LII:The Practical Guide to the U.S. Physician Office Laboratory

The Practical Guide to the U.S. Physician Office Laboratory

Written by: Rebecca A. Fein, M.S.A.H.I., M.B.A.
Edited by: Shawn Douglas

Introduction

This guide intends to give the reader practical information on the physician office laboratory (POL), assisting the reader with the decision-making processes related to becoming affiliated with a POL.

This guide provides a discussion on the history and trends related to the POL market, as well as testing considerations, staffing requirements, regulatory issues, related technology, and economic considerations.

No recommendations are made, though appropriate best practices are mentioned.

What is a physician office laboratory?

The definition of a physician office laboratory varies from state to state. Some states define the POL by the actual number of physicians in the practice, and others do not. When setting up a POL, the proprietor should consult their individual state regulatory body to ensure full compliance.

For the purpose of this paper, the definition provided by the State of New York is used, as New York regulations are strict, and using a stringent guideline for the rest of this guide is preferred:

In order to qualify as a physician office laboratory (POL), individual health care providers must operate the practice or be part of a legally constituted, independently owned, and managed partnership or group practice. Laboratories that are owned, managed and/or operated by managed care organizations, hospitals or consulting firms do not qualify for the POL exception and should apply for a clinical laboratory permit through the Clinical Laboratory Evaluation Program (New York State Department of Health, Wadsworth Center, 2014).

Based on the New York definition, a POL is thus a laboratory that provides the physician in-office laboratory testing services, thereby allowing the physician to have quicker access to laboratory results. Depending on the rules and regulations in any given state, the lab can be owned and operated either by a single physician practice or by more than one physician practice. In many states, additional regulations prohibit the acceptance of specimens from outside the clinician's practice.

Types of POLs and their workflow

POLs come in many different types. Nearly any practice can operate a POL. However, the most common types include gastroenterology, family practice, internal medicine, obstetrics and gynecology, and hematology and oncology practices. This is likely due to the need for these specialties to get quick results for treatment plan decisions.

According to United Healthcare's Oxford's In-Office Laboratory Testing and Procedures List (2012), the specialists that use an in-office laboratory include:

Primary care physicians and specialists: In some parts of the world, this type of doctor is referred to as a general practitioner. This doctor is the first point of contact for a patient and coordinates referrals to other physicians as necessary (dependent upon the insurance plan a patient has). Often these doctors are family medicine or internal medicine specialists by training. In some cases, these doctors are OB/GYNs, nephrologists, allergists, pediatricians, or emergency medicine specialists.

Dermatologists / dermatopathologists: A dermatologist is a doctor who specializes in skin conditions. Dermatologists can also board certify as dermatopathologists, which are trained in both dermatology and pathology. A dematopathologist examines tissue samples taken as part of a biopsy, for example.

Rheumatologists: Rheumatologists deal with issues related to joints, soft tissue, autoimmune diseases, vasculitis, and hereditary connective tissue disorders.

Urologists: Urologists examine issues related to the male and female urinary tract, as well as the male reproductive tract.

Pediatricians: Pediatricians are trained to treat medical conditions found in infants, children, and adolescents. Generally, they do not see patients over the age of 18.

Pulmonologists: Pulmonologists specialize in conditions related to the respiratory tract.

Hematologists / oncologists / pediatric hematologists: Hematologists specialize in blood-related conditions, oncologists in cancers, and pediatric hematologists in childhood blood disorders.

Obstetricians / gynecologists: Obstetricians specialize in conditions related to pregnancy. Often they are also gynecologists, specializing in women’s reproductive health conditions.

Reproductive endocrinologists / infertility: This is a sub-branch of the above specialty, addressing both male and female infertility issues.

Other specialists such as surgeons are not as likely to have a physician office lab. Surgeries often take place in a hospital, and therefore tests would be processed through the hospital lab.

Common clinical laboratory workflow: