Medical Director's Name on Forms

[lehooke]

Can someone help me find the reference for the inclusion of the Medical Director's name on all Blood Bank forms? I can't find it in either the AABB Stds. or Technical Manual. Thank you!

[adiescast]

Is it a CAP requirement (maybe in lab general)?

[David Saikin]

I don't believe it is a standard by AABB or CAP (but check the Lab General, it is not in the Transfusion Medicine Checklist). . . maybe a state regulation>

[heathervaught]

Maybe CLIA???

[KKidd]

I don't know of a requirement regarding the medical director. However, we did get dinged by the Joint Commission be cause I had one chartable form that did not have the address of the facility.

:judge::judge:

[L106]

I don't know of a requirement regarding the medical director. However, we did get dinged by the Joint Commission be cause I had one chartable form that did not have the address of the facility.

:judge::judge:

Interesting. We have never had our facility address on any of our Blood Bank forms, and none of the inspection/accreditation agencies has ever mentioned it. (We do have our facility name, city, and state on our forms.)

We got dinged several years ago by an inspector (can't remember which agency) because our facility stamp was on the back of all of our temperature recording charts instead of on the front.

Back to the original topic: Isn't it a requirement (CLIA & CAP ??) that the Medical Director's name be on all reports that go out? (But I've never heard of a requirement that the name be on Blood Bank forms.)

Edited June 22, 2010 by L106

[adiescast]

Yes, it would be reports and not forms.

This is what I found on the CAP checklist. It does not mention the medical director's name, so I guess the requirement must be somewhere else...

GEN.41096

Phase II

N/A YES NO

Does the paper or electronic report include the following elements?

1. Name and address of testing laboratory (see note below)

2. Patient name and identification number, or unique patient identifier

3. Name of physician of record, or legally authorized person ordering test, as appropriate

4. Date and time of specimen collection, when appropriate

5. Date of release of report (if not on the report, this information should be readily accessible)

6. Time of release of report, if applicable (if not on the report, this information should be readily accessible)

7. Specimen source, when applicable

8. Test result(s) (and units of measurement, when applicable)

9. Reference intervals, as applicable (see Note below)

10. Conditions of specimen that may limit adequacy of testing

NOTE: All of the above data elements, as applicable, must be available in the laboratory information system or in paper records, and must be in the report that is available / sent to the clinician, whether electronic or paper, including electronic reports in systems interfaced to the laboratory information system directly or through middleware or an interface engine. (For electronic reports, data elements need not all be present on one screen, but must be readily available.)

The paper or electronic report must include the name and address of reference laboratories where patient testing was performed. A “reference laboratory†includes outside reference laboratories as well as any affiliated or special function laboratory that is separately accredited and has a different CLIA registration number than the referring laboratory. For electronic reports, the name and address of reference laboratories need not all be present on the same screen(s) as the results but must be available in the information system.

Under some circumstances it may be appropriate to distribute lists or tables of reference intervals to all users and sites where reports are received. This system is usually fraught with difficulties, but if in place and rigidly controlled, it is acceptable.

Patient reports must state the name of the physician (or other legally authorized person) ordering the test(s) or a physician of record. In those institutions where there are multiple ordering physicians and/or frequent changing of attending physicians, the ordering physician should be easily identifiable through a computer audit trail or other records of the test order.

REFERENCES

1)

Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3713 [42CFR493.1291©]

2)

Grasbeck R, Alstrom T, eds. Reference values in laboratory medicine. The current state of the art. New York: Wiley, 1981

3)

Statland BE. Clinical decision levels for lab tests. Oradell, NJ: Medical Economics Books

4)

Rochman H. Clinical pathology in the elderly. New York: Karger, 1988:207216

5)

Tietz NW, ed. Clinical guide to laboratory tests. Philadelphia: WB Saunders, 1990

6)

NCCLS. How to define and determine reference intervals in the clinical laboratory; approved standard C28A2. Wayne, PA: NCCLS, 2000

There is a previous question that states the medical director must review the format of reports annually. I did not find anything in the Transfusion Medicine Section. CAP's checklist should reflect CLIA requirements, so it must be something other than CLIA or CAP (if it exists?).

[bbbirder]

I have never heard of this requirement.