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 observation, review of laboratory records, and interviews with technical supervisor #1; Dupage Medical Group - Lockport (DMG-L, CLIA ID# 14D2169778) failed to follow the laboratory's policy and notify CMS of the receipt of hematology proficiency testing samples received on 11-25-2019 from Dupage Medical Group - Tinley Park (DMG-TP, CLIA ID# 14D0420182) for the third American Proficiency Institute (API) proficiency testing (PT) event of 2019 for hematology and ran the samples (XE-11, XE-12, XE-13, XE-14, and XE-15) on 11-27-2019 prior to the submission deadline of 12-02-2019. 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 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 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 -- 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 observation, review of laboratory records and interviews with technical supervisor #1; Dupage Medical Group - Lockport (DMG-L, CLIA ID# 14D2169778) failed to follow the laboratory's policy and notify CMS of the receipt of hematology proficiency testing samples received on 11-25-2019 from Dupage Medical Group - Tinley Park (DMG-TP, CLIA ID# 14D0420182) for the third American Proficiency Institute (API) proficiency testing (PT) event of 2019 for hematology and ran the samples (XE-11, XE-12, XE-13, XE-14, and XE-15) on 11-27-2019 prior to the submission deadline of 12-02-2019. Findings Include: 1. During a tour of the laboratory facility at 9:10 am on 1-15-2020, the surveyor observed patients' specimens being testing on a Sysmex XN-1000, Serial Number 39108. 2. Interview with technical supervisor #1 (TS1) on 1-15-2020, at 9:20 am, confirmed the Sysmex XN- 1000 analyzer was used to perform the following tests: complete blood counts (CBC) with and without a differential, reticulocyte counts, and nucleated red blood cell counts (NRBCs). 3. Proficiency testing (PT) records for 2019 and 2020 were reviewed. 4. Review of PT records revealed a letter from the API that documented API was unable to fulfill the DMG-L request for Hematology-5S PT samples because the item was no longer available for 2019. 5. The DMG form, "Proficiency Testing Evaluation", documented the following information: Date Received: From TP 11-25- 19 Kit Description: Heme 3rd Date Survey Submitted: "Blank" Explanation &