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 lack of documentation and interview with staff, the laboratory failed to enroll in an approved proficiency testing program for the complete blood count (CBC) testing performed on the PocH-100i instrument. The laboratory performed 3 CBC tests since receiving the instrument in June of 2020. Findings include: 1. The laboratory lacked documentation of enrollment in an approved proficiency testing program for CBC testing on the PocH 100i instrument. 2. In an interview conducted on 09/08/2020 at approximately 1:30 P.M., staff confirmed they had not enrolled in an approved proficiency testing program for CBC testing. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with staff, the laboratory failed to establish a written policy for specimen collection, and labeling for compete blood counts tests. The laboratory performed 3 patient complete blood count (CBC) tests since June of 2020 when the instrument was installed. Findings include: 1. Procedure manual review failed to include the instructions for patient specimen collection that included the method the laboratory used to identify the patient, patient preparation and specimen collection instructions. 2. The laboratory used the PocH 100i operator's manual as their procedure manual. The PocH 100i operator's manual failed to include instructions for how the laboratory was to label patient specimens to ensure positive identification. 3. In an interview conducted on 09 /08/2020 at approximately 1:45 P.M., staff confirmed they had not added laboratory specific information to the manufacturer's operator's manual for how the laboratory collected patient CBC specimens from clinic patients. 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)