Biolife Plasma Services Lp

CLIA Laboratory Citation Details

2
Total Citations
6
Total Deficiencyies
3
Unique D-Tags
CMS Certification Number 26D2124373
Address 8484 Mexico Road, Saint Peters, MO, 63376
City Saint Peters
State MO
Zip Code63376
Phone(636) 272-2776

Citation History (2 surveys)

Survey - May 23, 2023

Survey Type: Standard

Survey Event ID: 4YZX11

Deficiency Tags: D6053 D6054 D6053 D6054

Summary:

Summary Statement of Deficiencies D6053 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the performance evaluations, policies, and interview with Technical Consultant (TC) #2, the TC failed to evaluate and document performance of individuals responsible for moderate complexity testing at least semiannually and within 6 months from initial certification during the first year for five of thirteen testing personnel. Findings: 1. Review of performance evaluations showed no semiannual performance evaluation was documented for TP #5 and TP #29. 2. Review of policy titled Moderate Complexity CLIA Testing Requirements states "competency of testing personnel mut be assessed initially, and within 6 months from initial certification." 3. Review of performance evaluations showed testing personnel were not assessed within 6 months of initial competency for TP #8, 17, 28, and 29 2. Interview with TC #2 on May 23, 2023 at 10:30 AM confirmed the technical consultant failed to evaluate and document performance evaluations at least semiannually and within 6 months of initial competency during the first year. 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. 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 2021/2022/2023 performance evaluations and interview with Technical Consultant (TC) #2, the TC failed to evaluate and document annual performance evaluations for six of eighteen testing personnel (TP). Findings: 1. Review of 2022 performance evaluations showed no annual performance evaluation for TP #7, #9, #14, #17, #19, and #32 for 2022. 2. Interview with TC #2 on May 23, 2023 at 10:30 AM confirmed the TC failed to evaluate and document annual performance evaluation for TP in 2022. -- 2 of 2 --

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Survey - May 26, 2021

Survey Type: Standard

Survey Event ID: KUEJ11

Deficiency Tags: D0000 D0000

Summary:

Summary Statement of Deficiencies D0000 The BioLife Plasma Services, LP's Laboratory was found to be in substantial compliance with 42 CFR Part 493, Requirements for Laboratories as a result of an onsite survey on May 26, 2021. 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 --

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