Csl Plasma

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records, regulations, and interview, the laboratory director failed to specify in writing the duties and responsibilities of 13 of 13 testing personnel engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing. Finding follow. A. Review of the form Position Description for "Tech Reception" under "Responsibilities List current duties and responsibilities" stated, "Performs finger stick to obtain sample to obtain donor's hematocrit and total protein levels" for testing personnel #1-13 (as listed on the CMS Form 209). No other duties and responsibilities of the testing personnel are mentioned. B. Review of the regulations for testing personnel responsibilities at 493.1425 (b) stated, "Each individual performing moderate complexity testing must- (b)(1) Follow the laboratory's procedures for specimen handling and processing, test analyses, reporting 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 maintaining records of patient test results; (b)(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples; (b)(3) Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed; (4) Follow the laboratory's established

Summary Statement of Deficiencies D0000 The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, educational credentials, documentation of training and interview, the laboratory failed to ensure training was performed by the facility for testing personnel prior to performing patient testing for total protein using the Reichert TS Meter - DSP refractometer for two of 11 testing personnel (two of two transfer employees). Findings follow. A. Review of the laboratory's policy and procedure titled Reception - CLIA Activities Learning Capsule, Version 5.0 doc net effective May 13, 2022, stated "Curriculum covers the finger-stick, total protein, hematocrit, and refractometer activities" and listed the following training activities: Course titled Introduction to CLIA Course titled Digital Refractometer Activities Course titled Fingerstick and Hematocrit Course titled Total Protein Performance of CLIA Reception Activities - Complete Digital Refractometer Activities Performance of CLIA Reception Activities - Document Digital Refractometer Activities B. Review of educational credentials and training records showed transfer employees had training records from a sister facility. 1. Testing personnel #6 as listed on the CMS form 209, hired 4/18/2021, had a high school diploma with documentation of training for total protein using the refractometer from a sister facility in San Antonio. The training documents from a sister facility included the following: Course titled Introduction to CLIA 8/17/2020 Course titled Digital Refractometer Activities 8/17/2020 Course titled Fingerstick and Hematocrit 8/17 /2020 Course titled Total Protein 8/17/2020 Performance of CLIA Reception 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 -- Activities - Complete Digital Refractometer Activities 6/12/2020 2. Testing personnel #8, hired 6/13/2021, had a high school diploma with documentation of training for total protein using the refractometer from a sister facility in San Antonio. The training documents from a sister facility included the following: Course titled Introduction to CLIA 8/17/2020 Course titled Digital Refractometer Activities 8/17/2020 Course titled Fingerstick and Hematocrit 8/17/2020 Course titled Total Protein 8/17/2020 Performance of CLIA Reception Activities - Complete Digital Refractometer Activities 4/22/2020 C. Interview with the Assistant Manager of Quality on May 26, 2022 at 1000 in the conference room acknowledged training documents looked different for these employees because they transferred from another facility and their training documents were performed at the other facility. The Technical Consultant Observation Worksheet (competency evaluations) were performed initially and at 6 months. Further interview with the Assistant Manager of Quality on May 26, 2022 at 1245 in the conference room confirmed training was performed at another site, and initial competency was assessed at this location, it's just the training that is not repeated. NOTE: Training was not performed at the facility where testing was conducted for transfer employees. -- 2 of 2 --