Medical Park Family Care

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 reviews of the environmental logs, Sysmex XP-300 Instructions For Use (IFU)manual, and an interview with the Technical Consultant (TC), the laboratory failed to ensure and document

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory test menu, the CAP (College of American Pathologists) proficiency testing (PT) records and website information, and interviews with the Technical Consultant and Testing Personnel (TP) #2, the surveyor determined the laboratory failed to enroll in a timely manner with an approved proficiency testing program to ensure receipt of all three 2018 PT events for moderate- complexity regulated tests. The findings include: 1. During the initial tour of the laboratory on 10/30/2018 at approximately 9:15 AM, TP #2 stated a Complete Blood Count (CBC) performed on the Sysmex KX-21N Hematology analyzer was the laboratory's only moderate-complexity test. 2. A review of the proficiency testing records revealed the laboratory had used CAP as the PT provider in 2017 and 2018, however there were no results for the 2018 first event (2018 FH1-A) Hematology survey. The only records in the binder for the first survey were instrument print-outs dated 3/8/2018 from five patient samples; a note on a