Delaware Public Health Laboratory

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based upon direct observation, review of policies and procedures, review of test records, and interview of facility personnel, the laboratory failed to have written procedures for the collection, storage and handling and transportation of specimens submitted by outside providers in the testing for 5 of 5 subspecialties. The findings included: 1. Upon observation of the processing section of the laboratory on June 4, 2025 at 9:30 AM the laboratory received specimens from outside sources via courier. The specimens were transported from the vehicle to the laboratory in a compartmentalized cooler, where temperatures were taken to ensure samples were within 2 to 8 degrees C. 2. Review of the laboratory's own written policy revealed no written procedures or policies for the collection, storage, handling and transportation of specimens submitted by outside providers. 3. A review of test records indicated a laboratory total annual test volume of 58,300 for the following five active CLIA subspecialties and associated codes: 110 Bacteriology, 115 Mycobacteriology, 140 Virology, 210 Syphilis Serology, 220 General Immunology. 4. In an interview on June 4, 2025 at 9:40 AM, the supervisor of the processing section, as well as the quality assurance manager confirmed that the laboratory was in the process of creating a policy and procedure guide for the pre-analytic portion of processing samples, including specimen transport temperature requirements and rejection criteria, but did not have one completed and approved at the time. 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 -- 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 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: I. Based on review of the manufacturer's instructions, review of patient records, and confirmed in interview with the Technical Supervisor (TS), the laboratory failed to follow manufacturer's instructions in ensuring Trichomonas Vaginalis specimens were not run on patients under the age of 14 for 15 of 8,246 Trichomonas Vaginalis specimens run on the Hologic Panther analyzer for 6 months reviewed. Findings Included: 1. A review of manufacturers instruction for the Aptima Combo 2 Assay Panther System (502446 Rev. 009) stated the following on page 20: "Limitations: P. The performance of the Aptima Combo 2 Assay has not been evaluated in adolescents less than 14 years of age." 2. A review of the laboratory's Laboratory Information Management System (LIMS) patient report generated from October 2024 to December 2024 and March 2025 to May 2025 (random review) showed 15 patient specimens whose age demographics fell under the age of 14 at the time of testing. 3. In an interview on 6/3/2025 at 1:57 PM, the TS of Microbiology confirmed that 15 of 8,246 Trichomonas Vaginalis patient specimens tested between the date ranges October 1 to December 31, 2024 and March 1 to May 31, 2025, according to the LIMS report, were of patients under the age of 14. II. Based on direct observation, review of the Becton Dickinson BBL Lowenstein-Jensen (L-J) Medium manufacturer's instructions, and confirmed in interview with the Technical Supervisor (TS) of Microbiology, the laboratory failed to ensure manufacturer's instructions were followed for storage/stability for 35 of 35 L-J media slants. Findings included: 1. Review of Becton Dickinson BBL Lowenstein-Jensen (L-J) Medium package insert (L007464, Rev. 11, October 2015) states, "Storage Instructions: On receipt, store tubes and bottles in the dark at 2-8 degrees C. Avoid freezing and overheating. Do not open until ready to use. Minimize exposure to light. Media stored as labeled until just prior to use may be inoculated up to the expiration date ..." 2. During a tour of the Microbiology department on 4/18/2024 at 1:32pm, 35 tubes of Becton Dickinson BBL L-J media, slant tubes, Lot 4185447, expiration date 2026-01-03, were observed in storage exposed to light in refrigerator DPHL MB00035 ISEN600016. 3. During an interview on 6/3/2025 at 2:59 pm, the TS of Microbiology confirmed the findings of the L-J media slant tubes being exposed directly to light. 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on direct observation, manufacturer's instructions, review of Insensix temperature ranges, and interview with the laboratory's quality assurance manager, the laboratory failed to define temperature ranges consistent with the manufacturer's instructions, where temperature dependent reagents and supplies were located at room temperature within the microbiology section and within 1 of 2 freezers. Findings Included: 1. In direct observation, on 6/3/2025 in the Microbiology section, the following reagents and supplies were found within the corresponding areas: a. Freezer DPHL MB0016 ISEN600024 (-31 to -15 degrees Celsius) - i. 3 Becton Dickinson BBL Meropenem Sensi-Disc boxes, Lot # 4120704, Manufacturer Storage Requirement -20 to -8 degrees Celsius ii. 1 Liofil Chem MIC Test Strip (Ceftazidime /Ceftazidime+Clavulanic acid), Lot #121923050, Manufacturer Storage Requirements -20 degrees Celsius iii. 1 Biomerieux ETEST Vancomycin Box, Lot #1011087740, Manufacturer Storage Requirements -20 to -8 degrees Celsius iv. 4 Bruker US IVD BTS Calibration Standards for MBT-CA System, Lot #6030424002, Manufacturer Storage Requirements -18 degrees Celsius b. Microbiology Gram Staining Bench ISEN600092 (15 to 30 degrees Celsius) - i. 1 Remel Gram Safranin bottle, Lot #138499, Manufacturer Storage Requirements 20 to 25 degrees Celsius ii. 1 Remel Gram Decolorizer bottle, Lot #137758, Manufacturer Storage Requirements 20 to 25 degrees Celsius iii. 1 Remel Gram Iodine bottle, Lot #140674, Manufacturer Storage Requirements 20 to 25 degrees Celsius iv. 2 Becton Dickinson Phoenix NMIC-306 boxes, Lot #5070931, Manufacturer Storage Requirements 15 to 25 Celsius v. 1 Becton Dickinson Phoenix PMIC-110 boxes, Lot #5063745, Manufacturer Storage Requirements 15 to 25 Celsius vi. 2 Becton Dickinson Pheonix NID boxes, Lot# 5085911, Manufacturer Storage Requirements 15 to 25 Celsius 2. In an interview on 6 /3/2025 at 3:12 PM, the TS of Microbiology and the laboratory's quality assurance manager confirmed that temperatures ranges set for the aforementioned freezers and room temperature overall were not consistent with manufacturer storage requirements of reagents and supplies stored. 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 review of manufacturer's instructions, laboratory maintenance records (3/1 /25-6/3/25), test volume records, and interview with the Technical Supervisor (TS) of Microbiology, as per the Form CMS-209, the laboratory failed to follow the operator's manual for the Hologic Panther System for daily maintenance requirements and cleaning for 3 of 3 months. Findings included: 1. A review of manufacturer's instructions (AW-20220-001 Rev. 001) for the Hologic Panther revealed the following maintenance requirements for the mag wash cleaning: "As part of system maintenance, it is required that this task be performed after each testing day. For example, if processing test orders on Monday-Friday, schedule the Mag Wash Clean task to be run after working hours on Monday-Friday." 2. A review of the laboratory's maintenance record titled, "Delaware Public Health Lab Panther Fusion Maintenance Log Report" from March 1, 2025 through June 3, 2025 revealed the laboratory failed to follow manufacturer's instructions to perform daily Mag Wash Clean maintenance after each day testing was performed on the following Hologic Panther Fusion -- 3 of 5 -- Analyzers: Serial Numbers # 01190, 01282 3. A review of the laboratory's test volume records between March 1, 2025 through June 3, 2025 showed daily Mag Wash Clean maintenance was not performed after testing for the following: Serial Number 00190 - 1760 CT/GC specimens, 124 qHCV specimens, 689 Trichomonas Vaginalis specimens Serial Number 01282 - 2,914 CT/GC specimens, 142 qHCV specimens, 2,277 Trichomonas Vaginalis specimens 4. In an interview on 6/03/25 at 3:18 PM, the TS of Microbiology confirmed the Mag Wash settings were not set to run after each testing day. Word Key: GC- Neisseria gonorrhea CT-Chlamydia trachomatis qHCV- Quantitative Hepatitis Virus D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) (e) The laboratory director must-- (e)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on review of laboratory policies, test records, and confirmed in interview the laboratory director failed to ensure the laboratory provided quality services for preanalytical phases of testing for 5 of 5 subspecialties. Findings Included: 1. Review of the laboratory's own written policy revealed no written procedures or policies approved, or signed by the laboratory director for the collection, storage, handling and transportation of specimens submitted by outside providers. 2. A review of test records indicated a laboratory total annual test volume of 47,854 for the following five active CLIA subspecialties and associated codes: 110 Bacteriology, 115 Mycobacteriology, 140 Virology, 210 Syphilis Serology, 220 General Immunology. 3. In an interview on June 4, 2025 at 9:40 AM, the supervisor of the processing section, as well as the quality assurance manager confirmed that the laboratory was in the process of creating a policy and procedure guide for the pre-analytic portion of processing samples, including specimen transport temperature requirements and rejection criteria, but did not have one completed and approved by the laboratory director at the time. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on laboratory personnel interview and laboratory policies and procedures record review, the laboratory director, high complexity testing, failed to specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each -- 4 of 5 -- individual is authorized to perform, whether supervision is required for specimen processing, test performance, or result reporting and whether supervisory or director review is required prior to reporting patient test results. Findings included: 1. The laboratory quality assurance manager confirmed on June 4, 2025 at 09:20 am that the laboratory maintained no documentation to indicate that the laboratory director had specified, in writing, the responsibilities and duties of each laboratory staff as required by this regulation. 2. According to laboratory documents, the laboratory performed and reported approximately 58,300 patient test results annually. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) (b)(2) Verification of the test procedures performed and establishment of the laboratorys test performance characteristics, including the precision and accuracy of each test and test system; This STANDARD is not met as evidenced by: Based on review of the laboratory's post-relocation instrument performance verification records, test records and interview, the Technical Supervisors of Microbiology and Virology failed to approve the verification of the test procedures performed and establishment of the laboratory's test performance prior to running patient samples for 4 of 4 test systems/instrumentation. Findings Included: 1. A review of the laboratory's post-relocation/move instrument performance verification records revealed the following information: a. Abbott Architect i1000, relocation /move date March 2025, verification performed April 4, 2025, technical supervisor sign-off date May 13, 2025. b. 2 Hologic Panthers (S/Ns #01190, 01282), relocation /move date April 2025, verification performed April 10, 2025, technical supervisor sign-off date April 29, 2025. c. 9 Fisher Scientific ABI 7500 Fast Dx, relocation/move dates S/N 275000961 (4/15/25), S/N 275011244 (4/15/25), S/N 275011803 (4/18/25), S/N 275030208 (4/18/25), S/N 275030208 (4/18/25), S/N 275030689 (4/23/25), S/N 275031535 (4/23/25), S/N 275031536 (5/2/25), S/N 275031953 (4/29/25), S/N 275031955 (4/29/2024), no technical supervisor sign-off until 5/20. d. 3 Illumina MiSeq Systems, relocation/move date October 2024, no instrument verification performed until February 2025, no technical supervisor sign-off until 2/25. 2. A review of the laboratory's test records revealed the following tests run between the time instruments were moved, before the technical supervisor reviewed and signed off on the post-relocation/move instrument performance verification: a. Abbott Architect i1000, date range 4/03/25 to 5/13/25: i. HCV-152 tests ii. HepB AUSAB-156 tests iii. HepB_Conf-2 tests iv. HepB-Core-156 tests v. HepB-CoreM-8 tests vi. HepB Surface Ag-156 tests vii. HIV EIA-65 tests viii. Syphilis TP-412 tests b. Hologic Panther, date range 4/10/25 to 4/29/25: i. CT/GC-1203 tests ii. Trichomonis Vaginalis-798 tests iii. qHCV-0 c. Fischer Scientific ABI 7500 Fast Dx, date range 4/15/25 to 5/20: i. Pertussis-18 tests ii. Flu/SC2-2805 tests iii. Measles-24 tests iv. Mumps-24 tests v. Non-variola-16 tests vi. Orthopox-16 tests vii. HSV/VZV-340 tests viii. TB-136 tests ix. Trioplex-14 tests x. Y.pestis-5 tests xi. F. tularensis-4 tests xii. Burkholderia-4 tests xiii. Brucella-6 tests xiv. B. anthracis-4 tests d. Illumina MiSeq Systems, date range 10 /24 to 2/25 i. M. tuberculosis-7 tests 4. In an interview on 6/4/25 at 9:20 AM, the laboratory's quality manager confirmed the technical supervisors did not sign-off and ensure completion of instrument verification post relocation, prior to running patient samples. -- 5 of 5 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of laboratory personnel competency assessment records and an interview with the Quality Manager, the laboratory failed to establish written policies and procedures to assess Technical Supervisors (TS) for competency in 2021 and 2022. Findings Included: 1. The personnel form CMS-209 filled out by the laboratory at the time of the survey listed 4 TS technical supervisors for the laboratory. 2. Review of the Quality Plan Micro, section 9.1 competency assessment, revealed, that the laboratory did not establish a TS competency assessment policy. 2. Interviews with Quality Manager on 8/30/2023 at 11:45 am confirmed they did not establish a written policy to assess TS for competency. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on a observation of the Tuberculosis (TB) laboratory and interview with technical supervisor (TS) #3, the laboratory failed to monitor the room temperature of the TB laboratory that stores calibration vials, test medium and tubes that require conditions for storage from 2021 to 2023. Findings Included: 1. Review of the Isensix temp track map on 08/29/2023, revealed the TB laboratory was not monitored by the system. 2. On August 30, 2023, a tour of the TB laboratory revealed, the follow BD Bactec MGIT supplies require to be stored at 2 to 25 degrees Celsius per the manufacturer: - Mycobacteria Growth Incubator Tubes - Lot# 3061954 - 3 of 3 boxes. - Susceptibility Test Medium - Lot# 3025516 - 4 of 4 boxes. - Calibration Vials - Lot# 3032627 - 1 of 1 box. 3. Interviews with TS #3 confirmed on 8/30/2023 at 10:00 am, the laboratory does not monitor the room temperature of the TB laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation of the laboratories, lack of records and an interview with technical supervisor (TS) #2 and #3, the laboratory failed to perform maintenance for 6 of 7 traceable timers observed in the laboratory on August 29, 2023 and August 30, 2023. Findings Included: 1. The laboratory could not provide a procedure for the performance for maintenance check for timers used for clinical testing. 2. On August 29, 2023 and August 30, 2023 the following timers were observed that were due to maintenance in the Virology and Tuberculosis (TB) laboratories: - Fisher Scientific Traceable - S/N#140799247 - Due 12/09/2016. - Fisher Scientific Traceable - S /N#111473801 - Due 04/22/2013. - Fisher Brand Traceable - S/N#192552834 - Due 10 /10/2021. - Fisher Brand Traceable - S/N#192552809 - Due 10/10/2021. - Fisher Brand Traceable - S/N#160303283 - Due 03/23/2018. - Fisher Brand Traceable - S /N#160203235 - Due 03/23/2018. - Fisher Brand Traceable - S/N#160303276 - Due 03 /23/2018. 3. Interviews with TS#2 and TS #3 on 8/30/2023 at 10:30 am confirmed the laboratory does not have a policy for the maintenance of timers in use. 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. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on a review laboratory records and an interview with the Quality Manager and technical supervisor (TS) #2, the laboratory failed to perform comparison studies every 6 month for 11 out of 11 Thermo Scientific ABI Fast 7500 Fast DX analyzers used to analyze virology tests. Findings Included: 1. On August 30, 2023 the laboratory could not provide comparison studies performed every 6 month for 11 out -- 2 of 3 -- of 11 Thermo Scientific ABI Fast 7500 Fast DX analyzers. 2. Interviews with the Quality Manager and TS#2 on 8/30/2023 at 1:00 pm confirmed comparison studies were not performed every 6 months to compare the Thermo Scientific ABI Fast 7500 Fast DX analyzers that run the same test. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Federal Jurisdictional Survey Federal surveyors from the Division of Clinical Laboratory Improvement & Quality CLIA Operations, Centers for Medicare and Medicaid Services (CMS) - Philadelphia CMS Office conducted an announced CLIA Recertification survey at the Delaware Public Health Laboratory. The laboratory is on compliance with 42 CFR part 493 with standard level deficiencies cited: D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of patient testing record and interview with staff, the laboratory failed to ensure that the Lab LIMS Sample Window solicited the correct collection times of specimens for 4 of 4 patients reviewed, as evidenced by: In review of the 4 patient testing records, the collection time is different or missing in the requisition form comparing to the Lab LIMS Sample Window. a. Sample # 1510686 default collection time @ 6/3/21 in LIMS 02:07:41 PM; in lab requisition form 2119 b. 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 -- Sample # 1506380 default collection time @ 5/24/21 in LIMS 01:44:36 PM; in lab requisition form 08:47 c. Sample # 1511712 default collection time @ 6/8/21in LIMS 02:16:48 PM; in lab requisition form: Blank d. Sample # 1511708 default collection time @ 6/7/21in LIMS 02:15:15 PM; in lab requisition form: Blank During an interview on 6/9/2021 at approximately 1 PM, the laboratory's Technical Supervisor #2 (TS2) confirmed above findings. 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 lack of documentation and interview, the laboratory failed to have a procedure available for the test "TaqPath COVID-19 Combo Kit EUA Method." Findings: 1. During a review of the laboratory's documentation on 6/9/2021, the surveyor could not locate a procedure for "TaqPath COVID-19 Combo Kit EUA Method." 2. During an interview on 6/10/2021 around 10:30 am TS#2 confirmed that a procedure was unavailable for this test method and that this test method. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observations and interview, the laboratory failed to label reagents and material with proper expiration dates. During a laboratory tour on 6/8/2021 at 10:30 am reagent labels read: 1- W8-1 Water Thermo Scientific Lot 185459 opened date 2 /25/2019. 2- Formic Acid EMSURE 98-100% CAS No: 64-18-6 Received date 10/12. 3- 3% H2O2 (Hydrogen peroxide) lot 127863 dated 12/17/18 (Handwritten label). 4- No expiration dates indicated for 1, 2 and 3. During an interview on 6/8/2021 at approximately 12 PM, the laboratory's Technical Supervisor #3 (TS3) confirmed above findings. 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 -- 2 of 4 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to verify performance specifications prior to patient testing for SARS-CoV-2 PCR testing and SARS-CoV-2 IgM testing. Findings: 1. During a tour of the laboratory on 6/9/2021 it was noted the laboratory has Applied Biosystems 7500 Fast Dx Real-time PCR Instruments (ABI) with the following serial numbers: a. 275000961 b. 275011244 c. 275011803 d. 275030208 e. 275030689 f. 275031535 g. 275031536 h. 275031953 i. 275031955 2. During a record review of "Flu-SC2 Multiplex Verification" on 6/9/2021, it was noted that accuracy was not verified for the following serial numbers: a. 275000961 b. 275011803 c. 275031953 d. 275031955 3. During a record review of "SARS-CoV-2 Thermo Kingfisher verification" on 6/9/2021, it was noted that accuracy was not verified for the following serial numbers: a. 275000961 b. 275031953 c. 275031955 4. TS#2 confirmed the findings during an interview on 6/10/2021 around 10:00 am. 5. During a record review of "Abbott Architect SARS-CoV-2 IgM verification" on 6/9 /2021 around 1pm, it was noted that precision had not been verified prior to patient testing. 6. TS#4 confirmed the findings during an interview on 6/9/2021 around 1:00 pm. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 observation and interview the laboratory failed to maintain calibration up to date to ensure proper calibration for below instruments: 1. A tour of the laboratory on 6/8/2021 at 10:30 AM, where the surveyors found below instruments (Pipettes) out of date for calibration and maintenance: a. Eppendorf 10 Micro litter Pipette; Pipette Serial No I62307H; No sticker b. Eppendorf Pipette; Pipette ID: 2036768; Calibrated: 10/15/19; Next due: Blank c. Eppendorf Pipette; Pipette ID: 4129135; Calibrated: 10 /15/19; Next due: Blank d. Eppendorf Pipette; Pipette ID: 3344267; Calibrated: 10/4 /19; Next due: Blank e. Pipette ID: 161611A; Calibrated: 10/9/19; Next due: 4/9/20 f. Pipette ID: 3524038; Calibrated: 10/16/19; Next due: 4/16/20 g. Pipette ID: 474313; calibrated: 10/16/19; Next due: 4/16/20 h. Pipette Serial No 11000170/V1222; No sticker i. Pipette Serial No 11001450/V1221; No sticker 2. During an interview on 6/8 /2021 at approximately 2 PM, the laboratory's Technical Supervisor #3 confirmed above findings. 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 -- 3 of 4 -- 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 lack of documentation and interview, the laboratory failed to monitor 2 of 2 IQCP plans over time. Findings: 1. During a review of the laboratory's documentation on 6/8/2021 the documents "MQ002 IQCP AST," and "MQ003 IQCP MediaQC," were last updated on 8/26/2019 to reflect the past 12 months of data. 2. During an interview on 6/8/2021 around 12:40pm TS#3 confirmed that the IQCPs had not been monitored over time. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of documentation, record review and interview two technical supervisors failed to evaluate the competency of 5 of 37 personnel during 2019 and 2020. Findings: 1. The laboratory's standard operating procedure (SOP) "Quality Assurance Plan" states under Competency Assessment, "Laboratory Section Managers or other designated technical managers must assess competency for all analyses performed at the DPH Laboratory." 2. Based on lack of documentation the following competency assessments were unavailable at the time of the survey: For the Microbiology section: a. TS#3 was missing TB, Bioterrorism, and Routine Bench competency for 2019 and 2020 b. TP#4 was missing TB and Routine Bench competency for 2020 c. TP#5 was missing Bioterrorism and Routine Bench competency for 2020 d. TP#8 was missing Routine Bench competency for 2020 For the Sexually Transmitted Infections section: a. TS#4 was missing Abbott Architect, Syphilis, and Hologic Panther competencies for 2019 and 2020 3. During an interview with TS#3 on 6/8/2021 around 11 am, she confirmed the findings for the Microbiology section. 4. During an interview with TS#4 on 6/9/2021 around 1 pm, she confirmed the findings for the Sexually Transmitted Infection section. -- 4 of 4 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of manual test requisition form (updated 01/15/2019), LIMS test report #504789 and interview with technical supervisors, the laboratory failed to ensure that collection time was included in the test requisition. The findings included: a. Manual test requisition form , updated 01/15/2019, did not include a data field for collection time. b. Manual test requisition form, updated 01/15/2019, included test requested for bacterial, urine, and stool cultures. c. HCV Quantitative test required separation of serum or plasma from the cells within 6 hours of draw. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially 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 -- available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on reviewing the laboratory's procedure manual (SOP), lack of documentation and confirmation by the testing personnel, the laboratory failed to document that the timer used on the RPR rotator was within the limits established in the SOP of 8 minutes plus or minus 15 seconds. The laboratory also failed to document that two testing personnel read the results of the RPR tests as required in the laboratory SOP. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on reviewing the laboratory's policy for proficiency testing (PT) and lack of documentation, the laboratory director failed to delegate in writing the responsibility to sign PT attestation statements as is required in its PT policy. -- 2 of 2 --