Csl Plasma Of Fort Worth

Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 form, personnel records, and confirmed in interview, the laboratory failed to have documentation that one of twenty testing persons (TP-4) met the qualifications required to perform moderate complexity testing prior to performing patient testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; or (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(i) Have earned a high school diploma or equivalent; and 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 -- This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 form, personnel records, and confirmed in interview, the laboratory failed to have documentation that one of twenty testing persons (TP-4) met the qualifications required to perform moderate complexity testing prior to performing patient testing. Findings included: 1. Review of the CMS-209 form included TP-1 through TP-20 listed to perform moderate complexity testing. 2. Review of personnel records for TP- 4 included a signed "Position Description" form by TP-4 dated on 09/03/2025. The form stated: "JOB SPECIFICATIONS Provide minimum hiring requirements, specialized knowledge, and other considerations required Education High school diploma or equivalent required" 3. Further review of the personnel records for TP-4 revealed the laboratory did NOT have documentation to ensure TP-4 was qualified to perform moderate complexity testing. The educational documents provided were from a foreign institution. The educational documents were NOT evaluated for a United States equivalency. On 10/08/2025 at 9:37 a.m. the laboratory was asked to provide a United States equivalency evaluation for the foreign educational documents. None were provided. 4. During an interview on 10/08/2025 at 11:12 a.m., the laboratory representatives stated that the facility did not have a United States equivalency evaluation for TP-4. This confirmed the laboratory failed to have documentation that one of twenty testing persons (TP-4) met the qualifications required to perform moderate complexity testing prior to performing patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Center Manager and Assisstant Manager for Quality were at the entrance conference conducted 10/14/2020. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the Center Manager and Assisstant Manager for Quality on 10/14/2020. 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 State Health and Human Services Commission, Health Facility Compliance Arlington Group. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of laboratory policy, personnel records, and confirmed in interview, the technical consultant failed to perform annual personnel competency assessment for 1 of 42 testing persons (TP-15) in 2019 (random review). Findings: 1. Review of the laboratory's personnel policy revealed: "Specific training for Training Personnel: Only trained personnel with approval of the Technical Consultant may independently perform regulated testing. Competency is evaluated during initial training, at six months, at twelve months and annually thereafter or whenever testing methodology changes. The competency assessment and approval by the Technical Consultant is documented on the Technical Consultant Observation Worksheet ..." 2. Review of personnel records revealed annual competency assessment was not performed for TP- 15 in 2019. TP-15 had documented competency assessments in 2018 and 2020. 3. The laboratory was asked to provide documentation of competency assessments for 2019 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 -- and none were provided. 4. During an interview on 10/14/2020 at 09:28 hours, the Assistant Manager for Quality stated that the facility had changed their policy from performing competency assessments from every 6 months to annually and TP-15's annual competency assessment was missed in the change, confirming the above findings. -- 2 of 2 --