St Luke Hospital & Living Center

Summary Statement of Deficiencies D5783

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, temperature monitoring records and interview, the laboratory failed to ensure that chemistry controls were stored at the required temperature. Findings: 1. A review of the manufacturer's instructions for Bio- Rad Liquichek Cardiac Markers Plus Control revealed that the proper unopened storage requirement was -20 degrees Celsius (C) to -70 degrees C. 2. A review of the temperature monitoring system records from 1/02/21 to 4/22/21 for the lab freezer showed temperatures recorded during this period failed to maintain consistent manufacturuer's required temperature. The period of daily temperatures reviewed for the freezer showed no dates when temperature was at the acceptable range to meet the manufacturer's requirements. Temperature log sheets listed an acceptable range of -14 C to -22 C. 3. Interview with General Supervisor (GS) 4/21/21 at 1 p.m. confirmed, the laboratory failed to ensure that chemistry controls were stored at the required temperature. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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: A proficiency testing record review on May 5, 2020 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the regulated analyte Bacteriology. Findings include: 1. Second event 2019 revealed a score of 50% for Bacteriology. 2. First event 2020 revealed a score of 50% for Bacteriology. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte Bacteriology. (refer to D2028) D2028 BACTERIOLOGY 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 -- CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A proficiency testing record review on May 5, 2020 revealed the laboratory failed to successfully participate in proficiency testing from American Proficiency Institute (API) for the regulated analyte Bacteriology. Findings include: 1. Second event 2019 revealed a score of 50% for Bacteriology. 2. First event 2020 revealed a score of 50% for Bacteriology. The laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events which resulted in unsatisfactory performance for the regulated analyte Bacteriology. -- 2 of 2 --