Federal Licensure Issues

Federal Licensure Guidelines Lawyers, Clinical Laboratory Regulation Matters

Federal Licensure Issues

Zimmerman Law Offices, P.C. represents clients throughout Illinois in clinical laboratory regulatory matters governed by the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS).

The firm assists labs in compliance with the Clinical Laboratories Improvement Amendments (CLIA), as overseen by the Division of Laboratory Services (DLS). The CLIA program is charged with ensuring quality laboratory testing.

The attorneys at Zimmerman Law Offices are Chicago-based attorneys with broad knowledge and experience in federal licensure guidelines for clinical labs. This firm represents clinical labs, laboratory directors, and lab staff in complying with CLIA standards and in adverse administrative and disciplinary actions.

Zimmerman Law Offices, P.C.:

  • Represents clinical laboratories in obtaining and maintaining their certificates under CLIA
  • Represents clinical labs relative to alleged CLIA deficiencies
  • Represents labs during inspections by the HHS CMS investigators
  • Counsels labs in developing a Plan of Correction to address and correct problems identified in a HHS CMS Statement of Deficiencies
  • Represents laboratory directors and clinical labs at trials before administrative law judges at HHS
  • Assists the lab director and technical supervisor in developing the lab’s protocols, policies and procedures, and creating a policy and procedure manual for employees

Tom Zimmerman works with clients to try to resolve deficiencies to the satisfaction of the Department. When HHS CMS has rejected the lab’s efforts at compliance, or proceeded with administrative and disciplinary action against individuals, he provides a vigorous defense against the Department.

Landmark Case in Favor of Lab Directors

Zimmerman Law Offices, P.C. successfully represented a laboratory director at trial before HHS in removing the suspension that barred him from operating any clinical laboratories. Under federal law, a lab director whose lab’s CLIA certificate was revoked cannot operate another clinical lab within two years. This landmark case was the first decision that ruled that the collateral sanction applies only to the person who directed the lab at the time of the infractions that led to the CLIA revocation, and that it does not apply to any former or subsequent director who didn’t bear ultimate responsibility for the misconduct. Prior to this decision, CMS applied the collateral sanction to every former and subsequent director. This case was the first that ruled that CMS’s application of the law was contrary to and frustrates the statutory purposes Congress intended for CLIA.

When the Department refused to honor the administrative law judge’s ruling, Mr. Zimmerman successfully sued the federal government in federal court to (a) hold unlawful and set aside the sanction against the lab director, (b) hold unlawful and set aside the HHS CMS denial of a person’s application for directorship of clinical laboratories, and (c) compel the agency to remove the two-year prohibition on owning or operating a clinical lab. As a result, the HHS CMS removed its ban on his client and approved his application for directorship of clinical laboratories.

Contact federal licensure guidelines attorney Thomas A. Zimmerman for authoritative counsel on CLIA compliance and defense against HHS CMS sanctions in relation to clinical laboratory operation, policy, and procedure.

Verdicts & Settlements

Clinical Laboratory Director Barred From Operating a Laboratory — The U.S. Department of Health and Human Services (HHS) entered a suspension that barred a person from operating any clinical laboratories. We won a trial before an HHS administrative law judge, which was the first decision in the nation that ruled that the sanction applies only to the person who directed the lab at the time of the infractions, and that it does not apply to any former or subsequent director who did not bear ultimate responsibility for the misconduct. When HHS refused to honor the administrative law judge’s ruling, we successfully sued the federal government in federal court to hold unlawful and set aside the sanction against the lab director. As a result, HHS removed its ban on the person and approved his application for directorship of clinical laboratories.

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