Summary:
Summary Statement of Deficiencies D0000 Gene Cheng MD is not in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The following requirements have not been met: 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 Proficiency testing record review, the laboratory failed to successfully participate in 2 of 3 proficiency events for the regulated analyte of Calcium. Findings include: 1. A record review of American Proficiency Institute Proficiency Testing (PT) results on August 29, 2019 revealed that the laboratory failed to obtain a satisfactory score of 80% leading to unsuccessful participation in 2 of 3 events for the regulated analyte of Calcium. 2. The laboratory received the following PT scores: 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 -- Event# Score 2018 Event - 3 40% 2019 Event - 2 40% This is the first unsuccessful PT performance for the regulated analyte of calcium. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and communication with staff, the laboratory failed successfully achieve satisfactory performance in 2 of 3 testing events in the specialty of chemistry for the regulated analyte of calcium. Findings include: 1. A record review of American Proficiency Institute Proficiency Testing (PT) records on August 29, 2019 revealed that the laboratory failed to obtain an acceptable score of 80% leading to unsuccessful PT participation in 2 of 3 testing events for the regulated analyte of calcium. PT Event # Score 2018 Event 3 40% 2019 Event 2 40% 2. The Laboratory Manager confirmed the proficiency testing failure above on August 29, 2019 at 9:30 AM. 3. The laboratory performs approximately 330 calcium tests annually. -- 2 of 2 --