Physician's Plasma Alliance

Summary Statement of Deficiencies 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: Based on review of the laboratory's procedure manual, employee personnel records, and interview with the center manager, the laboratory failed to have a procedure to include all six criteria for assessing personnel competency in 2023. The findings include: 1. Review of the laboratory procedure manual revealed the laboratory's "Training Process" procedure and competency documentation did not include the following six required criteria: a. Direct observation of routine patient test performance b. Monitoring the recording and reporting of test results c. Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records. d. Direct observation of performance of instrument maintenance and function checks e. Assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f. Assessment of problem solving skills. 2. Review of employee personnel records revealed eight of eight testing personnel competency assessments reviewed did not include the six required criteria in 2023. 3. Interview on 03.06.2024 at 12:30 p.m. with the center manager confirmed the testing personnel competency procedure did not include the six criteria for testing personnel competency assessment required by the Centers for Medicare and Medicaid Services (CMS) in 2023. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) 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 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the donor screening areas, review of the manufacturer's user's guide, lack of documentation, and interview with the center manager, the laboratory failed to monitor relative humidity in the areas where total protein donor testing was performed in 2023 and 2024. The findings include: 1. Observation of two donor testing areas on 03.06.2024 at 9:30 a.m. revealed two Reichert TS Meter D Refractometers (serial numbers 033880409 and 044680611) were in use for total protein donor testing. 2. A review of the manufacturer's user's guide revealed the following for environmental conditions; maximum relative humidity: 80% for temperatures up to 31 degrees Celsius decreasing linearly to 50% (relative humidity at 40 degrees Celsius). 3. The laboratory could not provide records of relative humidity monitoring for January 2023 through the date of the survey, March 6, 2024. 4. An interview on 03.06.2024 at 12:30 p.m. with the center manager confirmed the above survey finidngs. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of testing personnel competency assessment records and an interview with the center manager, the technical consultant failed to perform competency assessments for seven of eight testing personnel in 2023. The findings include: 1. A review of testing personnel competency assessment records revealed the technical consultant did not perform the 2023 competency assessments for nine of nine competencies performed on seven of eight testing personnel. 2. An interview with the center manager on 03.06.2024 at 12:30 p.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 08.16.2023 the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 0155D (CMS 155), the laboratory's 2022 and 2023 American Association of Bioanalysts (AAB) proficiency testing records, and 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 -- staff interview, the laboratory failed to successfully participate in the specialty of Hematology for the Cell ID or automated white blood cell differential (WBC Diff) for three out of three testing events, resulting in non-initial unsuccessful PT participation (Refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 0155D (CMS 155), the laboratory's 2022 and 2023 American Association of Bioanalysts (AAB) evaluation records, and staff interview, the laboratory failed to maintain satisfactory performance in three out of three PT events for the Cell ID or automated white blood cell differential (WBC Diff) analytes, resulting in non-initial unsuccessful PT participation. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory PT scores for Cell ID or WBC Diff analytes: 2022 Event three: Cell ID or WBC Diff: 72% 2023 Event one: Cell ID or WBC Diff: 0% 2023 Event two: Cell ID or WBC Diff: 64% 2. Request and review of the laboratory's AAB PT performance evaluation records revealed the following unsatisfactory scores for Cell ID or WBC Diff analytes: 2022 Event three: Cell ID or WBC Diff: 72% 2023 Event one: Cell ID or WBC Diff: no results available 2023 Event two: Cell ID or WBC Diff: 64% 3. Phone interview with the Quality Assurance (QA) Manager on 08.21.2023 at 3:20 pm confirmed the survey findings. 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 a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 0155D (CMS 155), the laboratory's 2022 and 2023 American Association of Bioanalysts (AAB) evaluation records, and phone interview with the Quality Assurance (QA) Manager, the laboratory director failed to provide overall management and direction to the laboratory for successful participation in proficiency testing (PT). (Refer to D6016) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(4)(i) Ensure that the proficiency testing samples are tested as -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER report 0155D (CMS 155), the laboratory's 2022 and 2023 American Association of Bioanalysts (AAB) evaluation records, and phone interview with the Quality Assurance (QA) Manager, the laboratory director failed to ensure successful participation in a Department of Health and Human Services (HHS) approved proficiency program. (Refer to D2130) -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Hematology: The laboratory failed to maintain satisfactory participation in two consecutive events for the Cell I.D. or automated white blood cell differential (WBC Diff) analyte and the white blood cell (WBC) analyte, resulting in the initial unsuccessful proficiency testing (PT) occurrence for Cell I.D. or WBC Diff and WBC (Refer to D2130 and D2131). D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2022-2023 Proficiency Testing (PT) performance summary records from the American Association of Bioanalysts (AAB) Proficiency Testing program and staff interview, the laboratory failed to maintain satisfactory performance for the Cell I.D. or automated white blood cell differential (WBC Diff) analyte in the 3rd event of 2022 and 1st event of 2023 and the white blood cell (WBC) analyte in the 1st and 2nd events of 2023, resulting in the initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 0155D report revealed unsatisfactory Cell I.D. or WBC Diff analyte scores of 72% for the 3rd event of 2022 and 0% for the 1st event of 2023 and WBC analyte scores of 0% for the 1st and 2nd events of 2023. 2. A request and review of the laboratory's AAB PT records revealed unsatisfactory Cell I.D.or WBC Diff analyte score of 72% for the 3rd event of 2022, WBC analyte score of 0% for the 2nd event of 2023, and no scores available for the 1st event of 2023, resulting in the initial unsuccessful PT occurrence. 3. Phone interview with Quality Assurance (QA) Manager on 08.21.2023 at 3:20 pm confirmed the above findings. D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the CMS CASPER Report 0155D and the laboratory's 2022-2023 Proficiency Testing (PT) performance summary records from the American Association of Bioanalysts (AAB) Proficiency Testing program and staff interview, the laboratory failed to achieve satisfactory performance for the overall specialty of Hematology in two consecutive PT events in 2023 (event 1 and 2). The findings include: 1. Review of CASPER CMS 155 report, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in two consecutive events: 2023 Event 1: 0% 2023 Event 2: 64% 2. Request and review of the AAB performance evaluation records revealed the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for specialty of Hematology in two consecutive events: 2023 Event 1: no results available 2023 Event 2: 64% 3. Phone interview with Quality Assurance (QA) Manager on 08.21.2023 at 3:20 pm confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: ==================================== Based on review of Total Protein quality control (QC) for February, March and April of 2019, donor testing review and interview with the Owner, the laboratory failed to meet QC criteria prior to testing donors. The findings include: 1. Review of Total Protein quality controls on 2/5/19, 2 /6/19, 2/8/19, 2/11/19, 2/12/19, 3/22/19 and 4/11/19 revealed high level quality control failed to meet acceptable QC criteria. 2. Review of donor Total Proteins tested revealed 2 on 2/6/19, 1 on 2/12/19, 3 on 3/22/19 and 2 on 4/11/19. 3. Interview with the Owner at approximately 2:30 p.m. June 12, 2019 confirmed the high level of Total Protein quality control failed to meet acceptable criteria prior to testing 8 donors. ===================================== 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 --