RE: OB-GYN Laboratory and Pathology Topics

Dear Colleagues:

Our long-time goal continues to be to meet the needs of our clinical physicians in an excellent manner.to be an excellent "help" to you.

The last thing any of us need is another committee or another set type of meeting for physicians to attend. As with our 8-pathologist group at LMC, I am confident that various ones of our OB-GYN community are more-or-less interested in each of the attached topics. They are topics which have brought about discussion within our pathology group. And we find ourselves in need of reasonable input from you, our OB-GYN colleagues.

If you have any significant personal interest in any of the attached topics and would be willing to give us some feedback, please let me know. We would hope to address each of these issues by one or more of our group meeting very informally (during a routine meal in the doctors' lounge.or some brief dialoging by e-mail.or any other method you prefer) with one or more OB-GYNs. Using any means of communication that you prefer, please let me know if any of this interests you and if you would be willing to give us clinical feedback.

Sincerely,

Ervin B. Shaw, M. D.
Director of Anatomic Pathology
FAX: 803-939-8722
voicemail: 803-791-2991 x2411
phone: 803-791-2411
e-mail: shaw@lexhealth.org

OB-GYN Current Topics
(as of Jan. 2005)

Clinical Lab Tests Topics:

1. Clinical laboratory reports in general: We need specific feedback from you concerning any annoying.if there are any.aspects of our clinical lab test reporting.
2. HSV II type-specific testing: Dr. Thompson recently brought this to our attention, that the HSV select II was a test (Western Blot) which did not cross-react with HSV I. Gary Ferguson has gone through the evaluation process and brought, and we now have type-specific testing also available as of 11/04. Is everyone aware of this; does anyone need additional information?  We are aware of recent publication of OB check @ 15 weeks, checking of HSV status. 
3. Recurrent spontaneous abortions; thrombophilias/hypercoagulopathies and pregnancy: We have heard of concern for proper testing for "lupus anticoagulant", etc. Dr. Armstrong is scheduled to speak to the OB-GYN quarterly meeting concerning this. We wonder if there is a place for a fairly comprehensive histological/lab-tests coordinated workup of such patients.
4. Pregnancy testing:
   • If the total serum BHCG is inconsistent with the clinical picture and is persistently elevated, a urine HCG test should be performed; heterophilic antibodies can interfere with any immunoassay test and produce false elevations (urine is neg. in those).We can also treat the serum sample with a heterophile blocking tube and re-assay (if no reasonable access to urine).Care should also be taken to consider the possibility of HCG-secreting tumors.
   • Detection of only very low levels of BHCG does not rule out pregnancy. Retest after 48 hours if pregnancy is really and truly expected.
   • Rarely, samples elevated > 300,000 mIU/mL may read as if falsely reduced or lowered within the reportable range (0-1000) due to a high dose "hook effect" artifact. Running samples undiluted and diluted will help reveal this problem.
   • We intend to cease the qualitative serum HCG test in favor of the quantitative test this month (12/04) at no change in charge to patient.
5. Group B. Strep testing: Are there any problems with turnaround time (TAT) and reporting of vaginal testing for this organism?
6. PMB in anticoagulated women: Given the frequency of severe PMB in women on coumadin, is there any interest in alternate methods of anti-coagulation that might need alternate monitoring tests? We are now able to extensively evaluate many testing and monitoring issues, including bleeding or thrombotic tendencies.
7. Masculinity (hirsutism) lab testing: Is there any need or role for step-wise, lab-managed, protocol testing coordinated by us and with specimens obtained from your offices or potentially available through the CMCs (upon triggering of the prescription/consultation by OB-GYN)? Or, should we just optimize a "profile"? At no charge by pathologist.
8. Prenatal laboratory testing: Is this all working to everyone's satisfaction? Should we explore any process refinements?
9. Labor & Delivery: Is the turnaround time (TAT) and scope of LMC lab testing available 24/7/365 meeting everyone's needs adequately? Should we explore any process refinements?
10. Executive Lab Profile: Though we are aware that the hospital offers Executive physicals and testing of all sorts, we have been recently asked of the feasibility of setting up an Executive Laboratory Profile. What are your thoughts of the most important items for such a profile?

Anatomic Pathology Topics:

1. Pathology and Cytology reports in general: We need specific feedback from you concerning any annoying.if there are any.aspects of our Anatomic Pathology reporting.
2. Method for HPV testing:
   • Which of two methods: Pap smears for HPV by HC II (Digene) or CISH (Ventana)? HC II has had a significant false-positive rate (over 20%), does not produce a result visible on a slide, and is inherently expensive (reagent cost) and must therefore be done in weekly batches. CISH produces a permanent slide with HPV visibility and ability to visually discern whether the virus has been integrated (or not) into the nuclear chromatin (higher probability of oncogenic risk when "integrated").negative for any false-positive problems; and the test can be done quickly and one at a time and actual results integrated into the initial reporting (if doctor has ok'ed "reflex testing" for ASCUS/AGUS) of the abnormal Pap smear. Have worked with MUSC on this. Ready for a decision from OB-GYNs in early 2005.
   • "High risk" versus "low risk" testing: we are seeing indications that there is decreased interest in low risk testing, nationally. Of our local practitioners, only about a dozen are continuing to request low risk testing (out of habit?). Is it possible that the MSO practitioners we are serving could largely agree to HPV testing for high-risk only (except for special cases)?
3. AGUS (and ASCUS) follow-up-"prompting" note in the Pap or biopsy report:
   • In that our group has been named in a lawsuit, the issue of report "recommendations" to clinicians has surfaced again; we must make a "recommending comment". What is the clinically preferable proper wording of Pap smear and biopsy reports (without "time bombs") in order to express the pathologist's concern. Any wisdom to offer us? [societal adverse impact of lawsuits]
   • Has ACOG.or the LMC OB-GYN community.arrived at a general best recommendation for reasonable clinical follow-up and biopsy/cytopathology sampling methods to support properly sensitive (find lesion if it's there) follow-up sampling? I would remind everyone that we must firmly remember that the final hysterectomy specimen in cases like this can even contain adenocarcinoma in-situ down in deeper glands, with the recent follow-up samples being negative (LMC-05-170, 29-years-old).
   • We continue to do all that we can do to technically assure that all of any type of ECC (or similar sample) actually gets on the pathology slides for microscopic diagnosis. We have used agar-stool agar pre-embedding and are exploring agar-cast cell blocks.both being our group's unique inventions. That is, we are straining to assure that there is no sample loss or waste.
4. Placenta pathology exams:
   • Especially if the pathology exam finds abnormalities, we hope to be able to assure that a report copy gets to the baby's, infant and childcare doctor. So, we have recently (11/04) revised the "green" placenta requisition sheet to capture that and some other information very helpful to a proper pathology examination.
   • Also, sometimes there is a problem in matching (where one portion of placenta might be abnormal and the other normal) multiple-gestation placentae with the specific baby (LMC-04-6995). How to assure ID of correct baby matches to any abnormal zone of a multiple-gestation placenta?
   • We have been in one "spat" (L-04-828) about "identical twins". Parents are now able to independently get blood specimens to genetics labs for "DNA polymorphism" testing as an alternative attempt to have early, more certain evidence of whether their twins are identical or not. In the case in question, we had histologically only been able to determine that the twins were "diamniotic dichorionic" (8-10% are identical); the reference lab DNA testing elsewhere, later,  indicated that the twins were "identical" with "a greater than 99% probability". Should we do anything different on the "front end" of a multiple gestation pregnancy? Should some of us get together and devise a suitable clinical-pathological correlative informational statement for the potential use of parents who are very anxious to know what type of twins their same-sex twins are?  Is buccal cytogenetics offered to parents while babies in-house at LMC?
   • Since placental pathology exams have long been reported to be especially valuable for malpractice defense, is there anything our department needs to do (or quit doing) with respect to placental exams?
5. IVF endometrial biopsy dating: Is our 8-pathologist group consistently doing an optimal job on this (we will check with Dr. Gail W.)?
6. Detection of polycystic ovaries (possible "metabolic syndrome"): How sensitive should the pathology team be in detection of "polycystic ovaries" in view of their relationship to "metabolic syndrome" and the increasing awareness and prevalence of that syndrome and the need for medical management in that syndrome?
7. Liquid-based Pap samples: How much.and what specific tests.future add-on testing is actually likely to become prevalent in the next couple of years?
8. Biopsy Adequacy: In that the pathologist is now often able to be more aware of the clinical situation (especially through the EMR), what would be a communicative way for pathologists to express doubts over sufficiency of a sample (scant ECCs in an AGUS work-up; scant endometrial biopsy in a "thickened endometrial stripe" work-up on a patient, say, on tamoxifen; single small and negative cervical biopsy on a patient with recurring "ASCUS, can't r/o dysplasia" Pap smears)? Again, in view of the above-noted lawsuit we're involved in, an adequacy/suboptimal/inadequacy statement must be an option for us (after all, such a statement legally must be made in every Pap smear case).
9. Incomplete-molar POCs: What is the clinical consequence of this diagnosis and what is the clinical consequence of under-diagnosis of this situation? We are currently in the process of a QA project in which we are utilizing expert consultation to refine our diagnostic threshold on both the lower end (non-molar hydropic POC vs. incomplete molar POC) and high end (incomplete molar POC vs. complete mole).
10. Liquid-based Pap smear concentration/enrichment systems: ThinPrep uses a fixed surface membrane, cloggable filter system to concentrate the cells (and debris) from a Pap sample aliquot onto a fixed-pore filter surface. SurePath (used at LMC) uses a non-fixed, liquid/molecular, barrier zone density gradient system to sift & separate cellularity of interest from debris and elements which are confounding and extraneous. See (http://www.palpath.com/papgradient.htm). FYI.