Scdmh Clinical Laboratory

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 a proficiency test desk review conducted on 03/03/2022, review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analyte white blood cell differential (WBC Diff) for three out of three consecutive proficiency testing events reviewed (2021, Events 1, 2 and 3). See D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a proficiency test desk review conducted on 03/03/2022, review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to achieve satisfactory performance for the analyte WBC Diff for three out of three consecutive testing events reviewed (2021, Events 1, 2, and 3) resulting in unsuccessful proficiency testing performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency test desk review conducted on 03/03/2022, review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory director failed to ensure proficiency testing for the analyte WBC Diff required by 42 CFR, Part 493.801 (see D6016). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency test desk review conducted on 03/03/2022, review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined the laboratory director failed to ensure the laboratory attained a result of 80% for the analyte WBC Diff. The laboratory failed three out of three consecutive proficiency testing events reviewed for WBC Diff (2021, Events 1,2 and 3). (see D2130) -- 2 of 2 --

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: During an onsite recertification survey performed on 11/10/2021, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of hematology, the analyte WBC Diff for two consecutive proficiency testing events reviewed (2021, Events 1 and 2). See D2121 and D2130. D2121 HEMATOLOGY CFR(s): 493.851(a) 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 -- 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: During an onsite recertification survey performed on 11/10/2021, based on review of the CASPER report 155D and laboratory proficiency testing records (graded report from API), it was determined that the laboratory failed to attain a score of at least 80 percent in proficiency testing for the specialty of hematology, the analyte WBC Diff for two consecutive proficiency testing events (2021, Events 1 and 2). The findings include: 1. Review of CASPER report 155D revealed the following Plt proficiency scores for your laboratory: a. 2021, Event 1: 53% b. 2021, Event 2: 47% 2. The scores were confirmed upon review of the graded API reports. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During the onsite recertification survey performed on 11/10/2021, based on review of CASPER report 155D and graded API results, it was determined that the laboratory failed to achieve satisfactory performance for platelets in two consecutive testing events (2021, Events 1 and 2) resulting in unsuccessful proficiency testing performance. See D2121. -- 2 of 2 --