Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 12/1/21 at Saltzman Tanis Pittell Levin & Jacobson Inc., DBA Pediatric Associates West Palm Beach, a clinical laboratory in West Palm Beach, Florida. Saltzman Tanis Pittell Levin & Jacobson Inc., DBA Pediatric Associates West Palm Beach is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to report throat cultures between 18-24 hours per their policy for 82 out 166 patients reported since 1/1/21. The findings included: Review of policy "Strep A Throat Culture" stated to incubate for 18-24 hours. Review of "Turn Around Time Report" from 01/01/21 to 12/01/21 revealed the following Patients results that were not read 18-24 hours: Patient #1 reported at 75 hours, Patient #2 reported at 73 hours, Patient #3 reported at 73 hours, Patient #4 reported at 72 hours, Patient #5 reported at 71 hours, Patient #6 reported at 71 hours, Patient #7 reported at 68 hours, Patient #8 reported at 68 hours, Patient #9 reported at 68 hours, Patient #10 reported at 66 hours, Patient #11 reported at 66 hours, Patient #12 reported at 65 hours, Patient #13 reported at 53 hours, Patient #14 reported at 52 hours, Patient #15 reported at 51 hours, Patient #16 reported at 49 hours, Patient #17 reported at 49 hours, Patient #18 reported at 49 hours, Patient #19 reported at 48 hours, Patient #20 reported at 48 hours, Patient #21 reported at 47 hours, Patient #22 reported at 47 hours, Patient #23 reported at 47 hours, Patient #24 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 -- reported at 46 hours, Patient #25 reported at 46 hours, Patient #26 reported at 45 hours, Patient #27 reported at 44 hours, Patient #27 reported at 44 hours, Patient #28 reported at 44 hours, Patient #29 reported at 44 hours, Patient #30 reported at 44 hours, Patient #31 reported at 44 hours, Patient #32 reported at 43 hours, Patient #33 reported at 42 hours, Patient #34 reported at 42 hours, Patient #35 reported at 41 hours, Patient #36 reported at 41 hours, Patient #37 reported at 41 hours, Patient #38 reported at 41 hours, Patient #39 reported at 40 hours, Patient #40 reported at 39 hours, Patient #41 reported at 39 hours, Patient #42 reported at 39 hours, Patient #43 reported at 39 hours, Patient #44 reported at 39 hours, Patient #45 reported at 38 hours, Patient #46 reported at 38 hours, Patient #47 reported at 38 hours, Patient #48 reported at 38 hours, Patient #49 reported at 33 hours, Patient #50 reported at 33 hours, Patient #51 reported at 32 hours, Patient #52 reported at 32 hours, Patient #53 reported at 32 hours, Patient #54 reported at 32 hours, Patient #55 reported at 31 hours, Patient #56 reported at 31 hours, Patient #57 reported at 31 hours, Patient #58 reported at 31 hours, Patient #59 reported at 31 hours, Patient #60 reported at 30 hours, Patient #61 reported at 30 hours, Patient #62 reported at 30 hours, Patient #63 reported at 30 hours, Patient #64 reported at 30 hours, Patient #65 reported at 30 hours, Patient #66 reported at 29 hours, Patient #67 reported at 29 hours, Patient #68 reported at 29 hours, Patient #69 reported at 29 hours, Patient #70 reported at 29 hours, Patient #71 reported at 29 hours, Patient #72 reported at 29 hours, Patient #73 reported at 29 hours, Patient #74 reported at 29 hours, Patient #75 reported at 28 hours, Patient #76 reported at 28 hours, Patient #77 reported at 28 hours, Patient #78 reported at 28 hours, Patient #79 reported at 28 hours, Patient #80 reported at 28 hours, Patient #81 reported at 28 hours, and Patient #82 reported at 13 hours. Interview on 12/1/21 at 1:50 p.m. the Laboratory Manager confirmed that the throat cultures were supposed to be reported 18-24 hours per their policy. -- 2 of 2 --