North Dakota Administrative Code Title 96 - Board of Clinical Laboratory Practice
Legal Basis & Purpose
The Board of Clinical Laboratory Practice was created by the North Dakota legislature (1989; Laws 1989, Ch. 538) under North Dakota Century Code (NDCC) Chapter 43‑48. Its purpose is to license and regulate clinical laboratory personnel; to investigate violations; and to impose disciplinary sanctions in order to protect public health and welfare.
The Administrative Code (Title 96) sets the detailed rules (licensure requirements, fees, discipline, ethics, exemptions, etc.) by which the Board implements the law in Chapter 43‑48. In ND law hierarchy, the statute (NDCC) is supreme over the administrative rules, but the rules have binding force within the scope the statute allows.
Key Provisions in Title 96
Here are the major components of the Title, with explanation.
| Article / Chapter | Subject | Key Rules / Requirements |
|---|---|---|
| Article 96‑01: General Administration | Organization, officers, staff of the Board; how the Board is structured. | E.g., Section 96‑01‑01‑01 defines how the Board is appointed (governor appoints, statutory qualifications), officers, compensation, staff powers. |
| Article 96‑02: Clinical Laboratory Personnel Licensure | The licensure, scope, exemptions, discipline, etc. | Includes multiple chapters: Licensure (96‑02‑02), Fees (96‑02‑03), Continuing Education (96‑02‑04), Discipline (96‑02‑09), Exemption from Licensure (96‑02‑10), etc. |
Some specific rules:
Initial license requirements (96‑02‑02‑01): Applicants must submit an application, pay fee, show required education, pass a national certifying exam, and one of several options: (a) passing exam within 2 years; or (b) having done 300 hours of clinical laboratory testing within 3 years; or (c) 30 continuing education hours in past 2 years. Also, applications must be signed/e‑attested
Requirements for specific licenses (96‑02‑02‑02): Different levels (medical technologist / clinical laboratory scientist; clinical laboratory specialist; clinical laboratory technician / medical laboratory technician). Each has educational prerequisites (structured clinical educational program recognized by the Board), passing of national exams. Clinical laboratory specialist license must designate specialty (e.g. chemistry, microbiology, hematology, blood bank, etc.), etc. Provisional permits are possible under certain conditions.
Fees (96‑02‑03‑01): The Board sets fees sufficient to cover licensure service costs. There are schedules for initial licensing (varies depending on time of year, type of license), renewal, late fees, provisional permits.
Discipline / Unprofessional conduct (96‑02‑09‑02): Enumerates what constitutes unprofessional conduct: scientific/professional misconduct (e.g. falsification, deceptive statements), failure to protect confidentiality, failure to maintain minimum standards or practicing beyond one's license scope, failure to report violations, problems with substance abuse or mental health affecting practice, etc
Code of Ethics (96‑02‑09‑03): Mandatory ethical standards: primary duty to patient, competence, confidentiality, truthfulness, avoiding conflicts of interest, etc.
Exemptions (96‑02‑10): Under some conditions certain tests (especially waived tests under FDA/CLIA or similar) or supervision by a licensed person can allow individuals to be exempt from needing a license. Also rules for how supervision must be done (training, documentation, competency assessment, etc.).
Supervision (96‑02‑10‑02): Defines what it means to supervise for purposes of exemption: supervisor must identify supervised individuals, ensure training and competency, do annual competency assessments, document training, be available, etc. Failure to properly supervise is unprofessional conduct.
Relationship with the Statute: NDCC Chapter 43‑48
Title 96 rules implement Chapter 43‑48. Some key statute provisions:
Definitions (43‑48‑01): Defines “clinical laboratory personnel,” “clinical laboratory testing,” structured clinical education, etc.
License Required (43‑48‑02): No person may practice as the kinds of clinical laboratory scientists or technicians unless licensed or exempt.
Exemptions (43‑48‑03): Certain persons are exempt from the licensing requirement (e.g. physicians, nurses within their scope, those doing research/teaching, persons performing “waived” whole blood glucose etc.)
Powers and Duties of Board (43‑48‑04): The Board can issue/renew licenses, set fees, discipline, adopt rules, issue subpoenas, etc.
Discipline (43‑48‑15): Specifies grounds for denying, revoking, or suspending licenses. While the Admin Code lays out the detailed standards of unprofessional conduct, the statute gives the legal authority.
Legal Force & Administrative Law Principles
The rules in Title 96 are binding on licensees and applicants once validly adopted under ND law (including rulemaking under ND Administrative Agencies Practice Act). They have the force of law in the sense that violation can lead to disciplinary action, refusal of licensure, etc.
Applicants/licensees have rights under the Administrative Agencies Practice Act (NDCC Chapter 28‑32): due process (notice, hearing), opportunity to present evidence, findings of fact supported by evidence, etc.
Courts reviewing Board decisions must follow standards of review: whether the Board acted within statutory authority; whether the Board’s findings are supported by a preponderance of the evidence; whether the Board followed required procedures. (Though I found no case specifically under clinical laboratory rules.)
Case Law – What Exists, Analogy & Gaps
I found no reported case that addresses Title 96 / Board of Clinical Laboratory Practice specifically (i.e. no published North Dakota Supreme Court or appellate case that examines a dispute about a specific refusal of clinical lab licensure under Title 96). Sometimes, rules are challenged, but I could not locate one.
What is available are cases under other medical or professional licensure regimes in ND that have similar features; we can use them by analogy to see how courts might treat Title 96 issues if cases arise.
Singha v. North Dakota State Board of Medical Examiners
Although this is about medical licensure (physicians), not clinical laboratory licensing, Singha is relevant in showing how ND Supreme Court treats administrative agency licensure decisions: the need to follow statutory requirement, what “educational equivalency” means under statute, and how to handle foreign‑educated applicants. Justia+2Justia+2
The Court in Singha stressed that if statute requires certain equivalency or accreditation, agencies cannot waive or reinterpret those beyond what the statute allows. If a candidate lacks what statute demands, the agency must deny; also that administrative law procedures (hearings, findings, etc.) apply.
Other licensure discipline cases (e.g. under NDCC chapters for Medicine, Pharmacy, etc.)
These show how unprofessional conduct is interpreted, how scope of practice is enforced, how ethical or disciplinary violations are evaluated. For example, in ND cases where a medical license was revoked or suspended for misconduct, false statements, or practicing beyond scope. These provide precedent for how similar provisions in rules like 96‑02‑09‑02 (unprofessional conduct) might be applied.
Because there’s no case directly under Title 96, one cannot point to a judicial interpretation of, say, what “structured clinical education recognized by the board” means under 96‑02‑02‐02, or how strictly “provisional permits” are to be granted under that rule. But the case law under other professions suggests courts will enforce statutes and rules as written, require that Board decisions be supported by factual findings, ensure due process, and respect statutory authority.
Hypothetical Issues & How They Might Be Handled (By Analogy)
Here are some possible legal questions that might arise under Title 96, and how similar issues have been treated elsewhere—this helps understand what courts may do.
| Hypothetical Dispute | Relevant Rule(s) | What Court Likely Focuses On |
|---|---|---|
| Applicant claims Board wrongly denied license because educational program wasn’t sufficiently “structured clinical education recognized by the board.” | 96‑02‑02‑02; definitions in 43‑48‑01 | Court would examine whether the program met accreditation or Board approval; whether Board followed rule in evaluating; whether applicant was given opportunity to present evidence and appeal. Analogous to Singha. |
| Licensee charged with unprofessional conduct under rules (e.g. false statement, breach of confidentiality). | 96‑02‑09‑02; NDCC 43‑48‑15 | Court would check whether the Board’s findings of fact are supported, that the conduct falls under the definition in rule/statute, that licensee got fair process, etc. |
| Someone practicing without license claims exemption (for waived tests under supervision) and is disciplined. | 96‑02‑10 sections; statute 43‑48‑03 | Court will interpret “waived tests,” what counts as supervision (documented), whether the exemption applies, whether Board’s interpretation is consistent with statute. |
| Dispute over the fee schedule or whether fees were properly adopted. | 96‑02‑03; powers under 43‑48‑04 | Court will check if Board acted within its statutory authority; whether rulemaking procedures were followed. |
Limitations & Gaps
As noted, lack of case law means certain terms/rules are not judicially fleshed out (e.g. what counts as “recognized program,” or what extent the continuing education requirement can substitute for direct practice hours).
Some of the rules are complex and leave discretionary powers to the Board (e.g. provisional permits, renewals). Discretion means outcomes may vary; courts often give deference to agency expertise in technical matters.
There may be unpublished or administrative hearing decisions that interpret these rules in practice (but not available in published case law).
Practical Takeaways
If you are applying under Title 96 (or advising someone), you must carefully examine both the statute (Chapter 43‑48) and the specific Administrative Code provisions—requirements are strict: education, exam, continuing education or practice hours, etc.
Because the Board has discretion (e.g. in recognizing programs or specialty areas, in provisional permits, in exemptions), applicants should document everything well: transcripts, structured education, supervised hours, competency, etc.
For disciplinary matters, licensees should ensure due process: notice of charges, opportunity to respond, hearing, sufficient findings of fact, etc.
If there's uncertainty (e.g. whether your program is “recognized” or whether an exemption applies), might consider legal counsel or administrative appeal, given the precedent in Singha and similar cases that courts will enforce statutory boundaries.
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