Family Practice Associates Of Chesterfield

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Family Practice Associates of Chesterfield on February 2, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows and include the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), CMS CLIA Laboratory Application for Certification form (CMS 116), proficiency testing (PT) records, and interview, the laboratory failed to rotate five (5) of 5 PT among testing personnel (TP) performing patient chemistry tests utilizing the Olympus and TOSOH analyzers during the twenty- two (22) months reviewed. *REPEAT DEFICIENCY Findings include: 1. During an entrance interview on 02/02/23 at approximately 10:00 AM, the inspector reviewed the laboratory's CMS 209 and CMS 116 forms with the laboratory manager. During the review, TP #1 and TP #2 were identified as responsible for performing non waived patient chemistry testing (General, Immunochemistry, Endocrinology, Glycohemoglobin) utilizing analyzers Olympus AU400, TOSOH G8, and TOSOH A1A 360 during the 22 months reviewed (April 2021 to the date of the inspection, 02 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- /02/23). See Personnel Code Sheet. 2. Review of the laboratory's American Proficiency Institute (API) PT records, a total of five (5) testing modules, revealed that TP #1 signed attestations as having performed the following Core Chemistry, Immunochemistry, Endocrinology, and Glycohemoglobin testing events: 2021 API Event 3; 2022 API Event 1; 2022 API Event 2; 2022 API Event 3; 2023 API Event 1. TP #1 performed 5 of 5 PT modules for the 22 months reviewed. 3. An interview with the laboratory manager on 02/02/23 at approximately 3:30 PM confirmed the above findings. 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 the laboratory's 2021 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted for Family Practice Associates of Chesterfield on April 27-28, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The survey also included an entrance interview and initial record review conducted remotely on 04/26/21. The inspector noted that the laboratory performs SARS-CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), CMS CLIA Laboratory Application for Certification form (CMS 116), proficiency testing (PT) records, and interviews, the laboratory failed to rotate PT among testing personnel (TP) performing patient chemistry tests utilizing the Olympus and TOSOH analyzers during the twenty-seven (27) months reviewed. Findings include: 1. During an entrance interview on 4/26/21 at approximately 11:00 AM, the inspector reviewed the laboratory's CMS 209 form with the primary laboratory tech. The review revealed Testing Personnel (TP) #1 and TP #2 were identified as responsible for performing non waived patient chemistry testing (General, Immunochemistry, Endocrinology, Glycohemoglobin) during the 27 months reviewed (January 2019 to 4/26/21). See Personnel Code Sheet. 2. Review of the CMS 116 form revealed the laboratory utilized analyzers Olympus AU400 (Serial 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 -- Number 9060461), TOSOH G8 (SN 11219006), and TOSOH A1A 360 (SN 11878301) for non waived chemistry testing during the review timeframe. 3. Review of the laboratory's American Proficiency Institute (API) PT and twice annual Olympus AU400 Low Density Lipoprotein (LDL) spilt sample proficiency records, a total of twelve (12) testing modules, revealed that TP #1 signed attestations as performed the following testing events reviewed: 2019 API Events 1-3 for Modules Core Chemistry, Immunochemistry, Endocrinology, Glycohemoglobin; 2019 Olympus AU400 Low Density Lipoprotein (LDL) spilt sample events 1 and 2; 2020 API Events 1-3 for Modules Core Chemistry, Immunochemistry, Endocrinology, Glycohemoglobin; 2020 Olympus AU400 Low Density Lipoprotein (LDL) spilt sample events 1 and 2. TP #1 performed twelve (12) of the 12 chemistry PT modules in the ten events for the 27 months reviewed. 4. In an interview with the primary testing personnel on 4/28/21 at approximately 1:30 PM, the above findings were confirmed. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of procedures, manufacturer package inserts, chemistry analyzer calibration verification records, patient test logs, lack of documentation, and interviews, the laboratory failed to follow their procedure to document TOSOH analyzer Prostate Specific Antigen (PSA) calibration verification twice annually in calendar year 2020. Findings include: 1. Review of the laboratory's procedures for the TOSOH analyzer and manufacturer's PSA package insert revealed instructions to "perform calibration verification at least once every six months for the PSA". 2. Review of the laboratory's TOSOH A1A calibration verification records for calendar year 2020 revealed one PSA calibration verification was performed (dated 07/01/20). The inspector requested to review additional documentation of PSA calibration verification performed in calendar year 2020. The documentation was not available for review. The lead testing personnel stated: "I did PSA verification again on 3/3/21. Our policy is to perform it every six months but there was a delay in getting it -- 2 of 3 -- completed." 3. Review of the patient test logs revealed that one hundred ninety (190) patient PSA specimens were resulted during the three month lapse in calibration verification. 4. In an interview with the primary testing personnel on 4/28/21 at approximately 1:30 PM, the above findings were confirmed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Family Practice Associates of Chesterfield on November 29, 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: D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on a review of 2017 proficiency testing (PT) records and interview, the laboratory failed to participate in one (1) approved PT program for the year before designating a change in programs. Findings include: 1. Review of the laboratory's 2017 PT records, a total of three (3) events, for hematology and chemistry revealed the laboratory enrolled and was scored by the following PT providers: 2017 1st Event- College of American Pathologists (CAP) for General Chemistry, Endocrinology, and Hematology Auto Differentials; 2017 2nd Event - American Proficiency Institute (API) for Routine Chemistry, Chemistry Endocrinology, and Hematology; 2017 3rd Event - American Proficiency Institute (API) for Routine Chemistry, Chemistry Endocrinology, and Hematology. The inspector inquired regarding the change from CAP to API for PT in 2017. The lead tech stated: "we were not satisfied with API in calendar year 2016 and wanted to try CAP. CAP's format was hard to use so we decided to switch back to API in 2017 after the first event". 2. In an interview with the practice manager and lead tech at approximately 4:00 PM, it was confirmed 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 7 -- laboratory failed, in 2017, to participate in one approved PT program for chemistry and hematology testing for a year before designating a change in programs as outlined above. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for Albumin in one (1) out of six (6) routine chemistry testing events reviewed. Findings include: 1. Review of the laboratory's 2017 and 2018 PT records, a total of 6 events, revealed Albumin scores of less than 80 % for the following routine chemistry event: 2017 College of American Pathologists C-A General Chemistry 1st Event : score 40% (samples CHM-03, CHM-04, CHM-05 were scored as unacceptable). 2. In an interview with the practice manager and lead tech at approximately 4:00 PM, it was confirmed that the laboratory received an unsatisfactory performance score for Albumin on the chemistry PT event listed above. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records, and an interview, the laboratory failed to document