Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of the validation documentation and procedures for the Nano Tech Frend analyzer and an interview with the Technical Consultant and the Testing Personnel, the surveyor determined the laboratory failed to ensure the Laboratory Director signed and dated his review and approval of these new procedures before use by the testing personnel. The findings include: 1. A review of the verification procedures (performed 9/27 thru 10/4/2016) for Thyroid Stimulating Hormone (TSH), Free T4, and Prostatic Specific Antigen (PSA) on the Nano Tech Frend, revealed only the Technical Consultant's signature with the date 11/3/2016. There was no evidence the Laboratory Director had approved the new testing procedures. The laboratory had previously used the Mini Vidas for testing these analytes until September 2016. 2. During an interview on 3/22/2018 at 2:15 PM, the surveyor explained approval of new procedures cannot be delegated, and then asked if the Laboratory Director had signed and dated his approval of the tests performed on the Frend analyzer before patient testing began. The Technical Consultant explained she had approved, signed and dated the verification data, then the Director had "looked" at it, however he had not signed the documents. When asked the date when patient testing began, the Testing Personnel reviewed her records, and answered 11/11/2016, thus confirming the above noted findings. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially 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 -- 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 a review of the 2016-2017 API (American Proficiency Institute) proficiency testing (PT) records, a lack of pipettor maintenance and calibration records, and interviews with the Technical Consultant, the surveyor determined the laboratory failed to implement a protocol for pipettor maintenance to insure accurate and reliable test results. The findings include: 1. A review of the API PT records revealed the laboratory failed Thyroid Stimulating Hormone (TSH) on Survey events 2016-Event #3 and 2017-Event #1. [This failure was previously written up by the CLIA Supervisor on 4/6/2017 during a CLIA PT desk review.] 2. A review of the