Dermatology Specialists Pa

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure a base solution used for Histopathology testing was not used after the expiration date had been exceeded. Findings are as follows: 1. The laboratory performed Histopathology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:15 a.m. on 10/10/19. 2. An expired Sodium Hydroxide bottle was observed in a flammable materials storage cabinet during the tour. See below. Stain Lot Exp date Sodium Hydroxide 025616 09/16/12 3. In an interview at 10:30 a.m. on 10/10/19, the GS confirmed the contents of the flammable materials cabinet were in use and the Sodium Hydroxide bottle was expired. D5805 TEST REPORT CFR(s): 493.1291(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 document review and interview with laboratory personnel, the laboratory failed to ensure test reports generated prior to 10/10/19 included the address of the laboratory location. Findings are as follows: 1. The laboratory performed Histopathology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:15 a.m. on 10/10/19. 2. The address of the laboratory location was not included on test reports reviewed on date of survey. See below Case number Date of testing JAD18-106778 06/07/18 JAD18-106860 06/08/18 JAD19-108789 07/01/19 3. In an interview at 1:45 p.m. on 10/10/19, the GS confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, record review and interview with laboratory personnel, the laboratory failed to establish and follow a procedure for maintenance and function checks of general laboratory equipment. Findings are as follows: 1. A tour of the laboratory on 2/1/18 at 12:05 a.m. revealed the presence of the following laboratory equipment: - TSP Waterbath with Cardinal Health Digital Thermometer (S/N = 61933003, Manufacturer Calibration Expiration Date = 10/30/08) - Leica Model EG1150H Embedder with Taylor 9940N Digital Thermometer (S/N = 4915 V3043, No Manufacturer Calibration Expiration Date seen) - Leica Model ASP 300 Tissue Processor with Interval Temperature sensor 2. A procedure that defines the maintenance and function check tasks, frequency, acceptable outcomes, and responsible persons could not be located in the Dermatology Specialists Equipment Maintenance and History Binder. 3. Thermometer function checks records from 2016 and 2017 for the equipment noted above could not be located in the laboratory's files. 4. The laboratory was unable to provide the missing procedure or records upon request. 5. In an interview on 2/1/18 at 3:30 p.m., the General Supervisor confirmed the above findings. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring 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 -- that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (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 document review and interview with laboratory personnel, the Technical Supervisor failed to evaluate the competency of 1 of 3 testing personnel at least annually in 2016. Findings are as follows: 1. A review of patient records located in the Special Stains & Immunohistochemical Orders Binder indicated that Testing Personnel 2 (TP2) had performed patient testing on the following dates in 2016: - June 8, 10, 11, 12, 15, & 17 - August 4, 5, 8, & 9, - December 15, 16, 19, 20, 21, 22, 26, 27, & 28 2. 2016 Competency Assessment records for TP2 were not found during review of laboratory documents. 3. The laboratory was unable to provide any competency assessment records for TP2 upon request. 4. In an interview on 2/1/18 at 1:30 PM, the General Supervisor confirmed the above findings. . -- 2 of 2 --