Comprehensive evaluation of

contemporary assisted reproduction

technology laboratory operations
to determine staffing levels that
promote patient safety and
quality care
Mina Alikani, Ph.D., H.C.L.D.,a Kathryn J. Go, Ph.D., H.C.L.D.,b Caroline McCaffrey, Ph.D., H.C.L.D.,c
and David H. McCulloh, Ph.D., H.C.L.D.c
a
Center for Human Reproduction, North Shore University Hospital, Manhasset, New York; b Reproductive Science Center of
New England, Lexington, Massachusetts; and c New York University Fertility Center, Langone Medical Center, New York
University, New York, New York

Objective: To consider how staffing requirements have changed with evolving and increasingly more complex assisted reproduction
technology (ART) laboratory practice.
Design: Analysis by four laboratory directors from three different ART programs of the level of complexity and time requirements for
contemporary ART laboratory activities to determine adequate staffing levels.
Setting: University-based and private ART programs.
Patient(s): None.
Intervention(s): None.
Main Outcome Measure(s): Human resource requirements for ART procedures.
Result(s): Both complexity and time required for completion of a contemporary ART cycle have increased significantly compared with
the same requirements for the ‘‘traditional cycle’’ of the past. The latter required roughly 9 personnel hours, but a contemporary cycle
can require up to 20 hours for completion. Consistent with this increase, a quantitative analysis shows that the number of embryologists
required for safe and efficient operation of the ART laboratory has also increased. This number depends on not only the volume but also
the types of procedures performed: the higher the number of complex procedures, the more personnel required. An interactive Personnel
Calculator is introduced that can help determine staffing needs.
Conclusion(s): The increased complexity of the contemporary ART laboratory requires a new look at the allocation of human re-
sources. Our work provides laboratory directors with a practical, individualized tool to determine their staffing requirements with a
view to increasing the safety and efficiency of operations. The work could serve as the basis
for revision of the 2008 American Society for Reproductive Medicine (ASRM) staffing guide- Use your smartphone
lines. (Fertil SterilÒ 2014;102:1350–6. Ó2014 by American Society for Reproductive Medicine.) to scan this QR code
Key Words: ART complexity, embryology laboratory, patient safety, PGD/PGS, staffing and connect to the
discussion forum for
this article now.*
Discuss: You can discuss this article with its authors and with other ASRM members at http://
fertstertforum.com/alikanim-art-laboratory-staffing-safety/ * Download a free QR code scanner by searching for “QR
scanner” in your smartphone’s app store or app marketplace.

T
Received May 5, 2014; revised July 22, 2014; accepted July 25, 2014; published online September 16,
2014. he past decade has seen dramatic
M.A. has nothing to disclose. K.J.G. has nothing to disclose. C.M. has nothing to disclose. D.H.M. has changes in assisted reproduction
received personal fees from Infertility and IVF Medical Associates of Western NY, Snyder, NY;
Biogenetics Corporation, Mountainside, NY; NYU Fertility Center, NYC, NY; and ReproART
technology (ART) practice,
(Georgian American Fertility Center) in Tbilisi, Republic of Georgia, unrelated to the submitted including the addition of many new
work. technologies and increased oversight
Reprint requests: Mina Alikani, Ph.D., H.C.L.D., North Shore University Hospital, Center for Human
Reproduction, 300 Community Drive, Manhasset, New York 11030 (E-mail: [email protected]). (1). As a result, safe and efficient oper-
ation of the ART laboratory has become
Fertility and Sterility® Vol. 102, No. 5, November 2014 0015-0282/$36.00
Copyright ©2014 American Society for Reproductive Medicine, Published by Elsevier Inc.
increasingly complex, requiring a deep
http://dx.doi.org/10.1016/j.fertnstert.2014.07.1246 understanding of laboratory activities

1350 VOL. 102 NO. 5 / NOVEMBER 2014

 Fertility and Sterility®

and the proper allocation of resources to support those activ- This traditional laboratory cycle, however, only applies to
ities. Different approaches to calculating staffing needs have a small proportion of current ART cycles. Thus, a reevaluation
been proposed (1). One approach used the number of in vitro of this concept is needed. We present a new approach to as-
fertilization (IVF) cycles, where each cycle was taken as the sessing staffing needs based on a detailed analysis and offer
sum of oocyte retrieval, insemination/intracytoplasmic sperm a logical and quantitative method for laboratory directors to
injection (ICSI), embryo culture, and embryo transfer; another determine minimum staffing requirements for their
considered each laboratory cycle as consisting of a full spec- laboratories.
trum of individual embryology subprocedures, including
oocyte retrieval, sperm preparation, embryo transfer, or cryo-
preservation. However, the most recently published guide- MATERIALS AND METHODS
lines on allocation of human resources in embryology A list of all activities in the contemporary ART laboratory was
laboratories date back to 2008 (2). The guidelines are based compiled. Four laboratory directors, representing or having
on the number of ‘‘laboratory cycles’’ performed. Although substantial experience with small, medium, and large pro-
the term laboratory cycle is not specifically defined, it can grams discussed and agreed on time requirements as well as
be reasonably assumed to refer to a ‘‘traditional’’ treatment the level of complexity of the various procedures on the list.
cycle that typically involves an oocyte retrieval procedure, Level of complexity refers to level of skill required and the
insemination of the oocytes, intrauterine transfer of the re- number of steps involved in each procedure; this definition
sulting embryos, and cryopreservation of surplus embryos may or may not conform to the categories defined by
when appropriate. Clinical Laboratory Improvement Amendments (CLIA) (3).

FIGURE 1

A flowchart representing complexity of the contemporary ART laboratory operations. This is a representative figure and does not depict all practiced
variations on treatment approaches. sIVF ¼ standard insemination.
Alikani. Staffing the contemporary IVF laboratory. Fertil Steril 2014.

VOL. 102 NO. 5 / NOVEMBER 2014 1351

ORIGINAL ARTICLE: ASSISTED REPRODUCTION

developed based on this evaluation, and it was validated by

TABLE 1
application to several facilities. The calculator was designed
Technologies, procedures, and processes that have added
to generate minimum staffing requirements based on the
significant complexity to the ART laboratory. main procedures handled by the laboratory. We opted to
Increasingly frequent and rapid integration of new, specialized exclude a detailed accounting of peripheral activities in the
techniques into daily use calculator to ensure its utility, keeping in mind that different
Intracytoplasmic sperm injection (ICSI) for treatment of laboratories handle those tasks differently. Nonetheless, it
(increasingly more challenging) male factor and non–male
factor infertility
should be noted that time required for activities such as re-
The use of the laser for assisted hatching and the associated viewing treatment plans with physicians and patients, im-
instrument maintenance and calibration requirements porting and exporting samples, data entry, consent checks,
Embryo biopsy and all its associated administrative tasks, such as and other similar tasks were considered when total time
management and communication of results and maintenance
of records and data required for different procedures was assessed. For example,
Blastocyst biopsy, possibly requiring embryo assisted hatching on a review of the treatment plan is part of the preparation for
day 3 and biopsy on day 5, day 6, and even day 7 of all cycles; data entry is included in the document manage-
development as well as possible requirement for immediate
vitrification of embryos after biopsy, and the imperative
ment portion in the calculator. Furthermore, the estimation
processing of individually identified and vitrified embryos and of time required is based on performance of procedures by
witnessing of the entire process reasonably well-trained embryologists. However, it is impor-
Increased requirements for witnessing to provide patients with the tant to acknowledge that a substantial amount of time and re-
assurance that gametes and embryos are always tracked
individually and accurately through all the treatment steps in sources are required for training of embryologists.
the laboratory Additionally, this analysis is limited to the embryology
Challenging cytogenetic techniques like nuclear fixation for laboratory and does not include the time required for diag-
fluorescent in situ hybridization (FISH) or, more recently, nostic semen analysis, processing of semen for intrauterine
preparation and loading of biopsied tissue in microtubes for
sample shipment and the imperative witnessing of these insemination, cryopreservation of sperm for later use, or
procedures endocrinology testing. We chose to restrict our calculations
Vitrification in addition to slow cooling as a method of to embryology tasks only (including sperm preparation for
cryopreservation
Use of multiple varied vessels with different requirements for
IVF-ICSI). The addition of other tasks would naturally in-
vitrification and the need for knowledge of devices and crease the workload and personnel time required to perform
handling after transport of embryos between programs all tasks.
Oocyte vitrification for fertility preservation for medical and The Interactive Personnel Calculator is available online.
nonmedical reasons
Thawing of oocytes and/or embryos in cycles where treatment The formulae used to devise the calculator are presented in
modalities/plans are often combined adding to the complexity the Results section. The calculator determines the number of
of each case personnel necessary by assessing six different activity types:
Time-lapse microscopy and incubation equipment with significant
operational time requirements and training, frequent service
[1] daily quality control tasks (QC); [2] IVF with embryo trans-
visits, maintenance, and software updates fer and cryopreservation but without preimplantation genetic
Use of commercial egg banks requiring high level of coordination, screening/diagnosis (PGS/PGD) (IVF); [3] IVF with embryo/
data sharing, and reviewing blastocyst biopsy for PGS/PGD and cryopreservation (IVF-
Administration of cryopreserved gametes and embryos, including
a rapidly increasing inventory, import, export, and donation PGD); [4] oocyte retrieval with oocyte cryopreservation
One on one interaction between embryologists and a better- (oocyte freeze); [5] cryopreserved embryo thaw/warming
informed and increasingly more involved patient population with embryo transfer (FET); and [6] cryopreserved oocyte
Increased oversight and regulations requiring inspections (CAP, thaw/warming with ICSI, culture, and embryo transfer (OOT).
JCAHO, state departments of health, FDA, SART) leading to
additional quality control and quality assurance activities, The sum of the products of personnel time for each proce-
including proficiency testing, structured documented training dure and the number of procedures performed determined the
of personnel, testing of contact materials or media products, total personnel time required for these procedures. Division of
updating of laboratory manuals, and commitment to
continued education and training
this time by the number of personnel hours available per year
Requirement for training and mentoring of fellows and teaching for one person (accounting for 5 days per week, 8 hours per
of medical students in academic centers day, time for lunch and breaks, as well as 10 vacation days
Requirements for data collection, analysis, and publication per year) yielded an estimate of the number of personnel
Administration of randomized controlled trials requiring
significant investment of time for patient and data needed. Further, we stipulated that because of witnessing
management needs and to ensure safety, no fewer than two people must
Conducting institutional review board approved research studies be present (during most days of operation) when procedures
in academic centers along with the accompanying
documentation
are performed. A witness can be anyone trained to witness
Alikani. Staffing the contemporary IVF laboratory. Fertil Steril 2014.
the procedures, but this is often another embryologist. Alter-
natively, andrologists, medical or laboratory assistants, or
even personnel expressly hired for the purpose of witnessing
To calculate the time required for different procedures, may perform these tasks. It should be stated that, to our
a detailed table was constructed by one director (MA) then knowledge, there is no ‘‘requirement’’ for witnessing as
evaluated, discussed in detail, and revised as agreed upon such, but to ensure safety and minimize unfortunate incidents
unanimously by all four directors with current hands-on lab- of misidentification (4–8), procedures must be witnessed
oratory experience. An Interactive Personnel Calculator was whenever the possibility of an identity error exists.

1352 VOL. 102 NO. 5 / NOVEMBER 2014

 Fertility and Sterility®

RESULTS involving PGS/PGD require even more personnel time,

The complexity of the contemporary ART laboratory opera- amounting to some 20.2 hours of work.
tions is depicted in a flow chart in Figure 1. The flow chart Table 3 is an analysis of different components incorpo-
does not detail all possible practice variations but represents rated in each type of activity in the contemporary ART labo-
a majority of common practices. ratory. Each activity has also been assigned a complexity
Table 1 lists technologies, procedures, and processes that level. Complexity was calculated based on five elements: [1]
are currently part of routine practice in many laboratories, time restriction, [2] requirement for intense/prolonged focus,
adding significant complexity to their operations. These [3] multiple complex steps, [4] potential irreversible harm to
vary from time- and labor-intensive procedures such as gametes/embryos, and [5] potential serious harm to the pa-
PGS/PGD with cryopreservation of biopsied embryos for later tient. Harm to the embryo is defined as any manipulation
thaw/warming and transfer, to substantial time that must be that impedes development, implantation, or progression to-
dedicated to administrative work related to increased over- ward delivery of a healthy infant. Harm to the patient encom-
sight by governmental entities (e.g., the U.S. Food and Drug passes both psychological and physical harm that would
Administration [FDA], the Centers for Disease Control and result as a consequence of inadvertent errors that lead to fail-
Prevention [CDC], or the New York State Department of ure of the treatment or misidentification of gametes or em-
Health) and nongovernmental and professional organiza- bryos. It should be noted that the last two elements are
tions (e.g., Joint Commission on Accreditation of Healthcare present during virtually all manipulations in the laboratory,
Organizations [JCAHO], Society for Assisted Reproductive but they were only included when the chances were increased
Technologies [SART], or College of American Pathologists or substantial. For example, case setup on the day before pro-
[CAP]). cedures was given a complexity level of 2 for time restriction
Table 2 compares the numbers of personnel hours esti- and intense, prolonged focus, but a procedure such as embryo
mated to be required to complete different types of cycles, ac- transfer was given a complexity of 4 because all but (possibly)
counting for the procedure and witnessing time requirements. one element (potential harm to gametes/embryos) apply to
The number of hours for a traditional cycle, a contemporary that procedure.
cycle, and a contemporary cycle that integrates PGS/PGD The Interactive Personnel Calculator is based in part on
were compared. Whereas in earlier years of IVF, a typical operational details presented in Tables 2 and 3. The calculator
IVF cycle required roughly 9.1 personnel hours, a standard operates on two levels: First, it provides a minimum of two
IVF cycle now requires substantially more time (roughly staff members for every day of operation in the embryology
12.6 person hours). More complex cycles, such as those laboratory. However, two individuals working simultaneously

TABLE 2

A comparison of the estimated number of person hours required for completion of a traditional versus contemporary versus contemporary with
PGD/PGS cycles (the latter requiring almost three times as many person hours as the traditional model).
IVF traditional IVF contemporary IVF/PGS/PGD
Procedure time (min) Witness (min) Procedure time (min) Witness (min) Procedure time (min) Witness (min)
Preparation all 30 0 60 0 80 0
Oocyte retrieval 60 10 60 10 60 10
Sperm preparation 60 10 60 10 60 10
Insemination/ICSI 20 10 40 20 40 20
Fertilization check 40 10 40 10 40 10
Day 2 check 20 0 20 0 20 0
Day 3
Check 20 0 20 0 20 0
Transfer 40 10 0 0 0 0
Cryo 40 10 0 0 0 0
Assisted hatching 20 0 20 0 60 0
Extended culture 0 0 40 10 40 10
Day 5
Check 0 0 20 0 20 0
Transfer 0 0 40 10 0 0
Biopsy 0 0 0 0 80 40
Cryo 0 0 40 20 80 40
Day 6
Check 0 0 20 0 20 0
Biopsy 0 0 0 0 80 40
Cryo 0 0 40 20 80 40
No. of minutes 350 60 520 110 780 220
No. of hours 5.83 1.00 8.67 1.83 13 3.67
Total time (h) 6.83 10.50 16.67
Note: Cryo ¼ cryopreservation (primarily vitrification); ICSI ¼ intracytoplasmic sperm injection; PGD ¼ preimplantation genetic diagnosis; PGS ¼ preimplantation genetic screening.
Alikani. Staffing the contemporary IVF laboratory. Fertil Steril 2014.

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ORIGINAL ARTICLE: ASSISTED REPRODUCTION

TABLE 3

Activities in the IVF laboratory including components and estimated complexity level.
Activity Component 1 Component 2 Component 3 Component 4 Component 5 Component 6 Complexity
Day-1 case set-up Record review Need assessment Dish labeling Media preparation Dish preparation 2
Day-0 oocyte retrieval, Laboratory preparations Follicular fluid search Cumulus dissection/wash Oocyte Culture Witnessing 2
12 oocytes
Oocyte cryo, 10 oocytes Record review/Pt ID Media/Dish Preparation Cryo container preparation Denuding/evaluating Vitrification Witnessing 4
eggs
Oocyte thaw, 10 oocytes Record review/Pt ID Media preparation Dish preparation Oocyte warming Oocyte culture Witnessing 4
Surgical sperm retrieval Laboratory preparations Operating room procedures Tissue/sample processing Tissue/sample cryo Witnessing 2
Sperm preparation, Simple Semen analysis Gradient preparation Sample preparation Analysis Witnessing 1
Sperm preparation, Complex Semen analysis Special treatments Sample preparation Analysis Witnessing 1
Insemination, standard Record review/Pt ID Oocyte preparation Insemination drop Insemination Witnessing 2
preparation
ICSI, simple, 12 oocytes Record review/Pt ID Oocyte preparation Dish preparation Microinjection Witnessing 4
ICSI, complex, 12 oocytes Record review/Pt ID Oocyte preparation Dish preparation Sperm search Microinjection Witnessing 4
PICSI Record review/Pt ID Oocyte preparation Dish preparation Sperm search Microinjection Witnessing 4
Insemination, split ICSI/ Record review/Pt ID Oocyte preparation Insemination Dish preparation Microinjection Witnessing 4
standard
Fertilization check, standard Oocyte denuding PN assessment Zygote culture Witnessing 2
Fertilization check, ICSI Pronucleus assessment Zygote culture Witnessing 1
Day-2 check, 10 zygotes Morphology assessment Micrographic record 1
Day-3 check, 10 zygotes Morphology assessment Micrographic record 1
Day-3 AHA, laser Record review/Pt ID Dish prep Laser alignment Assisted hatching Embryo culture 2
Day-3 AHA, chemical Record review/Pt ID Dish prep Microtool placement Assisted hatching Embryo wash Embryo culture 2
Day-3 transfer Record review/Pt ID Micrographic record Catheter preparation Catheter loading Catheter check Witnessing 4
Extended culture Changeover of embryos Witnessing 1
Day-3/-5 cryo, 4 embryos Record review/Pt ID Media/dish preparation Cryo container preparation Vitrification Witnessing 2
Day-3 biopsy Day-3 check Day 3 AHA Blastomere biopsy Embryo wash and Sample loading Witnessing 4
culture
Day-4 check Morphology assessment Micrographic record 1
Day-5 check Morphology assessment Micrographic record 1
Day-5 transfer Record review/Pt ID Micrographic record Catheter preparation Catheter loading Catheter check Witnessing 4
Day-5 cryo Record review/Pt ID Media/dish preparation Cryo container preparation Vitrification Witnessing 2
Day-5 biopsy Day-3 assisted hatching Day-5 check Dish preparation TE biopsy Sample loading Witnessing 4
Day-6 check Morphology Assessment Micrographic record 1
VOL. 102 NO. 5 / NOVEMBER 2014

Day-6 biopsy Day-3 assisted hatching Day-6 check Dish preparation TE biopsy Sample loading Witnessing 4
Embryo thaw Record review/Pt ID Media/dish preparation Embryo thaw Micrographic record Witnessing 3
Frozen embryo transfer Record review/Pt ID Micrographic record Catheter preparation Catheter loading Catheter check Witnessing 4
Note: Complexity was calculated based on five elements: time restriction; requirement for intense/prolonged focus; multiple complex steps; potential irreversible harm to embryos; potential serious harm to patient. AHA ¼ Assisted Hatching; Cryo ¼ cryopreservation
(primarily vitrification); ID¼ identification; PICSI ¼ ICSI with sperm selection; PN ¼ pronuclear; Pt ¼ patient; TE ¼ trophectoderm.
Alikani. Staffing the contemporary IVF laboratory. Fertil Steril 2014.
 Fertility and Sterility®

can only provide coverage for 250 days per year (50 weeks  how this increased complexity translates into increased time
5 days per week ¼ 250 days). Therefore, a third person is requirements for proper and safe completion of laboratory
required if the number of days of operation exceed 250 tasks. As shown in Table 2, the traditional IVF cycle of the
days—that is, nearly three people are required to operate the 1980s and 1990s required roughly 9.1 person hours for
laboratory for 351 days (allowing for 2 weeks of down time). completion, but a contemporary IVF cycle requires about
When the number of days of operation is 125 days or fewer, 12.6 person hours; a cycle including PGS/PGD, whether by
the calculator estimates the need as one person or fewer. How- blastomere or trophectoderm biopsy, may require more than
ever, it should be noted that two personnel are still required to 20.2 person hours, thanks to significantly more procedural
perform procedures and witnessing. In such cases, the 1 (or steps, including strict requirements for witnessing at all stages
fewer) person-year must be divided between no fewer than of the process.
two personnel. We are aware of two sources of staffing guidelines
At the second level, the calculator calculates the number of for ART laboratories. The first is an unpublished, word-
staff required to perform five different procedure types, of-mouth standard that has circulated in the ART community
including IVF (requiring 12.6 personnel hours); IVF/PGD for nearly 20 years. It suggests that one embryologist is
(requiring 20.2 personnel hours); frozen-thawed embryo trans- needed for every 100 IVF cycles annually. The second
fer (FET) (requiring 3.6 personnel hours); oocyte freeze source—and the only published guidelines currently available
(requiring 5.6 personnel hours); and oocyte thaw (requiring to laboratory, medical, and administrative directors for allo-
12.9 personnel hours). Additionally, the number of days of QC cation of human resources to the ART laboratory—is the
encompassing the number of incubators and the time require- guidelines published in 2008 by the Practice Committee of
ments for these activities are incorporated in this calculation. the ASRM in 2008. Both of these sources provide estimates
Finally, the two values generated from the two calculations of the minimum staffing that fall short of average staffing
we have described are compared, and the larger number is given levels determined using surveys and systematic analyses of
as the minimum staffing requirement. The number of personnel facilities in the United States (1). Furthermore, although these
increases above three with greater than 425 IVF cycles (when guidelines may address the needs of programs that perform up
only IVF is performed using a 351 days per year schedule). to 300 traditional cycles annually—where, according to the
The number then increases according to the estimated time de- scale, each embryologist would be expected to handle a
mand per procedure. The formulae are shown in Figure 2. maximum of 100 cycles—for programs performing 600 or
It should be noted that the number of personnel required more cycles or more complex cycles, the given scale of one
for smaller programs with lower numbers of procedures is embryologist for every 200 cycles is impractical and unrealis-
facility-dependent because different facilities may choose to tic. It is also inherently risk-laden.
provide witnessing of procedures in different ways. However, Manipulating tens of gametes and embryos on a daily ba-
as may be deduced from the American Society for Reproduc- sis while cognizant of the potentially grave consequences of
tive Medicine (ASRM) guidelines (2008), the number of people errors is mentally exhausting, particularly in a complex lab-
available must always be at least two, even if the program op- oratory environment. Mental exhaustion leads to loss of focus
erates for only 1 week out of the year. and generates disinterest. Exhaustion is also a contributor to
decreased productivity. It is therefore imperative that staffing
needs are assessed based on a careful breakdown of the
DISCUSSION numbers and types of procedures performed in the laboratory.
The evaluations presented here detail the increased The Interactive Personnel Calculator introduced here provides
complexity of contemporary ART practice and demonstrate just such an opportunity.

FIGURE 2

Calculation of staffing requirements for an embryology laboratory minimum personnel required (MPR).
Alikani. Staffing the contemporary IVF laboratory. Fertil Steril 2014.

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ORIGINAL ARTICLE: ASSISTED REPRODUCTION

We believe that it is important to acknowledge the activities should encourage a new set of guidelines for labo-
increased complexity of more recently adopted embryology ratory staffing that better reflect both the new complexities
procedures. More extensive witnessing and more individual- of the IVF laboratory operation and its central role in safe
ized treatment/tracking of embryos have become necessary in and successful treatment of ART patients.
association with the testing and screening of embryos for em-
bryo selection. Laboratories considering the adoption of these
REFERENCES
new techniques should be aware of the increased personnel
1. McCulloh DH. Quality control: Maintaining stability in the laboratory. In:
time requirements.
Gardner D, Weissman A, Howles CA, Shoham Z, eds. Textbook of assisted
We expect that the suggested staffing requirements will reproductive techniques. 4th ed., Vol. 1. London/New York: Informa Health-
be universal because the time requirements for the embry- care; 2012.
ology tasks are anticipated to be uniform whether they are 2. Practice Committee of the American Society for Reproductive Medicine and
performed in North America, South America, Europe, Asia, the Practice Committee of the Society for Assisted Reproductive Technology.
Australia, or elsewhere in the world. However, we acknowl- Revised guidelines for human embryology and andrology laboratories. Fertil
edge that there are some differences in personnel utiliza- Steril 2008;90(Suppl):S45–59.
3. U.S. Food and Drug Administration. Clinical Laboratory Improvement Amend-
tion/responsibilities from practice to practice, state to state,
ments (CLIA). Last updated: April 16, 2014. Available from http://www.fda.
country to country, and continent to continent. So it is gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/
reasonable to assume that there will be some differences in ucm124105.htm. Last accessed September 8, 2014.
staffing allocation depending on differences in personnel 4. Sullivan R. Sperm mix-up lawsuit is settled. New York Times, August 1, 1991.
utilization. Available from http://www.nytimes.com/1991/08/01/nyregion/sperm-mix-
What is certain is that administrators should be aware of up-lawsuit-is-settled.html. Last accessed September 8, 2014.
the increased personnel time requirements for procedures that 5. Nazar R. Parents of IVF sperm mix-up lose appeal. Mod Health, June 28, 2011.
Available from http://www.moderninfertilitytreatments.com/ivf/parents-of-
have been available for decades. Whereas the names and ac-
ivf-sperm-mix-up-loose-appeal/. Last accessed September 8, 2014.
ronyms for these procedures may not have changed, there 6. Seamons K. In mix-up, woman pregnant with other couple's twins.
have been substantial increases in time requirements over Fox News.com, April 14, 2014. Available from http://www.foxnews.
the years as the standard of care has evolved in association com/health/2014/04/14/in-mix-up-woman-pregnant-with-other-couple-
with extended culture durations and more cryopreservation twins/. Last accessed September 8, 2014.
events per patient treatment cycle. 7. James SD. Embryo mix-up woman gives birth, faces heartbreak ahead. ABC
News.com, September 28, 2009. Available from http://abcnews.go.com/
Although it is anticipated that efficiency should improve
Health/MindMoodNews/unintended-surrogate-mom-wrong-embryo-faces-
as more procedures are performed, it is also true that embry- heartbreak-birth/story?id¼8675885. Last accessed September 8, 2014.
ologists are faced with increasing responsibility for diligence, 8. Associated Press. Woman awarded $1 million in embryo mix-up. Los Angeles
as higher volumes also increase the risk of catastrophic errors Times, August 4, 2004. Available from http://articles.latimes.com/2004/aug/
of misidentification. This reevaluation of ART laboratory 04/local/me-embryo4. Last accessed September 8, 2014.

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