Annapolis Pediatrics

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the Director of Clinical Services, the laboratory did not ensure that all the testing personnel who tested patient samples performed the PT. Findings: 1. The laboratory currently has 20 testing personnel listed on the "Laboratory Personnel Report" (CMS-209) who perform microbiology testing. 2. A review of microbiology PT attestation worksheets from 2020 and 2021 showed that PT was performed by the same testing person in 4 of 5 events. 3. During an interview on 6/23/2022 at 10:30 AM, the Director of Clinical Services confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. 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 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with the technical consultant (TC), the laboratory did not ensure that an eye wash station was located in the laboratory area where testing occurs. Findings: 1. During a tour of the laboratory, it was observed that there was no eye wash station available in the laboratory where hematology testing is performed. Laboratory staff stated that the eyewash had been moved to a room next to the laboratory where waived testing kits were located. 2. During an interview on 11/1 /19 at 12:45 PM, the TC confirmed that there was no eye wash station located in the room where laboratory testing is performed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the technical consultant (TC), the laboratory did not ensure that hematology controls were labeled with the date that they expire. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Findings: 1. During a tour of the laboratory at 9:15 AM, it was observed that the opened and in use "Cell-Dyn 18 Plus" hematology controls in the laboratory refrigerator were labeled with the date that they were put in to use but were not labeled with the expiration date. A review of manufacturer instructions showed that the hematology controls expire 8 days after opening. 2. During an interview on 11/1 /19 at 12:45 PM, the TC stated that the controls are replaced weekly and confirmed that the in-use hematology controls were not labeled with the expiration date. D5781

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --