024). d . During interview on July 23,2025 at approximately 3:30pm, the Technical Supervisor for the Mycobacteriology Laboratory confirmed the laboratory did not perform calibration of the two centrifuge timers in the BLS3 laboratories. II. Parasitology Laboratory a. During tour of the Parasitology laboratory area on July 23, 2025 at approximately 3:15pm, a centrifuge with serial number 0002199-04-00 was observed in use for parasitology testing. b. Review of the laboratory's procedure "Parasitology Procedure Manual, Version: 10.0, P-MIC-003", page 16 revealed the following: "g. Centrifuge at 500 x g (approximately 1700 rpm) for 10 minutes. The centrifuge in the Parasitology room (Room 2220) is preset." c. The surveyor requested and was not provided documentation of the centrifuge timer calibration for 2 of 2 years (2023 and 2024). d. During interview on July 23,2025 at approximately 3:30pm, the Technical Supervisor for the Parasitology Laboratory confirmed the laboratory did not perform calibration of the centrifuge timer. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with laboratory staff, the laboratory failed to perform quality control for three of three reagents used for a microbial identification system. Findings included: 1. Review of the laboratory's quality control worksheets revealed the laboratory utilizes the bioMerieux API 20E test strip to identify gram negative rods. 2. Review of the bioMerieux API 20E instructions for use ("REF 20100 / 20150") provided to the surveyor by the laboratory stated on page 3 the following: "TDA test: add 1 drop of TDA reagent ... Indole test: add 1 drop of JAMES reagent ... VP test: add 1 drop of each VP 1 and VP 2 reagents.." 3. The surveyor requested quality control records for the TDA, Indole and VP reagents and found the laboratory used Hardy Diagnostics reagents rather than bioMerieux reagents. The laboratory failed to provide quality control records for the -- 3 of 4 -- Hardy Diagnostics reagents used with the bioMerieux API 20E test strip. 4. During interview on July 24, 2025, at approximately 10:00am, the Technical Supervisor for the Enteric Laboratory section confirmed the laboratory did not perform quality control testing for the above named Hardy Diagnostics reagents used for the bioMerieux API 20E test strip. Word Key: TDA - Tryptophan deaminase (Ferric Chloride) VP: Voges-Proskauer 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. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with technical supervisor #2 (TS #2), the laboratory failed to evaluate the relationship of measles testing performed on three different analyzers at least twice a year in 2024. Findings included: 1. On 07/24 /25 at 12:15 pm, TS #2 confirmed the laboratory performed measles testing using three Applied Biosystem 7500x (serial numbers: 275030091, 275012276, and 275030549). 2. A record review of the laboratory's 2024 analyzer comparison studies revealed no evidence the laboratory evaluated the relationship between the three instruments in 2024. 3. In an interview on 07/24/25 at 12:30 pm, TS #2 confirmed the findings. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals 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 Centers for Medicare and Medicaid (CMS) Personnel Form 209, the laboratory's quality system manual, personnel records, and interview with the laboratory director (LD), the technical supervisor failed to evaluate one of eight testing persons performing high complexity testing at least annually in 2024. Findings included: 1. Review of the submitted CMS 209 form, signed and dated by the LD on 07/08/25, revealed Testing Person #7 (TP #7) listed to perform high complexity testing. 2. Review of the laboratory's "Quality System Manual", section "19.8 On- Going Demonstration of Capability (ODOC) or Continued Proficiency/Competency" stated, " .... Competency must be demonstrated annually (based on the date of the initial training) and can be demonstrated on the test system ...." 3. Review of 2024 personnel records for eight testing persons performing high complexity testing revealed no annual competency assessed for TP #7. 4. In an interview on 07/22/25 at 10:00 am, the LD confirmed the findings. -- 4 of 4 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's approved Rapid Plasma Reagin (RPR) Test for Syphilis (Document ID P-MIC-026) procedure, Syphilis RPR Run Worksheet, and interview with the Technical Supervisor (TS#2), the laboratory failed to document quality control for the antigen-dispensing needle when a new lot of antigen was put into use. Findings include: 1. Record review conducted on 05/02/2023 of the laboratory's approved Syphilis Rapid Plasma Reagin (RPR) Test for Syphilis (Document ID P-MIC-026) procedure manual, revealed under section 6.4, "The antigen-dispensing needle is checked after a new needle or new lot of antigen is put into use." 2. Record review conducted on 05/02/2023 of the laboratory's approved Syphilis Rapid Plasma Reagin (RPR) Run Worksheet (Document ID: Micro 618E Rev. 0) revealed: "For each new lot of antigen and each new needle check needle drops per 0.5 mL 30 +/- 1 drop is acceptable." 3. Record review conducted on 05/02 /2023 of Syphilis Rapid Plasma Reagin (RPR) quality control (QC) records for the period of May 2022- May 2023 revealed no documentation that the antigen- dispensing needle was checked after antigen Lot #1032448 was put into use. 4. Staff interview with TS#2 on 05/02/2023 at 2:45 PM confirmed the findings above. 5. The laboratory performed 245 RPR tests annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on record review of 2022 and 2023 Tecan Freedom EVO Workstation preventive maintenance records and an interview with the laboratory Technical Supervisor (TS#3), the laboratory failed to document the Tecan Freedom EVO Workstation daily preventive maintenance procedures according to the laboratory's approved procedure instructions. Findings include: 1. Record review conducted on 05 /03/2023 of the Enzyme-linked Immunosorbent Assay (ELISA) Urine Drug Screen Using the Immunalysis/Tecan Freedom EVO Workstation approved procedure (Document ID: P-ORTOX-26, Revision 5) revealed daily instrument checks under the section 4.6.5 Instrument Preparation. 2. Record review conducted on 05/03/2023 revealed a lack of documentation confirming the daily instrument preparation checks were performed. 3. TS#3 confirmed on 05/03/2023 at 11:00 AM that the laboratory performed the daily instrument preparation checks, but did not document that they were performed. 4. The laboratory reported approximately 24,000 patient results annually during 2022. B. Based on record review of 2022 and 2023 GeneXpert System preventive maintenance records and interviews with the laboratory technical supervisors (TS#1 and TS#2), the laboratory failed to document the GeneXpert Systems daily preventive maintenance procedures according to the manufacturer instructions and the laboratory's approved procedure Findings include: 1. Record review conducted on 05/02/2023 of the GeneXpert Systems Operator Manual for systems SN# 84493 and SN# 810709, revealed manufacturer System Maintenance Tasks under Section 9.1 and System Maintenance Log under Section 9.2 (document 302-0528). 2. Record review conducted on 05/02/2023 of the GeneXpert CT/NG Assay Procedure (Document ID P-MIC-061) revealed under section 7.1 Preventive Maintenance and Backup, "Refer to the GeneXpert System Maintenance Log (Micro 658, Appendix I) for system maintenance schedules" 3. Record review conducted on 05/02/2023 of GeneXpert Systems Maintenance documentation (SN# 84493 and SN# 810709) for the period revealed the following documented system maintenance: 4. SN# 810709 for the period of January 2023 - April 2023: No quarterly system maintenance performed in 2023 No documentation of monthly system maintenance performed in April 2023, February 2023, and January 2023. No documentation of weekly system maintenance for the weeks of April 10, 18 & 26, 2023, March 2023, February 2023, and January 4 & 24, 2023. 5. SN# 844993 for the period of May 2022 - April 2023: No documentation of quarterly system maintenance for the period of 05 /2022-04/2023. No documentation of monthly system maintenance for April 2023, March 2023, February 2023, January 2023, July 2022, June 2022, and May 2022. No documentation of weekly system maintenance for the weeks of May 10, 2022, July 11 & 20, 2022, August 25, 2022, September 7, 2022, October 7, 2022, December 13, 2022, January 19, 2023, and March 1, 2023. 6. TS#1 and TS#2 confirmed the findings above on 05/02/2023 at 12:13 PM. 7. The laboratory reported approximately 1,200 patient GeneXpert results during 2022. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory director (LD) or technical supervisor (TS) failed to sign attestation statements documenting that proficiency testing (PT) samples were tested in the same manner as patient samples. Findings include: 1. Record review conducted on 06/16/2021 of 2020 and 2021 Urine Drug Testing and Chemical Terrorism PT records revealed the following: College of American Pathologists (CAP) 2020 Urine Toxicology (UT) PT attestation statements: a) UT-A 2020: LD or Designee signature missing, not signed. b) UT-C 2020: LD or Designee signature missing, not signed. Wadsworth Center Trace Elements PT attestation statement: a) Trace Elements 2020 Event 1: LD or Designee signature missing, not signed. CAP 2021 Urine Drug Adulterant/Integrity PT attestation statement: a) DAI-A 2021: LD or Designee signature missing, not signed. 2. Staff interview on 06/16/2021 at 10:45 am with the Urine Drug Testing Technical (TS1) and Chemical Terrorism Technical Supervisors (TS2) confirmed the above findings. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive 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 3 -- negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview with the Bacteriology Technical Supervisor (TS), the laboratory failed to document quality control (QC) for Oxidase, Catalase, Urea/PDA Discs, Gram Stain, and E. coli O157:H7 Latex Agglutionation Kit for the months of July 2019 through September 2019, Decemember 2020, and April 2020. Findings include: 1. Record review conducted on 06/16/2021 of 2019 and 2020 Bacteriology Quality Control Documentation Sheets (Micro 158. Rev.2 (5 /2013)) revealed no documented QC for the following reagents for the months of July 2019, August 2019, September 2019, December 2020, and April 2020: Oxidase Test (Performed each Week of Use), Catalase Test: (Perform Each Week of Use), Urea /PDA Discs: (Perform Each Day of Use), Gram Stain (Perform Each Week of Use), E. coli O157:H7 Latex Agglutination Kit: (Perform Each Day of Use). 2. Record review conducted on 06/16/2021 of Enteric Bacteriology Daily Worksheets- Plates (Micro 698 Rev. 5 (10/13)) revealed that patient samples were tested during the months of July 2019, August 2019, September 2019, December 2020, and April 2020. 3. Staff interview with the Bacteriology TS conducted on 06/16/2021 at 2:30 pm confirmed the above findings. 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: Based on record review of the Vermont Department of Health Laboratory (VDHL) Avioq Oral Fluid HIV-1 ELISA Standard Operating Procedure (SOP), VDHL Instructions for the Collection and Packaging of Orasure Oral Fluid Specimens for HIV-1 testing, Oral Fluid EIA HIV-1 test results, and interview with the Laboratory Director (LD), the laboratory failed to report specimens received greater than 21 days from the date of collection as Unsatisfactory for testing as stated in the VDHL Avioq Oral Fluid HIV-1 ELISA SOP and Collection and Packaging of Orasure Oral Fluid Specimens for HIV-1 Instructions. This is a repeat deficiency. Findings include: 1. Record review conducted on 06/15/2021 of the approved Avioq Oral Fluid HIV-1 ELISA SOP (P-MIC-133, Revision 3, Date Effective 08/27/19, Section 4.4 stated: "Criteria for specimen rejection: Specimens received at the VDHL more than 21 days after the date of collection. (Specimens verified to have been stored and shipped frozen may be acceptable even if received more than 21 days after the date of collection. Refer to the package insert.)" 2. Record review conducted on 06/15/2021 of the VDHL Instructions for the Collection and Packaging of Oral Fluid Specimens for HIV-1 stated under Collection of Specimen: a) "#12 Collected specimens may be stored at 4-37 C for a maximum of 21 days (including the time for shipping and -- 2 of 3 -- testing). Please ship as soon as possible, but within 14 days of collection, so that testing may be completed within the 21 days of collection." b) "The specimen may be rejected if specimens are greater than 21 days old." 3. Record review conducted on 06 /15/2021 of 684 HIV-1 Oral Fluid EIA test results of samples received from July 2019 to June 2021 revealed 4 test results were reported as "Nonreactive" and were received by the laboratory unfrozen and greater than 21 days from the sample collection date. Sample numbers included (20-061211-HIV-1), (20-009267-HIV-1), (20-031829-HIV- 1), and (19-000456-HIV-1). The review also revealed that 51 samples that were received by VDHL unfrozen and more than 21 days from the date of collection, but were reported as "Not Tested". 4. Interview with the LD on 06/15/2021 at 4:30 PM confirmed the findings above. -- 3 of 3 --

Summary Statement of Deficiencies D5517 MYCOLOGY CFR(s): 493.1263(a)(c) The laboratory must check each batch (prepared in-house), lot number (commercially prepared), and shipment of lactophenol cotton blue when prepared or opened for intended reactivity with a control organism(s). (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review of Mycology quality control (QC) records and staff interview with the Mycology Technical Supervisor (TS), the laboratory failed to check each batch and shipment of lactophenol cotton blue for intended reactivity prior to use for reporting patient results. Findings include: 1. Record review conducted on 05/21/2019 of Mycology QC records revealed no documentation confirming the laboratory tested each batch and shipment of lactophenol cotton blue for reactivity with control organisms prior to use. 2. Staff interview with the Mycology TS on 05/21/2019 at 4: 15 PM confirmed this finding. The interview further revealed that the lactophenol cotton blue was used by the laboratory to support the mycology testing identification process. 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 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 -- acceptability. This STANDARD is not met as evidenced by: A. Based on record review of the Vermont Department of Health Laboratory (VDHL) Cepheid GeneXpert Norovirus Real-Time RT- PCR Assay Standard Operating Procedure (SOP), Cephied GeneXpert Norovirus manufacturer instructions, Norovirus PCR test reports, and interview with Virology Technical Supervisor (TS), the laboratory failed to report positive and negative Norovirus PCR tests results according to the Cepheid GeneXpert Norovirus Real-Time RT- PCR Assay SOP and manufacturer instructions. Findings include: 1. Record review conducted on 05/22 /2019 of 3 Norovirus PCR test reports issued from 04/18/2019 through 05/06/2019 revealed 2 positive Norovirus PCR results for sample numbers (19VIR00114 and 19VIR00118) and 1 negative Norovirus PCR result for sample (19VIR00125). The review revealed Norovirus PCR results reported as "Positive" for samples 19VIR00114 and 19VIR00118 and "Negative" for sample 19VIR00125. 2. Record review conducted on 05/22/2019 of the approved Cephied GeneXpert Norovirus manufacturer instructions (301-2441, Rev. B January 2015) revealed in Section 15 Interpretation of Results, Table 1. Xpert Norovirus Assay Results: NORO GI DETECTED, NORO GII NOT DETECTED NORO GI NOT DETECTED, NORO GII DETECTED NORO GI DETECTED, NORO GII DETECTED NORO GI NOT DETECTED, NORO GII NOT DETECTED 3. Interview with the Virology TS on 05 /22/2019 at 10:00 AM confirmed these findings. B) Based on record review of the Vermont Department of Health Laboratory (VDHL) Avioq Oral Fluid HIV-1 ELISA Standard Operating Procedure (SOP), VDHL Instructions for the Collection and Packaging of Orasure Oral Fluid Specimens for HIV-1 and HIV-2, HIV-1 Oral Fluid EIA test results, and interview with the Diagnostic Immunology Technical Supervisor (TS), the laboratory failed to report specimens missing sample collection date and received greater than 21 days from the date of collection as Unsatisfactory for testing as stated in the VDHL Avioq Oral Fluid HIV-1 Eliza SOP and Collection and Packaging of Orasure Oral Fluid Specimens for HIV-1 and HIV-2 Instructions. Findings include: 1. Record review conducted on 05/22/2019 of 378 HIV-1 Oral Fluid EIA test results of samples received from 01/02/2019 to 05/20/2019 revealed 20 test results were reported as "Nonreactive" and missing date of collection. 2. Record review conducted on 05/22/2019 of the approved Avioq Oral Fluid HIV-1 ELISA SOP (P-MIC-133, Revision 2, Date Effective 06/21/2017, Section 4.4: "Specimen Rejection: Specimens to be rejected (c) received at VDHL unfrozen more than 21 days from the date of collection." 3. Record review conducted on 05/22/2019 of the VDHL Instructions for the Collection and Packaging of Oral Fluid Specimens for HIV-1 and HIV-2 stated under Collection of Specimen: a) "#13 Collected specimens may be stored at 4-37 C for a maximum of 21 days (including the time for shipping and testing). Please ship as soon as possible, but within 14 days of collection, so that testing may be completed within the 21 days of collection." b) "#14, "Fill out the Vermont Department of Health "Clinical Microbiology Request Form" (Micro 220) completely. The following information is required to ensure accurate and efficient processing of the specimen and reporting of test results: Date of Collection" c) "The specimen may be rejected if date of collection is missing on form and if specimens are greater than 21 days old." 4. Interview with the Diagnostic Immunology TS on 05/22 /2019 at 12:20 PM confirmed the findings above. 5. Record review conducted on 05 /22/2019 of 378 HIV-1 Oral Fluid EIA test results of samples received from 01/03 /2019 to 05/20/2019 revealed 18 test results were reported as "Nonreactive" and were received by the laboratory greater than 21 days from the sample collection date. Sample numbers ( 19-000807-HIV-1), (19-000803-HIV-1), (19-000808-HIV-1), (19- -- 2 of 3 -- 000809-HIV-1), (19-000804-HIV-1), (19-000805-HIV-1), (19-000806-HIV-1), (19- 002924-HIV-1), (19-002931-HIV-1), (19-002922-HIV-1), (19-002921-HIV-1), (19- 002929-HIV-1), (19-002920-HIV-1), (19-002919-HIV-1), (19-002186-HIV-1), (19- 001907-HIV-1), (19-001905-HIV-1), and (19-002928-HIV-1). -- 3 of 3 --