Schweiger Dermatology, Pc - Elmer

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on surveyor review of the lack of Temperature Records (TR) and interview with the Testing Personnel (TP), the laboratory failed to document Room Temperature (RT) where Histopathology test reagents were stored and tests were performed from 8 /16/18 to the date of the survey. The findings include: 1. There were no temperatures recorded. 2. The TP # 1 as listed on CMS form 209 confirmed on 10/21/21 at 10:15 am that the laboratory failed to accurately record RT. 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 D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory records, procedure manual and interview with the Laboratory Director (LD), the laboratory failed to establish a maintenance protocol for Linistain automated stainer when protocols were not provided by the manufacturer from 9/7/16 to the date of survey. The LD confirmed on 8/16/18 at 10: 30 am that the laboratory did not establish maintenance protocol. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require