The provision of specimen collection supplies is an essential function of every outreach program. Specimen collection scope and processes vary broadly across outreach customers. Some provider offices will perform phlebotomy for some or all patients, and others will only collect certain specimens such as culture swabs, urine, or Pap tests in the office. Some may perform testing in the office, at point of care or via a limited laboratory menu. Others may send all testing to an external laboratory.

Given these dynamics, there are many ways for a laboratory outreach program to add tremendous value for a customer, or to unintentionally run afoul of regulations.

Getting started

Begin by understanding the practice and their internal processes.

Identify phlebotomy needs and preferences. Include volumes and types of testing ordered.

• Onsite, performed by practice staff.
• Onsite, performed by laboratory staff.
• Offsite at a patient service center.
• Other.

Identify other specimen collection (non-blood) needs and preferences. Include volumes and types of testing ordered.

• Urine specimens
• Culture swabs
• Pap testing
• Other

If the customer is not a physician’s office, such as a skilled nursing facility or hospital, the supply needs will vary substantially, and the laboratory must adapt in accordance with customer needs.

Identifying unique needs

Next, identify the unique aspects of the practice that may influence how they will use the supplies that they receive from your laboratory.

• Do they use more than one laboratory?
• Do they also receive supplies from that laboratory?
• Do they perform any testing onsite that also requires collection supplies? If so, they must also secure and manage their own supplies.
• Is the practice part of your health system, with employed providers (“inreach”), or entirely independent?

Developing a plan

Then, work with the practice to develop your outreach supply provision plan.

• Identify the reasonable volume and types of supplies that you will provide to your customer.
• Offer convenient ordering mechanisms, such as a manual or electronic form, or phone call.
• Develop a reliable supply delivery process using your laboratory courier.
• Establish standing orders that will ensure a steady inventory and create a stat request process.

Ensuring regulatory compliance

Lastly, ensure regulatory compliance, especially when working with independent providers. The Physician Self-Referral Law (“Stark Law”), the Anti-Kickback Statute, and the Office of Inspector General each have opinions that impact the provision of laboratory outreach supplies.

Simply stated, if a supply is provided at no charge to a customer, the items or services must be capable of being used only as part of the laboratory test, without having any independent value. The laboratory is allowed to provide, “… items, devices or supplies (not including surgical items, devices or supplies) that are used solely to collect, transport, process or store specimens for the entity furnishing the items, devices or supplies or are used solely to order or communicate the results of tests or procedures for the entity.”

Standard supplies include phlebotomy needles, collection tubes, urine cups, culture swabs, liquid Pap vials, formalin vials, requisition forms, transport bags, and more. A simple rule of thumb is if the item is required for the laboratory to perform the testing, the laboratory can provide it to the customer. There have been cases where laboratories received substantial fines for providing collection supplies that allowed the office to perform testing within the office, with no specimen sent back to the laboratory. It is incumbent upon the laboratory to ensure compliance, requiring the laboratory to compare volumes of incoming specimens to the quantity of supplies provided.

Although it seems rudimentary, having an efficient and effective supply provision program is a cornerstone for laboratory outreach program success. By providing adequate specimen collection supplies in compliance with current regulations, the outreach laboratory-customer relationship is certain to succeed.