Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited. 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 surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and procedures, complaint intake records and interview with the technical consultant, the laboratory referred provider performed microscopy images to an laboratory individual, person 1, who is not employed by this laboratory and is not testing personnel of this laboratory (52D0719792) prior to the submission date. Findings include: 1. The technical consultant, who was the testing personnel, contacted person 1, who is not employed by this laboratory and is not tesitng personnel of this laboroatory, to identify Urine Sediment PM-4 prior to the submission date of the 2022-MiscQA_POC2 event. See D2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency 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 -- testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on surveyor review of Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and procedures, complaint intake records and interview with the technical consultant, the laboratory referred provider performed microscopy images to a laboratory individual, person 1, who is not employed by this laboratory or testing personnel of this laboratory (52D0719792) prior to the submission date for Urine Sediment PM-4 from event 2022-MiscQA_POC2. Findings include: 1. Review of the WSLH PT records showed event 2022-MiscQA_POC2 was due on November 4, 2022. Further review showed the laboratory submitted the results on November 3, 2022, at 11:30 AM. 2. Review of the "Microscopic Urinalysis Procedure" stated, "Refer to reference material (ie: urine atlas) if crystals are present to properly identify them." 3. Review of the "Proficiency Testing Procedure" stated, "PT samples must never be referred to another laboratory for confirmatory testing." 4. Complaint intake records show person 1 was contacted as follows: November 2, 2022 at 7:02 PM via facebook messenger with a urine picture asking for a second opinion between crystals and bacteria. November 2, 2022 at 7:23 PM, person 1 responded that it looked like crystals. 4. Complaint intake records show person 1 was contacted via facebook messager on December 1, 2022, at 5:53 PM with the message "Good news, crystals were CA carbonate. Bad news, proficiency test people said question was not graded because referees couldn't come to an agreement". 5. Interview with the technical consultant on January 13, 2023, at 11:00 AM confirmed the technical consultant would contact a laboratory individual who is not employed by this labortaory and is not a test personnel of this laboratory for help identifying urine sediment if testing personnel were unsure of they type of crystals or other urine sediment presented in the microscope. -- 2 of 2 --