Cardiovascular Association, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 11/13/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Proficiency Institute (API) proficiency testing records, and staff interview, the laboratory failed to have documentation of performing a self-evaluation of analytes that were 'not graded' by the proficiency testing program for three of six Chemistry-Core and three of six Hematology/Coagulation proficiency testing events in 2024 and 2025. Findings include: 1. A review of the American Proficiency Institute's Performance Evaluation revealed the following: "Laboratories should review the Performance Summary and Comparative Evaluation thoroughly for failures or 'not graded' analytes. Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. 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 a review the laboratory's American Proficiency Institute (API) proficiency testing records from 2023, the laboratory's records, and staff interview, the laboratory failed to have documentation of performing twice annual accuracy assessments in 2023 for one of one non-regulated analyte tested on the Beckman Coulter DxI 600 chemistry analyzer. Findings include: 1. A review of the laboratory's API proficiency testing records from 2023 revealed the laboratory failed to have documentation of the analyte B-Type Natriuretic Peptide (BNP) being tested in any of the 3 API chemistry events in 2023. 2. A review of the laboratory's records revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for BNP testing on the Beckman Coulter DxI 600 chemistry analyzer in 2023. 3. Further review of the laboratory's records revealed the laboratory performed an estimated 600 patient BNP tests in 2023. 4. In an interview on 2/13/24 at 11:05 a.m. in the conference room, after review of the records, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- 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 surveyor's observations, review of manufacturer instructions, laboratory's policies/procedures and staff interview, the laboratory failed to document amended expiration or open/preparation dates to ensure reagent stability for 5 of 5 controls /reagents in use observed. Findings included: 1. Surveyors observations on 02/13 /2024 at 0915 hours in the laboratory revealed the following 5 of 5 controls/reagents in use did not have documented open dates or amended expiration dates: a. L1 Coulter 6C Cell Control (Lot: 123175250; expiration date: 2024-03-02) - stored in the refrigerator b. L2 Coulter 6C Cell Control (Lot: 133185250; expiration date: 2024-03- 02) - stored in the refrigerator c. L3 Coulter 6C Cell Control (Lot: 143195250; expiration date: 2024-03-03) - stored in the refrigerator d. Coulter Latron CP-X Control (Lot: 103157330; expiration date: ) - stored on the countertop e. 2 vials labeled Clean B (no lot number or preparation/expiration date annotated on the secondary container) - stored on the countertop 2. In an interview on 02/13/2024 at 0930 in the laboratory, testing person number one confirmed the above controls /reagents were currently in use. 3. Review of manufacturer instructions for the above controls/reagents revealed: a - c. Coulter 6C Cell Control (L1, L2 and L3) manufacturer instructions for use (document A59928-AM, Ref. A59925, 628027) stated: "For opened vial stability, refer to the TABLE OF EXPECTED RESULTS for your system." And, the "Table of Expected Results" stated: "Assumes that the Instruction for Use section of the package insert is performed a maximum of 18 times within 16 days. " The laboratory did not track number of piercings/use of the control vials. d. Coulter Latron CP-X Control manufacturer instructions for use (document A59931-AM, Ref. 628024) stated: "Opened tubes are stable for 30 days when stored at recommended temperatures." e. Clean B solution did not have manufacturer instructions for use. The laboratory did not have on hand ACL Elite instrument's User Manual to determine preparation and/or stability requirements of Clean B solution. 4. Review of laboratory's policies/procedures revealed the laboratory did not address protocols for labeling of controls/reagents with amended expiration or open /preparation dates to ensure that reagents are not used beyond their stability, or to comply with the requirements. 5. In an interview on 02/13/2024 at 0930 hours in the laboratory, the facility's Technical Supervisor confirmed the findings. 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 the review of the manufacturer's training manual, the laboratory's maintenance logs in 2023, CMS 116 application, and confirmed in an interview, the laboratory failed to document 12 of 12 monthly maintenance on Beckman Coulter AU680 Chemistry Analyzer according to the manufacturer's training manual. The findings were: 1. Review the manufacture's training manual titled AU680 Chemistry -- 2 of 4 -- Analyzer In-Lab Training Manual (AU680 In-Lab Training Manual Version 1.0 (February 2016) under Chapter 6 Maintenance page 85 revealed "Monthly maintenance includes the following procedure: -Clean the Sample Probe, Reagent Probe, and HbA1c Wash Wells -Clean the Mix Bar Wash Wells -Clean the Wash Nozzle Unit and Check the Tube Mounting Joints -Clean the DI Water Tank, DI Filter, and Sample Probe Filter 2. Review the laboratory's maintenance logs in 2023 revealed no documentation for 12 of 12 monthly maintenance. 3. Review the CMS 116 application, signed by the laboratory director on 02/23/2024, revealed the routine chemistry annual volume was 10,000. 4. In an interview on 02/13/2024 at 2:39 pm in a conference room, the technical consultant confirmed the findings. Key: CMS=Center of Medicare and Medicaid Services D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: A. Based on review of manufacturer instructions for use, laboratory's Recombiplastin (thromboplastin) new lot rollover studies, policies/procedures, prothrombin time (PT) test volumes and staff interview, the laboratory failed to ensure 2 of 20 donors used in the 2023 new Recombiplastin lot's normal mean study passed the laboratory's donor screening prior to being included in the calculations of the new lot's mean of PT normal range. Findings included: 1. Review of manufacturer instructions for use for Recombiplastin reagent (document 0020002950, revision 03/2019) revealed: "Expected Values: (Normal) Ranges were calculated as recommended by CLSI document C28-A. These results were obtained using a specific lot of reagent. Due to many variables which may affect clotting times, each laboratory should verify its own normal range." 2. Review of laboratory's Recombiplastin lot rollover studies for new lot N0138518 (expiration date 2025-01-31), conducted on 08/10/2023 revealed the following donor questionnaire was used to determine donor acceptability for inclusion in calculation of new lot's mean of PT normal range: Questionnaire included: "True or False: Are you a (sic) healthy? True or False: I do not have a coagulopathy. True or False: I do not take any medications designated "blood thinners". True or False: I do not bleed easily. True or False: I can participate in coagulation studies as "normal control patient." Patient Signature: __________ Date: ___________ Director/ Instructor: ________ Date: ___________ Circle one: Pass Reinstruct Failed" 3. Review of the donor questionnaires for patients used in the Recombiplastin lot's N0138518 establishment study of mean of PT normal range revealed the following 2 of 20 patients had responses related to coagulation issues: a. Patient number 2 responded as follows: "True or False: I do not have a coagulopathy." - documented response by circling "False" "True or False: I do not take any medications designated "blood thinners"." - documented response by circling "False" b. Patient number 3 responded as follows: "True or False: I do not bleed easily." - documented response by circling "False" 4. Further review of the above questionnaires revealed there was no documentation of Director/Instructor signature/date, or documentation of whether the patient passed, failed or was reinstructed during the screening process. 5. Review of laboratory's Recombiplastin lot rollover studies for new lot N0138518 revealed Patient 2 and 3 were included in the calculation of new lot's mean of PT normal range. -- 3 of 4 -- 6. Review of laboratory's policies/procedures revealed there were no protocols delineated for performing patient screening, nor criteria established for patients acceptability for inclusion in the establishment studies of the new lot's mean of PT normal range. 7. Review of laboratory's test volumes revealed the laboratory performed 3279 PT tests in 2023. 8. In an interview on 02/13/2024 at 1410 hours in the conference room, the laboratory's Technical Supervisor confirmed the findings. B. Based on review of laboratory's Recombiplastin (thromboplastin) new lot rollover studies, policies/procedures, prothrombin time (PT) test volumes and staff interview, the laboratory failed to ensure ACL Elite hemostasis instrument's INR (International Normalized Ratio) calculations were accurate for one of one new Recombiplastin lot numbers placed in use in 2023. Findings included: 1. Review of laboratory's Recombiplastin lot rollover studies for new lot N0138518 (expiration date 2025-01- 31), conducted on 08/10/2023 revealed the laboratory did not verify whether the ACL Elite hemostasis instrument calculated the reportable INR correctly for the new lot number of Recombiplastin. 2. Review of laboratory's policies/procedures revealed the laboratory did not have protocols in place delineating steps to verify if the ACL Elite hemostasis instrument calculates the reportable INR correctly. 3. Review of laboratory's test volumes revealed the laboratory performed 3279 PT tests annually. 4. In an interview on 02/13/2024 at 1410 hours in the conference room, the laboratory's Technical Supervisor confirmed the findings. D6126 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(vi) The procedures for evaluation of the competency of the staff must include, but are not limted to assessment of problem solving skills. This STANDARD is not met as evidenced by: Based on a review of the laboratory's CMS 209 form, the laboratory's annual competency assessments and staff interview, the laboratory failed to assess problem solving skills for the annual competency assessment performed for one of one testing personnel performing high complexity testing in 2023. Findings include: 1. A review of the laboratory's submitted CMS 209 form revealed the laboratory employed one testing person performing high complexity testing in 2023. 2. A review of the laboratory's annual competency assessments performed in 2023 revealed the laboratory failed to assess problem solving skills for testing person #1. 3. In an interview on 2/13/24 at 10:50 a.m. in the conference room, after review of the records, the technical supervisor (as indicated on the CMS 209 form) confirmed the above findings. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An unannounced complaint survey was performed on 02/28/2023 in response to TX00444363. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. All allegations were substantiated and related deficiencies cited. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. 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 review of the manufacturer's instructions, surveyor observations, quality control and patient test records from November 2022 to February 2023, and confirmed in interview, the laboratory failed to ensure quality control material were not used past the open stability for five of ten analytes reviewed on the Beckman Coulter and DXI chemistry analyzers: Total Bilirubin (TBili), Cholesterol (CHOL), Triglyceride (TRIG), and Troponin I. Findings included: 1. Review of the package insert for the Biorad Liquid Assayed Multiqual (5351-00, 2020-02) under storage and stability stated "once thawed, opened, and stored tightly capped at 2-8, this product will be stable as follows: TBili, ALP: 9 days CHOL, TRIG: 7 days 2. Review of the package insert for the Biorad Liquichek Cardiac Markers Plus Control LT (16000202- 00S, 2023-02) under Storage and Stability stated "once thawed, opened, and stored tightly capped at 2-8C, this product will be stable as follows: Troponin I: 5 days 3. Surveyor observations on 02/28/2023 at 0944 hours in the laboratory indicated the following controls were put into use on the dates written on the bottle. Biorad Liquichek Cardiac Markers Plus Control LT Level 3 lot 67673, exp 08/31/2024 with Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the tech [initials] and "02/13" - [open stability expiration for Troponin 2/18/2023] Biorad Liquid Assayed Multiqual level 1 lot 45891, 10/31/2023 with the tech [initials] and "02/03" - [open stability expiration for TBili, ALP 2/12/2023 and 2/10/23 for CHOL and TRIG] 4. Random review of patient and laboratory test records from February 2023 confirmed the laboratory analyzed and reported the following five patients when they used expired open stability controls for the daily testing on the corresponding analytes. Tbili, ALP, CHOL, TRIG, Troponin I Accession #55176, collected 2/24/2023, analyzed 2/24/2023 Tbili, ALP, CHOL, TRIG Accession #55131, collected 02/24/2023, analyzed 02/24/2023 Accession #55196, collected 02 /27/2023, analyzed 02/27/2023 TBili, ALP Accession #54610, collected 02/13/2023, analyzed 02/13/2023 Accession #55190, collected 2/27/2023, analyzed 2/27/2023 5. An interview with the technical consultant on 02/28/2023 at 1435 hours in the laboratory confirmed the above findings. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 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 review of the manufacturer's instructions, random review of the laboratory and patient test records from 2022, and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and document one of two calibration verification every 6 months for the following 10 analytes: DBili, TBili, BUN, MG, PHS, GLU, CAL, TP, CHOL, and Trig. Findings included: 1. Review of the calibration verification records from 2022 for the following 10 analytes DBili, TBili, BUN, MG, PHS, GLU, CAL, TP, CHOL, and Trig contain documentation the laboratory used the following linearity materials. Audit Microcontrols Linearity FD Bilirubin Beckman AU - DBili, TBili Audit Microcontrols Linearity FD General Chemistry AU - BUN, MG, PHS, GLU, CAL, TP Audit Microcontrols Linearity FD Lipids Beckman AU - CHOL, Trig 2. Review of the package insert for the Audit Microcontrols Linearity FD Bilirubin Beckman AU (K825m-5, exp 09-15-23) under Storage and Stability stated "Linearity FD Bilirubin Beckman AU is stored at 2-8C and will remain stable in the unopened vial until the expiration date. After opening, -- 2 of 3 -- the contents should be used according to the instrument manufacturer ' s instructions and immediately returned to 2-8C. When used to monitor the precision of laboratory testing procedures for its assays, Linearity FD Bilirubin Beckman AU has a reconstituted stability of up to 2 days under the proper storage conditions. Leaving the vial uncapped, or prolonging its time at room temperature, will void this open vial stability claim. Make sure the contents of the vial are well mixed before use." 3. Review of the package insert for the Audit Microcontrols Linearity FD General Chemistry AU (K824M-5, exp 06/09/2024) under storage and stability stated " Linearity FD General Chemistry AU is stored at 2-8C and will remain stable in the unopened vial until the expiration date. After opening, the contents should be used according to the instrument manufacturer ' s instructions and immediately returned to 2-8C. When used to monitor the precision of laboratory testing procedures for its assays, Linearity FD General Chemistry AU has a reconstituted stability of up to 7 days under the proper storage conditions. Leaving the vial uncapped, or prolonging its time at room temperature, will void this open vial stability claim. Make sure the contents of the vial are well mixed before use." 4. Review of the package insert for the Audit Microcontrols Linearity FD Lipids Beckman AU (K826M-5, exp 08/10/2023) under storage and stability stated "Linearity FD Lipids Beckman AU is stored at 2-8C and will remain stable in the unopened vial until the expiration date. After opening, the contents should be used according to the instrument manufacturer ' s instructions and immediately returned to 2-8C. When used to monitor the precision of laboratory testing procedures for its assays, Linearity FD Lipids Beckman AU has a reconstituted stability of up to 5 days under the proper storage conditions. Leaving the vial uncapped, or prolonging its time at room temperature, will void this open vial stability claim. Make sure the contents of the vial are well mixed before use." 5. Surveyor observed on 02/28/2023 at 0948 hours the following Audit Microcontrols with the following open and run dates stored in the laboratory refrigerator. Audit Microcontrols Linearity FD Bilirubin Beckman AU (lot 06828, exp 09/15/2023) - "o [opened]: 05/12/2022; r [run]: 05/12; run: 11/04/2022) Audit Microcontrols Linearity FD General Chemistry AU (lot 06886, exp 06/09/2024) - "r [run]: 05/18; run: 11/04 /2022) Audit Microcontrols Linearity FD Lipids Beckman AU (lot 06889, exp 08/10 /2023) - o [opened]: 05/12/2022; r [run]: 05/12; run: 11/04/2022) 6. An interview with the primary testing person on 02/28/2023 at 1130 hours in the laboratory confirmed that the dates on the box were when they were reconstituted and used. 7. Review of the calibration verification records from 2022 confirmed the laboratory documented calibration verification for the following 10 analytes (DBili, TBili, BUN, MG, PHS, GLU, CAL, TP, CHOL, and Trig) in 05/2022 and 11/2022 using the linearity materials observed. No other calibration verification records were available for review. 8. Review of the CMS116 record state the laboratory performed 8000 chemistry tests annually. 9. An interview with the technical consultant on 02/28/2023 at 1430 hours in the laboratory confirmed the above findings. key: DBili - Direct Bilirubin TBili - Total Bilirubin BUN - blood urea nitrogen MG - Magnesium PHS - Phosphorus GLU- Glucose CAL -Calcium TP - Total Protein CHOL - Cholesterol Trig - Triglycerides -- 3 of 3 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: An unannounced revisit was performed on 10/21/21. Based on review of the laboratory plans of correction with a completion date of 8/10/21, review of laboratory and patient test records, and confirmed in interview, the laboratory director failed to ensure the laboratory quality assessment programs were established and maintained to assure quality of lab services in hematology. Refer to D5405, D5411 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory and patient test records from 2020-2021, and confirmed in interview, the laboratory failed to report 78 SARS- CoV-2 test results as required by 42 CFR 493.41 and 493.1100(a) for 46 of 46 days reviewed from 09/3/2020 to 4/15/2021. Findings were: 1. Review of the Instructions for Use for the Beckman Coulter Access SARS-CoV-2 IgG (C60543 C, July 2020) under CONDITIONS OF AUTHORIZATION FOR THE LABORATORY revealed "authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate." 2. Review of the laboratory test records from 2020 to 2021 revealed the laboratory started SARS-CoV-2 IgG patient testing using Beckman Coulter Access SARS-CoV-2 IgG on the Access DxI chemistry analyzer on 7/24/20. 3. Review of the laboratory policies available revealed no documentation of a policy/procedure related to SARS-CoV-2 test reporting. 4. Review of the laboratory SARS-CoV-2 IgG patient test records from 2020 to 2021 revealed no documentation the laboratory reported 78 of 78 patient test records on the following 46 of 46 days of testing. date accession 09 /03/2020 21376 09/03/2020 21410 09/03/2020 21411 09/04/2020 21454 09/08/2020 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 -- 21520 09/14/2020 21788 09/16/2020 21878 09/21/2020 22022 09/23/2020 22115 09 /25/2020 22180 10/06/2020 22549 10/07/2020 22587 10/08/2020 22617 10/12/2020 22684 10/12/2020 22695 10/13/2020 22720 10/15/2020 22859 10/26/2020 23158 11 /16/2020 23990 11/20/2020 24010 11/24/2020 24060 11/30/2020 24140 11/30/2020 24150 12/04/2020 24320 12/04/2020 24323 12/04/2020 24328 12/08/2020 24416 12 /08/2020 24445 12/08/2020 24450 12/08/2020 24447 12/08/2020 24451 12/08/2020 24452 12/14/2020 24628 12/17/2020 24720 12/17/2020 24751 12/18/2020 24777 12 /18/2020 24788 12/31/2020 24967 12/31/2020 24976 12/31/2020 24987 01/04/2021 25025 01/04/2021 25061 01/05/2021 25269 01/07/2021 25228 01/12/2021 25331 01 /12/2021 25347 01/13/2021 25402 01/14/2021 25459 01/15/2021 25520 01/15/2021 25527 01/20/2021 25650 01/20/2021 25673 01/21/2021 25682 01/21/2021 25702 01 /25/2021 25813 01/25/2021 25815 01/25/2021 25816 01/27/2021 25864 01/27/2021 25881 01/28/2021 25902 01/28/2021 25927 02/03/2021 26148 02/09/2021 26341 03 /01/2021 26781 03/04/2021 26952 03/04/2021 26953 03/04/2021 27132 03/08/2021 27045 03/08/2021 27063 03/08/2021 27066 03/22/2021 27576 03/25/2021 27675 03 /25/2021 27686 03/25/2021 27708 03/26/2021 27732 03/26/2021 27733 04/08/2021 28129 04/08/2021 28142 5. An interview with the technical consultant on 4/14/21 at 1540 hours in the conference room confirmed the above findings. He was unaware the laboratory was required to report Covid-19 test results. -- 2 of 2 --