Prevention of Retained: Small Miscellaneous Items (SMIs) Unretrieved Device Fragments (UDFs) Needles

Transcription

1 Prevention of Retained: Small Miscellaneous Items (SMIs) Unretrieved Device Fragments (UDFs) Needles Verna C. Gibbs MD Director, NoThing Left Behind Professor of Surgery UCSF; Staff Surgeon, SFVAMC

2 This FREE webinar is sponsored by a TWO YEAR ( ) CALIFORNIA COLLABORATIVE IN SURGICAL PATIENT SAFETY

3 Ground Rules This presentation is intended to be a job aide The goal is to help participants clarify their thinking which should lead to clearer and stronger actions Policy translation is site specific Predicated on the use of the Sponge ACCOUNTing System

4 Four Classes of Items 1. Soft Goods a) Surgical Sponges* b) Surgical Towels* c) Dressing sponges, Towels, Packs, Prep Swabs, Gauze pledgets 2. Small Miscellaneous Items (SMI) includes parts of instruments 3. Sharps/Needles 4. Instruments (the whole instrument) *cotton soft goods that contain a radiopaque marker for X-ray detection

5 Retained Surgical Items

6 National Quality Forum Serious Reportable Events (SRE) 2011 Update Event Unintended retention of a foreign object in a patient after surgery or other invasive procedure Applicable Settings: Hospitals Outpatient/Officebased Surgery Centers Ambulatory Practice Settings/ Office-based Practices Long-term Care/ Skilled Nursing Facilities Additional Specifications Includes medical or surgical items intentionally placed by provider(s) that are unintentionally left in place Excludes: a) objects present prior to surgery or other invasive procedure that are intentionally left in place; b) objects intentionally implanted as part of a planned intervention and; c) objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as microneedles, broken screws) Implementation Guidance This event is intended to capture: Occurrences of unintended retention of objects at any point after the surgery/ procedure ends regardless of setting (post anesthesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be removed after discovery Unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings

7 When is it Retained? It s considered to be retained if the item is in the patient! AFTER SURGERY When is it after surgery?

8 After Surgery is After all incisions have been closed in their entirety Devices have been removed Final surgical counts have concluded Patient has been taken from the operating/procedure room

9 Small Miscellaneous Items Small Miscellaneous Items and Unretrieved Device Fragments (UDFs) are frequently retained Increasingly reported! 70% of retained items in the Minnesota Hospital Association reports! 50% of items from the California Dept of Public Health! Majority of items from California Hospital Patient Safety Organization voluntary reporting system! Probably the second most common item other places (e.g. Pennsylvania, VA reports) have been bundled in the instrument category

10 The California Story CDPH reports from 10/25/ /24/2013 (7 years) where hospitals received administrative penalties of $25,000 - $100, Retained Surgical Item cases 43 cases involving Soft Goods 28 laps ; 12 raytex; 3 towels (1 ROT) 23 cases of Small Miscellaneous Items and UDFs 9 cases of a retained Instrument (56% are visceral retractors)

11 SMI Data Project Collaboration with CHPSO Reports are Patient Safety Work Product! Confidential! Privileged! Deidentified Illinois, Michigan, Missouri, Nebraska, North Carolina, California, Tennessee participated ended October 2012 Together with data from NLB sources there are 105 cases

12 Observations Problems with the quality of reporting insufficient information provided ~20% had no info [13/67] Of material cases, 54% had a retained SMI/UDF [29/54] 10/54 cases;18% were near miss but the information provided was so sketchy often difficult to discern

13 Observations In this series, Orthopedic surgeons had 38% of the UDF s followed by vascular proceduralists leaving guidewires, sheaths, stents and parts of wires and sheaths in vascular spaces. It was difficult to determine how many of these items were removed

14 Retained Items Guidewires, portions of vascular sheaths, introducers, stents 2.5 foot plastic drape 2.5 cm temporary neck pin stapler head in rectum 1x8" xeroform gauze ring band sizer for heart valve sizing Raney clips blade extender electrocautery tip tip of Bullard laryngoscope 8x5mm metal screw cap 3.5 cm piece of lumbar drain catheter Piece of screwdriver head retractor blade patellar protector metal portion of Heart String device piece of Rhotan dissector 2-4mm drill bits x 10 cases Suture sleeve of AICD lead 4 cm portion of fetal scalp electrode 5mm tip of right angle clamp piece of Weck cell sphere plastic tip of bipolar device endoscopic anti-fog solution bottle Steinman pin Breakaway part of lami bolt Part from Capio device Portion of uterine manipulator Nasal suction bulb

15 Interesting Findings Needles are the most frequently miscounted items in the OR yet very few reports of retained needles Under-reporting of retention or just miscounted? Objects post laparoscopic hysterectomy retained in the vagina increasingly reported

16 California AP events 7 years of public reporting currently includes cases from only 5 years reports = 15 cases/year! 43 cases (57%) soft goods 11/43 (26%) Ob 7 > Gyn 4 cases 28 laps; 12 raytex; 3 towels! 23 cases (31%) SMI+UDFs! 9 cases (12%) instruments! 0 cases sharps

17 CDPH 2011 FOIA request by CHPSO 114 releasable reports! 52 (46%) no information! 8 not RSI cases + no info = 53%! 26 (23%) soft goods! 19 (17%) UDFs! 7 (6%)SMI + UDFs = 23%! 2 retained sharps (1 needle/1 blade)! 0 instruments

18 UHC 2011 University Health Consortium 100 academic medical centers 428 RSI* reports! 171 (40%)UDFs! 137 (32%) soft goods! 77 (18%) Instruments (I doubt this! more likely SMI s + Instruments) + UDFs = 58%! 43 (10%) sharps *TJC definition Williams, JACS Sept 2014

19 NLB Vernacular Two Types of Case based on LOCATION of event I. OR CASES a. Radiopaque items b. Non-Radiopaque items II. Non-OR CASES

20 OR Cases Radiopaque Items Screws, bolts, parts of retractors Wires, baskets Drill bits, metallic fragments Stapler heads, suction tips NLB Vernacular

21 Radiopaque Items Identify early if something is missing Usually will be the scrub person! the circulating nurse is out of the field! the surgeon is focused on operation! discovery in SPD is too late Obtain an intraoperative x-ray Usually can find and retrieve these items Recognition is key

22 OR Cases Non-Radiopaque Items Plastic trocars, vessel loops, Rubber stoppers, flanges, eye protectors Tips from tunneling devices Pieces of wood NLB Vernacular

23 Non- Radiopaque Items Identify early if something is missing Usually will be the scrub person! the circulating nurse is out of the field! the surgeon is focused on operation! discovery in SPD is too late Obtain an intraoperative x-ray - why? Make a plan for further post-operative studies e.g. CT scan Report the incorrect final item count

24 Surgeon Every case should have a methodical wound examination performed before closing Use two sensory modalities touch and sight It s a human endeavor which might fail, but should be done

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26 Scrub Position Content experts on materiel! Check condition of all items passed and returned on the field! Requires knowledge about instruments, tools, surgical items! Standardized back table! Must speak up and question if something is amiss NLB Vernacular

27 Standardize Tables Reduce variation on how STs set up and maintain back tables Aids with discovery of a missing item Everything in its place Not my table Beyond counting

28 Non-OR Cases 1) Intravascular! Everywhere: cardiology, radiology, anesthesiology, ICU! Guidewires, catheters, sheaths, introducers 2) Interstitial! Subcutaneous space, breast tissue! Catheter parts, broken drains, wires NLB Vernacular

29 Guidewires Interventional Radiology can successfully remove these >90% of the time IF recognized and removed early Late discovery leads to fibrous adherence

30 Removal is desired MRI procedures problematic Magnetic fields can cause movement, migration Radiofrequency fields cause heating

31 Retention Prevention At least for Guidewires: Prevention! Proceduralist competency and expertise Training and experience! CLABSI protocol has last element on checklist: Guidewire is IN THE KIT Mitigation of Harm:! Immediate Post-procedure CXR

32 Infusion Device Pieces 2) Interstitial! Subcutaneous space Insertion and removal techniques lead to retention Post- removal inspection of device is key

33 Why do they occur? Catheter and guide wire fractures that result in UDFs can be caused by these inappropriate techniques: withdrawing a catheter through or over a needle shaping a device to conform to the patient s anatomy when the device wasn t designed to be reshaped

34 Why do they occur? using undue force and torque (rotational force) on insertion or withdrawal improperly manipulating a catheter using devices that are too small or too large using a device for an off-label purpose

35 Essential causes A. Provider errors and mistakes in use of the device! This is the most common finding B. Provider uses the device correctly but there is a problem with the device! 1) Manufacturer defects! 2) Worn and Used equipment! 3) New Unfamiliar Devices Multiple separable parts Non-radiopaque pieces of a multipart device

36 Essential causes A. Provider errors and mistakes in use of the device! This is the most common finding B. Provider uses the device correctly but there is a problem with the device! 1) Manufacturer defects! 2) Worn and Used equipment! 3) New Unfamiliar Devices Multiple separable parts Non-radiopaque pieces of a multipart device

37 Unretrieved Device Fragments Unretrieved Device Fragments (UDFs) Official FDA nomenclature, not bits and pieces Broken parts or pieces of devices and surgical items These are the items where the risk of retrieval > risk of retention mantra is frequently invoked

38 ECRI s Top 10 Emergency Care Research Institute #7 Retained devices and unretrieved fragments Second most common RSI

39 Device Fragments can lead to serious adverse events US FDA notification Jan 2008 Local tissue reaction, infection, thrombosis, perforation, obstruction, emboli Center for Devices and Radiological Health (CDRH) receives ~1000 adverse event reports a year related to UDFs TipsandArticlesonDeviceSafety/ucm htm

40 Disclosure vs. reporting Retained small item or UDF. Clinical decision NOT to remove.?? can cause harm DISCLOSE TO THE PATIENT Discuss about reporting Engage with OR leadership to hone multistakeholder prevention strategies

41 TJC Recommendations Log In Request Guest Access Contact Us Careers JCR Web Store Press Room Forgot password? Log In Help Search Go Accreditation Certification Standards Measurement Topics About Us Daily Update Home > About Us Joint Commission FAQ Page Sentinel Event - Retained foreign object after surgery Sometimes a needle or screw will break leaving a fragment behind. Is this a reviewable sentinel event? What about a retained sponge following vaginal delivery? When, exactly, is after surgery?" Why was this particular point in the process selected as the definition of after surgery?" Sentinel Event - Retained foreign object after surgery Q: Sometimes a needle or screw will break leaving a fragment behind. Is this a reviewable sentinel event? A: In some cases, a broken needle or screw fragment is recognized at the time of surgery and a clinical judgment is made to leave the fragment in the patient. That decision is based on an assessment of the relative risks of leaving it in versus removing it. It would therefore not be considered an unintentionally retained foreign object. back to top Q: What about a retained sponge following vaginal delivery? A: A retained sponge after a vaginal delivery is a reviewable sentinel event. The new language in the definition of reviewable sentinel events is, Unintended retention of a foreign object in a patient after surgery or other procedure. Note that it says other procedure not other invasive procedure. Vaginal delivery in the hospital is not an invasive procedure, but it is a procedure. More to the point, a retained sponge in this circumstance is indicative of the same underlying systemic problems that could cause other retained foreign body situations. back to top Q: When, exactly, is after surgery?" A: After surgery is any time after completion of the skin closure; even if the patient is still in the OR under anesthesia. Wednesday 7:36 CST, May 7, 2014 not an unintentionally retained foreign object so not a sentinel event so no RCA and no reporting required back to top Q: Why was this particular point in the process selected as the definition of after surgery?" A: The decision to define after surgery as the completion of skin closure was based on the premise that a failure to identify and correct an unintended retention of a foreign object prior to that point in the procedure represents a significant system failure, which requires analysis and redesign. It also places the patient at additional risk by virtue of extending the surgical procedure and time under anesthesia. back to top Can't find what you are looking for? Ask your own question? Ask a question about Sentinel Event - Retained foreign object after surgery Contact Us Site Map Copyright-Privacy Policy 2014 The Joint Commission, All Rights Reserved

42 NQF Required Reporting Serious Reportable Events (SRE) 2011 Update Event Unintended retention of a foreign object in a patient after surgery or other invasive procedure Applicable Settings: Hospitals Outpatient/Officebased Surgery Centers Ambulatory Practice Settings/ Office-based Practices Long-term Care/ Skilled Nursing Facilities Additional Specifications Includes medical or surgical items intentionally placed by provider(s) that are unintentionally left in place Excludes: a) objects present prior to surgery or other invasive procedure that are intentionally left in place; b) objects intentionally implanted as part of a planned intervention and; c) objects not present prior to surgery/procedure that are intentionally left in when the risk of removal exceeds the risk of retention (such as microneedles, broken screws) Implementation Guidance This event is intended to capture: Occurrences of unintended retention of objects at any point after the surgery/ procedure ends regardless of setting (post anesthesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be removed after discovery Unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings

43 CDPH rules

44 Recommendations So the NQF does not consider the unretrieved device fragments a SRE so probably not required to report Except in California you must report Voluntarily report to MedSun system Even if there is no requirement to report, should DISCLOSE to the patient and should conduct an RCA To inform the patient have to have info

45 When device breaks Collect all available parts Sequester them do NOT throw them away Consider getting an x-ray of site Obtain information about the item e.g. model #, lot and serial number Save an unbroken item for comparison with damaged goods Complete an incident report Report to MedSun

46 Med Sun The FDA Safety Information and Adverse Event Reporting Program Report on the FDA s MedWatch website! Select Report a Serious Medical Product Problem Online! Select Health Professional or Consumer/Patient on the right side of the page to begin the report

47 Patient Disclosure 1. Advise patients of the existence and nature of the UDF (show them what the item looks like). Include the following information: 1. material composition of the UDF, 2. the measurement/size of the fragment, 3. location, 4. x-rays findings with interpretation, 5. potential for injury e.g. migration, infection, embolization, thrombosis and 6. any procedures or treatments to be avoided or to be obtained

48 Retained Needles Most frequent item associated with miscounts What injury results from a lost suture needle? Do we have to take an xray if a miscount occurs? Discuss needles by SIZE of the needle not by size of the suture

49 Can cause symptoms Retained needle in eye Retained needle after thyroidectomy Retained needle in pelvis, causing pelvic pain,! hysterectomy Needles associated with symptoms were >13mm CT pelvis retained 34mm needle

50 What to do? Develop a rational needle management plan to prevent lost needles and reduce # of xrays Best effort for risk reduction Determine a size cut-off where xrays won t be taken for lost needle Discuss needles by SIZE of needle not by size of the suture

51 Animal model Cadaver pig model insertion of 39 surgical needles from 4-77mm Random selection of 9 segments in abdomen 8 plain radiographs 5 independent radiologists reviewed films Reviewers knew they were looking for surgical needles Ponrartana S. et.al. Annal of Surg 247:8, 2008

52 Results Total of 195 needles for each reviewer 69% overall sensitivity 135/195 detected 80% specificity - 32 false positives Needle size significant predictor of sensitivity (p<0.0001)! 4-10mm 29%! 11-24mm 84%! >25mm 99% Detection sensitivity under 50% for needles <10mm

53 Small Needle Detection Even if they can be seen, would they be removed?

54 Phantom X-ray model Skull Skull Pelvis Pelvis Dense bone Less dense Dense bone So1 2ssue Needle / torchar type metric, 40mm, 1/2c, taper V V V V 3-0, 2.0 metric, 24mm, 3/8c, reverse cutting V V V V 5-0, 1.0 metric, 8.0mm, 1/4, spatula N V V V 6-0, 0.7 metric, 11mm, 3/8c, reverse cutting V V V V 6-0, 0.7 metric, 8.0mm, 3/8c, reverse cutting N B V V 6-0, 1.0 metric, 6.5mm, 3/8c, spatula N V N V 7-0, 0.5 metric, 6.5mm, 3/8c, spatula B V B V 8-0, 0.4 metric, 7mm, 1/2c, spatula N N N V 9-0, 0.3 metric, 5.5mm, 1/2c, spatula N N N V 9-0, 0.3 metric, 5mm, 3/8c, taper N N N N 9-0, 0.3 metric, 3.8mm, 3/8c, taper N N N N 10-0, 0.2 metric, 16mm, straight spatula N N N V 10-0, 0.2 metric, 13mm, 1/4c, tapercut N N N V 10-0, 0.2 metric, 6.5mm, 3/8c, spatula N N N B 10-0, 0.2 metric, 5.5mm, 1/2c, spatula N N N B 19 gauge trochar plug V V V V 20 gauge trochar plug V V V V 23 gauge trochar plug N B V V Legend: V: Visible B: Barely visible N: Not visible Courtesy of St. Louis University

55 Define Large as >15mm L A R G E L A R G E

56 What to do? Develop a rational needle management plan to prevent lost needles Best effort for risk reduction All needles come back to scrub person on a needle holder to the safety zone Needles are put in needle container Keep numbers low Think and manage needles by SIZE of the needle not size of the suture

57 Needle Management Safety Zone Not any thing on the back table. Rectangular pan, made of plastic. Not metal magnitizes the instruments Sorting strategy Large vs Small

58 Dry Erase Board

59 Large Goes in Foam

60 Keep numbers low

61 A Needle Algorithm Keep numbers of needles on back table low ( <30), use needle counter boxes Separate small from large (>15mm) needles If a MISCOUNT occurs: look for needle then! If large needle (>15mm) get xray! If small needle no xray: unlikely will see needle on xray, unlikely will be able to find it, unlikely to result in injury Document the incorrect needle count and decisions if the needle isn t found Disclose to the patient

62 Close Calls If nothing else, start reporting near miss events Use this as an OR improvement opportunity Review them to change/improve practice

63 What to do? A 9mm needle was unaccounted for at the end of an open heart surgery. Do we have to disclose to the patient? Do we have to report this event to CDPH?

64 Answer This is an incorrect final count for needles and sharps Disclose to the patient, give them an option..?get a CT scan with 4-5mm cuts or not If +, you know where the needle is If -, you know that the needle isn t in the patient No CT?, You do not know with certainty that the needle is NOT in the patient. Report it to CDPH Do NOT charge the patient for the CT it s need is a consequence of error

65 Patient Disclosure Practitioner s obligation to disclose is based on norms of medical ethics, professionalism, public policy and law Ethical tenets of the standards of non-maleficence, beneficence, autonomy and justice apply Respect for autonomy requires avoidance of interfering with an individuals decision-making and presents an obligation of the MD to provide the necessary information for the patient to make a true decision Notions of justice fairness and equity require that patients be informed

66 Perspective Anecdotal observation as disclosure has been more widely enforced we have seen a decrease in the number of risk of retrieval > risk of retention cases.. hmmmmm

67 Apologies to MasterCard

68