Biolife Plasma Services, Lp

Summary Statement of Deficiencies D0000 The facility was found to be out of compliance with CLIA regulations 42 CFR Part 493. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.1409 Technical Consultant D6033 TECHNICAL CONSULTANT-MODERATE COMPLEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 form, laboratory policies, personnel records, and in interview with staff, the laboratory failed to have one of three technical consultants who met the qualification requirements of 493.1411 of this subpart. The laboratory failed to ensure one of three individuals employed met the minimum educational requirements to qualify as a technical consultant in the specialty of chemistry. Refer to D6035. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- in which the laboratory is located; AND (b)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i)(A) Hold an earned doctoral or master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(3)(i)(B) Meet either requirements in 493.1405(b)(3)(i)(B) or (b)(4)(i)(B) or (C); AND (b)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or (b)(4)(i)(B) Meet 493.1405(b)(5)(i)(B); and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(5)(i) Have earned an associate degree in medical laboratory technology, medical laboratory science, or clinical laboratory science; and (b)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in nonwaived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. (b)(6) For blood gas analysis, the individual must- (b)(6)(i) Be qualified under paragraph (b)(1), (2), (3) or (4) of this section; or (b)(6)(ii)(A) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (b)(6)(ii)(B) Have at least 2 years of laboratory training or experience, or both, in blood gas analysis; or (b) (7) Notwithstanding any other provision of this section, an individual is considered qualified as a technical consultant under this section if they were qualified and serving as a technical consultant for moderate complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 form, laboratory policies, personnel records, and in interview with staff, the laboratory failed to employ one or more individuals who were qualified to provide technical consultation for each of the specialties of service in which the laboratory performs moderate complexity tests. The laboratory failed to ensure one of three individuals employed met the minimum educational requirements to qualify as a technical consultant in the specialty of chemistry. Findings included: 1. Review of the CMS- 209 listed the three technical consultants. 2. Review of laboratory policy titled "Moderate Complexity CLIA Testing Requirements" stated: "RESPONSIBILITIES AND PROCEDURE ... 4.0 Obtain proof of education for all employees (Management or designee). 4.1 File CLIA acceptable proof of education for all employees, including those not certified to perform moderate complexity training, in the center CLIA binder. 4.1.1 All staff members must have CLIA acceptable proof of education documents on file in the center. Proof of education is CLIA acceptable if and only if it meets one of the following criteria in Figure 1 below ... Figure 1 ... Option 2 One of the following college degrees: Associate's Bachelor's Master's Doctoral in one of the following fields: Chemistry Biology Biochemistry Molecular Biology Microbiology Medical Technology Medical Laboratory Technology Clinical Laboratory Science Nursing OR Collage Transcripts showing graduation date with one of the following degrees: Associate's Bachelor's Master's Doctoral in one of the following fields: -- 2 of 3 -- Chemistry Biology Biochemistry Molecular Biology Microbiology Medical Technology Medical Laboratory Technology Clinical Laboratory Science Nursing ... 5.2 Individual designated to be Technical Consultant must meet the necessary criteria noted in CFR 493.1411." 3. Review of personnel documents for Technical Consultant- 1 (TC-1) revealed he did not meet the educational requirements to qualify as a technical consultant for moderate complexity testing (chemistry specialty). TC-1 did not meet requirements, as stated in CFR 493.1411 (D6035). 4. During an interview on 07/01/2025 at 10:57 a.m., the laboratory representatives confirmed the above findings. The laboratory failed to employ one of three individuals who were qualified to provide technical consultation for each of the specialties of service in which the laboratory performs moderate complexity tests. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of verification studies for the Reichert refractometer chemistry analyzer, laboratory policies, laboratory records, and confirmed in interview, the laboratory failed to ensure the normal range for 1 of 1 chemistry analytes (Total Protein) was verified by the laboratory's studies in 2023 (February) for 8 of 8 refractometers. Findings included: 1. According to verification studies, the laboratory added eight Reichert refractometer chemistry analyzers to their test menu on 03/2023. Refractometer Serial Numbers: 16962-0922, 17005-0922, 16993-0922, 16996-0922, 16994-0922, 16590-0722, 16592-0722, 16591-0722 Further review of the verification studies for the refractometers revealed the laboratory did NOT perform a normal range (reference range) study as required. 2. Review of the laboratory's policy titled "Donor Screening Job Aid" revealed normal range for total protein as follows: "Verifiable Reportable Range: 4.8-10.0 grams/dL" The laboratory was asked to provide the studies used to obtain these acceptable ranges. None were provided. 3. Review of laboratory records revealed an annual test volume of 35,232 tests for the total protein analyte. 4. During an interview on 04/13/2023 at 12:30 pm, the Quality 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 -- Manager and Center Manager confirmed the laboratory failed to perform a normal range verification study. -- 2 of 2 --