Summary:
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 surveyor review of proficiency testing records from Froedtert and Medical College Community Physicians - Mequon 1 (FMCCP-M) (52D2135321) and Froedtert and the Medical College of Wisconsin Community Physicians in West Bend (FMCCP-WB) (52D0678401), quality assurance records, and interview with a technical consultant, the laboratory did not test the KOH (potassium hydroxide) proficiency samples in the same manner as patient samples during the second event in 2019. Findings include: 1. Testing personnel, staff B, tested the same proficiency samples for KOH (Samples PM3 and PM4) at FMCCP-M (52D2135321) and FMCCP-WB(52D0678401) during the second event of 2019, resulting in inter- laboratory communication. See D2011. D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing records for 2019 and 2020 and interview with a technical consultant, the laboratory did not participate in an approved proficiency testing program for one year before designating a different program for chemistry. Findings include: 1. Review of proficiency testing records from 2019 showed the laboratory participated in the American Proficiency Institute (API) program for chemistry in event one. The laboratory participated in the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing chemistry program for events two and three. Review of proficiency testing records for 2020 showed the laboratory enrolled with the American Proficiency Institute (API) program for chemistry. 2. Interview with a technical consultant, staff C, on January 7, 2020 at 11: 05 AM, confirmed the laboratory did not participate in the WSLH chemistry proficiency testing program for one year prior to switching to the API chemistry proficiency testing program. Further interview confirmed the laboratory did not enroll with the WSLH program for chemistry in 2020. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing and quality assurance records, and interview with a technical consultant, the KOH (potassium hydroxide) proficiency test samples (PM3 and PM4) from event two in 2019 were tested by the same person at Froedtert and Medical College Community Physicians - Mequon 1 (FMCCP-M) (52D2135321) and Froedtert and the Medical College of Wisconsin Community Physicians in West Bend (FMCCP-WB) (52D0678401), resulting in inter-laboratory communication of proficiency testing results. Findings include: 1. Review of Wisconsin State Laboratory of Hygiene proficiency testing records from FMCCP-M and FMCCP-WB for the second event in 2019 of the miscellaneous quality assurance point of care (MiscQA_POC2) module showed: At FMCCP-M, 52D2135321 *The Proficiency Testing tracking form showed testing person, staff B, was assigned the PPM (Provider Performed Microscopy) challenges. The PPM test results include KOH testing on samples PM3 and PM4. *The Attestation Statement was signed by staff B and dated October 25, 2019. At FMCCP-WB, 52D0678401 *The Proficiency Testing tracking form showed testing person, staff B, was assigned testing of the PM samples (includes KOH testing of samples PM3 and PM4). *The Attestation Statement was signed by staff B and dated October 24, 2019. 2. Review of the Mequon Health Center Monthly Quality Assurance Audit Checklist from November 2019 showed the checklist included the following statement: "2019 - MiscQA-POC2 - Failed one cell ID for KOH - Not performed at CP anymore same tech performed this at MQ & WB". (Mequon & West Bend) 3. Interview with a technical consultant, staff -- 2 of 4 -- C, on January 7, 2020 at 11:15 AM confirmed staff B performed the KOH testing of proficiency testing samples at FMCCP-M (52D2135321) and FMCCP-WB (52D0678401) for the second event in 2019 resulting in inter-laboratory communication of proficiency testing results. 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)