What’s New in the Patient Safety World

December 2013



·         FDA Alert on Spinal Procedures and Anticoagulants

·         Lessons from the SFGH Missing Patient Incident

·         Lighten Up Your Patient’s Day!

·         Joint Commission CLABSI Toolkit

·         ECRI Institute’s 2014 Top 10 Technology Hazards




FDA Alert on Spinal Procedures and Anticoagulants



One of the cases in the recent round of actions by the California Department of Public Health (CDPH #CA00332399) was that of a patient who developed a spinal epidural hematoma and paraplegia on removal of an epidural catheter while she was on low molecular weight heparin (LMWH). The epidural catheter was removed by a physician’s assistant on the order of a physician, neither of whom was privileged to insert or remove such catheters and neither of whom was aware the patient was on LMWH.


Think this case is an extremely rare event? Think again. The FDA has just issued a safety alert with updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins (FDA 2013).


The full version of the FDA announcement has details of over 100 cases of spinal or epidural hematoma related to neuroaxial analgesia or spinal puncture in patients on enoxaparin over a 20 year period.


The FDA recommends that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations will be added to the labels of anticoagulants such as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.


The FDA alert recommends use of a preprocedure checklist that asks whether a patient is receiving anticoagulants and identifies the appropriate timing of anticoagulant dosing in relation to catheter placement or removal. Both the dose and the elimination half-life of the anticoagulant should be considered. For example, for enoxaparin placement or removal of a spinal catheter should be delayed for at least 12 hours after administration of prophylactic doses such as those used for DVT prevention. Longer delays (24 hours) are appropriate to consider for patients receiving higher therapeutic doses of enoxaparin.


The FDA alert recommends a postprocedure dose of enoxaparin should usually be given no sooner than 4 hours after catheter removal.


There are several practical issues raised in the CDPH case that are also valuable lessons. There are certain procedures that require specific hospital privileges that we strongly recommend you mandate the provider take a refresher course and satisfactorily complete a post-test at least every 2 years. Examples we recommend this for are moderate sedation and ordering PCA pumps. The same should apply to insertion and removal of epidural catheters.


Prior to insertion of an epidural catheter you can attach a checklist that must be completed before the epidural kit can be opened. That checklist should include a checkbox to indicate that the provider is privileged to insert the catheter. It should include another checkbox asking whether the patient is on anticoagulants and not allow the kit to be opened if the anticoagulants have not been discontinued for the specified period (we recommend that a table of the “safe” timeframes after discontinuation be part of the checklist, too).


The hospital in the CDPH case also began adding orange stickers with “Anticoagulant Therapy” to be placed on all epidural dressings after insertion.


The hospital also added a hard stop to physician ordering of Lovenox or various heparin preparations that requires a response to the following question “If patient has had any spinal procedures or epidural indwelling catheters in the last 48 hours please select from the list, otherwise select none”.


They also noted a couple features in their IT systems that might make ordering of anticoagulants in patients with epidural catheters more likely. One is use of a “renew all orders” button. Such could be clicked without the provider recognizing that an epidural catheter had been placed in the interim. Another was that physicians apparently could enter some orders via a nurse communication screen rather than the CPOE screen. Orders entered in this manner apparently might escape review by pharmacists or might not trigger any alerts. You should look at your systems to see whether such features are present.


It would also be important to include something about anticoagulation status in your “Ticket to Ride” communication tool to alert providers in areas such as Radiology that manipulation of the epidural catheter may be risky (or to alert them that procedures that might be done in Radiology, such as lumbar puncture, might be risky)


The consequences of spinal epidural hematomas are devastating. Development of systems to avoid this preventable complication are key.






CDPH (California Department of Public Health). Complaint #CA00332399.




FDA. Safety Announcement. FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. November 6, 2013




FDA. Safety Announcement. FDA Drug Safety Communication: Updated recommendations to decrease risk of spinal column bleeding and paralysis in patients on low molecular weight heparins. November 6, 2013 (full version).







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Lessons from the SFGH Missing Patient Incident



Our October 15, 2013 Patient Safety Tip of the Week “Missing Patients” had numerous recommendations about steps to be taken when a patient goes missing. That column was an update to our July 28, 2009 Patient Safety Tip of the Week “Wandering, Elopements, and Missing Patients”. We did the update because of the recent events at San Francisco General Hospital where a patient was found dead 17 days after going missing. We had hoped that details of their investigation would be shared so that other hospitals could learn from this unfortunate incident. However, details have been slow in coming and all we’ve seen are fragments published in the local media. Nevertheless, there are probably some lessons learned even from those few fragments.


Like any other incident with adverse patient outcomes we typically see a cascade of events that come together to allow that unfortunate outcome.


A timeline of the events in this case was presented by the Sheriff whose department oversees the security at SFGH (Yan 2013).


From descriptions in the media it does not sound like there was ever a point in time where someone said “We have a missing patient. Activate our missing patient protocol and procedures.” Apparently about 40 minutes went by before the hospital’s security staff was notified the patient was missing (Van Derbeken 2013). A nursing assistant had been looking for her unsuccessfully during that period. One likely contributing factor was that the patient apparently was being considered for discharge that day. When the physician went to see the patient prior to the planned discharge, the patient was already gone. That planned discharge and fact that she was not subject to a psychiatric “hold” apparently led to Sheriff’s Department deputies (the security for SFGH is provided by the Sheriff’s Department) to not really consider handling the case as a missing patient.


The attorney for dead patient’s family said the hospital should have known much sooner that one of its patients was missing. He pointed out that hospital staff had deactivated the patient’s bed alarm because she kept getting up (Palmer 2013).


Next, there was confusion over the description of the patient. Various reports to the Sheriff’s Department described her as Asian or African-American though she was white. (As per our previous columns, is this an example where having a photograph of the patient might have helped?) It was also unclear whether she was in street clothes or hospital gown.


Other communications issues include that the evening shift deputies stationed at the hospital were not briefed by previous deputies about the missing patient (Yan 2013).


Deputies tried to retrieve hospital surveillance-camera footage for clues of where the patient had gone, but "hardware problems" prevented them from doing so and it was over a week before those videos became available.


When searches were eventually done, they were incomplete. The perimeter of the 24-acre hospital grounds was searched and only about half of the stairwells were checked.


The Sheriff indicated some changes have already been implemented (Romney 2013). One is mandated daily patrols of fire stairwells. Another is required documentation of responses to “stand alone audible alarms” (which presumably would have occurred when the patient exited into the stairwell). Apparently none of the stairwell door alarms were deficient, broken or inoperable; they just weren’t all set to require manual deactivation (Sherbert 2013). Apparently now when those alarms ring, security staff will check each one, and nurses will make sure all unit patients are accounted for, as part of a new policy (Hoenen 2013). The video surveillance system is apparently also being reviewed for possible upgrade.


Also, a visitor to SFGH apparently noted that she had found herself locked in a similar stairwell at the hospital several months earlier (Rosato 2013). She had decided to skirt the elevator and walk down the stairs. There apparently were no signs that the doors would automatically lock. She had to bang on the doors until, finally, a nurse came and opened the door. We’ll bet you might have similar locked stairwells in your facility. Ask your security staff if they have ever received a cell phone call from someone locked in such a stairwell!


Not fully clear from the media are issues related to staffing of the security department of the hospital. Apparently the Sheriff’s Department is responsible for providing the security at the hospital. But the levels of training of that staff are apparently quite variable (Lamb 2013). The media reports do not detail the degree of continuity of security staff or whether all staff have participated in drills for missing patients. But apparently a number of changes are taking place in the deployment of staff and training and retraining.


It is also not clear whether all hospital staff are involved in a “missing patient” event. From the media descriptions it sounds like the security staff were expected to do everything. In a “missing patient” event, for which regular drills should be conducted, all hospital personnel must be cognizant of their role. Typically, designated staff have responsibilities to search specific sectors in a “grid” search. And there should be a “command central” which coordinates the search and records which areas of the facility and grounds that have been searched.


Now is a good time for all facilities to say “could that happen here?” and do a thorough review of your policies and procedures for missing patient incidents, including making sure you do appropriate drills for such incidents. Take the opportunity to learn from the events at SFGH in their unfortunate incident. We urge you to review the recommendations in our Patient Safety Tips of the Week for July 28, 2009 “Wandering, Elopements, and Missing Patients” and October 15, 2013 “Missing Patients” about steps to be taken when a patient goes missing.







Yan H. Body found in hospital stairwell: San Francisco sheriff details what went wrong. CNN; November 7, 2013




Van Derbeken J. Deputies missed stairwell in search for missing woman at Calif. hospital. San Francisco Chronicle; November 7, 2013




Palmer C. Lynne Spalding: Sheriff Tries to Explain How Deputies Overlooked Missing Patient. SF Weekly Nov. 6 2013




Romney L. Sheriff cites confusion, glitches in search for missing patient. LA Times. November 6, 2013




Sherbert E. Lynne Spalding: Here's What SFGH Is Doing to Make Hospital Safer After Missing Patient Found Dead. SF Weekly Nov. 7 2013




Hoenen L. Security failure blamed for patient’s death. San Francisco hospital overhauls procedures, awaits review results. Security Director News; November 11, 2013




Rosato J. SF General Visitor Says She Also Was Locked in Stairwell: Report. NBC Bay Area October 23, 2013




Lamb JO. Some San Francisco hospital security performed by low-level officers.

San Francisco Chronicle November 8, 2013






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Lighten Up Your Patient’s Day!



In many of our columns dealing with delirium we’ve noted the importance of using lighting in the hospital that mimics normal day/night cycles to help prevent delirium. But what about the rest of the patients in the hospital who may not be at risk for delirium? Is their condition and hospital course impacted by the lighting in the hospital?


Researchers from the Cleveland Clinic say “yes”. A new study (Bernhofer 2013) used light meters and wrist actigraphy to assess the sleep-waking patterns of hospital inpatients and correlated those parameters with patients’ pain levels and mood. Light exposure levels were low and sleep time was poor and fragmented. There was little sleep–wake synchronization with light. Fatigue and total mood disturbance scores were high and inversely associated with light. Pain levels were also high and positively associated with fatigue, but not directly with light exposure. Low light exposure significantly predicted fatigue and total mood disturbance. They concluded that inpatients were exposed to light levels insufficient for circadian entrainment. Nevertheless, higher light exposure was associated with less fatigue and lower total mood disturbance in participants with pain.


Though the study was small (40 total patients) this research demonstrates the need for further studies to see if altering light exposure for inpatients would be beneficial in affecting sleep–wake disturbances, mood and pain.


Admittedly there are lots of things other than ambient light that impact a patient’s sleep-waking patterns. See our August 6, 2013 Patient Safety Tip of the Week “Just Let Me Sleep!” for details.







Bernhofer EI, Higgins PA, Daly BJ, et al. Hospital lighting and its association with sleep, mood and pain in medical inpatients. Journal of Advanced Nursing 2013;

Article first published online : 27 OCT 2013, DOI: 10.1111/jan.12282





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Joint Commission CLABSI Toolkit



The Joint Commission, in collaboration with Joint Commission Resources and Joint Commission International, produced a 152-page monograph in 2012 containing the most current information, evidence-based guidance, and resources to assist healthcare organizations in reducing central line-associated bloodstream infections (CLABSIs).


Now the Joint Commission, Joint Commission Resources (JCR), and Joint Commission International (JCI) have developed a toolkit to supplement the monograph.


The toolkit and monograph describe the epidemiology, mechanisms, and risk factors for development of CLABSI’s, the economic and human impact, best practices and successful patient safety initiatives to prevent CLABSI's, including the work of Peter Pronovost and colleagues at Johns Hopkins and the Michigan Keystone Project. They emphasize the factors that lead to successful prevention programs.


The toolkit and monograph are loaded with tools to help you have a successful CLABSI prevention program.







The Joint Commission. Preventing Central Line-Associated Bloodstream Infections – A Global Challenge (monograph). May 16, 2012




The Joint Commission. CLABSI Toolkit - Preventing Central-Line Associated Bloodstream Infections: Useful Tools, An International Perspective. November 20, 2013





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ECRI Institute’s 2014 Top 10 Technology Hazards



Each year ECRI Institute puts out its list of the top 10 health technology hazards. The ECRI Institute 2014 Top 10 Health Technology Hazards list is now out:

  1. Alarm hazards
  2. Infusion pump medication errors
  3. CT radiation exposure in pediatric patients
  4. Data integrity failures in EHRs and other health IT systems
  5. Occupational radiation hazards in hybrid ORs
  6. Inadequate reprocessing of endoscopes and surgical instruments
  7. Neglecting change management for networked devices and systems
  8. Risks to pediatric patients from "adult" technologies
  9. Robotic surgery complications due to insufficient training
  10. Retained devices and unretrieved fragments


Most of the entities on the list are repeats from prior years and we’ve discussed most of them extensively. It’s no surprise that alarm hazards are #1 on this year’s list. However, there are some that are new to the list this year: #5 Occupational radiation hazards in hybrid ORs, #7 neglecting change management for networked devices and systems, and #9 robotic surgery complications due to insufficient training. In addition, #10 retained devices and unretrieved fragments is a former list member that returned this year.


Hybrid OR’s are surgical areas into which advanced imaging capabilities are brought. Unlike radiology suites or cath labs where personnel are very familiar with risks of ionizing radiation, personnel in these hybrid OR’s are less likely to be fully aware of the radiation hazards. And it is the OR staff that are especially at risk to radiation exposure. ECRI emphasizes the importance of radiation safety programs that include training, shielding, and monitoring.


Hazard #7 “neglecting change management for network devices and systems” has become a real problem. This refers to changes made to one device or system having “downstream” consequences that are unintended and unanticipated. They cite as an example an instance where PC software upgrades resulted in loss of remote display capability of the facility’s fetal monitoring devices.

Hazard #9 deals with robotic surgery complications. The glow is coming off robotic surgery. In the last few years we have seen more and more reports that robotic surgery for certain conditions does not, as touted, result in either better patient outcomes or fewer complications. In many cases, the widespread rapid adoption of robotic surgery has resulted in practitioners doing procedures before they have become sufficiently proficient with the new technology. Recently it has also been suggested that there may be significant underreporting of complications with robotic surgery (Cooper 2013).


One of the phenomena we’ve pointed out several times is that described by Charles Perrow in his classic book “Normal Accidents” (Perrow 1999) where he talks about how new technologies often simply “push the envelope”. He cites as an example how the introduction of maritime radar simply encouraged boats to travel faster and did little to reduce the occurrence of maritime accidents. Many of the hazards described by the ECRI Institute in their excellent reports on technology hazards are prime examples of that phenomenon.







ECRI Institute. ECRI Institute 2014 Top 10 Health Technology Hazards.




Cooper MA, Ibrahim A, Lyu H,  Makary MA. Underreporting of Robotic Surgery Complications. Journal for Healthcare Quality 2013; Article first published online: 27 AUG 2013




Perrow C. Normal Accidents: Living with high-risk technologies. Princeton, New Jersey: Princeton University Press, 1999





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Print “December 2013 What's New in the Patient Safety World (full column)

Print “December 2013 FDA Alert on Spinal Procedures and Anticoagulants

Print “December 2013 Lessons from the SFGH Missing Patient Incident

Print “December 2013 Lighten Up Your Patient’s Day!

Print “December 2013 Joint Commission CLABSI Toolkit

Print “December 2013 ECRI Institute’s 2014 Top 10 Technology Hazards



Print “December 2013 What's New in the Patient Safety World (full column in PDF version)










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