CPS Safety Watch/Alert: AHRQ Guidance

Patient Safety Organizations (PSOs) and their participants have struggled with interpreting the Patient Safety and Quality Improvement Act (PSQIA) with respect to handling patient safety work that may be necessary to satisfy mandatory reporting or other operational requirements. In an effort to ease anxiety and develop a common understanding, the Agency for Healthcare Research and Quality (AHRQ) has issued a statement (“Guidance”) on the interface of (1) PSO protection of Patient Safety Work Product (PSWP) and (2) mandatory reporting and operational requirements. AHRQ’s statement is available here. Below are some highlights, based on the questions CPS gets most often from its participants. CPS participants can always contact the Center’s staff with questions.

  • The PSQIA has always required that PSO participants keep the information required to satisfy mandatory reporting requirements outside of the PSWP “protected” space. The Guidance reinforces that requirement. However, the PSQIA and the Final Rule allow participants to gather information inside the PSES until they know whether it will need to be reported. If outside reporting is required, then the information gathered in the PSES that has not yet been reported to the PSO can be pulled back out, so that it can be used to satisfy the outside reporting requirement. The Guidance recognizes both this early PSES protection and the opportunity to pull information from the protected space when necessary.
  • Like the Final Rule, the Guidance emphasizes that analysis that takes place in the PSES cannot be “dropped out.” It must remain as PSWP.
  • If a participant has a known obligation under state or federal law to report certain information, the provider should plan on developing it outside the PSES, as it cannot be PSWP.
  • The Kentucky Supreme Court’s Tibbs decision held that work surrounding mandatory state reporting could not be protected, as the state retained the right to investigate how the provider was accomplishing its reporting obligations. AHRQ’s Guidance seems to question that position, noting instead that information related to the required reporting “form” could be protected once the essential reporting obligation has been fulfilled by submitting the actual form, as long as the original documents from which the report was developed are still available.
  • A variety of projects may take place after a patient safety event. AHRQ’s Guidance contains some helpful examples on pp. 6-7 of how that work can be viewed as inside or outside of the PSES, and when it will have to be non-PSWP because of outside reporting requirements.
  • AHRQ encourages PSOs and their participants to work with state agencies and regulators to determine what information they need access to and what can reliably be viewed as PSWP, so that there are fewer confrontations on the front lines about those issues. (NOTE: CPS has historically supported its participants in this communication wherever possible.)
  • The Guidance emphasizes that PSWP is protected because it has been developed for reporting to the PSO, and that the PSES is a protected space for developing that information. CPS has encouraged its participants to view PSO reporting as the end point of their PSES activities, and to actually report to the PSO. AHRQ’s Guidance underscores the importance of reporting.
  • The Guidance specifically mentions hospitals’ requirement under the Conditions of Participation to track adverse events, noting that there is a “legitimate outside obligation” to keep those records. 42 CFR 482.21(a)(2) (https://www.law.cornell.edu/cfr/text/42/482.21). Incident reports have been a flashpoint in many states with respect to surveyors’ ability to see PSWP. PSO participants should carefully consider what routinely reported event information goes into or out of the PSES.  For example, some PSO advisors recommend that basic incident data that includes just patient name, date, location and a brief description would allow regulators to conduct their own investigations while protecting the PSO participant’s deeper investigation and analysis of those events.
  • The action plans or other actions or changes that result from analysis inside the PSES cannot be protected and can always be shared with surveyors.

CPS Safety Watch/Alert: Contaminated Supply

PSOwatchIt has been reported to the Center for Patient Safety that some organizations have experienced sterile syringes and butterfly needles being contaminated within their sterile packaging.


  • Encourage staff to please be watchful of all sterile packages.
  • If the supplies/equipment are noted to be contaminated, they should not be utilized
  • Remind staff to file a report in your event reporting process to notify leadership
  • Leadership should follow up with the vendor

CPS Safety Watch/Alert: Home Health Medication Management

PSOalertA Home Health Care News article came out on 5/3/16 noting that medication mismanagement is an area in which home health agencies are woefully lacking. This article cited a Kaiser Health News Analysis of government records showed that inspectors identified 3,016 home health agencies (nearly a quarter of all agencies examined by Medicare) that inadequately reviewed or tracked medications for new patients. Medication mismanagement is seen as a major post-discharge complication as federal data shows that fewer than 50% of discharged patients are confident that they understand and can follow their discharge instructions.

Contributing factors to these medication errors include, lack of organization, lack of patient education and a lack of communication. Another factor which plays into the lack of communication is the fact that the government incentive to shift to electronic medical record was not set up to work across the continuum of care.  In effect, it contributes to setting up silos within the healthcare continuum as hospitals are not connected with home health care agencies outside of their own system and maybe not even within their own system depending on the software utilized by the hospital and the home health agency.

A review of data submitted to the Center for Patient Safety shows a similar trend in medication events.  Over a third of the medication events reported in the home health arena can be attributed to errors during med reconciliation and lack of communication during the transition from hospital to home health.

Suggested practices to reduce these errors include:

  1. Standardizing communication when a patient is being discharged from the hospital to home health. Include:
    1. Medication changes
    2. Completed and pending tests
    3. Follow up appointments
    4. DME needed by the patient
    5. Education provided to the patient
  2. Double-check medication
    1. Ensure important chronic medications were not stopped
    2. Make certain new medications are safe
    3. Double-check the interactions between medications
    4. Make certain patient hasn’t been prescribed two duplicate medications
  3. Transition the patient to home during the week
    1. Ensures that the patients primary care physician is available for medication questions
    2. Ensures that DME agencies are available to provide the patient with any equipment needed
  4. Patient Education
    1. Make certain the patient (and the family/primary caregiver) understand the diagnosis and medication prescribed
    2. Ensure they understand who they are to contact with any questions
    3. Is the patient/family aware of follow up appointments?
    4. Are they aware of lifestyle changes that may be required?
    5. If so have they been provided with information for support groups?

Patient safety is a major health issue which adversely affects patients in every health care setting.  Improving patient safety is a complex issue, which requires a total systems approach.  Implementing a patient safety culture in which leaders and front line staff put patient safety as a priority across the continuum of care is the foundation for preventing harm.  Reviewing processes and completing RCA’s of all events provides learning opportunities and also identifies areas of improvement.  But for the total systems process to work, an organization must have in place that strong patient safety culture where employees feel free to identify errors and unsafe conditions.










CPS Safety Watch/Alert: Patient Destination Decisions

Thousands of patients are treated and transported by EMS to a destination hospital every day. Most hospitals can meet the required needs of EMS patients; however, patients who have certain conditions, i.e. Stroke, STEMI, Trauma or Pediatrics, often require more specialized care as quickly as possible. These patients have time sensitive conditions called Time Critical Diagnosis (TCD).

TCD is about:

  • Early Identification
  • Appropriate Treatment
  • Appropriate Destination

Many EMS leaders, hospitals and other stakeholders have adopted the TCD concept of. This approach allows for specialized treatment when minutes matter. (more…)

CDC Urging Dialysis Providers and Facilities to Assess and Improve Infection Control Practices to Stop Hepatitis C Virus Transmission in Patients Undergoing Hemodialysis

The CDC issued a health advisory urging dialysis providers and facilities to assess and improve infection control practices to stop Hepatitis C viral transmission in patients undergoing hemodialysis. A health advisory may not require immediate attention but provides important information for a specific incident or situation.

The CDC received an increased number of reports of HCV infections between 2014 and 2015 associated with hemodialysis clinics in eight different states.  While investigations are ongoing initial evaluation demonstrated lapses in infection control associated with these infections. (more…)

CPS Safety Watch/Alert: EKG strip

Safety Watch - buttonThe Center for Patient Safety is issuing a PSO Watch in regards to documentation/chart accuracy. An event was shared where there was confusion regarding the appropriate identification of a patient’s EKG strip, resulting in a patient being treated for a dysrhythmia they did not have. This event brought to light many difficulties currently faced by hospitals and EMS providers:

  • Many hospitals are still in the process of transitioning from paper charts to electronic charts, causing confusion with processes.
  • In the hospitals, most units have systems that automatically print patient labels, or have patient names on EKG strips.
  • The ED departments and EMS agencies have very different systems to label orders/tests/blood work/EKG strips which causes confusion and communication breakdown.

To improve accuracy of patient documentation and communication between departments, CPS recommends the following:

  • Review processes for labeling documentation, and labeling placement, in the chart
  • Ensure standardization of processes
  • Reach out to other departments to ensure processes are standardized throughout system
  • Utilize standardized tool for communication/handoff of patient and test results

CPS Safety Watch/Alert: Intranasal Medication Administration

Safety WatchBased on industry data and recent findings from event data submitted to the PSO, the Center for Patient Safety is issuing a Safety Watch about intranasal medication administration.


Recently, an EMS provider mistakenly administered a medication intranasally when it should have been administered by IV route only. There were was no harm reported to the patient, however, the patient didn’t receive the therapeutic effects desired. This safety watch is to remind providers that not all medications are approved for intranasal administration and dosing can be different from other routes.

Intranasal medication administration is a safe and effective means of administering medication. This administration procedure offers many benefits including ease in administration,rapid absorption and no requirement for intravenous access. On a daily basis, EMS professionals use the intranasal route to save lives and reduce pain, however, not all medications can be administered intranasally.

An incorrectly administered medication can occur at any time, however, most medication errors reach the patient when there is no crosscheck process.

To mitigate and prevent future events, the Center recommends that the five medication rights be followed. In addition, develop a process to support providers with a cross check or medication read back procedure. Always follow medical direction and established protocols. As with all medication administration, the provider should insure the five rights:

  1. Right Dose
  2. Right Patient
  3. Right Route
  4. Right Time
  5. Right Drug

Therapeutic Intranasal Drug Delivery – http://intranasal.net/
Sedgwick County Medication Cross Check Video – https://www.youtube.com/watch?v=qktIdQ86piI

CPS Safety Watch/Alert: Reprocessed Flexible Bronchoscopes Pose Risk

PSOAlert!On September 17, 2015 the FDA issued a safety communication on “Infections Associated with Reprocessed Flexible Bronchoscopes”, following its earlier communication about similar concerns with duodenoscopes/endoscopes.
This alert is to reinforce the following highlights of the report, encouraging healthcare
providers to review processes and implement steps to ensure the safety of patients:

  • Bronchoscopes are a subset of devices that pose a high risk of infection if not adequately reprocessed.
  • Between January 2010 and June 2015 the FDA received 109 Medical Device Reports (MDRs) concerning infection/device contamination associated with flexible bronchoscopes.
  • In 2014 alone the FDA received 50 MDRs concerning infection/device contamination associated with flexible bronchoscopes that prompted further investigation.
  • A small number of MDRs document device contamination despite following manufacturer’s reprocessing instructions. These reports are still being investigated.

The complete report is available here.

The earlier published FDA communications addressed concerns about:

  • The complex design of ERCP endoscopes (duodenoscopes) providing a challenge to cleaning and high-level disinfection.
  • Potential for residual body fluids/organic debris to remain in the microscopic crevices of the moving parts of the elevator mechanism and expose patients to serious infections.
  • Seventy-five MDRs received between January 2013 and December 2014 related to potential microbial transmission from reprocessed endoscopes/duodenoscopes.
  • Instances of device contamination despite strict adherence to manufacturer’s reprocessing instructions.

Complete information from the FDA on these concerns are available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm.


  • Strict adherence to the manufacturer’s reprocessing instructions
  • Immediate removal of use of any bronchoscope that fails a leak test or shows visible signs of damage
  • Conduct maintenance and repair according to manufacturer’s recommendations
  • Implement a comprehensive reprocessing quality control program
  • Store bronchoscopes in a manner so as to minimize the risk of contamination


CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices:  http://emergency.cdc.gov/han/han00383.asp.

CPS Safety Watch/Alert: Expressed Breast Milk

Today, the Center released a Patient Safety Watch: Expressed Breast MilkSafety-Watch-09.28.2015
We encourage you to review the watch and share with others in your organization.

The Center for Patient Safety (CPS) is issuing a PSO Watch to raise awareness about the effects of providing expressed breast milk to the wrong infant, otherwise called “mixing up” breast milk. ECRI Institute recently published a newsletter article and referenced a significant number of events which involved the use of “mixed up” breast milk. CPS has also received a number of similar reports. Read more: download the Watch.

If you have questions, please contact any of the Center’s PSO Team members.

CPS Safety Watch/Alert: Missing & Lost Equipment in EMS

Attention EMS PSO Participants:

Safety Watch 08.25.2015The Center for Patient Safety is issuing a PSO Watch for Missing Lost Equipment in EMS.
Missing and lost emergency equipment is a common occurrence in EMS as indicated by events recently reported to the CPS PSO and concerns voiced from EMS leaders. Without the proper equipment immediately available, unnecessary harm might reach a patient. The Center for Patient Safety is issuing this Safety Watch to remind EMS providers and leaders about the potential risks associated with missing equipment. This is a call to action to prevent risk and patient harm.


PSO Case Law: Ungurian v. Beyzman, et al., 2020 PA Super 105:

A recent Pennsylvania case shows how courts narrowly interpret the PSQIA, ignoring the D & A pathway and the clear language of the Final Rule. (Ungurian v. Beyzman, et al., 2020 PA Super 105). The cour

Joint Commission New Sentinel Event Alert 61: Managing the Risks of Direct Oral Anticoagulants:

The Center for Patient Safety wants to share this important harm-prevention advice from The Joint Commission and its Sentinel Event Alert: Managing the Risks of Direct Oral Anticoagulants. The Joint Commis

CPS Safety Watch/Alert – Culture Can Improve the Control of Multi-Drug Resistant Organisms:

Issue: A number of events reported co CPS’ Patient Safety Organization (PSO) demonstrate poor handoff communication about the patients’ infectious disease status Examples include: Patient with

Read More


The Center for Patient Safety believes that collaboration and sharing are the best ways to drive improvement. We strive to provide the right solutions and resources to improve healthcare safety and quality.