Clinical File in Addiction Centers: How to Apply NOM-004 Correctly
Direct Answer
The clinical record in an addiction center must comply with NOM-004-SSA3-2012, which establishes the mandatory scientific, ethical, technological, and administrative criteria for the preparation, integration, use, management, filing, preservation, ownership, and confidentiality of the clinical record (see section 1 Objective and 5 Generalities). All rehabilitation centers—including "anexos" with health services—are subject to this standard. Non-compliance exposes the establishment to administrative sanctions, closure, and legal liability before COFEPRIS (now COFEPRIS/CONASAME).
Introduction
In addiction treatment, the clinical record is not a bureaucratic formality: it is the backbone of care, the legal evidence of what was done and why, and a protection tool for staff, patients, and the institution. Many rehabilitation centers and "anexos" in Mexico operate without complete records or build them informally. This is a mistake with real consequences.
What is NOM-004-SSA3-2012 and why does it apply to addiction?
Official Mexican Standard NOM-004-SSA3-2012, Clinical Record regulates clinical records in Mexico for all establishments providing medical care services (definition 4.3). It was published in the Official Gazette of the Federation and replaced NOM-168-SSA1-1998 (see Transitional Article). This standard is mandatory for health personnel and establishments providing medical care services in the public, social, and private sectors, including private practices (section 2 Scope of application).
Who does it apply to?
- Rehabilitation centers registered with the Ministry of Health
- Therapeutic communities
- "Anexos" that provide medical or psychological care
- Outpatient addiction treatment clinics
- Hospitals with detoxification units
Key rule: If clinical decisions are made in your establishment—medication, psychological evaluation, therapeutic intervention—NOM-004 applies without exception (section 5.1). The standard explicitly references NOM-028-SSA2-2009 for the prevention, treatment, and control of addictions (section 3.12).
Mandatory Elements of the Clinical Record in Addictions
The standard establishes a series of documents that must be present. Here are the most relevant for the addiction treatment context:
1. Clinical History
It must be prepared by medical personnel and other health professionals (section 6.1). It must include, in the order indicated:
- Patient identification sheet
- Reason for consultation or admission
- History of substance use: substances, frequency, quantity, route of administration, duration of use (personal pathological history, including tobacco, alcohol, and other psychoactive substance use and dependence, in accordance with NOM-028-SSA2-2009 – section 6.1.1)
- Family medical history (addiction patterns in the family)
- Personal pathological history: chronic diseases, previous hospitalizations, suicide attempts
- Current illness: clinical description of the admission state (inquire about previous conventional, alternative, and traditional treatments)
- Physical examination: vital signs (temperature, blood pressure, heart and respiratory rate), weight and height, general appearance, head, neck, chest, abdomen, limbs, and genitalia data (section 6.1.2)
- Previous and current results of laboratory, imaging, and other studies
- Diagnoses or clinical problems
- Prognosis
- Therapeutic indication
2. Admission Note / Initial Note
It must be prepared by the admitting physician (section 8.1 for hospitalization or 7.1 for emergencies). It must contain: date and time, vital signs, summary of interrogation, physical examination and mental status, relevant results, diagnoses, treatment, and prognosis.
3. Progress Notes
It must be prepared by the physician each time care is provided (section 6.2 and 8.3). In an addiction center, it is recommended:
- Daily during the first 72 hours
- Weekly during the stabilization phase
- Each time the therapeutic phase changes It must describe: evolution and update of the clinical picture (including substance abuse and dependence – section 6.2.1), vital signs, relevant results, diagnoses, prognosis, and treatment (dose, route, and frequency).
4. Interconsultation Notes
The request is prepared by the treating physician; the note is prepared by the consulted physician (section 6.3). It must contain: diagnostic criteria, study plan, diagnostic suggestions, and treatment.
5. Individualized Treatment Plan
It is not literally named in NOM-004, but it is required by NOM-028-SSA2-2009 (specific standard for addiction treatment centers). It must include: therapeutic objectives, planned interventions, responsible parties, and progress criteria. Both standards must be read complementarily (section 5.14).
6. Referral and Counter-referral Form
It must be prepared by a physician and a copy of the clinical summary attached (section 6.4 and 7.3). It contains: sending and receiving establishment, reason for referral, diagnostic impression (including substance abuse and dependence), and therapeutic management used.
7. Discharge Note
It must be prepared by the physician (section 8.9). It contains: admission/discharge date, reason for discharge, final diagnoses, summary of evolution, management during stay, pending clinical problems, management plan, recommendations for outpatient surveillance, attention to risk factors (including substance abuse and dependence), and prognosis.
8. Informed Consent
NOM-004 establishes it as mandatory (section 10.1). It must contain at least: name of the establishment, authorized act, indication of risks and benefits, authorization for contingencies, signature of the patient (or family member/guardian), signature of the physician, and two witnesses. In emergencies, Article 81 of the Regulations applies (section 10.1.4).
NOM-004 and NOM-028: How to Articulate Both Standards
A common mistake is to think that only one of the two standards applies to the center. The reality is:
| Aspect | NOM-004 | NOM-028 |
|---|---|---|
| Clinical record | ✅ Regulates | Complementary |
| Treatment plan | Implicit | ✅ Explicit |
| Responsible personnel | ✅ Health officer | ✅ Counselors, physicians |
| Physical facilities | Does not regulate | ✅ Regulates |
| Patient rights | ✅ Yes | ✅ Yes |
Practical conclusion: The clinical record in a rehabilitation center must meet the requirements of NOM-004 and be aligned with the therapeutic model and documentation standards required by NOM-028.
The "Anexos": Are They Obligated to Keep Clinical Records?
"Anexos" that operate exclusively as mutual aid groups—without health personnel, without medication, without diagnosis—are not formally subject to NOM-004 in its strict sense. However, when an "anexo":
- Has a doctor or nurse who administers medication
- Conducts formal psychological evaluations
- Receives subsidies or is in the process of regularization with the Ministry of Health... then it is obligated to keep clinical records according to NOM-004 (definition 4.3 and section 2). Furthermore, from a legal protection perspective, any "anexo" that documents interventions creates a responsibility that is better defended with a well-structured record.
Retention and Confidentiality of the Record
Minimum retention period
NOM-004 establishes a minimum of 5 years from the date of the last medical act (section 5.4). Records are the property of the institution or service provider, but the patient has ownership rights over their data (section 5.4).
Access to the record
- The patient has the right to access their record.
- In case of incapacity, the guardian or legal representative.
- Third parties do not have access without written authorization (section 5.5.1).
- Judicial, law enforcement, and administrative authorities may request it (section 5.6 and 5.7).
Electronic record
The standard allows electronic means provided that applicable legal provisions are met (section 5.12).
Common Errors in Addiction Centers
- Progress notes without the signature of the responsible professional — legally invalidate the document (section 5.10).
- Incomplete clinical history upon admission — common in centers with high turnover (section 6.1).
- Generic treatment plan — copying and pasting between records is a clinical and legal failure.
- No signed informed consent — especially serious in involuntary admissions (section 10.1).
- Physical records without adequate safeguarding — unauthorized access violates NOM-004 and the Federal Law on Protection of Personal Data Held by Private Parties (LFPDPPP) (section 5.5).
- Diagnoses without coding — ICD-10 is mandatory in Mexico for health establishments.
Step-by-Step: How to Structure the Record Upon Admission
- Verify patient identity and obtain data from the responsible family member.
- Apply initial evaluation (may include instruments such as AUDIT, ASSIST, CAGE, or a structured clinical interview).
- Draft clinical history with all sections of NOM-004 (section 6.1).
- Prepare admission note with presumptive diagnosis in ICD-10.
- Obtain informed consent signature (patient or guardian if applicable – section 10.1).
- Formulate the individualized treatment plan within the first 24–72 hours.
- Start progress notes from the first day (section 6.2).
- Open a physical folder or electronic record with a unique folio number (section 5.2).
Frequently Asked Questions (FAQ)
Does NOM-004 apply to all rehabilitation centers in Mexico?
Yes. Any establishment that provides medical care services—including addiction treatment—must comply with NOM-004-SSA3-2012. There is no exception based on center size or funding type (section 2).
What is the difference between a clinical record and a therapeutic record?
The clinical record is regulated by NOM-004 and contains medico-legal documents. The therapeutic record is a broader concept that some centers use to include activity logs, group attendance, and progress evaluations. The clinical record is the one with legal validity.
Can an addiction counselor sign progress notes?
It depends on state regulations and the formal role of the counselor within the team. Generally, notes with clinical implications must be signed by the center's health officer, who must be a health professional with a professional license (section 5.3 and 5.10).
What happens if COFEPRIS (or CONASAME) conducts a verification and the records are incomplete?
The establishment may receive anything from a warning to a temporary or permanent closure, depending on the severity of the non-compliance. Incomplete records are one of the most frequent findings in verification visits to addiction centers.
Is DSM-5 diagnosis mandatory or is ICD-10 sufficient?
For legal and reporting purposes to Mexican health authorities, ICD-10 is the official system. DSM-5 can be used complementarily for internal clinical guidance, but the official diagnosis in the record must be coded in ICD-10.
How long should the record of a patient who died during treatment be kept?
NOM-004 establishes a minimum of 5 years from the last medical act (section 5.4). However, in cases of death during treatment, it is recommended to keep the record indefinitely due to the risk of legal proceedings.
Do "anexos" without sanitary registration need to keep records?
Technically, if they do not provide health services, they are not obligated by NOM-004. But if they perform any act with clinical implications (medication supply, evaluations, psychological interventions), the obligation exists, and the absence of records leaves them in a position of high legal vulnerability.
Can the patient request a copy of their record?
Yes. The General Health Law and NOM-004 recognize this right. The center must provide it within a reasonable period. The cost of reproduction may be charged, but access cannot be denied.
What assessment instruments should be included in the record?
The results of any applied instrument (AUDIT, ASSIST, CAGE, DAST, cognitive evaluations, anxiety/depression scales) must be integrated into the record, preferably in the clinical history section or as documented annexes referenced in the progress notes (section 6.1.3).
Is there an official record format for addiction centers?
There is no single universal format. NOM-004 establishes the minimum elements it must contain (sections 5.13, 6, and 8), but each establishment can design its own formats as long as they comply with these minimum requirements and those established by NOM-028.
To Learn More
- Consult our article on involuntary commitment: legal and ethical framework in Mexico
- How to Regularize an Anexo in Mexico: The Guide Based on the CONASAMA 2025 Credential
- Discover how to conduct a clinically sound admission assessment in addictions
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Review our guide on what an "anexo" is in Mexico and how it operates legally
For Professionals Working in Addiction Centers
If you are a counselor, clinical coordinator, or director of a rehabilitation center and need a practical tool to help you structure care in a way that complies with Mexican regulations—including record formats, assessment guides, and intervention protocols—the Essential Manual of Addiction Counseling from ConsejeroEnAdicciones.com was designed exactly for that. It includes nine ready-to-use clinical formats, aligned with NOM-028, and an evidence-based intervention framework that you can implement from day one. It's not theory: it's a real working tool. Learn about the Essential Manual →
Author: Juan José López | ConsejeroEnAdicciones.com Certified addiction counselor with over 10 years of clinical experience in Mexico and the United States.