Summary:
Summary Statement of Deficiencies D0000 An Initial survey was performed on March 10, 2021 at Integrated Health, CLIA ID # 19D2182273. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of client service instructions and interview with personnel, the laboratory failed to ensure detailed written instructions for providers to maintain integrity of samples were established. Findings: 1. In interview on March 10, 2021 at 9:35 am, the Technical Supervisor stated that the laboratory has not started to receive patient samples for testing as of date of survey. 2. Review of the laboratory's client service form revealed the laboratory did have instructions provided for clients; however, the laboratory did not include (not an all inclusive list) the following instructions: a) specimen collection, handling and sampling b) specimen transportation with temperature requirements c) time frame for receiving of specimens d) record logs for sample receipt e) storage processes for specimens 2. In interview on March 10, 2021 at 12:44 pm, the Technical Supervisor stated the client service form did not include the above instructions. The Technical Supervisor confirmed the instructions provided to clients was not complete. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on policy and procedure manual review and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following policies: a) Complaint Investigations to include how to address, document, and handle complaints or problems reported to the laboratory b) Communications to include system to identify and document problems with breakdown in communication c) Twice a year instrument comparison of test results for alternate testing or blind samples 2. In interview on March 10, 2021 at 12:44 pm, Technical Supervisor confirmed the laboratory did not include the identified policies. 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)