Kenbridge Family Medicine

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kenbridge Family Medicine on August 30, 2024 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 and includes the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. 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 manufacturer's operation manual, procedures, hematology analyzer maintenance logs, instrument calibration records, lack of documentation, and interviews, the laboratory failed to: 1. document performance of twice annual hematology instrument preventative maintenance in calendar year 2023-**REPEAT DEFICIENCY, cross reference D5429; and 2. perform instrument calibration procedures for Complete Blood Count every six months according to their procedure during the twenty-two months reviewed (timeframe: 10/23/22 to 8/30/24), cross reference D5437. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) 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 -- For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of manufacturer's operation manual, procedures, hematology analyzer maintenance logs, lack of documentation, and interview, the laboratory failed to document performance of required twice annual instrument preventative maintenance in calendar year 2023. **REPEAT DEFICIENCY Findings include: 1. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually" (under heading: Preventative Maintenance). 2. Review of the laboratory procedure manual revealed a procedure (titled: Cell Dyn Emerald Laboratory Procedure -Maintenance) that outlined, "perform semi-annually grease/lubrication of pistons". 3. Review of the laboratory's Emerald hematology maintenance logs for calendar year 2023 revealed one record of the semi annual maintenance outlined above (recorded as performed on 5/3/23). The inspector requested to review additional documentation of the piston syringe maintenance in 2023. No records were available. 4. An exit interview with the technical consultant on 8/30/24 at 2:30 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 review of procedures, instrument calibration records, lack of documentation, and interview, the laboratory failed to perform instrument calibration procedures for Complete Blood Count (CBC) every six (6) months according to their procedure during the twenty-two (22) months reviewed (timeframe: 10/23/22 to 8/30/24). Findings include: 1. Review of the laboratory's procedure manual revealed a policy titled: Laboratory QC and Calibrations - General Procedures. Under subheading Hematology, the policy stated: "Calibrations will be performed every six months or more frequently as needed." 2. Review of the laboratory's Abbott Emerald instrument calibration documentation from 10/23/22 to the date of the inspection on 8/30/24, a total of 22 months, revealed that CBC calibrations were performed on: 2/28/23, 8/11 /23, and 7/22/24. The inspector noted an eleven month time span between the August 2023 calibration and the single calibration performed to date in 2024 (July). The inspector requested to review additional hematology calibration records for calendar -- 2 of 3 -- year 2024. No additional documentation was available for review. 3. An exit interview with technical consultant on 8/30/24 at 2:30 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Kenbridge Family Medicine on 10/20/22 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 is performing COVID-19 testing and is in compliance with the applicable COVID-19 reporting requirements. 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: A. Based on a tour of the patient testing room, manufacturer's instructions for use (IFU), lack of documentation and interviews, the lab failed to document and monitor the room temperature in the patient testing room for the BD Veritor Rapid Detection of SARS-CoV-2 (COVID-19) test kits and analyzer from 01/01/21 up to the date of survey on 10/20/22. Findings include: 1. Tour of the facility and interview with testing personnel on 10/20/21 at approximately 10:15 AM revealed a separate room in the adjoining facility used to perform COVID-19 test procedures. The room offered an easy access for patients to drive up and receive care and testing procedures. The surveyor asked how patients are processed for COVID-19 test procedures. They stated, "the test kits and analyzer is kept here in this room. We test patients in their cars, bring the swab in and label the cassette with patient information. We then go back to the main office and log that patient's test results into our electronic medical record." 2. Review of the BD Veritor Rapid Detection of SARS-CoV-2 (COVID-19) test kits and analyzer IFU revealed the following statement, "Storage- Kits may be stored at 2-30 degrees Celsius. Reagents and devices must be a room temperature (15- 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 -- 30 degrees Celsius) when used for testing." The inspector asked the testing personnel how they monitor the room temperature of the patient testing room in the adjoining building to ensure the kits and analyzer are maintained within the manufacturer's requirements on 10/20/22 at approximately 11:00 AM. They stated they do not monitor the separate room. 3. An exit interview with the technical consultant on 10/20 /22 at approximately 1215 confirmed the findings. B. Based on the review of manufacturer's instructions for use (IFU), lack of documentation and interviews, the lab failed to document the performance of the external positive and negative controls for the BD Veritor Rapid Detection of SARS-CoV-2 (COVID-19) test kits from 01/01 /21 up to the date of survey on 10/20/22. Findings include: 1. Review of the BD Veritor COVID-19 IFU revealed the following statements, "positive and negative controls swabs are supplied with each kit. BD recommends controls be run once for: each new kit lot, each new operator, and as required by internal quality control procedures and in accordance with local, state and federal regulation or accreditation requirements." 2. In an interview with the testing personnel on 10/20/21 at approximately 10:15 AM, the inspector asked how the lab performs and documents the positive and negative control swabs for each new kit lot. They stated, "I don't do that part, I think the other testing personnel does that part." The inspector requested to review documentation of the above-specified quality control procedures for each new kit lot received from 01/01/21 up to the date of the survey on 10/20/22. The documentation was not available for review. 3. An exit interview with the technical consultant on 10/20/22 at approximately 1215 confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review of maintenance logs, manufacturer's operation manual, lack of documentation and interview with technical consultant, the lab failed to perform the semi-annual maintenance on the Abbott Cell Dyn Emerald hematology analyzer from 07/22/21 up to the date of survey on 10/20/22. Findings include: 1. Review of the maintenance logs for the Abbott Cell Dyn Emerald analyzer (installed on 05/21/21) revealed the date of 07/22/21 as performance of the semi-annual maintenance (piston syringe lubrication). The maintenance logs lacked documentation of additional performance of the semi-annual maintenance after 07/22/21. The inspector requested to review additional documentation of the aforementioned maintenance. No other documentation was available for review. 2. Review of the Abbott Emerald Operations Manual revealed manufacturer's instructions to "perform Lubricating Syringe Pistons maintenance procedure twice annually". 3. An exit interview with the technical consultant on 10/20/22 at approximately 1215 confirmed the findings. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview with the the technical consultant (TC), the TC failed to perform and document the annual competency assessments for three of three TP in 2021. Findings include: 1. Review of the CMS-209 form revealed there were a total of three TP performing patient testing. 2. Review of the TP records revealed a lack of documentation by the TC of performance and review of the annual competency assessments for the following: TP A- 2021, TP B- 2021, and TP C- 2021. See attached TP code sheet. 3. An exit interview with the TC on 10/20/22 at approximately 1215 confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kenbridge Family Medicine on August 28, 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: 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 a review of the Laboratory Personnel Report Form (CMS 209), procedure and policy manual, personnel files, and an interview, the laboratory did not establish and follow a policy for one (1) technical consultant's competency assessment in calendar years 2016, 2017 and up to the date of the survey on August 28, 2018. Findings include: 1. Review of the CMS 209 revealed that Testing Personnel E serves as Technical Consultant (TC). (See Personnel Code Sheet) 2. Review of the laboratory procedure and policy manual revealed no protocol outlining documentation of the competency assessment of the TC. 3. Review of the personnel files revealed that the laboratory director failed to document competency assessments in calendar years 2016, 2017, and year to date 2018 for Testing Personnel E in the role of TC. 4. In an interview with the TC and primary testing personnel at approximately 3:30 PM, it was confirmed that laboratory did not establish and follow a policy for documenting competency assessment for the duties of the TC for the timeframe outlined above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- 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 a review of policies and procedures, quality control (QC) records, and interviews, the laboratory failed to perform evaluations to verify eight (8) of eight (8) lot numbers of hematology QC materials used for monitoring accuracy of patient complete blood count (CBC) testing during the nineteen (19) months reviewed. Findings include: 1. Review of the laboratory's procedure manual revealed no Abbott Emerald hematology instrument procedure for the verification of new lot numbers of Cell Dyn 18 Plus QC assayed ranges. 2. Review of the laboratory's Abbott Emerald QC records from January 2017 to the date of the survey on August 28, 2018 revealed the following eight (8) Cell Dyn 18 Plus QC lot numbers were utilized to monitor patient CBC test results analyzed on the laboratory's Emerald instrument: 6326, 7044, 7128, 7212, 7296, 8015, 8099, 8183. The inspector requested to review the laboratory's documentation that each of the eight (8) new lot numbers of QC were confirmed (verified). No documentation was available. 3. In an interview with the technical consultant and primary testing personnel at approximately 3:30 PM, it was confirmed that the laboratory failed to verify eight (8) of eight (8) commercially assayed Cell Dyn 18 Plus QC lot numbered materials as outlined above. -- 2 of 2 --