Joint Commision WT 02.01.01 compliance

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Happy Monday...
I wanted to know how sites identify the staff performing POCT per WT 02.01.01?  Do you list individual names of operators, lump POCT in job descriptions or titles to comply with this standard?
Thanks in advance :)



WT.02.01.01 The person from the hospital 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 hospital, 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.

9 Replies

We list the individual operators which I pull from my Medialab competency lists.

Hi Adonica, hope you are well.

I'm sure others have a more 'solid' way of meeting this element but this has worked for us for many years on meeting WT.02.01.01 and I am happy to share it with you.

We use the current competency rosters to identify testing personnel trained to perform each of the POC tests listed on that CLIA's testing menu (rosters are updated as new training/competency and annual competency assessment requirement is fulfilled because we do not have an electronic means to track WT competency). The rosters are held at each the testing site and the testing site is the owner of the POC Program requirements being met.

We use the current 'POC Test Site Manager' list (the requirement to stay current is to attend an annual class), in conjunction with the Nursing Management Supervisor/NM list, to identify those supervising WT. 

In our 'description/explanation' for this element we note what our 'POC Test Site Management' Program does as far as oversight of the testing site (duties which includes training and renewal of competency and tracking of current testing personnel).

Thanks and feel free to ask me direct questions pmann@utmb.edu.

We list in each procedure the scope and testing sites. Like below:
Level of Personnel: All staff on file in Telcor QML who have completed initial training and fulfilled the specific competency requirements as stated in this procedure.
Testing sites: Minneapolis Hospital, St. Paul Hospital, Children’s Minnetonka Ambulatory Surgery Center, Children’s MN NICU –Mercy.

Then in my training and competency SOP, we state that only trained trained staff with current competencies are granted access to testing in the point of care middleware.

We use the competency list to identify current operators.
We have a policy that lists the name of the all the designees for each area of the lab including the point of care coordinator who is responsible for overseeing the waived testing.

We were cited for this (JCAHO). The inspector wanted to see a signed document by the Medical Director designating their designees for various functions/responsibilities that fall directly on the Medical Director under CLIA and that JCAHO standard cited. I had no idea my trainers needed to be signed off by the Medical Director as designees. We are going to update the forms each year and have the Medical Director sign annually. Each designee form is used for one specific task but will often list more than one designee.

Thank you all for your responses :).

Ken, what did you do for the end users, regular operators?

I don't do anything special for regular operators. We only make delegation forms for trainers since that is explicitly designated to be the responsibility of the Medical Director "or their designee"

 As POCC i am only over one hospital (about a 250  bed)  with one off-site, so I am only POCC so likely easier for our site. CAP requires CLIA roles in the Org Profile - listed as technical consultant over POC.   In addition, POCC is listed as the delegated for "supervisor" duties (QC review, Proficiency Testing, etc) in a delegation document signed by Medical Director.  We also have a POCT Program policy that is signed by medical director that better outlines specifics. Here is a section of that policy. 

7.0     POCT RESPONSIBILITIES
The Point of Care Testing Program expects each site to take responsibility for all aspects of testing performed at their site, with the exception of those requirements mandated by CAP or the Laboratory Medical Director and/or the POCC. Each site should identify a Point of Care Test Champion. This person will be responsible for the day-to-day operations and will work in conjunction with the POCC.
 
7.1       Role of Laboratory Medical Director 
The Laboratory Medical Director has ultimate responsibility for insuring all standards and requirements are met at each site. They also:
·         Review and approve all policies and procedures 
·         Approve or deny new POCT.
·         Terminate testing in areas where there is evidence of flagrant disregard in following appropriate regulations and standards.
 
    7.2   Role of POCC
The Laboratory provides management service for POCT equipment via the POCC whose role is to liaise with clinical staff and support the use of POCT equipment. The POCC can provide assistance with:
·         identifying suitable POCT equipment for evaluation 
·         performing an evaluation 
·         installing POCT equipment 
·         writing procedures 
·         training staff 
·         preparing worksheets, log books, etc. 
·         maintenance schedules
·         QC programs
·         troubleshooting
·         monitoring and review of procedures
·         competency reviews
 
The POCT Coordinator is also responsible for monitoring that all POCT is performed to the same standard and regulations as would be expected from regular laboratory testing. They also alert the director to any problems concerning quality assurance. The POCT Coordinator can be contacted at 295-8562 or by email poc@kutopeka.com
 
 
7.3       Role of Clinical Staff/Operators
·         Use the equipment in a safe and responsible manner.
·         Follow all policies and procedures for POCT.
·         Use your unique user code No identifier or password will be shared with another staff member. If a staff member is found to be sharing their identifier they will no longer be allowed to perform POCT. 
·         Perform and document all applicable maintenance.
·         Satisfy and perform the quality control (QC) requirements pertaining to the specific instrument and document any corrective action.
·         Appropriately document all patient and QC results.
·         All staff members operating POCT equipment must have up to date competency and training records or they will not perform the test.
·         Recognize and confirm all unexpected or highly abnormal results. 

more on the WT 02.01.01
 We use QML and operator lockout for the "who is trained/competent" roster.

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Adonica Wilson
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