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 record review of American Proficiency Institute (API) proficiency testing scores and interview with the Testing Personnel (TP) #1, the laboratory failed to achieve satisfactory performance for two out of three testing events in chemistry for year 2021. (Refer to D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of 2021 Chemistry Core API proficiency testing scores and interview with the Testing Personnel (TP) #1, the laboratory failed to achieve a score of 80 percent for LDL Cholesterol (calculated) in 2 of 3 events (2021 Event 1, and 2021 Event 2), resulting in unsuccessful proficiency testing performance. Findings: 1. Review of American Proficiency Institute (API) proficiency testing scores for 2021 Chemistry Core revealed unsuccessful proficiency testing for LDL Cholesterol (calculated) with a 50% score for 2021 Event 1 and 50% score for 2021 Event 2. 2. Interview with the TP #1 on February 9, 2022 at 12:50 PM confirmed the laboratory failed to achieve satisfactory performance of LDL Cholesterol (calculated) for two out of three events in 2021. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on observation, record review and an interview with testing personnel (TP) #1, the laboratory failed to retain or be able to retrieve a copy of the patients test results report from their electronic medical record system, EPIC from January 1, 2020 to December 31, 2020. Findings: 1. Observed computer system in the laboratory with EPIC software used for the laboratory's electronic medical record system. 2. The laboratory failed to retrieve requested patient results reports from EPIC from January 1, 2020 to December 31, 2020. 3. Interview on February 9, 2022 at 12:45 PM with the TP #1, confirmed the laboratory was unable to retrieve data from EPIC for patients tested in 2020. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)