Shamrock General Hospital

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, records of calibration checks, and interview, the laboratory failed to have a procedure to define the frequency of calibration checks for two of two pipettes used in the laboratory to reconstitute controls and calibrators for chemistry testing performed on the Vitros 350. Findings follow. A. Review of the laboratory's policies and procedures did not show a procedure for the pipette calibration checks. B. Review of the calibration checks from 2019 - survey date, September 23, 2021 showed one calibration check performed on 01/20/2021 for one MLA Macro Pipette for the volume of 3000 uL. C. Interview with the Technical Consultant on September 23, 2021 at 1410 hours in her office confirmed one calibration check was performed in the last two years, that they rotate usage between the two pipettes, and they do not have a policy and procedure in place for the calibration check. 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 D0000 As a result of the CLIA recertification inspection, the laboratory is not in compliance with the following Conditions of Participation required for certification in the CLIA program at 42 CFR part 493: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director; 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 testing records from the proficiency testing company, American Proficiency Institute (API) and interview with facility personnel, the laboratory did not successfully participate in the specialty of hematology for the 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 -- analyte activated partial thromboplastin time (APTT) for 2 of 3 events in 2018. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records from the proficiency testing company, American Proficiency Institute (API) and interview with facility personnel, the laboratory did not successfully participate in the specialty of hematology for the analyte activated partial thromboplastin time (APTT) for 2 of 3 events in 2018. The findings included: 1. Based on a review of API proficiency testing results and the laboratory's self-grade findings, the laboratory received the following scores the analyte activated partial thromboplastin time (APTT) : 2018, 1st event: Score of 60 percent 2018, 2nd event: Score of 60 percent A score of less than 80 percent is unsatisfactory performance. Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. The laboratory was required to self-grade the analyte activated partial thromboplastin time (APTT) scores because API did not reach a consensus with participant scores. 2. In an interview at 10:54 hours on 2/21/2019 in the conference room, the Laboratory Manager stated the laboratory to run quality control materials as unknowns for