Phlebotomists and Equipment in Client Offices

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Phlebotomists and Equipment in Client Offices

According to the Department of Health and Human Services (HHS)1:
"When permitted by State law, a laboratory may make available to a physician's office a phlebotomist who collects specimens from patients for testing by the outside laboratory. While the mere placement of a laboratory employee in the physician's office would not necessarily serve as an inducement prohibited by the anti-kickback statute, the statute is implicated when the phlebotomist performs additional tasks normally the responsibility of the physician's office staff. These tasks include taking vital signs or other nursing functions, testing for the physician's office laboratory, or performing clerical services. Where the phlebotomist performs clerical or medical functions not directly related to collecting or processing laboratory specimens, a strong inference arises that they benefit from the physician's referrals to the laboratory. In such a case, the physician, the phlebotomist, and the laboratory may be exposed to the anti-kickback statute. This analysis applies equally to the placement of phlebotomists in other healthcare settings, including nursing homes, clinics, and hospitals. Furthermore, the mere existence of a contract between the laboratory and the health care provider that prohibits the phlebotomist from performing services unrelated to specimen collection does not eliminate the OIG's concern, where the phlebotomist is not closely monitored by his [or her] employer or where the contractual prohibition is not rigorously enforced."
HHS considers the laboratory's provision of computers or fax machines to a client office an inducement "unless such equipment is integral to, and exclusively used for, performance of the outside laboratory's work."
To summarize:
Laboratories may place phlebotomists or other employees in a physician's office if all of the following are done:
  • Employee only performs laboratory-related tasks.
  • A written understanding of what the employee can and cannot do is given to the physician.
  • Periodic audits are done to ensure the employee is following these policies.
Laboratories may place printers, computers, fax machines, or other equipment or products in client offices as long as the laboratory ensures that:
  • The physician understands the equipment belongs to the laboratory.
  • It is used for laboratory purposes like receiving reports or ordering tests.
  • Periodic audits are done to ensure that the client is using the equipment only for laboratory-related activities.
1. Department of Health and Human Services. Publication of OIG special fraud alerts; December 19, 1994. Sections, Provision of Phlebotomy Services to Physicians; Other inducements. Available at: https://www.oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html.