from the Division of Laboratory Systems,* Centers for Disease Control and Prevention, Atlanta, Georgia; the Wadsworth Center, New York State Department of Health, Albany, New York; the Albert Einstein College of Medicine, New York, New York; ARUP Laboratories and the University of Utah, Salt Lake City, Utah; the Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington; San Ramon Valley Primary Care, San Ramon, California; the Genetic Services Laboratory,** Sequenom Incorporated, San Diego, California; and the Department of Human Genetics, Mount Sinai School of Medicine, New York, New York.
What did they investigate? Simple....how genetic tests were orderded and how results were given. What really got my goat was the results.
First as a preface....the AMA in June put out a statement against DTC genetic testing Resolution 502, A-04. D-480.987 in case you want to check it out. This statement says:
Our AMA: (1) recommends that states restrict the performance of clinical and laboratory genetic testing to individuals under the personal supervision of a qualified health care professional......
Also in the AMA policy manual is E-2.131.....
Physicians who order genetic tests should have adequate knowledge to interpret information for patients. In the absence of adequate expertise in pre-test and post-test counseling, a physician should refer the patient to an appropriate specialist....
So with that backdrop I give you the study "Ordering Molecular Genetic Tests and Reporting Results. Practices in Laboratory and Clinical Settings."
To understand better the contributing factors to such compromised care, we investigated both pre- and postanalytical processes using cystic fibrosis mutation analysis as our model.
Ok this will be great! CF testing. When was the last time the OB went over pre and post test counselling for carrier status???? I can't wait to see the results...
1. We found that although the majority of test requisition forms requested patient/family information that was necessary for the proper interpretation of test results, in many cases, these data were not provided by the individuals filling out the forms.
2. We found instances in which result reports for diagnostic testing described individuals as carriers where only a single mutation was found with no comment pertaining to a diagnosis of cystic fibrosis.
3. Remarkably, a pilot survey of obstetrician-gynecologists revealed that office staff, including secretaries, often helped order genetic tests and reported test results to patients, raising questions about what efforts are undertaken to ensure personnel competency.
If you have any question as to why OB/Gyns get sued more often than anyone else.....look no further than the results of this study!
The Sherpa Says: The real pickle is this. The American College of Obstetrics and Gynecology recommends that every pregnant woman get "screened" for cystic fibrosis mutations. So the OBs are forced to do this testing.....oh wait, no they aren't. They could actually refer patients. Or even better, they could hire a geneticist. But why do that when they could just have their secretary do that work? Scary stuff!!! This makes DTC look pretty warm and fuzzy.
