Family Health Clinic, Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Family Health Clinic, INC on June 18, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The recertification inspection also included an off-site interview with the laboratory director on 6/20/25. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include three Conditions under 42 CFR part 493 CLIA Regulation: D2000 - 42 CFR. 493.801 Condition: Enrollment and Testing of Samples, D5400 - 42 CFR. 493.1250 Condition: Analytic Systems, D6000 - 42 CFR. 493.1403 Condition: Laboratories performing moderate complexity testing- Laboratory Director. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services CASPER 0096D CLIA Application and Survey Summary Report (CMS CASPER 0096D), CMS CLIA Laboratory Application for Certification form (CMS 116), proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to enroll in a hematology PT program for Complete Blood Count (CBC) for sixteen (16) of twenty-six (26) months reviewed (survey timeframe: 4/13/23 - 6/18/25, timeframe of non enrollment: 1/1/25-4/9/25). Findings include: 1. Review of the CASPER Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 0096D report during pre-survey preparation revealed a lack of hematology PT scores for the following speciality and analytes in calendar year 2024 and year to date 2025: 0760 HEMATOLOGY 0765 Cell Identification 0775 Red Blood Cell Count, RBC 0785 Hematocrit, HCT 0795 Hemoglobin, HGB 0805 While Blood Cell Count, WBC 0815 Platelets, PLT 2. Review of the CMS 116 form revealed that the laboratory director confirmed patient CBC testing in the speciality of hematology during the 26 month review timeframe of 4/13/23 to 6/18/25. 3. Review of the laboratory's available American Proficiency Institute (API) PT records for the review timeframe outlined above (2023 Events 2-3, Remedial Event #83R), a total of three events, revealed no PT records for calendar year 2024 and year to date 2025. The inspector inquired regarding the lack of PT documentation for 2024 Events 1-3 and the expected 2025 Event 1. The office manager stated on 6/18/25 at 1 PM, "I noticed that we did not have any 2024 records. Our previous McKesson sales rep was relied upon to enroll us in proficiency testing. When I recently discovered that the 2024 and 2025 enrollment deadlines were missed, we contacted API and placed a late order. Both years' enrollment deadlines were missed." 4. The inspector requested to review the laboratory's late enrollment for 2025 hematology PT modules. The provided API PT order (dated 4/9/25) revealed that the hematology module ordered would include partial annual shipment to include Event 2 and 3 (shipping dates in July and October 2025). 5. Interviews with the lead testing personnel and office manager on 6/18/25 at 2:00 PM, and lab director on 6/20/25 at 10 AM confirmed the above findings. 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 a review of available laboratory policies/procedures, Centers for Medicare and Medicaid Services Laboratory Personnel Report form, tour, manufacturer's package insert instructions, hematology quality control (QC) records, patient test logs, QC protocols, manufacturer user guide, lack of documentation, and interviews, the laboratory failed to: 1. document the new director's approval (signature and date) of the laboratory's policies/procedures for twenty-five (25) of 25 months -May 2023 to 6 /18/25 (Refer to D5407); 2. ensure that three (3) of 3 Sysmex XN-L Check hematology QC vials in use, stored in the laboratory were within the manufacturer's expiration dates as observed 6/18/25 (Refer to D5417); 3. perform daily hematology QC procedures per their protocol on four of one hundred nineteen days from 1/2/25 to 6/18/25 while reporting seventy-one patient Complete Blood Count results (Refer to D5447); and 4. follow protocol to perform/review statistical analysis to identify shifts and/or trends for the XN Check Tri Level control materials utilized to evaluate accuracy of the Sysmex Hematology analyzer for twenty-six (26) of 26 months reviewed - timeframe of April 13, 2023 to June 18, 2025 (Refer to D5469). D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) -- 2 of 7 -- (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), policies, lack of documentation, and interviews, the laboratory failed to document an approval/review of policies and procedures after a change in director for twenty-five (25) of 25 months (May 2023 to the date of the survey, on June 18, 2025). Findings include: 1. An interview and review of the CMS 209 personnel form with the office manager on 6/18/25 at 11:30 AM, revealed that a Laboratory Director (LD) change occurred during the recertification survey timeframe of 4/13/23-6/18/25. The new LD (LD A) took the position on 5/13/23. *See Personnel Code Sheet. 2. Review of the available policies/procedures revealed that LD A failed to document a review/approval after taking over the directorship of the laboratory services in May 2023. The inspector inquired regarding a record of the current LD's approval of the laboratory procedures. Documentation was not available for review. 3. Interviews with the lead testing personnel and office manager on 6/18/25 at 2:00 PM, and LD A on 6/20/25 at 10 AM confirmed the above findings. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a tour, review of manufacturer's package insert instructions, and interviews, the laboratory failed to ensure that three (3) of 3 Sysmex XN-L Check hematology quality control (QC) vials in use and stored in the laboratory were within the manufacturer's expiration dates as observed on June 18, 2025. Findings include: 1. During a laboratory tour on 6/18/25 at 10:30 AM, the inspector noted the following 3 hematology QC vials stored in the laboratory refrigerator opened for use: Level 1 (Lot Number 50671401) expiration date of 6/17/2025; Level 2 (Lot Number 50671402) expiration date of 6/17/2025; Level 3 (Lot Number 50671403) expiration date of 6/17 /2025; 3 of 3 were QC vials were expired while in use. The inspector inquired of the open date for the vials outlined above. No open date was able to be confirmed. The inspector noted no new lot numbered (in date) QC stored in the laboratory refrigerator. 2. A review of the manufacturer's hematology QC package insert revealed the open vial stability to be fourteen days and instructions to "not use beyond expiration date, discard once outdated". 3. The laboratory inspector inquired if the observed, expired QC vials were in use for monitoring the Sysmex hematology instrument quality functions. The primary testing personnel confirmed the expired QC vials were in use. The office manager stated on 6/18/25 at 10:45 AM, "We realized that we were out of in date QC and ordered a new lot. We are waiting for it to be shipped to us." 4. Interviews with the lead testing personnel and office manager on 6 /18/25 at 2:00 PM, and lab director on 6/20/25 at 10 AM confirmed the above findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) -- 3 of 7 -- (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on a review of daily hematology quality control (QC) records, patient test logs, lack of documentation, policies, manufacturer's user guide, and interviews, the laboratory failed to perform daily hematology QC procedures per their protocol on four (4) of one hundred nineteen (119) days from 1/2/25 to 6/18/25 while reporting seventy-one (71) patient Complete Blood Count (CBC) panel results. Findings include: 1. Review of the daily Sysmex XN 430 hematology QC records and patient CBC test logs from 1/2/25 to the date of the inspection, 6/18/25, revealed the following 4 dates lacked documentation of QC procedures: 3/26/25 - 20 patients reported; 3/27/25 - 12 patients reported; 3/28/25 - 15 patients reported; 3/31/25 - 24 patients reported; A total of 71 patient CBC results were reported without QC verification. The inspector requested to review QC for the dates outlined above. No records were available for review. 2. Review of the laboratory's policies revealed a "Quality Assessment" protocol that outlined (under heading Analytic), "QC is completed, analyzed, and accepted each day of testing". 3. Review of online Sysmex XN 430 User Guide revealed instructions in Section 2, "Quality control is performed in order to monitor an instrument's performance over time. XN-L Check tri level is the quality control material used to monitor the performance of the XN analyzer each day of operation. Quality control should be run according to licensing agency regulations." 4. Interviews with the lead testing personnel and office manager on 6/18/25 at 2:00 PM, and lab director on 6/20/25 at 10 AM confirmed the above findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (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. (d)(10)(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. (d)(10)(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. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) protocols, hematology QC records, manufacturer guide, lack of documentation, and interviews, the laboratory failed to follow their protocol to perform/review statistical analysis to identify shifts and/or trends for the XN Check Tri Level control materials utilized to evaluate accuracy of the Sysmex analyzer for twenty-six (26) of 26 months reviewed (timeframe of April 13, 2023 to June 18, 2025). Findings include: 1. Review of the laboratory's policies revealed a "Hematology Calibration and Quality Control QA Tracking" protocol that outlined that quantitative QC results are to be graphed, reviewed for shifts/trends,

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Family Health Clinic on 04/12/23 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: 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 a tour of the facility, record review and interviews, the lab failed to report 57 SARS-CoV-2 (COVID-19) positive test results for 121 of 121 testing dates from 04 /04/22 up to date of survey on 04/12/23. Findings include: 1. A tour of the facility, review of daily patient testing logs and interviews with the primary testing personnel, office manager and owner of the practice on 04/12/23 at 12:30 PM revealed the facility utilized the Consult Diagnostics COVID Antigen, Consult Diagnostic COVID and Flu A&B combo kits and Qualigen QuickVue COVID test kits perform to COVID-19 patient testing. During the same interview, the inspector requested to review how the lab reports positive COVID-19 results to the local health department. The owner of the practice stated that they believed they had been reporting through the Virginia Department of Health (VDH) on-line portal and would contact them for 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 -- verification. In an email correspondence on 04/12/23 at 1423, the office manager confirmed that VDH did not have records of the lab manually reporting positive COVID patient test results for the above-specified timeframe. 2. 57 positive results were not reported as required during the period of review (121 testing dates). 3. The laboratory performed 254 COVID-19 tests during the period of review. 4. An exit interview with the office manager via telephone on 04/12/23 at 1430 confirmed the findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of quality control records (QC), lack of documentation, daily patient testing logs and interview, the lab failed to perform at least two levels of QC materials on two days for the Abbott Cell Dyn 1700 hematology analyzer on 05/16/22 and 05/17/22 and reporting 22 and 14 patients respectively. Findings include: 1. Review of the daily QC records and patient testing logs from 06/01/21 to 11/16/22 for the Abbott Cell Dyn 1700 hematology analyzer revealed lack of documentation of QC procedures for the following dates: 05/16/22- 22 patients reported, and 05/17/22- 14 patients reported. The surveyor requested to review the QC documents for the above- specified dates. The documentation was not available for review. 2. An exit interview with the lab director and primary testing personnel on 04/12/23 at 1210 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Family Health Clinic on 04/12/23 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: 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 a tour of the facility, record review and interviews, the lab failed to report 57 SARS-CoV-2 (COVID-19) positive test results for 121 of 121 testing dates from 04 /04/22 up to date of survey on 04/12/23. Findings include: 1. A tour of the facility, review of daily patient testing logs and interviews with the primary testing personnel, office manager and owner of the practice on 04/12/23 at 12:30 PM revealed the facility utilized the Consult Diagnostics COVID Antigen, Consult Diagnostic COVID and Flu A&B combo kits and Qualigen QuickVue COVID test kits perform to COVID-19 patient testing. During the same interview, the inspector requested to review how the lab reports positive COVID-19 results to the local health department. The owner of the practice stated that they believed they had been reporting through the Virginia Department of Health (VDH) on-line portal and would contact them for 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 -- verification. In an email correspondence on 04/12/23 at 1423, the office manager confirmed that VDH did not have records of the lab manually reporting positive COVID patient test results for the above-specified timeframe. 2. 57 positive results were not reported as required during the period of review (121 testing dates). 3. The laboratory performed 254 COVID-19 tests during the period of review. 4. An exit interview with the office manager via telephone on 04/12/23 at 1430 confirmed the findings. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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 quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of quality control records (QC), lack of documentation, daily patient testing logs and interview, the lab failed to perform at least two levels of QC materials on two days for the Abbott Cell Dyn 1700 hematology analyzer on 05/16/22 and 05/17/22 and reporting 22 and 14 patients respectively. Findings include: 1. Review of the daily QC records and patient testing logs from 06/01/21 to 11/16/22 for the Abbott Cell Dyn 1700 hematology analyzer revealed lack of documentation of QC procedures for the following dates: 05/16/22- 22 patients reported, and 05/17/22- 14 patients reported. The surveyor requested to review the QC documents for the above- specified dates. The documentation was not available for review. 2. An exit interview with the lab director and primary testing personnel on 04/12/23 at 1210 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Family Health Clinic on March 21, 2019 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: 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 the review of quality control (QC) records, manufacturer package inserts (PI), instrument QC data review, daily patient testing records and interviews with testing personnel (TP) A and laboratory director, the laboratory failed to ensure that the Beckman Coulter Access 2 instrument had the correct mean value and lot number of the BioRad Lyphochek Specialty Immunoassay QC Levels 2 and 3 for the Vitamin D analyte for fifty-one (51) days and reported seventeen (17) patients. Dates of record review include November 13, 2018 to February 19, 2019. Findings include: 1. The laboratory utilizes the Beckman Coulter Access 2 instrument to perform Vitamin D 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 -- testing. Review of the BioRad Lyphochek Specialty Immunoassay QC (Levels 2 and 3) records for the Vitamin D analyte revealed that the QC lot numbers and mean values changed (to L2 25282 and L3 25283 exp 6/30/20) on November 13, 2018. The QC printouts from November 13, 2018 and up to February 19, 2019 from the instrument revealed that the lot number for Level 2 had had not been updated to the current lot in use (printouts had lot number 25272 exp 9/30/18). 2. An interview with TP A at approximately 12:45 PM and comparison of manufacturer PI established mean value to instrument mean value for the current lot number in use revealed that the mean values for Level 2 and Level 3 was not updated according to the PI: Level 2 (25282) - Established mean value by PI 30.8, instrument mean value was 35.82. Level 3 (25283)- Established mean value by PI 99.1, instrument mean value was 101.1. TP A stated that she/he uses the manufacturer PI established mean value for assigned QC levels for the Vitamin D assay. QC procedures performed on the following dates with the incorrect mean values and Level 2 lot number information: 11/13, 14, 16, 17, 19, 20, 21, 26, 27, 29 and 30/2018, 12/3, 4, 5, 6, 7, 11, 12, 14, 17, 18, 19, 20, 27 and 28 /2018, 01/ 2, 3, 4, 7, 8, 9, 11, 15, 16, 17, 18, 21, 22, 23, 25, 28, 29 and 30/2019, 02/1, 4, 6, 8, 11, 13, 18 and 19/2019. Total of 51 days. 3. Review of daily patient testing records revealed patients assayed with the incorrect lot number and means values for the following dates: 11/26/2018- Patient 032244 and 041048 reported, 12/11/2018- Patients 061261, 032757, 090657 and 082555 reported, 12/20/2018- patient 121864 reported, 12/28/2018- patients 120536, 102968, 091661, 122449 and 011861 reported, 01/08/2019- patient 022546 reported, 01/15/2019- patients 092151 and 081656 reported, 01/17/2019- patient 060872 reported, 02/08/2018- patient 010851 reported. Total of 17 patients. 4. An interview with the laboratory director and TP A at approximately 1:30 PM confirmed the findings. -- 2 of 2 --