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December Quality Audit: Space and Supplies

IVF Lab Space and Supplies QA Audit
IVF Lab Space and Supplies QA Audit

The ART Compass platform makes managing space and supplies easy! In December we focus on tissue inventory, supplies management, and discard workflows! December is a great time for most IVF labs to prepare for the coming year’s IVF cycles by performing inventory of both embryos (visually comparing what is in the tank to what is in the cryostorage database) and reagents and supplies, disposing of embryos that are not usable or no longer needed out of tanks, deep cleaning the lab, organizing storage spaces, and archiving records to make space for the next year’s cycles!

What do the CAP guidelines say about “space and supplies”, ie. cryostorage, physical storage, and reagents traceability and inventory?

Specimen Storage and Disposition

GEN.40506: Secured Specimen StorageThe original specimens (in the original container) and appropriately labeled aliquots are maintained in an appropriate manner when not in the possession of an authorized individual.
GEN.40507: Specimen Retention and StorageSpecimen retention and storage conditions are defined for each type of specimen tested by the laboratory using a chain-of-custody procedure.
RLM.08000: Specimen HandlingThere is a system to verify and maintain the identity of the specimen throughout receipt, storage, processing, and disposition.
RLM.12400: Specimen Storage/Long-Term DispositionThere is a written procedure regarding the length of storage, informed consent and long-term disposition of cryopreserved gametes or embryos.
RLM.03975: Specimen Handling and DispositionRecords allow for the tracking of the disposition for gametes or embryos handled or stored.
CAP Checklist Items related to Specimen Disposition and Storage

Records and Inventory

GEN.40509: Secured RecordsThe chain-of-custody collection records, security logs, and testing records are retained for an appropriate period of time, no less than two years and following applicable laws and regulations, in a limited-access, secured (locked) area that is only accessible to authorized laboratory personnel.
GEN.61900: Inventory ControlThere is an effective supply inventory control system in operation.
RLM.12000: InventoryRecords are available for the current inventory of all specimens that have been stored in its cryobanks.
CAP Checklist Items Related to Inventory

Embryo Cryostorage Inventory

A precise inventory is maintained for all embryos in storage by IVF laboratory staff. Once a year, the embryo inventory should be visually checked and confirmed with the embryo database. Patients who no longer wish to store their frozen embryos have several options. Frozen embryos may be discarded as medical waste. They may be donated for research studies, quality control or training of junior embryologists. When embryos are donated for lab use, they are thawed, studied scientifically, and then discarded after a few days. Typical research topics include new techniques for freezing or thawing embryos, new embryo culture methods, PGT-A or genetics studies and more!

Make some space! Embryo Discards

Embryo discards tend to pile up during the year. To discard frozen embryos, a consent form is typically signed (by both partners) and notarized or witnessed by IVF clinic staff. Many labs have a 30-60-day “cool down” waiting period, before at least two embryologists are needed to fulfill the patients’ wishes to discard embryos. Because multiple people are needed to properly locate the embryos in the storage tank and carefully confirm the identity, this is a time consuming a laborious process often superseded by the day–to–day demands of running an embryology lab. The embryologists will typically sign and date the consent form and other storage documents, attesting that they performed and witnessed the disposition according to the patients’ wishes and these should be kept permanently in the laboratory files. It is a good practice to provide written confirmation of the disposal of the embryos to the physician and patient chart.

Reagents and Supplies Inventory

Inventory control is vital to deliver quality IVF services. A carefully managed inventory ensures that the right quantities of reagents and consumables are available at the right time and place. It prevents waste from expired reagents (over-ordering), duplicate orders, or improper storage. All purchased supplies, reagents, and consumables should be included in the laboratory inventory. Information in the inventory should include lot number, date received, date put into use, expiration date, and special storage requirements. Inventory control management includes monitoring the physical storage environment (temperature, humidity, exposure to sunlight), keeping stock levels consistent with procedure numbers, conducting physical inventories, and disposing of expired products in a timely manner. You will want to ensure that the SDS and 510K folders in ART Compass are up-to date.

Tips to manage Space and Supplies

Designate a Place for Everything

Make sure everything in your lab has a specific place. Designate specific, clearly-labeled storage locations for each reagent or category of reagents to ensure that newly-delivered items can easily be found by all embryologists. Create a schedule to go through your reagents and remove expired and obsolete reagents from your storage space.

Label Everything

Establish a consistent labeling system that all embryologists and lab techs use to label aliquots and shared solutions. Don’t forget to also label shelves and cupboards, which can remind people of where items belong and help keep storage areas organized.

Create an Ordering Information Spreadsheet in ART Compass.

Keep an updated lab inventory and ensure all lab members update the LQMS module in ART Compass when receiving new items. A basic lab inventory spreadsheet can be created under “Documents and Forms” containing reagent names and ordering information (i.e. vendor, catalog number, price, etc.) Lot numbers and expiration dates may be included for good laboratory practice.

For larger IVF labs, create and maintain an ordering spreadsheet where embryologists can add items and quantities they need ordered for a given week. A designated member, such as the IVF supervisor, can then order these items in bulk for the entire lab.

The lab director or quality manager should start each month’s Quality Audit by answering “In Progress” to each question, then assign this survey to junior staff using the “assign” function. This will document both continuing education and quality assurance activities. As embryologists perform or learn about these activities, they can mark them as “complete”

Check Consents and Disposition Directives, Perform Tissue DiscardsWitnessing this procedure is non negotiable! Don’t forget, you can use the image archive function in ART Compass to record any part of this process., and permanently amend it to the patient record.
Prepare to Ship Tissues to long term storage.Long term fertility preservation samples, and other types of samples for long term storage can be prepared now for transfer in the new year. Long term storage facilities include: Reprotech, Cryopoint, Fairfax Cryobank, California Cryobank, Ovation, TMRW.
Review Discard Policy and Process. Pull 10 discards to ensure the process has been followed.A few good process points: Store tissue discards in a separate binder. Scan tissue discards into a separate (digital) folder. Don’t forget to mark tissue as “discarded” in cryostorage so the patient is not billed!
Review previous year’s cycle numbers, gas and dewar costs, and forecast needs for coming year. Review dewar and cryostorage options for coming year.Calculate how fast you will fill up space: High capacity tank options are MVE 6000, Vitrostash among others.
Make or update a list of all supplies and reagentsLog into the web version of ARTC. Navigate to the white tab, LQMS. Update reagents list and then record lot #, expiration date, date into stock and into service. Use your phone’s camera to image product invoices, certificates of analysis and store them permanently.
Update the SDS folder in ART Compass with current safety data sheets.Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products!
Count pieces in storage, check expiration dates, discard expired products.Take an inventory of plastics, reagents, and other stocks! Discard expired reagents.
Update the 510K folder in ART Compass with products that have FDA approval. Discontinue use of products when a suitable approved device is available.Log into the web version of ARTC. Navigate to the green tab, Documents and Forms. We have pre-populated your SDS folder with Vitrolife, Fujifilm/Irvine Scientific and Cooper products!
Update Standing Orders for the new year.
One Month Schedule of Tissue Discards, Cryostorage, and Supplies Inventory related IVF Lab QA Activities

SeptemberFDA Audit
OctoberStaff Audit
NovemberPatient Satisfaction and Security
DecemberSpace and Supplies
JanuaryPreventative Maintenance, Air Quality, and Deep Clean
February
March
April
May
June
July
August
The ARTC IVF Lab Playbook!

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