Summary:
Summary Statement of Deficiencies D0000 During a recertification survey completed on 12/04/19 for 42 CFR part 493 Laboratory Requirements, the facility was found out of compliance with the following condition: 42 CFR Part 493.803 Proficiency Testing, 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 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, and laboratory proficiency testing records, the laboratory failed to successfully participate in proficiency testing for Chloride. The laboratory reported performing 3,026 Chloride tests in a 12 month period. Findings are: A. Review of CASPER Report 153 and 96 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- from the CMS proficiency database revealed the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. 1st event score = 20% 3rd event score = 60% B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. See D2087 and D2094 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, and laboratory proficiency testing records, the laboratory failed achieve a proficiency test score of at least 80% for 2 of 3 test events in 2019 for the analyte Chloride. Findings are: A. Review of CASPER Report 153 and 96 from the CMS proficiency database revealed the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. 1st event score = 20% 3rd event score = 60% B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. C. Review of the laboratory's proficiency test records confirmed these findings. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the review of 2019 proficiency test records from the proficiency testing agency, Centers for Medicare & Medicaid Services (CMS) proficiency database, and laboratory proficiency testing records, the laboratory must undertake training and technical assistance for the unsuccessful participation in proficiency testing for Chloride. Findings are: A. Review of CASPER Report 153 and 96 from the CMS proficiency database revealed the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. 1st event score = 20% 3rd event score = 60% B. Review of proficiency test records from the proficiency testing agency also indicated the laboratory received failing scores for the analyte Chloride for two (2) of three (3) test events in 2019. 1. 1st event results indicated that the SDI (Standard Deviation Index, a method of comparing one laboratory to other similar laboratories) for 4 of 5 results were higher (>2.0) than the peer group. 2. 3rd event results indicated the SDI for 2 of 5 test results were higher (>2.0) than the peer group. C. Review of the laboratory's proficiency test records and