What makes an IVF program excellent?

August 27, 2013Carole 4 Comments »

Previously published on-line . Journal of Clinical Embryology. Vol.16 . Issue 3. pp.166-167 (http://embryologists.com/)

Patients are always asking me, “How can I find an excellent IVF program?” I usually tell them to review the annual outcome data that IVF programs report to the CDC or SART and look for programs with better than average live birth outcomes for their age group.

Some of my colleagues take issue with that answer because they argue that special circumstances exist (for example, cherry picking good prognosis patients; inaccurate reporting of data) which is why other programs have high pregnancy rates and therefore patients shouldn’t look to the published outcome data to find good IVF programs. I would agree that high pregnancy rates alone, especially if they come at the cost of higher order multiples and the accompanying obstetrical complications, are not a sufficient marker of excellent patient care. Another problem inherent in relying on this outcome data is that high pregnancy rates may be transient as programs open and close and staff moves around between programs.  Data two years old may not be meaningful because the quality of the program may have eroded in the meantime.

Would we be able to better identify good programs with a better reporting system? Geoffrey Sher, M.D, of Sher Fertility Clinics Centers for Reproductive Medicine, blogged about the weaknesses he sees in the current SART/CDC reporting system. Dr. Sher identified several problems with the current outcome reporting system that undermine its effectiveness as a tool for patients to identify high quality IVF programs, such as:

  • ·  Only 10% of clinics are audited.
  • ·   These clinics are notified of the audit in advance. 
  • ·    The audit only looks at 50 full-cycle and 25 partial-cycle records; reviewing documentation and confirming live births.
  • ·     The audit does not actually verify success rates because although the number of births (the numerator in the percentage) is confirmed, the number of total cycles initiated (the denominator) is not confirmed.
  • ·      The two year delay in reporting outcomes is particularly problematic when new procedures like aCGH become more widespread in that time, driving a move to fewer fresh transfers and more frozen transfers, making the fresh transfer pregnancy rate less meaningful in terms of total pregnancy outcomes.

Dr. Sher proposes that a more meaningful reporting system would categorize cycles by level of complexity, not just maternal age. Internally, his program’s own database incorporates age, ovarian stimulation cycle, ovarian reserve measured by basal FSH, number of eggs retrieved, and number of prior failed cycles as categories to stratify pregnancy outcomes.

Even with a perfected reporting system, we still need a better understanding of why some IVF programs are consistently strong and others weak. Doing good IVF is not rocket science. We know what embryos need in terms of media, temperature, pH, etc. to develop well. We know that a careful transfer of a single high quality embryo is likely to result in pregnancy. We may argue among ourselves as to the best stimulation for a certain type of patient, or the best media, cryopreservation method, or transfer day. And we certainly argue about how to detect the “most likely to implant “ embryo. Stellar results can be realized using very different methods in different programs – one size apparently does not fit all- particularly in terms of IVF protocols. We are probably helped by the fact that embryos have a lot of tolerance or plasticity and “life tends to find a way”, if at all possible.

Michael Alper, MD, of Boston IVF, and his international colleagues published an article in Human Reproduction, Is your IVF programme good?, which also argued for more robust standards and auditing of IVF programs and universal adoption of international quality control standards similar to ISO9001 standards for quality management. He suggests that a robust quality control program should include not just tracking of pregnancy rates but also other areas such as patient satisfaction, documentation of procedures, equipment quality and maintenance, safety, cleanliness, staff qualifications and training programs.

At least in the US, it is doubtful that we would ever embrace domestic, let alone international, standardization of protocols for IVF programs. Here, each IVF program may exist as its own fiefdom, with a weak external patchwork of regulatory oversight and largely voluntary standards to define operations and ensure patient quality. And based on the reaction of colleagues when this topic comes up, most IVF providers like it that way.

The scientific and medical knowledge needed to have an excellent program is not a secret so why aren’t all IVF programs excellent?  The simplest answer was given by Dr. Alper, in his paper when he said, “An IVF centre is only as good as the staff it employs”. This human factor—something invisible and unfortunately not reportable to the CDC—is responsible for ensuring that an IVF program will be excellent.

A great IVF program results from caring people doing consistently high quality work. For me, it boils down to one simple idea- consistently remembering that your service in the lab or the clinic is about the patient and not about you.

If you work in IVF long enough, you will eventually encounter some bad programs that give lip service to patient care while practicing primarily program self-care. Self-care means making patient care a priority only when it is easy or when it is cheap. On the other hand, excellent patient care means providers (clinicians and lab) care enough about their patients to follow medical standards, professional guidelines, or technical protocols –even when no one is looking.

Unfortunately, I have encountered programs that use lab manuals for “show and tell” for the inspector and then ignore these written procedures as soon as the inspector leaves the premises. In contrast, high quality IVF programs keep protocols and lab manuals up to date, even if the next inspection is two years away. High quality programs follow state and federal regulations, even when they could get away with not doing it. High quality programs work preemptively to avoid problems. For instance, having a risk management plan to first, prevent systemic errors and encourage transparency, and secondly, when the inevitable error occurs, address patient harm first and clinic impact second. In small programs, the use of a witness procedure when an embryologist must work solo goes the extra mile to protect patients. High quality programs staff appropriately for safety and patient service, even if doing so reduces profits. This is hard, really hard stuff because it forces programs to consistently put patients’ interest first.

Who is responsible for ensuring that the program delivers consistently high quality services? Is it CLIA? Is it FDA? Is it state or federal regulations? Is it ASRM or SART or ESHRE? No. These organizations can provide standards –and some can even enforce some of their standards- but they can’t provide or ensure that patients get high quality care. You, however, can ensure good patient care, because the quality of the patient care resides in the people that provide it. Ironically, excellent programs usually don’t chafe under any of this oversight; probably because their people have already made it a habit to do the right things for the right reasons- and not because they fear the consequences of non-compliance.

Program leaders- medical director, physicians, lab director, and senior nurses- set the expectations for patient care. If you are in a leadership position, you will find yourself in hard places where you need to make difficult decisions. At these crossroads, ask yourself: Is this decision best for the patient or best for me? If you want to have a great program, the choice is obvious, even when it is not easy.

© 2013, Carole. All rights reserved.

4 Responses to this entry

  • anonymous Says:

    I just found your blog and love the insight. I am 41 and after 2 years of trying for baby#2, who was conceived easily & naturally, we are headed to IVF. In all my research, the doc is important, but the lab quality seems to critical to good outcomes. I’ve interviewed several clinic with high success rates in my age band and to the doctors’ credit they cite their lab as key to success. This makes me slightly nervous as I can talk with the doctor, but not the lab. Although I haven’t asked to do that. We have chosen to work with a practice in S Florida, and I’m curious if a patient ask to speak with the head of the lab? If so what questions should I ask?

  • Carole Says:

    Hi Anonymous,
    Yes, of course, you can ask to speak with the head of the lab. Unfortunately, the trend is moving to more and more labs directed by off-site lab directors- which may make a face-to-face meeting less likely. Off-site direction typically means that the lab director is not on-site everyday and may not even be on-site when cycles are run.Legally, a CLIA certified high complexity lab director (HCLD) can direct up five labs, a primary lab and four others at which they don’t appear daily. There may be a senior embryologist (sometimes certified as a technical lab supervisor) who has responsibility for day to day operations. Some lab directors are not really there, except to sign paperwork and legitimize the practice. Others are very much involved in every aspect of the lab operations. If it were me, I’d want an on-site lab director.

    My feeling is that off-site lab direction does not benefit patients, but is used primarily to reduce overhead for practices. I come by this opinion as someone who has directed IVF labs in both on-site and off-site capacities. it is MUCH cheaper to hire an off-sire lab director (consultant) than to pay for an on-site PhD board certified lab director.

    Some of the things you want to know from whomever you talk with is how much experience does the lab have with the procedures you will be having– egg or embryo freezing, PGD or PGS, extended culture etc. You can ask for more recent unpublished pregnancy rates for patients like you (similar age group, protocols etc) since the CDC rates are two years behind. You might be interested in knowing whether the lab staff directly speak with patients during the time your case is in culture or if all lab info is transmitted via an intermediate (nursing staff or the doctor)? In general, you might want to know what kind of access you will have to staff (lab and nursing) to answer your questions as they arise.

    Good Luck!!

  • ERIN Says:

    Hi, I had a question about ACGH. I am on my second round of IVF and am 38. My first cycle I produced 15 eggs, I believe there were 12 to do the ACgh testing on. I had two blastocysts transferred on day 6 which resulted in a BFN. This round my doctor wants to do the testing on day 3 with a 5 day transfer. In your opinion is the genetic testing as accurate as they lead you to believe or will I have as good of a chance transferring 3 normal looking blastocysts on day 5. I can’t get a definite answer on how reliable these tests are am having a hard making a decision to try it again. Thank you

  • Carole Says:

    HI Erin,
    Different doctors prefer to do things differently but an argument can be made that because you can sample more cells for biopsy on day 5 compared to day 3, you get a more robust result- and less chance of randomly sampling one cell which is not representative of the embryo . I think the ideal protocol is culture to blast, biopsy and then freeze all blasts- keep them in the freezer pending results from the lab. Then transfer the highest scoring normal embryo in an FET the next month. This is the lowest risk approach because you don’t force a lab into doing rapid turnaround testing which sometimes gets screwed up and you don’t unnecessarily keep embryos hanging in clulture until late on day 6 pr day 7, when they are less viable.Also, there is evidence that preg results are higher in an FET cycle since the endometrium can be optimized for implantation, not overstimulated as a by product of ovarian stimulation protocols. So, I think the testing is valuable and there are better and worse ways to use it. Good luck with whatever you decide!! Carole

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