Northwoods Urology Of Texas, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 01/25/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). STANDARD LEVEL DEFICIENCIES were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records, policies/procedures and staff interview, the laboratory failed to document evaluation of "Not Graded" results for 4 of 4 PT events reviewed for 2022 and 2023. Findings included: 1. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as its PT provider. Review of API's instructions revealed: "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the following CONDITION LEVEL DEFICIENCIES: D5400- 42 C.F.R. 493.1250 Condition: Analytic systems D6076- 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the