Summary:
Summary Statement of Deficiencies D0000 Surveyor 35659 Surveyor attempted to perform an initial survey on 01/04/2018 and was unable to conduct survey due to laboratory not being at location specified in the CMS 116 form. The laboratory was found not in compliance with condition CFR 493.1771. D8100 INSPECTION REQUIREMENTS CFR(s): 493.1771 Each laboratory issued a CLIA certificate must meet the requirements in 493.1773 and the specific requirements for its certificate type, as specified in 493.1775 through 493.1780. All CLIA-exempt laboratories must comply with the inspection requirements in 493.1773 and 493.1780, when applicable. This CONDITION is not met as evidenced by: Surveyor 35659 The surveyor was prevented from performing a certification survey due to no laboratory facility was found at the address listed on the CMS 116 form as cited at: * D8301- The surveyor was unable to conduct an initial certification survey due to no laboratory facility was found at the address listed for the laboratory. D8301 INITIAL INSPECTION OF CERT OF COMPLIANCE LABS CFR(s): 493.1777(a) (a) Initial inspection. (a)(1) A laboratory issued a registration certificate must permit an initial inspection to assess the laboratory's compliance with the requirements of this part before CMS issues a certificate of compliance. (a)(2) The inspection may occur at any time during the laboratory's hours of operation. This STANDARD is not met as evidenced by: Surveyor 35659 The surveyor was unable to conduct an initial certification survey due 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 -- to no laboratory facility was found at the address listed for the laboratory. Findings follow: A. The surveyor arrived at 1116 AR-161, Jacksonville, AR, the site of the laboratory as listed on the CMS 116 form, at approximately 1330 on 01/04/2018. At that address was a single-story brick commercial building with a contiguous metal "garage style" structure on the right side. The brick building was locked and vacant. The view from the windows revealed that the interior was vacant with only a couch and vending machine in view. The view of the interior was unobstructed and allowed observation to the back of the building. The "garage" style metal addition was a tire service with the name "Chilango's Tire Shop". In an interview on 1/4/18 at approximately 1345 the owner of the tire shop stated that the brick building was recently rented to a party that intended to open a used car dealership. Three photos (contained in attachments) of the building were taken and the surveyor exited the premises on 1/4/18 at approximately 1400. B. On 1/5/18 at approximately 0900 surveyor 35659 called the telephone number listed for the laboratory on the CMS 116 form and reached the answering service for the person identified as number one on a separate personnel identification sheet and requested a call back. C. On 1/5/18 at approximately 0930, The surveyor received a call back from the person identified as person number one on the separate personnel identification sheet who said that he knew nothing about Mediscope Arkansas LLC laboratory, that a man whose name he could not remember contracted with him to provide assistance in setting up a laboratory in Arkansas. The surveyor informed him that no laboratory existed at the address on the CMS 116 form, that the CLIA certification would be suspended for the laboratory, and requested that he send contact information for the person who contracted him to establish the laboratory. D. On 1/5/18 at approximately 1000 the person identified as number one on the separate personnel identification list called back and said that his employee, identified as person number two on the separate personnel identification list, said that she had submitted a change of address CMS 116 form changing the address of the laboratory to JFK Blvd in North Little Rock, AR in July 2017 and that she was emailing the 116 form for change of address and the name and contact number of the laboratory owner. E The surveyor opened email on 1/5/18 at approximately 1015 and found an email from the person identified as number two on the separate personnel identification list dated 1/5/18 at 0955. The email identified the owner as the person identified as number three on the separate personnel identification list with the telephone number of 214-687-2392. She attached a copy of a second CMS 116 form which was submitted for a change of address and change of lab director dated 7/22/17. The name on the CMS 116 form and the tax ID on the second 116 form were the same as those submitted on the initial CMS 116 form. The lab director, identified as number 4 on the separate personnel identification list, was the same as that on the initial CMS 116 form. The address was changed to 6929 JFK Blvd, North Little Rock, AR 72116 and the CLIA # was listed as 04D2146378. Review of the SA CLIA work logs revealed that the second CMS 116 dated 7/22/17 was never received by the SA. Review of the CMS 116 system revealed that CLIA # 04D2146378 is not assigned to any laboratory and a review of the Tax ID in the CMS 116 system reveals that only Mediscope Arkansas LLC, CLIA # 04D2133880 is regestered under that Tax ID. F. On 1/5/18 at approximately 1500 the surveyor traveled to 6929 JFK Blvd to locate Mediscope of Arkansas LLC laboratory. 6929 JFK Blvd is the site of a shopping center with approximately 29 suites of which three are currently vacant. The surveyor visited all the suites at the location and found that Mediscope of Arkansas LLC laboratory does not occupy any of the suites at 6929 JFK Blvd. -- 2 of 2 --