Md Dept Of Health

Summary Statement of Deficiencies D0000 Federal surveyors from the Centers for Medicare & Medicaid Services (CMS) conducted an announced CLIA recertification survey at the MD Department of Health from April 16, 2024 to April 18, 2024. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following deficiencies were found during the announced routine CLIA recertification survey performed from April 16, 2024 to April 18, 2024. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview with Technical Supervisor #2 (TS #2), the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate the submitted results for one of 20 events. Findings include: 1. Record review on 04/17/2024 of 2022 and 2023 proficiency testing records revealed the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate the submitted results for one of 20 events. a. 2022 FrozenMicro 1 Event - five of five results (BOR-1, BOR-2, BOR-3, BOR-4, BOR-5) were not graded by the proficiency testing program. In the "Performance Summary" report under "Comments" stated, "Not scored". A review of the "2022 FrozenMicro 1 Event Notes" under the section, "Event Specific Information:" stated, "Not scored samples receive a 100% score but this may not be indicative of instrument/method performance and labs must perform an internal written self-evaluation to satisfy the regulatory/accreditation requirements." 2. Record review on 04/17/2023 of 2022 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 -- Frozen Micro 1 Event proficiency testing records revealed no evidence the laboratory documented a self-evaluation of non-graded results. 3. Interview with TS #2 on 04/18 /2023 at 12:20 pm confirmed the findings above. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, written laboratory policy and procedures, patient test requisitions, patient test reports, and interview with Technical Supervisor #2 (TS #2), the laboratory failed to follow written policies and procedures for handling and transporting specimens submitted for Carbapenemase testing for three of three patient reports. Findings include: 1. Review on 04/17/2024 of the "GeneXpert Carba-R" assay manufacturer's instructions revealed the following under "Sample Preparation and Storage" stated, "Rectal Swab Samples: Swabs in the transport tube can be stored at 15-28 C for up to five days." 2. Review of the laboratory's written policy and procedures revealed the following under "Cepheid Xpert CARBA-R SOP" section "Acceptable specimens:" stated, "1. The swabs are stable at 15-28 C for up to five days." 3. Record review of patient test requisitions and patient reports tested on 02 /23/2024 revealed the following for three of three patients: a. Patient specimen number A24517881 - Collected on 02/22/2024, received in the laboratory on 02/23 /2024 at 13.9C (colder than the minimum acceptable temperature), and reported on 02 /26/2024. b. Patient specimen number A24517880 - Collected on 02/22/2024, received in the laboratory on 02/23/2024 at 13.9C, and reported on 02/26/2024. c. Patient specimen number A24517881 - Collected on 02/22/2024, received in the laboratory on 02/23/2024 at 13.9C, and reported on 02/26/2024. 4. Interview with TS #4 on 04/18/2024 at 12:25 pm, confirmed the findings above. 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 observation, review of the Remel Lowenstein-Jensen (L-J) Medium manufacturer's instructions, and confirmed in interview with the TS of mycobacteriology, the laboratory failed to ensure manufacturer's instructions were followed for storage/stability for 100 of 100 L-J media slants. Findings included: 1. Review of Remel Lowenstein-Jensen (L-G) Medium IFU 8500 package insert states, "Limitations: 1. Media containing malachite green, such as L-J Medium, is photosensitive an should not be exposed to light during storage." 2. During a tour of -- 2 of 6 -- the Microbiology department media room on 4/18/2024 at 1:32pm, 100 tubes of Remel L-J media, slant tubes, Lot 798843, expiration date 2025-02-05, were observed in storage exposed to light. 3. During an interview on 4/18/24 at 1:33 pm, the TS of Mycobacteriology stated the L-J media slant tubes were not protected from light in the transparent refrigerators prior to inoculation, and confirmed the findings above. 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. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, and confirmed in an interview with the TS, the laboratory failed to monitor and document the room temperature requirements for 16 of 16 reagents stored in supply room 551. Findings included: 1. During a tour of the laboratory's microbiology section on 4/17/2024 at 1: 32pm, the following were observed in room 551 without temperature monitoring and documentation: a. One box BD BBL TB Auramine - Rhodamine T, Lot 3164265, expiration date 2024-05-31; manufacturer storage temperature requirements: 15-30C. b.Two boxes of BD TB Decolorizer, Lot 3306420, expiration date 2024-10-31; manufacturer storage temperature requirements: 15 - 30C. c. Two boxes of BD BBL TB Potassium Permanganate, expiration date 2024-11-30; manufacturer storage temperature requirements: 15-30C. d. Three boxes of BD TB Methylene Blue, expiration date 2024-11-30; manufacturer storage temperature requirements: 15-30C. e. Four boxes of BD BBL MycoPrep Kit, expiration date 2025-01-02; manufacturer storage temperature requirements: 15-25C. f. Four boxes of Sensititre Demineralized Water, expiration date 2026-03-26; manufacturer storage temperature requirements: 15 - 30C. 2. In direct observation, there was no thermometer placed in room 551. 3. During an interview on 4/17/24 at 1:56 pm, the TS stated that they did not monitor and document room temperature. *** Word Key: C = Celsius. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on manufacturer's instructions, direct observation,QC gram stain testing records, and interview with Technical Supervisor #1 (Microbiology) , the laboratory failed to ensure gram stains reagent (safranin) was not used passed its expiration date and used for 85 patients from testing date 3/5/2024 to the date of the survey as evidenced by: 1. In review of the manufacturer's instructions for the remel gram stain kit, under product deterioration states, "This product should not be used if... (2) the -- 3 of 6 -- expiration date has passed...". 2. In direct observation at 1002 on April 17, 2024 in the microbiology lab 5th floor, the remel safranin lot #122743 expiration date March 1, 2024, had a sign on it "for research only" and was available for patient use. 3. In review of the gram stain QC records from testing date 3/5/2024 to date of the survey showed: - lot #122743 safranin was used for 85 patients. 4. In interview with Technical Supervisor #1 (CMS-209, microbiology) at 1100 in the laboratory stated that he was aware that the safranin had expired, they had ordered more kits from thermal fisher but the gram stain kits were back ordered. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially 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 record review and interview with Technical Supervisor #4 (TS #4), the laboratory failed to ensure 15 of 15 Molecular Biology centrifuges were functioning properly for one of one function checks from January 2023 through December 2023. Findings include: 1. A record review on 04/18/2024 of the 2023 "Division Of Molecular Biology Section: Molecular Diagnostics Laboratory Centrifuges - Quality Control Record Form" revealed no evidence the times were checked for 15 of 15 centrifuges: a. Fisher Scientific - Serial Number 41779777. b. Heraecus (Biofuge Pico) - Serial Number 40250907. c. Beckman Coulter - Serial Number ALK14M02. d. Beckman Coulter - Serial Number GD93D01. e. Beckman Coulter - Serial Number ALK02G02. f. ThermoFisher Sorvall Pico - Serial Number 40511342. g. ThermoScientific - Serial Number 41293508. h. Fisher Scientific - Serial Number 41765826. i. Thermo Fisher 17 - Serial Number 41765817. j. Thermo Fisher 17 - Serial Number 41773028. k. Thermo Fisher - Serial Number 41765830. l. Thermo Fisher - Serial Number 41765827. m. Thermo Fisher - Serial Number 41773026. n. Beckman Coulter - Serial Number ALK99L21. o. Thermo Fisher - Serial Number 41773027. 2. Interview with TS #4 on 04/18/2024 at 12:40 pm confirmed the laboratory performed a function check for the above centrifuges annually. 3. Interview with TS #4 on 4/18/2024 at 12:45 pm confirmed the laboratory failed to verify the time for 15 of 15 Molecular Biology centrifuges for one of one function checks. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. -- 4 of 6 -- This STANDARD is not met as evidenced by: Based on a review of the Legionella Culture procedure, the serology quality control (QC) records and an interview with the Technical supervisor (TS) #17, the laboratory failed to document each batch/shipment of Pathcon Buffered Charcoal Yeast Extract (BCYE) media and Fisher BCYE polymyxin B, vancomycin and anisomycin (PAV) media used for Legionella Culture for its selectivity, inhibition, and biochemical response and to perform at least one negative organism a for each lot used from April 27, 2022, to April 10, 2024. Finding Include: 1. A review of the BCYE and BCYE/ PAV media on April 18, 2024 at 12:55 am, revealed, the documented QC did not include a description of selectivity, inhibition, and biochemical response seen for 24 of 24 lots of the Pathcon BCYE media and 24 of 24 lots of the Fisher BCYE/ PAV used from April 27, 2022, to April 10, 2024. 2. A review of the Legionella Culture procedure revealed, the laboratory did not include the use of at least one negative organism to confirm the inhibitory/biochemical characteristic for the BCYE and BCYE/ PAV selective media. 3. From April 27, 2022, to April 10, 2024, 24 lots of Pathcon BCYE media and 24 lots of Fisher BCYE/ PAV media were used for patient testing. 4. An interview with TS#17 (Form CMS 209, Page 9) confirmed the finding above on April 18, 2024, at 1:05 pm. 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 record review and interview with Technical Supervisor #2 (TS #2) and Technical Supervisor #4 (TS #4), the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results for molecular diagnostic testing using four ABI 7500 Fast Dx RT PCR analyzers during the review period of January 2023 through December 2023. Findings include: 1. Record review on 04/18/2024 of the molecular diagnostics test menu revealed the laboratory performed Arbovirus/Encephalitis, Bordetella pertussis, Bordetella parapertussis, Bordetella holmesii, Chikungunya Virus, Dengue Virus, Herpes Simplex Virus, CDC Influenza AB Screening/A Subtyping/B Genotyping, Sars-CoV2-CDC Flu/SC2 Multiplex Assay, and Zika Virus testing using ABI 7500 Fast Dx RT PCR analyzers. 2. Interview with TS #4 on 04/18/2024 at 11:00 am confirmed the Arbovirus /Encephalitis, Bordetella pertussis, Bordetella parapertussis, Bordetella holmesii, Chikungunya Virus, Dengue Virus, Herpes Simplex Virus, CDC Influenza AB Screening/A Subtyping/B Genotyping, Sars-CoV2-CDC Flu/SC2 Multiplex Assay, and Zika Virus testing using four ABI 7500 Fast Dx RT PCR analyzers (ABI #1 Serial Number 27500820, ABI #2 Serial Number 275010609, ABI #3 Serial Number 275011712, ABI #5 Serial Number 275030148). 3. Record review on 04/14/2024 from January 2023 through December 2023 revealed no evidence the laboratory evaluated and defined the relationship between the four ABI 7500 Fast Dx RT PCR analyzers twice a year. 4. Interview with TS #2 and TS #4 on 04/18/2024 at 11:30 am confirmed the above findings. -- 5 of 6 -- D5781

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel competency assessment records and interviews with laboratory managers and technical supervisors (TS) on 4/20/2022 at 8: 30 and 10:30 am, the laboratory failed to follow written policies and procedures to assess the competency for all testing personnel (TP) and establish written policies and procedures to assess TS and general supervisors (GS) for competency in 2020 and 2021. Findings Included: 1. The Laboratories Administration Quality Assurance Manual V2.0.7, C. Divisions - Technical Training and Competency, 2. Employee Continuing Competency states, "Environmental and Clinical testing personnel must demonstrate competency at least annually for each procedure they are trained to perform and when a test methodology or instrumentation changes". 2. On the day of survey, 04/20/2022 at 8:30 and 10:30 am, review of a sampling of competency assessment records revealed, the laboratory failed to perform all TP competency assessments annually in 2020 and 2021. 3. Review of the Administration employee continuing competency policy and MDH Laboratories Administration Quality Assurance Manual revealed, the laboratory did not establish a TS or GS competency assessment policy. 4. During the summation on 4/21/2022 at 5:00 pm, the laboratory confirmed they did not follow their written policy to assess testing personnel TP for competency assessment and did not establish a written policy to assess TS and GS for competency. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the number and severity of the deficiencies cited herein, the Condition: Analytic Systems was not met. The laboratory failed to monitor and document the defined conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting (see D5413), establish test performance specifications for its HIV-1 NAAT Assay test system before reporting patient HIV-1 NAAT Assay test results (see D5423), perform maintenance as defined by the laboratory and/or manufacturer (see D5429), and ensure that for each test system the laboratory had control procedures that monitor the accuracy and precision of the complete analytic process (see D5441). 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. This STANDARD is not met as evidenced by: Based on laboratory personnel interview and document review of logs for refrigerators, freezers, and ambient room temperatures, the laboratory failed to monitor temperatures to ensure the proper operation of test systems. Findings included: 1. Review of the Temperature Log for the refrigerator and freezer (ID#00062392) being used to store reagents and samples and confirmation by interview of TS and GS 4/20/2022 at 10:30 AM showed: i. Missing temperature recordings for 2/16/2022 and 3/7-3/9/2022. ii. No monthly sign off as indicated by required log data slot and no indication of who was designated to review on the log or other policy. 2. Review of the Temperature Log Room 421 and confirmation by interview of TS and GS 4/20/2022 at 10:30 AM showed: i. Missing temperature recordings for 2/16/2022 and 3/7-3/9/2022. ii. No monthly sign off as indicated by required log data slot and no indication of who was designated to review on the log or other policy. 3. According to laboratory personnel interviews with TS from 4/20/2022 and confirmation by review of submitted data on the CMS CLIA 116 form, the laboratory performed and reported approximately 435,393 Virology and 94,999 General Immunology assays annually. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) -- 2 of 4 -- 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: Based on laboratory personnel interviews and a record review of the laboratory's HIV- 1 NAAT Assay test system policies, procedures, and test specifications data on April 21, 2022, the laboratory failed to establish test performance specifications before reporting patient HIV-1 test results. Findings included: 1. Review of the laboratory test result report (Specimen Number A22005227001) and interview with the TS on 4 /21/2022 at 10:00 AM confirmed that the HIV-1 NAAT Assay is a Laboratory Developed Test. 2. Review of available laboratory documents, interview with the TS on 4/21/2022 at 10:00 AM, and follow up interview with the LD on 4/21/2022 at 4:05 PM, showed that the laboratory was only able to provide the raw data for the validation of the HIV-1 NAAT Assay and was unable to provide a validation showing that the laboratory had established performance specifications for this assay. 3. According to laboratory personnel interviews with TS from 4/21/2022 and confirmation by review of submitted data, the laboratory performed and reported approximately 8 patient HIV-1 NAAT Assays between 3/2020 and 4/2022. 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: A. Based on review of the Becton Dickinson FACS Calibur Flow Cytometry analyzer maintenance records, review of Becton Dickinson FACS Calibur Flow Cytometry user manual and interview with the technical supervisors (TS) on 4/21/2022 at 3:00 PM, the laboratory failed to follow the manufacturer user manual and document monthly maintenance for the Becton Dickinson FACS Calibur Flow Cytometry analyzer in 2020, 2021 and 2022. Finding Included: 1. The Becton Dickinson FACS Calibur Flow Cytometry analyzer maintenance log lists nine maintenance tasks to be performed on a monthly basis. 2. The The Becton Dickinson FACS Calibur Flow Cytometry analyzer maintenance log states, "Maintenance schedule is in accordance with manufacturers user manual preventative maintenance schedule ( FACSCaliber user manual)". 3. Review of the Becton Dickinson FACS Calibur Flow Cytometry analyzer maintenance records on 4/21/2022 at 2:50 PM revealed, the laboratory did not document monthly maintenance tasks performed in 2020, 2021 and 2022. 4. The TS confirmed the findings above on 4/21/2022 at 3:30 PM. B. Based on review of the M2000sp Maintenance Log SN10489 (3 of 3 months reviewed), review of M2000rt System Maintenance Log SN275021267 (9 of 10 months reviewed), and confirmed by -- 3 of 4 -- interview with the technical supervisor (TS) on 4/21/2022 at 8:30 AM, the laboratory failed to follow the manufacturer and laboratory requirements for performing and documenting weekly maintenance. Findings Included: 1. The M2000sp System Maintenance Log SN10489 requires the performance and documentation of weekly maintenance. i. Review of the March 2021 maintenance log showed that while testing was performed, weekly maintenance was not performed or documented for weeks 1,3, and 4. ii. Review of the June 2021 maintenance log showed that while testing was performed, weekly maintenance was not performed or documented for weeks 1,2, and 3. iii. Review of the March 2022 maintenance log showed that while testing was performed, weekly maintenance was not performed or documented for weeks 1,2, and 3. 2. The M2000rt System Maintenance Log SN275021267 requires the performance and documentation of weekly maintenance. i. Review of the January to June 2021 maintenance logs showed that while testing was performed, weekly maintenance was not performed or documented during each month. ii. Review of the January to June 2022 maintenance logs showed that while testing was performed, weekly maintenance was not performed or documented during each month (Except for Week 4 in February and March). 3. Based on information provided by the laboratory on the CMS CLIA 116 form and confirmation by the TS on 4/21/2022 at 8:30 AM, the laboratory performs approximately 435,393 Virology tests annually. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manuals for virology tests run on the 7500 Fast Dx Real Time PCR Instruments, review of 7500 Fast Dx Real Time PCR Instrument quality control (QC) records, and interview with the technical supervisor (TS) and laboratory director (LD), the laboratory failed to establish QC performance specification procedures for lot to lot QC performed for SARS-CoV2, Influenza, HSV, and Arbovirus tests run on the 7500 Fast Dx Real Time PCR Instruments from March 5th, 2020 to April 21st, 2020. Findings Included: 1. Review of the 7500 Fast Dx Real Time PCR Instruments QC records revealed, the following test assays used floating means with no established ranges: a. SARS-CoV2 -CDC FluSC2 Multiplex Assay. b. SARS-CoV2 Thermo Taqpath Multiplex Assay. c. Influenza. d. HSV. e. Arbovirus PCR Testing. 2. On 04/21/2022 at 3:00 pm, the TS confirmed there were no established QC performance procedures in use describing the laboratories process for floating means without establishing ranges, which was reaffirmed by the LD. 3. The CMS CLIA 116 form signed by the laboratory director on April 8th, 2022, states the laboratory performed and reported approximately 435,393 Virology tests a year. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the Maryland Department of Health Laboratory on March 3-5, 2020 by the CMS Philadelphia location CLIA surveyors.The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. 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 the CAP (College of American Pathologists), D (Bacteriology) 2018 and 2019 proficiency testing (PT) records, patient testing records and interview with the Bacteriology Technical Supervisor 2 (TS2), the laboratory did not test the proficiency testing samples it receives from the PT program in the same manner as it tests patient specimens. Findings: 1. The Bacteriology, Culture Record for patient revealed patient samples tested only by Identification (ID) by latex Antigen (Ag). 2. The Bacteriology, PT records for CAP (College of American Pathologists), D (Bacteriology) event C for 2018 revealed PT sample with Accession ID# DIAGA18100891 was tested by ID by latex Ag ,VITEK MS Matrix Assisted Laser Desorption Ionization Time-of-Flight (MALDI-TOF) Anaerobic and Aerobic Plated, and Sensititre instrument. Accession ID# DIAGA18100891 appeared on the following testing records: a.The Bacteriology, VITEK MS (MALDI-TOF) Results sheet for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- Accession ID# DIAGA18100891-1 b.Anaerobic Plate results for Accession ID# DIAGA18100891B-1 c.Aerobic Plate results for Accession ID# DIAGA18100891C-1 d.The Bacteriology, Simple Combo Report from Sensititre instrument for Specimen# A18100891001CAP 3. During the survey on 03/03/2020 at 11:30 AM the Bacteriology Technical Supervisor 2 (TS2) confirmed that the laboratory tested PT sample by additional testing methods of MALDI-TOF and Sensititre instrument. 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: Based on record review and interview the laboratory failed to establish and verify performance specifications for 2 of 2 new analytes tested using MAC-ELISA. Findings include: 1.The Powassen Virus MAC-ELISA Performance Evaluation failed to include sensitivity for the assay, and was signed by TS #4 on April 4,2019 and lab director on May 3, 2019. 2. The TS #4 has stated in interview performed on March 3, 2020 that she believed the requirement did not apply because the platform was existing prior to April 24, 2003. 3. The laboratory had performed this test and reported results on 106 patients prior to March 3, 2020. 4. The Jamestown Canyon Virus MAC- ELISA Performance Evaluation signed by the TS#4 on August 23, 2019 and laboratory director on August 28, 2019 lacked establishment of analytic sensitivity and specificity. The evaluation included testing of only serum samples. 5. TS#6 stated during interview at approximately 8:50 am on March 4, 2020 that patient testing included the testing of cerebrospinal fluid(CSF) samples. The TS further confirmed that no CSF samples were included in the assay evaluation study. 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 maintenance record review, procedure manual and interview with Technical supervisor (TS#8), the laboratory in the NBS division failed to perform preventative maintenance as defined by the manufacturer for the Quattro Micro API (Ariel) instrument for February 2018. Findings include: 1. Review of Daily Maintenance log records performed on March 3,2020 at approximately 11:50 AM revealed documentation showing "in- line filter changed on 03/24/18". 2. CMS Surveyor -- 2 of 4 -- requested the weekly and monthly maintenance records. At approximately 12:00 PM, TS#8 stated "The weekly maintenance is not needed, we only service the instrument daily and periodically as needed if the TIC(total ion chromatogram) is not accepted." 3. Procedure manual of the Quattro Micro API instrument was reviewed at approximately 12:25 PM, demonstrating daily, weekly, monthly and periodic maintenance is required for the instrument. 4. TS#8 confirmed on March 3, 2020 at 12: 25PM that the laboratory failed to perform maintenance as defined by the manufacturer. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not have control procedures in place that monitor performance of the Autodelfia instrument to determine what factors influence observed changes. Findings include: 1. A review of the quality control (QC) records for January 23, 2018 for the Autodelfia Instrument (1275) of the Newborn and Childhood Services (NBS) division showed for the neo-T4 analytes low control, 7 out of 65 points were greater than 2 standard deviations (SD) outside of QC limits. There was no documentation in the QC records documenting acknowledgement of the erratic low control performance. 2. During an interview on March 5, 2020 at approximately 9:30AM, the technical supervisor (TS#3) explained that as long as 2 of 3 controls are within limits the runs are accepted. TS#3 confirmed that there was no investigation to determine what factors might have influenced the low control performance. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to ensure that the quality assessment programs were maintained consistently among the different laboratory divisions and that

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --