At ReproMed, we follow strict quality control measures to ensure that all our specimens have optimal quality for achievement of pregnancy. Following freezing of each specimen, a proportionate aliquot is thawed after a minimum of 24 hours to allow the assessment of the number of motile sperm per vial. ReproMed guarantees a minimum of 10 million motile sperm per vial post-thaw in Standard and Pre-washed preparations. ReproMed also guarantees a minimum of 5 million motile sperm in IVF/ICSI vials. A Guaranteed Laboratory Report is provided with each specimen documenting the specimen parameters before freezing and after thawing.
Procedure for Specimen Quality Complaints:
ReproMed should be notified about any observations regarding the specimens’ quality by the treating physicians or their designates. In order to initiate a specimen quality investigation, ReproMed requires the following information to be sent by fax (416-233-9180) directed to the attention of the lab director.
| 1. |
A statement indicating that ReproMed’s procedures for thawing, handling and assessing of specimens were followed. |
| 2. |
Donor number. |
| 3. |
Specimen number. |
| 4. |
Patient name / code. |
| 5. |
Date of receipt. |
| 6. |
Thawing / insemination date. |
| 7. |
Post-thaw specimen quality parameters. |
We will endeavor to investigate all complaints and provide a response at the earliest, however please allow a minimum of 10 business days to process the request.
Conditions:
| 1. |
The receiving clinic should strictly adhere to the thawing instructions included with every specimen shipped from ReproMed. In addition, proper protocols for specimen evaluation such as the use of a warm stage (37°) during sperm motility assessment should be employed. |
| 2. |
ReproMed guarantees the specimen quality immediately following thawing; this does not extend to cover the quality following further processing done at the recipient laboratory. |
| 3. |
ReproMed will initiate a specimen quality investigation only upon receipt of the requested information from the treating physicians or their designate. Similarly, the results of our investigation will be conveyed directly to the treating physicians or their designates. |
| 4. |
Variability in specimen assessment is generally accepted as per the World Health Organization (WHO) standard guidelines, 1999 depending on personnel and counting methods used. Therefore, it is possible that the values estimated at the recipient laboratory will be lower than our guaranteed minimum values. This is does necessarily indicate the specimen does not meet the standards. Analytical variation will be considered before determining if the specimen is eligible for replacement. |
| 5. |
ReproMed does not guarantee the storage conditions outside its premises. Since our cryo-shippers can maintain vials up to 7 days, we can only guarantee specimens that have been thawed within 7 days of the shipping date. All complaints should be reported within 5 business days of thawing. |
| 6. |
In the event of a defective specimen quality, ReproMed’s liability is limited to supplying a replacement specimen. We are not liable for any consequential expenses, including but not limited to those incurred by the patient during infertility treatment. Shipping costs cannot be refunded unless specimens are compromised by the shipping process. |
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