Summary:
Summary Statement of Deficiencies D0000 A recertification survy was performed on The laboratory was found out of compliance with the CLIA regulations. The condition not met was: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director; Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's policies and procedures, pre-survey paperwork, internet search, review of pre-survey paperwork, quality control (QC) records, test reports, slides, and interview the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems in Histopathology test systems. 1. The laboratory failed to have a procedure that covered the quality control of the stains for five of five months reviewed (see D5403). 2. The laboratory failed to have a procedure for the accuracy assessments of dermatopathological interpretations for five of five months reviewed (see D5403). 3. The laboratory failed to document the intended reactivity to ensure predictable staining characteristics for the Hematoxylin and Eosin (H&E) stain used in dermatopathological interpretations 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 -- stained predictably for five of five months reviewed. (see D5473). 4. The laboratory failed to document the intended reactivity to ensure predictable staining characteristics for the Immunohistochemical (IHC) stains and Special stains for the interpretation of dermatopathological specimens for five of five months reviewed (see D5601). 5. The laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems identified in the analytic systems for five of five months reviewed (see D5791). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)