Summary:
Summary Statement of Deficiencies D0000 An unannounced, off-site CLIA proficiency testing (PT) desk review was conducted for AMDC Physicians on December 4, 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: 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 an off-site desk review of the laboratory's 2018 American Academy of Family Physicians (AAFP) PT records and interviews, the laboratory failed to attain a 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 -- score of at least eighty (80) percent of acceptable responses for White Blood Cell (WBC) Differential Identification in two (2) out of three (3) hematology testing events reviewed resulting in unsuccessful PT performance. See 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 an off-site desk review of the laboratory's 2018 American Academy of Family Physicians (AAFP) proficiency testing (PT) records and interviews, the laboratory failed to attain a score of at least eighty (80) percent (%) of acceptable responses for White Blood Cell (WBC) Differential Identification in two (2) out of three (3) hematology testing events reviewed, resulting in unsuccessful PT performance. Findings include: 1. Desk review of the laboratory's 2018 AAFP PT records revealed WBC Differential scores of less than eighty percent for the following events: 2018 2nd event - score of 53%; 2018 3rd event - score of 67%; resulting in an unsuccessful PT performance. 2. In a telephone interview with the lab director at approximately 11:30 AM, and in a conference call with the office manager and primary testing personnel at approximately 2:00 PM on December 4, 2018, and it was confirmed that the laboratory was unsuccessful for the PT events listed above. -- 2 of 2 --