Biolife Plasma Services - Boise

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on personnel record review and an interview with the plasma center manager, the technical consultant failed to evaluate the competency of preventive maintenance records as part of the biannual and annual competency assessment for all testing personnel since the last survey on April 29, 2016. Findings: 1. A record review of personnel competency assessments revealed the technical consultant failed to assess the competency of preventative maintenance records for 66 out of 66 testing personnel listed on the CMS-209 form. 2. An interview on February 7, 2018 at 2:00 PM, with the plasma center manager, confirmed that the assessment of preventative maintenance failed to be documented. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observation of performance of instrument maintenance and function checks. This STANDARD is not met as evidenced by: Based on personnel record review and an interview with the plasma center manager, the technical consultant failed to evaluate the competency of testing personnel by direct observation of performance of instrument maintenance and function checks as 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 -- part of the biannual and annual competency assessment for all testing personnel since the last survey on April 29, 2016. Findings: 1. A record review of personnel competency assessments revealed the technical consultant failed to evaluate by direct observation instrument maintenance and function checks for 66 out of 66 testing personnel listed on the CMS-209 form. 2. An interview on February 7, 2018 at 2:00 PM, with the plasma center manager, confirmed the direct observation of performance of instrument maintenance and function checks failed to be documented. -- 2 of 2 --