Louisiana Office Of Public Health Laboratory

Summary Statement of Deficiencies D0000 A recertification survey conducted November 18, 2025 through November 20, 2025. The laboratory was found in compliance with 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 review of the laboratory's policy, final test reports, and interview with the TS of Newborn Screening (NBS), the laboratory failed to follow its own policy for the turnaround time (TAT) of UNSAT (Unsatisfactory) specimens for 32 of 661 UNSAT specimens from January 1, 2025 to March 31, 2025 (random review). Findings Included: 1) Review of the laboratory's policy #4679 titled 'Louisiana Department of Health Office of Public Health Laboratory NBS Dried Blood Spot Specimen Sorting Protocol' revealed the following on page 4 of 5: "Unsatisfactory Sample Protocol I. Any submitter sending unsatisfactory samples to the lab will receive a fax and/or phone call from a NBS staff member on the day the sample is accessioned in the laboratory. -Facilities that have opted out of phone notifications: fax sent with unsatisfactory reason -Non-courier facilities: phone call with unsatisfactory information and fax if the fax number is available. -All other submitters: fax sent with unsatisfactory reason and phone call to confirm the fax was received. II. The NBS staff will record in the Add Notebook section in Neometrics - MSDS the date and time the submitting facility was contacted, to whom they spoke and the nature of the phone call. III. If the NBS staff is unable to speak with someone from the submitting facility on the day of the initial phone call then, they will make a follow-up call on the next business day. IV. If after a second call, the NBS staff is unable to speak with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- someone regarding the sample, a notation will be made in the Add Notebook section in Neometrics - MSDS and dated. In these instances, the NBS staff will notify the OPH Lab Medical Director with the sample information. V. The final lab report stating the sample was unsatisfactory will be released within 3 business days." 2. A random sample review of UNSAT final lab reports from January 1, 2025 to March 31, 2025 revealed 32 out of 661 UNSAT specimens failed to meet the laboratory's policy requirement of a three day TAT to the provider. 3. In an interview on November 20, 2025 at 10:54 AM in the NBS meeting room, the TS of NBS confirmed the findings of UNSAT lab reports sent beyond the laboratory's policy of a three business day TAT. Word Key: OPH - Office of Public Health (LA) TS - Technical Supervisor NBS - Newborn Screening MSDS - Material Safety Data Sheet TAT - Turnaround Time UNSAT - Unsatisfactory 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: I. Based on direct observation during a laboratory tour, review of room temperature records, review of the manufacturer's instructions for use (IFU), and an interview with the General Supervisor (GS) for specimen accessioning, the laboratory failed to define the proper storage temperature requirements for Aptima specimen collection kits and urine transport tubes consistent with the manufacturer's recommendation for 17 of 17 months. 1. During a tour of the laboratory's specimen accessioning storage room, A- 195, on 11/20/2025 at approximately 11:00 AM, the following collection kits and transport tubes were observed stored on open shelves: a. Aptima Multitest Swab Specimen Collection Kit Lot # 922105, Expiration Date: 12/31/2026 Quantity: 62 boxes (50 collection tubes per box) Temperature requirement printed on the kit: 15- 30C. b. Aptima Urine Specimen Transport Tube Lot #925911, Expiration Date: 07/31 /2027 Quantity: 54 boxes (50 transport tubes per box) Temperature requirement printed on the kit: 15-30C 2. A review of the room temperature log sheets for room A- 195 revealed the acceptable room temperature range was set at 10-35C from 07/2025 to 11/2025 (17 months). 3. A review of the IFU's for the Aptima collections kits revealed the following storage requirements: a. Aptima Multitest Swab Specimen Collection Kit Store collection kit at room temperature (15C to 30C) b. Aptima Urine Specimen Transport Tube Store urine specimen transport tubes at room temperature (15C to 30C) 4. During an interview on 11/20/2025 at approximately 11:05 AM, the General Supervisor for Specimen Accessioning confirmed the identified Aptima specimen collection kits and transport tubes were stored in room A-195 where the temperature log sheets from 07/2024 to 11/2025 had an acceptable room temperature range between 10-35C. 47107 II. Based on direct observation, review of the laboratory's policy, temperature records, test volumes, and interview with the Technical Supervisor (TS) of the Newborn Screening Section (NBS), the laboratory failed to monitor and document temperatures for 2 of 2 Inheco Shaker/Incubators -- 2 of 5 -- during testing of T-cell receptor excision circles (TREC) for the screening of Severe Combined Immunodeficiency (SCID). Findings Included: 1) During a tour of the laboratory on November 18, 2025 at 9:15 AM, two Inheco Shaker/Incubators (Serial Numbers #5143 & #5638) were observed in use within Room A107 of the NBS SCIDS testing area. 2) Review of the laboratory's policy #7724 titled 'Louisiana Department of Health Office of Public Health Laboratory TREC and SMN1 Testing Using NeoMDx and QuantStudio Dx' revealed the following on page 5 of 17: "15. Remove the plate from the Integra. Incubate and shake the plate for 8 minutes on the Inheco shaker at 25 degrees C (+/- 2 degrees C) and 700 rpm (+/- 100 rpm)... 18. Place the plate on the Inheco shaker and change the temperature setting to +70 degrees Celsius. 19. Once the shaker temperature reaches +70 degrees Celsius (+/- 2 degrees C), remove the plate and place on the Integra Pipettor. 20. Return plate to the +70 (+/- 2 degrees C) Inheco shaker and shake for 30 minutes at 700 rpm (+/- 100 rpm). 21. Stop the shaker and change the temperature settings to 25 degrees Celsius. Let the plate cool down to at least +35 degrees Celsius on the shaker..." 3) Review of the laboratory's temperature records revealed no documentation or monitoring of temperatures for the Inheco shaker/incubators. 4) Review of the laboratory's test volumes revealed an annual test volume of 46,375 for TREC. 5) In an interview on November 20, 2025 at 9:34 AM, in the NBS meeting room, the TS of NBS confirmed the findings the laboratory did not have a mechanism to document and monitor temperatures of the two Inheco shaker/incubators. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on direct observation during a laboratory tour, review of the manufacturer's instructions for use (IFU), review of the 2019 verification of performance for the Gold Standard Diagnostics(GSD) AIX1000 Rapid Plasma Reagin (RPR), an interview with the Sexually Transmitted Infections (STI) Testing Personnel (TP) and Technical Supervisor (TS), the laboratory failed to verify performance specification of the GSD AIX1000 RPR automated test system when utilizing the retry sample option for insufficient sample volume for one of one AIX1000 automated test system. 1. During a tour of the laboratory's RPR room, B105.02, on 11/20/2025 at approximately 1:30 PM, the following instrument was observed, used for Automated RPR testing. Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin Automated Test System Serial Number: 181267-119AG 2. A review of the GSD AIX1000 RPR automated test system IFU revealed a warning for the "retry sample" option available for insufficient sample volume. Although the option was available in the AIX1000 software, the feature had not been evaluated by the manufacturer. 3. In an interview on 11/20/2025 at approximately 1:35 PM, the STI TP was asked to describe the process in resolving -- 3 of 5 -- an insufficient sample volume when using the GSD AIX1000 RPR automated test system. The STI TP stated in cases when insufficient sample volume is suspected, the system will give an error message on the instrument screen with an option to retry sample. The option to retry is selected and that resolves the error message and the testing proceeds. If the same error message occurs on the retry, the sample is not test and is reflected in the final test report as not tested due to insufficient sample volume. 4. A review of the 2019 verification of performance specification for the GSD AIX1000 RPR automated test system revealed verification of performance specific to the use of the retry sample due to insufficient sample volume was not completed. 5. In a telephone interview on 11/24/2025 at approximately 2:45 PM, the STI TS confirmed the verification of performance specification completed in 2019 for the GSD AIX1000 RPR automated test system did not include the verification of performance specific to the use of the retry sample option for insufficient sample volumes. 6. Annual test volume for Syphilis = 13,791 D5783

Summary Statement of Deficiencies D0000 Complaint Investigation 4/4/2023 to 4/6/2023: The complaint was found unsubstantiated with no deficiencies cited. 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 review of the laboratory's procedure, laboratory's cutoff data documents, and interview with the Technical Supervisor, the laboratory failed to follow their procedure for their yearly review of adjusting and/or calculating new Newborn Screening cutoff points for 2021 to the date of the survey as evidenced by: 1. In review of the laboratory's procedure, titled "Procedure for Monitoring Cuttoff Values for Newborn Screening Neonatal Assay" states, "The data set will be monitored by continuously expanding the data range of samples analyzed to be inclusive of all data analyzed since the establishment of the new cutoff values. The data set is monitored monthly for up to one year; thereafter, the dataset will be reevaluated on a yearly basis." 2. In review of the laboratory cutoff data documents, for the following newborn screening assays, the laboratory did not review or recalculated the cutoffs for each assay on a yearly basis. a. C14:1 reviewed on 2/23/2018 b. C16 + C18 reviewed on 8/27/2018 c. CO/ (C16 + C18) reviewed in 2015 d. C3 reviewed in 2015 e. C3/C2 reviewed in 2015-2016 f. C3DC C4OH reviewed in 2015-2016 g. C4 reviewed in 2015-2016 h. C5 reviewed in 2015-2016 i. C5/C3 reviewed in 2015-2016 j. C5:1 reviewed in 2015-2016 k. C5DC_C6OH/C8 reviewed in 2015-2016 l. C8 reviewed in 2015-2016 m. C10 reviewed in 2015-2016 n. C10:1 reviewed in 2015-2016 o. C10:2 reviewed in 2015-2016 p. C8/C10 reviewed in 2015-2016 q. C14:1 reviewed in 2015- 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 -- 2016 r. C14:1/ C12:1 reviewed in 2015-2016 s. C14:2 reviewed in 2015-2016 t. C18:1 reviewed in 2015-2016 u. Ala reviewed on 11/27/2017 v. Arg reviewed in 2015-2016 w. Arg/Orn reviewed in 2015-2016 x. Val reviewed in 2015-2016 y. Cit reviewed in 2015-2016 z. Cit/Arg reviewed in 2015-2016 aa. Leu reviewed in 2015-2016 bb. Leu /Ala reviewed in 2015-2016 cc. Leu/Phe reviewed in 2015-2016 dd. Met/Phe reviewed in 2015-2016 ee. SUAC reviewed in 2015-2016 3. In interview with the Technical Supervisor on 4-6-2023 at 1348, he stated that the laboratory had not looked at the assays cutoffs annually and that it had been several years since they reviewed them. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP), quality control (QC) records, patient instrument reports, final patient reports, and interview with the Technical Supervisor(s), the laboratory failed to follow its IQCP for the BioFire FilmArray Gastrointestinal panel (GI) for 6 of 6 months from February 2022 through March 2023. Findings included: a. A review of the laboratory's Individualized Quality Control Plan (IQCP) for the Biofire GI Assay revealed, " ... external surrogate sample controls will continue to be performed for each new lot number or shipment of test materials or every 31 days, whichever is more frequent." b. The laboratory had four BioFire Film Array instruments used for testing (Serial Numbers (SN): 2FA02477, 2FA02652, 2FA05764, and 2FA05947) and their QC program required the following control material be performed on the BioFire Film Array instrument: External Control Maine Molecular Quality Controls, Inc (MMQCI) M239 which detected the following: Clostridium difficile toxin A/B, Plesiomonas shigelloides, Vibrio, Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Shigella /Enteroinvasive E. coli (EIEC), Cryptosporidium, Adenovirus, F 40/41, Sapovirus. MMQCI M240 which detected the following: Campylobacter, Salmonella, Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) It/st, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Astrovirus, Norovirus GI/GII, Rotavirus A. External Control Blank (Uninoculated Cary-Blair media). No organisms detected. Campylobacter, Clostridium difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio, Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic E. coli (ETEC) It/st, Shiga-like toxin-producing E. coli (STEC) stx1/stx2, Shigella/Enteroinvasive E. coli (EIEC), Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia, Adenovirus, F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, Sapovirus. c. Review of patient results from February 2022 through March 2023, revealed the laboratory failed to perform all external surrogate control (per their IQCP) on each instrument prior to analysis and reporting of patient final results, as follows: Date: 02 -- 2 of 3 -- /02/2022 BioFire SN: 2FA02477; The laboratory failed to perform external control blank, M239, and M240 QC. Patient Sample ID#: N22013072 was analyzed and reported on 02/25/2022. BioFire SN: 2FA05764; The laboratory failed to perform external control blank and M239 QC. Patient Sample ID#: N22013074 was analyzed and reported on 02/25/2022. BioFire SN: 2FA05947; The laboratory failed to perform external control blank and M240 QC. Patient Sample ID#: N22013075 was analyzed and reported on 02/25/2022. Date: 02/03/2022 BioFire SN: 2FA02652; The laboratory failed to perform M239 and M240 QC. Patient Sample ID#: N22013073 was analyzed and reported on 02/25/2022. Date: 04/28/2022 BioFire SN: 2FA02477; The laboratory failed to perform external control blank, M239, and M240 QC. Patient Sample ID#: N22026617 was analyzed on 04/28/2022 and reported on 04/29/2022. Patient Sample ID# N22026113 was analyzed and reported on 04/28/2022. Date: 06 /20/2022 BioFire SN: 2FA05947; The laboratory failed to perform external control blank and M239 QC. Patient Sample ID#: N22036745 was analyzed on 06/20/2022 and reported on 06/23/2022. Date: 08/01/2022 BioFire SN: 2FA02652; The laboratory failed to perform M239 and M240 QC. Patient Sample ID#: N22039965 was analyzed 08/01/2022 and reported on 10/10/2022. BioFire SN: 2FA05764; The laboratory failed to perform external control blank and M239 QC. Patient Sample ID#: N22043998 was analyzed on 08/01/2022 and reported on 10/03/2022. Date: 12 /01/2022 BioFire SN: 2FA02477; The laboratory failed to perform external control blank and M240 QC. Patient Sample ID#: N22069273 was analyzed and reported on 12/01/2022. Patient Sample ID#: N22071298 was analyzed and reported on 12/09 /2022. BioFire SN: 2FA02652; The laboratory failed to perform M239 and M240 QC. Patient Sample ID#: N22071299 was analyzed and reported on 12/09/2022. Date: 03 /23/2023 BioFire SN: 2FA02652; The laboratory failed to perform M239 QC. Patient Sample ID#: N23019218 was analyzed and reported on 03/23/2023. Date: 03/28 /2023 BioFire SN: 2FA02652; The laboratory failed to perform external control blank QC. Patient Sample ID#: N23019964 was analyzed and reported on 03/28/2023. BioFire SN: 2FA05947; The laboratory failed to perform M239 and M240 QC. Patient Sample ID#: N23019966 was analyzed and reported on 03/28/2023. Patient Sample ID#: N23019965 was analyzed and reported on 03/28/2023. The laboratory did not include M239, M240, and External Control Blank on each BioFire instrument (every 31 days) prior to patient testing. d. An interview on 04/06/2023 at 9:20 AM in conference room B201 with Technical Supervisors 1 and 2, as listed on the CMS-209, confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Federal Jurisdictional Recertification Survey The laboratory is in compliance with the CLIA regulations with standard level deficiencies cited. 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 rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on manufactures package insert, a review of policies and procedures, and interview with staff the laboratory failed to ensure their written policies were consistent with the manufacturer storage requirements for HAVAB samples. a. A review of the Architect System HAVAB-M (G6-5290/R05), page 3, revealed "Specimen Collection and Preparation For Analysis ...Storage: Specimens may be stored ...up to 3 days at room temperature (study performed at 21-30C)". b. A review of the Architect System HAVAB-G (G4-5668/R03), page 3, revealed "Specimen Collection and Preparation For Analysis ...Storage: Specimens may be stored ...up to 4 days at room temperature." c. A review of the laboratory's procedure Standard Operating Procedure HAVAB-M (Qualtrax ID: 6125, Revision: 3) published 06/28 /2021 pages 2-3, revealed "Specimen Information" revealed no room temperature storage criteria. d. A review of the laboratory's procedure Standard Operative Procedure HAVAB-G (Qualtrax ID: 7480, Revision 2) published 06/21/2021, page 2, revealed "Specimen Information ...Specimen stability and storage requirements ... Store and ship at room temperature for up to 4 days." The laboratory did not define range for room temperature storage. e. General Supervisor 3 provided the laboratory's 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 -- Room Temperature and Humidity Requirements form that included "Department: Virology/Serology ...Room #: B105.04 ...Acceptable Temperature Range for this Room/Location: 15-30C." The range was inconsistent with manufacturer's requirements for Architect System HAVAB-M (21-30C). f. An interview with Testing Personnel 11 (see CMS-209 form) on 06/30/2021 at 10:32 AM revealed the laboratory's HAVAB testing volume is approximately 1 sample every 3 weeks. g. An interview with General Supervisor 3 (see CMS-209 form) on 07/01/2021 at 1:52 PM confirmed the findings. *Acronyms: HAVAB= Hepatitis A Virus, HAVAB- M=Hepatitis A Virus Antibody Immunoglobulin M, HAVAB-G= Hepatitis A Virus Antibody Immunoglobulin G, C=degree Celsius. 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 manufacturer's instructions, review of policies and procedures, and interview with staff the laboratory failed to ensure calibration material for the BD MGIT 960 was not used when it had exceeded the expiration date. a. A review of BD BACTEC MGIT User Manual (Revision 16, Version G) page 93 revealed "6.2.2.2 Calibrator Replacement ...Calibrator tubes ...must be replaced prior to their expiration." b. A review of the laboratory's Opportunity For Improvement (OFI) Form revealed the following: 1. OFI # 1901020: "During a PM performed on the BACTEC MGIT 960 (SN#MG4032) by a BD Service Representative on 1/8/2019, the service representative noted that the onboard MGIT calibrators (Lot#: 6266913/Exp: 9/12 /2018) were expired. This expired lot of calibration tubes was used by the instrument to perform hourly calibration checks from 9/22/2018 through the date that the expired calibrators were replaced on 1/14/2019." 2. OFI # 2011022: "On 11/13/2020 the calibrators onboard the BD MGIT 960 expired." c. A review of the laboratory procedure Digestion, Decontamination, Smear Preparation Media Inoculation (Qualtrax ID: 4233, revision 5) published 05/07/2021, page 3, revealed "Quality Control1.b.Positive Control ...This control may also be run daily in parallel with the negative process control in the event that an expired calibrator is in use onboard the BD MGIT 960 ...." d. An interview with the Laboratory Director on 07/01/2021 at 11: 00 AM confirmed the laboratory used expired calibrators. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials -- 2 of 4 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation, a review of quality control data, and interview with staff, the laboratory failed to establish acceptable quality control criteria for the Treponema Assay (Syphilis): Syphilis IgG/IgM assay performed on the Diasorin for 6 of 6 lots number (11/2019 through 07/2021). a. On 06/30/2021 at 10:32 AM in Virology the Survey observed 2 Diasorin instruments (Serial Numbers 2210003400 and 2210003534). b. A review of the Syphilis Control QC Using Historical Standard Deviation forms from 11/08/2019 to 07/01/2021 revealed the laboratory established a single "shared" mean based on data point from both instruments. c. A review of the Syphilis LJ Monitoring Chart forms from 11/08/2019 to 07/01/2021 revealed the laboratory monitored quality control for both instruments against an established "shared" mean and showed each instrument had a distinct bias. d. In interview with the Virology Technical Supervisor and the General Supervisor 3 (see CMS-209 form) on 07/01/2021 at 2:24 PM confirmed the laboratory's method for establishing and evaluating Syphilis quality controls, the current method does not allow for instrument bias, and the laboratory's total test volume from 11/08/2019 to 7/1/2021 was 28,685. 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 review of 10 patient test reports, the laboratory's policy, manufacturer's instructions, interview with the laboratory director and quality assurance specialist, the laboratory failed to follow manufacturer's instructions and their policy for reporting EUA APTIMA SARS CoV-2 patient test results in April ,May, June 2021 as evidenced by: 1. According to manufacturer's instructions pg 22 under Interpretation of Results, a table is provided which outlines how test results should be reported on the final report. Based on this table, it states "SARS-CoV-2 result neg or POS" 2. In review of the laboratory's policy titled, "Aptima SARS CoV-2 on Panther" a table is provided which outlines how test results should be reported on the final report. Based on this table, it states "SARS-CoV-2 result neg or POS" 3. In review of the following 10 patient test reports, the laboratory did not report the actual result of the test as either neg or POS as stated in their policy and manufacturer's instructions. 1. received on 5/2/2021 patient #332552 2. received on 5/4/2021 patient #340330 3. received on 5 /12/2021 patient #3378026573 4. received on 5/14/2021 patient #36638 5. received on 6/14/2021 patient #4720 6. received on 4/21/2021 patient #213208029 7. received on 4 /14/2021 patient #59872 8. received on 4/26/2021 patient #6913 9. received on 6/2 /2021 patient# LA2020729310 10. received on 6/9/2021 patient # 337895 4. In interview with both the Laboratory Director and Quality Assurance specialist on 6/30 -- 3 of 4 -- /2021 @ 1313 stated that they were unaware of the manufacturer's requirements. The also believe the policy was reflective of the manufacturer's instructions. They did not know that they had to also report out neg or POS on the patient test report. -- 4 of 4 --