Thplasma Fair Lawn

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 surveyor review of Performance Specification (PS) records and interview with the Laboratory Director of Quality (DQ), the laboratory failed to ensure that all PS records were adequate for total protein test run on the Reichert Technologies TS Meter from May 2023 to 4/22/25. The findings include: 1. There was no Normal Patient Range study performed. 2. The DQ confirmed on 4/22/25 at 11:30 am, the laboratory failed to ensure that all PS records were adequate. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 surveyor review of the Test Reports (TR) for Total Protein and interview with the Director of Quality (DQ) the laboratory failed to ensure the TR included all the required information from May 2023 to 4/22/25. The findings include: 1. TR did not include the name address of the laboratory where Routine chemistry was performed. 2. The DQ confirmed on 4/22/25 at 12:00 pm, the laboratory failed to ensure the TR included all the required information. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of the Finial Report (FR), Procedure Manual (PM), and interview with the Director of Quality (DQ), the laboratory failed to ensure that the Reference Interval (RI) was accurate for total protein run on the Reichert Technologies TS meter form May 2023 to 4/22/25. The finding includes: 1. There was no RI on the FR for Total Protein. 2. The DQ confirmed on 4/22/25 at 11:30 am that the laboratory failed to ensure the RI was accurate. -- 2 of 2 --

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Quality Assurance Manager (QAM) the laboratory failed to review and evaluate results when they received an unacceptable score for total protein tests performed with the American Association of Bioanalysts (AAB), for event Q3-2022. The findings include: 1. The laboratory received an "*", "out of grading range or incorrect response" for sample 11 Total Protein in AAB event Chemistry Q3-2022. 2. There was no documented evidence that the laboratory reviewed the failed test result. 3. The QAM confirmed on 5/2/23 at 10:45 am that the laboratory did not review and document an evaluation of unacceptable PT results. 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; 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 surveyor review of the Procedure Manual (PM), Competency Assesment (CA) and interview with the Quality Assurance Manager (QAM) the Laboratory Director (LD) failed to establish a CA procedure with the required elements for Total Protein testing from 3/18/21 to the date of the survey. The findings include: 1. There was no documented evidence that intermediate test results, worksheets, quality control records, proficiency testing results, and preventive maintenance records were reviewed for the CA. 2. There was no documented evidence that. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples were reviewed for the CA. 3. The QAM confirmed on 5/2/23 at 1:40 pm that a CA was not maintianed. 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 surveyor review of the Personnel Files, Competency Assessment records and interview with the Quality Assurance Manager (QAM), the Technical Consultant (TC) failed to perform CA from 3/18/21 to the date of survey. The findings include: 1. The CA was not performed by the TC but was done by a non qualified testing personnel 2. The QMA confirmed on 5/2/23 at 10:15 am that the CA was not performed by the TC. -- 2 of 2 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Office Manager (OM), the laboratory failed to maintain Work Records (WR) for Chemistry test performed with the American Association of Bioanalysts (AAB) on events A, B, and C in 2020 events. The OM confirmed on 3/18/21 at 11:15 am that the laboratory did not maintain WR records for PT. . 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 --