Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification Survey was completed on November 1, 2021 at the Roger Hall MD Laboratory by the Maine Department of Health and Human Services, Division of Licensing and Certification. The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493. 1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY finding: 42 C.F.R. 493.1210 Condition: Routine chemistry In addition, the laboratory also had the following CONDITION LEVEL findings: 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- This CONDITION is not met as evidenced by: Based on review of the Proficiency Testing (PT) data report (Report 155) and graded results from the American Proficiency Institute (APl) and staff interview, the laboratory failed to successfully participate in proficiency testing (PT) for the subspecialty of Routine Chemistry. The laboratory had unsatisfactory PT scores for the 1st and 2nd events of 2020, the 1st and 3rd events of 2021, and the 3rd event 2021. See D2089 and D2096. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of the CASPER Proficiency Testing (PT) data report (155), graded results from the American Proficiency Institute (API) and staff interviews, the laboratory failed to successfully participate in PT for Routine Chemistry. Findings include: 1. Record review on 10/27/2021 of the CASPER 155 report revealed: a. Scores of 0% for API 2020 Event 2 and 2021 Event 3, were unsatisfactory due to a failure to participate for the following regulated Chemistry analytes: Cholesterol total, Cholesterol HDL, Creatinine, Glucose (non waived), Potassium and Triglycerides. 2. During interview with testing personnel #1 (TP1) on 10/27/2021 at 11:00 AM, TP1 stated: a. For 2021 event 3 there was a breakdown in communication between the office and TP1. TP1 did not know the event had arrived until it was past the due date. b. For 2020 Event 2 the laboratory was closed due to the PHE. 3. During interview with the laboratory director (LD) on 10/27/2021 at 11:00 AM, the LD confirmed the above findings. 4. Test volume from 01/01/2021 through 10/26/2021 for the above analytes is 1,082. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: -- 2 of 12 -- Based on lack of documentation, review of the Proficiency Testing (PT) data report (CASPER Report 155), graded results from the proficiency testing organization American Proficiency Institute (API), staff interviews and laboratory PT records, the laboratory failed to document appropriate training and investigation to correct problems with PT testing failures. Findings include: 1. Record review on 10/27/2021 of the CASPER 155 and graded results from API revealed: a. API 2020 Event 1 for Cholesterol, total, the score was 60% and was unsatisfactory. b. API 2021 Event 1 for Cholesterol, total, the Score was 60% and was unsatisfactory. 2. Record review on 10 /27/2021 of the laboratory's PT records revealed: a. API 2020 Event 1 for Cholesterol, total - Samples were repeated and a patient impact study performed. Staff training and investigation to correct problems associated with the failure was not performed. b. API 2021 Event 1 Cholesterol, total - Samples were repeated and daily QC for day of testing was in range. A patient impact study was performed. Staff training and investigation to correct problems associated with the failure was not performed. 3. During interview with testing personnel #1 (TP1) on 10/27/2021 at 10:00 AM, TP1 stated TP1 was unaware the extent