How to Start a Medical Practice: CLIA, OSHA and Supplies

General information, not legal or medical advice. It describes two federal requirements as published by CMS and OSHA, checked on 2026-10-31.

If you are opening a medical practice, two federal compliance programs decide a large part of what you buy and what you write down before the first patient: CLIA, which applies if your practice runs laboratory tests, and the OSHA bloodborne pathogens standard, which applies to employees with occupational exposure to blood or other potentially infectious materials. This guide walks through both in the order a startup meets them, then points to supply checklists for specific clinic types. It does not cover state licensure, payer enrollment or financing, which are separate processes.

What do you need to open a medical practice?

For the equipment-and-compliance side of opening a practice, you need a decision on in-house testing (and, if yes, a CLIA certificate), a written OSHA exposure control plan, a hepatitis B vaccine offer for exposed employees, a training schedule, a sharps injury log, and the supplies those programs call for. The sections below source each item.

What you need

• A CLIA decision. CMS states that “all laboratories must be properly certified to receive Medicare or Medicaid payments,” and that CLIA regulations are based on the complexity of the test method. If your practice will test specimens on site, confirm what certification applies. For the waived-test category, see CLIA-waived test.
• A written exposure control plan under OSHA 29 CFR 1910.1030, if any employee has occupational exposure.
• Hepatitis B vaccine availability for those employees, at no cost to them.
• A training schedule for initial assignment and every year after.
• A sharps injury log for percutaneous injuries from contaminated sharps.
• Supplies matched to your services. See the checklists linked under Steps.

Steps

Requirement	What the source says	Source
CLIA certification	All laboratories must be certified to receive Medicare or Medicaid payments; requirements follow test complexity.	CMS CLIA page
CLIA application	Submit Form CMS-116 and pay the fee online through pay.gov; CMS no longer accepts paper checks.	CMS CLIA page
Exposure control plan	Reviewed and updated at least annually and whenever tasks or procedures change.	29 CFR 1910.1030(c)(1)(iv)
Hepatitis B vaccine	The employer must make it available at no cost to employees who have occupational exposure.	29 CFR 1910.1030(f)(1)(ii)(A)
Training	At the time of initial assignment and at least annually thereafter.	29 CFR 1910.1030(g)(2)(ii)
Sharps injury log	Employers must keep a Sharps Injury Log for percutaneous injuries from contaminated sharps; document annually the consideration and implementation of safer medical devices.	OSHA bloodborne pathogens standards page

1. Decide whether you will test specimens in the practice. If yes, a CLIA certificate is part of your startup, because CMS ties Medicare and Medicaid payment to certification.
2. Apply through CMS. CMS directs applicants to the Certification Quick Start Guide, then to submit Form CMS-116 and pay the fee online at pay.gov. Questions go to your State Agency; a laboratory that is accredited contacts its Accreditation Organization.
3. Write the exposure control plan before staff start work with exposure, and set a calendar reminder for the annual review.
4. Arrange the hepatitis B vaccine offer for each employee with occupational exposure, at no cost to the employee.
5. Schedule training at assignment and annually.
6. Start the sharps injury log and add an annual entry for safer-device review.
7. Build your supply list from a checklist close to your service line: urgent care startup supplies, pediatric clinic supplies, and the general medical supplies for a doctor’s office. Dentists can use how to start a dental practice. For sharps safety law, see the Needlestick Safety and Prevention Act.

What can go wrong

• Testing on site without the right certification. CMS says laboratories must be certified to receive Medicare or Medicaid payments.
• A plan that is never revisited. The standard requires review at least annually and when tasks or procedures change, such as adding a new service.
• A missed vaccine offer. The standard requires the employer to make the hepatitis B vaccine available to exposed employees at no cost to them.
• Training that stops after day one. The standard requires it again at least annually.
• No sharps injury log. OSHA requires employers to keep one.

When to get professional help

Contact your State Agency (or your Accreditation Organization, if accredited) for CLIA questions, as CMS directs. For OSHA applicability to your staff and your plan, ask OSHA or a qualified occupational safety or healthcare compliance adviser. This page cannot determine which requirements apply to your specific practice.

FAQ

What do you need to open a medical practice?

On the equipment and compliance side: a decision on in-house testing (and a CLIA certificate if you test specimens), a written OSHA exposure control plan, a hepatitis B vaccine offer and training for exposed employees, a sharps injury log, and supplies matched to your services. State licensure, payer enrollment and financing are separate processes this guide does not cover.

How do I open a medical practice?

Opening involves several separate tracks. On the equipment and compliance side, the tracks documented above are CLIA certification if you test specimens and the OSHA bloodborne pathogens program for exposed employees. State licensure and payer enrollment are outside this guide.

What is on a medical practice startup checklist?

For compliance and supplies: a CLIA decision, a written exposure control plan, a hepatitis B vaccine offer, initial and annual training, a sharps injury log, and a supply list matched to your services.

Do I need a CLIA certificate?

CMS says laboratories must be properly certified to receive Medicare or Medicaid payments, and that requirements depend on test complexity. If you test specimens on site, ask your State Agency which certification applies.

How often must the exposure control plan be updated?

At least annually, and whenever tasks or procedures change, under 29 CFR 1910.1030(c)(1)(iv).

Sources

• CMS, Clinical Laboratory Improvement Amendments (CLIA): cms.gov/medicare/quality/clinical-laboratory-improvement-amendments, checked 2026-10-31.
• OSHA, Bloodborne Pathogens, 29 CFR 1910.1030: osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030, checked 2026-10-31.
• OSHA, Bloodborne pathogens standards: osha.gov/bloodborne-pathogens/standards, checked 2026-10-31.