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Issue #12 




A Note from the CEO


Dear Reader, 


The long awaited date of October 1, 2013, is nearly upon us. While the emphasis on this particular day is how the Healthcare Insurance Marketplace (Exchange) will actually function across the country, the work of healthcare providers has been focused on aligning their organizations to deliver the services necessary to fulfill the benefits of the health plans that will be participating in the marketplace...broad services and lower cost...and implementing IT solutions to support those services. It is an exciting time to be in the healthcare industry!


A common theme behind everything we are stressing to our clients and partners is just how broad the continuum of care is becoming in today's healthcare industry, and how important it is to actively manage risk, quality and safety (RQS) in these diverse settings. The expanding diversity of patient care settings, the increasing acceptance of and dependence on IT, and the pressing need for organizational efficiency and integration all pose challenges to maintaining an effective RQS strategy and keeping the patient's needs at the center of care. But, with challenges come opportunities for improvement. In this issue of the Clarity Post, we look at some of these challenges and the ways we can adapt to the changes happening around us.


Anna Marie Hajek

President & CEO

Clarity Group, Inc.


Healthcare News & Trends



Patient Safety Awareness



A Quick Look at "Convenient Care Clinics" from a Risk-Quality-Safety Perspective


By: Heather Annolino, RN, MBA, CPHRM, Director, RQS Consulting Services, Clarity Group, Inc.


As the popularity of walk-in retail health clinics or "convenient care clinics" continues to grow, it is important that we understand the impact these facilities have on the population and the healthcare industry. Studies estimate that the number of retail clinics will increase by more than 100% by the end of 2015 and with numbers like these, it is clear that they are here to stay.

Our white paper, A Quick Look at "Convenient Care Clinics" from a Risk-Quality-Safety (RQS) Perspective, identifies ways retail clinics can contribute to patient safety improvement as well as some of the risk-quality-safety concerns we need to address in order for them to become a valued partner in the healthcare delivery landscape.


All Things Rural



National Rural Health Day


Mark your calendars - National Rural Health Day is November 21st. Rural healthcare providers across America play a critical role in our country's health system - we look forward to recognizing their contributions!


NRHA Webinar - Embracing Patient- and Family-Centered Care


Clarity is committed to providing content-rich educational opportunities through the National Rural Health Association's (NRHA) free webinar series. On September 5, we sponsored our latest webinar, Embracing Patient- and Family-Centered Care. 


Highlights from the Webinar:


Today's journey through healthcare reform is more varied and tumultuous than it has been in decades. It does not matter what aspect of healthcare reform we talk about, at the heart of each discussion should be the patient and what it takes to keep the patient at the center of his/her journey through the healthcare delivery system. However, as health systems manage the changes in healthcare reform and expand their philosophy to care for their communities, there is very little mention of what this experience should look like from the patient's perspective. Here are some reasons why improving the patient and family experience is vital:


  • Patient experience surveys - payments to hospitals adjusted in part on how well they do on these surveys
  • Increasing healthcare costs shifting to the patient
  • Potential impact on referral patterns when patients have a choice
  • Patients and families are the only team members always present through an episode of care
  • Patients and families, when involved, improve adherence, outcomes and safety
  • Rising consumer and patient expectations
  • Mandate for healthcare entities to post quality and cost measures

It has become clear that this approach is increasingly linked to improved health outcomes, lower healthcare costs, reduced errors, and greater patient and family satisfaction making it an important piece of any healthcare system's strategy. The following are recommendations to help you begin your journey toward patient- and family-centered care and achieve these benefits: 
  • Start by educating all senior leadership and include patients and their families at the start of these discussions
  • Assess current state of patient- and family-centered care, patterns of care, access to information, etc. 
  • Develop an action plan and integrate strategies into the organization's mission, vision, philosophy and definition of quality
  • Appoint a family steering committee that includes hospital members and patients and their families
  • Start out with general areas to be addressed such as what works well and what doesn't and address the issues through a collaborative process
  • As the group becomes comfortable, branch out to more specific areas such as assessing policy and procedure development. Other various committees can extend the membership to include patients and families
  • Develop ongoing education programs to support patients, their families and staff
  • Monitor change, evaluate processes, measure the impact and celebrate the successes
To learn more about patient- and family-centered care in the rural healthcare setting, listen to the webinar

Clarity's Small & Rural Benchmarking Program Celebrates Two Years of Growth


Clarity's Benchmark for Excellence in Patient Safety™ (BFEPS) Program is entering into its third year of data collection, reporting and shared best practices. Introduced in June of 2011, the program has experienced consistent growth and momentum in building a base of members with over 12,000 submitted events from which to extrapolate patient safety knowledge and facilitate sharing among participants. 


Participation in the program is voluntary for those small and rural facilities that use Clarity's Healthcare SafetyZone� Portal, a web-based tool for patient safety data collection, follow up and analysis.


"What's interesting and very pleasing to see is that after the first year, member organizations began voluntarily facilitating deeper dives into their collected data, and not simply relying on high-level event reports," said Tom Piotrowski, Clinical Informatics Director at Clarity Group, Inc. "For example, the group requested a more in-depth look at medication errors and specifically the overall process of medication administration. That then led to a discussion on whether certain tools increase frequency of certain types of errors. This is important because it shows that the members are actively participating in the program and not just passively receiving reports from us every three months. This in turn leads to awareness and understanding that goes beyond incident reporting, such as the culture of safety within an organization." 


To learn more about the BFEPS program's two-year anniversary, read our press release


Cyber Risk in the Information Age



Expanding the Boundaries of Your Knowledge on Cyber Liability


By: Drew Shaler, Risk-Quality-Safety Associate, Clarity Group, Inc.


Cyber liability is not a new concept. It is, however, a growing risk exposure in the healthcare industry. In December of 2012, the Ponemon Institute conducted a study on data breaches in healthcare organizations between the years 2011 and 2012. They discovered that, "94 percent of health-care organizations surveyed suffered at least one data breach in 2011 and 2012, with 45 percent of the organizations experiencing more than five data breaches during that time(1)." The study also found that, "these breaches could be costing the U.S. health-care industry an average of $7 billion annually(1)." In an age where healthcare costs are persistently rising, organizations cannot afford to have an exposure as expensive as this.


In July 2013, a data breach at Advocate Health Care was reported to be the largest breach of federally protected records by a healthcare provider in U.S. history. Computers housing patient records that belonged to Advocate were not encrypted, giving the thieves easy access to the data. From this recent example, it is clear that healthcare organizations are highly susceptible to losing valuable patient information to cyber terrorists. Data breaches are starting to become one of the more profound problems within the healthcare industry and implementing strategies to prevent them from occurring needs to be a priority.


Data breaches not only affect healthcare providers, but we must also consider the implications on individual consumers whose information has been compromised. To protect both of these entities, the government has passed several laws. For the consumer, there is the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This Act regulates the use and disclosure of Protected Health Information (PHI) held by covered entities such as hospitals, clinics, health insurance companies, etc. The government also passed The Health Information Technology for Economic and Clinical Health Act (HITECH) in an attempt to balance support for electronic data transfer and storage with the potential for harmful disclosure of sensitive information. In just this past year, the HIPAA Omnibus Rule was passed, which implements statutory amendments for HIPAA, while strengthening HITECH Breach notification requirements. The final omnibus rule enhances a patient's privacy protections, changes a covered entity's notice of privacy practices, provides individuals new rights to their health information, strengthens the ability to enforce the law, and requires updates to business associate contracts. As cyber breaches continue to become more prevalent, it will also become more heavily regulated in the future.


With the process of trying to recover information and managing government fines and penalties, cyber liability can be a huge hassle for organizations to control. Here are some strategies a healthcare organization can use to help mitigate the risk of cyber breaches:


  • Requiring passwords to be changed on a regular basis
  • Encrypting all electronic devices that store sensitive and personal information
  • Encrypting emails as well as remote connections that contain or access personal information
  • Ensuring computers are not left open or unlocked when employees are not at work areas
  • Implementing networks that have both firewalls and anti-virus programs
  • Limiting access to confidential information whether in software, hardware or system access
  • Appropriately destroying confidential information when it is no longer needed
  • Auditing third-party vendors and determining appropriate contractual allocation of liability
  • Conducting regular risk assessments to expose any hardware or software weaknesses
  • Creating a written IT security policy that outlines policies for physical security, account management, and backup and recovery along with other relevant items
  • Developing an appropriate breach response team before a breach occurs
  • Updating policies and procedures when there are regulation updates and changes in technology
  • Creating a "Bring Your Own Device" or BYOD policy that requires employee-owned devices to have the most up-to-date encryption and virus protection software
As more digital information is produced by the healthcare industry and society continues to embrace technology, it is very important that cyber liability be kept top of mind. Prevention strategies can no longer be an afterthought, but they must be built into an organization's operational structure from the beginning. 


Clinical Risk Management Issues



Use of Sample Medications in Physician Practices


In these challenging economic times, physician practices may help their patients obtain the medication that they need and cannot afford by providing them with sample medications. Issuing sample medications is a high-risk activity for physician offices and if the decision is made to dispense sample medications, it is prudent to create and consistently use a medication management system. It is vital that this system include adequate preparation and education of physician office staff in order to mitigate potential risk exposure. The following outlines a Risk Modification Process for physicians and their office staff to consider in acquiring, storing, dispensing and disposing of sample medications.


Risk Modification Process: Sample Medications


  1. Develop a Protocol for Determining the Appropriate Indications for Use
  2. Develop Appropriate Office Policies to Monitor Sample Medications
    1. Establish policies with your office staff to ensure that proper storage, inventory management, tracking/logging, labeling and disposing of sample medications are all in place
    2. Pay special attention to any state laws regarding disposal of medications
    3. Pre-determine how a drug recall will be handled and how patients who might have received that medication as a sample from your office will be contacted
  3. Storage of Sample Medications
    1. Keep all medications locked and in secured areas
    2. Know and follow manufacturer recommendations for storage
    3. If refrigeration is required, be sure to monitor the appropriate refrigeration temperatures. Develop a process to notify the practice if there has been a refrigeration (electricity) malfunction when the office is closed
  4. Inventory of Sample Medications
    1. Develop an inventory process. This process serves multiple purposes such as preventing unauthorized medication removal, removal of outdated and recalled medications, and providing a way to trace back what medications have been distributed
  5.  Labeling of Medications for Patient Use
    1. All medications provided to patients need to be clearly labeled with medication name, strength and dosage unit, lot number and expiration date, instructions for use, information required by the FDA, and cautionary statements (e.g. "May cause drowsiness")
    2. Leave an open space to affix a label for the specific patient that includes, at a minimum:
      1. Patient name
      2. Date dispensed
      3. Reason for medication
      4. Clear directions for use
      5. Amount that should be taken
      6. Frequency of taking the medication
      7. Special instructions/precautions for use
      8. Any significant side effects
  6. Issuing of Medications
    1. Ensure that only those with prescribing authority dispense the medication
    2. The physician is responsible for reviewing the patient's medical record to make sure there are no drug allergies, sensitivities, etc. to the sample medication being provided
    3. When dispensing medications, the physician is responsible for patient education
  7. Documentation
    1. Document in the patient's record:
      1. That medication was dispensed
      2. The lot number
      3. The expiration date
      4. That the patient received appropriate education regarding dosage, use, side effects, etc.
  8. Monitoring
    1. The physician office is responsible for contacting the patient if there is a drug recall on a medication dispensed from the practice
    2. The physician office is responsible for tracking any adverse drug reactions related to the medication and reporting this reaction to FDA MedWatch
    3. Document that the patient has been notified about a recall and the adverse drug report has been filed in the case of any adverse drug reaction

Patient Safety Organizations



PSO Announcement from the Office of the National Coordinator for Health Information Technology


Clarity PSO has been a leader in helping our clients implement AHRQ's Common Format reporting, and has carried this through the Ambulatory Safety Initiative we began in 2012. The announcement made by the Office of the National Coordinator for Health Information Technology (ONC) on July 3, 2013 supports the work we have been doing, and we will continue to work with the ONC in their efforts to promote patient safety across the healthcare continuum of service settings.


Announcement from the ONC:


The Office of the National Coordinator for Health Information Technology announces the publication of the final version of the Health IT Patient Safety Action and Surveillance Plan ("Health IT Safety Plan" or "Plan") on June 27, 2013. The Plan builds on recommendations of the 2011 Institute of Medicine (IOM) Report, Health IT and Patient Safety: Building Safer Systems for Better Care, and provides a roadmap for increasing knowledge of health IT safety and ensuring that health IT is used to make care safer. The Plan leverages existing authorities to strengthen patient safety efforts across government programs and the private sector-including health care providers, health IT developers, patient safety organizations (PSOs), and accrediting and oversight bodies.


AHRQ will be working together with ONC to:


  • Collaborate with PSOs, providers, and developers to add a focus of health IT to their collection, aggregation, analysis, and mitigation of providers' adverse event reports. AHRQ will also provide guidance to PSOs on how they can work with EHR developers to identify and mitigate health IT risks.
  • Provide tools and resources to help providers identify, describe, and report health IT-related events and hazards.
  • Support the research and development of tools and guidance for using health IT to improve safety and mitigate health IT safety risks.
  • Begin development of Common Formats for ambulatory care that will enhance reporting of health IT events outside the hospital.


More information about the Plan and its implementation is available at

Clarity PSO Learning Series #3: A Continued Exploration of Ambulatory Safety in Modern Healthcare Systems


Contributors: Tom Piotrowski, RN, MSN, CSSGB, Executive Director, Clarity PSO  -  Heather Annolino, RN, MBA, CPHRM, Director, RQS Consulting Services, Clarity Group, Inc.


Just Released!


For the third report in our PSO Learning Series, we looked at the mindset of the care providers who practice in ambulatory settings and the unique circumstantial challenges that make practicing in these setting so different from working in the traditional inpatient settings.


Since August 2012, Clarity PSO has been conducting a pilot study (The Ambulatory Safety Initiative) with two of our large client health systems. During the study, we reviewed and analyzed three aspects of data: professional liability claims history, results from an Office Practice Survey (OPS) and safety events reported to the participants' incident reporting system (in this case, Clarity's Healthcare SafetyZone� Portal) under the Ambulatory Safety Module (ASM). After drilling down into the survey and conducting interviews with the individual providers, we began to see the need for a more cohesive effort toward patient safety practices. 


View the full report to see what the healthcare providers had to say about participating in the initiative and what we learned about patient safety in ambulatory settings. 


PSOs Made Easy!


According to the Affordable Care Act's PSO mandate, those hospitals that are participating in the private insurance market and have 50 or more beds need to report to a Patient Safety Organization by 2015. As this mandate starts to become a reality, it is important that you as a healthcare provider understand what this means to your organization. Listen to PSOs Made Easy to learn the basics of a Patient Safety Organization and prepare yourself for the changes that are coming. 


Want more? Visit Clarity PSO's Learning Library for white papers and other educational resources. 


Clarity Spotlight



Public Webinar: Patient- and Family-Centered Care


Since our webinar on Patient- and Family-Centered Care was so well received in the small and rural community, we are offering a public version on October 9, 2013 at 1:00 pm CDT that relates to the entire healthcare community.


During the webinar, our speaker will discuss: 


  • The core concepts of patient- and family-centered care and how these concepts enhance quality, safety and the experience of care 
  • Effective ways to partner with patients and healthcare providers to transform the patient-caregiver relationship into a collaborative partnership 
  • Strategies to inspire patients and healthcare providers to transform the patient-caregiver relationship into a collaborative partnership


Learn more about the webinar and register.


Upcoming Events


NRHA's 12th Annual Critical Access Hospital Conference

October 2 - 4, 2013

Austin, TX

Booth #106


Embracing Patient- and Family-Centered Care Webinar
October 9, 2013

1:00 pm - 2:00 pm CDT

Webinar Details


ASHRM 2013 Annual Conference & Exhibition

October 27 - 30, 2013

Austin, TX

Booth #734


Coming Soon! Clarity White Paper


Healthcare Captives - The Risk, Quality, Safety (RQS) Perspective 

In the coming weeks, Clarity will be releasing Part 2 in our white paper series on healthcare captives. This white paper will take a closer look at the importance of having a solid RQS plan in addressing challenges toward patient safety and ultimately mitigating claims in a captive insurance setting. As you will learn, the goal of any good RQS strategy is to improve processes, improve patient safety and decrease risk exposures, but the challenge is maintaining a pro-active strategy in the extremely busy and necessarily task-focused environments as with most insureds. Stay tuned for the release of the white paper! 



Phone: 773-864-8280       Email:      Website:       Twitter: @claritygrp

Clarity Post is a publication of Clarity Group, Inc.

Managing Editor: Jaclyn Saffa 

Contributing Editor: Christopher Hajek


This newsletter contains links to sites which are not owned or maintained by Clarity Group, Inc. Clarity Group is not responsible for the content of non-Clarity Group linked sites, and the views expressed on non-Clarity Group sites do not necessarily reflect the views of Clarity Group, Inc.


This information is provided for informational and educational purposes only and should not be construed as financial, medical and/or legal advice. Specific questions regarding this information should be addressed to local advisors and legal counsel. 2013 Clarity Group, Inc. All rights reserved.