Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted by the Pennsylvania State Agency on 10/30/2025 found the Pennsylvania Dermatology Partners Bensalem laboratory to be out of compliance with the following condition: 493.1250 Condition: Analytic systems. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of temperature logs, lack of documentation, and interview with the Laboratory Director, the laboratory failed to meet applicable analytic systems requirements as required under 493.1282, when refrigerator storage temperatures were below the laboratory's acceptable range for Immunohistochemical (IHC) stains used when histopathology microscopic examinations were performed for 15 of 34 days from 10/01/2024 to 10/30/2025. Refer to D5781 D5781