THE DO'S AND DON'TS FOR CLIA WAIVED TESTING COMPLIANCE IN AMBULATORY CARE SETTINGS
Policies and procedures for waived tests are established, current approved, and readily available.
The person from the organization whose name appears on the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) certificate identifies the staff responsible for performing and supervising waived testing.
Note 1: Responsible staff may be employees of the organization, contracted staff, or employees of a contracted service.
Note 2: Responsible staff may be identified within job descriptions or by listing job titles or individual names.
Staff and licensed independent practitioners performing waived tests are competent.
The organization performs quality control checks for waived testing on each procedure. Note: Internal quality controls may include electronic, liquid, or control zone. External quality controls may include electronic or liquid.
The organization maintains records of waived testing.
For 01.01.01, its a given that policies must be written and established, approved and readily available for everyone to access. This goes without saying and applies to everything Medicare, Joint Commission alike. Then for 02.01.01, the named individual on your CLIA certificate must be the one that supervises this CLIA program and his/her name would need to be on the countersigned documents of the staff. I.e. Staff assessments of competency, the person named on the certificate would be listed on the document. There must be a written job description with the tasks of CLIA waived testing in their specific job description along with a list of employees that have been trained and determined to be competent in your CLIA program. The list should have their names, their titles, and the job they perform as it relates to the CLIA waived testing.
03.01.01, its all about the competency of the staff. To assist you in getting your hands around the actual competency evaluation of your staff, we have created an easy to use competency evaluation sheet. It captures the staff competency, the use and maintenance of the equipment or devices used, and it captures the observation of the competency in both direct observation and spoken test. You can get this competency evaluation here.
Then last but not least...you must maintain the records of waived testing. This goes without saying, whereas you will need to follow the statute of limitation for record maintaining before destructions per your state laws.