The Center For Cancer And Blood Disorders

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, and confirmed in interview, the laboratory failed to ensure one of one bottle of CD38-PC5.5 reagent did not exceed its expiration date. Findings included: 1. During a tour of the laboratory on 04/28/2025 at 12:34 p.m., the surveyor observed the following stored in the reagent refrigerator: 1 bottle of CD38-P5.5; Lot # 200072; expiration date: 05/06/2024 2. During an interview on 04/28/2025 at 12:49 p.m., the General Supervisor/Testing Person confirmed the laboratory failed to ensure one of one bottle of CD38-PC5.5 reagent did not exceed its expiration date. D5781

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 Entrance and exit conferences were held with the laboratory representative. 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 representative at the entrance and exit conferences. The laboratory representative was 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