Artificial Intelligence in Healthcare
Artificial Intelligence

Part 2: Who Regulates Healthcare AI?

Artificial Intelligence & Regulatory Compliance


Written by Joanne Byron, BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS




This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.  AI is advancing rapidly, so we encourage you to reference the new Artificial Intelligence article category for the latest articles.  As stated in Part 1, the Office of the National Coordinator for Health Information Technology (ONC) and the Agency for Healthcare Research and Quality (AHRQ), with support from the Robert Wood Johnson Foundation, turned to an independent group of scientists and academics to consider how AI might shape the future of public health, community health, and healthcare delivery.  The question remains, how will the use of AI be regulated for health care use?


Artificial Intelligence/Machine Learning has gained heightened attention globally.  Augmented Intelligence has been embraced as a concept by physician organizations to underscore that emerging AI systems are designed to aid humans in clinical decision-making, implementation and administration to scale healthcare, according to Act Online Key Terminology for AI in Health.


Although the United States is making progress in developing domestic AI regulation, including with the National Institute of Standards and Technology (NIST) AI Risk Management Framework, the existing laws and regulations that apply to AI systems is still a work-in-progress.  The goals are to protect people from unsafe or ineffective systems. 


So, Who Regulates Healthcare AI?


What seems like a simple question is really a complex situation.  This article only scratches the surface of various regulatory agencies involved in the regulation of AI.  The Health & Human Services (HHS) response to OMB Memorandum 21-06 “Guidance for Regulation of Artificial Intelligence Applications” was drafted in November 2020 and is directed to the heads of all Executive Branch departments and agencies, including independent regulatory agencies.  Much has happened since then.


On April 25, 2023, the Federal Trade Commission (FTC), the Civil Rights Division of the U.S. Department of Justice (DOJ), the Consumer Financial Protection Bureau (CFPB), and the U.S. Equal Employment Opportunity Commission (EEOC) released a joint statement highlighting their commitment to "vigorously use [their] collective authorities to protect individuals" with respect to artificial intelligence and automated systems (AI), which have the potential to negatively impact civil rights, fair competition, consumer protection, and equal opportunity.


The joint statement from the DOJ, FTC, CFPB, and EEOC signifies a growing awareness and concern among federal agencies about the potential risks and challenges posed by AI and automated systems. As AI continues to become more integrated into all aspects of daily life, the importance of addressing potential biases, transparency issues, and flawed design becomes increasingly critical.


Federal Trade Commission (FTC) Raises Concerns


The FTC’s mission is to protect consumers and competition through preventing anticompetitive, deceptive and unfair business practices.  This is achieved through law enforcement, advocacy, and education without unduly burdening legitimate business activity.  The FTC Act’s prohibition on deceptive or unfair conduct can apply if you make, sell, or use a tool that is effectively designed to deceive – even if that’s not its intended or sole purpose. The FTC’s action should help protect healthcare organizations by limiting deceptive or exaggerated promises of what a medical device or AI software can actually do.  It’s not uncommon for advertisers to say that some new-fangled technology makes their product better – perhaps to justify a higher price or influence labor decisions.


On May 18, 2023, the FTC issued a warning that the increasing use of consumers’ biometric information and related technologies, including those powered by machine learning, raises significant consumer privacy and data security concerns and the potential for bias and discrimination. Biometric information refers to data that depict or describe physical, biological, or behavioral traits, characteristics, or measurements of or relating to an identified or identifiable person’s body.


The Federal Drug Administration & AI


The Food & Drug Administration (FDA) released a discussion paper in 2019 and then an action plan on January 21, 2021 regarding Artificial Intelligence and Machine Learning, or AI/ML.  This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software.  Then, in April 2023, the FDA is publishing a draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions."

  • This draft guidance proposes a science-based approach to ensuring that AI/ML-enabled devices can be safely, effectively, and rapidly modified, updated, and improved in response to new data.

The approach the FDA is proposing in this draft guidance would put safe and effective advancements in the hands of health care providers and users faster, increasing the pace of medical device innovation in the United States and enabling more personalized medicine.

  • This means, for example, that diagnostic devices could be built to adapt to the data and needs of individual health care facilities and that therapeutic devices could be built to learn and adapt to deliver treatments according to individual users' particular characteristics and needs.

National Institute of Standards and Technology (NIST) AI Risk Management Framework


Released on January 26, 2023, NIST’s AI Risk Management Framework or “AI RMF” which is intended to be used voluntarily to improve the ability to incorporate trustworthiness considerations into the design, development, use, and evaluation of AI products, services, and systems.  The Framework was developed through a consensus-driven, open, transparent, and collaborative process with the intention to build on, align with, and support AI risk management efforts by others.


Recently NIST launched the Trustworthy and Responsible AI Resource Center (AIRC), which will facilitate implementation of, and international alignment with, the AI RMF.  We recommend watching the introduction video:  https://www.nist.gov/video/introduction-nist-ai-risk-management-framework-ai-rmf-10-explainer-video


For healthcare HIPAA covered entities, NIST is likely a familiar organization to you.  NIST published prior documents related to AI.  The initial draft of the AI RMF was published March 17, 2022 and a second draft on August 18, 2022.


The Health Insurance Portability and Accountability Act (HIPAA)

Public Law 104-191


The Office for Civil Rights (OCR) is responsible for enforcing the HIPAA Privacy and Security Rules (45 C.F.R. Parts 160 and 164, Subparts A, C, and E). One of the ways that OCR carries out this responsibility is to investigate complaints.  As health care organizations evolve with the use of AI, there is increased potential for cyber criminals to exploit vulnerabilities.


At the present, there are two exclusions existing in the HIPAA Privacy Rule that allow Covered Entities to share Protected Health Information (PHI) with device vendors and other organizations without the authorization of the individual(s) to whom the PHI relates. The two exclusions can be found in 45 CFR §164.512(b)(1) and 45 CFR §164.512(i)(1). Respectively, they relate to:

  • Disclosures to vendors regulated by the Federal Drug Administration are permitted by the Privacy Rule for the “purpose of activities related to the quality, safety or effectiveness of such FDA-regulated product or activity”.   The FDA regulates the sale of all medical device products, including personal health devices that transmit data to AI-driven healthcare solutions as described above.
  • PHI can also be disclosed without authorization for research purposes without being de-identified if the disclosure is approved by an Institutional Review Board or Privacy Board. In such circumstances, the disclosed PHI must remain in the possession of the Covered Entity and the disclosure(s) can only be for the purpose of preparatory research (i.e., programming a “Supervised Learning Algorithm”).


Conclusion


Simply stated, a shift to AI calls for new skills.  It warrants increased knowledge of HIPAA privacy, security and anticipating other legal issues surrounding it’s use in healthcare.


Needless to say, it is important to maintain a robust HIPAA program and utilize information from the National Institute of Standards and Technology (NIST) AI Risk Management Framework as mentioned above.


In the context of HIPAA, healthcare data, and AI technologies, AI developers and vendors should consider that HIPAA only provides a federal floor of privacy and security standards. Often, other state and federal laws can apply that pre-empt HIPAA – particularly with regard to healthcare adjacent data – or apply to more organizations than Covered Entities and Business Associates.  Also, many Managed Service Providers (MSP) companies providing services to healthcare organizations should be aware of AI applications and security vulnerabilities.


If your organization plans or is using AI for medical diagnostics, reference the annual joint publication by the U.S. Government Accountability Office (GAO) and the National Academy of Medicine published each September entitled “Technology Assessment – Artificial Intelligence in Health Care – Benefits and Challenges of Machine Learning Technologies for Medical Diagnostics”.   A new publication is posted each year: https://www.gao.gov/products/gao-22-104629


AIHC will continue to post articles related to artificial intelligence with regards to healthcare compliance.  Click Here for additional articles on various HIPAA topics.  Click Here for articles relating to Artificial Intelligence. Visit the AIHC Certifications page with online compliance learning opportunities.

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Auditing, Managing Denials Is Important to Good A/R Hygiene
Auditing

Compliance & Internal Investigations

Written by: Joanne Byron, BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS




Are you an internal auditor conducting “routine” reviews? Have you ever uncovered erroneous or potentially fraudulent evidence? Once your suspicions have been reported to the Compliance Officer, were you asked to partake in evidence gathering during the investigation? The content of this article is for educational purposes and not intended as consulting or legal advice.


For those of you more experienced auditors, additional training in how to handle evidence during an internal investigation not only advances your career but helps secure evidence that can be used if an actual crime has been committed. I also recommend reading When Healthcare White-Collar Crimes Turn Red, an AIHC blog article from 2021.


Do you need to convince executives that crime is a potential problem for your organization? The Department of Justice (DOJ) posts “News & Noteworthy” cases here. 


What Comes to Mind When You Hear the Word “Forensic”?

 

Most of us think about investigations as seen on television programs, such as “CSI” or “Bones.” Forensic science is a critical element of the criminal justice system – “Forensic scientists examine and analyze evidence from crime scenes and elsewhere to develop objective findings that can assist in the investigation and prosecution of perpetrators of crime or absolve an innocent person from suspicion.”


According to the Merriam-Webster dictionary, the word forensic is defined as the following:

  • Belonging to, used in, or suitable to courts of judicature or to public discussion and debate
  • Relating to or dealing with the application of scientific knowledge to legal problems

Your auditing and compliance skills become valuable to professional law enforcement, but you need to know what, when and how to handle a situation which could potentially turn into criminal charges against someone within your organization. First, let’s start with prevention.


Is It an Internal or External Investigation?


Internal Investigations are conducted by skilled employees (or a consultant under contract working for the organization) trained to perform specialized audits to gather evidence when there is suspected fraud, abuse or crime. These investigations are typically conducted to gather information sufficient for legal counsel to determine whether an external investigation is warranted by the appropriate authorities.  These employees are often referred to as Internal Forensic Auditors or Internal Investigators. For the purpose of this course, we will refer to this position as an Internal Forensic Auditor.


Internal Forensic Auditors report to a Board of Directors, Compliance Officer and/or Audit Committee of the health care organization and typically work under the direction of the organization’s legal counsel.


External Forensic Auditors are independent of the organization they are auditing. They are experts working as an investigator for an accounting or consulting firm, CMS, a police department, the FBI or another agency as described above.


The process of conducting a forensic investigation is, in many ways, similar to the process of conducting an audit, but with some additional considerations. The various stages are briefly described below. 


Step 1: Accepting the Investigation


Review information regarding the matter and consider whether you (and your team) have the necessary skills and experience to accept the work.

  • Forensic investigations are specialized in nature, and the work requires detailed knowledge of fraud investigation techniques and the legal framework.
  • Investigators must also have received training in interview and interrogation techniques and in how to maintain the safe custody of evidence gathered.
  • Investigators must be able to address potential conflicts of interest or bias and achieve objectivity.

Step 2: Planning the Investigation


The investigating team must carefully consider what they have been asked to achieve and plan their work accordingly. The objectives of the investigation will include:

  • Recognize if there is sufficient evidence to warrant a forensic investigation. If so, then anticipate planning required to achieve the following:

      o Identify the type of fraud that has been operating, how long it has been operating for,
    and how the fraud has been concealed;

           Determine deadlines and timeframes to complete the investigation which may
    be driven by regulatory factors;

      o Identify the fraudster(s) involved;

      o Quantify the financial loss suffered by the organization;

      o Gather evidence for potential use in court proceedings;

           Identify the type of report format required and record evidence appropriately; and

      o Provide advice to prevent the reoccurrence of the fraud. 

The investigators should also consider the best way to gather evidence. They may choose the use of computer assisted audit techniques or other various methods appropriate for the situation.


Step 3:  Gathering Evidence – Fact Finding


In order to gather detailed evidence, the investigator must understand the specific type of fraud that is suspected. The evidence should be sufficient to ultimately prove the identity of the fraudster(s), the mechanics of the fraud scheme, and the amount of damage or loss suffered by the organization.


It is important that the investigating team is skilled in collecting evidence that can be used in a court case and in keeping a clear and secure chain of custody until the evidence is presented in court. If any evidence is inconclusive, or there are gaps in the chain of custody, then the evidence may be challenged in court or even become inadmissible. Investigators must be alert to documents being falsified, damaged or destroyed by the suspect(s). 


“Chain of custody” is defined by Dictionary.com as “the order in which a piece of criminal evidence should be handled by persons investigating a case, specifically, the unbroken trail of accountability that ensures the physical security of samples, data and records in a criminal investigation.” To prove the chain of custody, and ultimately show that the evidence has remained intact, prosecutors generally need internal investigators who can testify:

  • That the evidence offered in court is the same evidence they collected or received.
  • To the time and date the evidence was received or transferred to another provider.
  • That there was no tampering with the item while it was in custody.

Evidence can be gathered using various techniques, including: 

  • Testing controls to gather evidence which identifies the weaknesses which allowed the fraud to be perpetrated;
  • Using analytical procedures to compare trends over time or to provide comparatives between different segments of the business;
  • Applying computer assisted audit techniques which may help to identify the timing and location of relevant details being altered in the computer system;
  • Discussions and interviews with employees;
  • Substantive techniques such as: reconciliations, cash counts and reviews of documentation.

Step 4: Analyzing Data


After evidence and facts have been gathered and recorded, it is time to analyze all the data. The goal of data analysis is to determine if there is a relationship between the independent and dependent variables and to look for patterns within the data. 


Recording and organizing data may take different forms depending on the kind of information being collected. The way you collect your data should relate to how you’re planning to analyze and use it. Regardless of what method you decide to use, recording should be done concurrently with data collection if possible, or soon afterwards, so that nothing gets lost and memory doesn’t fade. Some of the things to do with the information collected can include:

  • Gather together information from all sources and observations;
  • Make photocopies of all recording forms, records, audio or video recordings, and any other collected materials to guard against loss, accidental erasure, or other problems;
  • Enter narratives, numbers, and other information into a computer program where they can be arranged and/or worked on in various ways;
  • Perform any mathematical or similar operations needed to get quantitative information ready for analysis;
      o These could include entering numerical observations into a chart, table, or spreadsheet, or figuring the mean (average), median (midpoint), and/or mode (most frequently occurring) of a set of numbers.
  • Transcribe (making an exact, word-for-word text version of) the contents of audio or video
    recordings;
  • Code data (translating data), particularly qualitative data that isn’t expressed in numbers, into a form that allows it to be processed by a specific software program or subjected to statistical analysis; and
  • Organize data in ways that make it easier to work with. This will depend on your research design and your evaluation questions.
      o Consider grouping observations by the dependent variable (indicator of success) they
    relate to, by individuals or groups of participants, by time, by activity, etc.
      o You might also want to group observations in several different ways so that you can study interactions among different variables. 

There are two kinds of data you’re apt to be working with. However, not all evaluations will necessarily include both.

  • Quantitative data refers to the information that is collected as, or can be translated into, numbers which can then be displayed and analyzed mathematically.
  • Qualitative data can be collected as descriptions, anecdotes, opinions, quotes, interpretations, etc. They are generally not able to be reduced to numbers and/or are considered more valuable or informative if left as narratives.

As you might expect, quantitative and qualitative information need to be analyzed differently. The investigation is likely to lead to legal proceedings against one or several suspects. Therefore, members of the investigative team must be comfortable with appearing in court to explain how the investigation was conducted and how the evidence was gathered.


Step 5: Report Your Findings


Draft the report in an objective manner. Do not draw conclusions, just report the facts. The checklist below summarizes what a typical report should contain:

  • Provide a Summary of the Investigation or Case
  • Describe the Investigation Plan
  • Case Notes – Keep an Investigator Diary
  • Information Interview Summaries
  • Interview Reports
  • Analysis of Investigation
  • Conclusion
  • Recommendations and Additional Action(s) Required With This Case
  • Exhibit Listing - attachments and evidence related to the case

Conclusion


An Ounce of Prevention Is Worth a Pound of Cure – So Learn More About Health Care Crime


A little precaution before a crisis occurs is preferable to a lot of legal complications, “bad press” and huge potential losses afterward. Preventing fraud in your organization starts with not hiring criminals! That might sound ridiculous, but are we really doing everything we should during the hiring phase of employees and contractors?


Most organizations are using the LEIE on the OIG website to screen new hires and conduct monthly verifications. But is this enough?


Unverified employees can put your organization at risk with a dramatic impact on your company’s brand reputation, performance and finances. Screening employees at hire, and periodically during employment, is a must for creating a safe workplace.


Below is a “short list” of screening tactics to consider before extending an offer to a candidate for hire. Be sure to review your procedure with legal counsel or a human resources expert to avoid any potential legal consequences with the U.S. Equal Employment Opportunity Commission (EEOC) related to changing your current hiring practices.

  • Criminal background check
  • Office of Inspector General (OIG) Exclusions Database check
  • Education – verify graduation, degree
  • Professional Certifications (check all certifications with the certifying agency – do not accept certificates from the potential employee as proof)

The EEOC has a webpage dedicated to help employers that addresses “Background Checks – What Employers Need to Know.” The information on this page is a joint publication between the EEOC and the Federal Trade Commission or FTC.


When making personnel decisions, which include hiring, retention, promotion, and reassignment, the EEOC states that employers should consider the background of applicants and employees. For example, the EEOC states you may want to consider verifying:

Except for certain restrictions related to medical and genetic information (per HIPAA, addressed further on the EEOC website), it's not illegal for an employer to ask questions about an applicant's or employee's background or to require a background check.


AIHC offers training – a “how to” participate in or conduct an internal investigation. The course is offered online with the option to certify (with a professional proctor online). The program is entitled Internal Forensic Auditor. If this course seems too intense, you may want to begin with the Auditing for Compliance online program.

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General Compliance

Consent and COVID Testing of Employees

Written By: Compliance Blogger




This article addresses COVID testing and consent considerations for:  healthcare organizations, nursing homes and business associates or non-healthcare workplaces. This article is not intended as legal or consulting advice.  Employers are encouraged to collaborate with state, territorial, tribal and local health officials to determine whether and how to implement COVID testing strategies.


SARS-CoV-2 (COVID-19) continues to be a health risk to be mitigated by health care institutions and at the workplace. Employers paying for testing of employees should put procedures in place for rapid notification of results and establish appropriate measures based on testing results, including instructions regarding self-isolation and restrictions on workplace access.


An employer’s testing program (including the implementation of a testing protocol to test employees) may be complex and technical. Certain aspects of the testing program may be more relevant than others to an employee’s decision whether to accept an offered test. Obtain guidance from experts to assist your organization in navigating risk.


Business Associates (non-healthcare organizations)


The Center for Disease Control (CDC) provides guidance for non-healthcare workplaces, which would apply to most business associates who have partnered with a health care institution, such as legal or accounting firms; medical billing companies; IT managed service providers, etc. Workplace-based testing should not be conducted without the employee’s informed consent. Encourage and answer questions during the consent process.


Informed Consent


Informed consent requires disclosure, understanding, and free choice, and is necessary for an employee to act independently and make choices according to their values, goals, and preferences. Consult legal counsel when developing your informed consent form for employees.


To fully support employee decision-making and consent, employers should take the following measures when developing a testing program:

  • Ensure safeguards are in place to protect an employee’s privacy and confidentiality.
  • Provide complete and understandable information about how the employer’s testing program may impact employees’ lives, such as if a positive test result or declination to participate in testing may mean exclusion from work.
  • Explain any parts of the testing program an employee would consider especially important when deciding whether to participate. This involves explaining the key reasons that may guide their decision.
  • Provide information about the testing program in the employee’s preferred language using non-technical terms. Consider obtaining employee input on the readability of the information. Employers can use the CDC tool to create clear messages: https://www.cdc.gov/ccindex/
  • Encourage supervisors and co-workers to avoid pressuring employees to participate in testing.
  • The consent process is active information sharing between an employer or their representative and an employee, in which the employer discloses the information, answers questions to facilitate understanding, and promotes the employee’s free choice.

Disclosures for Non-healthcare Workplace Testing


Individuals tested are required to receive patient fact sheets as part of the test’s emergency use authorization (EUA):

A basic disclosure for COVID-19 should include the following elements to provide information to employees so they understand what is involved when consenting to the test, such as clear information on the manufacturer and name of the test, the type of test, the purpose of the test, the performance specifications of the test, any limitations associated with the test, who will pay for the test, how the test will be performed, how and when they will receive test results, and; how to understand what the results mean, actions associated with negative or positive results, the difference between testing for workplace screening versus for medical diagnosis, who will receive the results, how the results may be used, and any consequences for declining to be tested.


According to the Americans with Disabilities Act (ADA), when employers implement any mandatory testing of employees, it must be “job related and consistent with business necessity.” In the context of the COVID-19 pandemic, the U.S. EEOC notes that testing to determine if an employee has SARS-CoV-2 infection with an “accurate and reliable test” is permissible as a condition to enter the workplace because an employee with the virus will “pose a direct threat to the health of others.” EEOC notes that tests administered by employers which are consistent with current CDC guidance will meet the ADA’s business necessity standard. However, workplace-based testing should not be conducted without the employee’s consent.


Infection Control for Healthcare Facilities


The CDC has made recent changes to infection control guidance for all U.S. settings where healthcare is delivered, including home health. The updated healthcare infection prevention and control (IPC) recommendations as of September 10, 2021 are in response to the COVID-19 vaccination. Consult with legal counsel regarding disclosures and consents appropriate for your organization.


Healthcare Personnel (HCP): HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, dental healthcare personnel, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).


Healthcare settings refers to places where healthcare is delivered and includes, but is not limited to, acute care facilities, long-term acute-care facilities, inpatient rehabilitation facilities, nursing homes, home healthcare, vehicles where healthcare is delivered (e.g., mobile clinics), and outpatient facilities, such as dialysis centers, physician offices, dental offices, and others.


Source control is the use of respirators, well-fitting facemasks, or well-fitting cloth masks to cover a person’s mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing. Source control devices should not be placed on children under age 2, anyone who cannot wear one safely, such as someone who has a disability or an underlying medical condition that precludes wearing one safely, or anyone who is unconscious, incapacitated, or otherwise unable to remove their source control device without assistance. Face shields alone are not recommended for source control.


IPC Measures


Several of the IPC measures (e.g., use of source control, screening testing) are influenced by levels of SARS-CoV-2 transmission in the community. There are two different indicators in CDC’s COVID-19 Data Tracker which are used to determine the level of SARS-CoV-2 transmission for the county where the healthcare facility is located – Access the COVID Data Tracker:

If the two indicators suggest different transmission levels, the higher level is selected.


Source control and physical distancing (when physical distancing is feasible and will not interfere with provision of care) are recommended for everyone in a healthcare setting. This is particularly important for individuals, regardless of their vaccination status, who live or work in counties with substantial to high community transmission or who have:

  • Not been fully vaccinated; or
  • Suspected or confirmed SARS-CoV-2 infection or other respiratory infection (e.g., those with runny nose, cough, sneeze); or
  • Had close contact (patients and visitors) or a higher-risk exposure (HCP) with someone with SARS-CoV-2 infection for 14 days after their exposure, including those residing or working in areas of a healthcare facility experiencing SARS-CoV-2 transmission (i.e., outbreak); or
  • Moderate to severe immunocompromised; or
  • Otherwise had source control and physical distancing recommended by public health authorities.

Perform SARS-CoV-2 Testing


Anyone with even mild symptoms of COVID-19, regardless of vaccination status, should receive a viral test as soon as possible, according to the CDC recommendation.


Asymptomatic HCP with a higher-risk exposure and patients with close contact with someone with SARS-CoV-2 infection, regardless of vaccination status, should have a series of two viral tests for SARS-CoV-2 infection.

  • In these situations, testing is recommended immediately (but not earlier than 2 days after the exposure) and, if negative, again 5–7 days after the exposure.
  • Note - testing is not recommended for people who have had SARS-CoV-2 infection in the last 90 days if they remain asymptomatic; this is because some people may have detectable virus from their prior infection during this period (additional information is available here). Criteria for use of post-exposure prophylaxis are described elsewhere.

Expanded screening testing of asymptomatic HCP without known exposures was required in nursing homes and could be considered in other settings. It should be conducted as follows:

  • Fully vaccinated HCP may be exempt from expanded screening testing.
  • Guidance for expanded screening testing for nursing homes was described in the Interim Infection Prevention and Control Recommendations to Prevent SARS-CoV-2 Spread in Nursing Homes | CDC but is no longer available.

Performance of pre-procedure or pre-admission viral testing is at the discretion of the facility. The yield of this testing for identifying asymptomatic infection is likely low when performed on vaccinated individuals or those in counties with low or moderate transmission. However, these results might continue to be useful in some situations (e.g., when performing higher risk procedures on unvaccinated people) to inform the type of infection control precautions used (e.g., room assignment/cohorting, or PPE used).


Click Here for more detailed information about infection control guidance.

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