Smith Mountain Lake Family Practice Pc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Smith Mountain Lake Family Practice on October 7, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director (LD) and testing personnel (TP) for five (5) of six (6) events reviewed (survey timeframe: January 18, 2024 to October 7, 2025). Findings include: 1. Review of the CMS 209 personnel form revealed that the LD identified two TP as responsible for performing non-waived hematology Complete Blood Counts (CBC) during the review timeframe of 1/18/24-10/7/25. 2. Review of the laboratory's Wisconsin State Laboratory of Hygiene (WSLH) hematology PT documentation (2024 Events 1-3, 2025 Events 1-3), a total of 6 events, revealed no signed LD or TP attestation statements for the following Complete Blood Count (CBC) modules: 2024 Event 1, 2024 Event 3, 2025 Event 1, 2025 Event 2, 2025 Event 3. 3. The inspector requested to review LD and TP attestation signatures for 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 -- event listed above. The documentation was not available for review. The primary TP stated on 10/7/25 at 2:00 PM, "I was not aware that we had to sign attestations. I saw the forms in the packet but did not know they were necessary." 4. An interview with the primary TP and LD on 10/7/25 at 2:45 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Smith Mountain Lake Family Practice, PC on January 17, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of quality control (QC) log book, procedures (manufacturer's user manual / package insert), analyzer onboard data files, lack of documentation, and interviews, the laboratory failed to follow manufacturer's instructions for Hemoglobin A1C QC verification during twelve (12) of 12 months in calendar year 2023. Findings include: 1. During a laboratory tour on 1/17/24 at 11:00 AM, the inspector noted one Abbott Alere Afinion AS100 in use for patient point of care Hemoglobin A1C testing. 2. During a review of the laboratory's hematology QC logs, the inspector noted Abbott Alere Afinion QC log sheets were included in the QC binder. The inspector noted QC log sheets for calendar years 2022 and 2024. The inspector noted no QC was recorded in calendar year 2023. 3. Review of the laboratory's procedures revealed an Abbott Alere Afinion manufacturer's user guide with the following instructions: A. "Use quality control materials to confirm that the analyzer and test kit are working properly"; B. "This is a CLIA waived test. If the laboratory modifies the test instructions, including quality control, the test will no longer meet the requirements of for waived categorization. A modified test is regarded as highly complex and applicable CLIA requirements."; C. "Control Testing - run QC with each new shipment/lot number, at least every 30 days, when training new testing 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 -- personnel, and anytime an unexpected test result is obtained." 4. Review of the laboratory's procedures revealed an Abbott Afinion HbA1c Control package insert with the following instructions: "Quality control testing using Afinion HbA1c Control should be done to confirm that the Afinion Analyzer System is working properly and provides reliable results. Only when controls are used routinely and the values obtained are within acceptable ranges can accurate results for patient samples be assured. Frequency of control testing- controls should be analyzed with each new shipment of Afinion HbA1c Test kits, with each new test lot, at least every 30 days, when training new operators in correct use of the test kit and analyzer, anytime an unexpected test result is obtained. It is recommended to keep a permanent record of all quality control results. The Afinion Analyzer automatically stores the control results in a separate file record (consult the user manual)." 5. The inspector requested to review HbA1c QC log sheets for calendar year 2023. No additional records were available for review. The inspector and lead testing personnel (TP) reviewed the analyzer's onboard QC data logs and verified there were no QC files for 2023. The lead TP stated on 1/17/24 at 12:30 PM, "I realized while preparing for the inspection that we had not run QC last year. We had a change in staffing last year and it was overlooked." 6. An exit interview with the technical consultant and lead TP on 1/17 /24 at 1 PM confirmed the above 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 a review of procedures, hematology calibration records, lack of documentation, and an interview, the laboratory failed to document calibration procedures every six (6) months for Complete Blood Count (CBC) testing according to the manufacturer's instructions during the twenty-three months reviewed (February 2022 to 1/17/24). Findings include: 1. Review of the laboratory's procedures revealed a Medonic M Series hematology analyzer user guide that outlined instructions to calibrate CBC testing on the analyzer at a frequency of every 6 months. 2. Review of the laboratory's Medonic instrument's CBC calibration records from February 2022 to the date of the inspection, 1/17/23, revealed calibration documentation on 6/21/22, 11 /21/22, 10/3/23, and 12/13/23. The inspector noted that a 6 month calibration would have been due in May 2023 and requested to review additional calibration records. No additional records were available for the eleven month timeframe between 11/21/22 and 10/3/23. 3. An exit interview with the technical consultant and lead testing personnel on 1/17/24 at 1 PM confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Smith Mountain Lake Family Practice was conducted on 09/19/23 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: D2000 - 42 C.F.R. 493.801 Condition- Enrollment and Testing of Samples. 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 proficiency testing (PT) records, lack of documentation, and interview, the laboratory failed to enroll in a PT program for White Blood Cell Count (WBC), Red Blood Cell Count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Platelet Count (PLT), and Cell Identification (Cell ID) from January 2023 up to date of survey on 09/19/23. Findings include: 1. Review of the CASPER PT Failure to Re- Enroll 0164S Report revealed lack of re-enrollment with a PT company for the WBC, RBC, HGB, HCT, PLT and Cell ID analytes for 2023. Review of the CASPER Individual Laboratory Profile 0155D Report revealed lack of documentation of scores reported to CMS for the specified analytes as of 09/19/23. 2. An 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 2 -- technical consultant on 09/19/23 at 09:25 AM revealed that the laboratory had previously been enrolled in with the American Academy of Family Physicians for the year 2022. They stated that "significant changes had occurred within the office over the last year and that they didn't realize that proficiency testing had not been sent." The technical consultant confirmed findings. -- 2 of 2 --

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