Community Health Clinic

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Community Health Clinic (Richlands) was conducted on 04/05/22 and 4/06/22 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. D2017- 42 C.F.R 493.807 (a)(b) Condition- Reinstatement of Nonwaived Laboratories. 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: 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 -- Based on off-site proficiency testing (PT) desk review, communication with the laboratory director on 04/05/22 and 4/06/22, the laboratory failed to achieve satisfactory performance of at least 80% for three consecutive events for the White Blood Cell Differential (WBC Diff) analyte for the second and third events in 2021 and the first event in 2022, resulting in a repeat unsuccessful performance. Refer to D2130. 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 the off-site review of the Medical Laboratory Evaluation (MLE) Proficiency Testing (PT) scores, the CASPER 155D Individual Laboratory Profile report, and communication with the laboratory director, the laboratory has not participated in reinstatement testing for the White Blood Cell Differential (WBC Diff) analyte. Findings include: 1. As of the date of the desk review, the laboratory has not submitted evidence of satisfactory performance on two consecutive PT events for the analyte of WBC Diff. 2. A phone conference with the laboratory director on 04/05/22 at 9 AM revealed the laboratory director was unaware of the PT failure. They requested the day to review the results. The laboratory director acknowledged that the lab did not have evidence of two consecutive successful performance scores with the MLE for the analyte of WBC Diff. 3. An email communication with the laboratory director on 04/06/22 at 1518 revealed that the laboratory has voluntarily withdrawn its certification for the analyte of WBC Diff. 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 the off-site review of the proficiency testing (PT) scores for the second and third events in 2021 and the first event in 2022, the CASPER 0155D Individual Laboratory Profile report, and an interview with the laboratory director, the laboratory failed to achieve satisfactory performance of at least 80% for three consecutive events for the White Blood Cell Differential (WBC Diff) analyte. Findings include: 1. -- 2 of 3 -- Review of the Medical Laboratory Evaluation (MLE) hematology PT scores and the CASPER 0155D Individual Laboratory PT report revealed the following scores: 2021 2nd event WBC Diff- 0% 2021 3rd event WBC Diff- 0% 2022 1st event WBC Diff- 46% The laboratory received a repeat unsuccessful MLE PT score for the above listed analyte. 2. A phone conference with the laboratory director on 04/05/22 at 9 AM and an email communication on 04/06/22 at 1518 confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Community Health Clinic (Richlands) was conducted on 12/02/21 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The laboratory was not in compliance with the following Conditions under 42 CFR part 493 CLIA Regulations: D2016 - 42 C.F.R. 493.803 (a)(b)(c) Condition- Successful Participation. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the proficiency testing (PT) records for the third event in 2021, the CASPER 0153D Unsatisfactory and Unsuccessful PT Report and interview with 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 -- primary testing personnel, the laboratory failed to participate in the Medical Laboratory Evaluation (MLE) Hematology proficiency testing schedule for one of three testing events in 2021 (Refer to D2123). Based on the review of the proficiency testing (PT) scores for the second and third events in 2021, the CASPER 0153D Unsatisfactory and Unsuccessful PT Report, and an interview with the primary testing personnel, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the White Blood Cell Differential (WBC Diff) parameter, in which the laboratory received scores of 0% for both events, resulting in unsuccessful performance (Refer to D2130). 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 the review of proficiency testing (PT) records, the CASPER 0153D Unsatisfactory and Unsuccessful PT Report, and an interview with the primary testing personnel, the laboratory failed to participate in one of three Complete Blood Count (CBC) PT events in 2021. Findings include: 1. Review of the CASPER 0153D Unsatisfactory and Unsuccessful PT Report and the Medical Laboratory Evaluation (MLE) PT records for the third event in 2021 revealed the laboratory received a score of 0%: 2021 MLE-M3- 0%- for the CBC module (Notation by MLE-failure to participate). 2. An interview with the primary testing personnel on 12/02/21 at approximately 10:30 AM confirmed the findings. 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 the review the proficiency testing (PT) scores for the second and third events in 2021, the CASPER 0153D Unsatisfactory and Unsuccessful PT report and interview with the primary testing personnel, the laboratory failed to achieve satisfactory performance of at least 80% for two consecutive events for the White Blood Cell Differential (WBC Diff) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) hematology PT scores and the CASPER 0153D Unsuccessful PT report revealed the following scores: 2021 2nd event WBC Diff- 0% 2021 3rd event WBC Diff- 0% The laboratory -- 2 of 3 -- received an unsuccessful MLE PT score for the above listed analyte. 2. An interview with the primary testing personnel on 12/02/21 at approximately 10:30 AM confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced CLIA complaint investigation was conducted at the Community Health Clinic (Richlands) on 10/05/21 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5400 - 42 C.F. R. 493-1250 Condition: Analytic Systems ***REPEAT DEFICIENCY*** D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity Laboratory Director ***REPEAT DEFICIENCY*** 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: ***REPEAT DEFICIENCY*** Based on the review of policy and procedures (P&P),

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Community Health Clinic on May 25, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The initial contact and entrance interview with laboratory conducted on April 19, 2021 with off-site record review of documentation on May 24, 2021. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D3000 - 42 C.F.R. 493-1100 Condition: Reporting of SARS-CoV-2 Test Reports. 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 record review and interviews, the lab failed to report SARS-CoV-2 negative test results for sixty-three (63) of 63 testing dates from 09/01/20 through 03/15/21. Findings include: 1. An interview and review of available SARS-CoV-2 patient test results and daily testing logs with the primary testing personnel on 05/25/21 at 12:30 PM revealed the site performed Healgen COVID-19 IgG/IgM Rapid Test (whole blood /serum/plasma) test method on 09/01/20 and up to 03/15/21 and the CareStart COVID- 19 Antigen nasopharyngeal or nasal swab test method from 01/01/21 up to 03/15/21. 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 -- 2. 123 negative results were not reported as required during the period of review (64 testing dates). 3. The laboratory performed 142 SARS-CoV-2 tests during the period of review. 4. An exit interview with the primary testing personnel on 05/25/21 at approximately 2:00 PM confirmed the findings. A phone interview with the laboratory director on 05/26/21 at approximately 3:50 PM confirmed the above-listed findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification on-site survey was conducted at the Community Health Clinic (Richlands) on May 25, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on April 19, 2021 with off-site record review of documentation on May 17, 2021. Specific deficiencies cited are as follows: The laboratory was not in compliance with the following 42 CFR part 493 CLIA Regulations: D5200 - 42 C.F.R. 493-1230 Condition: General Laboratory Systems, D5400 - 42 C.F.R. 493-1250 Condition: Analytic Systems, D6000 - 42 C.F.R. 493-1403 Condition: Moderate Complexity Laboratory Director and, D6063 - 42 C.F.R. 493-1421 Condition: Laboratory Testing Personnel. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: **REPEAT DEFICIENCY** Based on the review of proficiency testing (PT) records, lack of documentation, the laboratory's 2018

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Community Health Clinic (Richlands site) on December 18, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and interview, the laboratory director failed to sign one (1) of six (6) attestation statements reviewed. PT record review included 2017 and 2018 testing events. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) PT records for all three events in 2017 and 2018 revealed that the laboratory director did not sign the 2017 MLE 3rd event (M3) attestation statement. 2. An interview with the laboratory director at approximately 2: 00 PM confirmed the above-listed findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records and interview, the laboratory 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 -- director failed to review and sign one (1) of six (6) PT results reviewed. PT record review included 2017 and 2018 testing events. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) PT records for all three events in 2017 and 2018 revealed that the laboratory director did not review and sign the 2018 MLE 1st event (M1) PT results. 2. An interview with the laboratory director at approximately 2: 00 PM confirmed the above-listed findings. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on a tour of the laboratory, review of manufacturer's package insert (PI) and interviews, the laboratory failed to label thirteen (13) of the sixteen (16) hematology quality control (QC) materials with opened-vial expiration date according the manufacturer's PI on the date of survey on December 18, 2018. Findings include: 1. Tour of the laboratory revealed that the laboratory utilizes the Horiba Medical Mintrol hematology QC materials. The current box in the refrigerator contained 16 vials of QC material (4 low level, 4 normal level and 4 high level) lot number MX 414 expiration date January 5, 2019. Thirteen of the 16 vials did not have an open date nor a revised expiration date. (Cross Reference D5417) The inspector asked the primary testing personnel (TP) at approximately 1:15 PM, which vials was currently in use for QC procedures. She/he indicated that they would randomly pick one of each level and run daily QC. 2. Review of the Horiba Medical Mintrol PI revealed the following statement: "- 5. Stability and storage- Opened tubs are stable for 16 days provided they are handled properly, and provided the instructions in section "instructions for use" are followed." 3. An interview with the laboratory director at approximately 2:00 PM confirmed the above-listed findings. 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 a tour of the laboratory, review of the manufacturer's package insert (PI) and interviews, the laboratory failed to ensure that three (3) of the sixteen (16) hematology quality control (QC) materials were not used beyond the manufacturer's opened-vial expiration date from November 23, 2018 to the date of survey on December 18, 2018. Findings include: 1. Tour of the laboratory revealed that the laboratory utilizes the Horiba Medical Mintrol hematology QC materials. The current box in the refrigerator contained 16 vials of QC material (4 low level, 4 normal level and 4 high level) lot number MX 414 expiration date January 5, 2019. Three of the 16 vials had hand- written opened date of November 7, 2018. The primary testing personnel (TP) -- 2 of 4 -- confirmed, in an interview at approximately 1:15 PM, that the 3 vials with the hand- written opened date of November 7, 2018 were still in use at the date of survey on December 18, 2018. 2. Review of the Horiba Medical Mintrol PI revealed the following statement: "- 5. Stability and storage- Opened tubs are stable for 16 days provided they are handled properly, and provided the instructions in section "instructions for use" are followed." 3. An interview with the laboratory director at approximately 2:00 PM confirmed the above-listed findings. 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 the review of hematology records, policy and procedures, phone call with technical service, and interviews, the laboratory failed to follow the manufacturer's requirement and the established policy and procedures for performing calibration procedures at least once every six (6) months in the calendar year 2018. Findings include: 1. Review of the hematology records revealed that the laboratory performed the calibration procedures for the Horiba ABX Micros 60 hematology instrument on February 2, 2018. There was no other 2018 calibration documentation available for review at the date of survey on December 18, 2018. 2. Review of the policy and procedure manual revealed the following statement (signed by the laboratory director December 2016): "Calibration procedures- perform and document calibration procedures at least six (6) months and as recommended by the manufacturer." 3. A phone call with Horiba technical service at approximately 1:50 PM confirmed that the manufacturer requires calibration of the hematology instrument every 6 months. 4. An interview with the laboratory director at approximately 2:00 PM confirmed the above- listed findings. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on the review of two (2) patient test reports and an interview, the laboratory failed to ensure that the patient test results provided the name and address of the testing facility. Findings include: 1. The laboratory utilizes the Horiba ABX Micros 60 instrument print out as the final patient test result. The inspector reviewed 2 patient results. The reports did not have the laboratory's name and address on the reports. 2. An interview with the laboratory director at approximately 2:00 PM confirmed the above-listed findings. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, policy and procedures, and interviews, the laboratory director failed to follow the established policy and ensure that one (1) of one (1) new TP had documented training and competency assessments prior to performing patient testing procedures for hematology on August 23, 2018. Findings include: 1. Review of CLIA CMS-209 form revealed that TP A was a new TP (See attached TP Code Sheet). 2. Review of TP records and an interview with TP A at approximately 12:00 PM revealed that there was no documentation of training and competency assessment for TP A. She/he stated that they began testing on August 23, 2018. 3. Review of the policy and procedure manual revealed the following statement (signed by the laboratory director December 2016): "Testing personnel: New testing personnel will be evaluated with forms from Appendix 1 prior to assignment in the lab." 3. Interview with the laboratory director at approximately 2:00 PM confirmed the above-listed findings. -- 4 of 4 --