Continuity of Care During an Emergency IVF Laboratory Shutdown

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Continuity of Care During an Emergency IVF Laboratory Shutdown
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Authors:

Kathryn J Go PhDa, Jay C Patel MAa, Jon C Boyera, Charles L Bormann PhDb, John C Petrozza Jr MDb, Jill A Attaman MDb, Kelly W Linden RNb, Andrea Lanes PhDa, Elizabeth S Ginsburg MDa, Mark D Hornstein MDa and Serene S Srouji MDa

aDepartment of Obstetrics & Gynecology, Brigham & Women’s Hospital, Boston MA
bDepartment of Obstetris & Gynecology, Massachusetts General Hospital, Boston MA

Acknowledgement: Catherine Racowsky PhD, who was instrumental in the initial lab shutdown planning 

Abstract:

When an incident that negatively affects the structural integrity or environmental conditions of the Laboratory occurs and entails temporary de-commissioning to manage exposure of the laboratory to VOCs and mold, a plan for continuity of patient care while expediently achieving repair and restoration of laboratory operations is required. The management of a water leak into the laboratory with no interruption of patient care despite laboratory closure is described, providing expeditious demolition and reconstruction of the laboratory, deferral of oocyte retrievals and Assisted Reproductive Technology (ART) to a local IVF clinic and laboratory, and installation of a temporary onsite laboratory for warming and transfer of cryopreserved embryos. Emphasis was placed on establishing baseline detection of mold or its byproducts as well as VOCs, careful selection of construction materials to avoid VOCs and noxious solvents, sealants and adhesives, preservation of the laboratory environment with expedient repair, and continuous monitoring of air quality to ensure optimal conditions for resumption of laboratory operations. 

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Introduction

The In Vitro Fertilization (IVF) Laboratory is integral to the provision of advanced therapy for infertility, and comprises a safeguarded workspace against toxins, micro-organisms and volatile organic compounds (VOCs). Potentially released from common construction materials, e.g., adhesives, insulation and linoleum, VOCs such as formaldehyde, benzene and acetone have been identified as noxious and toxic to in vitro cultures of gametes and embryos, and must be actively excluded from IVF laboratories (1, 2, 3). In addition, mold, its spore and its airborne products pose well-described risks to those who work or live in environments where dampness has enabled its colonization and aerosolization (4) and could potentially contaminate cell cultures or media (5).

         IVF laboratories are vulnerable to unforeseen events that may compromise their structural and operational integrity. These can range from extreme weather-related events such as earthquakes (6), hurricanes and floods (7) to more mundane, leaks in water pipes leading to wetness, potential saturation and damage to ceilings, walls and flooring (8). Whether catastrophic or localized, water damage necessitates expedient repair and possible suspension of laboratory operations. The risks from water damage are greater than what is superficially observed: the possibility for mold to colonize wall and flooring materials, and release spores or toxins into the laboratory environment, must be urgently addressed to protect gamete and embryo cultures as well as the well-being of embryologists. The response, repair and recovery process must be carefully managed.

         Here, we describe the execution of a plan designed specifically to address water-damage-induced interruption of an IVF laboratory’s operations. A multidisciplinary approach  addressed  a) the demolition and re-construction of the affected laboratory space;  b) the relocation of laboratory operations to a pre-designated site ; and c) communication of the planned process to continue  patient care and services to staff and patients. While this strategy was developed to address water damage specifically, it can be extrapolated to an array of similar circumstances and be a template for an emergency response.

Identification of water leakage into the laboratory and the immediate response

         When water seepage at a wall juncture where a metal pipe emerged in the IVF laboratory was detected, the laboratory supervisor assessed the area and determined this resulted from a slow dripping process and not a rapid flow, originating from an upper floor. The lab supervisor immediately reported the leak to the Hospital’s engineering department, environmental affairs, and to the laboratory and clinical teams. The risk of mold growth is known to increase when porous organic building materials have been wet for 24-48 hours (9).  

         Within 24 hours, leaders from IVF, engineering and  environmental affairs met. Goals were to collect information on the leak source, evaluate the extent of impact on the IVF laboratory, and to determine what construction activities, controls and projections for a safe work plan would be required. In recognition of the risks posed by mold and its rapid proliferation in wet building materials, industry-standard high-volume pump and air-o-cell filter cartridges were used to identify existing or nascent contamination. The urgency of mold containment was central in informing the plan and pace of management.

         Determination of the scope of the damage and the repair solution

         A plan to guide construction in the IVF suite (laboratory and procedure room) had been developed in response to an earlier water leak in the laboratory that had led to protracted closure and renovation with program closure. (8). Minimizing, and ultimately eliminating, toxic products from off-gassing of construction materials in the laboratory (1) is critical;  volatile organic compounds (VOCs) release can continue after construction is completed and must be evacuated.

 The Pre-construction risk assessment (PCRA) was the first order of business in establishing the plan for managing the potential suspension of laboratory operations. Applied as a checklist (Table 1), the PCRA addressed demolition and reconstruction, review of material Safety Data Sheets (SDSs) for any materials used, assessment of the renovated space for safety and environmental conditions, and approval for resumption of clinical operations (Table 2). Managed by the Environmental Affairs department in conjunction with a committee of engineers, contractors,  specialists in environmental health, infection control, safety and clinical compliance, and IVF leadership, the PCRA collated the findings from investigation of the damaged site and surroundings.  This determined the scope of required repairs and outlined the materials and monitoring necessary for safe and effective completion of the project. The PCRA informed the decision to close the laboratory and the duration of closure, the plan for construction. and the solution for providing continued patient care.

 Construction

According to the  PCRA,  the plan and timeline for safe removal of damaged materials and sequence of repair events for re-construction was set.  The Safety Data Sheets (SDSs) for all building materials, adhesives and other products were reviewed to evaluate potential for VOCs release exceeding safe thresholds for IVF environments (Table 3 (1)). Detailed plans for containment, ventilation and environmental factor measurement to protect the space surrounding the worksite were created.  This included the type of containment material, required air pressure gradients and exchange rates, as well as type and frequency of air quality sampling, within the area. The PCRA committee agreed that any deviation from the approved, outlined plan would require a separate review process by members.

With this in place, the laboratory prepared for suspension in activity. When all clinical procedures and cryopreservation were completed and the culture incubators were empty, instruments and supplies were moved or shielded to prepare for construction .

The laboratory space undergoing limited demolition and construction was contained and divided by a combination of temporary hard construction barrier walls (STARC Systems RealWall) and impermeable plastic drapes (Husky-polyethylene sheeting) with zipper door access, providing the highest class (IV) containment. Continuous negative pressure maintained at -0.03 inches of water gauge was established via 2000 cfm electric HEPA filtered blower unit placed inside the containment area to ensure all air from the IVF space was flowing into the contained construction area. An additional layer of carbon filtration material was placed on the intake and discharge openings of the HEPA unit. This configuration helped to ensure that dust particles or mold spores generated during demolition, removal and installation of drywall were filtered from the air prior to being released back into the lab environment. The carbon filter material is designed to reduce levels of volatile solvent vapors form adhesives, primers and paints applied during construction. Monitoring comprised a FLIR infrared camera and Protimeter moisture meter to determine material water saturation levels; MonitoringRAE Systems Photoionization Detector (PID) for measuring VOCs; TSI DustTrak for monitoring particulate levels and size ranges; TSI Q-Trak IAQ Monitor for tracking temperature, humidity, carbon dioxide and carbon monoxide levels; and the Zefon high volume pump and air-o-cell filter cassettes for measuring mold spores.

 Levels of VOCs, particulates and mold were continuously tracked during preparation, demolition, repair and recovery phases of the project with agreement to stop all work if thresholds for any category were approached (Table 2,, Figure 1, Figure 2, Figure 3). Work was carried out by three shifts of workers, for 24 hours daily.

Continuity of patient care: deferral of cases to an alternate site

Continuity of patient care was possible through our collegial relationships with programs in our area.  Another local center coordinated requests for emergency privileges for our physicians, scrub technicians and embryologists to perform oocyte retrievals, embryo transfers and the full array of assisted reproductive techniques in their IVF unit. Financial managers from each program determined how the cycle IVF fees would be allocated to the diverted care center (DCC).  Representatives from both IVF teams met daily to determine how the diverted cases would be integrated into the DCC’s schedule. The DCC provided their operating room, anesthesia staff, ultrasound machine, and oocyte aspiration pump and needles. Given different practice techniques, our team provided the embryo transfer catheters and performed all transfers with our embryologists. All patients met clinical criteria for having oocyte retrieval and anesthesia at the DCC, e.g., BMI <40 kg/m2; some cycles were cancelled or postponed.

A checklist (Table 4) was developed to ensure all operational, administrative and logistic factors were addressed.

         Patients who were in cycle were called by their attending physicians and offered cycle cancellation or to have their procedures at the DCC. Patients who were poised to start cycles were offered to wait a cycle or consider care at the DCC. All patients accepted care at the DCC.

Cycle monitoring remained on site as it was not affected by laboratory construction. A plan for distributing information and instructions to all affected patients and to staff at both centers was developed, for obtaining of informed consent, parking, directions to the DCC and delivery of semen specimens. Our nursing team could not obtain privileges at the DCC due to union restrictions. In order to maintain continuity of care, our surgical nurses contacted patients prior to and following their procedures to review instructions which were distributed to patients through our electronic medical record system.

Laboratory-specific preparation at the DCC entailed installation of extra incubators, import of culture supplies and laboratory ware, retrieval aspiration sets and suction pump, embryo transfer catheters, cryopreservation supplies and a charged portable cryostorage tank. Incubators and cryo storage tanks were connected to the DCC laboratory’s monitoring and alarm systems.

Secure WiFi was available at the DCC for access to our electronic medical record and IVF-specific software. Laptop computers were brought to the DCC for embryologist data entry. Physicians used internet-linked desktop computers for clinical data entry.

Continuity of patient care: creation of an onsite limited-purpose laboratory and procedure room

A temporary laboratory, restricted to warming of cryopreserved embryos, was assembled by installing two smaller incubators, two stereo microscopes, and a refrigerator in a demarcated area of an available operating room. An adjacent operating room was used for the embryo transfer procedures, fulfilling the required proximity for safe transit of the loaded embryo transfer catheter from microscope to physician.

Three physician teams – performing procedures at the DCC, embryo transfers on site and clinical rounds on site – and two embryology teams, on site and at the DCC – were established and scheduled daily as needed.

Results

Initial mold and VOC readings taken before demolition began and immediately prior to recommission of the laboratory are shown in Table 5, indicating that there was no detectable contamination of the laboratory by spores and no deterioration in air quality, respectively, at these stages of the process.

Deployment of the PCRA and moving procedures to the DCC and the temporary CET Laboratory allowed continuous patient care concurrently  at both centers. Comparison of key performance metrics for the DCC’s and our patients (Figure 4) reflected similar outcomes in that interval. No negative experiences were reported by patients who received care at the DCC. The total elapsed time from identification of the water damage to resumption of operations was 13 days.   

Discussion

Interruption of infertility treatment, can cause significant distress to patients. The inability to provide services owing to a laboratory closure can arise at any time from structural, plumbing or electrical failures in the workspace. When a water leak that damaged the ceiling and a wall in the IVF laboratory became apparent, a structured, multi-faceted plan for managing suspension of operations and expedient repair was deployed. This was the product of, ironically, a previous but more extensive flooding of the IVF laboratory several years earlier, requiring complete demolition and re-building of the entire space. The legacy of that experience was the development of the PCRA - a strategy to re-construct the laboratory and set the parameters for re-opening with preservation of optimal air quality, the factor most vulnerable to the rebuilding process and materials.
         Regularly scheduled communication throughout the assessment, construction and preparation for resumption of operations at the affected laboratory and about deferred operations at the DCC was essential. This was integral to successful achievement of three goals: a) protection of the affected laboratory from the introduction and after-effects of environmental toxins during its repair; b) a detailed, structured plan for provision of care at two sites during the repair and re-validation period; and c) full preparation of all staff in anticipating and preparing for each phase.

       Collectively, these events were decisive in ensuring the continuation of treatment cycles in an era when another interruption to patient care after the pandemic-induced shutdown would have been intolerable, while maintaining all IVF treatment quality measures.

Although the PCRA was applied to an emergency involving water incursion and the specific risks posed by mold and the effluent from damaged drywall and other building materials, its universal utility could apply to an array of challenges. Having a practical, checklist-approach to confronting an operation-interrupting emergency can mitigate its duress.

This clinical team was fortunate to enjoy collegial relationships with local (and competing) IVF practices that were receptive to accepting our patients requiring oocyte retrieval and fresh transfer. The spirit of cooperativity and empathy of the DCC was integral to the rapid procurement of operative privileges and authorized access.  In our own hospital, department colleagues allowed us to install ad hoc laboratory and procedure areas confined to the warming and transfer of cryopreserved embryos.

An effective contingency plan is invaluable to manage laboratory closures that can result from plumbing or structural failures. Indeed, a standard in the College of American Pathologists’ checklist used for the survey and accreditation of clinical laboratories, Laboratory General, requires the organization to have a plan to accommodate circumstances that threaten operations (10).

The time and effort allocated to developing a plan to manage these emergencies and ensuring that all of the resources can be summoned as needed is an excellent investment towards optimal management and swift recovery of operations. 

References

  1. Mortimer D, Cohen J, Mortimer ST, Harper JC, Swain JE, Gilligan AV. Cairo consensus on the IVF laboratory environment and air quality: report of an expert meeting. RBMO 2018; 36: 568-74.
  2. Cohen J, Gillian A, Esposito W, Schimmel T, Dale B. Ambient air and its potential effects on conception in vitro. Hum Reprod 1997; 12: 1742-1749.
  3. Agarwal AJ, Chattopadhyay R, Ghosh S, Ghoumik A, Goswami SK, Chakravarty B. Volatile organic compounds and good laboratory practice for the in vitro fertilization laboratory: the important parameters for successful outcome in extended culture. J Assist Reprod Genet 2017; 34: 999-1006.
  4. United States Environmental Protection Agency. Mold and health. https://www.epa.gov/mold/mold-and-health.
  5. Kastrop PMM, de Graaf-Miltenburg LAM, Gutknecht DR, Weima SM. Microbial contamination of embryo cultures in an ART laboratory: sources and management. Hum Reprod 2007; 22: 2243-8.
  6. Ishihara O, Yoshimura Y. Damages at Japanese assisted reproductive technology clinics by the Great Eastern Japan Earthquake of 2011. Fertil Steril 2011; 95: 2568-70.
  7. Dickey R, Lu PY, Sartor BM, Dunaway HE, Pyrzak R, Klumpp AM. Steps taken to protect and rescue cryopreserved embryos during Hurrican Katrina Fertil Steril 2006; 86: 732-4.
  8. Bormann CL, Lewis EI (2016) Risk and disaster management for the IVF laboratory. In: Fleming S, Varghese A (eds) Organization and management of IVF units. Pages 71-83. Springer, Cham.

 

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