J Lee Md Medical Corporation

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on observation of the Alfa Wassermann ACE Alera (serial number 10020237) chemistry analyzer, review of 2022 -2024 proficiency testing reports from AAB (American Association of Bioanalysts) and CMS (report 155D, Individual Laboratory Profile), and laboratory proficiency testing records; and interview with laboratory personnel, it was revealed that the laboratory failed to attain minimum satisfactory scores of 80% for Calcium. Findings included: a. AAB and CMS reported unsatisfactory scores for Calcium based on the laboratory's unacceptable results, as follows:. Event/Year Score Unacceptable Results -------------------------------------------------------- 3 / 2022 0% 5 out of 5 1 / 2024 60% 2 out of 5 b. Laboratory personnel affirmed (10/29/25 at 2:30 PM) the aforementioned proficiency testing records indicative of unsatisfactory testing. c. The laboratory reported 800 test results annually for Calcium (LAB144A, Laboratory Testing Declaration, 9/14/25). The reliability and quality of results reported for Calcium during the timeframes September -December 2022 and January - April 2024, could not be assured duting this Survey. Laboratory personnel affirmed (10/29/25 at 2:30 PM) the monthly test volumes. Several results randomly selected for review are, as follows. Month Total test Date Sample ID volume ------------------------------------------------------ 2022 Sept 200 9/08/22 103282 2022 Dec 290 12/08/22 104425 2024 Jan 400 1/05/24 109025 2024 Feb 320 2/01/24 109361 . D2121 HEMATOLOGY CFR(s): 493.851(a) 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 -- (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on observation of the Cell Dyn 1800 (serial number 19406AY) hematology analyzer, review of 2024 proficiency testing reports from AAB (American Association of Bioanalysts) and CMS (report 155D, Individual Laboratory Profile), and laboratory proficiency testing records; and interview with laboratory personnel, it was revealed that the laboratory failed to attain minimum satisfactory scores of 80% for Red Blood Cell Count (RBC). Findings included: a. AAB and CMS reported the unsatisfactory score of 60% for the 1st Event of 2024 based on the laboratory's 2 unacceptable results out of 5 for RBC. b. Laboratory personnel affirmed (10/29/25 at 2:30 PM) the aforementioned proficiency testing records indicative of unsatisfactory testing. c. The reliability and quality of results reported for RBC during the timeframe January - April 2024, could not be assured during this Survey. The laboratory reported 600 test resulats annually (LAB144A, Laboratory Testing Declaration, 9/14/25). Several randomly selected for review are, as follows: Date Sample ID ------------------------------------------------ 1/05/24 109025 2/01/24 109361 " 109368 " 109374 . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation of the TheraTest Laboratories Inc test system (serial number 2801) utilizing ELISA methodology, review of proficiency testing reports from CAP (College of American Pathologists), API (American Proficiency Institute), and AAB (American Association of Bioanalysts) for 2022 - 2024, laboratory proficiency testing records and records for alternate methods for verifying accuracy of testing, and interview with laboratory personnel, it was revealed that the laboratory failed to verify the accuracy of testing for Vitamin D in 2022, 2023, and 2025; CRP-HS (C-Reactive Protein, High Sensitivity) in 2024, and the following ANA (Anti-Nuclear Antibodies) analytes in 2022, 2023, and 2024: ssDNA RNP/Sm Chromatin dsDNA SSA (Ro) Scl- 70 Sm SSB (La) Centromere a. VITAMIN D 1. In 2022, the laboratory participated in CAP's proficiency testing program as their chosen means to verify the accuracy of testing for Vitamin D. In 2023 - 2025, the labortory switched to participating in API's program. The laboratory reported unacceptable results indicating unsatisfactory testing and failed to verify accuracy of testing, as follows: Program Event Unacceptable Results Score --------------------------------------------------------- CAP A/ 2022 2 out of 3 = 33% CAP B/ 2022 3 out of 3 = 0% API 1 / 2023 1 out of 2 = 50% API 2 / 2025 0 out of 2 = 0% 2. Laboratory personnel affirmed (10/29/25 at 1:30PM) the aforementioned unacceptable results and unsatisfactory scores. 3. The laboratory failed to provide for review any additional records utilizing alternate means to verify the accuracy of testing for Vitamin D during 2022, 2023, and 2025. 4. And thus, the laboratory failed to prove that testing for Vitamin D was accurate during all of 2022, the first half of 2023 and the second half of 2025. 5. The reliability and quality of -- 2 of 4 -- results reported for Vitamin D in 2022, 2023, and 2025 could not be assured during this Survey. The laboratory reported 300 results annually (LAB116 Laboratory Testing Declaration, 9/14/25). A few results randomly selected for review are, as follows: Date Sample IDs ------------------------------------------------- 3/06/22 273635; 273637; 273642 4/03/22 2737440 5/21/22 2737514; 2737642 1/14/23 2738832 3/05 /23 2739216 5/21/23 2739438; 2739632 8/02/25 81644 9/06/25 81647 10/18/25 81926 b. CRP-HS 1. In 2024, the laboratory participated in AAB's proficiency testing program for CRP-HS as their chosen means to comply with this regulation to verify the accuracy of non-regulated analytes. 2. For the 3rd Event of 2024, the laboratory received two unknowns for testing and reported 1 unacceptable result out of 2 for an unsatisfactory score of 50%. 3. Laboratory personnel affirmed (10/29/25 at 1:30PM) the aforementioned findings. 4. The laboratory failed to provide for review any additional records utilizing alternate means to verify the accuracy of testing for CRP- HS during 2024. 5. And thus, the laboratory failed to prove that testing for CRP-HS was accurate during the timeframe September - December 2024. 6. The reliability and quality of results reported for CRP-HS could not be assured during this Survey. The laboratory reported 600 results annually (LAB116 Laboratory Testing Declaration, 9 /14/25). c. ANA/9 1. In 2022: the laboratory participated in CAP's program, "S2 - Special Immunology", as the chosen means to comply with this regulation. The S2 program didn't include testing for ssDNA, Chromatin, SCL-70, and Centromere. i. The laboratory failed to provide for review any records for alternate means of verifying the accuracy of testing for ssDNA, Chromatin, SCL-70, and Centromere in 2022; and thus, the laboratory failed to verify accuracy of testing during 2022. 2. In 2023: the laboratory participated in TheraTest Laboratories, Inc's proficiency testing program for ssDNA, Chromatin, Centromere, and Scl-70 as the chosen means to verify the accuracy of testing. i. The laboratory failed to have records from TheraTest evaluating/scoring results for dsDNA, Sm, RNP/Sm, SSA (Ro), and SSB (La); and thus, the laboratory failed to verify accuracy of testing for these five analytes in 2023. 3. In 2024: the laboratory failed to have records verifying the accuracy of testing for all nine analytes: ssDNA, dsDNA, Sm, RNP/Sm, SSA (Ro), SSB (La), Chromatin, Scl-70, and Centromere; and thus, it was revealed the laboratory failed to verify the accuracy of testing during 2024. 4. The reliability and quality of results reported in 2022 - 2024 could not be assured. The laboratory reported a combined total of 4,500 results annually (LAB116 Laboratory Testing Declaration, 9/14/25). A few randomly selected from the afrementioned timeframes are, as follows: Date Sample ID ------------------------------ 2/05/22 273479 3/20/22 2737268 4/16/22 2737495 7/10/22 2738005; 2738008 11/20/22 2738581; 2738585 3/25/23 2739319 7/15/23 2739917 12 /26/23 2740417 3/17/24 2741062 9/02/24 27420574 10/26/24 80181 12/14/24 80485 . D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical -- 3 of 4 -- parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on observation of the Alpha Wassermann ACE Alera chemistry analyzer, review of the GEMCAL Calibrator Reference Serum (Lot # F4770, Exp Date 11/30 /25), the lack of records, and interview with the Testing Person, it was determined that the laboratory failed to verify assay calibrations at least once every six months. Findings included: a. Following the manufacturer's instructions, the analyzer was calibrated using Alpha Wasserman's GEMCAL Calibrator consisting of a single reference concentration. b. Records documented the calibrations were verified, as follows: Dates of Calibration Verification ------------------------------------------------ 6 /23/23 7/11/24 7/11/25 c. The laboratory failed to have additional records verifying calibrations. Laboratory personnel affirmed (10/29/25 at 5 PM) the aforementioned dates and that calibrations were verified once per year. d. And thus, the laboratory failed to comply with this requirement to perform calibration verifications at least once every 6 months. e. The reliability and quality of results obtained using the Alpha Wasserman test system could not be assured in 2022 - June 2025. The laboratory reported a combined total of 9,450 chemistry results annually (LAB116 Laboratory Testing Declaration, 9/14/25). A few randomly selected from this timeframe for review are, as follows: Date Sample ID ------------------------------------------------ 8/25 /22 103140 9/08/22 103282 12/08/22 104425 12/05/23 108689 1/05/24 109025 2/01 /24 109374 . D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on the serious and cumulative nature of deficiencies cited, the Laboratory Director is herein cited for not ensuring acceptable test performances in 2022 - 2025. Findings included: a. Under the Laboratory Director's management, the laboratory failed to maintain satisfactory testing for Calcium. See D2087. b. Under the Laboratory Director's management, the laboratory failed to maintain satisfactory testing for RBC. See D2121. c. Under the Laboratory Director's management, the laboratory failed to verify that testing was accurate. See D5217. d. Under the Laboratory Director's management, the laboratory failed to verify calibrations at least once every six months. See D5439. -- 4 of 4 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, the proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed RF (Rheumatoid Factor) qual and enrolled with CAP (College of American Pathologist) proficiency testing (PT) program to verify the accuracy of the testing system. b. The laboratory attained a score of 60 % for RF in the Q1 2020 CAP Diagnostic Immunology PT program which was unsatisfactory analyte performance for the testing event. c. The laboratory performed in approximately 35 patient samples monthly. d. The laboratory staff affirmed (4/27/22 @11:10 am) that the laboratory attained a score of 60 % for RF qual in the Q1 2020 CAP Diagnostic Immunology PT program which was unsatisfactory analyte performance for the testing event. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, the proficiency testing (PT) result 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 -- and interview with the laboratory staff, it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event was unsatisfactory analyte performance for the testing event. The findings included: a. The laboratory performed routine chemistry using ACE Wasserman system and enrolled with AAB (American Association of Bioanalysts) proficiency testing (PT) program to verify the accuracy of the testing system. b. The laboratory attained a score of 60 % for GGT (gamma glutamyl transferase) in the Q2 2021 AAB PT program which was unsatisfactory analyte performance for the testing event. c. The laboratory performed GGT in approximately 42 patient samples monthly. d. The laboratory staff affirmed (4/27/22 @10:10 am) that the laboratory attained a score of 60 % for GGT (gamma glutamyl transferase) in the Q2 2021 PT program which was unsatisfactory analyte performance for the testing event. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, the proficiency testing (PT) result reports, and interview with the laboratory staff, it was determined that the laboratory failed to verify the accuracy of any test or procedure it performs that is not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed hs CRP is not listed in the subpart I of 42 CFR part 493, by ACE Wasserman system. b. The laboratory elected to enroll with AAB (American Association of Bioanalysts) PT program to verify, at least twice annually, the accuracy of the testing system. b. The laboratory attained scores of 0 % for hs CRP in both of Q1 and Q2 2021 AAB PT events, which were unsatisfactory analyte performance for the testing events. c. The laboratory performed hs CRP in approximately 154 patient samples monthly. d. The laboratory staff affirmed (4/27/22 @10:10 am) that the laboratory attained scores of 0 % for hs CRP in both of Q1 and Q2 2021 AAB PT events were unsatisfactory analyte performance. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, the instrument verification documents, and interview with the laboratory staff, it was determined that the laboratory failed to have the current laboratory director approved, signed, and dated for procedures or changes in procedures before use. The findings included: a. The laboratory was moved to a new location. b. The laboratory had performed verifications for the existing instruments for ACE Wasserman and Celldym 1800 systems. c. There were no evidence that the current laboratory director had approved, signed, and dated the verification documents. D6016 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the laboratory's records, the proficiency testing (PT) resault reports and interview with the laboratory staff, it was determined that the laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of this part. The findings included: a. The laboratory performed routine chemistry, hematology, and general immunology. b. The laboratory elected and enrolled its PT with 1) AAB (American Association of Bioanalysts), 2) CAP (Colleage of American pathologists) to verify the accuracy of the test systems and proccedures it performed to verify and ensure the accuracy of the patient test results reports. c. The laboratory director failed to ensure that the proficiency testing samples were tested as required under Subpart H of this part, see D-2075, D-2087 and D-5217. -- 3 of 3 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2020) event of the College of American Pathologists (CAP) proficiency testing records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Rheumatoid Factor (RF). The findings included: 1. For Q1-2020, CAP reported score of 20% for RF analyte. 2. Based on the laboratory's annual testing declaration for 2018-2020 the laboratory analyzed and reported 150 RF tests during the time the laboratory had unsatisfactory proficiency testing results. c. The TP affirmed (09/29/2020) the laboratory received the above unsatisfactory proficiency testing score. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the first quarter (Q1-2019) event of the American Association of Bioanalysts (AAB) proficiency testing records and interview with the testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for Alkaline Phosphatase. The finding included: 1 For Q1-2019, AAB reported an unsatisfactory score of 40% for the Alkaline 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 -- Phosphatase test. The laboratory failed to report an acceptable test value for three (3) out of five (5) tested samples: Sample # Reported Acceptable Range 1 77 82-152 2 26 71-132 5 20 23-42 2. Based on the laboratory testing declaration submitted at the time of the survey on 09/29/2020 for 2018-2020 the laboratory analyzed and reported approximately 600 Alkaline Phosphatase tests during the time the laboratory had unsatisfactory proficiency testing results. 3. The TP affirmed 09/29/2020 at approximately 11:00 a.m. that the laboratory received the above unsatisfactory proficiency testing score. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of laboratory written policies and procedures and interview with the laboratory director (LD) and testing personnel (TP), it was determined that the laboratory failed to establish and follow written procedures for Hematology and Chemistry. The findings included: 1. On the day of the survey 09/29/2020 at approximately 1:30 p.m. the laboratory failed to provide written policies and procedures for Hematology and Chemistry. 2. For eight (8) out of eight (8) random patient test results reviewed covering period from January 01/11/2019 to 09/21/2020, four (4) patients had Hematology and Chemistry tests ordered, analyzed, and reported for which the laboratory had no policies and procedures written. 3. The LD and TP confirmed on 09/29/2020 at approximately 2:00 p.m. that the laboratory lacked established written policies and procedures for Hematology and Chemistry. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on the lack of documentation of critical values, critical or life threatening test reporting protocol, and interview with the testing personnel (TP); it was determined that the laboratory failed to document, establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. The findings included: 1. On the day of the survey 09/29/2020 at approximately 11:00 a.m. based on document review; the surveyor found that the laboratory had no policy available or procedure established as to what were the laboratory's critical values for both Chemistry and Hematology. 2. The laboratory had no policy and procedure established as to when to inform provider and documentation of follow up of a critical or life threatening result. 3. For one (1) out of eight (8) random patient test results reviewed covering period from 01/11/10 to 09/14/2020 critical values results reporting for CBC were not documented. 4. The TP -- 2 of 3 -- affirmed (09/29/2020) that the laboratory has not established policy or written procedure for critical values and the steps to take to inform the providers. 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 review of laboratory documnetation records and interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that the quality assessment programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings included: See D-5791 D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. This STANDARD is not met as evidenced by: Based on interview with the laboratory director and testing personnel on September 29, 2020 at approximately 2:00 p.m., the laboratory director failed to ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. Findings include: 1. The laboratory did not have a policy or procedure covering reporting of critical values/abnormal test results. See D5791. 2. The laboratory fail to find written policies and procedures for Chemistry and Hematology. See D 5401. -- 3 of 3 --

Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of 2017: event 2 proficiency testing reports from CMS (report 155D, Individual Laboratory Profile) and CAP (College of American Pathologists), laboratory proficiency testing documents, and patients test records; and interview with laboratory personnel, the laboratory failed to attain a score of at least 80% for the ANA screening test (Anti-Nuclear Antibody) using the high-complexity TheraTest system. Findings include: a. CMS and CAP reported the score of 60% for ANA testing for the 2nd event of 2017. b. Laboratory proficiency testing records revealed the laboratory obtained 2 unacceptable results out of 5 on 9/12/17, as follows: Sample ID Lab result Acceptable result ---------------------------------------------------------------- ANA-07 Positive Negative ANA-10 Positive Negative c. Laboratory personnel affirmed (2/20/18) the aforementioned unsatisfactory results and score; and thus, unsatisfactory testing for ANA. d. The reliability and quality of patients results reported could not be assured. Based on the stated estimated annual test volume, the laboraotry reported approximately 38 ANA results each month during the timeframe September to November 2017. A few examples are as follows: Date Sample ID ----------------------------------- 8/13/17 7063 8/13/17 7084 9/12/17 7146 9/25/17 7192 10/01/17 7294 10/01/17 7332 . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 -- This STANDARD is not met as evidenced by: Based on review of 2016 - 2017 proficiency testing reports from DEQAS (Vitamin D External Quality Assessment Scheme), laboratory proficiency testing records, and patients test reports; and interview with the Laboratory Director/Technical Consultant, the laboratory failed to verify the accuracy of testing for Vitamin D using the TheraTest ELISA system. Findings include: a. The laboratory chose to participate in DEQAS' proficiency testing program as the means to satisfy the requirement to verify the accuracy of testing using the Euroimmun 25-OH Vitamin D Kit. b. The laboratory reported 5 unacceptable results out of 5 in 2016 and 2017; as follows, and thus, accuracy was not verified: Date Specimen # Reported Target --------------------------------------------------------- 11/06/16 501 56.3 96.2 " 502 23.8 40.0 " 503 50.0 80.6 " 504 32.5 57.6 " 505 12.5 21.7 8/12/17 516 31.8 46.5 " 517 44.5 68.3 " 518 77.3 105.0 " 519 22.8 33.2 " 520 78.8 104.1 c. The Laboratory Director /Technical Consultant affirmed (2/20/18) the aforementioned unacceptable results, which were all lower than the Target values. d. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 15 Vitamin D results each month during the timeframes November 2016 - January 2017, and August - September 2017. A few examples are as follows: Date Sample ID ----------------------------------- 11/06/16 4989 " 5013 " 5016 12/27/16 6095 " 6102 " 6107 8/12/17 7000 " 7009 " 7123 -- 2 of 2 --