Summary:
Summary Statement of Deficiencies D0000 An unannounced CLIA off-site proficiency testing desk review of Brackenrich Family Practice was conducted on August 12, 2020 by a Medical Facilities Inspector of the Virginia Department of Health's Office of Licensure and Certification. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. Specific deficiencies cited are as follows: 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 third event in 2019 and the second event in 2020, the review of the CASPER 0155D Individual PT report and an interview with the primary testing personnel, the laboratory failed to achieved 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 -- satisfactory performance of at least 80% for two out of three consecutive events for the Hematocrit (HCT) parameter, in which the laboratory received scores of 20% and 60% respectively, 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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) scores for the third event in 2019 and second event in 2020, the CASPER 0155D Individual PT report and a telephone 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 Hematocrit (HCT) parameter, resulting in unsuccessful performance. Findings include: 1. Review of the MLE hematology PT scores and the CASPER 0155D Individual PT report revealed the following scores: 2019 3rd event, M3 HCT- 20% 2020 2nd event, M2 HCT- 60% The laboratory received an unsuccessful MLE PT score for the above listed analyte. 2. A telephone interview with the primary testing personnel on August 12, 2020 at approximately 9: 00 AM confirmed the findings. -- 2 of 2 --