Family Medicine Group Of Oxford

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing program. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000 - 42 C.F.R. 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 surveyor desk review of the laboratory proficiency testing (PT) records 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 -- (graded copies from the American Proficiency Institute (API) and the CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory failed to achieve satisfactory performance in two of two testing events (2024-Event 1, and 2024-Event 2) resulting in unsuccessful participation in routine chemistry for IRON, TOTAL. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute (API) and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8 /12/2024, the laboratory has not successfully performed proficiency testing for IRON, TOTAL in two of two testing events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for IRON, TOTAL: IRON, TOTAL: Year 2024-1st Event 20% Year 2024-2nd Event 60% 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER reports 0153D/0155D from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to provide overall management and direction of the laboratory services. 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 surveyor desk review of the laboratory proficiency testing records (graded copies from the American Proficiency Institute and CASPER report 0153D/0155D -- 2 of 3 -- from the Centers for Medicare and Medicaid Services data system) on 8/12/2024, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies 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 review of the Vitros 5600 Integrated Chemistry System quality control (QC) records from the date of installation on 9/11/2023 through 7/16/2024, the manufacturer's assay information sheets with acceptable control ranges, and interview with Testing Personnel #1, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the laboratory failed to retain the manufacturer's assay information sheets for two of five lots of controls, in use during this time frame, for at least 2 years. Findings include: 1. Review of the Vitros 5600 Integrated Chemistry System QC records from the date of installation on 9/11/2023 through 7/16/2024 revealed three lots of BioRad Liquid Assayed Multiqual controls were used for quality control testing for routine chemistry tests during this time frame. 2. BioRad Liquid Assayed Multiqual control Lot #45810--Level 1 and Level 3--was in use from 9/11 /2023 through 10/31/2023, 7 weeks of the 44 weeks that the Vitros 5600 Integrated chemistry system was in use. The manufacturer's assay information sheet, containing acceptable ranges for routine chemistry tests, for this lot of controls was not available on the day of the survey. 3. Review of the Vitros 5600 Integrated Chemistry System QC records from the date of installation on 9/11/2023 through 7/16/2024 revealed two lots of BioRad Liquichek Immunoassay Plus controls were used for quality control testing for thyroid stimulating hormone (TSH), prostate specific antigen (PSA), testosterone, ferritin, free thyroxine (FT4), free triiodothyronine (FT3), insulin, folate, and vitamin B12 tests during this time frame. 4. BioRad Liquichek Immunoassay Plus control Lot #85320--Levels 1, 2, and 3--was in use from 9/11/2023 through 5/28 /2024, 38 weeks of the 44 weeks that the Vitros 5600 Integrated chemistry system was 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 -- in use. The manufacturer's assay information sheet, containing acceptable ranges for this lot of controls was not available on the day of the survey. 5. In an interview on 7 /17/2024 at 3:30 p.m., Testing Personnel #1 confirmed the manufacturer's assay information sheets, with acceptable control ranges, for BioRad Liquid Assayed Multiqual control Lot #45810 and BioRad Liquichek Immunoassay Plus control Lot #85320 were not retained. 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 Biosite Triage Meter records and interview with Testing Personnel #1 on the CMS 209 personnel form, the laboratory failed to perform calibration verification on the Biosite Triage Meter at least once every 6 months for creatine kinase-MB (CK-MB), troponin, and D-dimer testing for two of three six- month calibration verification procedures due. Findings include: 1. Review of Biosite Triage Meter records since the last survey on 10/11/22 revealed no documentation of calibration verification for CK-MB, troponin, and D-dimer testing since 3/19/23. 2. In an interview on 7/17/24 at 4:15 p.m., Testing Personnel #1 confirmed that calibration verification had not been performed for CK-MB, troponin, and D-dimer testing on the Biosite Triage Meter since 3/19/23. 3. The laboratory failed to perform two of the three, six-month calibration verification procedures due since the last survey-- September 2023 and March 2024. The Biosite Triage Meter was in use for CK-MB, troponin, and D-dimer testing from October 2023 through June 2024, nine months past the calibration verification due date of September 2023. THIS IS A REPEAT DEFICIENCY. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test -- 2 of 3 -- results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individual Quality Control Plan (IQCP), quality control (QC) records for the Quidel Triage Meter Pro analyzer, and patient test results, the laboratory failed to ensure results of at least two control materials met the manufacturer's criteria for acceptability for 3 of the 4 months reviewed, when 20 patient Troponin I test results were reported. Findings include: 1. The laboratory's IQCP for the Quidel Triage Meter Pro analyzer states that two levels of control will be performed with each new lot of cartridges and at least monthly. 2. Review of QC records for the Quidel Triage Meter Pro analyzer from 12/19/2023 through 5/10/2024 revealed one of two controls was outside the manufacturer's acceptable range for Troponin I with the monthly performance of controls on 1/30/2024, 2/29/2024, and 4/3 /2024. The last acceptable QC results were performed on 12/19/2023, before the Quidel Triage Meter Pro analyzer was taken out of use on 5/10/2024. 3. Review of patient test results revealed Troponin I results were reported on the following 20 patients from 12/20/23 through 5/10/2024: 12/27/2023--Patient #175182 12/28/2023-- Patient #175246 01/12/2024--Patient #176010 01/23/2024--Patient #176088 01/25 /2024--Patient #176198 02/07/2024--Patient #176766 02/08/2024--Patient #176851 02 /12/2024--Patient #176967 02/17/2024--Patient #177233 03/08/2024--Patient #178106 03/15/2024--Patient #178384 03/27/2024--Patient #178887 04/01/2024-- Patient #179020 04/11/2024--Patient #179464 04/23/2024--Patient #179926 04/30 /2024--Patient #180212 05/02/2024--Patient #180308 05/03/2024--Patient #180404 05 /06/2024--Patient #180423 05/10/2024--Patient #180587 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 review of the verification of performance specifications for the Ortho Clinical Diagnostics Vitros 5600 Integrated Chemistry System, performed at installation in August 2023, and lack of documentation of review of these records, the laboratory director failed to ensure that the verification procedures used were adequate to determine the accuracy, precision, and linearity of the Vitros 5600 Integrated Chemistry System, for ten of ten months in which the analyzer was put in use for patient chemistry and immunoassay testing. Findings include: 1. Review of the verification of performance specifications for the Vitros 5600 Integrated Chemistry System revealed a linearity study, precision, and method comparison with the reference laboratory were performed in August 2023. 2. There was no documentation of review of these records by the laboratory director to ensure the verification procedures were adequate to determine the accuracy, precision, and linearity of the Vitros 5600 Integrated Chemistry System before the system was put in use for patient testing on 9/11/2023. -- 3 of 3 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's Technical Policies and Procedures Manual and personnel records since the last survey on 3/24/21, the laboratory failed to establish written policies and procedures to assess competency of the technical consultant, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, responsible for technical oversight of the laboratory. Findings include: Review of personnel records since the last survey on 3/24/21 revealed no competency assessments performed by the laboratory director of the technical consultant, listed on the CMS 209 personnel form, responsible for technical oversight of the laboratory. Review of the laboratory's Technical Policies and Procedures Manual revealed no written policies and procedures for assessing competency of the technical consultant. THIS IS A REPEAT DEFICIENCY. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 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 -- Based on review of quality control (QC) records for testosterone testing on the Qualigen FastPack IP System from 4/4/22 through 9/30/22, patient test records, and the laboratory's written Individualized Quality Control Plan (IQCP), the laboratory failed to follow its written IQCP for performing external quality control each week of testing for seven weeks during this time frame, when a total of 32 patient testosterone results were reported. Findings include: The laboratory's IQCP states that two levels of external QC are performed each week of testing. Review of QC records for testosterone testing on the Qualigen FastPack IP System and patient test records from 4/4/22 through 9/30/22 revealed two levels of external QC were not performed on the following weeks of patient testing: Week 5/16/22 - 5/20/22--Patient specimens # 153875, #153883, #153880, #153909, #153958 reported. Week 5/23/22 - 5/27/22-- Patient specimens #154109, #154131, #154139, #154187 reported. Week 5/31/22 - 6/3 /22--Level 2 control was outside manufacturer's acceptable range--Patient specimens #154246, #154279, #154230, #154396, #154398 reported. Week 6/6/22 - 6/10/22-- Patient specimens #154487, #154496, #154492, #154475, #154572, #154588, #154607, #154638, #154642, #154655 reported. Week 8/15/22 - 8/22/22--Patient specimens #157142 and #157311 reported. Week 9/16/22 - 9/22/22--Patient specimen #131306 reported. Week 9/23/22 - 9/30/22--Patient specimens #131723, #131751, #131794, #131801, #131807 reported. 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 patient test logs, quality control (QC) records for the Siemens Dimension Xpand chemistry analyzer from 3/1/22 through 8/31/22, manufacturer's package insert for Bio-Rad Liquichek Immunoassay Plus controls, Lot #85231 and Lot #85233, and confirmation by Testing Personnel #1 listed on the CMS 209 personnel form, Bio-Rad Liquichek Immunoassay Plus controls Level 1 (Lot #85231) and Level 2 (Lot #85233) were used for quality control testing for 24 weeks after they had exceeded their expiration date of 2/28/22, with a total of 1,319 thyroid stimulating hormone (TSH) patient results reported, a total of 478 free thyroxine (FT4) patient results reported, and a total of 295 prostate specific antigen (PSA) patient results reported during this time frame. Findings include: Review of the manufacturer's package insert for Bio-Rad Liquichek Immunoassay Plus controls Level 1 (Lot #85231) and Level 3 (Lot #85233) revealed Lot #85231 and Lot #85233 had an expiration date of 2/28/22. Review of QC records for the Siemens Dimension Xpand chemistry analyzer from 3/1/22 through 8/31/22 revealed Lot #85231 and Lot #85233 were used for quality control testing for TSH, FT4, and PSA from 3/1/22 through 8/12 /22. Review of patient test logs from 3/1/22 through 8/12/22 revealed during this time frame, a total of 1,319 TSH patient results, 478 FT4 patient results, and 295 PSA patient results were reported. Testing Personnel #1 confirmed new lots of Bio-Rad Liquichek Immunoassay Plus controls (Lot #85321 and Lot #85323, expiration date 5 /31/24) were put in use on 8/15/22. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) -- 2 of 4 -- Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Cell Dyn Emerald hematology analyzer calibration records since the last survey on 3/24/21 and interview with Testing Personnel #1 listed on the CMS 209 personnel form on 10/11/22 at 4:50 p.m., the laboratory failed to perform calibration on complete blood counts (CBC) performed on the Cell Dyn Emerald hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Review of the Cell Dyn Emerald calibration records since the last survey on 3/24/21 revealed calibration was not performed from 10/2/21 until the Cell Dyn Emerald was taken out of service on 9/28/22. This exceeds the 6 month timeframe required by the manufacturer. 2. Interview with TP #1 on 10/11/22 at 4:50 p.m. confirmed CBC calibrations were not performed every 6 months, as required by the manufacturer. THIS A REPEAT DEFICIENCY. 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 Biosite Triage Meter records since the last survey on 3/24/21 and interview with Testing Personnel #1 on the CMS 209 personnel form on 10/11/22 at 4: 00 p.m., the laboratory failed to perform calibration verification on the Biosite Triage -- 3 of 4 -- Meter at least once every 6 months for creatine kinase-MB (CK-MB), troponin, and D- dimer testing. Findings include: 1. Review of Biosite Triage Meter records since the last survey on 3/24/21 revealed no documentation of calibration verification for CK- MB, troponin, and D-dimer testing since the last survey on 3/24/21. 2. In an interview on 10/11/22 at 4:00 p.m., Testing Personnel #1 confirmed that calibration verification had not been performed for CK-MB, troponin, and D-dimer testing on the Biosite Triage Meter since April 2021, shortly after the last survey on 3/24/21. These calibration verification records (performed in April 2021) were not available for review on the day of the survey, 10/11/22. THIS IS A REPEAT DEFICIENCY. -- 4 of 4 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/19/2021, the laboratory has not successfully participated in proficiency testing for TOTAL CHOLESTEROL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute TOTAL CHOLESTEROL:: Year 2020 3rd Event 60% Year 2021 2nd Event 40% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two 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 -- consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/19/2021, the laboratory has not successfully participated in proficiency testing for TOTAL CHOLESTEROL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for TOTAL CHOLESTEROL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute TOTAL CHOLESTEROL:: Year 2020 3rd Event 60% Year 2021 2nd Event 40% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

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 patient records for the Abbott ID NOW COVID-19 molecular test (including reporting log) and the Healgen COVID-19 IgG/IgM Rapid Test Cassette and an interview with Testing Personnel (TP) #1 at 12:00 pm on 3/24/21, the laboratory failed to report after 9/23/2020 all SARS-CoV-2 results (positive and negatives) to the Secretary of Health and Human Services via the Mississippi State Department of Health (MSDH) Epidemiology program. Findings include: 1. Review of the QC and patient result logs and the positive and negative patient report logs for the Abbott ID NOW COVID-19 test indicated that no SARS-CoV-2 patient results had been reported to MSDH Epidemiology since December 2020. 2. Review of the patient result logs and the positive and negative patient report logs for the Healgen COVID-19 IgG/IgM Rapid Test Cassette indicated that no patient results had been reported to MSDH Epidemiology since December 2020 3. Interview with TP #1 on 3 /24/21 at 12:00 pm confirmed that the laboratory had not reported any COVID-19 test results to MSDH Epidemiology since December 2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the testing personnel (TP) #1 listed on the Centers of Medicare & Medicaid Services (CMS) 209 personnel form at 3:00 pm on 3/24/21, the Laboratory Director failed to follow written policies to assess competency of the TC (technical consultant) at least annually. There was no evaluation for the TC on the day of survey for the years 2019 or 2020. Findings include: 1. Interview with TP#1 at 3:00 pm confirmed there was no competency documented by the laboratory director for the TC since the last survey on 8/7/18. 2. Based on review of the personnel records the day of survey, 3/24/21, the laboratory director failed to follow policies and evaluate the technical consultant at least annually for the years 2019 and 2020. THIS IS A REPEAT DEFICIENCY D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency records from 2020 and 2021 and interview with TP #1 at 10:30 am, on the day of survey (3/24/21), the laboratory failed to verify the accuracy of Healgen COVID-19 IgG/IgM Antibody testing at least twice annually since the laboratory began testing with the kit on 8/4/20. Findings include: 1. Review of the proficiency records from 2020 and 2021 revealed the Healgen COVID-19 IgG /IgM Antibody test had not been included. 2. There was no documentation that indicated that the Healgen COVID-19 IgG/IGM antibody test had been verified for accuracy by comparison with another known assay. 3. Interview with TP #1 at 10:30 am on 3/24/21 confirmed that accuracy had not been verified on the Healgen COVID- 19 IgG/IgM antibody test kit twice annually. 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 the number of deficiencies cited for analytic systems, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 to monitor and evaluate the overall quality of the analytic systems and correct identified -- 2 of 6 -- problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Refer to D tag 5421: No performance specifications verified for the Healgen COVID-19 IgG/IgM Rapid Test Cassette kit prior to start of testing. Refer to D tag 5437: Cell Dyn Emerald calibration not performed as required every 6 months. Refer to D tag 5439: Triage Meter SOB panel and Qualigen Fast Past Vitamin D and Testosterone calibration verification not performed as required every 6 months Refer to D tag 5449: Healgen COVID-19 IgG/IgM Rapid Test Cassette tests performed without QC testing. Refer to D tag 5479: Remel RA Rapid test performed with no documentation of QC performed with patients. 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 review of the Healgen COVID-19 IgG/IgM Rapid Test Cassette, lack of documentation of verification of performance specifications, and interview with testing personnel (TP) #1 on 3/24/21 at 10:00 am, the laboratory failed to verify the manufacturer's performance specifications before reporting patient test results. Findings: 1. No documentation of verification of performance specifications for the Healgen COVID-19 IgG/IgM Antibody Rapid Test Cassette was available for review on the day of survey. 2. Interview with TP #1 on 3/24/21 at 10:00 am revealed no verification of performance specifications was completed before testing patients. 3. Seventy-six patients had been tested by the laboratory since 8/4/20. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Cell Dyn Emerald hematology analyzer calibration records since the last survey on 3/4/18 and interview with testing personnel (TP) #1 listed on the CMS (Center for Medicare & Medicaid Services) 209 personnel form at 1:00 pm on the day of survey, the laboratory failed to perform calibration on CBC (complete -- 3 of 6 -- blood count) performed on the Cell Dyn Emerald hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Review of the Cell Dyn Emerald calibration records from 3/4/18 through 3/24/21 revealed calibration had not been performed since 3/11/20. This exceeds the 6 month timeframe required by the manufacturer. 2. Interview with TP #1 at 1:00 pm on 3/24/21 confirmed CBC calibrations were not performed every 6 months as required by the manufacturer. 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: A. Based on review of Biosite Triage Meter records from 3/2/19 through 3/24/21 and confirmation with testing personnel (TP) #1, the laboratory failed to perform calibration verification on the Biosite Triage Meter chemistry analyzer every 6 months for the Shortness of Breath (SOB) cardiac panel (CK, troponin, BNP, D- dimer). Findings include: 1. Review of the laboratory Biosite Triage Meter SOB panel (CK, Troponin, BNP and D-dimer) from 3/2/19 through 3/23/21 revealed calibration verification had not been performed on the SOB panel. 2. Interview with TP #1 at 2: 00 pm confirmed that calibration verification had not been performed on the SOB cardiac panel every 6 months as required by the manufacturer. B. Based on review of the Qualigen Fast Pack System records from 3/2/19 through 3/23/21, and confirmation with TP #1, the laboratory failed to perform calibration verification on the Qualigen Fast Pack system every 6 months for Vitamin D and testosterone. 1. Review of the manufacturer's requirements for the Qualigen Fast Pack Testosterone and Vitamin D assays indicate that calibration verification is required every 6 months for both assays. 2. Review of the Qualigen Fast Pack testosterone records from 4/3/19 through 3/24/21 revealed no calibration verification had been performed. 2. Review of the Qualigen Fast Pack Vitamin D records from 3/4/19 through 3/9/21 revealed calibration verification had been performed on 1/29/20, 2/12/20 and 3/9/21. The time periods from 3/4/19 to 1/29/20 and 2/12/20 to 3/9/21 exceed the manufacturer's calibration -- 4 of 6 -- verification requirement. 3. Interview with TP #1 at 2:00 pm confirmed that calibration verifications had not been performed on the Vitamin D or testosterone in the time frame required by the manufacturer. 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 of quality control records for the Healgen COVID-19 IgG/IgM Rapid Test Cassette and interview with testing personnel (TP) #1 at 10:30 am on 3/24/21, the laboratory failed to include a positive and negative control on each day of patient testing for the Healgen COVID-19 IgG/IgM Rapid Test Cassette performed from 8/4/20 through 3/24/21 for antibodies to SARS-CoV-2. Findings Include: 1. Review of the annual laboratory test count revealed 76 patients had been tested with the Healgen COVID-19 IgG/IgM Rapid Test since the lab started using this test kit on 8/4/20. 2. Review of the Healgen COVID-19 IgG/IgM Rapid Test Cassette kit revealed there was no quality control (QC) material (positive or negative) available. 3. Interview with TP #1 indicated that the manufacturer had not provided QC material in the kit and none had been obtained by the laboratory. 4. Interview with the TP #1 at 10:30 am on 3/24/21 confirmed that TP were not performing two levels of QC each day of patient testing with the Healgen COVID-19 IgG/IgM Rapid Test Cassette. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation of quality control records for the BioKit rheumajet RF (rheumatoid factor) from 1/31/19 through 3/24/21 and interview with staff at 2:00 pm, the laboratory failed to document as performed the quality control (QC) results for the rheumajet RF test kit each day of testing patients. Findings include: 1. There was no documentation to indicate that QC was performed each day of patient testing as required. 2. Interview with TP #1 confirmed that QC material, both positive and negative, was being tested along with patient samples each day of testing. QC results were not documented in any way. Patient results were entered directly into the LIS, so no log was kept on which QC results might be noted. 3. The laboratory performed approximately 304 RF patient testing between 1/31/19/ and 3/24/21. THIS IS A REPEAT DEFICIENCY D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 5 of 6 -- CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 patient records for the Abbott ID NOW COVID-19 molecular test (including reporting log) and the Healgen COVID-19 IgG/IgM Rapid Test Cassette and an interview with Testing Personnel (TP) #1 at 12:00 pm on 3/24/21, the laboratory failed to report after 9/23/2020 all SARS-CoV-2 results (positive and negatives) to the Secretary of Health and Human Services via the Mississippi State Department of Health (MSDH) Epidemiology program. Findings include: 1. Review of the QC and patient result logs and the positive and negative patient report logs for the Abbott ID NOW COVID-19 test indicated that no SARS-CoV-2 patient results had been reported to MSDH Epidemiology since December 2020. 2. Review of the patient result logs and the positive and negative patient report logs for the Healgen COVID-19 IgG/IgM Rapid Test Cassette indicated that no patient results had been reported to MSDH Epidemiology since December 2020 3. Interview with TP #1 on 3 /24/21 at 12:00 pm confirmed that the laboratory had not reported any COVID-19 test results to MSDH Epidemiology since December 2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES 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 -- CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and interview with the testing personnel (TP) #1 listed on the Centers of Medicare & Medicaid Services (CMS) 209 personnel form at 3:00 pm on 3/24/21, the Laboratory Director failed to follow written policies to assess competency of the TC (technical consultant) at least annually. There was no evaluation for the TC on the day of survey for the years 2019 or 2020. Findings include: 1. Interview with TP#1 at 3:00 pm confirmed there was no competency documented by the laboratory director for the TC since the last survey on 8/7/18. 2. Based on review of the personnel records the day of survey, 3/24/21, the laboratory director failed to follow policies and evaluate the technical consultant at least annually for the years 2019 and 2020. THIS IS A REPEAT DEFICIENCY D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency records from 2020 and 2021 and interview with TP #1 at 10:30 am, on the day of survey (3/24/21), the laboratory failed to verify the accuracy of Healgen COVID-19 IgG/IgM Antibody testing at least twice annually since the laboratory began testing with the kit on 8/4/20. Findings include: 1. Review of the proficiency records from 2020 and 2021 revealed the Healgen COVID-19 IgG /IgM Antibody test had not been included. 2. There was no documentation that indicated that the Healgen COVID-19 IgG/IGM antibody test had been verified for accuracy by comparison with another known assay. 3. Interview with TP #1 at 10:30 am on 3/24/21 confirmed that accuracy had not been verified on the Healgen COVID- 19 IgG/IgM antibody test kit twice annually. 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 the number of deficiencies cited for analytic systems, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 to monitor and evaluate the overall quality of the analytic systems and correct identified -- 2 of 6 -- problems as specified in 493.1289 for each specialty and subspecialty of testing performed. Refer to D tag 5421: No performance specifications verified for the Healgen COVID-19 IgG/IgM Rapid Test Cassette kit prior to start of testing. Refer to D tag 5437: Cell Dyn Emerald calibration not performed as required every 6 months. Refer to D tag 5439: Triage Meter SOB panel and Qualigen Fast Past Vitamin D and Testosterone calibration verification not performed as required every 6 months Refer to D tag 5449: Healgen COVID-19 IgG/IgM Rapid Test Cassette tests performed without QC testing. Refer to D tag 5479: Remel RA Rapid test performed with no documentation of QC performed with patients. 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 review of the Healgen COVID-19 IgG/IgM Rapid Test Cassette, lack of documentation of verification of performance specifications, and interview with testing personnel (TP) #1 on 3/24/21 at 10:00 am, the laboratory failed to verify the manufacturer's performance specifications before reporting patient test results. Findings: 1. No documentation of verification of performance specifications for the Healgen COVID-19 IgG/IgM Antibody Rapid Test Cassette was available for review on the day of survey. 2. Interview with TP #1 on 3/24/21 at 10:00 am revealed no verification of performance specifications was completed before testing patients. 3. Seventy-six patients had been tested by the laboratory since 8/4/20. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on review of the Cell Dyn Emerald hematology analyzer calibration records since the last survey on 3/4/18 and interview with testing personnel (TP) #1 listed on the CMS (Center for Medicare & Medicaid Services) 209 personnel form at 1:00 pm on the day of survey, the laboratory failed to perform calibration on CBC (complete -- 3 of 6 -- blood count) performed on the Cell Dyn Emerald hematology analyzer every 6 months as required by the manufacturer. Findings include: 1. Review of the Cell Dyn Emerald calibration records from 3/4/18 through 3/24/21 revealed calibration had not been performed since 3/11/20. This exceeds the 6 month timeframe required by the manufacturer. 2. Interview with TP #1 at 1:00 pm on 3/24/21 confirmed CBC calibrations were not performed every 6 months as required by the manufacturer. 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: A. Based on review of Biosite Triage Meter records from 3/2/19 through 3/24/21 and confirmation with testing personnel (TP) #1, the laboratory failed to perform calibration verification on the Biosite Triage Meter chemistry analyzer every 6 months for the Shortness of Breath (SOB) cardiac panel (CK, troponin, BNP, D- dimer). Findings include: 1. Review of the laboratory Biosite Triage Meter SOB panel (CK, Troponin, BNP and D-dimer) from 3/2/19 through 3/23/21 revealed calibration verification had not been performed on the SOB panel. 2. Interview with TP #1 at 2: 00 pm confirmed that calibration verification had not been performed on the SOB cardiac panel every 6 months as required by the manufacturer. B. Based on review of the Qualigen Fast Pack System records from 3/2/19 through 3/23/21, and confirmation with TP #1, the laboratory failed to perform calibration verification on the Qualigen Fast Pack system every 6 months for Vitamin D and testosterone. 1. Review of the manufacturer's requirements for the Qualigen Fast Pack Testosterone and Vitamin D assays indicate that calibration verification is required every 6 months for both assays. 2. Review of the Qualigen Fast Pack testosterone records from 4/3/19 through 3/24/21 revealed no calibration verification had been performed. 2. Review of the Qualigen Fast Pack Vitamin D records from 3/4/19 through 3/9/21 revealed calibration verification had been performed on 1/29/20, 2/12/20 and 3/9/21. The time periods from 3/4/19 to 1/29/20 and 2/12/20 to 3/9/21 exceed the manufacturer's calibration -- 4 of 6 -- verification requirement. 3. Interview with TP #1 at 2:00 pm confirmed that calibration verifications had not been performed on the Vitamin D or testosterone in the time frame required by the manufacturer. 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 of quality control records for the Healgen COVID-19 IgG/IgM Rapid Test Cassette and interview with testing personnel (TP) #1 at 10:30 am on 3/24/21, the laboratory failed to include a positive and negative control on each day of patient testing for the Healgen COVID-19 IgG/IgM Rapid Test Cassette performed from 8/4/20 through 3/24/21 for antibodies to SARS-CoV-2. Findings Include: 1. Review of the annual laboratory test count revealed 76 patients had been tested with the Healgen COVID-19 IgG/IgM Rapid Test since the lab started using this test kit on 8/4/20. 2. Review of the Healgen COVID-19 IgG/IgM Rapid Test Cassette kit revealed there was no quality control (QC) material (positive or negative) available. 3. Interview with TP #1 indicated that the manufacturer had not provided QC material in the kit and none had been obtained by the laboratory. 4. Interview with the TP #1 at 10:30 am on 3/24/21 confirmed that TP were not performing two levels of QC each day of patient testing with the Healgen COVID-19 IgG/IgM Rapid Test Cassette. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation of quality control records for the BioKit rheumajet RF (rheumatoid factor) from 1/31/19 through 3/24/21 and interview with staff at 2:00 pm, the laboratory failed to document as performed the quality control (QC) results for the rheumajet RF test kit each day of testing patients. Findings include: 1. There was no documentation to indicate that QC was performed each day of patient testing as required. 2. Interview with TP #1 confirmed that QC material, both positive and negative, was being tested along with patient samples each day of testing. QC results were not documented in any way. Patient results were entered directly into the LIS, so no log was kept on which QC results might be noted. 3. The laboratory performed approximately 304 RF patient testing between 1/31/19/ and 3/24/21. THIS IS A REPEAT DEFICIENCY D6019 LABORATORY DIRECTOR RESPONSIBILITIES -- 5 of 6 -- CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel documented annual evaluations/competency and interview with the technical consultant, the laboratory failed to follow written policies to assess employees and, if applicable, technical consultant competency at least annually since employment of the new technical consultant, 7/17. On the day of survey, the evaulation of an annual competency for the technical consultant, did not reflect technical consultant duties (D6049) for the year 2017 and 2018, as of the day of the survey, performed by the laboratory director. The competency/evaulation was based on testing personnel duties instead of technical consultant duties and responsibilities. D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory records from last survey, 9/9/16 through day of survey, and interview with staff at 4:00 pm on 8/7/18, the laboratory failed to document 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 2 -- quality control (QC) results for the the Rapid Test- Rheumajet RF (rheumatoid factor) test kit Findings include: On the day of survey, the RF testing records, to include patient testing logs and QC (quality control) documentation, were not available. This was confirmed by staff interview. An unopened Rapid Test - Rheumajet RF test kit (lot number B27926) was in the refrigerator and staff indicated that it was the kit being used by the laboratory to perform RF patient testing. According to staff RF patient results are entered into the LIS but QC results, performed with patient testing, could not be produced the day of survey. The laboratory performed 122 RF tests on patients from 7/17 until 7/18. -- 2 of 2 --