Laboratory

Parent Issue

CMS Revises Surveyor Guidance for Laboratories

The Centers for Medicare & Medicaid Services (CMS) has issued revised guidance for clinical laboratory surveyors, with updates to State Operations Manual (SOM) Chapter 6. That chapter, intended to help regional office and state surveyors administer the Clinical Laboratory Improvement Amendments program, has been revised to remove outdated information and ensure each section matches current policies and procedures.

CMS Revises Guidance for Hospital Outreach Laboratory CLFS Reporting Requirements

The Centers for Medicare & Medicaid Services (CMS) has issued revised guidance for laboratories that are required to report private payer data for laboratory tests under the clinical laboratory fee schedule (CLFS). In response to advocacy from CHA, CMS revised its guidance for hospital outreach laboratories on reporting applicable information attributed to non-patients.

CDPH Laboratory Field Services Changes License Delivery System

As of June 18, the California Department of Public Health’s Laboratory Field Services (LFS) is using a new method to deliver licenses and certificates for laboratory personnel, allowing them to download and print active licenses directly from the online system. LFS will no longer mail licenses, and licensees will no longer need to request or pay for a duplicate license.

CMS Issues Guidance on Clinical Laboratory Fee Schedule Reporting Requirements

The Centers for Medicare & Medicaid Services (CMS) has issued additional guidance for laboratories that are required to report private payer data for laboratory tests under the clinical laboratory fee schedule (CLFS). CHA urges any hospital with a laboratory that bills Medicare on a Form CMS-1450 14x Type of Bill to carefully review the guidance to determine its status as an applicable laboratory.

Budget Trailer Bill Recognizes Alternative Quality Control in Clinical Laboratories

The budget trailer bill adopted as part of the state’s final 2015-16 budget amends Section 1220 of the Business and Professions Code pertaining to clinical laboratories. Specifically, the budget trailer bill allows clinical laboratories to establish an alternative quality control program that meets federal regulations under the Clinical Laboratory Improvement Act and that may include the use of alternative quality control testing procedures already recognized by the Centers for Medicare & Medicaid Services (CMS). Until now, the California Department of Public Health has interpreted regulations in a way that did not recognize federally approved alternative quality control methods, requiring labs to perform frequent quality control tests, which are substantially more expensive than the current federally recognized equivalent quality control (EQC) procedures and the impending individualized quality control plans (IQCPs).