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 the laboratory's certificate of compliance registration date, an email from the Laboratory Consultant (LC), and an interview with the Laboratory Director (LD), the laboratory failed to obtain a registration, accreditation or compliance certificate before performing and reporting patient results for tests not categorized as waived. This deficient practice had the potential to affect 558 patients. Findings Include: 1. An email sent 04/29/2021 at 1:58 PM to the inspector from the LC stated troponin/CK- MB/myoglobin serum testing began 04/05/2019. 2. Review of the laboratory's certificate of registration confirmed 06/17/2020 as the date of registration. 3. Review of patient logs from 08/01/2019 through 05/27/2020 revealed troponin/CK-MB /myoglobin serum test results were reported. 4. The LD confirmed the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- tested troponin/CK-MB/myoglobin prior to registering for a certificate of compliance on 06/17/2020. The interview occurred on 05/11/2021 at 10:15 AM. CK-MB: creatine kinase muscle brain 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 record review and an interview with the Laboratory Director (LD), the laboratory failed to enroll in a proficiency testing (PT) program for the sub-specialties of virology, chemistry and bacteriology. All patient virology, chemistry and bacteriology testing performed in this laboratory from 06/17/2020 through 03/01/2021 had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to enroll in a proficiency testing (PT) program for the regulated toxicology analytes. (Refer to D2001) D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on an interview with the Laboratory Director (LD), and review of proficiency testing records (PT), the laboratory failed to enroll in a proficiency testing program for the regulated virology, chemistry and bacteriology analytes. All patient virology, chemistry and bacteriology testing performed in this laboratory from 06/17/2020 through 03/01/2021 had the potential to be affected by this deficient practice. Findings Include: 1. Review of PT documents and enrollment found no records. 2. The Inspector requested the laboratory's 2020 PT documents and enrollment records for virology, chemistry and bacteriology from the LD. The LD confirmed the laboratory was not enrolled with a PT provider for virology, chemistry and bacteriology in 2020 and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 05/11/2021 at 10:49 AM. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 2 of 8 -- 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)