Excelsior Diagnostic Lab

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) reagents in use, Bio-Rad Liquid Assayed Multiqual controls Manufactuers Package Insert (MPI), and interview with the Technical Supervisor (TS), the laboratory failed to put proper expiration dates on the Bio-Rad Liquid Assayed Multiqual controls control reagents in use for the Beckman Coulter DxC AU-700 analyzer on 3/16/26. The findings include: 1. The MPI stated "Thawed opened: Once thawed, opened and stored tightly capped sat 2 to 8C, This product will be stable as follows: All analytes: 14 days, Except: Alkaline Phosphatase, AST/SGOT, Bilirubin (Neonatal) and Bilirubin Total: 9 days. Bilirubin (Direct), Cholesterol (HDL), Cholinesterase, Creatine Kinase (CK), Phosphorus and Triglycerides: 7 days. LAP Arylamides: 3 days" 2. Bio-Rad Liquid Assayed Multiqual QC Lot 4630 in use had an open date of 3/16/26 and expiration date of 4/13/26. 3. The laboratory did not put proper expiration dates on the Bio-Rad Liquid Assayed Multiqual controls after being thawed and opened. 4. The TS confirmed on 3/18/26 at 12:05 pm the laboratory failed to put proper expiration dates on the QC reagents in use. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, 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 -- precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to ensure the PS for the Sysmex CA-600 analyzer were adequate before patient testing from 1/8/24 to 3/18/26 . The findings include: 1. Linearity was not performed. 2. The TS confirmed on 3/18/26 at 12:30 pm, the LD not ensure the PS records were not adequate. -- 2 of 2 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on Surveyor observation of COVID test results and interview with the General Supervisor (GS) the laboratory failed to report COVID test results to the state of New Jersey (NJ) under the NJ requirements for a NJ State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.A.C. 8:44-2.11(a) Reporting by laboratory supervisors in the calendar years 2022 and 2023. The finding includes: 1. There was no documented evidence that the laboratory reported positive and negative COVID test results to the State of NJ. 2. The GS confirmed on 12/12/23 the laboratory was not following the state statute. . 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 --

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: Based on an office review of the CASPER reports 153 and 155 and proficiency testing provider reports, the laboratory failed to achieve a score of at least 80% or more in two out of three events for Chemistry tests with Wisconsin Laboratory of Hygiene Evaluation. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve at least 80% for the Calcium test. The finding includes: 1. The laboratory scored 0% in 2-18 and 40% in 1- 19 PT events with Wisconsin State Laboratory of Hygiene. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 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 Testing Personnel (TP), the laboratory failed to maintain the attestation statement for Hematology PT provided by the Wisconsin State Laboratory of Hygiene (WSLH) for the first event of 2019. The TP confirmed on 5/1/19 at 11:05 am that attestation statement was not maintained. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to retain PT records performed with the 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 -- Wisconsin State Laboratory of Hygiene for event 1 for 2019. The finding includes. 1) There were no graded results for " Module 1314, Chemistry endocrinology Therapeutic drugs". 2) The TP confirmed on 5/1/19 at 11:30 am that the laboratory failed to retain PT records. 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 Testing Personnel (TP), the laboratory failed to evaluate results when they received an unacceptable score in Hematology tests performed on the Sysmex XS 1000i analyzer with the Wisconsin State Laboratory of Hygiene (WSLH) in the 2019- HemReg1 event. The findings include: 1. The laboratory received "Fail" in 2019- HemReg1 on samples AF5-1 and AF5-2 for Mean Corpuscular Volume (MCV). 2. There was no documented evidence that the laboratory investigated the failures. 3. The TP confirmed on 5/1/19 at 10:42 am that the laboratory did not perform and document an evaluation of unacceptable PT results. 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 surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to follow their "Quality Control Responsibilities" (QCR) procedure from August 2018 to the date of the survey. The finding include: 1 The QCR procedure stated "It is the responsibility of the person performing a particular procedure to initiate