Summary:
Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's Quality Control (QC) records and interview with the laboratory director and the testing person, the laboratory failed to follow the manufacturer's instructions for performing external positive and negative controls with each new lot of Henry Schein One Step urine pregnancy kit. FINDINGS: 1. On 5/9/2018 at approximately 3:00 PM the laboratory director and the testing person confirmed surveyor's findings that there were no records of external positive and negative controls for the for Henry Schein One Step uhCG, lot number HCG6110056 expiration date 9/30/18 from January 2017 through the survey date. 2. Approximately 22 patient specimens were tested and reported for uhCG during the above time frame. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on a surveyor's review of laboratory's temperature documentation and interview with the laboratory director and the testing person, the laboratory failed to follow the manufacturer's temperature requirement for the laboratory testing. FINDINGS: 1. The laboratory performs throat culture. The manufacturer of the throat culture media used for testing and the laboratory's temperature policy require that the incubator temperature to be in the range of 35-37 degree Celsius. On May 9, 2018 at approximately 3:00 PM the laboratory director and the testing person confirmed surveyor's findings that the incubator temperature was out of range, when patient samples were incubated for throat culture for 22 days from January 2, 2017 through April 4, 2018. 2. Approximately 60 patient samples were tested and reported for throat culture during this time frame. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a surveyor's review of hematology quality control (QC) records and an interview with the testing person and the laboratory director, the laboratory failed to ensure that hematology QC test results were within acceptable range prior to testing patient specimens. FINDINGS: On May 9, 2018 at approximately 3:00 PM, the testing person and the laboratory director confirmed surveyor's findings that the testing personnel failed to take and document