CAP accreditation

After the birth of the first test-tube baby in 1978, increasing pregnancy rate has become the goal of laboratories around the world. Embryo culture depends on the management of reproductive laboratories, whereas the stable operation of a reproductive laboratory relies on the regular and strict quality control. The Center of Reproductive Medicine at CCH has continued to promote further education for staff and equipment upgrades in order to pursue high quality.Moreover, the center has been accredited by the College of American Pathologists (CAP).
The CAP accreditation programs advocate the high quality, high efficiency, and standardized technology of a laboratory. There are strict requirements for the operating procedures, quality control, and examination technology to standardize and internationalize the results of the medical laboratory. So far, the CAP has over 18,000 accredited professional members all over the world, involving more than 8,000 global laboratories. Therefore, it has been recognized as the most credible accreditation authority of clinical laboratories in the world.

The CAP accreditation is a rigorous and expensive process, which includes application for accreditation, on-site inspection, defect reply, certification release, and self-check. Before entering the process of accreditation, a laboratory will be tested for its capacity and decided for its eligibility to apply. The laboratory will have to purchase the capacity test items from the CAP, complete the tests within 3 weeks, and send the results back. There will be 3 rounds of tests, and the CAP will reveal the correct answers after the completion of the tests. An application for accreditation may only be filed if the laboratory has passed all 3 rounds of tests. After approving the application, experts from the CAP will form a review committee to conduct on-site inspections within the scheduled time.The members of the committee may come from different countries, including the US, India, Australia, Hong Kong, etc. The committee will examine the laboratory records and the process of quality control for the last two years.The committee will also review each of the 500 more provisions regarding the relevant records of staff quality, equipment, facility, environment, and biosafety, as well as the laboratory management.

After finishing the review, the committee will discuss the identified problems with the laboratory team on the same day. Once the consensus is reached, the laboratory will have to submit the defect reply and attach the evidence of improvement like revised documents within 30 days. The accreditation will be granted with the release of certification after the approval of the CAP review. Subsequent to the accreditation, the CAP will provide customized documents to laboratories for self-check in the next year. Reevaluation will be conducted in the second year to ensure that the quality of the operating procedures meets the international standard of the CAP.

The Center of Reproductive Medicine at CCH was first accredited by the CAP in 2010. Until 2019, the center has extended the accreditation for 4 consecutive times and achieved the CAP accreditation with “zero defect” for multiple times. Our laboratory has advanced the ability of risk assessment, efficacy enhancement, quality improvement, and most importantly, the increase of the pregnancy rate through these strict requirements in order to complete more families.