Carilion Clinic Family Medicine- Oakgrove

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic Family Medicine-Oakgrove on 06/28/23 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: 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 the manufacturer operator's guide, lack of documentation, and interview, the lab failed to perform and document the monthly maintenance for the hematology analyzer for 14 of 20 months reviewed. Dates of record review include 10 /01/23 up to 05/31/23. Findings include: 1. Review of the manufacturer operator's guide revealed instructions for performing monthly cleaning procedures utilizing the Boule Cleaning Kit (cleaning procedure and clot prevention) listed under "Section 8: Cleaning, Maintenance & Transport", "8.2 Monthly Cleaning". 2. Review of the available maintenance records for the Medonic M-series analyzer revealed lack of documentation of the performance of the monthly maintenance for 14 of 20 months reviewed: November, December 2021; January, May-November 2022; and January, March-May 2023. The inspector requested to review aforementioned documents. The documents were not available for review. 3. An exit interview with the technical consultant and primary testing personnel on 06/28/23 at 11:15 AM confirmed the findings. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic Family Medicine- Oakgrove on August 13, 2021 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 the review of policy and procedures (P&P), lack of documentation, and interview, the laboratory did not have a P&P for performing competency assessments on testing personnel at the date of the survey on 08/13/21. Findings include: 1. Review of the available P&P's revealed lack of documentation of a policy for performing competency assessments on testing personnel performing patient testing. 2. During an exit interview with the technical consultant on 08/13/21 at approximately 12:00 PM, the documentation was not available for review and the above-specified finding confirmed. 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. 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 -- 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 technical consultant (TC), the TC failed to perform and document the semi-annual and annual competency assessment for one (1) of 1 new TP. Dates of record review include 06/03/19 up to 08/13/21. Findings include: 1. Review of the CMS-209 form revealed that TP A was trained and performing patient testing on 09/25/19. See attached TP code sheet. 2. Review of TP A's personnel records revealed lack of documentation by the TC of performance and review of the semi-annual and annual competency assessments at the date of survey on 08/13/21. 3. During an exit interview with the TC on 08/13/21 at approximately 12:00 PM, the documentation was not available for review and the above-specified findings confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Clinic Family Medicine- Oak Grove on April 11, 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on an interview with the technical consultant, quality control (QC) records, lack of documentation, and policy and procedures (P&P), the laboratory failed to retain the manufacturer's assay sheets for acceptable ranges and the end of lot statistical analysis for seven (7) of seven (7) CDS Boule Con-diff hematology QC materials utilized from January 1, 2017 and up to August 31, 2018. Findings include: 1. An interview with the technical consultant at approximately 9:30 AM revealed that the laboratory utilizes the CDS Boule Con-diff hematology QC materials to perform daily QC procedures. The technical consultant revealed that the manufacturer assay sheets and end of the lot statistical analysis for 7 of the 7 lot numbers were not retained during intra-office moving of records. 2. Review of the daily QC records for the CDS Medonic CA 620 hematology analyzer revealed the following lot numbers and lack of documentation for the manufacturer assay sheets and end of the lot statistical analysis from January 1, 2017 and up to August 31, 2018: Lot number 2161121, 2161122 and 2161123, Lot number 2170221, 2170222 and 2170223, Lot number 2170521, 2170522 and 2170523, Lot number 2170821, 2170822 and 2170823, Lot number 2171121, 2171122 and 2171123, Lot number 2180231, 2180232 and 2180233 and, Lot number 2180531, 2180532 and 2180533. Total of 7 lot numbers. 3. Review of 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 -- P&P revealed the following statement: "Quality Control (signed by lab director 8 /2018)- Documentation proving the accuracy of the analytical system are reviewed by the laboratory director or designee and maintained in writing for the staff and representative of approved regulatory agencies." 4. During the exit interview at approximately 11:45 AM, the technical consultant confirmed the findings. -- 2 of 2 --