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The Pennsylvania Patient Safety Authority has updated its “Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks” (PPSA 2022).
PPSA really stresses that it’s everyone’s responsibility to ensure correct patient, procedure, and laterality. That includes scheduling staff, registration clerks, ancillary staff, nursing staff, the operating provider, anesthesia provider, and the patient. All have an obligation to speak up if they note a discrepancy in any information on the schedule, consent, history and physical, and any office notes. Reconciliation of discrepancies is the responsibility of the operating provider prior to the procedure.
It also stresses the importance of having all relevant documents and imaging studies available. All parties should have reviewed these themselves rather than relying on others. It also stresses active, rather than passive, verification by the patient and others.
We’re glad to see an emphasis also on the importance of including site and side of the procedure at the time of initial scheduling. In several of our columns we have lamented that sometimes the scheduling is performed by non-clinical individuals on either side. In our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” we noted the Minnesota Alliance for Patient Safety created a sample booking form that contains a section which must be filled out by the physician performing the surgery (i.e. that cannot be delegated to staff).
The PPSA recommendations have a good section on site marking. You may wish to also see our May 14, 2019 Patient Safety Tip of the Week “Wrong-Site Surgery and Difficult-to-Mark Sites” regarding sites that are difficult to mark, such as dental, ocular, or spine sites.
There is one area where we think better clarification is due. The recommendations state that “The provider performing the procedure should announce the time-out.” We don’t have a problem with that. But it should not mean that he/she “leads” the timeout. We like the “Minnesota Timeout” concept in which someone other than the surgeon leads the time out process. That helps prevent team members from simply agreeing with the surgeon. The timeout is supposed to be an active rather than passive process and there should not be undue deference to the surgeon. Every member of the team needs to speak up and not be afraid to challenge any aspect.
In the Minnesota Timeout, after the surgeon announces the timeout, the circulating Nurse reads from the patient’s informed consent the patient name, procedure, and laterality (or level), and notes the position of the patient. The anesthesia care provider reads patient’s name from the anesthesia record and states shorthand version of procedure. He/she also states antibiotic name, dose, and minutes from administration time. The scrub person states the shorthand version of procedure for which he/she has set up and verbally confirms he/she sees the surgical site marking (if there is a site marking). If an anatomical diagram is used in lieu of physical site marking, the circulating nurse and team use the diagram to verbally acknowledge the surgical site. The surgeon then states the patient’s name, complete procedure, and site—from memory. Discrepancies are resolved before procedure start.
What’s missing from the Minnesota Timeout? There is no mention of using the other primary source documents (scheduling form, office or hospital notes, history & physical) and no mention about presence and accuracy of appropriate imaging studies.
Here’s the full list of the PPSA recommendations:
Recommendations to ensure the correct surgical procedure is performed on the correct site, side and patient
Preoperative verification and reconciliation
1. The site and side of procedure should be specified when the procedure is scheduled.
2. The procedure, site and side should be noted in the medical record on the history and physical exam record or the procedure note.
3. The procedure, site and side should be discussed and documented on the informed consent form.
4. The individuals, including scheduling staff, registration clerks, ancillary staff, nursing staff, the operating provider and the patient, have an obligation to speak up if they note a discrepancy in any information on the schedule, consent, history and physical, and any office notes. Reconciliation of discrepancies is the responsibility of the operating provider prior to the procedure.
5. The information to verify the correct patient, procedure, side and site, including the patient's or family's verbal understanding, when possible, must be verified by the circulating nurse/designee, anesthesia provider and operating provider. This verification shall be documented in a manner determined by the healthcare facility.
6. Verbal verification with the patient or their representative should be conducted whenever possible. The verbal verification must be done using questions that require active response of specific information rather than passive agreement. Example: Can you tell me your full name? What is your date of birth? What procedure are you having performed today?
7. Patient identification must require at least two unique identifiers, for example, name and date of birth.
8. Discrepancies must be reconciled and documented by the operating provider prior to the procedure.
Site Marking—Site marking recommendations apply to all procedures where there is more than one possible location for the procedure.
9. The site must be marked by the provider responsible for the procedure, for example, surgeon, proceduralist or interventional radiologist, prior to the patient entering the procedure area. The mark must be confirmed by the attending nurse/designee. The mark must also be confirmed by an alert patient or patient representative when possible. The mark must coincide with the schedule, history and physical, and consent.
10. The site must be marked with the provider's initials with an indelible marker.
11. The mark must be made as close to the incision site as possible, so that it is visible in the prepped and draped field.
Time-out and intraoperative verification
12. Prior to the induction of anesthesia, the circulating nurse and the anesthesia provider, verify the patient's identity, procedure, site, side, consent and site marking. The patient is included in this verification whenever possible.
13. The provider performing the procedure should announce the time-out. This occurs after the patient is prepped and draped, and immediately prior to skin incision/puncture.
14. Separate formal time-outs must be done for separate procedures, including anesthetic blocks, by the person performing that procedure.
15. The noncritical activities in the procedure area must stop during the time-out, including music and nonessential talking that could distract team members.
16. The relevant patient documents should be available and actively confirmed during the time-out process. Relevant documents include a history and physical, consent, operating room schedule and radiographic studies when applicable.
17. The site mark should be referenced in the prepped and draped field during the time-out.
18. The members of the surgical team should actively and verbally verify agreement with the surgical site, side and relevant documents. Active participation should be used at all times. For example, ''Which side is the surgery on?'' instead of ''The surgery is on the left side. Do you agree?''
19. Staff should be engaged in the process and the operating provider should specifically encourage team members to speak up with any concerns during the time-out. The operating provider is responsible for resolving any questions or concerns based on primary sources of information and to the satisfaction of all members of the team before proceeding.
20. Utilize intraoperative imaging whenever possible for procedures where exact site is not easily determined through external visualization, for example, X-ray and fluoroscopy, to verify spinal level, rib section level or ureter to be stented.
21. Incorporate accountability for these recommendations into the facility's quality assurance and formal evaluation process. This includes both individual and team performance evaluations, ongoing professional practice evaluations and focused professional practice evaluations.
Recommendations to ensure nerve blocks are performed at the correct site and correct patient
Preoperative verification and reconciliation
1. Confirm patient identity using at least two forms of patient identification.
2. Reconcile and verify the exact site and laterality of the surgical procedure and the perioperative nerve block site using all forms of available primary and confirmatory patient sources, including surgical consent, patient or representative, or both, operative provider's notes (if available), surgical schedule, and history and physical.
3. If any sources differ, the process stops and a member from the anesthesia block team notifies the surgeon to resolve the conflicting information.
Anesthesia site marking
4. After confirming the information in the preoperative verification, the responsible anesthesia provider will use a standardized, institutionally approved mark that is distinct from the one used for the surgical site to mark the perioperative nerve block site.
5. Place the mark close to the injection site to ensure it is visible in the prepped and draped field.
6. Repeat the marking process when there are multiple injection sites.
7. Secure a block team consisting of at least two people with independent roles (for example, responsible anesthesia provider and preoperative or holding area nurse or circulating nurse).
a. Engage the anesthesia provider to initiate the time-out.
b. The anesthesia provider should be present during the time out and during the nerve block.
8. Conduct a time-out before:
a. Sedating the patient, when possible.
b. Inserting the needle or as close to the procedure as possible.
c. Each nerve block.
9. Minimize distractions and stop all unrelated activity before conducting the time-out.
10. Both the anesthesia provider and block team member verify the procedure that is documented and on the surgical consent (and anesthesia consent if used).
11. Locate and visibly confirm the anesthesia site mark during the time-out.
12. Repeat the time-out process when there are changes to:
a. Block team.
b. Patient location within the perioperative area.
c. Patient positioning.
d. Planned nerve block site.
13. Incorporate accountability for these recommendations into the facility's quality assurance and formal evaluation process. This includes both individual and team performance evaluations, ongoing professional practice evaluations and focused professional practice evaluations.
The PPSA recommendations appear to be aimed at those surgeries and other procedures that are likely performed in an OR or procedural room. Don’t forget that many of the same principles should apply for those procedures done at the bedside (see our columns for June 6, 2011 “Timeouts Outside the OR”, July 2014 “Wrong-Sided Thoracenteses”, and February 15, 2022 “Wrong-Side Chest Tubes”).
We should also mention that a recent article in Outpatient Surgery (Gapinski-Kloiber 2022) described use of a mobile software application that might help avoid wrong site surgery. “Surgeons can use the platform to record their discussions with patients in the clinic about the planned procedure, including the site and laterality. This cloud-based statement of the intended surgical plan and verbal confirmation by the patient is accessible leading up to the procedure, including just before the time out, to help providers confirm the correct patient and site. The platform also has a visual cue component, which uses alliteration and colors to help staff identify the correct site of the surgery. A member of the pre-op team uses the platform’s app to listen to the recording of the surgeon-patient statement and scans the proper procedure card into the system. In the OR, members of the surgical team also listen to the statement before conducting the safety time out, which is recorded by the app.“
“In a study involving use of this technology, researchers found no incidences of wrong-site surgery in 487 orthopedic procedures. However, the tool did catch 17 near misses. The researchers were surprised by how many seemingly small errors occurred, including misspelled names and laterality mistakes, and that they were caught at various points of care between surgeons’ offices and operating rooms. The technology can track these close calls and advance staff education and communication by reporting them objectively to surgical leadership.”
Some of our prior columns related to wrong-site surgery:
September 23, 2008 “Checklists and Wrong Site Surgery”
June 5, 2007 “Patient Safety in Ambulatory Surgery”
July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons from Ophthalmology”
July 1, 2008 “WHO’s New Surgical Safety Checklist”
January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 2013 “How Frequent are Surgical Never Events?”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
March 15, 2016 “Dental Patient Safety”
May 17, 2016 “Patient Safety Issues in Cataract Surgery”
July 19, 2016 “Infants and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s Electronic Procedural Timeout”
May 2, 2017 “Anatomy of a Wrong Procedure”
June 2017 “Another Way to Verify Checklist Compliance”
March 26, 2019 “Patient Misidentification”
May 14, 2019 “Wrong-Site Surgery and Difficult-to-Mark Sites”
May 2020 “Poor Timeout Compliance: Ring a Bell?”
September 14, 2021 “Wrong Eye Injections”
October 5, 2021 “Wrong Side Again”
November 9, 2021 “Ensuring Safe Site Surgery”
February 15, 2022 “Wrong-Side Chest Tubes”
Patient Safety Authority/Department of Health. Final Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks. Pennsylvania Bulletin 2022; 52(12): 1591-1724 March 19, 2022
Minnesota Alliance for Patient Safety. Sample booking form
Harder KA. Safe Surgery Process Steps (including the Minnesota Time Out) to Prevent Wrong Surgery. Minnesota Department of Health
Gapinski-Kloiber K. Why Does Wrong-Site Surgery Keep Happening? Put policies in place to make sure surgeons always cut where they should. Outpatient Surgery 2022; April 7, 2022
Availability of clinical decision support tools at the right time can be effective in helping clinicians care for patients. But there is a relative paucity of published data on the actual impact of CDSS on patient outcomes. Intermountain Healthcare recently reported patient outcomes after implementation of an electronic pneumonia clinical decision support tool, ePNa, at 16 community hospitals in their system (Dean 2022). Results were striking, with a 38% reduction in severity-adjusted 30-day mortality. It also improved disposition for emergency department (ED) community-acquired pneumonia (CAP) patients.
Clinical decision support tools for predicting severity of community-acquired pneumonia have long been used. Tools such as the PSI (Pneumonia Severity Index) and CURB-65 Score have been useful in suggesting which CAP patients should be hospitalized and which might merit ICU admission.
ePNa is a newer CDSS tool for managing patients with suspected CAP (Dean 2020). It is real-time clinical decision support embedded within the electronic health record, based upon American Thoracic Society/Infectious Disease Society of America guidelines for pneumonia. It utilizes data elements that are already in the electronic medical record (age, mental status, vital signs, oxygen saturation, several lab test results, and radiologic findings).
Like the prior tools, it offers suggestions about patient disposition (discharge home, admit to hospital, admit to ICU). But it also provides recommendations about antibiotic choice and microbiologic studies (such as blood culture, tests for Legionella or MRSA or viral pathogens).
Intermountain Healthcare rolled out the ePNA in clusters at 16 of their community hospitals. Almost 7000 patients were included in the analysis. ePNa was utilized by emergency department clinicians in 67% of eligible patients. Unadjusted mortality was 8.6% before and 4.8% after deployment. After adjustment for severity of illness, the odds ratio for 30-day all-cause mortality was 0.62 (P<0.001) after deployment. Lower mortality was consistent across all hospital clusters. Reductions in mortality were greatest for those patients with severe disease.
Use of the tool also improved both antibiotic selection and time to initiation of antibiotic therapy. Prescribing an antibiotic concordant with the ATS/IDSA increased from 83.5 to 90.2% (P<0.001). Mean time from emergency department admission to first antibiotic was 159.4 minutes at baseline and 150.9 after deployment (P<0.001).
Outpatient disposition from the emergency department increased from 29.2% to 46.9% and 7-day secondary hospital admission was unchanged. Both inpatient hospitalization rates and ICU admissions were reduced after implementation of ePNa.
These results are quite impressive, especially since we suspect many ED physicians were probably using tools like PSI and CURB-65 prior to implementation of ePNa. The ePNa tool appears to be easy to use, improves patient outcomes, and improves utilization of healthcare system resources. Nice work!
Dean NC, Vines CG, Carr JR, et al. A Pragmatic Stepped-wedge, Cluster-controlled Trial of Real-time Pneumonia Clinical Decision Support. American Journal Respiratory and Critical Care Medicine 2022; Online ahead of print March 8, 2022
MedCalc. PSI/PORT Score: Pneumonia Severity Index for CAP.
MedCalc. CURB-65 Score for Pneumonia Severity.
Dean NC, Vines CG, Rubin J, et al. Implementation of Real-Time Electronic Clinical Decision Support for Emergency Department Patients with Pneumonia Across a Healthcare System. AMIA Annu Symp Proc 2020; 2019: 353-362
ECRI (ECRI 2022) has released it’s annual Top 10 Patient Safety Concerns for 2022:
1. Workforce shortages
2. Healthcare worker mental health problems linked to COVID-19
3. Bias and racism in addressing patient safety
4. Vaccine coverage gaps and errors
5. Cognitive biases and diagnostic error
6. Nonventilator healthcare-associated pneumonia
7. Human factors in operationalizing telehealth
8. International supply chain disruptions
9. Products subject to emergency use authorization
10. Telemetry monitoring
The COVID-19 pandemic has obviously weighed heavily on their choices.
We suggest you go to the ECRI site for full details on each of those concerns, so we’ll only comment on a few.
Workforce shortages should be near the top of everyone’s list. Burnout has taken its toll on an already aging workforce. Our January 2022 What's New in the Patient Safety World column “Another Striking Nurse Staffing Study” noted the impending shortage of nursing staff. But the anticipated shortages really apply to all categories of healthcare worker.
We have discussed several of the other concerns in columns over the years. Diagnostic error and the influence of cognitive biases on diagnostic error have long been on any lists of patient safety concerns. Our prior columns are listed below, including our most recent November 16, 2021 Patient Safety Tip of the Week “Cognitive Biases and Heuristics in the Delivery Room”.
Telemetry monitoring has also been a frequent topic. Unnecessary telemetry monitoring is a significant contributor to alarm fatigue and it is usually our number one target when we advise hospitals in reducing alarm fatigue. But there are other problems associated with telemetry monitoring. Our columns listed below have discussed telemetry units transposed on the wrong patients, battery-related issues, incidents during intrahospital transports, communication issues, and others. Our June 23, 2020 Patient Safety Tip of the Week “Telemetry Incidents” summarizes many of the issues encountered with telemetry.
See also our other columns related to COVID-19:
Some of our prior columns on cognitive biases and diagnostic error:
Some of our prior columns on the hazards associated with telemetry:
ECRI. Top 10 Patient Safety Concerns 2022. ECRI March 2022
Add COVID-19 deaths to the list of medical events that are more likely to occur on weekends compared to weekdays,
The average number of global deaths from COVID-19 were 6% higher on weekends compared to weekdays throughout the pandemic (Reuters 2022). According to a study presented at the European Congress of Clinical Microbiology & Infectious Diseases 2022 (Manzoor 2022), there were on average 449 more COVID deaths worldwide on weekends than weekdays (8,532 vs 8,083). The increase was particularly large when specifically comparing Sunday to Monday (8,850 vs. 7,219). The United States had the highest absolute increase in weekend COVID-19 deaths (average 1,483 weekend deaths vs 1,220 weekday deaths).
The data come from the World Health Organization COVID-19 database. All global deaths over a 2-year period from March 7, 2020 to March 7, 2022 were included. Though the authors acknowledge that reporting delays might contribute to those statistics, they feel that hospital staffing levels and system factors are more likely to contribute.
Various studies have demonstrated higher mortality rates for patients admitted on weekends with strokes, atrial fibrillation, diverticulosis surgery, a variety of other surgical procedures, head trauma, COPD, CHF, perinatal events, ICU admissions, ESRD, and other conditions. In fact, in our June 2011 What’s New in the Patient Safety World “Another Study on Dangers of Weekend Admissions” we noted a study (Ricciardi 2011) that found that mortality rates were higher for 15 of 26 major diagnostic categories when patients were admitted on weekends. Even after adjustment for comorbidities and a variety of other clinical and demographic characteristics there remained a significant increase in mortality, on the order of 10% higher for those admitted on weekends.
Though some studies have cast doubt on the weekend effect, our own opinion is that the “weekend effect” and “after-hours effect” are real phenomena and that the causes are multifactorial, including both patient-based and system-based contributing factors. Yes, patients admitted at these times are likely sicker and have a higher severity of illness and therefore are likely to have a higher mortality rate. However, as we’ve pointed out over and over, hospitals do not provide the same levels of service 24 hours a day, seven days a week. Staffing patterns, in terms of volume and even more so in terms of experience, are the most obvious difference but there are many others as well. Many diagnostic tests are not as readily available during these times. On-site physician availability may be different and cross-coverage by physicians who lack detailed knowledge about individual patients is common. You also see more verbal orders, which of course are error-prone, at night and on weekends. But the most significant difference is nurse workload on weekends. We’ve described the tremendous increase in nurse responsibilities on weekends due to lack of other staff (no clerical staff, delayed imaging, physicians not on site) that add additional responsibilities to their jobs. Our December 15, 2009 Patient Safety Tip of the Week “The Weekend Effect” discussed how adding non-clinical administrative tasks to already overburdened nursing staff on weekends may be detrimental to patient care. Just do rounds on one of your med/surg floors or ICU’s on a weekend. You’ll see nurses answering phones all day long, causing interruptions in some attention-critical nursing activities. Calls from radiology and the lab that might go directly to physicians now often go first to the nurse on the floor, who then has to try to track down the physician. They end up filing lab and radiology reports or faxing medication orders down to pharmacy, activities often done by clerical staff during daytime hours. Even in those facilities that have CPOE, nurses off-hours often end up entering those orders into the computer because the physicians are off-site and are phoning in verbal orders. You’ll also see nurses giving directions to the increased numbers of visitors typically seen on weekends. They may even end up doing some housekeeping chores and delivering food trays. All of these interruptions and distractions obviously interfere with nurses’ ability to attend to their clinically important tasks (see our Patient Safety Tips of the Week for August 25, 2009 “Interruptions, Distractions, Inattention…Oops!” and May 4, 2010 “More on the Impact of Interruptions”). That is why we think that simply addressing nurse:patient staffing ratios without addressing nurse workload issues may be short-sighted.
All you have to do is spend some time in your hospital on weekends and you’ll readily see that things are different on weekends.
Some of our previous columns on the “weekend effect”:
· February 26, 2008 “Nightmares….The Hospital at Night”
· December 15, 2009 “The Weekend Effect”
· July 20, 2010 “More on the Weekend Effect/After-Hours Effect”
· October 2008 “Hospital at Night Project”
· September 2009 “After-Hours Surgery – Is There a Downside?”
· December 21, 2010 “More Bad News About Off-Hours Care”
· June 2011 “Another Study on Dangers of Weekend Admissions”
· September 2011 “Add COPD to Perilous Weekends”
· August 2012 “More on the Weekend Effect”
· June 2013 “Oh No! Not Fridays Too!”
· November 2013 “The Weekend Effect: Not One Simple Answer”
· August 2014 “The Weekend Effect in Pediatric Surgery”
· October 2014 “What Time of Day Do You Want Your Surgery?”
· December 2014 “Another Procedure to Avoid Late in the Day or on Weekends”
· January 2015 “Emergency Surgery Also Very Costly”
· May 2015 “HAC’s and the Weekend Effect”
· August 2015 “More Stats on the Weekend Effect”
· September 2015 “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”
· February 23, 2016 “Weekend Effect Solutions?”
· June 2016 “Weekend Effect Challenged”
· October 4, 2016 “More on After-Hours Surgery”
· July 25, 2017 “Can We Influence the “Weekend Effect”?”
· August 15, 2017 “Delayed Emergency Surgery and Mortality Risk”
· September 2020 “Care Processes and the Weekend Effect”
· October 13, 2020 “Night-Time Surgery”
· December 15, 2020 “Our Perennial Pre-Holiday Warning: “Be Careful Out There!””
Reuters Staff. COVID-19 Hospital Death Rates Go Up on Weekends. Reuters 2022; April 19, 2022
Manzoor F, Redelmeier DA. COVID-19 Deaths on Weekends. European Congress of Clinical Microbiology & Infectious Diseases 2022. April 5, 2022
Ricciardi R, Roberts PL, Read TE, et al. Mortality Rate After Nonelective Hospital Admission. Arch Surg. 2011; 146(5): 545-551
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