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 a review of proficiency testing (PT) records from American Proficiency Institute (API) and an interview with the technical consultant (TC) on 9/21/2023, the laboratory failed to enroll in proficiency testing for 2023. The findings include: 1. A review of proficiency testing records from API identified that the laboratory failed to enroll and participate in PT for all analytes performed by the laboratory in 2023. The analytes include: pH, pCO2, pO2, sodium, potassium, chloride, calcium, bicarbonate, hematocrit, hemoglobin, glucose, lactate, carbon monoxide, methaemoglobin, oxyhemoglobin, deoxyhemoglobin, urea, protime/ international ratio, troponin, creatinine and ionized calcium. 2. An interview with the TC on 9/21/2023 at 8:47 am confirmed that the laboratory failed to enroll and participate in PT for all analytes for 2023. 3. The laboratory reports performing 8753 tests annually. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation from the American Proficiency Institute (API) and an interview with the technical (TC) on 9/21/2023, the laboratory failed to document the review of PT results for the specialty of chemistry. The findings include: 1. A review of PT documents for the specialty of chemistry from API identified that the laboratory failed to document the review and evaluation of PT results by the laboratory director for events two (2) and three (3) in 2022. 2. An interview with the TC on 9/21/2023 at 8:38 am confirmed that the laboratory director failed to document the review and evaluation of PT results. 3. The laboratory reports performing 8461 chemistry tests annually. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review of Quality Control (QC) documentation and an interview with the technical consultant (TC) on 9/21/2023, the laboratory failed to perform two levels of external QC daily with testing on the Abbott i-STAT. The findings include: 1. A record review of laboratory QC documents identified that the laboratory failed to have two levels of QC each day of patient testing on i-STAT since 10/7/2022 for the following analytes: sodium, potassium, chloride, calcium, ionized calcium, glucose, urea, hematocrit, hemoglobin, creatinine, troponin, protime, pH, pCO2 and pO2. 2. An interview with the TC on 9/21/2023 at 11:22 am confirmed that the laboratory failed to perform external QC on the i-STAT. 3. The laboratory reports performing 8753 tests annually. -- 2 of 2 --