Summary:
Summary Statement of Deficiencies D5980 PPM LABORATORY DIRECTOR CFR(s): 493.1355 The laboratory must have a director who meets the qualification requirements of 493. 1357 and provides overall management and direction in accordance with 493.1359. This CONDITION is not met as evidenced by: Based on desk reivew survey of the laboratory director affiliations per laboratory request on Janurary 24, 2019 at 08:00 am, the laboratory failed to ensure the laboratory director directed no more than five moderate or high complexity laboratories. Findings include: a. Upon request of the laboratory quality assement (QA) monitoring staff, the affiliations of the current laboratoy director were reviewed for number of clinics associated with this organization. b. Within the ASPEN CMS- 116, the current laboratory director as of 1/24/2019 is listed as the laboratory director for six PPM laboratory's. Laboratory's listed: 05D0937914 05D0705060 05D0937909 05D0937916 05D2077488 05D1038563 c. This deficient practice was afirmed on January 24, 2019 at approximately 08:00 am by interview with the QA. d. These laboratories are recorded perform approximately 745 PPMP tests annually 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 --