Formula Wellness Park Cities

Summary Statement of Deficiencies D0000 On 06/29/2021, an unannounced onsite visit to Formula Wellness, 4342 Lovers Lane, Dallas, TX, 75225, CLIA number 45D2191410 was conducted to investigate complaint TX00386501 and to perform an initial survey for compliance with CMS 42 CFR regulations. The entrance conference was held on 06/29/2021 at 10:25 am with the laboratory director, the Chief Executive Officer of Formula Diagnostics, the Minnesota state agency surveyor conducting the complaint investigation on this laboratory's temporary site located in Jackson, Minnesota, Testing Person-2 (as listed on the submitted Center for Medicare and Medicaid Services (CMS) 209 form) from the Minnesota temporary testing site, and two Texas state agency CLIA surveyors. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR and Complaint TX00386501 was substantiated. 493.1100 Facility Administration, 493.1250 Analytic Systems 493.1403 Laboratory Director, (moderate complexity) 493.1409 Technical Consultant The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 On 06/29/2021, an unannounced onsite visit to Formula Wellness, 4342 Lovers Lane, Dallas, TX, 75225, CLIA number 45D2191410 was conducted to investigate complaint TX00386501 and to perform an initial survey for compliance with CMS 42 CFR regulations. The entrance conference was held on 06/29/2021 at 10:25 am with the laboratory director, the Chief Executive Officer of Formula Diagnostics, the Minnesota state agency surveyor conducting the complaint investigation on this laboratory's temporary site located in Jackson, Minnesota, Testing Person-2 (as listed on the submitted Center for Medicare and Medicaid Services (CMS) 209 form) from the Minnesota temporary testing site, and two Texas state agency CLIA surveyors. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR and Complaint TX00386501 was substantiated. 493.1100 Facility Administration, 493.1250 Analytic Systems 493.1403 Laboratory Director, (moderate complexity) 493.1409 Technical Consultant The laboratory's failure to be in compliance with these regulations was found to pose IMMEDIATE JEOPARDY to the patients served by the laboratory Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the