Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 13, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institite (API) proficiency testing (PT) records and staff interview, the laboratory failed to document each step of the testing and reporting of proficiency testing samples in the speciality of hematology on the 1st testing event of 2018. Findings include: 1. Review of API PT records for the 1st testing event of 2018 revealed no attestation statement signed by the testing personnel and laboratory director. 2. Review of PT records for the 1st testing event of 2018 also revealed no instrument printouts showing the actual results obtained on the hematology analyzer. 3. Interview with the office manager and testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- personnel #1 (see CMS 209) on February 13, 2019 at 1 pm in the break room confirmed the attestation statement and instrument printouts for PT event 1 of 2018 are not available. 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 the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API) and staff interview, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for white blood cell count (WBC) # 805. Findings include: Refer to 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 review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API) and staff interview, the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for white blood cell count (WBC) # 805. Findings include: 1. Review of the laboratory's PT results from API revealed the laboratory failed WBC on event 2 of 2017 with a score of 0% for non- participation and event 3 of 2017 with a score of 60%. 2. Interview with the office manager and testing personnel #1 (see CMS 209) on February 13, 2019 at 1 pm in the break room confirmed the laboratory failed WBC on events 2 and 3 of 2017 resulting in the first unsuccessful performance. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 -- 2 of 5 -- 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 review of laboratory records, lack of records to review and staff interview, the laboratory director failed to provide overall management and direction of the laboratory. Note: This is a repeat Condition level deficency and was also cited on the 2014 and 2016 surveys. Findings include: Refer to: D 6016, D 6019, D 6021 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 review of the laboratory's proficiency testing (PT) reports and staff interview, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for white blood cell count (WBC) # 805. Findings include: 1. Review of the laboratory's PT results from API revealed the laboratory failed WBC on event 2 of 2017 with a score of 0% for non- participation. 2. Review of the laboratory's PT results from API revealed the laboratory failed WBC on event 3 of 2017 with a score of 60%. 3. Interview with the office manager and testing personnel #1 (see CMS 209) on February 13, 2019 at 1 pm in the break room confirmed the laboratory failed WBC with a score of 0% on event 2 of 2017 for non-participation and event 3 of 2017 with a score of 60% resulting in the first unsuccessful performance. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved