Biolife Plasma Services Lp

Summary Statement of Deficiencies D0000 A Recertification survey was performed at BioLife Plasma Services, LP, CLIA ID 19D2184406, on July 23, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, calibration verification records, and interview with personnel, the laboratory failed to perform their calibration verification Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- procedures semi-annually in 2023. Findings: 1. Review of the laboratory's "Control Verification of Refractometer" procedure revealed "Testing Name: Calibration verification; Controls used: low, normal, high; Frequency: semi-annually based on date of Precision & Specification; Documentation: Quality Control Record- Refractometer Calibration Verification." 2. Review of the laboratory's "Refractometer Calibration Verification, Precision and Specification Testing" procedure revealed "Complete calibration verification for all in-service and back up refractometers semi- annually on the first business day of the semi-annual period + ten (10) calendar days." 3. Review of the laboratory's 2023 calibration records revealed the laboratory did not perform calibration verification semi-annually: a) Refractometer 14024-0320: performed January 18, 2023 and April 2023; due October 2023 b) Refractometer 14007-0320: performed April 7, 2023; due October 2023 c) Refractometer 14025- 0320; performed April 7, 2023; due October 2023 d) Refractometer 13972-0320; performed April 7, 2023; due October 2023 e) Refractometer 13976-0320; performed April 7, 2023; due October 2023 f) Refractometer 14017-0320: performed April 11, 2023; due October 2023 4. In interview on July 23, 2024 at 12:03 pm, the Quality Manager stated the calibration verification procedures should be done six months from date last performed. 5. In further interview on July 23, 2023 at 12:03 pm, the Senior Operations Manager Trainee confirmed the laboratory did not perform calibration verification procedures semi-annually in 2023. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of quality control (QC) records, patient test logs, and interview with personnel, the laboratory failed to perform two (2) levels of controls for total protein testing for forty six (46) of forty nine (49) days reviewed. Findings: 1. Observation by surveyor during the laboratory tour on July 23, 2024 at 9: 35 am revealed the laboratory utilizes Reichart TS refractometers for total protein testing. 2. Review of the laboratory's QC records revealed the laboratory did not perform two (2) levels of QC for the following dateson Refractometer 14024-0320: May 29, 2024 May 30, 2024 May 31, 2024 June 1, 2024 June 2, 2024 June 4, 2024 June 5, 2024 June 6, 2024 June 7, 2024 June 9, 2024 June 11, 2024 June 12, 2024 June 13, 2024 June 14, 2024 June 15, 2024 June 16, 2024 June 18, 2024 June 19, 2024 June 20, 2024 June 21, 2024 June 22, 2024 June 25, 2024 June 26, 2024 June 27, 2024 June 28, 2024 June 29, 2024 June 30, 2024 July 2, 2024 July 3, 2024 July 4, 2024 July 5, 2024 July 6, 2024 July 7, 2024 July 9, 2024 July 10, 2024 July 11, 2024 July 12, 2024 July 13, 2024 July 14, 2024 July 16, 2024 July 17, 2024 July 18, 2024 July 19, 2024 July 20, 2024 July 21, 2024 July 23, 2024 3. Review of patient test logs ("Refractometer Details Report") for Refractometer 14024-0230 from May 29, 2024 through July 23, 2024 revealed the following five (5) randomly selected patients were tested without documentation of QC: May 29, 2024: Patient A11657733 Patient A10874733 Patient A10697733 Patient A05620671 Patient A05358733 4. Further review of patient test logs for Refractometer 14024-0230 from May 29, 2024 through July 23, 2024 revealed a total of 1,626 patients were tested without QC performance. -- 2 of 6 -- 5. In interview on July 23, 2024 at 3:39 pm, the Quality Manager stated the laboratory did not have documentation of QC performed for the identified dates. 6. In further interview on July 23, 2024 at 3:42 pm, the Senior Operations Manager Trainee stated he thought the laboratory had an out of service refractometer still linked to the computer. The Senior Operations Manager Trainee confirmed the laboratory's documents showed the refractometer as still in use without QC performed. D5783

Summary Statement of Deficiencies D0000 A Certification survey was performed on November 23, 2022 at BioLife Plasma Services L.P., CLIA ID # 19D2184406. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's policies revealed the laboratory did not have written policies and procedures that included the following: a) Performance specification: detailed procedures for performing accuracy and precision (day-to-day, run-to-run, and within-run, as well as, operator variance), reportable and reference range studies, and actions to take when data from the studies fail to meet acceptability criteria 2. In interview on November 23, 2022 at 12:17 pm, the Quality Manager confirmed the laboratory did not include the identified polices and procedures. 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 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 -- 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 D0000 An Initial Survey was performed at BioLife Plasma Services, L.P., CLIA ID # 19D2184406 on March 9, 2021. BioLife Plasma Services, L.P. was found not in compliance with the following CONDITION LEVEL DEFICIENCES: 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1407 CONDITION: Laboratories Performing Moderate Complexity Testing; Technical Consultant D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: I. Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for Technical Consultant were complete. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include competency assessment criteria and frequency of performance for personnel serving as Technical Consultant. 2. Review of the laboratory's CMS 209 form (Laboratory Personnel Report) revealed the following personnel serves as Technical Consultants: a) Personnel 2 b) Personnel 3 3. Review of personnel records revealed the Laboratory Director did not perform a competency assessment for the duties as Technical Consultant for the following personnel: a) Personnel 2 b) Personnel 3 4. In interview on March 9, 2021 at 3:20 pm, the Quality Manager confirmed the laboratory did not have a competency assessment policy for the duties of Technical Consultant and that the Laboratory Director did not perform a competency assessment for the above personnel serving as Technical Consultants. II. Based on record review and interview with personnel, the laboratory failed to ensure initial competency assessments were performed and documented by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- the Laboratory Director for nine (9) of eleven (11) personnel reviewed. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory performs inital competency assessments for all new testing personnel. 2. Review of personnel records revealed the Laboratory Director did not perform and document the initial competency assessment for the following nine (9) of eleven (11) personnel: a) Personnel 5 b) Personnel 6 c) Personnel 7 d) Personnel 8 e) Personnel 9 f) Personnel 10 g) Personnel 14 h) Personnel 15 i) Personnel 21 3. In interview on March 9, 2021 at 3:20 pm, the Quality Manager confirmed the initial competency assessments for the above personnel were not performed by the Laboratory Director. III. Based on record review and interview with personnel , the laboratory failed to ensure the 6 month competency assessments were performed and documented by a qualified Technical Consultant for eight (8) of eight (8) personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory performs a 6 month competency assessment for testing personnel. 2. Review of laboratory's CMS 209 (Laboratory Personnel Report) form revealed the laboratory employs two (2) Technical Consultants; however, both Technical Consultants did not have a Louisiana state License. 3. Review of personnel records revealed the 6 month competency assessments were performed by the Technical Consultants for the following eight (8) of eight (8) testing personnel: a) Personnel 4 b) Personnel 5 c) Personnel 6 d) Personnel 9 e) Personnel 10 f) Personnel 11 g) Personnel 15 h) Personnel 21 4. In interview on March 9, 2021 at 3:20 pm, the Quality Manager confirmed the 6 month assessments were performed by the Technical Consultants who did not meet moderate testing qualifications. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on observation, record review, and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. Findings: 1. The Laboratory Director failed to ensure the laboratory employed a Technical Consultant that met the qualifications for a moderate complexity testing laboratory. Refer to D6028. 2. The Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established and maintained. Refer to D6030. D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the laboratory employed a Technical Consultant that met the qualifications for a moderate complexity testing laboratory. Refer to D6035. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures for assessing personnel competency were established and maintained. Findings: 1. The laboratory failed to ensure written policies and procedures to address competency for Technical Consultant were complete. Refer to D5209 I. 2. The laboratory failed to ensure initial competency assessments were performed and documented by the Laboratory Director for nine (9) of eleven (11) personnel reviewed. Refer to D5209 II. 3. The laboratory failed to ensure the 6 month competency assessments were performed and documented by a qualified Technical Consultant for eight (8) of eight (8) personnel. Refer to D5209 III. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY 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 record review and interview with personnel, the Technical Consultant failed to provide technical oversight of the laboratory for moderate complexity testing. 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 -- 3 of 4 -- both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; 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 in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived 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) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on review of personnel records and interview with personnel, the Technical Consultant failed to meet the qualifications for personnel serving as Technical Consultant of a moderate complexity testing laboratory. Findings: 1. Review of the laboratory's CMS 209 (Laboratory Personnel Report) form revealed the following personnel serving as Technical Consultants: a) Personnel 2 b) Personnel 3 2. Review of personnel records revealed the following Technical Consultants did not possess a current Louisiana state license: a) Personnel 2 b) Personnel 3 3. In interview on March 9, 2021, at 1:55 pm, the Quality Manager confirmed she was unaware that the Technical Consultants needed a state license to serve in this position. -- 4 of 4 --