Summary:
Summary Statement of Deficiencies D8103 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(b)(c)(d) (b) General Requirements. As part of the inspection process, CMS or a CMS agent may require the laboratory to do the following: (b)(1) Test samples, including proficiency testing samples, or perform procedures. (b)(2) Permit interviews of all personnel concerning the laboratory's compliance with the applicable requirements of this part. (b)(3) Permit laboratory personnel to be observed performing all phases of the total testing process preanalytic, analytic, and postanalytic). (b)(4) Permit CMS or a CMS agent access to all areas encompassed under the certificate including, but not limited to, the following: (b)(4)(i) Specimen procurement and processing areas. (b)(4) (ii) Storage facilities for specimens, reagents, supplies, records, and reports. (b)(4)(iii) Testing and reporting areas. (b)(5) Provide CMS or a CMS agent with copies or exact duplicates of all records and data it requires. (c) Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection. (d) Requirement to provide information and data. A laboratory must provide, upon request, all information and data needed by CMS or a CMS agent to make a determination of the laboratory's compliance with the applicable requirements of this part. This STANDARD is not met as evidenced by: Base on a complaint initiated by CMS Seattle Branch Location and onsite survey of the Rapid Reliable Testing , LLC on 03/15/2022 the laboratory was found to be non existent. Findings include. 1. Onsite survey on 03/15/2022 shows the site address listed on the CMS 116 located which is 11954 NE Glisan Street, PMB 431, Portland, OR. 97220 is a Postal Service Annex for mail and package delivery for Private Mail Boxes. 2. An interview with the Postal Office Manager confirm that this PMB 431 belongs to a different person since 02/04/2013 not associated the laboratory. 3. The SA surveyor confirmed that the laboratory is non existent on 03/15/2022 @ 10:12 AM. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --