March 2011

Waived testing
The article “New go-to guide for solving POC conundrums” (January 2011, page 7) points out that CLIA has a single requirement for waived tests, which is that the laboratory must follow manufacturer instructions. It is worth emphasizing, however, that the CAP Laboratory Accreditation Program has extensive requirements for waived testing. These requirements are the same as those for nonwaived testing in many areas: for example, proficiency testing, procedure manuals, instrument maintenance, specimen handling, results reporting, and laboratory safety.

The Laboratory Accreditation Program also has requirements that apply specifically to waived tests—requirements that are less stringent than nonwaived requirements—in the areas of test validation, calibration, quality control, reagent handling, and personnel.

Stephen J. Sarewitz, MD
Seattle
Member, CAP Accreditation
Education Committee

Devaluing pathologist’s time
I enjoyed Karen Titus’ article about patient consults (“A meeting of minds on patient consults,” January 2011, page 1). (I agree—“Seeing the specimen itself wasn’t strictly the point. It was mainly an excuse for patients to ask questions, much as going to a Cubs game is often an excuse to sit in the bleachers and drink Old Style.”)

I think many of us are willing to talk to patients, and it is easy to do and rewarding when it is just once in a while. I probably talk to a patient once every week or two. My most memorable time was a few years ago. It was a Friday night and a patient had been in the hospital being worked up for days, and finally someone ordered a test that is done in my laboratory and it was definitive for multiple myeloma. The resident came down to talk to me about it, and the attending was gone and she really wanted to inform the patient so he wasn’t left hanging for yet another day. But she wasn’t sure how to tell him, so I went up there with the protein electrophoresis and immunofixation films and talked to the patient with visual aids in hand.

The problem with doing a lot of consults for which you are not paid is that it can end up devaluing the pathologist’s time: “If you have time to do this for free, then you must not be as busy as I (e.g. surgeon) am.”

Overall, an interesting and thought-provoking article.

Irene J. Check, PhD, D(ABMLI)
Director, Clinical Pathology Division
Pathology and Laboratory Medicine
NorthShore University HealthSystem
Evanston, Ill.

Pathologists do see patients
It is disheartening to me to read in CAP TODAY (January 2011, page 1) about the “idea” of pathologist-performed patient consults as if it is a new concept. There are many pathologists in routine practice and in academic settings who visit with patients every day and convey diagnoses and provide explanations. Two such groups are cytopathologists who perform FNAs and blood bankers who run transfusion services. I can’t tell you the number of times I have given patients cancer diagnoses and comforted them and held a hand or dried a tear or shed a tear. I can’t tell you the number of times I have drawn a cyst on paper and explained accumulation of contents, and so on. The population of pathologists for whom not seeing patients is the norm has created the impression that this is the norm for everyone, when that is not the case.

Charles D. Sturgis, MD
CellNetix Pathology
Everett, Wash.

An invaluable fellowship
I have been perusing the CAP TODAY articles on patient consults (November 2010�January 2011) and wish to relate my experience to you.

In 1968, as a young board-certified pathologist, I underwent a one-year fellowship in hematology/oncology at the City of Hope, Duarte, Calif., under Ernest Beutler, MD. I had total inpatient responsibilities for hematology and oncology patients referred for diagnosis and treatment.

That experience of working under Dr. Beutler, a brilliant teacher, and the other highly competent fellows, has enabled me not only to understand the mentality and thinking of clinicians but also to approach and interact with patients without hesitation or difficulty, and to be at ease during my long years of active general pathology practice.

H.W. Gordon, MD
Ukiah Valley Medical Center
Ukiah, Calif.

What pathologists should know
The recent articles about pathologists directly consulting with patients reminded me of a saying of a former boss, Fremont “Bud” Davis, MD, of Hollywood Presbyterian Hospital, Los Angeles. His view was, and he said, “The pathologist should know everything the internist does, except the dosages.” I add such knowledge should be not only for disease histology but also for the pathophysiology of disease, that is, clinical pathology.

Larry Sherman, MD, JD
St. Louis, Mo.

Home INR testing
In reading the article on the Home INR Study (“Study aside, INR testing still homeward bound?” January 2011, page 42), I feel compelled to respond with our experience with point-of-care INRs. It took our laboratory many years, and testing of multiple meters, to finally bring a POC meter into our outpatient laboratory area. The majority of my staff are baccalaureate MTs so they know about good laboratory practice.

We set up our program by training a finite number of laboratory personnel so that we could limit the subjectiveness of the process. We also wanted the INRs to correlate with our coagulation instrumentation in the main laboratory. On the patients who request a fingerstick INR, we perform three fingersticks, and on the fourth INR we perform a venipuncture. Any patient with an INR over four on the POC meter has blood drawn for the INR. This schedule was set up because of the correlation study we did with our coagulation instrument and the INR meter. Note: Most meters are the same; it is the strips that people have to monitor closely.

I agree with Lynn Oertel, MS, ANP, that some patients who are difficult to get blood from with a venipuncture, who live in remote areas, or who are savvy about warfarin can be good candidates for POC INRs. I disagree with Jack Ansell, MD, and David Phillips that if diabetes patients can use a glucose meter, then warfarin patients should have no problems. Diabetes patients can usually tell if their glucose is high or low; it is difficult for warfarin patients to tell if their INR is therapeutic. The consequences of a low or high INR can be life-threatening.

We have had patients come in to have their meters checked out just to find out their strips were bad. We have had patients come in who say they have been increasing their warfarin but their INRs are not increasing, and when we do a venipuncture, we find out that their INR is critical and they have to be treated with vitamin K or fresh frozen plasma. I do phlebotomy training for home health nurses in our area, and most of them get no training on INR meters. As was said in the article, training is crucial.

I believe the results of the THINRS study; in fact, it’s better than what we have experienced. We in laboratory medicine must always be vigilant and make sure that the patients are getting quality results, especially if they have their own meters. Patients must always be at the forefront of everything we do, and expediency should never be substituted for quality.

Marilyn C. Kenyon, MT(ASCP)
Director of Laboratory Services
St. Joseph Hospital
Bangor, Me.