Frequently Asked Questions

Employers that run drug tests in house often ask whether they need a CLIA certificate from CMS. The answer depends on why the test is done, not on the test itself. The FAQ on whether employers can drug test on site covers the general setup, and this answer covers the federal lab certification question.

The general rule. A laboratory under 42 CFR 493.2 examines human specimens to provide information for the diagnosis, prevention or treatment of disease or the assessment of health, and 42 CFR 493.3(a) requires it to hold a CLIA certificate unless an exception applies. Certificate types include a certificate of waiver, registration certificate, certificate of compliance, certificate for provider-performed microscopy procedures, and certificate of accreditation. Section 493.5 sorts tests into waived, moderate complexity and high complexity categories.

Exceptions that matter for drug testing. Section 493.3(b) excludes components or functions of laboratories that do testing for forensic purposes, research labs that do not report patient-specific results, and labs certified by SAMHSA that perform drug testing under SAMHSA guidelines, for those tests. SAMHSA certification is explained in certified laboratories.

Purpose controls. CMS letter S&C-08-35 (September 5, 2008) explains that drug testing done only for employment decisions, such as hiring or firing, is forensic and outside CLIA. The letter quotes the preamble to the CLIA rules: the determining factor is not the test itself, but the purpose for which the test is conducted. If results are used to refer, offer or make treatment available to the employee, the testing assesses health, and the site must get a CLIA certificate or stop that testing.

Mixed programs. CMS's guide on obtaining a CLIA certificate states that if even one test is used to assess health, the lab needs a certificate. An employer that runs forensic screening and also provides results to an employee assistance or treatment program should review how results are used.

Waived tests. Waived tests are simple tests with a low risk of an incorrect result, and the FDA decides which tests qualify. A site that needs CLIA coverage and performs only waived tests can hold a certificate of waiver and must follow the manufacturer's instructions (42 CFR 493.15).

State overlay. Some states run their own lab licensing. CMS notes that New York and Washington run their own HHS-approved laboratory programs, so a lab there may not need a federal CLIA certificate, though New York's exemption is partial. Many states also have drug testing statutes that limit on-site screening or require lab confirmation. Employers weighing an in-house testing program should check state law along with CLIA.

Rule changes. CMS has proposed updates to the CLIA rules, covered in the Learn Laws® news item on CMS CLIA updates.

Medicare Advantage organizations and Part D sponsors must run a compliance program with seven core elements, and training is one of them. The rules are at 42 CFR 422.503(b)(4)(vi) for Medicare Advantage and 42 CFR 423.504(b)(4)(vi) for Part D, and the two sections track each other closely. The FAQ on compliance training covers the general concept.

The seven core elements. The compliance program must be effective in preventing, detecting and correcting noncompliance with CMS program requirements and fraud, waste and abuse. It must include:

• Written policies, procedures and standards of conduct, including a commitment to comply with federal and state standards and a policy of non-intimidation and non-retaliation.
• A compliance officer and a compliance committee that report to the CEO or senior management and to the governing body. The compliance officer must be an employee of the plan sponsor, its parent or a corporate affiliate, not of a first tier, downstream or related entity.
• Effective training and education.
• Effective lines of communication, including a way to report issues anonymously and confidentially.
• Well-publicized disciplinary standards.
• An effective system for routine monitoring, auditing and identifying compliance risks.
• Procedures for prompt response to compliance issues as they are raised.

Who must be trained. The training element covers the compliance officer, organization employees, the chief executive and other senior administrators, managers, and governing body members. Training must take place at least annually and be part of orientation for new employees and new appointments to a chief executive, manager or governing body member position (42 CFR 422.503(b)(4)(vi)(C) and 423.504(b)(4)(vi)(C)).

First tier, downstream and related entities. CMS's Contract Year 2019 rule (83 FR 16440, April 16, 2018, effective June 15, 2018) removed the regulatory requirements for sponsors to provide compliance training to first tier, downstream and related entities, including the mandatory use of CMS-developed training. The rule did not remove the sponsor's accountability. Plan sponsors remain responsible for compliance by the entities they contract with, and many sponsors still require their own training or attestations in contracts.

Board oversight. The governing body must be knowledgeable about the content and operation of the compliance program and exercise reasonable oversight of its implementation and effectiveness. Training for board members supports that duty.

Documentation. Sponsors should keep training rosters, completion dates, content outlines and board minutes. Records showing that each group received training within the year and at onboarding support the documentation of this element.

Related topics. CMS oversight of plan quality is covered in the Learn Laws® news item on NCQA deeming authority. Sponsors that handle protected health information also train staff under HIPAA, which the FAQ on whether HIPAA training is mandatory covers.

Nursing homes that take part in Medicare or Medicaid must run a training program for staff under 42 CFR 483.95. The program covers new and existing staff, individuals providing services under contract, and volunteers, consistent with their expected roles. The amount and type of training are set by the facility assessment in 42 CFR 483.71. Healthcare privacy training is covered separately in HIPAA training in healthcare.

Required training topics. Section 483.95 lists these areas:

• Effective communications for direct care staff.
• Resident rights and facility responsibilities.
• Abuse, neglect, exploitation and misappropriation of resident property, including procedures for reporting and dementia management and resident abuse prevention.
• Quality assurance and performance improvement.
• Infection control, including the facility's written standards, policies and procedures.
• Compliance and ethics, with annual training required if the operating organization runs five or more facilities.
• Behavioral health, in line with the facility assessment.

Nurse aide in-service. Nurse aides must receive in-service training of at least 12 hours per year. It must be enough to keep aides competent, must address areas of weakness found in performance reviews, and must include dementia management and resident abuse prevention training. Aides serving residents with cognitive impairments also need training on their care (42 CFR 483.95(g)).

Paid feeding assistants. A paid feeding assistant must complete a training program approved by the state before feeding residents (42 CFR 483.95(h)).

The facility assessment link. Section 483.71 requires a facility-wide assessment of the resources needed to care for residents, reviewed and updated as needed and at least annually. The assessment must inform staffing decisions and include a plan for recruitment and retention of direct care staff. Because training under 483.95 must be based on the assessment, the two sections work together. Section 483.71 was added and section 483.95 was amended by the May 10, 2024 minimum staffing rule, and the facility assessment must also solicit input from residents, resident representatives and family members.

Staffing rule repeal. CMS's 2024 minimum staffing standards for long-term care facilities were repealed in an interim final rule with comment period (90 FR 55687, December 3, 2025, effective February 2, 2026). The training requirements in 483.95 were not part of that repeal. The Learn Laws® news item on the staffing repeal has the background.

Documentation. Survey review can include training records, in-service hours for each aide, and evidence that content matches the facility assessment. Facilities should keep sign-in sheets, curricula and completion dates for each topic and each staff group. Workforce programs are covered in the news item on the nurses for nursing homes program.