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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to enroll in a proficiency testing (PT) program for the subspecialty of Toxicology. This deficient practice had the potential to affect 19,800 patients tested under the subspecialty of Toxicology from 07/01/2023 through 10/18/2023. Findings Include: 1. The laboratory failed to enroll in a PT program for the subspecialty of Toxicology. (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; 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 record review and an interview with Testing Personnel (TP) #1, the laboratory failed to enroll in a proficiency testing (PT) program for the subspecialty of Toxicology. This deficient practice had the potential to affect 19,800 patients tested under the subspecialty of Toxicology from 07/01/2023 through 10/18/2023. Findings Include: 1. Review of the "Advanced Pain & Spine Institute" policies and procedures, signed and dated by the Laboratory Director on 06/02/2023 failed to find policies and procedures for PT. 2. The inspector requested the 2023 PT records for Toxicology from TP #1. 3. TP #1 confirmed the laboratory was not enrolled with an HHS approved PT provider for the subspecialty of Toxicology and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 10/18/2023 at 11:15 AM. 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)