CHPSO December Patient Safety News

December 2013
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Lessons Learned

Are You Ready for the 2014 National Patient Safety Goal on Alarm Management?

Clinical alarm systems are intended to alert caregivers of potential patient problems, but if they are not properly managed, they can compromise patient safety. This is a multifaceted problem. In some situations, individual alarm signals are difficult to detect. At the same time, many patient care areas have numerous alarm signals and the resulting noise and displayed information tends to desensitize staff and cause them to miss or ignore alarm signals or even disable them. Other issues associated with effective clinical alarm system management include too many devices with alarms, default settings that are not at an actionable level, and alarm limits that are too narrow. These issues vary greatly among hospitals and even within different units of a single hospital.

The Joint Commission has been following these concerns and in June 2013, designated clinical alarm safety as a National Patient Safety Goal. Many hospitals are currently developing their implementation plan, so we have added a checklist developed by Association for the Advancement of Medical Instrumentation (AAMI) to assist in that planning.

If you are interested in joining a focus group that will be developing a statewide implementation plan, please contact the CHPSO Director of Quality and Patient Safety, Rhonda Filipp at rfilipp@chpso.org.

☐ Dates for compliance with The Joint Commission National Patient Safety Goal on Alarm Management:

  • As of July 1, 2014, leaders establish alarm system safety as a hospital priority.
  • During 2014, identify the most important alarm signals to manage.
  • As of January 1, 2016, establish policies and procedures for managing the alarms identified above and educate staff and licensed independent practitioners about the purpose and proper operation of alarm systems for which they are responsible.

☐ Link to National Patient Safety Goal on Alarm Management:

http://www.jointcommission.org/assets/1/18/JCP0713_Announce_New_NSPG.pdf

☐ Take a proactive system approach

  • Assemble a multidisciplinary team.
  • Review recent events and near-misses.
  • Analyze your current system, including culture, infrastructure, practices, and technology.
  • Identify failures and determine causes.
  • Develop realistic strategies to minimize risk.
  • Carefully plan for implementation.
  • Monitor the effectiveness of strategies and modify as needed.
  • Provide feedback to staff.
  • Celebrate your successes!

☐ Deal with challenges and barriers to implement improved alarm management

  • Measurement of alarm status.
  • Technology limitations.
  • Competing priorities.
  • Overwhelming number of devices with alarms.
  • Financial constraints.

☐ Implement easy strategies first – consider:

  • Change electrocardiographic electrodes daily.
  • Prepare skin properly before applying electrodes.
  • Change telemetry batteries daily.
  • Develop plan to customize physiologic alarms.
  • Implement initial and ongoing education.
  • Consider the appropriateness of the use of devices with alarms.

☐ Always focus on goal to make alarm management safer

  • Minimize patient safety vulnerabilities and reduce risk.
  • Continually improve effectiveness and efficiency of alarm management.

References:

The Joint Commission Announces 2014 National Patient Safety Goal. Available at The Joint Commission website: http://www.jointcommission.org/assets/1/18/JCP0713_Announce_New_NSPG.pdf

The Joint Commission’s National Patient Safety Goal on Alarm Management: How Do We Get Started? Sept. 25, 2013. AAMI Foundation HTSI webinar. http://www.aami.org/meetings/webinars/HTSI/resources.html


Proposed rule includes provisions implementing ACA’s PSO reporting requirements

The Department of Health and Human Services (HHS) issued a proposed rule (officially issued December 2, 2013—see page 171 of the rule for details) implementing a number of provisions of the Affordable Care Act (ACA), including the provision that hospitals must satisfy certain patient safety and quality improvement requirements in order to contract with a qualified health plan (QHP) through the new health insurance exchange (in California, that is Covered California).

As originally written, the ACA required QHPs to contract with hospitals that have more than 50 beds only if they meet certain patient safety standards, including the use of a patient safety evaluation system (PSES) by January 1, 2015. The proposed rule clarifies the PSES provision, defining a PSES as the collection, management or analysis of information for reporting to or by a patient safety organization (PSO).

The Centers for Medicare & Medicaid Services (CMS) proposes to delay the PSO participation requirement, noting the challenges in meeting the 2015 deadline. In phase one, CMS proposes that, as a temporary alternative to PSO participation, hospitals could qualify for QHP contracts if they meet the Medicare Conditions of Participation, as evidenced by being either Medicare-certified (having a Medicare CCN) or being Medicaid-only and having a Medicaid-only CCN. Under the current proposal, phase one would last two years or until CMS issues further regulation.

CMS also requests suggestions for exceptions to the future PSO participation requirement. Comments on the proposed rule are due by December 26. Please contact rjaffe@chpso.org with any comments.

About CHPSO

CHPSO members gain extraordinary access to incident data analysis and the collective intelligence of patient safety experts nationwide. We maintain close alliances with other national PSOs, quality and safety agencies, research institutes and think tanks. This translates into exponential improvements, economically and clinically.

Membership is offered at no charge for members of the California Hospital Association and the Regional Hospital Associations. Membership is also available to hospitals outside of California for a nominal fee. Further information is on our web site.


Mechanical barriers for preventing transfusion errors

Ellen O. LaChance, MS, MT(ASCP)SBB

Mechanical barrier products were first developed by two physicians after a mistransfusion led to the death of an elderly patient in New Jersey in 1987, and several brands are now available.1 Mechanical barriers are designed to force the patient identity check immediately before a blood transfusion.


The mechanical barrier is a lock put on a zip-top overbag that contains the appropriately labeled blood component intended for transfusion. The combination code to the lock is placed on the patient’s wristband and on the specimen tube at the time of specimen collection. The code is nowhere else – not in the patient’s chart, posted at the nurses’ station, or on any forms. So if the locked blood component is taken to the wrong patient, the lock won’t open, as the code on the blood will not match the code on the patient’s wristband. Similarly, if the wrong blood component is taken to a patient, that patient’s wristband code won’t match the one used to lock the unit and the lock will not open.

Exhibit 1: Steps in using a mechanical barrier

  • When drawing sample, apply code label to wristband and apply code label to tube.
  • In blood bank:
    • Scan specimen tube barcode to associate code with patient.
    • Once blood component is identified for recipient and labeled, place in zip-top bag.
    • Set lock using code and apply to bag.
  • For administration, after verifying patient ID, use code on patient’s band to open lock.

If used properly, barrier products will not only prevent mistransfusions as described above, but can also address errors during specimen collection. If there is wrong-blood-in-tube (WBIT) and the cross-matched blood is taken to the patient whose (incorrect) name was on the specimen tube, the lock won’t open because the wristband code either won’t be there or will be incorrect. For example, Northwestern Memorial Hospital (Chicago, IL) found that the barrier system detected 24% of WBIT cases over 6 years.2

Exhibit 2: How barrier products help to detect WBIT

  • Nurse draws blood from John Robbins and places code label TYLK on wristband and code label TYLK on tube, gets distracted and later labels tube with wrong name (“Jeff Dobbins”).
  • Blood matching John Robbins labeled “Jeff Dobbins” arrives on ward.
  • Blood brought to “Jeff Dobbins”, whose name band matches the blood label, but nurse cannot open lock because patient does not have code TYLK on his wristband.

How are barrier products used by hospitals?

Some blood banks lock all components; others lock only red blood cells (RBCs). Most mechanical barrier users lock components used in all units (medical floors, OR, ED, outpatient infusion/oncology), and do not make exceptions, for example, for the trauma area. The locks take a matter of seconds to open, so speed in accessing the blood has not been a significant issue.

Other approaches to patient ID

There are many approaches to assuring that patient identification (ID) is confirmed prior to transfusion, including:

  • Two-nurse check of two unique identifiers, often full name and medical record number
  • A check of three unique identifiers: in addition to the name and medical record number, a blood bank ID (BBID) from a blood band can be added
  • Bedside barcode scanning to confirm patient identity and correct blood component

As with all safety devices and procedures, if all steps are completed correctly with every patient, every time, these other approaches should prevent the misadministration of blood. Unfortunately, many clinical studies have shown that this just doesn’t happen. Some examples from the literature include:

  • Three-quarters of 4,046 observed transfusion cases in 233 hospitals lacked completion of one or more of four patient ID steps3
  • Six aspects of patient ID pose a significant “opportunity for WBIT”, based on a review of samples from 122 facilities4
  • In an analysis of ten years’ experience of transfusion errors in New York, 40% of ABO-incompatible transfusions were tied to failure at pre-transfusion patient ID checks, and 14% to sample collection errors5

Authors studied barcode medication administration systems (BCMA) use at five hospitals and identified 15 types of workarounds. Nurses over-rode BCMA alerts for 4.2% of patients charted.6

Exhibit 3: Barrier product use at four facilities

Reading Hospital (Reading, PA)

  • Level II trauma center, about 1000 transfusions/month
  • Serious event (WBIT) led the blood bank team to evaluate mechanical barriers
  • Barrier product has been in place for ten years
  • Used for all cross-matched blood, including trauma patients
  • Known to have prevented two or more serious events

Newton Medical Center (Newton, KS)

  • Community hospital, 130–150 transfusions/month
  • Despite use of an EMR and bedside scanning, the Risk Management team tracked several near-misses over an 18-month period
  • No clinical consequences in these cases but the events were deemed unacceptable
  • Mechanical barrier product has been in place several months
  • No near-misses since it was implemented
  • The combination of the EMR with bedside scanning and the mechanical barrier has led to 99.3% nurse compliance to following all positive patient ID steps, up from 62% compliance 18 months earlier

Miami Valley Hospital (Dayton, OH)

  • Part of large integrated delivery network (IDN); all five facilities use mechanical barriers
  • Miami Valley Hospital does about 2,100 transfusions/month
  • Mechanical barriers were evaluated and implemented after a near-miss occurred, relating to wrong blood taken from remote refrigerator for a surgical patient
  • No serious events or near-misses since the barrier product was put in place
  • Barrier product is used for all cross-matched blood, including for trauma and NICU patients

Eastern Maine Medical Center (Bangor, ME)

  • Regional medical center, about 550 components/month
  • Locks are only used for RBCs; uncross-matched group O’s and neonates excluded
  • Mechanical barriers have been in place over six years
  • No serious events or near-misses since the barrier product was put in place
  • Barrier products have detected two instances of WBIT that would not have been detected by other methods

Considerations when moving to a mechanical barrier

As with any new process, there are several considerations that must be evaluated to prepare for a smooth implementation:

  • Strong culture of safety – from nursing to medical staff and leadership
  • Clear language used during implementation to reinforce that it is not okay to bypass a safety device
  • Procedures needed for both routine process and exceptions, including when:
    • Bands are cut off or covered by drapes in the OR
    • Lock won’t open
    • Blood bank receives a specimen without code
    • Massive transfusions
  • Consider all sources of specimens:
    • Inpatients collected by phlebotomy team
    • Inpatients collected by nurses
    • Patients getting preadmission testing
    • Outpatients
  • Cost
    • Consider the frequency and cost of obtaining and processing a second sample to verify blood type and compare to the cost of a barrier product.

Summary

There is no perfect system. If every transfusionist correctly followed all patient ID steps every time before a transfusion, safety devices, such as barrier devices or barcode scanners, would not be necessary. But we’re human, we get rushed and distracted, and steps get missed unintentionally, leading to errors. Mechanical barriers are one simple approach to prevent errors that can occur anywhere in the transfusion process—from the collection of the pre-transfusion specimen to the actual transfusion of the blood product.

References

1. BloodLoc™ (Novatek Medical, Inc.) was introduced in the early 1990s and, FinalCheck® Recipient Safety System (Typenex Medical, LLC) was introduced in 2011.
2.Garcia-Godos, N , Sumugod, R D , Garland, F D , Masarik, S R , Lindholm, P F , Ramsey, G. Role of a wristband-coded mechanical barrier system in the interception of misidentified blood bank specimens. Transfusion. September 2011;51(3):285A-297A.
3. Novis D, Miller K, Howanitz P, Renner S, Walsh M. Audit of transfusion procedures in 660 hospitals. A College of American Pathologists Q-Probes study of patient identification and vital sign monitoring frequencies in 16494 transfusions. Archives Of Pathology & Laboratory Medicine. May 2003;127(5):541-548.
4.Grimm E, Friedberg R, Wilkinson D, AuBuchon J, Souers R, Lehman C. Blood bank safety practices: mislabeled samples and wrong blood in tube-a Q-probes analysis of 122 clinical laboratories. Archives Of Pathology & Laboratory Medicine. August 2010;134(8):1108-1115.
5. Linden J, Wagner K, Voytovich A, Sheehan J. Transfusion errors in New York State: an analysis of 10 years' experience. Transfusion . October 2000;40(10):1207-1213.
6. Koppel R, Wetterneck T, Telles J, Karsh B. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. Journal Of The American Medical Informatics Association: JAMIA. July 2008;15(4):408-423.

More on the author:

Ellen LaChance is the manager of the Transfusion and Tissue Service at Eastern Maine Medical Center and Affiliated Laboratory, Inc. in Bangor, Maine. Ellen has been a volunteer assessor with the AABB accreditation program since 1982, and has served on the Transfusion Service Accreditation Committee.


Hierarchy of corrective actions

Actions addressing safety concerns can be placed in a hierarchy, from strongest to weakest, based upon our knowledge of human behavior and human factors design. The above article highlights the use of a strong action; a forcing function (a locked bag with the unlock code taped to the patient’s arm band) to dramatically reduce the risk of mistranfusion. Alternatives of similar strength to forcing functions include a combination of process simplification and simplification such as a double check technique developed in South Carolina. http://www.thefinalcheck.org/final-check/.

Following are actions ordered by strength produced by the VA’s National Center for Patient Safety, found at http://www.patientsafety.va.gov/CogAids/RCA/index.html. This hierarchy can help guide choice of appropriate measures for addressing safety concerns. Stronger actions are encouraged for serious concerns, though actions need to be carefully chosen and implemented. Stronger actions have stronger effects, so the risk of adverse consequences from an incorrectly-applied or incorrectly-designed action is higher.

Strongest actions examples

  • Architectural/physical plant changes
  • New device with usability testing before purchasing
  • Engineering control or interlock (forcing functions)
  • Simplify the process and remove unnecessary steps
  • Standardize on equipment or process or care maps
  • Tangible involvement and action by leadership in support of patient safety

Intermediate actions examples

  • Increase in staffing/decrease in workload
  • Software enhancements/modifications
  • Eliminate/reduce distractions (sterile medical environment)
  • Checklist/cognitive aid
  • Eliminate look and sound alikes
  • Read back
  • Enhanced documentation/communication
  • Redundancy

Weakest actions examples

  • Double checks
  • Warnings and labels
  • New procedure/memorandum/policy
  • Training
  • Additional study/analysis

Event: The Highs and Lows of Insulin Errors and How to Prevent Them

December 16, 2013 - 11:30am – 12:30pm Pacific

Register for this event

Join this CHPSO / ECRI webinar on insulin safety using shared information from members regarding errors with insulin therapy, including prescribing, transcribing, dispensing, storage, administering and monitoring, as well as review suggested methods to enhance insulin safety.

Learning Objectives

  • Recognize insulin as a high-alert medication.
  • Describe the differences between available insulin products.
  • Identify potential errors with insulin use.
  • Identify methods to enhance the safety of insulin.

Continuing education

This activity has been approved for 1.0 California State Nursing contact hours by the provider, Debora Simmons, who is approved by the California Board of Registered Nursing, Provider Number CEP 13677.

This call is for members only. Registration, at no charge, is required and available at www.chpso.org/form/registration-chpso-ecri-december-call. A CHPSO website member account is required. Registrants will receive an email December 13 with participation information. Participants registering on or after December 13 should contact CHPSO for participation information at (916) 552-2600.

Event: Alarming Events

CHPSO monthly member call

Monday, January 13, 2014, 10 – 11 a.m. Pacific

Register for this event

Join Dr. Rory Jaffe in a discussion about alarm-related events been reported to CHPSO.

  • Review selected details of reported alarm-related events
  • Open discussion about potential causes in the cases and proposed improvement activities
  • Discuss The Joint Commission’s National Patient Safety Goal on clinical alarm safety and formation of a focus group to develop a statewide approach for development and dissemination of practice guidelines.

This call is for members only. Registration, at no charge, is required and available at www.chpso.org/form/january-member-call. A CHPSO website member account is required. Registrants will receive an email January 10 with participation information. Participants registering on or after January 10 should contact CHPSO for participation information at (916) 552-2600.


Resources for members only at www.CHPSO.org

CHPSO’s revised website turns one year old this month!

Our collection of materials for members only has been growing. Do you have your website user account? Anyone registering for a user account with a CHPSO member hospital email address is approved. Once your account is confirmed, you will have access to:

  • register for upcoming events including monthly member webinars and CHPSO / ECRI calls;
  • the CHPSO Webinar archive, including this summer’s webinar series on Causal Analysis, Dr. Verna Gibbs’ Bits & Pieces Presentation, Maximizing your AHRQ Culture of Safety Survey, CHPSO / ECRI webinars and many more;
  • materials to help establish your Patient Safety Evaluation System (PSES), including a PSES template and toolkit; and
  • useful tools tested, proved and provided by other CHPSO member hospitals for event investigation and correction action measurement.

We encourage any hospital personnel of a member hospital to create a user account to access these great resources.

If you have any suggestions on other tools you would like to see available for members, please let us know at info@chpso.org.

Clinical Peer Review Impact on Quality and Safety – Newest Findings

From QA to QI

Marc T. Edwards, MD, MBA

In the fall of 2011, I initiated the Longitudinal Clinical Peer Review Effectiveness Study and solicited updated information from physician and hospital leaders at 470 hospitals that had participated in either or both of two prior national studies. The study showed that self-reporting of adverse events, near misses and hazardous conditions – a practice proven to enhance aviation safety – is beginning to be embraced in healthcare and is producing the expected results.

The quality of case review and the use of committee discussion for peer review decision-making were identified as additional factors influencing program quality impact. The results also have important implications for nursing practice, regardless of whether a formal nursing peer review program is in place. The full report is featured in the September/October issue of the Journal of Healthcare Management (see abstract) complemented by an online-only supplement with item-level tallies.

Unfortunately, despite a high rate of program change, very little progress has been made in adopting the QI model (http://QAtoQI.com/QImodel.htm), which is associated not only with greater quality and safety, but also with significantly improved physician engagement and physician-hospital relations. Four of every five hospitals have substantial room for improvement in peer review program structure, process and/or governance. I have explored much of this territory in past CHPSO Patient Safety News articles, including: April 2013 - Multispecialty Review Committees, December 2012 - Benefits of the QI Model, September 2012 - How to Promote Self-Reporting, July 2012 - Self-Reporting, May 2012 - Learning from Defects, January 2012 - Measuring Clinical Performance, November 2011 - Learning to Improve Safety, September 2011 - QA vs. QI, and July 2011 - Hidden Potential for Improvement.

The Clinical Peer Review Program Self-Assessment Tool has been updated to reflect these latest findings. You can quickly and easily evaluate your own program at: http://QAtoQI.com/set.htm. Use the results to help communicate the need for change or track progress with improvement efforts. See the February 2013 newsletter for practical tips on transforming peer review.

Coming Next: Patient Safety Culture

Good or Lucky?

One barrier to change is resistance by those who have not experienced a bad event. Most of us were trained to learn from our personal experience; quite useful in many situations, especially when scientific evidence is weak or absent. Given the vast variety of situations patients present with and the limits of scientific evidence, there are many situations in which human intuition and experience are valuable. You can often hear experienced professionals say that they made a “gut” decision; one made from instinct and intuition developed through their own experiences.

However, safer practices often are aimed at reducing rare but severe adverse outcomes. A bit of math will show that personal experience often is unreliable, and a history of good outcomes should not reassure one that his or her practices are actually safe.

For example, the incidence of wrong-site surgery is roughly 1 in 100,000 cases. How many cases would an OR team have to perform without incident before they are reasonably (95 percent) sure that their practice is at least as good as the nationwide average?

They would have had to have performed about 460,000 procedures uneventfully just to be assured that they are average; to prove performance is significantly better would take even more cases.

So numbers can help persuade, if a provider resists change saying that he has never had a problem (particularly if he believes himself to be data-driven). Ask: how many times have you done that procedure? What is an acceptable rate of error? If a target rate is 1/n, then the amount of event-free experience needed is well over 4*n (a rough approximation, but good enough—in our example above 4*n would be 400,000 when 460,000 were actually needed). Those eye-popping numbers should help people see that having no problems does not necessarily distinguish between good and lucky.

References

Agresti A, Coull BA. Approximate Is Better than “Exact” for Interval Estimation of Binomial Proportions. The American Statistician. 1998;52(2):119–126.

Kwaan MR, Studdert DM, Zinner MJ, Gawande A. Incidence, patterns, and prevention of wrong-site surgery. Archives of surgery (Chicago, Ill.: 1960). 2006;141(4):353–7; discussion 357–8.

For those interested in the math, the following could be readily calculated in a spreadsheet. If you have had no adverse events in ‘n’ cases, then:
    nadj = n + 3.84
    padj = 1.92 / nadj
Risk of adverse event is less than = padj + 1.95 * sqrt ( padj / nadj * ( 1 – padj ))

Note: nadj means n-adjusted, padj is p-adjusted, and the above calculates the 95% upper limit of the Agresti-Coull Interval

Upcoming Patient Safety Events

California Hospital Patient Safety Organization

Unless noted, all CHPSO events are for members only, are free and require registration. The registration link will be located on each webinar’s webpage. All times are for the Pacific Time Zone. For more information, contact info@chpso.org or call (916) 552-2600.
December 16
11:30 a.m.‑12:30 p.m.
The Highs and Lows of Insulin Errors and How to Prevent Them
CHPSO / ECRI webinar

Hospital Council of Northern and Central California

December 19
11 a.m.‑12:30 p.m.
Therapeutic Packing, Vaginal Packing and Wound Packing: Preventing Retention

Hospital Association of San Diego and Imperial Counties

For more information visit www.patientsafetycouncil.org or contact Alicia Muñoz.

December 4
11:30 a.m.‑4 p.m.
HQI Regional Quality Leader Network Program & Luncheon
December 5
9:30 a.m.‑12 p.m.
Safe Table
HASD&IC Offices




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