Lab Ordering Rights in Pennsylvania: Scope, Regulations, and Clinical Exceptions

Questions about lab ordering rights come up in many clinical and wellness settings. In Pennsylvania, the rules are shaped by a combination of state licensure laws, federal laboratory requirements, and institutional policies. 

These overlapping layers can make it difficult to determine exactly who has the authority to order tests. Missteps not only risk billing issues but can also create regulatory problems and compromise patient care.

This guide explores the scope of lab ordering in Pennsylvania, outlining which professionals hold ordering privileges, how direct access testing works, and what exceptions or special cases require extra caution.

Disclaimer:

This article is for educational purposes only and does not constitute legal advice. Regulations and policies may change, and healthcare professionals should consult Pennsylvania state law, federal CLIA standards, payer requirements, and their own legal counsel before making decisions about lab ordering authority.

Foundational legal and regulatory structures

Laboratory testing in Pennsylvania operates under both federal and state oversight.

CLIA certification and laboratory complexity

All clinical laboratories must hold a CLIA certificate, which classifies testing into waived, moderate, or high complexity. Waived tests include basic point-of-care screenings, while moderate and high complexity tests require additional oversight, qualified personnel, and stricter recordkeeping. The higher the complexity, the greater the responsibility for training, quality control, and reporting.

The Pennsylvania clinical laboratory act

The state requires all laboratories to hold a valid permit under the Clinical Laboratory Act. Each laboratory must designate a qualified director, follow quality assurance protocols, and complete annual registration. This ensures laboratories maintain consistent standards across testing, specimen handling, and result reporting.

Qualifications for supervisors and technologists

Personnel requirements vary by lab type. Supervisors typically need advanced science degrees with years of laboratory experience, while technologists may qualify through formal training programs or by established employment history. These qualifications are intended to ensure that individuals overseeing or performing tests have the expertise needed to maintain accuracy.

Oversight by the division of laboratory improvement

The Division of Laboratory Improvement within the Pennsylvania Department of Health monitors laboratories for compliance, conducts inspections, and enforces licensure laws, which apply to over 9,000 laboratories statewide.

Hospital lab operations and billing standards

Hospitals either operate their own permitted laboratories or contract with external partners. Rules against improper markups and pass-through billing are supported by ethical practice requirements such as disclosure of charges and restrictions on solicitation/advertising. Institutions referring laboratory work to third parties must follow these standards to avoid compliance risks.

Advertising and legislative updates

Historically, Pennsylvania placed restrictions on laboratory advertising to consumers. Recent proposals have considered easing some restrictions, but advertising to the general public isn’t permitted. Clinics and laboratories should continue to monitor updates from state agencies to remain aligned with current law.

Authorized ordering professionals in Pennsylvania

Laboratory ordering rights are tied directly to licensure and professional scope.

Healthcare providers

Physicians, osteopathic physicians, nurse practitioners (CRNPs), and physician assistants may order laboratory tests within their scope of practice. 

Chiropractors are recognized providers but are limited to tests that align with their practice act and musculoskeletal focus.

Scope of practice and specialty constraints

Even when authorized, professionals must remain within their legal scope. Aligning test selection with each provider’s scope protects both compliance and patient safety.

Institutional delegation: The role of RNs and MAs

Registered nurses, medical assistants, and other clinical staff may enter lab orders into electronic records under the direction of an authorized provider. However, they cannot initiate or select tests independently. Standing orders must be documented, signed, and periodically reviewed by a qualified provider.

Exceptions and specialized scenarios

Certain provider roles and care models present additional considerations.

Naturopathic Doctors and Certified Nutrition Specialists

Pennsylvania now registers naturopathic doctors under the Naturopathic Doctor Registration Act (NDRA). Registrants aren’t licensed as physicians, and current rules don’t grant independent authority to order clinical lab tests (orders must come from a licensed member of the healing arts or another person authorized by statute). 

Certified Nutrition Specialists may participate in care teams but don’t have standalone ordering authority.

Non-licensed providers

Health coaches, functional medicine providers without medical licensure, and other non-licensed providers cannot order or interpret laboratory tests independently. They may only do so in collaboration with licensed providers or through structured referral arrangements.

Out-of-state providers

Clinicians located outside of Pennsylvania who order testing for Pennsylvania patients must comply with Pennsylvania laboratory laws. Laboratories located outside the Commonwealth may solicit and receive Pennsylvania specimens only if properly licensed and compliant with applicable regulations.

Pharmacists and point-of-care testing

Pharmacists may order and perform certain point-of-care tests in CLIA-waived settings where authorized by state law. Pennsylvania recognizes CLIA-waived screening sites and has updated laws affecting pharmacy practice. Pharmacies need to adhere to state protocols and keep accurate records of testing activities.

Public health reporting requirements

Pennsylvania requires laboratories and providers to participate in disease reporting when certain results are detected. Laboratories are required to provide case-report forms, and ordering providers are responsible for ensuring complete and accurate patient data is supplied to public health authorities.

Documentation, ordering standards, and result access

Compliance isn’t only about who can order labs but also how those orders and results are managed.

Requisition standards and recordkeeping

Orders should include the ordering provider’s identifying information, clinical justification/diagnosis, and contact details, and must be retained in laboratory records. For Medicare beneficiaries, diagnostic tests should be ordered by the treating provider and supported by medical necessity.

Interpretation, responsibility, and collaboration

The ordering provider is responsible for reviewing and acting upon lab results. Laboratories are expected to reject orders submitted by individuals acting outside their scope. 

Pharmacists who order tests under their authority must communicate results to prescribers when appropriate, per applicable practice agreements and CLIA requirements.

Direct‑to‑patient result access (HIPAA/CLIA)

Patients have a federal right to obtain their completed lab reports directly from laboratories under HIPAA/CLIA.

Frequently asked questions (FAQs)

Below are concise answers to common questions that clinics and providers face.

Can a Registered Nurse order lab tests independently in Pennsylvania?

No. RNs may carry out standing orders or enter requests, but cannot initiate tests independently.

Do chiropractors have full lab ordering privileges?

No. Chiropractors are limited to tests directly related to their musculoskeletal scope of practice.

Can patients order labs on their own?

Yes. Direct-to-consumer lab testing is available, but costs are often out-of-pocket and subject to CLIA laboratory standards.

Are pharmacists able to order diagnostic tests?

Yes, under certain conditions. Pharmacists may perform limited point-of-care testing if their facility holds a CLIA waiver and appropriate agreements are in place.

Do naturopathic doctors have lab ordering rights in Pennsylvania?

No. Because they aren’t licensed in the state, they cannot order tests independently.

Key takeaways

• Laboratory testing in Pennsylvania is governed by both CLIA and state law, with authority tied to licensure and professional scope.
• Physicians, nurse practitioners, physician assistants, and chiropractors (within limits) may order tests, while non-licensed providers cannot.
• Pharmacists may perform certain point-of-care tests when operating under waiver agreements and documented protocols.
• Standing orders and delegation must be carefully documented, with responsibility remaining with the licensed provider.
• Public health reporting rules make providers accountable for ensuring that positive or significant results are communicated accurately and promptly.

Disclaimer:

This article is for educational purposes only and does not constitute legal advice. Regulations and policies may change, and healthcare professionals should consult Pennsylvania state law, federal CLIA standards, payer requirements, and their own legal counsel before making decisions about lab ordering authority.