Summary:
Summary Statement of Deficiencies 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 5/14/2020, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Proficiency Institute COMPATIBILITY TESTING: Year 2019 1st Event 80% Year 2019 2nd Event 80% Year 2020 1st Event 80% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of 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 -- three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 5/14/2020, the laboratory has not successfully participated in proficiency testing for COMPATIBILITY TESTING. Findings include: Our records indicate the following proficiency testing scores for your laboratory for COMPATIBILITY TESTING: PROFICIENCY TESTING PROVIDER: American Proficiency Institute COMPATIBILITY TESTING: Year 2019 1st Event 80% Year 2019 2nd Event 80% Year 2020 1st Event 80% Scores less than 100% for these analytes or parameters indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. Repeat failures are scored as non-initial unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 5-14-2020, the laboratory director did not provide overall management and direction in accordance with 493.1445 of this subpart. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider) on 5-14-2020, the laboratory director failed to ensure the proficiency testing samples were tested as required under subpart H of this part. -- 2 of 2 --