New York State Department of Health - NYPORTS
|Summary of Pulmonary Related Cases-Code 915 (Unexpected Death)|
|Category of Adverse Outcome||Subtype||#||Root Causes||Risk Reduction Strategies||Expert Comments Additional root causes risk, reduction strategies, and evidence-based literature support.|
|Thrombo-embolic events (22 cases)||Air embolism||1||1. CVL removed while seated 2. Pt was post surgery and RT to neck; compression difficult||1. Follow protocol which requires pts supine||This is a rare event but underscores the need to have patients supine when removing a CVL.|
|Failure of prophylaxis||5||Not identified||Not identified||Perhaps SCDs alone are inadequate to prevent VTE in cases of pelvic surgery or when there is a pelvic inflammatory process. In some cases, despite what would be fully adequate prophylactic measures, several patients had fatal events.|
|Failure of therapy||1||1. PE developed despite heparin for DVT 2. PTT never therapeutic; overweight patient||1. More timely application of heparin protocol||Most heparin policies don’t adequately deal with the problem of dose adjustment for patients far in excess of ideal body weight. Perhaps that should have been examined for adequacy in this RCA.|
|Failure to diagnose||9||1. Atypical presentation / vague sx 2. Overcrowding / patients left in ER for extended time 3. Not an expected diagnosis – i.e., low risk patient||1. Protocol to determine who is responsible for patients boarding in ER||The symptoms described are vague and the patients were truly low-risk. Most of the events were sudden and catastrophic. The real “Root cause” is that VTE can be elusive and a masquerader. This is really not a systems issue, although analysis of these cases identified things that could be improved in general, they were not relevant to the cases and would not have changed the outcomes.|
|Failure to give prophylaxis||6||Not identified||Not identified||In all cases some sort of prophylaxis was indicated. The hospitals were unanimous in their unwillingness to apply current guidelines in determining the appropriateness of patients for VTE prophylaxis.|
|Aspiration (10 cases)||While feeding||2||1. Family fed patient; not observed||1. Family members may not feed patients w/o supervision||Lack of speech pathology evaluation / assessment for safe feeding / swallowing|
|Undertreated ilieus / obstruction||3||1. Early signs of ilieus not recognized / treated. 2. Lack of communication of findings (obstruction) on XR to clinical staff 3. NGT had been removed in a patient with obstruction and not replaced after diagnosis was made||1. More aggressive management of early signs of ilieus 2. Improve communication between rads and clinical staff 3. Better communication among staff re: need for NGT||Difficult balance between patient comfort (no NGTs) and safety (NGTs help prevent vomiting). However in 2 of these cases there was clearly evidence that NGT was indicated.|
|Post conscious sedation||2||1. Patient had history of problems with CS not known to staff 2. Different staff took history pre-CS (and may have known about potential problems) than did the procedure||1. Change pre-CS worksheet to ask more direct questions re: previous problems with CS 2. Schedule same OR staff for repeat cases|
|Feeding tube related||3||1. NGT inserted in lung; X-ray not reviewed (although it was THOUGHT that this happened) 2. Patient receiving TFs left ward with TFs running; not monitored||1. Review p/p for preliminary radiology reports 2. Hold TFs or send RN with patient when they leave||The cases of the NGT in the lung are grossly negligent. NGT inserted by RN, but no physician saw the Xray even though physicians were there while patients deteriorating. In one case they were assuming radiology would read the film for them; in another case it was “signed out.” If you put in an NGT you must read the film (or find MD to do it for you if an RN).|
|Lab / Tests (3 cases)||Failure to communicate abnormal values||1||1. Wrong physician name on requisition 2. Primary care provider given inaccurate verbal report||Not clearly identified||Primary care MD name must be attached to all inpatients as backup. Positive cultures from a normally sterile body cavity should be a “panic value” and necessitate a telephone call to pt’s MD|
|Incorrectly interpreted tests||1||1. CXR misread as pleural effusion; patient died of CHF||Not clearly identified|
|Tests not ordered||1||1. Platelet count too low for procedure; had been OK 2 weeks prior||1. P/P change requiring tests within one week of procedure|
|Monitoring (17 cases)||Asthma||3||1. Failure to recognize significance of hypercapnia on ABG in an acute asthma exacerbation. 2. Undertreatment of patient with asthma exacerbation / premature discharge by MD despite objection of RN (justified given lack of improvement shown by patient) 3. Failure to obtain ABG in ill patient with asthma exacerbation 4. Failure to give adequate discharge instructions (patient left w/o - ?if secondary to long wait)||1. Education of staff; suspension of treating MD 2. Reinforcement of backup policy and availability of ER director 24/7 to resolve differences 3. Education of staff re: need for earlier ABG and safe intubation technique 4. Not clearly identified – referred to committee||Education of staff important here. The case of undertreatment / premature discharge apparently was an example of the treating MD forcing RN staff to do what they didn’t believe was correct and they either didn’t have adequate backup or didn’t know about it / use it. The patient who left while waiting for discharge instructions is an issue but unlikely related to the outcome (died at home within hours). There is some overlap here with the “oximetry” category in that in 2 cases the treating providers were misled by normal saturations.|
|Disconnect from monitor or equipment||4||1. Patient disconnected from oximeter for transport; expired while in unit awaiting transport. 2. Oxygen ran out during transport; developed respiratory distress leading to death 3. Ventilated patient not adequately assessed when agitated; paralytic given instead – patient had self-extubated and died 4. Patient intubated and ventilated on floor waiting for ICU bed became disconnected and died while not being closely monitored||1. Change in policy that pulse oximeter is not to be disconnected until patient physically leaves the unit 2. Train transport staff in oxygen tank management and the emergency procedures if tank runs out, involve respiratory in all transports with oxygen 3. Education of staff on management of ventilated patients 4. Evaluate transfer process, evaluate ways to make ICU beds more available, education of nurses on ventilator management outside of critical care units||Patient transport from critical care units to testing areas is always a difficult issue. Transporters are not particularly skilled in patient care and the availability of nursing staff / respiratory staff to accompany patients is something that should be examined closely.|
|Intubation / difficult airway||3||1. Patient with difficult airway self-extubated; could not be reintubated (after three previous episodes) 2. Patient with epiglottitis deteriorated suddenly and could not be intubated 3. Patient with difficult airway could not be intubated when needed||1. Earlier consideration of tracheostomy given history of self-extubation; review of policy for securing ET tubes 2. Policy for patients with upper airway obstruction – need immediate eval by anesthesia in controlled environment 3. Focused on interpretation of ABGs and evaluation of respiratory distress rather than management of difficult airway||Hospitals should have policy for management of difficult airway including availability of emergency tracheostomy / cricothyroidotomy capability. Adult epiglottitis is truly an emergency; when the diagnosis is made the airway must be closely monitored much in the way the #2 identifies.|
|Sleep apnea||2||1. Administration of benzodiazepines to patients who have OSA led to worsening of nighttime hypoxemia and death||1. More aggressive screening of hospitalized patients for OSA and caution with use of respiratory depressants in this population||This seemed to be an issue with psychiatry units / detox units where medical assistance / consultation may be less readily available. In both cases the need for benzodiazepines was real.|
|Oximetry||6||1. False reliance on normal pulse oximetry resulting in delayed recognition of severity of illness 2. Patient weaning from ventilator, oximetry alarms not adequate, patient died without alarms sounding 3. Inadequate monitoring of ventilation during anesthesia (i.e., false reassurance by normal oximetry; fatal hypercapnea) 4. Inappropriate response to low saturation in patient with COPD and CO2 retention; oxygen changed from 3L to 100% and patient died of CO2 narcosis 5. Agitated patient becoming hypoxic restrained and not reassessed frequently enough; found dead||1. Education 2. Education on equipment, protocol for monitoring while weaning, how to effectively use alarms on current equipment 3. Education of staff re: oxygen requirements in different populations; changes in hospital oxygen policy especially concerning rapidity of adjustments 4. Education, enforcement of current restraint policy that mandated more frequent assessments of the patient. Some of this may have related to staff shortage||Pulse oximetry only measures oxygenation; patients can be in big trouble with normal saturations. The oximeter does not eliminate the need for ABGs in some instances. Hopefully the ability to measure pCO2 transcutaneously is not far away.|
|Unclassified (7 cases)||Death for unknown reasons||7||The lack of information given in the RCAs here precluded any root causes from being identified.||None identified||There were cases in which further information should have yielded root causes. The information contained in the RCAs was very poor quality and incomplete.|
|Summary of Medication Related Cases Code 915 (Unexpected Death)|
|Category of Adverse Outcome||Subtype||#||Root Causes||Risk Reduction Strategies|
|Anticoagulant and Thrombolytic agents||Excessive Dosage administered||4||
1. The pharmacy computer system has been adjusted to flag anticoagulant medications with the patient’s weight.
2. Pharmacy computer system should have dosage parameters programmed.
3. Guidelines for the use and proper dosing of anticoagulants post catheterization to be developed.
4. Fragmin removed from OR pharmacy to prevent use.
5. Formal referral required for any patient prescribed Lepirudin. This will be indicated in the pharmacy computer.
6. Education program instituted.
7. Coumadin policy being revised to include more frequent assessment of PT/INR.
8. INR reference chart posted.
|1. Dissemination of information on dosage adjustments for Lovenox (enoxaparin) to staff through pharmacy newsletter or formal education process.
2. High caution must be practiced to any therapeutic substitutions of anticoagulants such as the substitution of Fragmin (dalteparin) for Lovenox (enoxaparin).
3. Pharmacy system should be programmed to flag renal function when Lepirudin is ordered.
4. Revise policy addressing notification of panic values from laboratory.
5. Establish guidelines for anticoagulation induction including daily values for INR/PT. Standard of Care: No. Preventable errors
|Concurrent use of anticoagulants||2||1. Patient received Heparin and Lovenox concurrently for 2 days while also on Coumadin. Heparin solution borrowed to initiate infusion thus missing pharmacy review. Physicians not queried by nursing staff on triple anticoagulant therapy. Excessive loading dose of Coumadin given. Elevated INR of 6+ not communicated
2. Orders not sent to pharmacy due to this being a ED admission. Education to staff on concomitant use of anticoagulants not distributed.
|1. All heparin premixed bags removed from floor.
2. New policy addressing notification of panic values instituted.
3. Nursing staff education
4. INR reference chart posted.
5. Education on the concomitant use of anticoagulants.
6. Correction of the faxing of orders process to the pharmacy from the ED for patients admitted.
|1. Protocols, guidelines, and standard order forms should prominently remind practitioners to assess all drug therapy (including ED) and avoid concomitant use of heparin products.
2. Establish an escalation P&P to guide staff when faced with improper or unsafe drug use.
3. Be sure that computer alerts for duplicate therapy have not been suppressed.
4. Educate nursing on risks inherent in borrowing high alert medications from other patient’s supplies.
5. Education of staff of the concomitant use of anticoagulants should include the dissemination of the Institute for Safe Medication Practices (ISMP) alert (2/21/2001). Standard of Care: No. Preventable errors
|Drug Interaction||1||Drug Interaction||1. Coumadin policy being revised to include more frequent assessment of PT/INR.||1. Patients should be advised to fill prescriptions at one pharmacy to address drug interaction issues. Standard of Care: No. Preventable error|
|Inappropriate use of thrombolytic||1||1. Activase (tPA) administered with elevated INR One patient presented to ED with left-sided weakness and atrial fibrillation. Patient was on coumadin. Patient had protime of 17.2 seconds and INR of 2.13. TPA administered with knowledge of levels. Patient also placed on Lovenox. Intracerebral hemorrhage within 48 hours. Staff questioned use of these agents but did not escalate situation.||1. Guidelines developed for use of TPA.||1. Establish an escalation P&P to guide staff when faced with improper or unsafe drug use.
2. Communication of drug therapy administered in the emergency department must be accomplished and indicated as part of patient’s therapy.
3. Be sure that computer alerts for drug interactions have not been suppressed.
4. Use protocols, guidelines and standard order forms to assure that current and recent drug therapy is considered before ordering, dispensing, and administering thrombolytic products. Standard of Care: No. Preventable error
|Sedative/Hypnotics||Illegible Handwriting||2||1. Librium 100mg given versus 5 mg intended 2. Librium 25 mg given X 7 instead of Lopressor 25mg||1. Pharmacy computer interface for Pyxis system. 2. Pharmacy follow-up with physician on illegible handwriting.||1. Follow the 5 “R”s of medication administration: Right patient, right drug, right dose, right route, right time. 2. Formal policy on illegible handwriting should be implemented. Standard of Care: No. Preventable errors|
|Cardiac Medications||Excessive Dosage-Incorrect medication administered||4||1. Excessive dosage of two cardiac medications (Lisinopril and Carvedilol) administered to an acutely ill dehydrated elderly patient. Lisinopril given at an excessive starting dosage for condition of patient. Carvedilol dosage escalation in excess of manufacturers guidelines. Carvedilol prescribed BID. Patient received 2 doses of Carvedilol in less than 10 hrs. 2. Patient on Cardizem IV drip and Timentin. Pump intended to be adjusted to infuse Timentin. Instead 50mg of diltiazem infused in 30 minutes due to programming error. Pump alert indicating empty bag of Cardizem. Nurse hung new bag. Family of patient alerted nurse. Patient family alerted staff patient was dead 15 minutes later. 3. Patient on Cardizem IV drip and antibiotic. Pump intended to be adjusted to infuse Timentin. Instead 60 -100mg of diltiazem infused. Pump alerted to empty bag. Patient assessed, asystole in 15-30 min. Triple channel pump used on unauthorized floor. Staff not educated on use. 4. Patient received Catapres 0.1mg that was not o||1. Pharmacy system to create a flag for Carvedilol orders. 2. Revise medication administration policy to reflect 10 hrs. between bid dosing. 3. Encourage use of specific pathways with dosing guidelines. 4. Triple channel pump will only be used in ED/CCU/ICU. 5. High-risk medication list to be created. They will be labeled as such on IV bags near where it enters the pump. 6. Exploring other multichannel pump manufacturers. 7. Implement medication pass procedure including flow chart that addresses process to ensure meds are secured in an emergent situation. 8. Plastic see through cups should be used instead of soufflé cup utilized during this med error. 9. Use technology- Pyxis system to assist nursing and pharmacy in reducing errors||1. Follow the 5 “R”s of medication administration: Right patient, right drug, right dose, right route, right time. 2. Standardize and control drug reference standards. 3. Establish an escalation P&P to guide staff when faced with improper or unsafe drug use. 4. Develop high risk medication list and label IVs as such. 5. Label lines or color code to distinguish medications. 6. Use technology such as Pyxis system to assist nursing and pharmacy in reducing errors. Standard of Care: No. Preventable errors|
|General Anesthetics||Questionable use of medication||1||1. Use if Diprivan in an non-intubated patient for central line placement. Nursing staff and pharmacy questioned usage. Resident performing procedure did not have adequate training with central lines.||1. Sedation-analgesia and escalation policies have been revised to prohibit use of Diprivan in non-intubated patients. Education programs implemented.||1. Establish an escalation P&P to guide staff when faced with improper or unsafe drug use. Standard of Care: No. Preventable error|
|Liposomal Medication||Incorrect drug/dosage administered||1||1. Amphotericin B administered instead of Amphotericin B Liposomal. Resident ordered incorrect dose of Amphotericn B. Drug was obtained after hours of pharmacy operation with lack of familiarity of the medication. Two nurses did not notice the alert sign and warning sign that dosage is based on body weight.||1. The nursing administrator must consult with on-call pharmacist 2. Revision of existing P&P on medication administration with education programs and newsletters. 3. Utilize pharmacy warning stickers to alert professionals to look alike/sound alike drugs.||1. Do not store the two Amphotericin B products side by side. 2. Utilize pharmacy warning stickers to alert professionals to look alike/sound alike drugs. 3. Encourage prescribing of liposomal products using brand name. 4. “If you need more than three call the pharmacy” guideline should be an integral part of a hospital’s culture. 5. In order to preserve a redundant check system, these products are best restricted to dispensing by a pharmacist after required preparation and labeling. Storage in patient care areas or automated dispensing equipment is discouraged. 6. Lipid-based products may be seen as “milky” rather than as a clear solution. Verify that the correct medication is Being used if staff, patients or family members notice a change in the solution’s appearance from previous infusions. 7. Disseminate ISMP warning alerts such as 8/18/98 issue concerning lipid-based products. Medication errors have also resulted from confusion between liposomal doxorubicin (Doxil) and the conventional form of doxorubi|
|Electrolytes||Supplementation without monitoring||4||1. Elderly patient with hypokalemia receiving KCL supplementation for 5 days without monitoring. Verbal orders given for renewal of orders. Patient not seen by physician during 5 days. Peak K+ level of 8.9 reached. 2. Elderly patient with hypokalemia receiving KCL supplementation without daily monitoring. No K+ values for 3 days. Patient experienced renal failure. Peak K+ reached 6.6 3. Elderly patient received KCL supplementation before level known. Patient had a K+ of 5.7 before supplementation. K+ level reached 7.9 4. Elderly patient given K+ Supplementation when level in normal range. Standard of care post op CABG required K+ supplementation for level below 4.0. Verbal order confirmed administration. K+ level reached 7.5||1. Existing policy in effect requiring acute care patients be seen daily to be enforced. 2. Institute clear guidelines for the adequate coverage in a provider’s absence. 3. Identified lapses in patient coverage will be reported to VP of Medical affairs. 4. Medical director for physician group to review policy for physician coverage 5. Establish guidelines for potassium supplementation including daily values for K+ to be ordered especially for patients with reduced renal function. 6. Review lab policy on reporting panic values (present panic value is 6.5) 7. Guidelines for ordering and administering potassium in the CTICU being reviewed. 8. Removal of concentrated solution from floor.||1. Increase communication between Lab and pharmacy. with development of a safety net mechanism. 2. Concentrated KCL should be removed from nursing units. Standard of Care: No. Preventable errors|
|Communication failure||1||1. One patient received KCL supplementation after the wrong K+ value was reported. Value reported (2.7) was for a patient with a similar name.||1. Policy of communication to unit to be changed. Complete patient identification to be supplied including full name, unit, room etc. 2. Critical lab values policy to be revised. 3. Floor unit will coordinate phone results with computer printout before taking treatment action.||1. Increase communication between lab and pharmacy with the implementation of a safety net mechanism. Standard of Care: No. Preventable error|
|Excessive dosage administered||1||1. K+ administered in a 10X overdose Infant given excessive dosage due to decimal point error. NP did not place decimal point correctly. Calculation error not identified in pharmacy or by nursing. Policy for preparation of KCL not followed. Pharmacy assistant working beyond scope of practice when IV prepared. Pharmacy short staffing.||1. Pharmacy system programmed for maximum single doses by weight for several medications. 2. New pharmacy system to be installed and will interact with the electronic patient record and will have CPOE 3. Pediatric order sheet developed 4. KCL policies throughout institution consolidated and reconciled. 5. Pharmacy assistant policies to be enforced. 6. Additional pharmacy staff to be hired. 7. New policy requires all high alert weight based IVPBs to be doubled checked when ordered and again when administered.||1. Establish an escalation P&P to guide staff when faced with improper or unsafe drug use. 2. Consider using color identification for pediatric order sheet. 3. Require all orders for high alert medications be doubled checked when ordered, dispensed, and administered. 4. Consider implementation of computerized physician order entry (CPOE). Standard of Care: No. Preventable error|
|Drug Interaction||1||1. K+ increased due to use of ACE inhibitor K+ level elevated 5.9 not treated. Patient discharged on Vasotec 5mg. Patient complaint of N&V just prior to discharge. Patient transported next day to ED from rehab with K+ of 7.6||1. Critical lab values policy to be revised. Review lab policy on reporting panic values. 2. Increase communication between Lab and pharmacy. with development of a safety net mechanism. 3. Establish guidelines for potassium supplementation including daily values for K+ to be ordered especially for patients with reduced renal function.||1. Pharmacy computer alerts should be active and attention should be paid to all alerts. 2. Ambulatory patients should be advised to fill prescriptions at one pharmacy to address drug interaction issues. Standard of Care: No. Preventable error|
|Narcotics||Excessive dosage administered||5||1. Morphine drip ordered at 2mg/hr. Patient received 86mg in one hour. Lock out function of pump not activated. Archived memory indicted Settings were changed 4 times in a two minute period. Patient was a cancer patient in severe pain with possible suicidal tendencies 2. Morphine ordered at 10mg/100cc @ 10cc/hr. Patient received 250mg/100cc @10cc/hr. Patient expired 3 hours later. Availability of multidose narcotic vial. Potential language/communication barrier. Nursing shift to shift report inadequate. Faxed orders to pharmacy not verified. 3. Demerol 100mg/Vistaril 25mg ordered for a 75 y.o. given q2h vs. q4h. Patient medicated at 0600 and 0805. Found expired at 0915.Failure to follow P&P. Change of shift report did not include info on last dose. Medication orders not clearly written. Format on MAR had minimal spacing for meds given more than 4X per day. 4. Excessive dosage of Fentanyl utilized due to history of sleep apnea. 49 y.o. suffered hypoxia and cardiac arrest during surgery. 5. IVDA on methadone||1. Lock out function to be used on all pumps using controlled substances. 2. Process improvement related to identification of suicide risk. 3. Double check of settings on pumps utilized in oncology. 4. Removal of high potency multidose narcotic vials from patient floors. 5. Standardize dilutions of narcotic infusions. 6. MAR revised. 7. Pharmacy follow-up with physician on illegible handwriting. 8. Revision of existing P&P on medication administration with education programs and newsletters. 9. Encourage use of specific pathways with dosing guidelines.||1. Consider limiting preparation of narcotic infusions to the pharmacy department 2. Develop formal policy for pharmacy follow-up with all prescriber illegible handwriting. This policy should include escalation provision. 3. Encourage specific pathways with dosing guidelines. 4. Consider performing baseline blood level of Methadone upon admission. Standard of Care: No. Preventable errors|
|Antibiotics||Error of omission||1||1. 79yo with aspiration pneumonia prescribed Unasyn stat and Q6hrs. Doses not given for 24 hours. Pneumonia protocol not followed. Nurse to nurse report or communication between ED and floor not accomplished.||1. Enforcement of pneumonia protocol. 2. Increase Communication between units.||Standard of Care: No. Preventable error|
|Chemotherapy||Incorrect dosage administered.||2||1. Methotrexate (MTX) ordered weekly and given daily for 9 days. Order incorrectly entered in progress note by attending physician. Methotrexate was not a restricted order drug when used daily. Patient also on prednisone for several days. Patient seen by several physicians including a pulmonologist during error period. Patient experienced respiratory failure on 9th day, intubated and transferred to ICU. Patient expired 3 days later with pancytopenia related to methotrexate toxicity. Methotrexate was not a restricted order drug when used daily. 2. Patient received Procarbazine earlier than delineated in protocol. In addition, patient did not receive adequate rescue for high dose methotrexate (MTX) administration. Inadequate documentation in patient’s treatment protocol. Blood levels not drawn; test canceled by lab tech without proper notification. Patient was transferred between rehab unit and oncology and treatment protocols not sent with patient. Oncologist did not seek out MTX levels prior to continuing administration of chemotherapy.||1. Policy to state that Methotrexate can only be ordered by hematology or oncology on a daily regimen. 2. Pharmacy computer system will flag methotrexate daily dosing.||1. Make sure to configure pharmacy systems to avoid defaulting to a daily dosing schedule. 2. Have a pharmacist conduct a prospective drug utilization review before dispensing oral methotrexate to determine its indication for use, verify proper dosing, confirm the correct dosing schedule on medication administration records and prescription labels, ensure staff and patient education, and promote appropriate monitoring of the patient. 3. Use preventive measures when dispensing methotrexate on an ambulatory basis. Perform mandatory counseling, including advising patients to contact their physician if they miss taking a dose. 4. Consider implementing automatic stop orders on methotrexate. Standard of Care: No. Preventable errors|