ADLM endorses the Medical Laboratory Personnel Shortage Relief Act of 2024

In a letter addressed to United States Rep. Deborah Ross, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) endorsed the Medical Laboratory Personnel Shortage Relief Act of 2024. The act would direct federal funding to grapple with the national shortage of medical laboratory professionals that is affecting healthcare delivery.

The shortage has led to increased workloads and stress for staff, raising risks of errors and delays in test results, ADLM emphasized in the letter.

In rural and underserved areas, some laboratories face temporary closures because of a lack of personnel, limiting patient access to timely and essential diagnostic care. ADLM supports the inclusion of medical laboratory professionals in the National Health Service Corps (NHSC), which will prioritize placement in shortage areas.

Under the bill, loan repayment incentives for medical laboratory personnel would alleviate financial burdens for new professionals. This would encourage recent graduates to enter and remain in laboratory professions. Longer term, ADLM believes this initiative also would reduce diagnostic delays and support better patient outcomes.

The act also provides funding for educational programs, particularly for institutions prioritizing culturally competent care. By supporting underrepresented groups, this legislation promotes a diverse, well-prepared laboratory workforce capable of meeting the evolving demands of modern healthcare.

ADLM writes to presidential transition team on LDT Final Rule

In a letter to President Trump’s transition team, ADLM called for the new administration to revoke the Food and Drug Administration (FDA) final rule on laboratory-developed tests (LDTs). This rule, if implemented, would regulate laboratories that develop LDTs as if they were medical device manufacturers. The rule fails to recognize the difference between the two sectors: Manufacturers develop and sell their devices to anyone, whereas laboratories develop LDTs for their patients only at the request of an ordering physician.

ADLM is concerned that if this rule is implemented, it will hinder the development of new LDTs, which were critical to advancing care, and significantly increase the costs associated with LDT testing, thus forcing laboratories to reduce or eliminate LDTs. Revoking this rule would preserve patient access to these tests while giving Congress the opportunity to modernize the existing structure if needed under the Clinical Laboratory Improvement Amendments.

The letter also noted that during the first Trump administration, ADLM worked closely with White House staff during the COVID pandemic by serving on the National Testing Implementation Forum and offering insights and guidance on how to deal with SARS-Cov-2 testing issues.

Office of the Inspector General: HIPAA audits must do more to protect against cyber threats

In recent years, cyberattacks have become an increasing concern for healthcare providers and patients alike. In its report to Congress for 2022, the Department of Health and Human Services (HHS), Office for Civil Rights (OCR), stated that it received 64,592 reported breaches affecting 42 million individuals and that most of the associated security incidents were related to the hacking of healthcare providers. These cyberattacks raise the question of whether OCR's audits for ensuring the protection of electronic protected health information have been effective.

Now a new HHS Office of Inspector General (OIG) audit has found that OCR’s audits only assessed 8 of 180 HIPAA rules requirements. Only 2 of those 8 requirements were related to security rule administrative safeguards and none were related to physical and technical security safeguards.

The OIG provided recommendations aimed at enhancing the OCR’s HIPPA audit program, including that it expand its HIPAA audits to assess compliance with physical and technical safeguards from the HIPAA Security Rule; document and implement standards and guidance for ensuring that deficiencies identified during the HIPAA audits are corrected in a timely manner; and define metrics for monitoring the effectiveness of OCR’s HIPAA audits.