Summary:
Summary Statement of Deficiencies D0000 An offsite PPM survey was conducted on May 21, 2020, for all previous deficiencies cited on February 25, 2020. All deficiencies have been corrected, and no new noncompliance was found. The facility is in compliance with all regulations surveyed. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and an interview with the laboratory director and office manager, the laboratory failed to implement and established safety procedure to ensure protection from physical, biochemical, and biohazardous materials. Findings include: 1. During the laboratory tour it was observed there was not a maintenance log or eyewash equipment in the phlebotomy or the testing laboratory area. 2. An interview with the laboratory director and office manager, during the laboratory tour on 02/25/2020 at approximately 01:30 p.m., confirmed the absence of eyewash equipment and maintenance log. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: A review of the procedure manual and an interview with the laboratory director, the laboratory failed to have an adequate Quality Assurance (QA) policy specific to the specialty of Provider Performed Microscopy(PPM) in 2018, 2019 and 2020. Findings include: 1.) Procedure manual review revealed that the clinic does not have an adequate (QA) policy specific to PPM testing. 2.) An interview with the laboratory director at approximately at 03:35 pm, on 02/25/2020 in the break room, confirmed that the clinic did not have an adequate written QA policy specific to PPM testing. 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 policy and procedure manual (SOP), lack of microscopic qualitative quality control (QC) documents, lack of maintenance records, interviews with the laboratory director and office manager, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems as required. Findings include: For details refer to D5403, D5291, D5435, and D5449 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)