Hobart K Richey Md Pa

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at Hobart K Richey MD PA on 04/03/2024 - 04/08/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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, record review, and interview with the office manager, the laboratory failed to ensure the potassium hydroxide that was used for mycology (fungi) and parasitology (scabies) testing was not expired prior to performing 27 patient tests from 11/03/23- 04/02/24. Findings included: A tour of the laboratory on 04/03/2024 at 03:00 PM, revealed the expiration date was 10/19/2023 on the bottle of potassium hydroxide (Lot number 1292) used for mycology (fungi) and parasitology (scabies) testing. A review of the patient fungi and scabies result log revealed 27 tests had been performed after the 10/19/2023 expiration date. The testing was performed on 11/03/23 (1 test), 11/14/23 (1 test), 11/15/23 (1 test), 11/21/23 (3 tests), 12/4/23 (1 test), 12/5/23(1 test), 12/7/23 (3 tests), 01/02/24 (2 tests), 01/03/24 (1 test), 01/10/24 (1 test), 01/29/24 (3 test), 01/31/24 (1 test), 02/06/24 (1 test), 02/21/24 (1 test), 03/13 /24 (1 test), 03/15/24 (1 test), 03/28/24 (1 test), 04/01/2024 (1 test), and 04/02/24 (2 test). On 04/03/2024 at 3:05 PM, the Office Manager confirmed the potassium hydroxide was expired and patients were tested. 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 D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to perform peer review every 6 months in Virology for 1 (2017) out of 2 (2016-2018) years reviewed and in Parasitology for 2 out of 2 (2016-2018) years reviewed (See D5217). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to perform peer review every 6 months in Virology for 1 (2017) out of 2 (2016-2018) years reviewed and in Parasitology for 2 out of 2 (2016-2018) years reviewed. This is a repeat deficiency from the 01/27/14 recertification survey. Findings Included: Review of peer review for Virology found Tzank testing peer review performed 01/06 /16, 05/20/16, 06/07/16, 08/25/16, 10/05/16, 01/13/17, 01/15/17, 01/23/17, 03/30/17, 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 -- (10 month gap between these dates) 01/18/18, 01/19/18. Review of peer review for Parasitology found no peer reviews for the Scabies testing. During an interview on 01 /25/18 at 2:00 PM the Office Manager confirmed that there were no other peer reviews. This is a repeat deficiency from the 01/27/14 recertification survey. Review of the