Dental Record Keeping Is Key to Quality Assurance

Proper record keeping is an indispensable part of any dental practice.

By Kandis V. Garland, RDH, MS, CDIPC On Aug 16, 2024 0

Quality assurance in dentistry is an umbrella term that encompasses proactive tasks that create an optimal environment for patient care^.1 Record keeping is one of these important quality assurance measures. Oral health professionals must maintain proper legal patient records including patient assessment data and treatment notes, privacy information, insurance information, and radiographs.

Dental records contain information necessary for patient treatment, act as a communication tool, provide legal protection, and include information for authorized third parties, such as insurance providers or the legal system.^2,3 Often considered a breach of the standard of care, poor record keeping is one of the most common complaints in litigation against dental practices.^3,4 Litigation or accusations of malpractice typically aim to determine whether the standard of care was followed.⁵ The standard of care in dentistry considers what a reasonable oral health professional would do when faced with the same situation.⁵ Good record keeping is the standard of care and protects oral health professionals.

Administrative measures and program evaluation are key components for meeting the standard of care, implementing quality assurance measures, and ensuring regulatory compliance.^6,7 Poor record keeping and noncompliance with regulatory agencies may be classified as medical errors.^8,9 Many of the highly publicized dental infection control breaches relate to poor sterilization practices, as well as improper or inadequate record keeping with infection control and prevention.^9,10

Dental practices must comply with mandates and recommendations (including record keeping) from state and federal regulatory agencies such as the Occupational Safety and Health Administration (OSHA) and the United States Centers for Disease Control and Prevention (CDC).^6,7,11 Practices should also consider reviewing best practice recommendations from the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI), a voluntary consensus organization that provides the most comprehensive guidance for steam sterilization.

As the scope of record keeping for dentistry is wide, the role of the infection control coordinator (ICC) is critical. Anyone appointed in the role of ICC must have comprehensive knowledge of infection control policies, procedures, guidance recommendations, and regulatory requirements.

Good record keeping is the cornerstone of any good infection control and prevention plan. Proper documentation is key in training staff, complying with OSHA and other infection control guidance, and ensuring safety for patients. Lack of clear documentation has been identified in many infection control breach cases.^9,10 Dental practices should follow record keeping guidance from three organizations: OSHA, CDC, and ANSI/AAMI.

Occupational Safety and Health Administration

As a regulatory agency, OSHA has enforcement capabilities, meaning it can investigate and impose fines.¹¹ The primary OSHA standards that dental offices must comply with are the Bloodborne Pathogens (BBP) Standard (29 CFR 1910.1030); the Hazard Communication (HAZCOM) Standard (29 CFR 1910.1200); and the Respiratory Protection Standard (29 CFR 1910.134).^12-14 Several other OSHA standards exist, but the aforementioned standards are the main focus for the ICC.

The OSHA BBP standard requires employers must have an exposure control plan, a site-specific document that demonstrates how the office complies with OSHA standards. The plan must include: a copy of the OSHA BBP standard; a list that determines job categories in which employees might have exposure to BBPs; and how the office implements methods of exposure control such as standard precautions, engineering and work practice controls, personal protective equipment (PPE), housekeeping, employee hepatitis B vaccination records, post-exposure evaluations and follow-up, how hazards are communicated to employees, documentation of training, and record keeping. The exposure control plan must be updated at least annually.¹²

The OSHA BBP standard also states that employers must ensure that employees use standard precautions, engineering controls, and work practice controls. They must provide PPE that is laundered either by a service or on-site, so employees do not take contaminated garments home.

Employers are required to offer the hepatitis B vaccine and maintain a post-exposure protocol. Employees have the right to decline the vaccine and post-exposure protocol, but they should be counseled about the risks associated with declination.

Employers must provide BBP standard training upon hire, when new job tasks with exposure risks are undertaken, and at least annually. Lastly, employers are required to maintain personal health records for all at-risk employees and documentation of BBP training.¹²

ICCs must also be familiar with the HAZCOM standard, which relates to exposure to chemicals used in the dental office.¹³ Employers must implement a HAZCOM program to be OSHA compliant. The employer is required to provide a written description of how the office meets the HAZCOM standard that includes ensuring that hazardous chemicals contain a label, keeping safety data sheets (SDS) for hazardous chemicals in an easily accessed area, and providing training for employees.¹³

Record keeping for all OSHA documents and compliance is varied. Table 1 outlines the type and required frequency of OSHA records. The exposure control plan containing vaccine information, exposure incidents information, and post-exposure information must be reviewed at least annually and kept indefinitely.¹²

Training records related to the BBP and HAZCOM must be kept for at least 3 years. Employee medical records must be kept for the duration of employment plus 30 years. An OSHA sharps injury log must be kept for 5 years. Sterilization records, including mechanical, chemical, and biological logs, must be kept according to the facility, state, or federal guidance, which is a bit more unclear.¹² OSHA does not provide specific record keeping guidance on the length of time sterilization records must be kept, so deferring to best practices guidance from ANSI/AAMI is prudent.

United States Centers for Disease Control and Prevention

As an advisory body, the CDC makes evidence-based recommendations for best practices^6,7 and sets guidance for minimum compliance standards. If a state adopts any language from a CDC guideline document or if it is tied to a regulatory (OSHA) standard, the CDC guidance then becomes law. The CDC cannot investigate or impose fines.

Developing a keen understanding of CDC guidelines is key to implementing a safe work environment. The CDC guidelines contain evidence-based recommendations for infection control procedures categorized according to the supporting data, theoretical rationale, and applicability.⁶

Items in Category IA and IB are strongly recommended based on research evidence, but not mandatory. Category IC items are required/mandated (enforceable by OSHA). Items in Category II are suggested but not mandatory, while the Unresolved Issue items are not recommended or mandatory.⁶

Table 2 outlines recommendations and provides examples. The CDC also includes guidance for safe practices related to hand hygiene, PPE, latex hypersensitivity, sterilization and disinfection of instruments, storage of instruments, environmental infection control, dental unit waterlines, handpieces, radiology equipment, single-use disposable items, parenteral medications, pre-procedural rinsing, handling of biopsy specimens, dental laboratory, laser smoke, and prion diseases.^6,7

The CDC guidelines provide recommendations related to all elements of a comprehensive infection control and prevention program called a program evaluation.^6,7 Effective program evaluation is a systematic way to ensure procedures are useful, feasible, ethical, and accurate.

Program evaluation is an essential organizational practice, however, compliance challenges still exist in practice. As with OSHA, the CDC recommends keeping records for sterilization monitoring (mechanical, chemical, and biological) and keeping employee medical records for work related evaluations, screenings, immunizations, exposures, and postexposure management all in accordance with state and local regulations. The CDC provides additional guidance for managing and maintaining dental unit water lines (DUWL).^6,7 Since DUWLs do not fall under any OSHA standard, guidance then defers to CDC.

American National Standards Institute/Association for the Advancement of Medical Instrumentation

A document from ANSI/AAMI, referred to as ST79, is a comprehensive guide to steam sterilization and sterility assurance.¹⁵ This document is available only for a fee. ST79 is intended for ambulatory healthcare settings, which include a small section for dentistry related primarily to instrument processing.¹⁵

In dentistry, participation with ANSI/AAMI is voluntary, as it is not a regulatory body. Therefore, compliance with ANSI/AAMI is not required unless ST79 is adopted by the facility, state board, or accrediting body.¹⁵ The ST79 document provides procedure specific guidance along with a rationale so staff members can understand the intent. Language from ST79 includes guidance on the following:¹⁵monitoring and documentation of cleaning equipment; mechanical, chemical, and biological monitoring; and instrument labeling and tracking for traceability.

Conclusion

Record keeping guidance varies and overlaps among OSHA, CDC, and ANSI/AAMI. The ICC is charged with understanding the requirements of record keeping to ensure compliance and to help avoid litigation. Proper record keeping protects patient safety and ensures practices are compliant with prudent infection control and prevention measures.

References

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Occupational Safety and Health Administration. Bloodborne Pathogens Standard. Available at: osha.gov/laws-regs/regulations/standardnumber/딦/딦.1030. Accessed July 2, 2023.
Occupational Safety and Health Administration. Hazard Communication Standard. Available at: osha.gov/laws-regs/regulations/standardnumber/딦/딦.1200. Accessed July 2, 2024.
Occupational Health and Safety Administration. Respiratory Protection Standard. Available at: osha.gov/laws-regs/regulations/standardnumber/딦/딦.134. Accessed July 2, 2024.
Advancement of Medical Instrumentation/American National Standards Institute. ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Available at: aami.org/standards/ansi-aami-st79. Accessed July 2, 2024.

From Dimensions of Dental Hygiene. August/September 2024; 22(5):14; 16-19