Doctors Clinical Laboratory Services

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at DOCTORS CLINICAL LABORATORY SERVICES from August 26, 2025 to August 27, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, review of package inserts and staff interview, the laboratory failed to properly label hematology quality control vials XN Check from Sysmex for the Sysmex Analyzer XN-1000 on 08/26/2025. Findings included: 1-During the laboratory tour on 08/26/2025 at 11:15 AM, the surveyor observed that the laboratory was using XN CHECK Cell Control with Lot number 51961101 for L1, 51961102 for level L2 and 51961103 for level L3, the vials had no open date and new expiration date. 2-Review of the XN-Check Cell Control user instructions revealed that used controls had an expiration date of seven days after first use. 3-During an interview on 08/26/2025 at 11:40 PM the laboratory manager confirmed that the vials were not labeled with the new expiration date. 49641 Based on observation, record review and staff interview, the laboratory failed to identify three glass jars used for immunology testing as per laboratory procedures for Human Herpesvirus (HSV), Helicobacter Pilory (H.P), and Antinuclear Antibody (ANA), with appropriate concentration, dates of preparation and date of expiration for August 26th of 2025 and August 27th of 2025. Findings included: 1- During a tour of the laboratory on 08/26/2025 at 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 -- approximately 11:04 AM, observed three jars with liquid inside, labeled #1- QI WASH BUFFER HSV (1&2), #2- H. Pilory (30ml-720ml), #3- ANA (60ml-1000ml), respectively stored in the refrigerator approximately at 2 to 8 degrees Celsius. There was no labeling information for date of preparation, date of expiration of reagent as appropriate. 2- Review of the BIO-RAD HSV Type 1 & 2 IgG Enzyme Immunoassay (EIA) procedure stated in Section 4 REAGENTS Wash Concentrate Dilute in 1 liter of water or deionized water. Also, in section 6 "PRECAUTIONS FOR USERS for Invitro Diagnostic Use Users item 7 Wash Concentrate Cat No. 25190 not to be used beyond their expiration date." 3- Review of the procedure manuals for PILORI DETECT IgG # 25226 has instructions for REAGENT PREPARATION a diluent /wash preparation solution: " ...the final volume 750ML. Transfer the resulting solution to a Washer bottle and label it Working Diluent/Wash, store at 2-8 until the expiration date listed on the concentrate bottle." 4- Review of the BIO-RAD EIA ANA screening test procedure in Table 1. Wash Concentrate Preparation/Storage first bullet stated, "Requires dilution to prepare a Working Wash Solution." Second bullet stated, "Working Wash Solution is table for 14 days when stored at 2-8 C." Continued with "Warning for Users item 11. Do not use kit beyond its expiration date. The date is printed in kit boxes." 5- Review of the GENERAL LABORATORY PROCEDURE V.2 stated 1. All reagents, standards, controls, calibrators, stains, culture media and other critical supplies used in testing, etc. must be labeled with: date received, date opened, expiration date, safety hazard stickers (if applicable), storage requirements. Procedure also stated 3. Titer, strength or concentration must be identified when necessary. 6- Interview on 08/27/2025 at approximately 1:43 PM the TP4 confirmed that reagent jars for HSV, HP and ANA were not labeled as per procedure. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 observation and staff interview, the laboratory failed to ensure not to exceed their expiration dates for Hematology Immersion oil reagent used since 09-08-2024 through August 27, 2025. Findings included: 1- During a tour of the laboratory on 08 /26/2025 at approximately 11:15 AM, observed three small bottles with dropper oil on the bench next to the microscope. 2- Review of the CMS-209 form submitted on 08- 27-2025 and signed by the Laboratory Director on 08/01/2025, revealed that there were seven testing personnel (TP) in total, the two General Supervisors (TP1 and TP2) and other five personnel TP3, TP4, TP5, TP6 and TP7. 3-Review of the bottle labeling read low viscosity immersion oil Lot # 1293, Expiration Date 2024-09-08, with handwritten "6-8-22" blue Sharpe ink. 4- Review of the Hematology Procedure on Manual Differential Count, revealed in the SCAN PROCEDURE step 4. Using 100X oil objective, place a drop of oil on the slide and examine the smear for Platelet Morphology and count. Also, in step 5 stated "To perform the differential ..." and concluded with " ...you should use the 100X (oil) objective or 50X if available." 5- Sysmex XN Hematology Analyzers procedure signed by the laboratory director on 07 /10/2024, states in table D. Differential Criteria: PLATELETS - SCAN the slide when Greater than 500,000 or less than 50,000, Immature Granulocytes (IG%) review slide when greater than (>) 5%. 6- Review of the Red Blood Cell (RBC) Morphology procedure stated in section 1. RBC EVALUTION " ... However, when quantitating -- 2 of 3 -- RBC morphology it should be performed using the 100X oil-immersion lens b. Using 100X evaluate abnormalities and inclusions ..." 7- Interview on 08/26/2025 at approximately 11:20 AM the GS/TP2 confirmed that the immersion oil in use was expired since 09-08-2024. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform maintenance for chemistry analyzer Cobas e 601 and Cobas c 501 as specified by the manufacturer for period reviewed January through December of 2024 and January through July of 2025. Findings included: 1- Review of the CMS-209 form submitted on 08-27-2025 and signed by the Laboratory Director on 08/01/2025, revealed that there were seven testing personnel (TP) in total, the two General Supervisors (TP1 and TP2) and other five personnel TP3, TP4, TP5, TP6 and TP7. 2- Review of maintenance records PN 3548-00-0113 for the Cobas e 601 SN 2486-23 revealed that the laboratory did not follow manufacturer instructions for the following events: a) every three months - to replace Pinch valve tubing from January 2024 through December 2024, and from January 2025 through March of 2025 b) every six months - to replace Pipettor seal from January 2024 through December 2024, and from January 2025 through July of 2025 3- Review of maintenance records PN 3547-00-0113 for COBAS c 501 SN 1146-13 revealed that the laboratory did not follow manufacturer instructions for the following events: a) every two months - to replace ISE measuring cartridges from January 2024 through December 2024, and from January 2025 through July of 2025. b) quarterly (#1) - to replace ISE pinch valve tubing from January 2024 through December 2024, and from January 2025 through July of 2025 c) quarterly (#2) - to replace ISE sipper tubing from January 2024 through December 2024, and from January 2025 through July of 2025, d) quarterly (#3) - to clean ultrasonic tubing from April 2024 through December 2024 e) every six months (#1) - to replace ISE reference cartridge from January 2024 through December 2024, and from January 2025 through July of 2025 f) every six months (#2) - to replace syringe seals, from January 2024 through December 2024 and from January 2025 through July of 2025. 4- Interview on 08/27/2025 at approximately 1:43 PM the TP4 admitted that maintenance was not recorded as per manufacturer frequency. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 10/25/2023 to 11/09/2023 found the DOCTORS CLINICAL LABORATORY SERVICES INC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, Testing Person (TP) failed to sign attestation for Proficiency Testing (PT) for 15 out of 15 modules reviewed from American Association of Bioanalysts (AAB)/Medical Laboratory Evaluation (MLE) PT in 2023. Findings included: -Review of AAB/MLE PT "GENERAL INSTRUCTIONS" on section "REPORTING RESULTS" stated: "Be sure to keep attestations statements printed from your online reporting form. The attestations must be signed for each analyte by the analyst performing the procedure and kept in files for inspection purposes." - Review of the following Modules of AAB/MLE PT records of 2023 revealed that the laboratory failed to have the analyst that performed each test to sign the attestation: Non-Chemistry M1: Culture ID, Urine; Parasitology; Coagulation; Parasitology. Chemistry M1: Fecal Occult Blood; Chemistry; Therapeutic Drug Monitoring; Tumors Markers; Urinalysis Module. Non-Chemistry M2: Parasitology; Miscellaneous Culture, Bacteriology. Chemistry M2: Endocrinology 1; Chemistry. During an interview on 10/26/2023 at 2:25 PM, General Supervisor confirmed that the laboratory failed to have TP sign the attestations forms for the modules listed above. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to keep the instrument print out for 4 out of 6 patient test results reviewed in 2022 and 2023. Findings included: -Review of "POLICY RECORDS" revealed that "Doctor's Clinical Laboratory will maintain records on accordance with State and federal guidelines" and on "GUIDELINES" it stated: " Instrument print out must be stored for 2 years" Review of 6 final patient reports (P#1, P#2, P#3, P#4, P#5 and P#6) revealed that for patients P#2, P#3, P#4 and P#6, the laboratory failed to have the instruments print out for the following tests: P#2: Reported on 02/10/2022 for the following Chemistry tests performed on the Cobas C501 : Albumin, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Total Bilirubin (TBIL), Blood Urea Nitrogen (BUN), Calcium (Ca), Cholesterol, Creatinine, Glucose, Total Protein (TP), Sodium, Potassium, Chloride, Triglycerides, Carbon Dioxide-CO2, Globulin. The laboratory could not provide the instrument print out for the tests results reported. P#3: Reported on 02/10/2023 for the following Chemistry tests performed on the Cobas C501 : Albumin, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Total Bilirubin (TBIL), Blood Urea Nitrogen (BUN), Calcium (Ca), Cholesterol, Creatinine, Glucose, Total Protein (TP), Sodium, Potassium, Chloride, Triglycerides, Carbon Dioxide-CO2, Globulin. The laboratory could not provide the instrument print out for the tests results reported. PH#4: Reported on 02/24/2023 for the following Chemistry tests performed on the Cobas C501 : Albumin, Alkaline Phosphatase (ALP), Alanine transaminase (ALT), Aspartate aminotransferase (AST), Total Bilirubin (TBIL), Blood Urea Nitrogen (BUN), Calcium (Ca), Cholesterol, Creatinine, Glucose, Total Protein (TP), Sodium, Potassium, Chloride, Triglycerides, Carbon Dioxide-CO2, Globulin. The laboratory could not provide the instrument print out for the tests results reported. This patient also had reported test results for the Urinalysis performed on the Cobas U601, the laboratory could not provide the instrument print out for this test result. P#6: reported on 10/25/2023 reported test results for Urinalysis performed on the Cobas U601, the laboratory could not provide the instrument print out for this test result. During an interview on 10/26/2023 at 1:35 PM, the General Supervisor confirmed that the laboratory failed to have the instruments print out for the reported tests listed 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 record review and interview, the laboratory failed to read urine cultures (UC) at 24 hours per their policy for 4 out of 6 patients reviewed for September and October of 2023. Findings included: Review of the policy "Urine Culture" revealed -- 2 of 3 -- that it stated: "Incubate overnight and read the following morning." Review of 6 patients final reports (P#10, P#11, P#12, P#13, P#14 and P#15) and worksheet reports for the cases of reference revealed that patients P#10, P#11, P#12, P#13 were not read at 24 hours period incubation as per following information: -P#10 was plated on 09/16 /2023 and reported on 09/18/2023 with no growth, no reading done on the 24 hours. - P#11 was plated on 09/16/2023 and reported on 09/19/2023 with growth for Escherichia Coli, no reading done on the 24 hours. -P#12 was plated on 10/21/2023 and reported on 10/23/2023 with no growth, no reading done on the 24 hours. -P#13 was plated on 10/21/2023 and reported on 10/24/2023 with growth for Escherichia Coli, no reading done on the 24 hours. During an interview on 10/26/2023 at 10:30 AM, the Microbiology Supervisor confirmed that the laboratory failed to read the UC listed above at 24 hours as per their policy. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 11/09/2021 to 11/12/2021 found that DOCTORS CLINICAL LABORATORY SERVICES clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited: -D5300. Preanalytic Systems. -D5400. Analytic Systems. 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 lack of records and interview, the laboratory failed to report 14,302 test results to Florida Department of Health (FDOH) from 06/24/2020 to 11/12/2021. The laboratory performed 2804 with rapid tests to detect Immunoglobulin G (IgG) /Immunoglobulin M (IgM) for SARS-COV-2 using Healgen and Ecotest; 10628 tests using Roche Elecsys to detect Anti-SARS-CoV-2 antibodies and 880 tests with Elecsys to detect Anti SARS CoV 2 S antibodies to the spike protein. Findings include: -The laboratory performed 14,312 tests to detect SARS-CoV-2 antibodies from 06/24/2020 to 11/12/2021: a) 10628 tests using Elecsys Anti-SARS-CoV-2 from 06/24/2020 to 11/12/2021. b) 880 tests using Elecsys to detect Anti SARS CoV 2 S from 03/30/2021 to 11/12/2021. c) 2804 tests using the rapid tests for IgG /IgM to SARS-COV-2 using Healgen and Ecotest from 07/01/2020 to 11/12/2021. -The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory had no records of reports to the FDOH for 14302 tests performed from 06 /24/2020 to 11/12/2021. During an interview on 11/12/2021 at 5:00 PM, the General Supervisor explained that the laboratory reported 10 tests in July 2020, but they received a phone call from Dr JM from Department of Health on 07/23/2020, where they were told not to report the antibodies and they stopped reporting. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with Laboratory Supervisor (LS), the laboratory failed to retain quality control records for the following tests: Hema Screen, ASI Mono II, AIMSTEP, Erythrocytes Sedimentation Rate (ESR), ASI Sickle Cell and ASI Rapid Plasma Reagin (RPR) Card for year 2020. Findings include: Review of Daily Quality Control (QC) records for Hema Screen occult blood, ASI Mononucleosis antibodies, AIMSTEP Pregnancy, ESR, Sickle Cell and RPR tests revealed that there were not records for 2020. During an interview on 11/12/2021 at 4: 30 PM, the LS explained that the laboratory moved the records of reference to an outside storage space that the laboratory rented, they tried to locate the records of reference during the inspection, but they were not able to find them. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated from 01/01/2020 to 11/12/2021. (see D5311) 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated 01/01/2020 to 11/12/2021. Findings include: Review of QFT-Plus Instructions for Use stated "Tubes must be transferred to a 37 Celsius (C) 1C incubator within 2 hours. If QFT-Plus Blood Collection Tubes are not incubated at 37 C directly after blood collection and shaking, invert the tubes to mix 10 times (10x) prior to incubator at 37 C. Incubate the QFT-Plus Blood collection tubes upright at 371 C for 16 to 24 hours. In order to obtain valid results from the QFT-Plus assay, the operator needs to perform specific tasks within set times. Prior to harvesting plasma, samples in QFT-Plus Blood Collection Tubes must have been incubated at 37 C for 16-24 hours." QFT-Plus Blood Collection Tubes also contain the following controls: Nil (the negative control) and mitogen (the positive control). Review of QuantiFERON Incubator logs revealed the laboratory was not documenting the collection time and incubation in and out time for QFT blood specimens from 01/01/2020 to 11/12/2021. Review of CMS-116 Laboratory Application revealed 14,865 patients had been tested from 01/01/2021 to 11/12/2021. During an interview on 11/12/2021 at 1:00 PM, the office manager confirmed laboratory failed to follow manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of specimen received and incubated. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 record review and staff interview, the laboratory did not meet the condition for analytic systems. Findings include: -Based on observation and interview, the laboratory failed to validate the ASI Rapid Plasma Reagin (RPR) Card Test for Syphilis testing without humidifying covers during rotation time from 01/01/2020 to 11/12/2021. Refer to D5423. -Based on lack of documentation and staff interview, the laboratory failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12/2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11/12/2021. Refer to D5449. 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 -- 3 of 5 -- 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 observation and interview, the laboratory failed to validate the ASI Rapid Plasma Reagin (RPR) Card Test test for Syphilis testing with no humidifying covers use during rotation time from 01/01/2020 to 11/12/2021. Findings include: Review of the ASI RPR Card Test Syphilis package insert approved by the Food and Drug Administration (FDA)stated that RPR cards are rotated for 8 minutes at 100 rpm on mechanical rotator with humidifying cover. During laboratory tour on 11/12/2021 at 1: 20 PM, the surveyor noticed that no humidifying cover for the RPR rotator were available in the laboratory. During an interview on 11/12/2021 at 01:50 PM, testing personnel B confirmed that the laboratory failed to validate the ASI RPR Card Test Syphilis without use of humidifyng covers as per FDA approved manufacturer guidelines for Syphilis testing from 01/01/2020 to 11/12/2021 and that the laboratory performed 8,834 RPR tests during this period of time. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12/2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11/12/2021. Findings include: Review of Manufacturer Instructions (MI) for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette and Ecotest COVID-19 IgG/IgM Rapid Test Device Quality Control for qualitative serology tests revealed that both MI recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. The laboratory performed 2804 tests from 07/01/2020 till 11/12/2021. During an interview on 11/12/2021 at 2:00 PM, with Laboratory Manager, she confirmed that the laboratory failed to follow MI to test a positive and negative control for the tests of references for the period of 07/01/2020 to 11/12/2021. 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 -- 4 of 5 -- 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 record review and interview, the laboratory Quality Assessment (QA) failed to identify and correct the following deficiencies: failure to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated from 01/01/2020 to 11/12/2021, failure to validate the ASI Rapid Plasma Reagin (RPR) Card Test for use without humidifying covers outside of the Food and Drug Administration (FDA) approved manufacturer guidelines for Syphilis testing from 01/01/2020 to 11/12/2021 and failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12 /2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11 /12/2021. Findings include: Refer to D5311, D5421 and D5449. 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 (LD) failed to ensure the Quality Assessment (QA) identified and corrected problems in analytic systems for 2 (2020 and 2021) out of 2 years reviewed. Refer to D5791. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 11/09/2021 to 11/12/2021 found that DOCTORS CLINICAL LABORATORY SERVICES clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following conditions were cited: -D5300. Preanalytic Systems. -D5400. Analytic Systems. 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 lack of records and interview, the laboratory failed to report 14,302 test results to Florida Department of Health (FDOH) from 06/24/2020 to 11/12/2021. The laboratory performed 2804 with rapid tests to detect Immunoglobulin G (IgG) /Immunoglobulin M (IgM) for SARS-COV-2 using Healgen and Ecotest; 10628 tests using Roche Elecsys to detect Anti-SARS-CoV-2 antibodies and 880 tests with Elecsys to detect Anti SARS CoV 2 S antibodies to the spike protein. Findings include: -The laboratory performed 14,312 tests to detect SARS-CoV-2 antibodies from 06/24/2020 to 11/12/2021: a) 10628 tests using Elecsys Anti-SARS-CoV-2 from 06/24/2020 to 11/12/2021. b) 880 tests using Elecsys to detect Anti SARS CoV 2 S from 03/30/2021 to 11/12/2021. c) 2804 tests using the rapid tests for IgG /IgM to SARS-COV-2 using Healgen and Ecotest from 07/01/2020 to 11/12/2021. -The Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- laboratory had no records of reports to the FDOH for 14302 tests performed from 06 /24/2020 to 11/12/2021. During an interview on 11/12/2021 at 5:00 PM, the General Supervisor explained that the laboratory reported 10 tests in July 2020, but they received a phone call from Dr JM from Department of Health on 07/23/2020, where they were told not to report the antibodies and they stopped reporting. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with Laboratory Supervisor (LS), the laboratory failed to retain quality control records for the following tests: Hema Screen, ASI Mono II, AIMSTEP, Erythrocytes Sedimentation Rate (ESR), ASI Sickle Cell and ASI Rapid Plasma Reagin (RPR) Card for year 2020. Findings include: Review of Daily Quality Control (QC) records for Hema Screen occult blood, ASI Mononucleosis antibodies, AIMSTEP Pregnancy, ESR, Sickle Cell and RPR tests revealed that there were not records for 2020. During an interview on 11/12/2021 at 4: 30 PM, the LS explained that the laboratory moved the records of reference to an outside storage space that the laboratory rented, they tried to locate the records of reference during the inspection, but they were not able to find them. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated from 01/01/2020 to 11/12/2021. (see D5311) 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. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated 01/01/2020 to 11/12/2021. Findings include: Review of QFT-Plus Instructions for Use stated "Tubes must be transferred to a 37 Celsius (C) 1C incubator within 2 hours. If QFT-Plus Blood Collection Tubes are not incubated at 37 C directly after blood collection and shaking, invert the tubes to mix 10 times (10x) prior to incubator at 37 C. Incubate the QFT-Plus Blood collection tubes upright at 371 C for 16 to 24 hours. In order to obtain valid results from the QFT-Plus assay, the operator needs to perform specific tasks within set times. Prior to harvesting plasma, samples in QFT-Plus Blood Collection Tubes must have been incubated at 37 C for 16-24 hours." QFT-Plus Blood Collection Tubes also contain the following controls: Nil (the negative control) and mitogen (the positive control). Review of QuantiFERON Incubator logs revealed the laboratory was not documenting the collection time and incubation in and out time for QFT blood specimens from 01/01/2020 to 11/12/2021. Review of CMS-116 Laboratory Application revealed 14,865 patients had been tested from 01/01/2021 to 11/12/2021. During an interview on 11/12/2021 at 1:00 PM, the office manager confirmed laboratory failed to follow manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of specimen received and incubated. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 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 record review and staff interview, the laboratory did not meet the condition for analytic systems. Findings include: -Based on observation and interview, the laboratory failed to validate the ASI Rapid Plasma Reagin (RPR) Card Test for Syphilis testing without humidifying covers during rotation time from 01/01/2020 to 11/12/2021. Refer to D5423. -Based on lack of documentation and staff interview, the laboratory failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12/2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11/12/2021. Refer to D5449. 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 -- 3 of 5 -- 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 observation and interview, the laboratory failed to validate the ASI Rapid Plasma Reagin (RPR) Card Test test for Syphilis testing with no humidifying covers use during rotation time from 01/01/2020 to 11/12/2021. Findings include: Review of the ASI RPR Card Test Syphilis package insert approved by the Food and Drug Administration (FDA)stated that RPR cards are rotated for 8 minutes at 100 rpm on mechanical rotator with humidifying cover. During laboratory tour on 11/12/2021 at 1: 20 PM, the surveyor noticed that no humidifying cover for the RPR rotator were available in the laboratory. During an interview on 11/12/2021 at 01:50 PM, testing personnel B confirmed that the laboratory failed to validate the ASI RPR Card Test Syphilis without use of humidifyng covers as per FDA approved manufacturer guidelines for Syphilis testing from 01/01/2020 to 11/12/2021 and that the laboratory performed 8,834 RPR tests during this period of time. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12/2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11/12/2021. Findings include: Review of Manufacturer Instructions (MI) for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette and Ecotest COVID-19 IgG/IgM Rapid Test Device Quality Control for qualitative serology tests revealed that both MI recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. The laboratory performed 2804 tests from 07/01/2020 till 11/12/2021. During an interview on 11/12/2021 at 2:00 PM, with Laboratory Manager, she confirmed that the laboratory failed to follow MI to test a positive and negative control for the tests of references for the period of 07/01/2020 to 11/12/2021. 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 -- 4 of 5 -- 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 record review and interview, the laboratory Quality Assessment (QA) failed to identify and correct the following deficiencies: failure to follow Qiagen QuantiFERON- Tuberculosis (TB) Gold Plus (QFT-Plus) manufacturer's instructions to ensure the quality of blood specimens prior to testing by documenting the time and date of blood specimens received and incubated from 01/01/2020 to 11/12/2021, failure to validate the ASI Rapid Plasma Reagin (RPR) Card Test for use without humidifying covers outside of the Food and Drug Administration (FDA) approved manufacturer guidelines for Syphilis testing from 01/01/2020 to 11/12/2021 and failed to document and perform external positive and negative controls for Healgen Scientific LLC COVID-19 IgG/IgM Rapid Test Cassette from 07/01/2020 to 11/12 /2021 and for Ecotest COVID-19 IgG/IgM Rapid Test Device from 04/08/2021 to 11 /12/2021. Findings include: Refer to D5311, D5421 and D5449. 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 (LD) failed to ensure the Quality Assessment (QA) identified and corrected problems in analytic systems for 2 (2020 and 2021) out of 2 years reviewed. Refer to D5791. -- 5 of 5 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the laboratory's proficiency testing records for 2018 and 2019, the laboratory did not have successful performance in proficiency testing for the subspecialty of routine chemistry. Refer to D2096. Findings include: Review of the American Associates of Bioanalysts (AAB) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on April 2, 2019 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, chloride for two out of two testing events in 2018 and 2019. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful participation in proficiency testing for the sub-specialty of routine chemistry. Findings include: On April 2, 2019 on or about 10:00 AM the American Association of Bioanalysts (AAB) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, chloride, as shown below. Event #3, 2018 chloride-60% Event #1, 2019 chloride-20% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the subspecialty of routine chemistry. Findings include: On April 2, 2019, on or about 10:00 AM, the American Association of Bioanalysts (AAB) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two back to back testing events for the analyte, chloride, in the sub-specialty of routine chemistry. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2096. D6016 LABORATORY DIRECTOR RESPONSIBILITIES 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 the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in -- 2 of 3 -- the subspecialty of routine chemistry. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on April 2, 2019 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2018 chloride-60 % Event #1, 2019 chloride- 20%. -- 3 of 3 --