Facility Name Address Phone_____ - Nevada State Health Division

More documents

Recommendations

Info

EXEMPT LABORATORY ATTESTATION FORM TAG REGULATION TEXT performing CLIA Waived tests ONLY for the physician or associates of the physicians’ private practice. Y N N/A Comments If “Yes”, proceed to remaining regulations. L0002 Regulation NAC652.155(2)(b)(1) Type Rule Regulation Definition Interpretive Guideline Custom Help The director, a designee of the director or a licensed physician at the laboratory at which the waived test is performed: (1) Verifies that the person is competent to perform the test; This provision applies to the personnel performing the waived testing in the physician’s office. Training and competency assessment records for each testing personnel for all tests performed are documented in writing and signed by the lab director or designee. This must be done with all current and new employees. L0003 Regulation NAC652.155(2)(b)(2) Type Rule Regulation Definition Interpretive Guideline Custom Help The director or a designee of the director at the laboratory at which the test is performed : (2) Ensures that the test is performed in accordance with instructions of the manufacturer of the test; This provision ensures that all tests are performed according to manufacturer’s instructions. Manufacturer’s instructions are to be followed step by step. Written procedures are available at bench (test manufacturer’s package inserts are acceptable). Kits/reagents are stored according to manufacturer’s instructions. 2
EXE MPT LABORATORY ATTESTATION FORM TAG REGULATION TEXT Y N N/A Comments A daily temperature log for room, refrigerator, and freezer (if applicable) must be kept. The correct temperature range must be established and noted on the log, and the daily temperatures must be within that range or corrective action must be taken. Expiration dates must not be exceeded, and must be modified upon opening, when applicable. (No expired reagents/supplies should be in-use.) A system should be in place to maintain positive patient identification throughout the testing process. Ex: name and date of birth or patient number. L0004 Regulation NAC652.155(2)(b)(3) Type Rule Regulation Definition Interpretive Guideline Custom Help The director or a designee of the director at the laboratory at which the test is performed: (3) Validates and verifies the manner in which the test is performed by using controls which ensure that the results of the test will be accurate and reliable. Two levels of control to be run each day of patient testing, internal, external and electronic controls are acceptable. All controls, internal, external or electronic must be documented. The results of the controls must be within range per the package insert. The range for the controls, along with the lot number of the kit and controls must be noted on the control log sheet along with the daily results. Trial controls must be run with each test kit that will be in use and the written control logs must be available for the surveyor to review. 3
Page 1: Facility Name _____________________
Page 5 and 6: EXEMPT LABORATORY ATTESTATION FORM

Facility Name Address Phone_____ - Nevada State Health Division

Create successful ePaper yourself

Delete template?

Save as template?