New York State Department of Health - NYPORTS

Appendix C Excerpts from code 912 analysis: (Incorrect Procedure or Treatment: Invasive)
Category of Adverse Outcomes Subtype # Root Causes Risk Reduction Strategies
Wrong site procedures Anesthesia related 7 1. No indication of site for procedure on the consent. 1. Develop specific procedures for what to do in the event the consent is not completed. 1a. Establish a nursing policy that includes the statement that patient will not be released to the O.R. until appropriate physician comes to the nursing unit to complete consent form. 1b. Establish pre-admission policies giving staff more time to obtain a completed consent. i.e. Submit consent 48 hours before the date of surgery.
2. The process in place did not prevent misidentification of the patient. 2. Develop a step when confirming laterality prior to surgery, which gives the name of the patient, as well as the site for surgery, to assist the surgeon in identifying the patient.
3. Time lapse between confirmation of laterality and administrating anesthesia. 3. Institute additional step in the laterality confirmation, which includes verbalization of intent to proceed to the surgical team, immediately prior to doing so. This would provide a final safety net. 3a. The syringe for blocking will no longer be placed on the Mayo stand, but will now be placed on the Pre-op table, and given only after the final verification.
4. Failure to confirm anesthetic was being injected into proper site, before administering the medication. 4. See 3 and 3a.
5. Thinking of one site, but blocking another. 5. See 3 and 3a.
6. Lack of formal procedure for invasive procedure done outside the surgical suite, in two cases. 6. Consent for anesthesia will be obtained by the anesthesiologist prior to performing any anesthetic procedure, or administration of anesthetic drug. 6a. Confirmation of this pre-operative check will be acknowledged on the consent form by the anesthetist’s signature in the area confirming site/side prior to entering the O.R. 6b. Pre-op verification policy should be followed regardless of setting of procedure. 6c. No procedure shall be exempt from the normal process to confirm laterality.
Unnecessary treatment or procedure Unnecessary Surgery 9 1. General process of dictating normal studies. 1. Assure “normal” CT report dictation, includes mention of organs that are absent.
2. Radiological log error. 2. Institute safeguards and mechanisms to improve communication, in addition to consistency in what is written on log information. 2a. Include clarification of test ordered, and rule-out diagnoses on all radiological logs; separating this information in columns.
3. Necessary information was omitted on the treatment plan reviewed prior to procedure. 3. Consolidate records to minimize duplicative recording of the same information 3a. Revise policies and procedures to include at least three independent verifications of site location and patient identification.
4. Failure to collect adequate information. 4. See 3a.
5. Procedure was based on a previous report, not present condition. 5. Stress importance of confirming dates on dated material, addressing
6. Mismatch in pre-op and post-op pathology
7. Incorrect pathological findings.
8. Erroneous lab results
9. Failure to adhere to general practice.
Wrong Surgical device Knee components 3 1. Lack of implant verification policy in all cases. 1. Establish policy for implant verification, which establishes verification process, take place at a time that would allow for correction or replacement if warranted.
2. Lack of established protocol for each staff members’ responsibility in a procedure. 2. Revise policy to include protocol for each staff members’ responsibility in a procedure: i.e. confirmation appropriating equipment and supplies (component parts). 2a. Institute use of a check sheet that confirms surgical components and responsibilities in the process.
3. Poor packaging for implant, in two of the three cases. 3. Contact manufacturer, to increase the size of the font in packaging that delineates laterality, or colors of packaging. 3a. Separate component parts on supply cart, and in storage rooms by laterality not size. 3b. Schedule specific sided procedures on alternate days, or times of day.
4. Incomplete verification of correct surgical component 4. Assure orthopedic implant training modules are intact, and expand to include: selection of implant, verification of size, type, name, and laterality; have vendor workshops with testable objectives. See also 1, 2, and 2a.
5. Lack of policy for dispute resolution. 5. Include a policy that addresses proper procedure in the event of a dispute.
Wrong site procedures Anesthesia related 7 1. No indication of site for procedure on the consent. 1. Develop specific procedures for what to do in the event the consent is not completed. 1a. Establish a nursing policy that includes the statement that patient will not be released to the O.R. until appropriate physician comes to the nursing unit to complete consent form. 1b. Establish pre-admission policies giving staff more time to obtain a completed consent. i.e. Submit consent 48 hours before the date of surgery.
2. The process in place did not prevent misidentification of the patient. 2. Develop a step when confirming laterality prior to surgery, which gives the name of the patient, as well as the site for surgery, to assist the surgeon in identifying the patient.
3. Time lapse between confirmation of laterality and administrating anesthesia. 3. Institute additional step in the laterality confirmation, which includes verbalization of intent to proceed to the surgical team, immediately prior to doing so. This would provide a final safety net. 3a. The syringe for blocking will no longer be placed on the Mayo stand, but will now be placed on the Pre-op table, and given only after the final verification.
4. Failure to confirm anesthetic was being injected into proper site, before administering the medication. 4. See 3 and 3a.
5. Thinking of one site, but blocking another. 5. See 3 and 3a.
6. Lack of formal procedure for invasive procedure done outside the surgical suite, in two cases. 6. Consent for anesthesia will be obtained by the anesthesiologist prior to performing any anesthetic procedure, or administration of anesthetic drug. 6a. Confirmation of this pre-operative check will be acknowledged on the consent form by the anesthetist’s signature in the area confirming site/side prior to entering the O.R. 6b. Pre-op verification policy should be followed regardless of setting of procedure. 6c. No procedure shall be exempt from the normal process to confirm laterality.
Unnecessary treatment or procedure Unnecessary Surgery 9 1. General process of dictating normal studies. 1. Assure “normal” CT report dictation, includes mention of organs that are absent.
2. Radiological log error. 2. Institute safeguards and mechanisms to improve communication, in addition to consistency in what is written on log information. 2a. Include clarification of test ordered, and rule-out diagnoses on all radiological logs; separating this information in columns.
3. Necessary information was omitted on the treatment plan reviewed prior to procedure. 3. Consolidate records to minimize duplicative recording of the same information 3a. Revise policies and procedures to include at least three independent verifications of site location and patient identification.
4. Failure to collect adequate information. 4. See 3a.
5. Procedure was based on a previous report, not present condition. 5. Stress importance of confirming dates on dated material, addressing
6. Mismatch in pre-op and post-op pathology
7. Incorrect pathological findings.
8. Erroneous lab results
9. Failure to adhere to general practice.
Wrong Surgical device Knee components 3 1. Lack of implant verification policy in all cases. 1. Establish policy for implant verification, which establishes verification process, take place at a time that would allow for correction or replacement if warranted.
2. Lack of established protocol for each staff members’ responsibility in a procedure. 2. Revise policy to include protocol for each staff members’ responsibility in a procedure: i.e. confirmation appropriating equipment and supplies (component parts). 2a. Institute use of a check sheet that confirms surgical components and responsibilities in the process.
3. Poor packaging for implant, in two of the three cases. 3. Contact manufacturer, to increase the size of the font in packaging that delineates laterality, or colors of packaging. 3a. Separate component parts on supply cart, and in storage rooms by laterality not size. 3b. Schedule specific sided procedures on alternate days, or times of day.
4. Incomplete verification of correct surgical component 4. Assure orthopedic implant training modules are intact, and expand to include: selection of implant, verification of size, type, name, and laterality; have vendor workshops with testable objectives. See also 1, 2, and 2a.
5. Lack of policy for dispute resolution. 5. Include a policy that addresses proper procedure in the event of a dispute.