Summary:
Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of established policies and procedures for review, the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct problems identified with complaint investigations and communications, see D5205 and D5207 for findings. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of policies and procedures submitted for review and documentation received by the State Agency related to multiple complaints against Premier Lab Solutions (CLIA# 03D2122216), the laboratory failed to have a system in place to ensure that it documents and investigates all complaints and problems reported to the laboratory. Findings include: 1. The Arizona State Agency, CLIA Program received Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- multiple complaints against Premier Lab Solutions (CLIA# 03D2122216) during the timeframe of June 1, 2020 through June 10, 2020, related to the delay of reported test results for SARS-CoV-2 testing and a lack of communication regarding the delay of test results for SARS-CoV-2 testing. 2. The laboratory submitted evidence of a phone text received by laboratory staff on June 7, 2020 from a client inquiring about the status of SARS-CoV-2 test results from specimens that were collected during the timeframe of May 26, 2020 through June 5, 2020. The text from the client stated, "No new results since 5/27. Missing at least 50". 3. On June 1, 2020 the Arizona State Agency, CLIA Program received documentation from another client inquiring about the status of SARS-CoV-2 test results from specimens that were collected on May 27, 2020 and the laboratory's response was vague and did not include any indication of when the test results would be received and did not offer any other type of resolution. 4. No documentation was submitted by the laboratory that indicated the laboratory has a system in place to document all complaints and problems reported to the laboratory. 5. No documentation was submitted by the laboratory that indicated the laboratory conducted investigations of the complaints or problems in order to resolve the issues that were communicated to laboratory staff. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on lack of established policies and procedures submitted for review, the laboratory failed to have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings include: 1. The Arizona State Agency, CLIA Program received multiple complaints against Premier Lab Solutions (CLIA# 03D2122216) during the timeframe of June 1, 2020 through June 10, 2020 related to the delay of reported test results for SARS-CoV-2 testing and lack of communication regarding the delay of test results for SARS-CoV-2 testing. 2. On June 11, 2020 the Arizona State Agency, CLIA Program requested electronic documentation from the lab specific to established policies and procedures regarding communication between the laboratory and the laboratory's clients. 3. No documentation was submitted by the laboratory that indicated the laboratory has a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: -- 2 of 5 -- Based on lack of Quality Assessment documentation submitted for review, the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the laboratory with regard to complaint investigations and communication. Findings include: 1. No documentation was submitted for review to indicate that the laboratory established policies and procedures to monitor, assess and resolve complaints received by the laboratory for the delay in SARS-CoV-2 testing. See D5205 for findings. 2. No documentation was submitted for review to indicate that the laboratory established policies and procedures to monitor, assess and resolve communication issues related to the delay in SARS-CoV-2 testing. See D5207 for findings. 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)