Florida Dept Of Health Bureau Of Public Health Lab

Summary Statement of Deficiencies 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 observation, policies and procedures, record review, and interview with technical supervisor #10 (TS #10), the laboratory failed to follow written laboratory procedures for one of one QC (Quality Control) lot change. Findings include: 1. Direct observation on 03/27/25 at 12:55 pm during a laboratory tour, revealed the laboratory performed the molecular detection of drug resistance in Mycobacterium tuberculosis complex using the Deeplex assay (Next Generation Sequencing). 2. Review of the laboratory's written policies and procedures titled, "Molecular Detection of Drug Resistance in Mycobacterium tuberculosis complex with the Deeplex Assay" section, "VIII. Quality Control/Quality Assurance" stated the following: a. "e. Prior to use of a new lot of Deeplex Myc-TB reagents, the reagents will be compared to the previous lot by testing one previously assayed sample." 3. Record review on 03/27/25 of lot changes documented on the "Deeplex Worksheet" from 01/06/25 through 01/31/25 revealed no evidence the laboratory compared the new lot (Lot# 241209DP46 - put into place on 01/31/25) to the previous lot (Lot# 231212DP41 - put into place on 01/06/25). 4. Interview on 03/27/25 at 03:15 pm with TS #10 confirmed the findings above. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (a) Test systems must be selected by the laboratory. The testing must be performed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, review of the laboratory's policy, email from General Supervisor #9 (GS) and interviews with GS #9 (GS) and Technical Supervisor (TS) #4, the laboratory failed to follow manufacturer's instructions and the laboratory's policy with Abbott Architect HIV, AG/AB and Abbott Architect Anti-HCV Assays for the second recentrifugation of specimens for 2025 as evidenced by: 1. Based on review of the manufacturer's instructions for Abbott Architect HIV, AG/AB states, "To ensure consistency in results, specimens must be transferred to a centrifuge tube and centrifuged at >10,000 RCF (Relative Centrifugal Force) for 10 minutes before testing if they: Contain Fibrin, red blood cells, or other particulate matter or were frozen and thawed. " Based on review of the manufacturer's instruction for Abbott Architect Anti-HCV states, "To ensure consistency in results, specimens must be transferred to a centrifuge tube and centrifuged at >10,000 RCF (Relative Centrifugal Force) for 10 minutes before testing if they: Contain Fibrin, red blood cells, or other particulate matter or were frozen and thawed " 2. In review of the laboratory's two policies titled: Abbott Architect HIV, AG /AB and Abbott Architect Anti-HCV Assays, both state the following: "To ensure consistency in results, specimens must be transferred to a centrifuge tube and centrifuged at >10,000 RCF (Relative Centrifugal Force) for 10 minutes before testing if they: Contain Fibrin, red blood cells, or other particulate matter or were frozen and thawed." 3. In review of the GS #9 email sent on March 26,2025 at 1112 titled Immediately Cease Second Centrifugation directed at all serology staff states "Please do not second spin samples for the Hepatitis bench until further notice. If you have a sample that warrants recentrifugation per manufacturer's recommendations, please pour off before recentrifuging. The PI is attached for reference". 4. In interview with GS #9 on March 26,2025 at 1046 she stated that they recentrifuge all specimens with the primary tube and do no transferred in a centrifuge tube if it meets the criteria i.e. any clots. 5. In interview with TS #4 on March 26, 2025 at 1413 he confirmed that the HIV AB/AG was also not following manufacturer's instructions when recertifugation was warranted. 6. The laboratory performed 14,631 Anti-HCV annnually and 59,818 HIV AB/AG annually. 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 the observation of the media laboratory, lack of temperature records, and interview with the media preparation room personnel, the laboratory failed to -- 2 of 6 -- document the condition of storage for biological chemicals stored in the media laboratory for 21 out of 21 months (July 17, 2023, to March 27, 2025). Findings Included: 1. Observation of the media laboratory revealed, the following sampling (13 bottles) of biological chemicals labeled with storage conditions: a. 1 of 1 bottle of OXOID Bacteriological Peptone, Lot#3530167, expiration date: 2027/09, stored at: 10C - 30C. b. 1 of 1 bottle of OXOID CM0115 Simmons Citrate Agar, Lot#3450933, expiration date: 2027/03, stored at: 10C - 30C. c. 1 of 1 bottle of OXOID CM0119B Charcoal Agar, Lot#3513916, expiration date: 2027/07, stored at: 10C - 30C. d. 1 of 1 bottle of OXOID SS Agar, Lot#3642868, expiration date: 2027/07, stored at: 10C - 30C. e. 1 of 1 bottle of OXOID CM0007 MacConkey Agar, Lot#3566108, expiration date: 2027/10, stored at: 10C - 30C. f. 1 of 1 bottle of BD Peptone, Lot#4207141, expiration date: 2028-03-28, stored at: 2C - 25C. g. 1 of 1 bottle of BD Casitone, Lot#2024882, stored at: 2C - 25C. h. 1 of 1 bottle of BD Difco Cooked Meat Agar, Lot#3277640, expiration date: 2026-08-10, stored at: 2C - 25C. i. 1 of 1 bottle of BD Difco Cystine Agar, Lot#1153608, expiration date: 2026-05, stored at: 2C - 25C. j. 1 of 1 bottle of BD Difco Malonate Broth, Lot#4003561, expiration date: 2025-11-30, stored at: 2C - 25C. k. 1 of 1 bottle of BD BBL Motility Test Medium, Lot#2298713, expiration date: 2026-10-31, stored at: 2C - 25C. l. 1 of 1 bottle of BD BBL Litmus Milk, Lot#2214358, expiration date: 2026-05-31, stored at: 2C - 25C. m. 1 of 1 bottle of Remel GC Agar Base, Lot#814254, expiration date: 2028-06-20, Store tightly closed in a dry place below 30C. 2. The laboratory could not provide documentation for monitored temperature in the media laboratory. 3. An interview with the media preparation room personnel on March 26, 2025, at 2:30 pm, confirmed temperatures were not monitored in the media room from July 2023 to March 2025. Key: Celsius - C. II. Based on manufacturer's instructions, observation, record review, and interview with technical supervisor #2 (TS #2), the laboratory failed to store the TruSight Cystic Fibrosis Library Prep kit according to manufacturer's instructions for three of three months. The laboratory failed to document the temperature for three of three months for the electric slide warmer used in the detection of mycobacteria. Findings include: A. NEWBORN SCREENING (NBS) - TRUSIGHT CYSTIC FIBROSIS LIBRARY PREP KIT: 1. Review of manufacturer's instructions on 03/25/25 titled "TruSight Cystic Fibrosis Package Insert" (page 10) section "TruSight Cystic Fibrosis Library Prep, Box 1" states, "Box 1 reagents are shipped frozen and are stable when stored at -25C to -15C." 2. Observation on 3/26/25 at 10:55 am of the WVR Freezer (location HY33402 and serial# SYM-WB51857053-1508) revealed three boxes of TruSight Cystic Fibrosis Library Prep kit (Lot# A179518) with a manufacturer's storage requirement of -25C to -15C. 3. Record review of WVR freezer temperature records (location HY33402 and serial# SYM-WB51857053-1508) from 01/02/25 through 03 /26/25 revealed the following: a. January 2025 - 11 of 23 documented temperatures colder than -25C (specific days 8,9,15,16,18,21,24,24,29,30,31) b. February 2025 - 3 of 23 documented temperatures colder than -25C (specific days 5,20,27) c. March 2025 - 9 of 21 documented temperatures colder than -25C (specific days 13,14,18,19,20,21,22,25,26) 4. Interview with TS #2 on 03/26/25 at 11:05 confirmed the findings above. B. TUBERCULOSIS (TB) - ACID-FAST STAIN PROCEDURE FOR MYCOBACTERIA: 1. On 03/27/2025, review of the laboratory' procedure, titled, "Acid-Fast Stain Procedures for Mycobacteria Standard Operating Protocol" section "VII. Sample Requirements:" stated the following: a. "1. Concentrated or unconcentrated specimens (use auramine O staining method and Ziehl-Neelson for confirmation). Read and report smears with each batch of AFB specimens processed." b. Page 4, ..."f. Transfer the air-dried slide to an electric slide warmer (85 degree centigrade) for an additional 15 minutes, at which time the slide can be removed for staining." 2. Review of the laboratory's environmental monitoring logs from January 2025 through March 2025 revealed the laboratory did not monitor and document the -- 3 of 6 -- electric slide warmer for three of three months. 3. Interview on 03/27/25 at 02:00 pm with technical supervisor #10 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. This STANDARD is not met as evidenced by: Based on observations of chemicals and interviews with Technical Supervisors (TS) #5 and the media preparation personnel, the laboratory failed to label clinical chemicals with expiration dates in two of the four laboratories observed. Findings Included: 1. On March 26, 2025, at 10:45 a.m., observation of the media laboratory revealed one bottle of Acros Organics Pyridoxal hydrochloride (HCL), Lot#A036352, received October 19, 2016, no expiration date. 2. On March 27, 2025, at 3:41 pm, observation of the microbiology laboratory revealed 2 of 2 bottles of iodine did not have expiration dates: a. Fisher Potassium Iodine, Lot#942646, Received August 18, 2011. b. Fisher Chemical Iodine, Lot#934812, Received October 18, 1993. 3. An interview with the media preparation personnel on March 26, 2025, at 11:00 a.m confirmed the Pyridoxal hydrochloride used to make Orthana Arginine media was not labeled with an expiration date. 4. An interview with TS#5 on March 27, 2025, at 4:00 pm, confirmed the potassium iodide and stock iodine bottles used for microscopic parasite examinations were not labeled with an expiration dates. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the intestinal Ova & Parasites (O&P) standard operating procedure (SOP), lack of centrifuge maintenance documentation, and interview with technical supervisor (TS) #5, the laboratory failed to document centrifuge function checks for one of one Centra GP8R centrifuge used to spin down intestinal O&P specimens. Findings Included: 1. The Intestinal O&P SOP, 2. Intestinal O&P Prep Protocol, i, states, "Centrifuge tubes for three minutes at 2000 RPM and allow to come to a full stop". 2. On March 27, 2025, at 11:35 am, the laboratory could not provide documentation of centrifuge function checks for 1 of 1 IEC Centra GP8R centrifuge used to spin down intestinal O&P specimens. 3. From January 1, 2024, to March 26, 2025, 1,457 intestinal specimens' specimen were examined. 4. An interview with TS#5 on March 27, 2025, at 11:45 am, confirmed the IEC Centra GP8R centrifuge function checks were not perfromed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 4 of 6 -- (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: I. Based on a review of the Biofire Torch Respiratory Panel (RP2.1) quality control (QC) records and interview with technical supervisor (TS) #8, the laboratory failed to perform two external controls each day of patient testing for the Biofire RP2.1 for 21 out of 21 months (July 2023 to March 2025). Findings Included: 1. On March 27, 2025, at 2:20 p.m., the laboratory could not provide documentation of external QC performed each day specimens were analyzed with the RP2.1 panel from July 15, 2023, to March 27, 2025. 2. The laboratory could not provide an individualized quality control plan for the frequency of QC performed for the RP2.1 panel used from July 15, 2023, to March 27, 2025. 3. From July 15, 2023, to March 27, 2025, 171 specimens were analyzed with the Biofire RP2.1 panels. 4. An interview with TS#8 on On March 27, 2025, at 2:30 pm, confirmed QC was not performed each day of patient testing. II. Based on observation, record review, and interview with technical supervisor #10 (TS #10), the laboratory failed to perform QC (Quality Control) as stated in the laboratory's IQCP (Individualized Quality Control Plan) for six of ten months (06/17/24 through 03/03/25). Findings include: 1. Direct observation on 03/27 /25 at 12:45 pm during a laboratory tour, revealed the laboratory performs the detection of Mycobacterium tuberculosis complex and its resistance to rifampin using the GeneXpert analyzer. 2. Interview on 03/27/25 at 2:00 pm with TS #10 confirmed an IQCP was approved by the laboratory director on 06/16/2022. 3. Record review of the laboratory's QCP (Quality Control Plan) stated, "Three levels of external controls (one negative control, one wild type M. tuberculosis complex DNA, and one MDR M. tuberculosis complex DNA) will be tested as follows: with each new lot or shipment of MTB/RIF cartridges, at least once monthly, after system maintenance or PM, after software upgrades, and after instrument relocation." 4. Record review of QC between 06/07/24 through 03/03/25 revealed the laboratory failed to perform external QC for six of ten months as follows: a. External QC not performed between 06/07/25 and 08 /20/24 b. External QC not performed between 08/20/25 and 12/18/25 c. External QC not performed between 12/18/25 and 03/03/25 5. Interview on 03/27/25 at 2:20 pm with TS #10 confirmed the findings above. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on a review of the Giemsa Plus Stain for Blood and Tissue Parasites standard operating procedure (SOP), lack of quality control documents, and interview with technical supervisor (TS) #5, the laboratory failed to document blood parasite quality control (QC) for 123 of 123 specimens examined from July 2023 to March 2025. -- 5 of 6 -- Findings Included: 1. The Giemsa Plus Stain for Blood and Tissue Parasites SOP states, VIII. Quality Control, "All lots numbers of Giemsa Plus stain set have been tested using the QC Slide Malarial Blood slide and are acceptable." 2. On March 26, 2025, at 3:50 pm, the laboratory was able to provide documentation of QC performed for the blood parasite microscopic examination for 123 specimens examined from July 2023 to March 2025. 3. An interview with TS#5 on March 26, 2025, at 4:00 pm confirmed QC was not documented for blood parasite microscopic examination. 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 observation, record review, and interview with technical supervisor #10 (TS #10), the laboratory failed to perform comparison studies on eight different BioRad Variant 250 HPLC (High-Performance Liquid Chromatography) analyzers used to perform hemoglobinopathies variants at least twice a year for one of one year (2024). The laboratory failed to perform comparison studies on two different BD Max analyzers used to perform Mycobacterium tuberculosis complex testing at least twice a year for one of one year (2024). Findings include: A. NEWBORN SCREENING (NBS) - BIORAD VARIANT 250 HPLC ANALYZERS: 1. Direct observation on 03 /27/25 at 12:40 pm during a laboratory tour, revealed the laboratory performs Mycobacterium tuberculosis complex testing using two BD Max analyzers interchangeably: a. BD Max - serial #CT0578 b. BD Max - serial #CT1519 2. Record review on 03/27/25 from January 2024 through December 2024 revealed one comparison study (performed on 06/19/24). 3. Interview on 03/27/25 at 1:00 pm with TS #10 confirmed the laboratory performed one comparison study between January 2024 through December 2024. B. TUBERCULOSIS (TB) - BD MAX ANALYZERS: 1. Direct observation on 03/26/25 at 10:15 am during a laboratory tour, revealed the laboratory performs hemoglobinopathies (Types A, F, C, D, E, S) on eight different BioRad Variant 250 HPLC analyzers. 2. On 03/26/25 a request for comparison studies between the analyzers from January 2024 through December 2024 revealed no evidence a comparison study was performed at least twice a year for one of one year (2024). 3. Interview on 03/26/25 at 11:40 am with TS #2 confirmed the above findings. -- 6 of 6 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on direct observations, review of manufacturer's instructions, and interview, the laboratory failed to follow manufacturer's instructions for the Aptima Combo 2 Assay (panther system) for cross contamination during the March 2022 revisit as evidenced by: 1. In review of the manufacturer's instructions for Aptima Combo 2 Assay (panther system) pg 5 General information states, "Avoid-contamination during the specimen handling steps. Specimens can contain extremely high level of organisms. Ensure that specimen containers do not contact one another, and discard used materials without passing over open containers..." 2. In direct observation on 3-29- 2022 @1005, the following patients were observed together touching each other in a plastic biohazard bag: a. Patient #3610130932 (urine tube) b. Patient #3610130935 (urine tube) c. Patient #31610130929 (urine tube) 3. In direct observation 3-29-2022 @1007, there were 45 urine specimens from Orange County that were stuffed touching each other in one metal cylinder shipping container shipped FedEX 4. In direct observation on 3-29-2022 @1009, laboratory personnel were opening the packaged metal cylinder shipping containers, and placed hundreds aptima urine tubes in a white bucket (the urine tubes were touching each other) before going to the department for testing. 4.. In interview with the Quality Control officer on 3-29-2022 @1010, stated that she were not aware that the Aptima's could not touch each as per the manufacturer's instructions. 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 D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based review of the laboratory's policies, manufacturer's instructions, laboratory records, and interview with laboratory staff, the laboratory failed to meet to meet the requirements for preanalytic systems as evidenced by: 1.The laboratory failed to follow their own policies for their specimen acceptability criteria and to ensure specimen integrity in the preanalytic system (see D5311-A). 2. The laboratory failed to follow their written policy for transport requirements established for mycobacteriology specimens for 19 of 40 specimens received in the laboratory (see D5311-B). 3. The laboratory failed to make available a electronic or paper manual for their clients and have up to date information on specimen storage, specimen acceptability/ rejection and specimen preservation (see D5317) 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 7 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's policies, manufacturer's instructions, laboratory records, and interviews with the laboratory staff, the laboratory failed to follow their own policies for their specimen acceptability criteria and to ensure specimen integrity in the preanalytic system as evidenced by: SARS-CoV-2 specimens In review of the laboratory's policy Detection of influenza and SARS-CoV-2 by a real-time RT PCR Multiplex Assay states, "store specimens at 2-8 degrees and ship overnight on ice packs ..." In review of the manufacturer's instructions for Influenza SARS-CoV-2 Multiplex assay states, "store specimens at 2-8 degrees and ship overnight on ice packs ... " In review of the laboratory's policy SOP 2.1.2 Unsatisfactory specimens state, "Specimen should be rejected under the following conditions: improper collection storage, or transport of sample." In review of the laboratory's excel spreadsheet labeled, "Bureau of Public Health Laboratories Test Catalogue" the laboratory did not have SARS-CoV-2 tests listed. It did not include the conditions of transport in the document. This document was presented to the surveyor as their client service manual effective 9/6/2019. In review of the Florida Department of Health After Hours Specimen Delivery log, the following SARS-CoV-2 specimens were marked as no under the column "is refrigeration required" 6-05-2021 @1512 COVID- 19 specimens 6-20-2021 @1518 COVID-19 specimens 6-21-2021 @1728 COVID-19 specimens 6-21-2021 @ 2129 COVID-19 specimens 6-22-2021 @1250 COVID-19 specimens 6-22-2021 @2129 COVID-19 specimens 6-23-2021 @1205 COVID-19 specimens The following specimens did not have any indication of what temperature they are required to be stored. On the worksheet to track specimens from the courier they were left blank under the column "is refrigeration required." 6-07-2021 @0601 COVID-19 specimens 6-07-2021 @0802 COVID-19 specimens 6-16-2021 COVID- 19 from duval county In interview with the laboratory director and Serology Technical Supervisor on 6/24/2021 @1400 they stated "We cannot tell which COVID specimens were recorded as room temperature." They were unsure which SARS-CoV- 2 assay these specimens were used on, where they came from, and how many specimens there were in each delivery. Microbiology (enterics) In review of the manufacturer's instructions for the Medical Chemical Corporation instructions under collection, storage, and transport states, "If immediate transportation to a laboratory is not possible refrigerate at 2-8 degrees C for up to 96 hours." In review of the laboratory's procedure under enteric culture- stool pg. 4 states,"specimens must be submitted in Modified Cary-Blair derived or type of transport media only within 48 hours of collection." In review of 4 of 14 patients, the following patients were pass the 48 and 96 hour time frame. a. Patient #JBC21000169 collected 5/26/2021, date received 6/2/2021, no documentation on the lab's enteric culture record as when they were plated. b. Patient #JBC2100226 collected 06/2/2021, date received 06/21/2021, no documentation on the lab's enteric culture record as when they were plated. c. Patient #JBC2100227 collected 6/16/2021, date received 06/21/2021, no documentation on the lab's enteric record as when they were plated. d. Patient #JBE2100223 collected 5/11/2021, date received 05/18/2021, no documentation on the lab's enteric record as when they were plated Sample requirement HSV-1 and HSV-2 In review of the laboratory's policy "rPCR of Herpesvirus (CMV, HHV-6, HSV-1, HSV-2) on the Applied Biosystems 7500 Fast DX Standard Operation Procedure, " pg 4 states under sample requirements: "Specimens must be maintained at the proper temperature as follows: 2 to 8 degrees C for up to 72 hours or -70 C or colder continuously." In review of the laboratory's policy "SOP section 2.1.2 Unsatisfactory specimens" states "A specimen should be rejected under the following -- 2 of 7 -- conditions: Improper collection,storage, or transport of sample." In review of the following patients they did not meet the 72 hour time frame: a. Sample# JVT21009541 date collected: 6/09/2021 date received: 6/16/2021 b. Sample# JVT21009540 date collected 6/10/2021 date received: 6/6/2021 c. Sample#JVT21008971 date collected 5/20/2021 date received: 5/27/2021 d. Sample# JVT21008972 date collected 5/20/2021 date received: 5/27/2021 e. Sample#JVT21005398 date collected 3/16/2021 date received: 03/25/2021 f. sample#JVT21009451 date collected 06/03/2021 date received: 06/03/2021 g. sample#JVT21009544 date collected 06/11/2021 date received: 06/16/2021 h. sample#JVT21006514 date collected 04/08/2021 date received: 04/13/2021 i. sample#JVT21009453 date collected 06/4/2021 date received: 06/10/2021 In interview with the virology General Supervisor @1245 on 6/22/2021 stated, "I don't think the correction times is correct." On a follow-up interview with the Laboratory Director on 6/22/2021 @1405 she stated that she thought it may be a LIS limitation or /and an IT issue that the specimens on the final reports may not be reflecting the receipt time in the lab. In addition, she thought they may have to change their process to when they accession the specimens when they get them rather than days later when they are ready to test. 41221 B. Based on sample record review, the laboratory's written procedure, interview with accessioning staff and laboratory supervisor and direct observation, the laboratory failed to follow their written policy for transport requirements established for mycobacteriology specimens for 19 of 40 specimens received in the laboratory within 24 hours for 6/23/21. Findings: 1) In review of the BD MAX Real-time PCR Standard Operating Procedure Version 2, November 1, 2018 under VII. Sample Requirements states, "Specimens should be collected in a sterile container and stored at 2-8 C and should arrive in the Mycobacteriology Laboratory within 24 hours of collection." 2) A sampling of 40 requisitions and preliminary reports for specimens received on 6/23/21 were reviewed. 19 of 40 reports showed specimen receive time in the laboratory was greater than 24 hours after collection. All specimens were processed for testing. Examples: LIMS Report# Specimen Type Date Collected Date Received 10698296 CSF 06/18/2021 06/23/2021 10698220 Bronchial Lavage 06/17/2021 06/23/2021 10698222 Bronchial Lavage 06 /17/2021 06/23/2021 10698223 Bronchial Wash 06/18/2021 06/23/2021 10698240 Bronchial Wash 06/21/2021 06/23/2021 (Remaining samples listed in evidence) 3) Based on observation on 06/23/2021 at 1045 hours in the TB laboratory processing area, 8 shipping containers containing specimens were unpacked for processing. The laboratory did not have means to ensure specimens were 2-8 degrees Celsius. The laboratory does not have documentation to ensure conditions of transport were within their acceptability criteria. 4) In interview with accessioning staff in the triage area on 06/23/2021 at 1040 hours the surveyor asked "How do you know how the specimens for each area should be received?" Triage staff stated that someone from each laboratory department will tell them. 5) In interview with the Mycobacteriology laboratory supervisor in her office on 06/24/2021 at 1415 hours it was confirmed that all 40 specimens received on 06/23/2021 were processed and tested. The supervisor confirmed that no specimen is rejected unless it is missing a crucial identifier such as a name. 6) The laboratory has an approximate annual mycobacteriology test volume of 84,500. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. -- 3 of 7 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's client service manual spreadsheet, and interview, the laboratory failed to make available a electronic or paper manual for their clients and have up to date information on specimen storage, specimen acceptability/ rejection and specimen preservation as evidenced by: 1. In interview with the Laboratory Director on 6/23/2021 @1530 stated she didn't think they had a client service manual, but later was able to find the excel spread sheet on the computer. In questioning further after she found the manual, the Laboratory Director stated that she didn't know if her clients had the manual available to them. She stated that in the past she has sent out memos or had her staff talk with the laboratories on the phone if they had questions concerning testing. 2. In review of the laboratory's excel spread sheet labeled, "Bureau of Public Health Laboratories Test Catalogue." The following tests in the chart worksheets did not have specimen storage and preservation and conditions for transport listed: Vacccina Virus Detection Detection PCR Arbovirus Plague, reduction test Arbovirus IgG Varicella Zoster Virus IgM Hepatitis A, PCR Enteric Culture Throat (Beta Strep) Aerobic isolate ID Aerobic isolate (for Diphtheria) Anaerobic cultures TB cultures Real time PCR NAAT for TB AFB cultures for ID TB drug Susceptibilities Syphilis confirmation TPA Syphilis Total antibody Syphilis RPR Chlamdydia screen and Gonorrhea HIV-1 Oral sure CD4/CD8 count/ratio HIV-1 viral load HIV-1 Genotyping Gonorrhea Culture Herpes Simplex virus type IgG Parasite, blood Toxoplasma IgG Cytomegalovirus IgG Zika Virus Varicella zoster virus IgG Ehrlichia IgG Rocky Mountain Spotted Fever IgG Rubella IgM Measles IgG Q fever IFA Chikungunya virus Dengue virus DNA probe/Gen probe (mycobacterium) Ebola GeneXpert MTD/RTF Hep B Surface Antigen Confirmation Test Legionella IFA Mumps IgG and IGM Mycology culture Ova and parasites, intestinal Salmonella typing Gene Expert PCR The following tests did not have listed conditions for specimen acceptability and rejection: Vacccina Virus Detection Detection PCR Arbovirus Plague, reduction test Varicella Zoster virus culture Arbo virus IgG VZV IgM Hepatitis A PCR B. pertussis Culture PCR Syphilis confirmation TPA Measles IgG Q fever IFA DNA probe/Gen probe (mycobacterium) Hep B Surface Antigen Confirmation Test Mumps IgG and IGM Mycology culture Ova and parasites, intestinal Gene Expert PCR 3. In the exit conference on 6/25/2021 @1041 with the Laboratory Director and her staff, she stated that she was aware that it was not updated. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the laboratory's COVID-19 verification studies document review, interview with the viral technical supervisor and laboratory director, the laboratory failed to demonstrate that they had validated test performance specifications for their -- 4 of 7 -- SARS- CoV-2 multiplex rRT-PCR EUA (emergency use authorization) test for 5 of 7 ABI 7500 instruments that was used before patient testing as evidenced by: 1.The laboratory could not provide documentation to show that they had performed validations on the ABI 7500 instruments used for the CDC multiplex SAR-CoV-2 PCR on instruments labeled 1,3,4,5,6 by the laboratory. 2. They did not have the following documentation that showed Accuracy Precision 3. In an interview with the virology Technical Supervisor on 6/22/2021 @1301 she stated that they only did validations on 2 of the 7 instruments. 4. In an interview with the Laboratory Director on 6/22/2021 @1515 she stated, "We should have done all of the instruments." (referring to validation of ABI 7500) D5781

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of proficiency test records and interview with staff, the laboratory failed to perform proficiency testing in the same manner and using the same methods as patient testing. Findings: 1. Review of American Association of Bioanalysts (AAB) Bacteriology proficiency test records on January 17, 2019, at 3:30pm revealed the laboratory used various commercial microbial identification systems (MIS) to identify bacteria in proficiency test samples in addition to the routine laboratory tests performed on patient samples. The laboratory routinely identifies bacteria in patient samples using individual biochemicals, records the reactions and submits the reactions to an online database which calculates the phenotypic identification. The records reviewed included the following proficiency testing events and test methods performed by the laboratory. a. 2016 - Event 3: The laboratory used the "API Staph" MIS and individual biochemicals to identify bacteria in samples 1, 2 and 5; and used the "API Strep 20" MIS and individual biochemicals to identify bacteria in sample 2. b. 2017 - Event 1: The laboratory used the "API Staph" MIS and individual biochemicals to identify bacteria in samples 2 and 3. The laboratory used the "API Strep 20" MIS and individual biochemicals to identify bacteria in sample 5. c. 2017 - Event 2: The laboratory used the "API Staph" MIS and individual biochemicals to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- identify bacteria in sample 1; and used the "API 20 Strep" MIS and individual biochemicals to identify bacteria in samples 1 and 2. The laboratory used the "RapID ANA II" MIS and individual biochemicals to identify bacteria in sample 1. d. 2017 - Event 3: The laboratory used the "API 20 Strep" MIS and individual biochemicals to identify bacteria in sample 2; used "API Staph" MIS and individual biochemicals to identify bacteria in sample 3 and 5; and used the "RapID ANA II" MIS and individual biochemicals to identify bacteria in sample 3. e. 2018 - Event 1: The laboratory used the "API Staph" MIS, the "RapID ANA II" MIS and individual biochemicals to identify bacteria in sample 3. f. 2018 - Event 2: The laboratory used the "API Staph" MIS and individual biochemicals to identify bacteria in sample 3. g. 2018 - Event 3: The laboratory used the "API 20 Strep" MIS and individual biochemicals to identify bacteria in samples1 and 2; and used the "API Staph" MIS and individual biochemicals to identify bacteria in samples 3 and 5. 2. On January 17, 2019 at 8: 15am, the surveyor requested quality control records for the "API Staph", "API 20 Strep" and "Rapid ANA II" MISs. TP-M stated the laboratory does not perform quality control testing on the microbial identification systems because these test methods are not used for patient testing. 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 review of proficiency testing records for the years 2016, 2017 and 2018, and interview with staff, the Laboratory Director or designee and testing personnel failed to sign proficiency test attestation statements. Findings: 1. Review of American Proficiency (API) GC Culture test records on the morning of January 15, 2019, revealed the Laboratory Director or designee, and testing personnel failed to sign API's attestation statements attesting to the routine integration of the proficiency samples into the patient workload using the laboratory's routine methods for the following testing events: a. 2017 - Event 3 b. 2018 - Event 2 and 3 2. Review of AAB Bacteriology test records for on the morning of January 15, 2019, revealed the Laboratory Director or designee, and testing personnel failed to sign AAB's attestation statement attesting to the routine integration of the proficiency samples into the patient workload using the laboratory's routine methods for the following testing events: a. 2017- Event 1 and 3 b. 2018 - Event 2 and 3 3. Review of AAB Parasitology test records on the morning of January 15, 2019, revealed the Laboratory Director or designee, and testing personnel failed to sign AAB's attestation statement attesting to the routine integration of the proficiency samples into the patient workload using the laboratory's routine methods for the following testing events: a. 2018 - Event 2 and 3 4. During interview on January 16, 2019 at 4pm, the technical supervisor (TS-M) confirmed the attestation statements listed above were not signed by the Laboratory Director or designee and testing personnel. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on review of proficiency test records and interview with staff, the laboratory failed to test proficiency samples the same number of times that patient samples are tested. Findings: 1. Review of API GC Culture proficiency testing records on the morning of January 15, 2019, revealed samples were tested by two testing personnel for the following events. a. 2016 - Event 3: Test records included two different "Oxidase Positive Worksheet", a form used by the testing personnel to record test results. One "Oxidase Positive Worksheet" was dated October 20, 2016 and the other was dated October 21, 2016. The forms contained no name or initials of the testing personnel, but handwriting was different. Two API "Data Entry Worksheet" forms were included in the records, both containing test results. One form was signed by TP- M and dated October 28, 2016. The other form was signed by TP-M1 and dated October 31, 2016. b. 2017 - Event 1: Test records included forms for recording test results for Accuprobe Neisseria gonorrhoea Culture Identification Kit. Accuprobe testing performed on March 7, 2017 was labeled with the following sample numbers and the testing personnel's name: GC-01 TP-M1; GC-04 TP-M1; GC-01 TP-M; GC- 02 TP-M; GC-04 TP-M and GC-04 TP-M. c. 2017 - Event 3: Test records included forms for recording test results for Accuprobe Neisseria gonorrhoea Culture Identification Kit. Accuprobe testing performed on October 3, 2017 was labeled with the following sample numbers and the testing personnel's name: GC-12 TP-M1; GC- 15 TP-M1; GC-12 TP-M and GC-15 TP-M. d. 2018 - Event 2: Test records included forms for recording test results for Accuprobe Neisseria gonorrhoea Culture Identification Kit. Accuprobe testing performed on July 3, 2018 was labeled with the following sample numbers and the testing personnel's name: GC-02 TP-M1; GC-09 TP-M1 and GC-09 TP-M. API "Data Entry Worksheet" forms were included in the records, both containing test results. One form was signed by TP-M and dated July 5, 2018. The other form was signed by TP-M1 and dated July 5, 2018. e. 2018 - Event 3: Test records included forms for recording test results for Accuprobe Neisseria gonorrhoea Culture Identification Kit. Accuprobe testing performed on October 3, 2018 was labeled with the following sample numbers and the testing personnel's name: GC-12 TP-M1; GC-13 TP-M1;GC-12 TP-M ad GC-13 TP-M. API "Data Entry Worksheet" forms were included in the records, both containing test results. One form was signed by TP-M and dated October 5, 2018. The other form was signed by TP-M and dated October 12, 2018. The record also included two "Oxidase Positive Worksheet" forms. One was dated September 28, 2018, the other had no date. Neither form included the testing personnel name or initials, but handwriting was different. 2. During interview on the morning of January 17, 2019, TP-M confirmed the proficiency testing listed above was performed by both TP-M and TP-M1. TP-M confirmed patient samples were routinely tested only one time, by one testing personnel. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, review of the Quality Assurance Plan for the Microbiology Laboratory and interview with staff, the laboratory failed to -- 3 of 7 -- review proficiency test scores. Findings: 1. Review of AAB proficiency test records revealed the laboratory failed to review test scores for the programs Bacteriology and Parasitology for all three events in years 2017 and 2018. 2. During interview the morning of January 16, 2019, TS-M confirmed the laboratory did not document review of proficiency test scores for the programs and events listed above. 3. The Quality Assurance Plan for the Microbiology Laboratory states the following on page number 4 under the heading "E. Proficiency Testing": "4. Results are evaluated by survey provider against peer group responses and reported back to the laboratory. Internally, results are evaluated by the section supervisor. Outliers (if present) are investigated, and after investigation, the report should be signed by the CLIA Laboratory Director". 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: Based on review of proficiency testing records, review of the Quality Assurance Plan for the Microbiology Laboratory and interview with staff, the laboratory failed to follow it's policy to investigate unacceptable proficiency test results. Findings: 1. Review of API proficiency testing records on the morning of January 15, 2019, revealed the following scores. Bacteriology program: a. 2017 - Event 2 - 80% b. 2017 - Event 3 - 80% c. 2018 - Event 1 - 90% Parasitology program: a. 2017 - Event 3 - 90% 2. During interview on the morning of January 16, 2019, TS-M confirmed the laboratory did not investigate the proficiency test samples scored as unacceptable for the events listed above. 3. The Quality Assurance Plan for the Microbiology Laboratory states the following on page number 4 under the heading "E. Proficiency Testing": "4. Results are evaluated......supervisor. Outliers (if present) are investigated, and after investigation, the report should be signed by the CLIA Laboratory Director. 5. If the laboratory testing of a PT challenge does not produce acceptable results, the cause of the error must be investigated and corrected." D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(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: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: -- 4 of 7 -- Based on record review and interview the laboratory failed to document the validation protocol actual measurements taken, reactions and observations for accuracy, precision, reportable ranges and reference interval. Findings include: 1. The Virology laboratory failed to verify and document the accuracy, precision, reference range and reportable range for the quantitative Rickettsia Real -Time PCR assay and CDC Rubella Virus Real Time RT-PCR prior to the start of testing in 2017 and 2018. The laboratory validation protocol did not have a summary and conclusion that showed the evaluation/calculations for each new test performed. 2.The Virology laboratory implemented the Rickettsia on October 17, 2017 and CDC Rubella Virus Real Time RT-PCR on October 9, 2018 but failed to include accuracy, precision or reportable range in the validation protocol approved by the laboratory director. The laboratory failed to calculate the percent within run, between run and total precision by dividing observed results over known results to determine a percentage. 3. During the interview on January 17, 2019 at 1:00pm the Technical Supervisor confirmed the laboratory validation protocol did not include written summary and calculations to show the validation performance of accuracy, precision, reference and reportable range for each new test procedure. 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 quality control records, the laboratory procedure manual, the owner manual for the GeneXpert Carba-R Assay, the Individualized Quality Control Plan (IQCP) for the GeneXpert Carba-R Assay and interview with laboratory staff, the laboratory failed to perform quality control testing for the GeneXpert Carba-R Assay as required and failed to establish a complete IQCP. Findings: 1. Bacteriology quality control records reviewed on the afternoon of January 16, 2019, did not include records for external quality control for the GeneXpert Carba-R assay. 2. During interview on the morning of January 17, 2019, TS-M stated the GeneXpert Carba-R assay contains two internal controls and the laboratory does not perform any additional quality control testing. 3. The laboratory's procedure for the GeneXpert Carba-R assay states on page 2 under "VII. Quality Control" the following: "Each test includes a Sample Processing Control and a Probe Check Control. Sample Processing Control (SPC)-Ensures the sample was processed correctly. The SPC contains spores of Bacillus globigii in the form of a dry bead that is included in each cartridge to verify adequate processing of the sample. The SPC verifies that lysis of bacteria has occurred if the organisms are present and verifies that sample processing is adequate. Additionally, this control detects sample-associated inhibition of the real-time PCR assay, ensures the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction, and that the PCR reagents are functional. The SPC should be positive in a negative sample and can be negative or positive in a positive sample. The SPC passes if it meets the validated acceptance criteria. Probe Check Control -- 5 of 7 -- (PCC)-Before the start of the PCR reaction, the GeneXpert System measures the fluorescence signal from the probes to monitor bead rehydration, reaction tube filling, probe integrity, and dye stability. Probe Check passes if it meets the assigned acceptance criteria." 4. The manufacturer's manual for the GeneXpert Carba-R assay states on page 8 under "11 Quality Control" the following: "Built-in Quality Controls Each test includes a Sample Processing Control and a Probe Check Control. Sample Processing Control (SPC)-Ensures the sample was processed correctly. The SPC contains spores of Bacillus globigii in the form of a dry bead that is included in each cartridge to verify adequate processing of the sample. The SPC verifies that lysis of bacteria has occurred if the organisms are present and verifies that sample processing is adequate. Additionally, this control detects sample-associated inhibition of the real- time PCR assay, ensures the PCR reaction conditions (temperature and time) are appropriate for the amplification reaction, and that the PCR reagents are functional. The SPC should be positive in a negative sample and can be negative or positive in a positive sample. The SPC passes if it meets the validated acceptance criteria. Probe Check Control (PCC)-Before the start of the PCR reaction, the GeneXpert System measures the fluorescence signal from the probes to monitor bead rehydration, reaction tube filling, probe integrity, and dye stability. Probe Check passes if it meets the assigned acceptance criteria. External Controls External controls described in Section 6.4 are available but not provided and may be used in accordance with local, state, and federal accrediting organizations, as applicable. Always use external controls, according to the manufacturer ' s instructions." 5. On the morning of January 18, 2019, the laboratory director provided an IQCP for the GeneXpert Carba-R assay. Review of the IQCP on January 23, 2019 revealed the IQCP was incomplete and unacceptable due to the following: a. The introductory section of the IQCP refers to "lysis of MTB" at the bottom of page 2. The GeneXpert Carba-R assay is FDA approved for testing of Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii only. b. The Risk Assessment (RA) refers to "appropriate storage conditions for sputum specimens" for mitigating risks associated with specimen storage on the top of page 2. The GeneXpert Carba-R assay is not FDA approved for testing of sputum specimens. c. In several areas, the Risk Assessment suggests the storage of reagents and performance of the test at room temperature is mitigated by use of a thermostat in the storage and testing area and mitigated by a 24 hour recorder on the refrigeratosr and freezers. The Risk Assessment does not address the monitoring of temperatures by laboratory staff. d. On page 5, the IQCP refers to "Internal Controls (SPC, PCC, QC1 and QC2) are performed for each test to ensure that the proper specimen processing......no reagent quality issue." The laboratory procedure manual and manufacturer's manual to not reference the use of internal controls QC1 and QC2. d. The laboratory did not provide historical external quality control data to support the Quality Control Plan (QCP). e. The IQCP does not contain Quality Assessment monitoring of the IQCP. 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 negative reactivity, as well as graded reactivity, if applicable. (g) The laboratory must document all control procedures performed. -- 6 of 7 -- This STANDARD is not met as evidenced by: Based on interview with staff, review of test records and review of manufacturer package insert, the laboratory failed to document quality control testing for the RIM E. coli 0157:H7 Latex Kit. Findings: 1. STEC (Shiga toxin-producing E.coli) Microbiology Worksheets were reviewed at approximately 2pm on January 16, 2019. The top portion of the worksheet contains a chart for documenting the sample identification code, the culture results, the PCR (polymerase chain reaction) results and the serotying results. The bottom portion of the worksheet contains space to record the lot numbers and expiration dates for the media, PCR reagents and serogrouping reagents used in the testing process. The serogrouping reagents included both the RIM E. coli 0157:H7 Latex Kit and Somatic O Antibodies for Big 6 (anti- sera). Lot numbers were recorded for each test, but no expiration dates were recorded. No quality control results for any testing were recorded on the worksheets. 2. Review of the RIM E.coli 0157:H7 Latex Kit manufacturer's package insert at approximately 2pm on January 16, 2019, revealed the following instructions: "Quality Control A Positive and Negative Control is included with each kit. Test controls with each new kit lot number and shipment or following applicable regulatory guidelines." 3. During interview on January 17, 2019, at 8:15am, the TP-M stated the laboratory does not document quality control results for the RIM E.coli 0157:H7 Latex Kit. -- 7 of 7 --