Summary:
Summary Statement of Deficiencies D0000 A Certification Survey was performed at St. Martin Hospital, CLIA ID # 19D461104, on August 19, 2019 through August 23, 2019. St. Martin Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1250 CONDITION: Analytic systems 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories Performind Moderate Complexity Testing; Technical Consultant 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 review of proficiency test results from the CMS 155D and American Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 28 -- Proficiency Institute (API) and interview with personnel, the laboratory failed to successfully participate in proficiency testing. Refer to D2163. D2163 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(g) 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 record review and interview with personnel, the laboratory failed to achieve an overall satisfactory proficiency test score for two (2) out of three (3) consecutive events for ABO/RHO in 2017. Findings: 1. Review of the laboratory's American Proficiency Institute (API) proficiency test results for the Immunohematology 3rd event revealed the laboratory received an 80% for D (Rho) type. 2. Review of the CMS CASPER Report 0155D for proficiency test scores revealed the laboratory received less than 100 percent for the following two (2) out of three (3) events for ABO/RHO: 2017 1st Event 80% ABO Group 2017 3rd Event 80% D (Rho) type 3. In interview on August 23,2019, Testing Personnel 1 confirmed the laboratory had an unsuccessful proficiency test score for the Rh 3rd event in 2017. Testing Personnel 1 stated the laboratory performed an assessment for the identified unsuccessful proficiency test results. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to verify the accuracy of all non-regulated analytes at least twice annually. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed "The Laboratory participates in the American Proficiency Institute (API) proficiency testing program. The specimens are scheduled to be shipped three times each year (or two times a year, where applicable)." 2. Review of the laboratory's API PT records for 2018 and 2019 revealed the laboratory failed to participate for the 2019 1st event for the following analytes: 2019 Chemistry Miscellaneous 1st Event: "Notes Failure to Participate" PSA, Ammonia, Ferritin, Folate, Prealbumin, Transferring, Urine Chloride, Urine Creatinine, Urine Microalbumin, Urine Potassium, Urine Sodium, Urine Total Protein, Vitamin B-12, Amphetamines, Barbiturates, Benzodiazepine, Cannabinoids, Cocaine, Opiates, and Phencyclidine 3. Further review of the the API records for the identified Chemistry Event revealed API ships proficiency samples twice a year. 4. Review of the laboratory's "Performance Review and