Falfurrias Family Clinic Pllc

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's Medonic M-series hematology analyzer maintenance records from January 2023 to June 2023, and staff interview, it was revealed the laboratory failed to have documentation of performing monthly maintenance for 2 of 6 months. The findings include: 1. A review of the laboratory's Medonic M-series hematology analyzer maintenance records from January 2023 to June 2023 revealed the laboratory failed to have documentation of performing monthly maintenance for 2 of 6 months. The months missing documentation were: January 2023 February 2023 2. The laboratory was asked to provide documentation of performing the required monthly maintenance. No documentation was provided. 3. An interview with the technical consultant on 07/12/2023 at 1050 hours in the employee lounge - after his review of the records- confirmed the findings. D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility 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 in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with 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