Summary:
Summary Statement of Deficiencies D0000 The following deficiency was cited during a complaint survey completed on 03/11 /2021 for the federal requirements of 42 CFR Part 493 for Laboratories. Intake NM00047971 was substantiated. 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 review of an email from the Technical Consultant, the laboratory website, and on interviews with laboratory staff, the laboratory failed to communicate information regarding patient care centers (locations where patients have blood or other body fluids collected) for SARS-CoV-2 (the strain of a coronavirus that causes COVID-19, a upper respiratory virus), positive patients with the public and ordering providers. Findings are: A. Review of a complaint dated 10/24/2020 indicated the laboratory refused to perform a blood draw on a SARS-CoV-2 positive patient. B. Review of the laboratory's corporate website on 10/28/2020 had no information for its clients regarding the availability of collection services for patients with SARS-CoV-2 infections. 1. "[Name of Facility] Update - 31 July 2020" and "[Name of Facility] Update - 10 September 2020" had information about updated hours and links to patient care center hours but no specific information to guide the public on which centers accept SARS-CoV-2 positive patients. 2. The list of patient care centers do not indicate which centers accept SARS-CoV-2 positive patients. C. During interview on 11/18/2020, the Technical Consultant stated the laboratory did not have a written policy for SARS-CoV-2 positive patients. The verbal policy was to send these patients to two patient care centers located in a nearby city (45 minute drive from this location). D. During interview on 03/11/2021 at 4:00 pm, 3 of 3 Testing Personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- stated that the laboratory did not have a written policy at the time of the incident in October 2020 and still do not have one as of the day of the survey. E. Review of an email dated 10/22/2020 from the Technical Consultant to laboratory staff in response to the incident indicated, "[Patient Care Center] is the place to send them until they are declared negative by the State." -- 2 of 2 --