CMS NEWS FOR IMMEDIATE RELEASE October 4, 2018 Contact: CMS Media Relations (202) 690-6145 | CMS Media Inquiries

CMS to Strengthen Oversight of Medicare’s Accreditation Organizations
Agency’s website will increase transparency into Accrediting Organization performance, and CMS will streamline and strengthen the validation of Accrediting Organization surveys
Today, the Centers for Medicare & Medicaid Services (CMS) took action to improve quality and safety in healthcare facilities and empower patients with information to make decisions about where to receive care.
“Today we are taking action to improve our oversight of Accrediting Organizations, including by increasing transparency for patients on the organizations’ performance,” said CMS Administrator Seema Verma. “The public trusts CMS to ensure the quality and safety of patient care, and we take this responsibility very seriously. Today’s changes will bolster the processes for overseeing how effective Accrediting Organizations, who work on CMS’ behalf, are in evaluating healthcare facilities.”
Currently, Medicare-participating healthcare providers and suppliers are surveyed either by State survey agencies or by Accrediting Organizations (AOs) to ensure that they meet CMS’ quality and safety standards. AOs receive deeming authority from CMS, which affirms that AOs’ health and safety standards meet or exceed those of Medicare. Only facilities and suppliers that have been deemed by state or AO surveyors to meet CMS’ standards may receive payments from Medicare. There are currently 10 CMS-approved AOs, each of which surveys one or more different types of facilities.
CMS will enhance and strengthen its oversight and quality transparency of AOs in three ways: 1) the public posting of AO performance data; 2) a redesigned process for AO validation surveys and 3) the release of the Annual Report to Congress. Taken together, these efforts will provide important insights to the public and assist AOs, providers, and suppliers in ensuring patient health and safety.
Posting AO Performance Data Online
To increase transparency for consumers, CMS will post new information on the CMS.Gov website, including: The latest quality-of-care deficiency findings following complaint surveys at facilities accredited by AOs; a list of providers determined by CMS to be out of compliance, with information included on the provider’s AO; and overall performance data for AOs themselves. To view AO performance data, visit: https://qcor.cms.gov/hosp_cop/HospitalCOPs.html
Today, the public relies on accreditation status as a way to gauge providers’ and suppliers’ quality of care. By posting more detail—accredited hospitals’ complaint surveys, out-of-compliance information, and performance data for AOs themselves—CMS will offer the public more nuanced information than accreditation status alone provides. The agency is currently prohibited by law from disclosing the actual surveys done by AOs, except for surveys of home health agencies and surveys related to an enforcement action.
Pilot Testing Direct Observation for AO Validation Surveys
CMS is testing a more streamlined, efficient way to assess AOs’ ability to ensure that facilities and suppliers comply with CMS requirements.
CMS evaluates the ability of AOs to accurately assess providers’ and suppliers’ compliance with health and safety standards through a validation survey process. Historically, CMS has measured the effectiveness of AOs by choosing a sample of facilities, performing state-conducted assessment surveys within 60 days following AO surveys, and comparing results of the state surveys with the AO surveys. In a pilot test, CMS will eliminate the second state-conducted validation survey and instead use direct observation during the original AO-run survey to evaluate AOs’ ability to assess compliance with CMS’s Conditions of Participation.
Direct observation will enable CMS not only to evaluate AO performance more effectively, but also to suggest improvements and address concerns with AOs immediately. This approach will relieve providers from having to undergo the burden of a state’s follow up assessment. The approach is another example of the wide-ranging effort at CMS to eliminate duplication and relieve burden, reducing the amount of time that healthcare facilities must spend on compliance activities.
CMS will also analyze and incorporate State complaint investigations of accredited facilities as part of the agency’s strengthened validation program. This work will focus on identifying and monitoring accredited facilities that are out of compliance with Medicare health and safety requirements. CMS will use this information as an additional indicator of AO performance.
Posting the Most Recent Annual Report to Congress Regarding AO Performance
CMS has also posted the most recent annual Report to Congress, the “Review of Medicare’s Program for Oversight of Accrediting Organizations and the Clinical Laboratory Improvement Validation Program Fiscal Year 2017,” on the CMS website. As the changes announced today inform and bolster our oversight of AOs, CMS will continue to publish this report online annually to demonstrate the impact of these changes on the oversight of AOs and to provide greater transparency for the public. The FY 2017 Report to Congress is posted online: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html
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High Level Disinfection Scoring Re-Evaluated

By Sylvia Garcia-Houchins, RN, CIC, director of infection prevention and control, The Joint Commission

After a careful evaluation of high-level disinfection (HLD) and sterilization process steps, The Joint Commission has refined its scoring as of September 1 to focus on the process steps that pose the highest risk to patients if they fail.

Last year, 72 percent of surveyed hospitals and critical access hospitals were found to be noncompliant with The Joint Commission’s high-level disinfection and sterilization standard IC.02.02.01. We are refining some of the scoring guidelines to clarify expectations.

Seven areas have scoring revisions specific to High Level Disinfection—the common theme is establishing processes that support manufacturers’ instructions.

The Joint Commission will continue to score IC.02.02.01 as noncompliant whenever manufacturer instructions are not followed. Over the next several months, we will closely monitor the revisions to ensure consistent scoring.

Instruments
Wipe & Flush at Point of Use, As Needed
There is no expectation that visible blood or tissue be removed from instruments at the point of use.

Clinically appropriate wiping/flushing of soiled instruments may be observed during a case in the operating or procedure room. Facilities may be asked about their wiping/flushing policy, but there’s no expectation that all instruments will be wiped or flushed. Instrument cleaning should be performed in the decontamination area with appropriate personal protective equipment (PPE), facilities and other equipment that will protect employees from possible exposure/ injury.

Organizations will also be scored if an instrument that is ready for use on a patient is visibly soiled.

Surveyors may ask staff to:
watch the case being opened
describe what they check for when opening a tray
open a tray that will not be needed for 24 hours
explain what they would do if they found an instrument with bioburden when opening a sterile pack or tray.
Maintain the Moisture of Soiled Instruments
The facility may choose the manner in which it keeps soiled instruments moist. The Joint Commission requires that a process is in place to maintain moisture, as recommended by the instrument manufacturer, the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN). The process and product choice are the organization’s decision.

Options include:
moistened towels
containers that maintain moisture,
products for maintaining moisture in accordance with manufacturer instructions
Transporting Soiled Instruments Safely
Non-sharps must be transported in a way that cannot lead to contamination.

Occupational Safety and Health Administration (OSHA) states reusable sharps must be placed in a puncture-resistant red container or one marked “biohazardous”, and this requirement is reflected in the refined scoring guidelines.

AAMI provides reasonable guidance on transportation and the issue of bottom or side leaks on crash carts in section 6.5.3 Transportation Equipment, if you’ve purchased the manual. In a nutshell, carts need to be appropriate for transport of the items being moved. If the instruments are in containers with solid sides and bottom and are covered, an open cart may be appropriate. If the items are placed in open bins and then on an open cart, the organization should use a cover for the cart. Items in closed case carts do not need to be covered.

The cart should be designed to prevent items from falling off. Surveyors may ask infection control/operating room and Central Sterile Processing management if they have evaluated that risk and if items have ever fallen off.

Ensuring the Sterilant Reaches All Surface
All surfaces of the instruments undergoing sterilization must be accessible for the sterilant to reach them. Manufacturer instructions provide information on how to prepare items for sterilization. In addition, AAMI and AORN state that items should be sterilized in the open (unratcheted) position and disassembled in accordance with manufacturer instructions.

We recognize that some instruments, such as scissors, are likely to close after sterilization when they are being transported or stored. Therefore, surveyors will review the process for ensuring the item is prepared in a manner that will ensure exposure to the sterilant. Surveyors will observe the instruments coming through the cleaning process to ensure that they have been disassembled and are packaged in accordance with manufacturer instructions. They will also review peel packs to see if items that are awaiting sterilization or have just been sterilized are in the unratcheted position.

In order to ensure accurate scoring, surveyors may ask for manufacturer instructions for use to confirm whether an item should be taken apart.

Surveyors may ask staff to prepare a tray from those waiting to ensure instruments are opened and inspected during assembly. They will be watching how staff checks for cleanliness of instruments that are being processed. In some cases, staff may be asked to open a rigid or wrapped tray awaiting sterilization to confirm that items are being opened or disassembled in accordance with manufacturer instructions.

Careful Instrument Release after Sterilization
Instrument release should be a thoughtful and deliberate process to ensure only sterilized items are released.

Internal and external, if the internal indicator is not visible through packaging, chemical indicators must be used for every item undergoing sterilization. Physical monitoring of cycle (e.g., time, temperature, and pressure) and a check of the external (or internal if visible through the packaging) chemical indicators must occur before each non-implant load is released. Implant loads may be released after all of the following actions:
verification that the physical parameters of the sterilization cycle have been met
a biologic indicator has been done and is negative
a type 5 integrating indicator (aka integrator) confirms the process.
Unless there’s a facility policy allowing emergent release of implant loads before the biologic indicators is read, surveyors will score as not compliant with the standard if the result of the biologic is not recorded prior to use. If a facility policy does allow individuals to proceed without reading the biological indicators in emergent situations, the policy must be followed.

Storage of Items that have undergone High Level Disinfection, including endoscopes and endocavity probe

Items must be stored in a way that’s consistent with their intended use. This means that items that require a minimum of high-level disinfection may be stored in a way that protects from contamination even if they were sterilized.

Again, manufacturers’ instructions for use must be followed for storage. If instructions for use do not provide direction on storage requirements, items should be stored in a way that prevents contamination. Surveyors will score based on compliance with facility policy or risk assessment unless the manufacturer’s instructions for storage were not followed, or the containers/ locations of storage are visibly soiled, or if staff are observed contaminating other high level-disinfected products.

Dry Endoscopes Before Storing
Recent articles have indicated that a key component of ensuring that microorganisms do not replicate during storage is careful drying – not the duration of storage. Surveyors will check for compliance with manufacturers’ instructions for drying scopes. but will no longer score any finding related to hang time unless a reprocessing frequency has been specified by the endoscope manufacturer and is not followed.

Any IC02.02.01 findings on survey before September 1 will not be removed. Hospitals that are in the clarification window or that are preparing their Evidence of Standards Compliance (ESC) report should document compliance based upon the refined scoring guidelines. If you believe that your organization received an adverse decision based solely on a finding that would no longer be scored, please contact the Standards Interpretation Group via the online form or email me directly.

We want the survey process to be as transparent as possible and hope that scoring refinements will help organizations focus their efforts on keeping patients safe!

On the Radar: TJC Provides Updated Guidance for Scribes

By Patricia Cook

Courtemanche & Associates
August 16, 2018

The Joint Commission announced the following updated guidance for scribes and/or documentation assistants this week:
Definition: A documentation assistant or scribe may be an unlicensed, certified, (MA, ophthalmic tech) or licensed person (RN, LPN, PA) who provides documentation assistance to a physician or other licensed independent practitioner (such as a nursing practitioner) consistent with the roles and responsibilities defined in the job description, and within the scope of his or her certification or licensure.
Persons in the Role of Scribe and/or Documentation Assistants must have a job description and shall have the following competencies/education as a minimum standard:
Medical terminology
HIPAA
Principles of billing, coding, and reimbursement
Ability to navigate and understand the functionality of the organization’s Electronic medical record (EMR) as needed to function within their assigned duties
Computerized order entry, clinical decision support and reminders, and proper methods for pending orders for authentication and submission
TJC advises the amount of training required in these areas will vary depending upon the person’s past training and experience.
Organization should develop a policy/procedure regarding processes associated with the use of documentation assistants. Policies should:
Restrict /prohibit documentation assistants/scribes from using a physician or LIP’s log-in and define the proper log-in procedures and purpose.
Define the scope of documentation that may be entered by the documentation assistant/ scribe
Sets forth the requirements for physician review of information and orders entered by the documentation assistant, and the order entry and submission process.
In alignment with the other standards in the Human Resources Chapter that apply to those who provide care, treatment and/or services to your patients; orientation and ongoing training and education to the role must be provided.
Organizations that elect to provide these services through a contractual arrangement are reminded that all clinical contracting requirements apply.
Orders: All types of personnel performing documentation assistance may, at the direction of a physician or another LIP, enter orders into an EMR. The use of repeat-back of the order by the documentation assistant is encouraged, especially for new medication orders. Documentation assistants who are not authorized to submit orders should leave the order as pending for a certified or licensed personnel to activate or submit the orders after verification. These specifications should be outlined within the organization’s policies and procedures and /or job descriptions.
Transcribing orders into the EMR while providing documentation assistance is not considered a verbal order. Verbal orders are different because they are expected to be acted upon immediately by individuals who are practicing within the scope of their licensure, certification, or practice in accordance with law and regulation as well as with organizational policy.
TJC has not indicated how the above guidance will be used as a component of the survey process.

The Joint Commission: Speak Up About Your Care

Speak up

• If you don’t understand something or if something doesn’t seem right.

• If you speak another language and would like a translator.

• If you need medical forms explained.

• If you think you’re being confused with another patient.

• If you don’t recognize a medicine or think you’re about to get the wrong medicine.

• If you are not getting your medicine or treatment when you should.

• About your allergies and reactions you’ve had to medicines.

Pay attention…

• Check identification (ID) badges worn by doctors, nurses and other staff.

• Check the ID badge of anyone who asks to take your newborn baby.

• Don’t be afraid to remind doctors and nurses to wash their hands.

Educate yourself…

• So you can make well-informed decisions about your care.

• Ask doctors and nurses about their training and experience treating your condition.

• Ask for written information about your condition.

• Find out how long treatment should last, and how you should feel during treatment.

• Ask for instruction on how to use your medical equipment.

Advocates (family members and friends) can help…

• Give advice and support — but they should respect your decisions about the care you want.

• Ask questions, and write down important information and instructions for you.

• Make sure you get the correct medicines and treatments.

• Go over the consent form, so you all understand it.

• Get instructions for follow-up care, and find out who to call if your condition gets worse.

Know about your new medicine…

• Find out how it will help.

• Ask for information about it, including brand and generic names.

• Ask about side effects.

• Find out if it is safe to take with your other medicines and vitamins.

• Ask for a printed prescription if you can’t read the handwriting.

• Read the label on the bag of intravenous (IV) fluid so you know what’s in it and that it is for you.

• Ask how long it will take the IV to run out.

Use a quality health care organization that…

• Has experience taking care of people with your condition.

• Your doctor believes has the best care for your condition.

• Is accredited, meaning it meets certain quality standards.

• Has a culture that values safety and quality, and works every day to improve care.

Participate in all decisions about your care…

• Discuss each step of your care with your doctor.

• Don’t be afraid to get a second or third opinion.

• Share your up-to-date list of medicines and vitamins with doctors and nurses.

• Share copies of your medical records with your health care team.
The goal of Speak Up™ is to help patients and their advocates become active in their care.

Speak Up™ materials are intended for the public and have been put into a simplified (i.e., easy-to-read) format to reach a wider audience. They are not meant to be comprehensive statements of standards interpretation or other accreditation requirements, nor are they intended to represent evidence-based clinical practices or clinical practice guidelines. Thus, care should be exercised in using the content of Speak Up™ materials. Speak Up™ materials are available to all health care organizations; their use does not indicate that an organization is accredited by The Joint Commission.
4/18
SpeakUp™ Speak Up™ About Your Care
©2018 The Joint Commission | May be copied and distributed | Department of Corporate Communications

Announcing a New Partnership!

I am pleased to announce that MBD Consulting, LLC has a new partnership with MSL Healthcare Partners.  MSL Healthcare Partners will be partnering with MBD Consulting to provide Life Safety and Environment of Care expertise to our already highly experienced group.  Our Principal, Maureen D’Agostino said, “their website states a clear vision that fits well with MBD Consulting. One belief, one philosophy”

From their web site, At MSL Healthcare Partners, we have an obsession with safety. We will never conceal, compromise or apologize for our dedication to making the healthcare environment safer, with an ultimate goal of completely eliminating preventable errors. Yes, we’re saying it, and we’ll say it again: We believe that all members of the healthcare community can work together to one day eliminate preventable errors in our healthcare environments. To achieve such a goal, the status quo will not suffice. The lowest common denominator, the bare minimum, the excuses, the don’t-raise-your-head-up philosophy will never do.

Welcome to the MBD Consulting family.

 

Joint Commission Advises Hospitals to Help Staff After Traumatic Events

 

By Maria Castellucci Modern Healthcare | January 31, 2018
The Joint Commission issued an advisory report this week urging its accredited healthcare organizations to provide support services to staff after traumatic patient events.

Healthcare providers can experience psychological trauma when their patients experience adverse health events like an unexpected death or medical error. The emotional toll such events can have on providers has been coined “second victims” and although healthcare organizations have begun to address the issue, programs and tools haven’t been widely adopted, according to the Joint Commission.

“We are trying to improve the awareness and importance of this issue,” said Dr. Ana McKee, executive vice president and chief medical director of the Joint Commission.

In its advisory, which was sent out to the roughly 21,000 healthcare organizations it accredits, the Joint Commission offers various tactics for healthcare leaders to support staff after traumatic events. The commission recommends organizations create a culture that encourages communication about defects and errors, engage all team members to share lessons learned when an adverse event occurs and provide guidance to staff about how they can properly support each other during trauma.

“(Doing) nothing is not the right answer … an organization has to find some approach to raise awareness about the second victim,” McKee said.

The commission also offers ways for healthcare organizations to implement “second victim” programs. These programs provide peer-to-peer support services to staff and have been adopted at some hospitals and health systems across the country like Johns Hopkins University and Health System.

Rise, which was launched in 2011 at Johns Hopkins, is a 24/7 call center staffed by roughly 30 clinicians at the organization who have volunteered to be part of the program. The participants are trained in psychological first aid, a technique used to help victims debrief soon after a traumatic patient event.

“It’s intended to be a safe (space for staff) — we don’t report it to managers,” said Dr. Albert Wu, a professor of health policy and management at Johns Hopkins who helped launched the program.

The program has encouraged staff at Johns Hopkins to be more open about their emotions, Wu said. Whole clinical teams will go together for support after a particularly traumatic event. “It is changing the culture,” he said.

The Joint Commission took best practices from “second victim” programs like Johns Hopkins in its recommendations. Healthcare organizations are encouraged if they want to form such a program to obtain buy-in from leadership, emphasize the importance of patient safety and develop an educational campaign.

At Nationwide Children’s Hospital, resources to establish the YOU Matter Second Victim Program were initially scarce.

Jenna Merandi, director of the “second victim” program, said she partnered with the marketing department to raise awareness. Informational messages were displayed on digital quality boards and Merandi and her team spoke at meetings across various departments.

“The first several years we didn’t have funds, we started from the ground up,” she said. “(After) we showed the value of the program and how it was changing the culture, we did receive funding and support.”

YOU Matter Second Victim Program, which first launched in 2013, has now trained more than 700 Nationwide staff members to be peer supporters.

The Columbus, Ohio-based children’s hospital has surveyed its staff on feelings of burnout and stress since the program has been in place, and the results are promising.

“We have been able to show the effectiveness of the program … it’s improving negative psychological impact on front line staff,” she said

CMS Bans Texting of Patient Orders!

By Debra A. Geroux
248.258.2603
geroux@butzel.com

January 3, 2018

In a Letter to State Surveyors, the Centers for Medicare & Medicaid Services (“CMS”) has clarified its position on texting patient information, and more notably Orders, among members of a patient’s care team. In a nutshell: Don’t Do It!
In its December 28, 2017 Memo regarding Texting of Patient Information among Healthcare Providers, CMS recognizes the benefits and long standing practice of texting patient information among members of a patient’s healthcare team, but explains that it is only permissible if performed through a secure, encrypted platform in accordance with HIPAA privacy and security regulations. CMS expects that providers and organizations that utilize secure, encrypted texting systems will implement procedures for regularly assessing the security of the system.
However, CMS also indicates that, as it concerns Orders from a provider to a member of the care team, texting is never permissible, encrypted or otherwise, as the Conditions of Participation and Conditions for Coverage mandate that Orders be dated, timed, authenticated and promptly placed in the medical record. See 42 CFR 482.24(b).[1] According to CMS, the best (and preferred) practice for entering orders is through Computerized Provider Order Entry (CPOE), which ensure immediate and authenticated entry into the electronic health record.
While the texting prohibition has not yet been addressed in the Interpretative Guidelines,[2] Interpretive Guideline A-0454 concerning section 482.24(c)(2) provides slight guidance on the “promptly” directive, noting that it is to be “performed readily or immediately” so that all members of the patient’s care team have access to it. The use of texting for Orders does not meet either the requirements for authentication or prompt placement, at a minimum.
Healthcare providers and entities must take steps to educate staff about the problems associated with texting generally, and texting Orders specifically. While CMS recognizes texting is commonplace, it does not mean it can be condoned. If not already in place, hospitals and entities that are subject to certification surveys should take steps to eradicate these standard practices through policy changes and education.

 

 

Thanks to AHRQ: Toolkit To Promote Safe Surgery In Hospitals

The Toolkit To Promote Safe Surgery helps perioperative and surgical units in hospitals identify opportunities to improve care and safety practices and implement evidence-based interventions to prevent surgical site infections. The toolkit has evidence-based, practical resources that reflect the real-world experiences of the frontline clinicians and subject matter experts who participated in the AHRQ Safety Program for Surgery, a national implementation project in which approximately 200 hospitals participated and successfully reduced surgical site infections. It builds on AHRQ’s Comprehensive Unit-based Safety Program (CUSP) and the core CUSP toolkit by providing specific tools focused on the surgical setting to help hospitals reduce surgical site infections and other complications.
The toolkit has two complementary guides that should be used together and are a good starting point: Applying CUSP To Promote Safe Surgery, and Surgical Complication Prevention. These two guides address respectively adaptive and technical work, which are both critical elements for improvement to occur. Technical work changes procedural aspects of care that can be explicitly defined, such as surgical skin preparation procedures. Adaptive work is designed to change the attitudes, values, beliefs, and behaviors of the people who deliver care and improve safety culture within an organization, thereby enabling consistent use of evidence-based practices. Both guides should be used simultaneously. Supplemental tools accompany the guides.
The toolkit also includes 15 instructional modules to help clinical teams address specific areas of competency. The modules are spread across the three phases that clinical teams will undergo as part of their quality improvement efforts: onboarding, implementation, and sustainability.
Toolkit Materials
The toolkit includes two guides, supplemental tools for each guide, and 15 instructional modules within three phases to support change at the unit level.
Guides
Applying CUSP To Promote Safe Surgery
Supplemental tools
Surgical Complication Prevention
Supplemental tools
Instructional modules
Onboarding
Implementation
Sustainability

Go to:  https://www.ahrq.gov/professionals/quality-patient-safety/hais/tools/surgery/index.html

Geisinger Holy Spirit Hospital Cited After Patient Dies Under Restraint

December 27, 2017

The patient became combative and was held down by two security guards while a physician and a nurse applied the restraints.
A hospital in central Pennsylvania has been cited by the Pennsylvania Department of Health after a patient died while being placed in restraints.
An investigation into Geisinger Holy Spirit Hospital’s handling of a restrained patient indicated staff failed to “protect the patient’s safety during restraint application” on September 26, reports Penn Live.
According to the health department’s investigative report, the patient became agitated and belligerent and attempted to exit the hospital, pushing through staff members.
Two security guards then held the patient down on a bed while a physician and a nurse applied restraints. The unidentified patient’s body went limp, their face turned blue and they began foaming at the mouth, according to the report.
The hospital staff declared a code blue, used to label a patient in cardiac arrest. The patient later died from what the hospital called a “diffuse anoxic brain injury,” which is typically caused by severe head trauma, according to The Sentinel.
The department says some of the restraints that were used did not have a required order from a doctor.
Another violation included failure to report the death to the Pennsylvania Patient Safety Authority within a week of the incident. The hospital also did not notify the patient’s family of the event, says the report.
The hospital submitted a plan of correction but the first version was rejected by the state.
The second plan was approved and includes educating staff about the use of restraints and the establishment of a “code grey team” to be trained in handling a combative patient who does not have a weapon. The report did not give elaborate details on the hospital’s plan to institute the team.

While we would prefer not to restrain patients, at times such measures are indicated for the safety of all involved. We are saddened whenever a patient passes away, and are confident that the care our team provided was consistent with Geisinger Holy Spirit’s mission of delivering professional and compassionate care to all,” says Lori Moran, director of corporate communications at Geisinger Holy Spirit.
Holy Spirit has a locked mental health unit and specializes in mental health crisis situations.

About the Author

Amy Rock, Web Editor
Amy Rock is the Campus Safety Web Editor.