Cmg Farmville Laboratory

Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of CMG Farmville Laboratory was conducted on December 3, 2020 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 2020, the review of the CASPER 0153D Unsuccessful (2 of 3) PT report and an 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 -- interview with the primary testing personnel, the laboratory failed to achieved satisfactory performance of at least 80% for two out of three consecutive events for the Platelets (PLT) parameter, in which the laboratory received scores of 60% for both events, resulting in unsuccessful performance (Cross Reference D 2130). 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) scores for the first and third events in 2020, the CASPER 0153D Unsuccessful PT report and an interview with the primary testing personnel, the laboratory failed to achieve satisfactory performance of at least 80% for two out of three consecutive events for the Platelets (PLT) parameter resulting in unsuccessful performance. Findings include: 1. Review of the Medical Laboratory Evaluation (MLE) hematology PT scores and the CASPER 0153D Unsuccessful PT report revealed the following scores: 2020 1st event PLT- 60% 2020 3rd event PLT- 60% The laboratory received an unsuccessful MLE PT score for the above listed analyte. 2. A phone call interview with the primary testing personnel at approximately 2:10 PM on December 3, 2020 confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CMG Farmville Laboratory on August 13-14, 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: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a laboratory tour, review of policies and procedures, equipment maintenance records, and interviews, the laboratory failed to follow their Revolutions Per Minute (RPM) calibration protocol for one (1) of two (2) centrifuges located in the specimen processing area during the twenty-two (22) months reviewed. Findings include: 1. During a tour on August 13, 2019 at approximately 2:00 PM, the inspector noted 2 Unico Powerspin centrifuges in specimen processing areas: Unit 1-Clinical Engineering Tag ID 211273- on urinalysis specimen processing bench, Unit 2- Clinical Engineering Tag ID 212075- on blood specimen processing bench. 2. Review of the policy and procedure manual's Quality Assurance (QA) section revealed the following 2 policies: General Lab Equipment Maintenance Policy that stated "All general lab equipment (used to process specimens) will have yearly preventative maintenance and calibrations. This applies to centrifuges, pipettes, microscopes"; Specimen Processing Policy that stated "centrifugation phase for serum or plasma 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 -- specimen processing is 10 to 15 minutes at 3200-3500 RPM". 3. Review of the equipment maintenance records (October 2017 to the date of the survey) revealed no RPM calibration documentation for the Unit 2 Unico centrifuge (Tag ID 212075 utilized for blood specimen processing). The inspector requested to review a 3200- 3500 RPM calibration verification. No documentation was available for review. 4. In an interview with the technical consultant and laboratory managers at approximately 2: 30 PM on 8/14/19, 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 laboratory tour, review of calibration records for the chemistry analyzer and an interview, the laboratory failed to perform calibration verification twice a year for Sodium (Na), Potassium (K), and Chloride (CL) analytes during the twenty-two (22) months reviewed. Findings include: 1. During a tour on August 13, 2019 at approximately 2:00 PM, the inspector noted an Ortho Clinical Vitros 350 in use for patient chemistry testing. 2. Review of the laboratory's Vitros 350 chemistry analyzer calibration records from October 1, 2017 to the date of the survey (22 month timeframe) revealed that Na, K, and CL calibrations were completed with a two (2) point calibration. The inspector requested to review calibration verification documentation for the analytes outlined above. The documentation was not available for review. 3. In an interview with the technical consultant and laboratory managers at approximately 2:30 PM on 8/14/19, the above findings were confirmed. -- 2 of 2 --