Summary:
Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on review of laboratory records (to include analyzer quality control (QC), maintenance, calibrations and patient reported results) and interviews with the laboratory director/technical consultant (LD/TC) and testing personnel (TP), the laboratory failed to obtain a certificate of registration before performing and reporting patient results for tests not categorized as waived. Findings Include: 1. Based on review of the Cell Dyn Ruby hematology analyzer QC, calibration and maintenance from installation on 8/15/23 through 2/13/2024, it was confirmed the first patient CBC (complete blood count) was reported on 8/30/2023. Approximately 1,600 CBC patient results have been reported since 8/30/2023. 2. Based on review of the Alinity CI Series chemistry analyzer QC, calibration and maintenance from installation on 6/27 /2023 through 2/13/2024, it was confirmed the first patient chemistry test results were reported on 7/24/2023. Approximately 12,000 chemistry patient results have been 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 -- reported since 7/24/2023. 3. Based on the Centers for Medicare & Medicaid (CMS) database the laboratory initially had a certificate of waiver and submitted a CMS 116 application form to the CLIA program which was entered into the CMS database on November 8,2023. It was determined the laboratory operated out of the scope of their certificate performing moderate chemistry testing, for 4 of 7 months. 4. Based on the CMS data base and hematology records and patients CBC results, the laboratory operated out of the scope of their certificate performing moderate hematology testing, for 2 of 7 months. 5. In an interview with the LD/TC on 2/13/2024 at 5:00 p.m., the LD/TC were not aware the laboratory was reporting patient test results before the laboratory certificate was upgraded to a certificate of compliance. 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 the Centers of Medicare and Medicaid Services (CMS) database system for proficiency and interview with the laboratory director/technical consultant (LD/TC), the laboratory failed to enroll and participate in an HHS approved proficiency testing (PT) program for Hematology -CBC (Complete Blood Count), Chemistry (General Chemistry, Endocrinology and Immunology). Findings Include: 1. Based on review of the CMS Casper report for proficiency testing, the laboratory did not generate a report for any proficiency testing program for the year 2023 or 2024. 2. Based on review of laboratory documents there was no documentation on the day of survey for enrollment or participation in an HHS approved proficiency program for Hematology, General Chemistry, Endocrinology or Immunology for 2023. 3. The LD/TC confirmed on 2/13/2024 at 3:30 p.m. that the laboratory was not enrolled in proficiency testing for Hematology, General Chemistry, Endocrinology and Immunology testing for 1 of 1 proficiency events in 2023. 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)