Winnsboro Medical Clinic

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Winnsboro Medical Clinic, - CLIA ID 19D1023920 on October 13, 2021. Winnsboro Medical Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 observation during the laboratory tour and review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to successfully participate in proficiency testing for Chemistry. Findings: 1. The laboratory failed to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- achieve a score of at least 80% for Sodium (NA) in two out of three consecutive testing events, resulting in an initial unsuccessful performance. Refer to D2096. 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 direct observation during the laboratory tour and review of proficiency testing results from the CASPER 155D report, the laboratory failed to achieve a score of at least 80% for Sodium (NA) in two out of three consecutive testing events, resulting in an initial unsuccessful performance. Findings: 1. Direct observation during the laboratory tour on October 13, 2021 at 9:30 am revealed the laboratory utilizes the Beckman Coulter AU480 Chemistry analyzer for Sodium (NA) testing. 2. Review of the CASPER 155D report proficiency test results for Sodium (NA) revealed the laboratory received the following scores resulting in an initial unsuccessful performance: a) 2021 1st Event NA score received 0% b) 2021 3rd Event NA score received 0% D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of installation records, test menu, and interview with personnel, the laboratory failed to have complete performance verification studies for the Abbott Ruby Cell-Dyn Emerald 22 Hematology analyer. Findings: 1. Observation by surveyor during the laboratory tour on October 13, 2021 at 10:37 am revealed the laboratory utilizes the Abbott Ruby Cell-Dyn Emerald 22 Hematology analyzer for Complete Blood Count (CBC) testing. 2. Review of the laboratory's installation records for the Ruby Cell-Dyn Emerald 22 Hematology analyzer revealed the laboratory started patient testing on May 28, 2021. 3. Review of the summary page in the installation records revealed the laboratory performed the performance verification with raw data to support the studies for the following: a) Accuracy: method comparison b) Precision: Day-to-Day, Run-to-Run, and Within Run c) Reporatable Range: Linearity d) Reference Range 4. Further review of the installation records revealed the laboratory did not have the raw data to support complete precision for operator variance. 5. In interview on October 13, 2021 at 12:07 pm, the Technical Consultant stated that multiple operators participated in the studies but no raw data or signatures were included in the installation binder. 6. Review of the laboratory's test menu revealed the laboratory performs 4,000 CBC test annually. -- 2 of 6 -- 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: I. Based on observation by surveyor, review of maintenance logs, and interview with personnel, the laboratory failed to ensure quarterly maintenance for the Beckman Coulter AU480 instrument was performed as required from January 1, 2021 through October 13, 2021. Findings: 1. Observation by surveyor during the laboratory tour on October 13, 2021 at 9:30 am revealed the laboratory utilizes the Beckman Coulter AU 480 instrument for Chemistry testing. 2. Review of the laboratory's "AU480 Maintenance Schedule" revealed the following quarterly maintenance tasks: a) Quarterly Maintenance *Clean the Air Filters *Replace the Detergent Rolling Tube 3. Further review of the "AU480 Maintenance Schedule" log revealed the quarterly maintenance tasks was to be performed during the following months in 2021 but the laboratory did not have documentation to support performance: a) January 2021 b) April 2021 c) July 2021 d) October 2021 4. In interview on October 13, 2021 at 12:40 pm, the Technical Consultant stated the maintenance was most likely performed and documented in the instrument but was not checked off the maintenance log. II. Based on observation by surveyor, review of maintenance logs, and interview with personnel, the laboratory failed to ensure three (3) of four (4) semi-annual maintenance tasks for the Abbott Ruby Cell-Dyn Emerald 22 instrument was performed as required for 2020 and 2021. Findings: 1. Observation by surveyor during the laboratory tour on October 13, 2021 at 9:30 am revealed the laboratory utilizes the Abbott Ruby Cell-Dyn Emerald 22 instrument for Hematology testing. 2. Review of the laboratory's "Cell-Dyn Emerald Maintenance Log" revealed the following semi-annual maintenance tasks: a) Semi-annual *Lubicate the Pistons 3. Further review of the "Cell-Dyn Emerald Maintenance Log" revealed the laboratory did not document the semi-annual maintenance tasks were to be performed for the following months in 2020 and 2021: a) March 2020 b) August 2020 c) August 2021 4. In interview on October 13, 2021 at 1:17 pm, the Technical Consultant stated the maintenance was performed but not documented by testing personnel on the maintenance log. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory studies and quality control -- 3 of 6 -- records as well as interview with personnel, the laboratory failed to have in-house data to support the reduction in frequency of quality control (QC) for the Biofire Filmarray Torch analyzer. Findings: 1. Observation by surveyor during the laboratory tour on October 13, 2021 at 9:30 am revealed the laboratory utilizes the BioFire Filmarray Torch analyzer along with the Zeptometrix Natrol Respiratory Panel 2.1 quality control material for virology testing. 2. Review of the laboratory's Individualized Quality Control Plan (IQCP) revealed the laboratory reduced the frequency of QC to every thirty (30) days or with new lot/shipment. 3. Further review of the laboratory's IQCP and quality control records revealed the laboratory did not have the data to support reduction of the QC data prior to patient testing. 4. In interview on October 13, 2021 at 4:00 pm, the Technical Consultant stated the laboratory performed quality control every 30 days since the start of patient testing in December 2020 but due to QC supply shortages the laboratory was unable to perform quality control as required to reduce frequency. The Technical Consultant confirmed the IQCP was not complete. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of quality control records, manufacturer's quality control package inserts and interview with personnel, the laboratory failed to establish its own expected range of responses for the Zeptometrix quality control (QC) material. Findings: 1. Observation by surveyor during the laboratory tour on October 13, 2021 at 9:30 am revealed the laboratory utilizes the following analyzers and quality control (QC) material for virology testing: a) BioFire Filmarray Torch analyzer with Zeptometrix NaTrol Respiratory Panel 2.1 (RP2.1) quality control b) Cepheid GeneXpert analyzer with Zeptometrix Natrol SARS-Related Coronovirus 2 (SARS-CoV-2) External Run Controls c) Cepheid GeneXpert analyzer with Zeptometrix Natrol FLU/RSV/SARS-CoV-2 External Run Controls 2. Review of the manufacturer's quality control package inserts under "Expected Results" revealed the following statement: a) Zeptometrix NaTrol Respiratory Panel 2.1 (RP2.1) quality control: "Each Laboratory must evaluate the product and establish their own acceptance criteria" b) Zeptometrix NaTrol SARS-Related Coronovirus 2 (SARS- CoV-2) External Run Control: "Each Laboratory must evaluate the product and establish their own acceptance criteria" c) Zeptometrix Natrol FLU/RSV/SARS-CoV- 2 External Run Control: "Each Laboratory must evaluate the product and establish their own acceptance criteria" 3. Review of the laboratory's quality control records revealed the laboratory did not establish their own range of acceptance criteria for each of the Zeptometrix NaTrol QC materials in use: a) Zeptometrix NaTrol -- 4 of 6 -- Respiratory Panel 2.1 (RP2.1) quality control: no QC material in stock at time of survey b) Zeptometrix NaTrol SARS-Related Coronovirus 2 (SARS-CoV-2) External Run Control: Lot 325642 Expiration 12/30/21 c) Zeptometrix Natrol FLU/RSV/SARS- CoV-2 External Run Control: Positive control Lot 325902 Expiration 3/9/22 d) Zeptometrix Natrol FLU/RSV/SARS-CoV-2 External Run Control: Negative control Lot 325574 Expiration 2/11/22 4. In interview on October 13, 2021 at 3:30 pm, the Technical Consultant stated she was unaware that this QC material should be established. The Technical Consultant confirmed the laboratory uses the responses provided by the manufacturer and does not establish their own. 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 observation during the laboratory tour and review of the CASPER 155D report for proficiency testing, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure performance verification studies were complete. Refer to D5421. 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 direct observation during the laboratory tour and review of proficiency -- 5 of 6 -- testing CASPER 155D reports, the laboratory failed to ensure proficiency samples are tested as required. Findings: 1. The laboratory failed to achieve a score of at least 80% for Sodium (NA) in two out of three consecutive testing events, resulting in an initial unsuccessful performance. Refer to D2096. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure that a quality control program was established to assure quality laboratory services were provided. Findings: 1. The laboratory failed to have a complete Individualized Quality Control Plan (IQCP) to support the reduction in frequency of quality control (QC) for the Biofire Filmarray Torch analyzer. Refer to D5445. 2. The laboratory failed to establish its own expected range of responses for the Zeptometrix quality control (QC) material. Refer to D5469. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(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 observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure that the laboratory performed required maintenance. Refer to D5429. -- 6 of 6 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on June 18, 2020. Winnsboro Medical Center, CLIA ID 19D1023920, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of laboratories performing nonwaived testing 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 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 proficiency testing (PT) results from the CASPER 155D report and proficiency testing records from American Proficiency Institute (API), 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 3 -- laboratory failed to successfully participate in proficiency testing for Endocrinology. Findings: 1. The laboratory failed to achieve satisfactory performance of Free Thyroxine in three of four consecutive events resulting in an initial unsuccessful participation. Refer to D2107. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, the laboratory failed to achieve satisfactory performance for Free Thyroxine (FT4) in three (3) of four (4) consecutive events resulting in non-initial unsuccessful participation. Findings: 1. Review of CMS-155D report and proficiency testing results from American Proficiency Institute (API) revealed the laboratory received an unsatisfactory performance for the following events for Free Thyroxine (FT4): a. Event 1 of 2019 received a score of 20% b. Event 3 of 2019 received a score of 60% c. Event 1 of 2020 received a score of 20% D2098 ENDOCRINOLOGY CFR(s): 493.843(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 record review of the CMS-155D and proficiency testing results, the laboratory failed to achieve satisfactory responses for Endocrinology testing. Findings: 1. Review of the CMS-155D report and proficiency testing records from American Proficiency Institute (API) revealed the laboratory received unsatisfactory performance for the following analytes: a. Free Thyroxine (FT4): 1) 2019 Event 3 received a score of 60% 2) 2020 Event 1 received a score of 20% b. Triiodothyronine uptake (T3 Uptake): 2020 Event 1 received a score of 20% c. Thyroxine (T4): 2020 Event 1 received a score of 20% D2107 ENDOCRINOLOGY CFR(s): 493.843(f) -- 2 of 3 -- 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 a review of the CMS-155D Report and proficiency testing results, the laboratory failed to achieve satisfactory performance of Free Thyroxine in three of four consecutive events resulting in a non-initial unsuccessful participation. Findings: 1. Review of CMS-155D report and proficiency testing results from American Proficiency Institute (API) revealed the laboratory received an unsatisfactory performance for the following events for Free Thyroxine (FT4): a. Event 1 of 2019 received a score of 20% b. Event 3 of 2019 received a score of 60% c. Event 1 of 2020 received a score of 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 record review, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. 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 record review, the Laboratory Director failed to ensure that proficiency testing results are satisfactory as required. Findings: 1. The laboratory failed to achieve satisfactory responses for Endocrinology testing. Refer to D2098. 2. The laboratory failed to achieve satisfactory performance of Free Thyroxine in three of four consecutive events resulting in an initial unsuccessful participation. Refer to D2107. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A PT Desk Review was performed on December 12, 2019. Winnsboro Medical Clinic - 19D1023920 was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of Nonwaived Testing 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 proficiency testing results from the CMS-153, CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to successfully 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 -- participate in proficiency testing as evidence by: 1. The laboratory failed to achieve a score of at least 80% for Hematology analytes in three of four testing events. Refer to D2130 2. The laboratory failed to acieve an overall score of at least 80% for two of three consecutive testing events in the specialty of Hematology. Refer to D2131 3. The laboratory failed to achieve a satisfactory score for Free Thyroxine (Free TY) for two of three proficiency testing events resulting in initial unsuccessful performance in Endocrinology. Refer to D2107 D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing results from the CMS-153, CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to achieve a score of at least 80% for Red Blood Cells in three of four testing events. 1. Review of proficiency testing records and the CMS 155D Report revealed the laboratory received a score of 0% for three of four proficiency testing events resulting in non initial unsuccessful performance for Red Blood Cell: a. 2019 Event 2: Score of 0% for Red Blood Cell (RBC) b. 2019 Event 1: Score of 100% for Red Blood Cell (RBC) b. 2018 Event 3: Score of 0% for Red Blood Cell (RBC) e. 2018 Event 2: Score of 0% for Red Blood Cell (RBC) D2107 ENDOCRINOLOGY CFR(s): 493.843(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 record review, the laboratory failed to achieve a satisfactory score for Free Thyroxine (Free TY) for two of three proficiency testing events resulting in initial unsuccessful performance in Endocrinology. Findings: 1. Review of the CMS 0155D and American Proficiency Institute (API) records revealed the laboratory received the following results for Free TY testing: a) Event 1 2019: Score of 20% b) Event 2 2019: Score of 80% b) Event 3 2019: Score of 60% -- 2 of 4 -- D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) results, the laboratory failed to participate in Event 2 of 2019 resulting in an unsatisfactory performance and a score of zero for White Blood Cell Differential (WBC Diff), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC) and Platelets. The findings are as follows: 1. Review of American Proficiency Institute (API) proficiency testing records and CASPER 155D report revealed the laboratory did not participate in Event 2 of 2019 for Hematology testing resulting in the following unsatisfactory scores: Event 2 of 2019 WBC Diff score of 0%. RBC score of 0%. HCT score of 0%. HGB score of 0%. WBC score of 0%. Platelets score of 0%. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing results from the CMS-155D and American Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for Hematology analytes in three of four testing events. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the laboratory received a score of 0% for three of four proficiency testing events resulting in non initial unsuccessful performance for Red Blood Cell: a. 2019 Event 2: Score of 0% for Red Blood Cell (RBC) b. 2019 Event 1: Score of 100% for Red Blood Cell (RBC) b. 2018 Event 3: Score of 0% for Red Blood Cell (RBC) e. 2018 Event 2: Score of 0% for Red Blood Cell (RBC) 2. Review of proficiency testing records and the CMS 155D Report revealed the laboratory received a score of less than 80% for the following two of three proficiency testing events resulting in initial unsuccessful performance for Hematocrit: a. 2019 Event 2: Score of 0% for Hematocrit b. 2019 Event 1: Score of 100% for Hematocrit c. 2018 Event 3: Score of 40% for Hematocrit D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on review of proficiency testing records and CMS Report 0155D, the laboratory failed to acieve an overall score of at least 80% for two of three consecutive testing events in the specialty of Hematology. Findings: 1. Review of proficiency testing records and Casper Report 0155D revealed the laboratory received an overall score of 0% for the following two consecutive events in Hematolgy: a. 2019 Event 2: Score of 0% for Hematology b. 2018 Event 3: Score of 70% for Hematology 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Refer to D6016. 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: The laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to participate in Event 2 of 2019 resulting in an unsatisfactory performance and a score of zero for White Blood Cell Differential (WBC Diff), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC) and Platelets. Refer to D2123 2. The laboratory failed to achieve a score of at least 80% for Hematology analytes in three of four testing events. Refer to D2130 3. The laboratory failed to acieve an overall score of at least 80% for two of three consecutive testing events in the specialty of Hematology. Refer to D2131 4. The laboratory failed to achieve a satisfactory score for Free Thyroxine (Free TY) for two of three proficiency testing events resulting in initial unsuccessful performance in Endocrinology. Refer to D2107 -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Winnsboro Medical Clinic - CLIA ID # 19D1023920 on April 5, 2019. Winnsboro Medical Clinic was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing; Technical Consultant 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 proficiency testing results from the CMS-155D and American Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing as evidence by: 1. The laboratory failed to attain a score of at least 80% for the Red Blood Cell and Hematocrit testing. Refer to D2121. 2. The laboratory failed to attain a satisfactory score score of at least 80% for Hematology in Event 3 of 2018. Refer to D2122. 3. The laboratory failed to achieve a score of at least 80% for Red Blood Cells in two of three consecutive events resulting in intial unsuccessful participation. Refer to D2130. D2121 HEMATOLOGY CFR(s): 493.851(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 CMS 155D Report and American Proficiency Institute (API) and interview with personnel, the laboratory failed to attain a score of at least 80% for the Red Blood Cell and Hematocrit testing. Findings: 1. Review of the API Proficiency Testing Records revealed the laboratory did not achieve a score of at least 80% for the specialty of Hematology for the following events: For the 2nd event in 2018 the laboratory received a score of 0% for Red Blood Cell (RBC). For the 3rd event in 2018 the laboratory received a score of 0% for Red Blood Cell (RBC). For the 3rd event in 2018 the laboratory received a score of 40% for Hematocrit (HCT). 2. In interview on April 5, 2019 at 11:40 am, the Technical Consultant stated the laboratory stopped testing of RBC and contacted the state office. The Technical Consultant further stated the laboratory contacted theCell Dyn Emerald analyzer field service representative to perform maintenance and will start testing after a successful API survey is reported. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing results, the laboratory failed to attain a satisfactory score score of at least 80% for Hematology in Event 3 of 2018. Findings are: 1. Review of CASPER Reports 0155D along with API Proficiency Testing Records revealed the laboratory received an overall score of 70 % for Hematology in the second event of 2018. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing results from the CMS-155D and American -- 2 of 6 -- Proficiency Institute (API), the laboratory failed to achieve a score of at least 80% for Red Blood Cells in two of three consecutive events resulting in intial unsuccessful participation. Findings: 1. Review of proficiency testing records and the CMS 155D Report revealed the following unsatisfactory proficiency testing scores for Red Blood Cell (RBC) resulting in unsuccessful participation: a. 2018 Event 2: Score of 0% b. 2018 Event 3: Score of 0% D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --