Advanced Central Laboratory

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of testing for urine toxicology confirmation testing at least twice annually for 2 (1 event in 2017 and 1 event in 2018) of 4 events reviewed. Findings include: 1. A review of "Split-Specimen" testing records revealed a lack of verification of accuracy testing for one testing event in 2017 and one testing event in 2018 for the following urine toxicology confirmation testing listed on the laboratory test menu: a. Gabapentin b. Hydroxybupropion c. Mitragynine d. N- DesMethylcitalopram e. Pregablin f. Secobarbital g. Tapentadol 2. A review of the "Proficiency Testing (PT) and Split-Specimen Testing" procedure showed a section titled "Mechanism of Review: Split-Specimen Testing" that states, "Split-Specimen testing is required on five specimens twice each year for all unregulated analytes not enrolled in PT." 3. An interview on 7/11/19 at 9:38 am with the GS confirmed verification of accuracy testing was not performed twice annually in 2017 and 2018. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to document

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 review of the CMS database and review of the American Association of Bioanalysts (AAB) graded proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: magnesium (MG). Findings include: Review of the CMS database and the AAB proficiency testing reports showed unsatisfactory performance for the chemistry analyte: two of two events. Refer to D2089 and D2096. D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) 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 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 CMS database and review of the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to participate in a testing event for the chemistry analyte magnesium, which is unsatisfactory performance resulting in a testing event score of 0%. Findings include: Sodium PT Event Score 3rd event 2018 40% 2nd event 2018 0% D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte magnesium in two of two consecutive testing events. Findings include: Unsatisfactory performance for two of two consecutive proficiency testing events constituting unsuccessful performance for magnesium: Magnesium PT event Score 3rd event 2018 40% 2nd event 2018 0% -- 2 of 2 --