Ashcake Family Physicians, Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Ashcake Family Physicians on July 23, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Ashcake Family Physicians was not in compliance with the applicable Conditions and Standards under 42 CFR part 493 CLIA Regulations. Specific deficiencies are as follows: D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: A. Based on a review of the maintenance checklists, manufacturer's Instructions for Use, lack of documentation, and interviews, the laboratory failed to perform yearly maintenance on the Beckman Coulter DxH 500 Hematology analyzer for twenty (20) of 20 months reviewed. Review timeframe November 2023 through June 2025. Findings include: 1. Review of the laboratory's Hematology maintenance checklists revealed required yearly maintenance of: lubricate pistons, and replace the rinsing head O-ring (or every 18000 cycles). 2. Review of the November 2023 through June 2025 maintenance checklists for the Beckman Coulter DxH 500 Hematology analyzer revealed a lack of yearly maintenance documented during the 20 months reviewed. 3. A review of the manufacturer's Beckman Coulter DxH 500 Instructions for Use revealed that piston lubrication should be done yearly, and replacing the Rinsing Head O-ring should be done yearly or every 18,000 cycles. 4. During an interview with the primary testing personnel (TP) at 11:45 AM, the inspector inquired about the lack of yearly maintenance and requested to review documentation of the annual maintenance if performed by the Beckman Coulter service engineer. The TP stated that 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 -- laboratory did not have an engineer come in to perform yearly preventative maintenance (PM). 5. An interview with the primary TP on 7/23/25 at 1:00 PM confirmed the above findings. B. Based on a review of the laboratory policies, maintenance checklists, daily start-up documentation, Beckman Coulter DxH 500 Training guide, and interview, the laboratory failed to perform daily shutdown of the Hematology analyzer for fourteen (14) days of the 20 months reviewed. Review timeframe November 2023 through June 2025. Findings include: 1. Review of the lab's CBC (Complete Blood Count) manual revealed a policy that stated, "When all specimens have been performed for the day, a daily shutdown will need to be initiated". 2. Review of the November 2023 through June 2025 maintenance checklists for the Beckman Coulter DxH 500 Hematology analyzer revealed a lack of daily shutdown documented on: 2024: 3/8, 3/18, 3/19, 6/3, 6/4, 6/28, 7/19, 8/29, 10 /14, 12/31, and 2025: 4/1, 6/2, 6/3, 6/10. A total of 14 days. 3. Review of the daily Beckman Coulter DxH 500 start up documentation revealed the instrument start up printout contains a "Date of last Shutdown". Review of the start-up documentation for the 14 days after the missed shutdowns listed above confirmed that shutdown did not occur. 4. Review of the Beckman Coulter DxH 500 Training guide revealed that the manufacturer "recommends shut down once every 24 hours". The guide explained that the shut down removes the diluent and introduces the cleaner into the system. 5. An interview with the primary Testing Personnel on 7/23/25 at 1:00 PM confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. This STANDARD is not met as evidenced by: Based on a review of laboratory's hematology quality control (QC) records, procedures, lack of documentation, and interviews, the laboratory failed to perform an evaluation of statistical analysis to identify possible shifts and trends for Complete Blood Count (CBC) testing on the Beckman Coulter DxH 500 hematology analyzer for two (2) of 20 months reviewed. Review timeframe October 2023 through June 2025. Findings include: 1. Review of the Hematology QC Log Books for October 2023 through June 2025 revealed QC printouts for each lot and level of QC (abnormal Low, Normal, abnormal High). The printouts included a statistical Mean, SD (Standard deviation) and CV (Coefficient of Variation) for each QC level. The QC printouts for October 2023 through June 2025 lacked a director signature or initials indicating review. 2. Review of the laboratory's Quality Assessment (QA) Plan and Documentation Log Book revealed: a QA Attestation that included "the correction of any problems detected", a QC category that included "QC results were examined for possible problems", and a comment box for "Problem Resolution". 3. Review of the laboratory's Quality Assurance Implementation policy revealed that "At the end of each month, a Monthly Quality Assurance Checklist is completed." The policy indicates that the monthly review includes laboratory staff and the laboratory director, and that Quality control results are reviewed for trends and shifts. The QA checklists for October 2023 through June 2025 were reviewed.. The two (2) months of April 2024 and July 2024 lacked a director signature indicating QC evaluation and QA participation. 4. An interview with the primary testing personnel on 7/23/25 at 1:00 PM confirmed the findings above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Ashcake Family Physicians was conducted on 04/29-05/03/22 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. The laboratory must achieve satisfactory performance of at least 80% for two consecutive events for the White Blood Cell Differential (WBC DIFF) analyte. Citations issued and notice sent to Northeastern and Midwestern Operations Branch Philadelphia Office on 05/03/22. 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 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 -- compliance history. This CONDITION is not met as evidenced by: A. Based on off-site proficiency testing (PT) desk review and interview with the testing personnel and laboratory director on 04/29/2022, 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. B. Based on off-site proficiency testing (PT) desk review and interview with the testing personnel and laboratory director on 04/29/2022, the laboratory failed to participate in one of one Complete Blood Count (CBC) events reviewed. Refer to D2123. 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 American Association of Bioanalysts (AAB) Proficiency Testing (PT) records, the CASPER 155D Individual Laboratory Profile report, and interview with the testing personnel and 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 had not submitted evidence of satisfactory performance on two consecutive PT events for the analyte of WBC Diff. 2. As of the date of the desk review, the laboratory had not submitted evidence that is has voluntarily withdrawn its certification for the analyte of WBC Diff. 3. A phone interview with the testing personnel and laboratory director on 04/29/22 at 11:50 AM revealed the "lab ceased patient testing with the older hematology analzyer on 10/19/21. The new hematology analzyer was installed and verification completed on 01/13/22 and patient testing began on 01/14/22. We encountered issues with the PT samples from AAB for the first event in 2022 and did not submit the results within the required timeframe." 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 -- 2 of 3 -- 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 and an interview, the laboratory failed to participate in one of one Complete Blood Count (CBC) PT event reviewed. Findings include: 1. Review of the CASPER 0155D Individual Laboratory Profile Report and the American Association of Bioanalysts (AAB) PT records for the first event in 2022 revealed the laboratory received a score of 0%. 2022 Event A- 0%- for the CBC module (Notation by API-"NR" not reported ). 2. A phone interview with the testing personnel and laboratory director on 04/29/22 at 11:50 AM revealed the "lab ceased patient testing with the older hematology analzyer on 10/19/21. The new hematology analzyer was installed and verification completed on 01/13/22 and patient testing began on 01/14/22. We encountered issues with the PT samples from AAB for the first event in 2022 and did not submit the results within the required timeframe." 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. Review of the American Association of Bioanalysts (AAB) hematology PT records and the CASPER 0155D Individual Laboratory PT report revealed the following scores: 2021 2nd event WBC Diff- 26% 2021 3rd event WBC Diff- 67 2022 1st event WBC Diff- 0% The laboratory received a repeat unsuccessful AAB PT score for the above listed analyte. 2. A phone conference with the testing personnel and laboratory director on 04/29/22 at 11:50 AM confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Ashcake Family Physicians 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 the review of the proficiency testing (PT) scores for the second and third 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 -- events in 2021, the review of the CASPER 0153D Unsatisfactory and Unsuccessful PT report and an interview with the primary testing personnel, the laboratory failed to achieved 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 26% and 67% respectively, resulting in unsuccessful performance (Refer to D2130). 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 American Association of Bioanalysts (AAB) hematology PT scores and the CASPER 0153D Unsuccessful PT report revealed the following scores: 2021 2nd event WBC Diff- 26% 2021 3rd event WBC Diff- 67% The laboratory received an unsuccessful AAB PT score for the above listed analyte. 2. An interview with the primary testing personnel on 12/02/21 at approximately 10:00 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Ashcake Family Physicians was conducted on August 11, 2020 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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 the review of the proficiency testing (PT) scores for the third event in 2019 and the second event in 2020, the review of the CASPER 0155D Individual PT report, 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 -- and an interview with the primary testing personnel, the laboratory failed to achieved satisfactory performance of at least 80% for two out of three consecutive events for the Hematocrit (HCT) parameter, in which the laboratory received scores of 0% and 40% respectively, resulting in unsuccessful performance (Cross Reference D 2130). 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 American Association of Bioanalysts (AAB) proficiency testing (PT) scores for the third event in 2019 and second events in 2020, the CASPER 0155D Individual PT report, and a telephone interview with the primary testing personnel, the laboratory failed to achieve satisfactory performance of at least 80% for two out of three consecutive events for the Hematocrit (HCT) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the AAB hematology PT scores and the CASPER 0155D Individual PT report revealed the following scores: 2019 3rd event HCT- 0% 2020 2nd event HCT- 40% The laboratory received an unsuccessful AAB PT score for the above listed analyte. 2. A telephone interview with the primary testing personnel on August 11, 2020 at approximately 10: 30 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency test desk review was conducted for Ashcake Family Physicians on May 4 2020 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: 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 an off-site desk review of the laboratory's American Association of Bioanalysists proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty percent of acceptable responses for White Blood 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 -- Cell counts and Cell Identification in two consecutive hematology testing events reviewed, resulting in unsuccessful PT performance (reviewed: 2019 third event, 2020 first event). See 2130. 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 an off-site desk review of proficiency testing (PT) records (2019 third event, 2020 first event) and interviews, the laboratory failed to attain a score of at least eighty percent (80%) of acceptable responses for White Blood Cell (WBC) counts and WBC Differential Identification (WBC Diff) in the two (2) consecutive hematology testing events reviewed, resulting in unsuccessful PT performance. Findings include: 1. Review of the laboratory's American Association of Bioanalysts (AAB) PT records revealed WBC count and WBC Diff scores of less than 80% for the following consecutive events: AAB 2019 Hematology Module C Event 3 - WBC = 0%, WBC Diff 0%; AAB report noted "results not reported to AAB for five of five challenge samples resulting in score of zero"; AAB 2020 Hematology Module A Event 1 - WBC = 60%, WBC Diff 73%; AAB report noted "results score is below CMS limit"; resulting in an unsuccessful PT performance. 2. In an email correspondence interview with the lab director on 5/4/20 at approximately 10:30 AM, and a telephone interview with AAB technical support specialist at approximately 4:30 PM, the above findings were confirmed. -- 2 of 2 --