Diagnostic Procedures in an Ambulatory Organization (including OBS); Including Waived Testing, Patient Self Testing

Diagnostic procedures, including laboratory, radiology, and non-peri-operative EKG's, will only be performed by 
individuals with specific training gained from programs sponsored by the practice, manufacturer or other outside programs approved by the organization. Because we have facilities to examine the patient and document history, our organization stresses the importance of clinical correlation. Lab results will be considered if they correlate with the patients overall clinical picture. 
The individual will also have a proven competency on file or will be in a preceptorship with an instructor with proven 
competency.  Competency of the individual is assessed after orientation and maybe assessed every 12 months but no less 
than annually. Current competency is assessed using at least 2 of the following methods per person per test: 
1. Performing a test on a blind specimen (a sample with  known value that is now tested by personnel who do not 
   know the results)
2. Having the supervisor or qualified delegate periodically observe routine work
3. Monitoring each user's quality control performance
4. Having written testing that is specific to the method 

Our organization generally uses rule 2 and rule 3.
The director named on the CLIA certificate or waiver establishes the policies and procedures that define the 
context in which waived test results are used in patient care, treatment, and services, before initial use of the test 
for patient testing, periodically thereafter, but at least once every three years and when there are changes in 
procedures; i.e. manufacturer's updates or a different manufacturer is used. Although quality control tests are helpful, our organization recognizes that quality control failure is a real scenario. We thus train our staff to recognize critical values that change our plan of care, and if detected, notify senior staff members and repeat the test with quality control.
Procedures governing specific testing are: 
1.  Specimen type, when applicable 
2.  Specimen collection, when applicable
3.  Specimen identification and labeling
4.  Specimen preservation, when applicable
5.  Storage considerations for test components; storage is away from direct light, temperature requirements are met, open container expiration dates, are noted and tracked.
6.  Reagent use, including not using a reagent after its expiration date.
7.  Instrument calibration when applicable is according to manufacturers' recommendations
8.  Quality control, testing of equipment, frequency and type
9.  Action for reporting 'misreads' or errors. The following will occur if a misread is found or noted :

                   It will be reported to the medical director. 

                   If a patient is involved, they will be told to wait for the physician to speak to them.

10.  Log of equipment maintenance, when applicable
11. Performance of the test
12. Result of follow up recommendations; i.e. a recommendation to repeat the test when results are higher or lower than the reportable range of the test. 
Procedures are specific to the test to be preformed, but may refer to manufacturers' manuals, which are readily available 
to staff members performing tests. Quality control checks are conducted on each procedure and related equipment, identified by the organization. Waived tests must include at least 2 quality control tests. At least one of these quality control tests should be external to the test.
1.  Clinical use of results is consistent with the practices policies and the manufacturer's requirements.  Patient will be treated based on test results if they correlate with clinical picture.
2.  Additionally safety equipment required. Gloves are recommended for use when staff is touching mucous membranes or using blood products
3.  Manufacturers' requirements are followed
4.  Accepted guidelines for 'in range' results.  In-range is determined based on the quality control requirements of manufacturers. 
5.  Frequency of control checks; Control checks occur every time a new box or lot is opened. Due to our low volume of glucose tests, boxes of test strips are most often open for one patient. We therefore instruct our staff to check quality control before each patient unless more than one test is performed on multiple patients in a day. 
6.  Identity of staff members who may perform testing and document the results as well as the identity of staff members who direct or supervise testing is documented. 
7.  In this organization the Medical Director or the Administrator is responsible to supervise testing; Medical Director  is responsible for reviewing the results. 
8.  In this organization a designated employee informs the patient of the results
9.  Documentation of competency of individual(s)performing testing are located in the employee's file.

10. Quality control checks are performed using internal and external means if commercially available. 

11. Test results that result in change in patient care must be correlated with clinical picture. If this is not the case, the test must be repeated.  

12. Our organization will provide staff checklists and forms to ensure quality control is appropriately performed and to minimize mistakes.
Glucometer quality control requirements include two levels of control.Only a glucometer that can be calibrated using 2 levels of control, which is of the same quality and caliber as used by any other similar facility, will be used in this organization. Documentation of results of testing are kept in a glucose log along with the calibrated range specific to the lot number of test strips. Calibrations are performed whenever a new test strip bottle is open, or at the beginning at every day where glucose tests are performed. Because our volume of glucose monitoring is so low, it is this organizations policy to perform quality control of glucometer before every test performed unless more than one test is performed a day. Documentation of the controls performed, calibrations, safety equipment utilized, etc will be documented in a log. Any errors in testing or instrument problems will be correlated to the individual test being run at that time.The organization will assure that it maintains its CLIA waiver or its CLIA certificate for testing being performed within the organization. It is not billed through OBS, thus a separate one for the OBS is not needed.

Pregnancy tests contain an internal quality control mechanism. The presence of the "Control" line indicated correct internal control technique. If there is a deviation from the expected control result, the physician will be notified. In addition to the internal control, an external control is recommended for the pregnancy test, but not required. These external controls will be performed with every lot. If results of external control deviates from the expected, the physician will be notified and the lot will be rejected.



Our organization is committed to providing high level of care to our patients as well as nurturing a productive and comfortable work environment. We thus encourage our management to frequently assess the market for the newest equipment. New equipment that is more accurate, decreases worker fatigue, and is available at a reasonable price point will be reviewed. If new equipment can bring a discernible difference to our practice, it will be purchased and implemented. 
Patient Self Testing: 
The Medical Director has approved the process of a patient utilizing their own glucose meter to perform a self test 
either prior to and/or after a surgery/procedure.   The results of the testing will be for screening purposes only. Patients who are insulin dependent or require multiple hypoglycemic drugs, or have a history of poorly controlled diabetes are encouraged to test their own sugar the day before and the day of their procedure. They are encouraged to contact us if they notice any gross deviations in their blood sugar, especially deviations that drop below the reference range. Licensed independent practitioners will be notified of this deviation and a clinical course will be decided based on the overall clinical picture.Before a patient is asked to utilize their own glucose monitor for self testing, or rely on the value stated by the patient of their morning finger stick before the procedure, competency of the patient to perform this test will be confirmed either by the length of time the patient has been a diabetic or observing the patient perform their first test.

Approved By Governing Board    
Control #81.12