Titan Health Partners Llc

Summary Statement of Deficiencies 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 surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Consultant (TC) the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology/Coagulation tests performed with the American Proficiency Institute (API), for 3st event 2022. The findings include: 1. The laboratory received grades 20% for Erythrocyte Count, 40% for Hematocrite, 60% for Hemoglobin. 2. The TC confirmed on 3/17/23 at 10:45 pm that the laboratory did not document an evaluation of unacceptable PT results. 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: a) Based on surveyor review of the Procedure Manual (PM), and interview with the Techincal Consultant (TC), the laboratory failed to to follow their procedure for "Monthly Ending Quality Control Review" for Complete Blood Counts (CBC) performed on the ABX Micros 60 analyzers from the calendar year 2022 to the date of survey. The findings include: 1) The PM stated "The end of the month QC report with Levey-Jennings graphs should be printed out, reviewed by testing personnel to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- identify and deviation from the mean of the controls". "At the en of the month, the IQAP (interlaboraotory Quality Assurance Program) data will be reviewed. 2) There was no documented evidence that the aforementioned procedure was performed. 3) The TC confirmed on 3/15/23 at 11:30 am that the laboratory did not follow the above mentioned procedure. b) Based on surveyor review of the Procedure Manual (PM), and interview with the TC, the laboratory failed to to follow their procedure for "Quality Control

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Records (PR) and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to delegate competency evaluation to a qualified person for the performance of Complete Blood Count analysis from 8/23/18 to the date of the survey. The TC confirmed at 1:20 pm that LD did not delegate the evaluation of competency to a qualified person. 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 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 surveyor review of the Proficiency Testing (PT) records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate results when the laboratory received an unacceptable PT score for Hematology tests performed with the Medical Laboratory Evaluation (MLE) in 2-2018. The finding includes: 1. There was no review or evaluation documented when the laboratory received an unacceptable result for specimen HD-8 Granulocytes Percent in event 2018 MLE - M2. 2. The TS confirmed on 8/23/18 at 10:00 am that the laboratory did not perform and document an evaluation of unacceptable PT performance. D5781