Vernon J Harris Eechc Dba

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Drs Meyer, Day and Loving, PC on 03/02/22 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. 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: **REPEAT DEFICIENCY** Based on review of policy and procedures (P&P), calibration records, lack of documentation, and interview, the lab failed to follow the established P&P for performing the calibration procedures every six months on the hematology analyzer for 12 of 12 months reviewed. Findings include: 1. Tour of the lab testing area on 03/02/22 at approximately 09:30 AM revealed the lab utilizes the Beckman Coulter AcTDiff hematology analyzer to perform Complete Blood Count (CBC) patient testing. 2. Review of the P&P revealed a "CBC Calibration" policy that stated, "Calibration frequency for Beckman Coulter AcTDiff CBC is as least once 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 -- every six months." 3. Review of calibration records revealed documentation of calibration procedures on 04/22/20 and 03/27/21. There was lack of documentation of calibration procedures between the specified dates. Additional documentation was not available for review upon request. 4. An exit interview with the lab director and testing personnel on 03/02/22 at approximately 1200 confirmed the findings. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of policy and procedures (P&P), the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation and interview, the lab director failed to follow the established P&P for performing annual competency assessments for three of three TP in 2019, 2020 and 2021. Findings include: 1. Review of P&P revealed the following statements, "Quality Assurance Plan 6. Personnel Assessment- At least annually, the laboratory director and /or technical consultant will review the performance of each employee working in the laboratory to assure employee competency. The written result of the review will be filled in the individual's personnel file." 2. Review of the CLIA CMS 209 form revealed there are three TP (TP A, B and C). See attached Testing Personnel code sheet. 3. Review of TP records revealed lack of documentation of annual competency assessments for TP A, B and C in 2019, 2020 and 2021. The surveyor requested to review annual competency assessment documentation and there were no documents available for review. 4. An exit interview with the lab director and testing personnel on 03/02/22 at approximately 1200 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Drs Meyer, Day and Lovings, PC was conducted on 01/21/22 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. 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 first and third events in 2021, the review of the CASPER 0155D Individual Laboratory Profile 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 PT events for the Hematocrit (HCT) parameter, in which the laboratory received scores of 40% and 60% 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) records for the first and third events in 2021, the CASPER 0155D Individual Laboratory Profile PT report and communication with the primary testing personnel, the laboratory failed to achieve satisfactory performance of at least 80% for two out of three PT events for the Hematocrit (HCT) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the American Proficiency Institute (API) hematology PT scores and the CASPER 0155D Individual Laboratory Profile PT report revealed the following scores: 2021 1st event HCT- 40% 2021 3rd event HCT- 60% The laboratory received an unsuccessful API PT score for the above listed analyte. 2. An interview with the primary testing personnel on 01/21/22 at approximately 12:45 PM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at the laboratory of Dr.'s Meyer, Day, and Lovings, PC on October 16, 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: 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 policies and procedures, hematology calibration records, and an interview, the laboratory failed to document Beckman Coulter AcTdiff calibration procedures every six months for Complete Blood Count (CBC) patient testing according to their written procedure in calendar year 2018. Findings include: 1. Review of the laboratory's Quality Assurance (QA) procedure manual revealed a "CBC Calibration" policy that stated "calibration frequency for Beckman Coulter AcTdiff CBC is at least once every six (6) months". 2. Review of the AcTdiff instrument calibration documentation from January 2018 to the date of the inspection on 10/17/19, a total of twenty-two (22) months, revealed the following calibration records: 03/14/18, 11/03/18, and 04/20/19. The inspector requested to review 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 -- additional calibration records for the AcTdiff analyzer during the timeframe of 09/14 /18 to 11/03/18. No additional calibration documentation was available for review. The lead testing personnel stated at, approximately 2:00 PM, "We did miss the deadline for the calibration in that time period. I do not recall why it was missed." 3. In an interview with the lead testing personnel at approximately 3:30 PM, the above findings were confirmed. 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. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of policies and procedures, Quality Control (QC) records, and an interview, the laboratory failed to establish and follow a written policy for QC statistics review in order to monitor, assess and correct problems with their hematology analyzer for twenty-one (21) of the twenty-two (22) months reviewed. Findings include: 1. Review of the laboratory's policies and procedures revealed no quality assurance plan to review, monitor, assess and correct QC statistical concerns with their Beckman Coulter AcTdiff analyzer. 2. Review of QC records from January 2018 through September 2019 (timeframe of 22 months) revealed a lab director review sheet with director signature indicating monthly QC statistics record review for November 2018 (dated 12/14/18). The inspector requested to review additional hematology QC statistics review. No records were available. The lead testing personnel stated, at approximately 3:00 PM, "I print the QC daily log and look at it to make sure we have not missed any QC. I do not look at the statistic data or print the graphs routinely. I can ask our LD to review the charts monthly going forward". 3. In an interview with the lead testing personnel at approximately 3:30 PM, the above findings were confirmed. -- 2 of 2 --