|
Dear ASHI members,
As most of you are aware, CMS updated CLIA regulations for Histocompatibility at the end of last year which take effect on December 28, 2024. Among the updated regulations are changes to the CLIA personnel requirements for Director/Technical Supervisor that are of concern to many in our society. Of particular concern are the changes to who qualifies to train as a Director/Technical Supervisor and potential increases to the training time. This topic has been an item for discussion on every ASHI Executive Committee and ASHI Board of Directors agenda since the changes were announced. To address the concerns of our community, we had a conference call with CMS on May 30 to get clarification on these changes. On this call, we learned that CMS is working on a guidance document that we hope will answer the questions we posed and the clarifications we requested regarding director training and qualifications of foreign trained MDs. Additionally, we asked for clarification for international directors who trained and are currently directing an ASHI-certified laboratory if they would qualify to direct a US laboratory. Although our meeting was amicable, CMS made it clear to us that until that guidance document comes out (before December 2024), they will not comment on it further. This is all CMS would commit to at this time. We recognize the issues associated with this, particularly as it pertains to our need to publish updated standards. Our last communication to CMS occurred during the ATC meeting last week. We stated that ASHI is very concerned that more restrictive requirements will lead to a shortage of qualified Laboratory Directors in our field, thus ultimately impacting patient care.
As this process continues, we are also staying in touch with responses from various societies to the updated CMS guidance for high complexity laboratories. This is thanks to ASHI members who are members in those other societies. Unfortunately, there are no other high complexity lab personnel who will be as widely affected as histocompatibility for training of directors.
Although we do not yet have concrete answers to our questions, we wanted to let our HLA community know that this topic remains top and center for ASHI leadership. When the ASHI Board met on June 7, the topic was given high priority. Please be assured that ASHI leadership is working diligently to obtain answers and guidance for these impactful changes. We will communicate further updates as they become available.
Sincerely,
| 
