Titan Health Partners Llc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM), Patient Test Reports (PTR) and interview with the Testing Personnel (TP), the laboratory failed to follow the Micros 60 Flags and Codes procedure from 6/16/25 to 7/29/25. The findings include: 1. Surveyor review of five PTR revealed that accession number 58119 had $ flags on results from the analyzer. 2. The PM stated for results with the "$" flag to " Invert tube and rerun. If flag does not appear, report result. Otherwise send out to reference lab. 3. There was no documented evidence the laboratory reran the sample or sent it to a reference lab. 4. The TP confirmed on 7/29/25 at 10:55 am, laboratory did not follow the procedure for Micros 60 Flags and Codes. D5779

Summary Statement of Deficiencies D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PS for the Horiba ABX Micros 60 analyzer were adequate from 6/9/22 to the date of survey. The findings include: 1. The LD failed to approve and sign the PS before the analyzer was put into use. 2. TP # 3 as listed on CMS-209 form confirmed on 9/27/23 at 2:00pm the LD failed to approve and sign the PS. 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 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Technical Consultant (TC), the laboratory failed to follow the procedure for Critical Values (CV) in October 2018. The finding includes: 1. The CV procedure stated "CV must be documented in the patients' medical record along with the physician or nurse practitioner who was notified" but there was not documented evidence the PM was followed for patient 436245 who had a Critical White Blood cell count. 2. The TC confirmed on 12/4/18 at 11:10 am that the CV procedure was not followed. 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 --