Auerbach Hematology Oncology Assoc Pc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not have signed attestation statements for staff performing proficiency testing for event 1 of 2024. Findings: 1. The staff performing proficiency testing for event 1 of 2024 did not sign attestation statements showing that the staff performed the testing in the same manner as patient testing. 2. This was confirmed with testing person #4 at 12:00 pm on 9/20/2024. 3. This deficient practice was corrected during the survey on 9/27/2024. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not ensure that the laboratory director reviewed and provided

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with testing personnel (TP), the laboratory did not ensure that an eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory, it was observed that there was no eye wash station available in the laboratory where laboratory testing is performed. 2. During an interview on 12/02/2022 at 1:45 PM, TP #4 confirmed that the eye wash station was not located in the room where laboratory testing is performed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on hematology instrument maintenance record review and interview with testing personnel (TP), the laboratory did not ensure that maintenance was performed on the hematology analyzer as recommended by the manufacturer. Findings: 1. The laboratory uses a Medonic M-Series hematology analyzer to perform CBC (complete blood cell count) analysis. The instrument manual recommends that the laboratory 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 -- perform a cleaning procedure every 6 months which takes 1 hour and 15 minutes. 2. A review of monthly hematology analyzer maintenance records from January 2021 to November 2022 showed that 6 month instrument cleaning was documented 1 time out of 21 months on 07/30/2021. 3. During an interview on 12/02/2022 at 1:45 PM, TP #4 confirmed that 6-month hematology analyzer maintenance was not documented. D5783

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency test records, the laboratory (lab) director did not sign attestation records for one of six proficiency test events reviewed. Findings: 1. For each proficiency test event the laboratory director is required to sign an attestation declaring that the unknown test samples will be tested in the same manner as patient samples; and 2. It was observed, during record review that the lab was missing the attestation statement (signed by the lab director) for the first hematology event in 2017. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on review of hematology proficiency test records, the lab records did not include the identification of the testing person performing the blood cell morphology challenge. Findings: 1. The testing person was not identified in the blood cell morphology/identification testing records for the first event of 2018; 2. The testing person was not identified in the blood cell morphology/identification testing records for the third and second event of 2017; and 3. The testing person was not identified in the blood cell morphology/identification testing records for the third and second event of 2016. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory (lab) did not follow written procedures to label patient slides to ensure positive identification of the patient slides. Findings: 1. The laboratory performs a Wright's stain on the patient blood that is prepared on the glass slide. The patient slide is then observed under the microscope and the observations are resulted onto a patient log and transcribed into the patient chart; 2. The lab procedure posted on the automatic slide stainer instructs the lab to label slides with the patient name and date; 3. All ten of the most current slides sitting on the counter alongside the microscope were observed to be labeled with the patient name only; and 4. At 10:00 am on the day of survey this observation was confirmed during interview with lab staff. 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 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)