In the most recent edition of CAP STATLINE (February 28, 2013–Volume 29, Number 5) , there is an interesting article about a New York State Senate bill that seeks to require laboratories to provide laboratory results directly to patients upon request yet continue to prohibit pathologists from speaking with patients.
The CAP and the New York State Society of Pathologists (NYSSPATH) have written a letter to the NY state senator who introduced the bill, Toby Ann Stavisky (D). The letter contains the exact language CAP and NYSSPATH wish to change as well as a brief description as to why the changes are important.
The senator’s desire to provide patients with their test results in a timely fashion is laudable, but there are, in my opinion, a few problems with the bill.
Although the CAP and NYSSPATH do a very good job of addressing some problems with their proposed amendments, I still foresee a couple big issues that could arise, even if the senator adopts the amendments and the bill becomes law.
Here is the text of the bill (The CAP/NYSSPATH edits are bolded, underlined and struck through):
Release of test results to patients.
1. A clinical laboratory shall, upon request, report the results of any test, examination or analysis of a specimen submitted for evidence of human disease or medical condition directly to the person on whom the test was performed,
in additionsubsequent to when the test has been reported to the physician, or health care practitioner, who ordered such test or examination, except in cases of immediate medical jeopardy when results may be provided immediately to the patient.2. Nothing in this section shall authorize a clinical laboratory to engage in the practice of any health care profession under title eight of the education law; provided, however, a physician at the laboratory who performed or supervised the test may contact or confer with the patient. The report issued pursuant to this section shall contain a clear statement, presented in a prominent manner, to the effect that the report should not be viewed as medical advice and is not meant to replace direct communication with a physician or other health care practitioner.
I agree with the CAP/NYSSPATH that the bill’s language should be expanded to include non-physician practitioners and that results should not be provided to patients until after the ordering provider has received them.
There has been an incredible increase in the number of non-physician practitioners (Nurse Practitioners, Doctors of Nursing Practice, Physician Assistants, etc), and to allow labs to release results to physicians only would be complicated and violate the spirit of the bill, which is to give all patients easier access to their test results.
I also agree pathologists should be allowed to discuss results directly with patients. Pathologists are physicians too, and not only that, courts have found we have a duty to patients even if we have never met them.
In addition, there are times when a pathologist is the physician best positioned to explain how a test is performed and what a particular test result means. I run across instances on a fairly regular basis in which the provider who ordered a test does not even completely understand it.
So with what in the bill do I have problems?
Clinical pathology results only, please
As far as I can tell, this bill will require labs to report both anatomic and clinical pathology results to patients upon request. I do not believe reporting anatomic pathology results is a good idea.
Clinical pathology reports generally consist of numbers and metric units (and ”positive” and “negative” in the case of molecular pathology), the significance of which is only apparent with a deep understanding of disease processes.
Anatomic pathology reports, however, contain words like “carcinoma”, “malignancy”, “cancer”, etc. Everyone knows what those words mean. I would hate for a patient to receive a report telling them they have a malignancy with no one immediately available to help them understand the ramifications of that diagnosis.
For example, a diagnosis of metastatic melanoma is significantly different from a Gleason grade 3 + 3 prostatic adenocarcinoma in less than 5% of only one core biopsy, but a frightened patient at home alone in front of their computer may not know that.
Some things are best learned in the provider’s office.
What constitutes “immediate medical jeopardy”?
The amendment makes clear labs should be able to reserve the right to provide patients with test results before their provider in cases of “immediate medical jeopardy”. This raises many questions in my mind.
How exactly is the lab to know the patient is in immediate medical jeopardy? Will all alert values and critical results need to be called to every patient immediately in addition to the provider? Will labs need to call patients with chronic renal failure about their elevated creatinine and anemia every single time? Will labs have to keep track of when they notified the patient for laboratory inspections, as they do when they call providers?
And what about critical anatomic pathology diagnoses like adipose tissue or lack of placental villi in an endometrial curettage specimen? Are labs supposed to notify the patient their OB/gyn perforated their uterus or that they may have an ectopic pregnancy before the OB/gyn is even informed?
What are the labs supposed to tell the patient when they call with a critical value, given the ordering provider may not even know the result yet? Have them call the provider immediately? Go directly to the closest ER? Call an ambulance?
In addition, there are some circumstances (thankfully not common) in which a “normal” result is actually bad for that particular patient. In that case, could a lab potentially get in trouble for not reporting a “normal” result to a patient?
There are some potentially very serious liability issues here.
Good idea, but questions still remain
I believe greater transparency in medicine is a good thing, including providing laboratory results directly to patients. There are, however, some issues that need to be resolved, at least in my mind, including the added potential liability labs could face as a result.
Why shouldn’t patients have their results? They paid for the tests. It’s a commodity. I hate that my doctor quit without notice, gave my records to a group that I did not want to use, and the group would not give me my own records without paying for them. I already paid for them once, why should I have to pay for them again.
I believe they do deserve to see their results. I just want them to be released in a manner that does not cause patients angst or put their providers in difficult positions for no good reason.
As I said, I am for more transparency in medicine and you should not have had the difficulties you did in trying to obtain your records.
Thanks for the comment.
i personally dont want patients calling the labs for the results and talking to the pathologist about their anatomic pathology. that is not our role at all. but patients should be able to get their records with a proper release from themselves and the clinician who ordered the tests. thats fair. we need to have another update about clinicians doing pathology billing for anatomic pathology. we also need another update on the reduction in the pathology codes and what was the response to the CAP letter to CMS. thank you.
i personally dont want patients calling the labs for the results and talking to the pathologist about their anatomic pathology. that is not our role at all. but patients should be able to get their records with a proper release from themselves and the clinician who ordered the tests. thats fair. we need to have another update about clinicians doing billing for lab work for anatomic pathology and when the loophole to the stark law is going to shut. we also need another update on the reduction in the pathology codes and what was the response to the CAP letter to CMS. thank you.
Patients need and deserve direct reporting of their laboratory and pathology reports. We cannot ask patients to be more responsible for their health care and then deny them the tools with which to do so.
Please refer to your own related blog post #5. How could this outcome have been different if the patient had direct access to the test result?
Currently, 7 states have laws which expressly allow direct reporting to patients and another 23 states have no law prohibiting direct report. To think that patients will be harmed by direct reporting is overly paternalistic.
Lab results are data. They will always require healthcare providers to provide context and interpretation. Informed patients recognize this.