Project Of The Quad Cities, The

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records, Certification and Survey Provider enhanced Reporting (CASPER) report 0096D, laboratory procedures, lack of documentation, and interview, the laboratory failed to: to make their results from the American Proficiency Institute (API) Gram Stain proficiency testing (PT) event one of 2021 publicly available (D2005), test microbiology Gram stain proficiency samples for the morphology component like patient specimens are tested and as instructed by the American Proficiency Institute (API) for eight of eight PT events reviewed from 2021 through 2023 (Refer to D2006), the laboratory received an unsatisfactory performance for American Proficiency Institute's (API) Gram Stain proficiency testing (PT) event one of two events reviewed in 2023 (Refer to D2020), and create and follow

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review, the Laboratory Personnel Report (CMS 209), and an interview with the office staff; the laboratory failed to establish written procedures to assess employees performing Microbiology testing, affecting 1 out of 1 testing personnel (TP1). Findings: 1. The CMS 209, personnel records, and the laboratory's policies and procedures were reviewed. 2. The laboratory's competency policy failed to include the following: *A written competency procedure for Gram Staining; *A written competency procedure for Potassium Oxide (KOH) for fungal identification and *A written competency procedure for Wet Preparation testing. 3. TP1 was listed on the CMS 209 for performing the above tests. 4. The personnel documents revealed that TP1 had not been trained or assessed for competency to perform the above Microbiology tests prior to testing patients. 5. The laboratory failed to establish and implement written competency procedures to assess TP1 before testing patients. 6. On an Initial survey conducted on 03/12/20 at 12:00 PM, the office staff confirmed the above findings. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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)