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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 surveyor review of policies and procedures and competence evaluation records, and interview with the Director of Operations, the laboratory has not developed policies and procedures or documented the assessment of the competence of one of one technical consultant. Findings include: 1. Review of policies and procedures showed no evidence of established procedures to assess the competence of the technical consultant in fulfilling their responsibilities. 2. Review of competence evaluation records from 2021 and 2022 showed no documented evaluation of the performance of the technical consultant. 3. Interview with the Director of Operations (staff A) on April 13, 2022 at 8:25 AM confirmed the laboratory had not developed procedures to evaluate the competence of the technical consultant and had not documented assessment of the competence of the technical consultant since the current consultant assumed the responsibilities of the role in January 2020. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate 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 2 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Director of Operations, the laboratory director did not verify that the manufacturer's performance specifications for nine of nine analytes tested on the Tosoh AIA 900 were comparable to those obtained by the laboratory after the laboratory moved the analyzer and prior to patient testing. Findings include: 1. Review of laboratory records showed the laboratory evaluated performance specifications for prostate-specific antigen, estradiol, testosterone, progesterone, dehydroepiandrosterone, free triiodothyronine, free thyroxine, follicle-stimulating hormone, and thyroid stimulating hormone tests on the Tosoh AIA900 analyzer. The laboratory director approved the evaluations on April 6, 2022. 2. Interview with the Director of Operations (staff A) on April 13, 2022 at 10:12 AM confirmed the laboratory moved and reinstalled the Tosoh AIA 900 analyzer in March 2022 and confirmed the laboratory performed patient testing on the analyzer starting on March 21, 2022. Further interview confirmed the director did not approve the performance evaluation studies prior to the use of the analyzer for patient testing. -- 2 of 2 --

Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on surveyor review of patient medical records and interview with the Director of Operations, two of two laboratory request forms did not include all required elements. Findings include: 1. Review of patient medical records revealed the following: a). Lab test order form for patient 1 did not include the date of specimen collection. b). Lab test order form for patient 2 did not include the test to be performed, the date of specimen collection, or the ordering provider. 2. Interview with the Director of Operations, staff A, at 12:30 PM on March 28, 2018, confirmed the required elements were not present on the test order forms. 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 --