Summary:
Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 26, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd and 3rd events of 2018), resulting in the first Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- unsuccessful occurrence for hemoglobin (HGB), analyte # 795. Findings include: Refer to D 2123 & D 2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Report 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd and 3rd events of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB), analyte # 795. Findings include: 1. Desk review of Casper Reports 155 disclosed the laboratory failed analyte #795 HGB on events 2 and 3 of 2018 with scores of 0%. 2. Desk review of the laboratory's proficiency testing reports from the College of American Pathologist (CAP) confirms the laboratory failed HGB on event 2 of 2018 with unsatisfactory scores on samples FH9 6, 7, 8, 9, and 10 and failed event 3 of 2018 with a score of 0% for lack of response. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Report 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd and 3rd events of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB), analyte # 795. Refer to D 6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Report 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd and 3rd events of 2018), resulting in the first unsuccessful occurrence for hemoglobin (HGB), analyte # 795. Findings include: 1. Desk review of Casper Reports 155 disclosed the laboratory failed analyte #795 HGB on events 2 and 3 of 2018 with scores of 0%. 2. Desk review -- 2 of 3 -- of the laboratory's proficiency testing reports from the College of American Pathologist (CAP) confirms the laboratory failed HGB on event 2 of 2018 with unsatisfactory scores on samples FH9 6, 7, 8, 9,and 10 and failed event 3 of 2018 with a score of 0% for lack of response. -- 3 of 3 --