Eastern Pathology

Summary Statement of Deficiencies D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) 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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based upon review of laboratory personnel records and the West Virginia licensure database, the laboratory director (LD) has not met the responsibilities required, including assuring compliance of high complexity testing personnel (TP) with the applicable regulations. Findings: 1. A review of laboratory TP records and the West Virginia licensure database, 1 of 3 TP performing high complexity testing had an expired West Virginia laboratory license, required by WV 64 CSR 57, Clinical Laboratory Technician and Scientist Licensure and Certification Rule. 2. The TP West Virginia laboratory license expired 3-1-2019. D6170 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(a) Each individual performing high complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. 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 a review of laboratory testing personnel files, the West Virginia licensure verification database, and an interview with the laboratory manager (LM), there was 1 of 3 testing personnel (TP) performing high complexity testing that did not possess a current West Virginia laboratory license as required by the state rule WV 64 CSR 57 Clinical Laboratory Technician and Scientist Licensure and Certification Rule. Findings: 1. A review of laboratory personnel files identified 1 of 3 testing personnel performing high complexity testing had an expired West Virginia Laboratory license. 2. A West Virginia licensure database inquiry confirmed the expired West Virginia Laboratory license for 1 of 3 testing personnel performing high complexity testing. 3. An interview with LM, on 1/14/2020 at approximately 9:44 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's validation/verification records for Immuno- Histochemical (IHC) stains and interview with the Laboratory Manager (LM), the laboratory failed to verify the accuracy of new lot numbers of 5 of 5 IHC stains prior to analyzing patient specimens. Record review was from February 2016 to January 2018. The findings include: 1. Review of the IHC validation/verification records identified a lack of documentation of the verification of accuracy for new lot numbers of 5 of 5 IHC stains (Ep-CAM/Epi, Melan A, p53, CD34, and Factor XIIIA). 2. On 1 /22/18 at approximately 2:30 PM, the LM confirmed the findings. 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 --