STANDING ORDER PROTOCOL

Urine Drug Screening (UDS) — Presumptive and Confirmatory Testing

Organization Type: Addiction, Substance Use Disorder, and Behavioral/Mental Health Treatment

State: North Carolina

Effective Date: _______________

Review Date: _______________

Approved By: _______________ (Medical Director / Authorizing Physician)

License #: _______________

SECTION 1: PURPOSE AND SCOPE

1.1 Purpose

This standing order authorizes designated clinical staff to collect urine specimens and perform presumptive (screening) urine drug testing, and to initiate confirmatory (definitive) testing when clinically indicated, without requiring an individualized physician order for each test. Drug testing is used as a therapeutic tool to support recovery — not as a punitive measure.

1.2 Scope

This protocol applies to all patients admitted to or actively receiving services for substance use disorder (SUD), addiction, and/or co-occurring behavioral/mental health disorders within the organization's programs, including:

• Outpatient services (ASAM Level 1.0)

• Intensive outpatient / partial hospitalization (ASAM Level 2.0)

• Residential / inpatient services (ASAM Levels 3.0–4.0)

• Medication-assisted treatment (MAT) / office-based opioid treatment (OBOT)

1.3 Authorized Personnel

The following staff may perform specimen collection and point-of-care testing under this standing order:

• Registered Nurses (RN)

• Licensed Practical Nurses (LPN)

• Certified Medical Assistants (CMA)

• Certified Nursing Assistants (CNA), under RN supervision

• Other clinical staff as designated by the Medical Director and permitted under North Carolina scope-of-practice laws

SECTION 2: GUIDING PRINCIPLES

2.1 Drug testing should be used as a tool for supporting recovery rather than exacting punishment. Every effort should be made to ensure patients understand that drug testing is a therapeutic component of treatment.

2.2 Drug testing can neither diagnose nor rule out a substance use disorder. Results must be interpreted in combination with patient history, physical examination, and psychosocial assessment.

2.3 Drug testing can serve important clinical purposes including:

• Screening for withdrawal risk

• Monitoring medication adherence (e.g., buprenorphine, naltrexone, methadone)

• Determining substance use objectively when clinical findings do not match self-report

• Helping patients understand what substances they have been exposed to

• Measuring treatment progress

• Informing level-of-care placement decisions

2.4 Patients have the right to refuse drug testing. Admission and discharge decisions shall not be based solely on drug test results or refusal of testing. Refusal shall be documented along with the clinician's interpretation of its clinical relevance.

2.5 Unexpected results shall be addressed therapeutically, not punitively. Negative results should be positively reinforced.

SECTION 3: PATIENT CONSENT AND CONFIDENTIALITY

3.1 Informed Consent

• Written informed consent for drug testing shall be obtained from each patient at intake, prior to the first specimen collection.

• The consent form shall explain: the purpose of testing, types of tests used, how results will be used clinically, confidentiality protections, and any circumstances under which results may be disclosed to third parties.

• For patients involved with the criminal justice system, child protective services, or treatment courts, any mandatory reporting obligations shall be discussed with the patient at the outset and documented.

3.2 Confidentiality

• All drug test results are protected health information and shall be maintained in strict confidence in accordance with:

  • 42 CFR Part 2 (federal confidentiality of substance use disorder patient records)

  • HIPAA Privacy Rule (45 CFR Parts 160 and 164)

  • North Carolina General Statutes governing medical records confidentiality

• Results shall not be disclosed to any outside entity (employers, law enforcement, family members, etc.) without the patient's specific written consent, except as required by law.

• When results must be shared with outside entities, positive presumptive results should be confirmed with definitive testing before disclosure. If presumptive results are shared, they must be clearly labeled as "presumptive."

• Staff shall receive annual training on 42 CFR Part 2 requirements and organizational confidentiality policies.

3.3 Special Populations

• Pregnant patients: Explicit written consent shall be obtained. Staff shall be knowledgeable about North Carolina reporting requirements. Clinicians should have honest discussions about confidentiality and any exceptions.

• Minors: Consent and confidentiality shall comply with North Carolina minor consent laws and 42 CFR Part 2 protections.

SECTION 4: PRESUMPTIVE (SCREENING) TESTING PROTOCOL

4.1 Test Type

• Point-of-care (POC) immunoassay urine drug screen cups that are CLIA-waived shall be used for presumptive screening.

• The organization shall maintain a current CLIA Certificate of Waiver.

4.2 Recommended Minimum Panel

The standard screening panel shall include, at minimum, the following analytes (to be reviewed and updated annually based on regional substance use trends in North Carolina):

• Amphetamines

• Barbiturates

• Benzodiazepines

• Buprenorphine

• Cocaine (benzoylecgonine)

• Fentanyl

• Marijuana (THC)

• Methadone

• Methamphetamine

• Opiates (morphine/codeine)

• Oxycodone

• Phencyclidine (PCP)

• Tramadol

• Ethyl glucuronide (EtG) for alcohol detection

Note: Standard "NIDA-5" or "SAMHSA-5" panels are NOT adequate for clinical addiction medicine use. Panels should be tailored to include fentanyl and fentanyl analogs, which are highly prevalent in North Carolina, as well as buprenorphine for MAT adherence monitoring.

Additional analytes (e.g., synthetic cannabinoids/K2, kratom, gabapentin) may be added based on clinical judgment, patient self-report, and local substance use trends.

4.3 Specimen Validity Testing

Each specimen shall be assessed for validity. At minimum, the following shall be checked:

• Temperature (90–100°F / 32–38°C within 4 minutes of collection)

• Creatinine concentration

• Specific gravity

• pH

• Oxidants / adulterants (nitrites, glutaraldehyde, bleach)

Specimens that fail validity criteria shall be documented as "invalid" or "substituted" and the patient shall be asked to provide a new specimen. The clinical team shall address the issue therapeutically.

4.4 Specimen Collection Procedures

• Collection shall occur in a designated, secure restroom or collection area.

• Water sources in the collection area should be secured (e.g., bluing agent in toilet, faucets turned off or taped) to minimize adulteration risk.

• The patient shall empty pockets and leave personal belongings outside the collection area.

• Direct observation of collection is NOT routinely required but may be implemented when there is documented clinical concern for specimen tampering, in accordance with organizational policy and patient dignity.

• The specimen shall be labeled with the patient's name, date of birth, date and time of collection, and the collector's initials.

• Chain-of-custody procedures shall be followed when specimens are sent for confirmatory testing.

SECTION 5: TESTING FREQUENCY

5.1 General Principles

Testing frequency shall be individualized based on patient acuity, level of care, and phase of treatment. Random, unannounced testing is preferred when feasible.

5.2 Recommended Frequency Schedule

Intake/Admission:

• All patients shall have a UDS performed at intake as part of the initial assessment.

Early Treatment (first 90 days):

• At least weekly during the initial phase of treatment.

• For MAT patients: approximately 1 week post-induction, and at each step-down in visit frequency.

Stabilization Phase (90 days – 6 months):

• At least biweekly (every 2 weeks), or as clinically indicated.

Maintenance/Continuing Care (>6 months, stable recovery):

• At least monthly.

• Individual consideration may be given for less frequent testing (e.g., quarterly) for patients in sustained stable recovery.

5.3 Increased Frequency Indications

Testing frequency should be increased when:

• A patient returns to substance use after a period of abstinence

• There is a change in clinical status (e.g., sedation, agitation, behavioral changes)

• The patient is experiencing significant psychosocial stressors

• Following weekends, holidays, or paydays (outpatient settings)

• Clinical findings are inconsistent with patient self-report

5.4 Clinically Indicated Testing

In addition to the scheduled frequency, authorized staff may collect a specimen at any time when there is clinical concern, including but not limited to:

• Apparent intoxication or withdrawal symptoms

• Medication non-adherence concerns

• Prior to level-of-care transitions

• As part of contingency management protocols

SECTION 6: CONFIRMATORY (DEFINITIVE) TESTING PROTOCOL

6.1 Indications for Confirmatory Testing

Confirmatory testing using chromatography/mass spectrometry (LC-MS/MS or GC-MS) at a CLIA-certified reference laboratory shall be ordered when:

• Presumptive test results are inconsistent with the patient's self-reported use or prescribed medications

• Presumptive test results are unexpected (positive or negative) and will inform clinical decisions with major implications (e.g., medication changes, level-of-care changes)

• Results may have legal or non-clinical consequences for the patient (e.g., court-mandated treatment, child protective services involvement, probation)

• The patient disputes a presumptive positive result

• Presumptive testing is not available for a substance of clinical interest

• The clinician suspects cross-reactivity or a false positive/negative

6.2 Ordering Confirmatory Tests

• Authorized clinical staff may initiate confirmatory testing under this standing order by sending the specimen (or a split specimen) to the designated CLIA-certified reference laboratory.

• The ordering clinician or Medical Director shall be notified when confirmatory testing is initiated.

• Chain-of-custody documentation shall accompany all specimens sent for confirmatory testing.

6.3 Reference Laboratory

• The organization shall maintain a contract with a CLIA-certified reference laboratory capable of performing definitive testing via LC-MS/MS or GC-MS.

• Laboratory name: _______________

• CLIA #: _______________

• Contact: _______________

SECTION 7: INTERPRETATION AND CLINICAL RESPONSE

7.1 Interpretation

• All drug test results shall be interpreted by a clinician whose scope of practice includes ordering and interpreting drug tests (physician, nurse practitioner, physician assistant, or other qualified provider).

• Interpretation shall consider: the specific test used, cutoff values, detection windows, the patient's prescribed medications, potential cross-reactivity, and specimen validity.

• Presumptive results are preliminary. A negative result does not exclude the presence of a substance below the cutoff threshold.

7.2 Clinical Response to Results

• Expected negative results: Positively reinforce the patient's progress.

• Expected positive results (e.g., prescribed buprenorphine detected): Document as consistent with treatment plan.

• Unexpected positive results: Address therapeutically. Explore with the patient in a non-judgmental manner. Consider confirmatory testing. Adjust treatment plan as clinically indicated (e.g., increase visit frequency, intensify counseling, reassess level of care).

• Unexpected negative results (e.g., prescribed medication NOT detected): Assess for non-adherence, diversion, or specimen validity issues. Consider confirmatory testing.

• Invalid/adulterated specimen: Document and address therapeutically. Request a new specimen.

7.3 Documentation

All of the following shall be documented in the patient's medical record:

• Rationale for the drug test

• Date and time of collection

• Collector identity

• Specimen validity results

• Presumptive test results

• Confirmatory test results (when applicable)

• Clinical interpretation and any treatment plan modifications

• Patient's current medications and potential sources of cross-reactivity

• Patient refusal (if applicable), with clinician's interpretation of clinical relevance

SECTION 8: QUALITY ASSURANCE

8.1 The organization shall maintain a current CLIA Certificate of Waiver and comply with all applicable CLIA regulations for point-of-care testing.

8.2 POC testing devices shall be stored, maintained, and operated according to manufacturer instructions. Quality control testing shall be performed per manufacturer specifications and documented.

8.3 Staff performing specimen collection and POC testing shall receive initial training and annual competency assessment, including:

• Proper specimen collection technique

• Operation and interpretation of POC devices

• Specimen validity assessment

• Chain-of-custody procedures

• Confidentiality requirements (42 CFR Part 2, HIPAA)

• Therapeutic use of drug testing

8.4 The drug testing panel shall be reviewed at least annually and updated based on:

• Changes in local and national substance use trends

• Collaboration with the reference laboratory regarding regional patterns

• Availability of new testing technologies

8.5 This standing order protocol shall be reviewed and reauthorized by the Medical Director at least annually.

SECTION 9: REGULATORY COMPLIANCE

This protocol is designed to comply with:

• 42 CFR Part 2 (Confidentiality of Substance Use Disorder Patient Records)

• HIPAA Privacy Rule (45 CFR Parts 160 and 164)

• Clinical Laboratory Improvement Amendments (CLIA)

• The Joint Commission Standards for Behavioral Health Organizations

• North Carolina Medical Board regulations

• North Carolina General Statutes governing controlled substances and medical records

• ASAM Appropriate Use of Drug Testing in Clinical Addiction Medicine (2017)

• SAMHSA Treatment Improvement Protocols

Note: This standing order does not replace the need for individualized clinical judgment. The authorizing physician/Medical Director retains ultimate responsibility for the clinical care of patients. North Carolina-specific regulations regarding scope of practice, standing orders, and laboratory testing should be verified with legal counsel.

AUTHORIZATION

I hereby authorize the above standing order protocol for urine drug screening and confirmation testing at this organization.

Medical Director / Authorizing Physician (Print): _______________

Signature: _______________

Date: _______________

DEA #: _______________

NPI #: _______________

Review Date: _______________

Next Review Due: _______________

Key evidence supporting this protocol:

The ASAM Appropriate Use of Drug Testing in Clinical Addiction Medicine consensus document provides the foundational framework, recommending that drug testing panels be individualized and go beyond the standard NIDA-5, that testing frequency be at least weekly in early treatment and at least monthly in stable recovery, and that testing be used therapeutically rather than punitively. 

[2]

 ASAM emphasizes that specimen validity testing (creatinine, specific gravity, pH, adulterants) is essential, and that confirmatory testing via chromatography/mass spectrometry at CLIA-certified laboratories should be used when results carry major clinical or legal implications. 

[2]

The Joint Commission requires that behavioral health organizations follow a written policy on drug testing that considers diagnosis, treatment progress, history of use, and clinical judgment. 

[4]

 ASAM's 2024 guidance further reinforces that drug testing should not be used punitively, that patients have the right to refuse, and that admission/discharge decisions should not be based solely on test results. 

[6]

Regarding confidentiality, 42 CFR Part 2 provides federal protections for substance use disorder treatment records, and ASAM recommends that results be kept confidential to the extent permitted by law, with caution exercised when sharing with outside entities. 

[2]

 North Carolina is not among the states that classify maternal substance use as child abuse under the ASAM 2017 listing, but state-specific legal counsel should verify current requirements. 

[2]

For panel selection, fentanyl testing is critical given that many standard panels do not detect fentanyl or its analogs, and fentanyl is a leading cause of overdose deaths in North Carolina. 

[1][7]

 Ethyl glucuronide (EtG) testing is recommended for alcohol detection in addiction treatment populations. 

[2]

 A 16-panel CLIA-waived cup has been used successfully in clinical practice for SUD treatment monitoring. 

[8]

Important caveats: This document should be reviewed by the organization's legal counsel to ensure compliance with current North Carolina statutes (including NC Medical Board rules on standing orders and scope of practice for non-physician staff) and by the Medical Director before implementation. State-specific CLIA waiver requirements should also be confirmed, as some states have regulations that differ from federal guidelines.