Appendix C_HSWLSCTD 2018-003_PERT TD.pdf

Commanding Officer United States Coast Guard Health, Safety, and Work-Life Service Center

300 E. Main Street Suite 1000 Norfolk, Va. 23510-9109 Staff Symbol: (h) Phone: (757) 628-4787

HSWLSCTD 2018-003

23 February 2018

HEALTH, SAFETY AND WORK-LIFE SERVICE CENTER TECHNICAL DIRECTIVE 2018-003

Subj: PATIENT EVENT REPORTING TEMPLATE (PERT)

Ref: (a) Coast Guard Medical Manual, COMDTINST M6000.1 (series)

1. PURPOSE. This publication provides standardized technical directives (TD) issued by the Health, Safety, and Work-Life Service Center (HSWL SC) that addresses the roles and responsibilities, procedures, and guidelines for reporting of adverse patient events.

2. ACTION. This TD publication applies to all the HSWL SC organizational elements at all types of Coast Guard (CG) units. HSWL SC retains the authority to provide technical direction over all HSWL SC organizational elements. This TD is used to clarify policy that falls under the responsibilities and authorities of the HSWL SC. Internet release is authorized.

3. DIRECTIVES AFFECTED. Quality Improvement Implementation Guide 52 is cancelled.

4. DISCUSSION. Ref (A) requires CG clinics to comply with adverse event monitoring and reporting criteria. This TD serves as standardized guidance for understanding, documenting, and reporting using a PERT. The PERT provides an effective non-punitive method of documenting that may have quality assurance/risk management implications involving patients, visitors, or others. The reported data are used to monitor, evaluate, and improve the quality and safety of patient care and services.

The provisions of this TD are intended to ensure all personnel assigned to CG clinics are familiar with and abide by the content of this directive for reporting adverse events.

5. DISCLAIMER. This guidance is not a substitute for applicable legal guidance, nor is it itself a rule.

It is intended to provide operational guidance for CG personnel and is not intended to nor does it impose legally-binding requirements on any party outside the CG.

6. MAJOR CHANGES. None.

DISTRIBUTION – SDL No. 168

A B C D E F G H

NON-STANDARD DISTRIBUTION:

a b c d e f g h i j k l m n o p q r s t u v w x y z

HSWLSCTD 2018-003

7. ENVIRONMENTAL ASPECT AND IMPACT CONSIDERATIONS.

a. The development of this TD and the general policies contained within it have been thoroughly reviewed by the originating office in conjunction with the Office of Environmental Management, and are categorically excluded (CE) under current USCG CE #33 from further environmental analysis, in accordance with Section 2.B.2 and Figure 2-1 of the National Environmental Policy Act Implementing Procedures and Policy for Considering Environmental Impacts, COMDTINST M16475.1 (series).

b. This TD will not have any of the following: significant cumulative impacts on the human environment; substantial controversy or substantial change to existing environmental conditions;

or inconsistencies with any Federal, State, or local laws or administrative determinations relating to the environment. All future specific actions resulting from the general policies in this TD must be individually evaluated for compliance with the National Environmental Policy Act (NEPA), Council on Environmental Policy NEPA Regulations at 40 CFR Parts 1500-1508, DHS and CG NEPA policy, and compliance with all other environmental mandates.

8. DISTRIBUTION. No paper distribution will be made of this TD. An electronic version will be located on the CGPortal: https://cgportal2.uscg.mil/units/hswlsc/SitePages/Unit%20Directives.aspx.

9. PROCEDURE. See enclosure.

10. RECORDS MANAGEMENT CONSIDERATIONS. This TD has been thoroughly reviewed during the directives clearance process and it has been determined there are no further records scheduling requirements, in accordance with Federal Records Act, 44 U.S.C. 3101 et seq., National Archives and Records Administration (NARA) requirements, and the Information and Life Cycle Management Manual, COMDTINST M5212.12 (series). This policy does not have any significant or substantial changes to existing records management requirements.

11. FORMS/REPORTS. None.

12. REQUEST FOR CHANGES. Recommendations for improvements to this TD are encouraged and should be submitted to HSWL SC (om); 300 East Main Street; Suite 1000; Norfolk, VA 23510- 9109.

E. W. JOHNSON /s/ Captain, U.S. Coast Guard Commanding Officer, Health, Safety, & Work-Life Service Center

Encl: (1) Instructions for Completing a Patient Event Reporting Template (PERT)

Enclosure (1) to HSWLSCTD 2018-003

Instructions for Completing a Patient Event Reporting Template (PERT)

Purpose of PERT: To provide an effective non-punitive method of documenting adverse events and near miss events that may have quality assurance/risk management implications involving patients, visitors, or others. The reported data are used to monitor, evaluate, and improve functional processes, human factors to include environment of care, as well as the quality and safety of patient care and services. Based on the nature of the event, other documentation (e.g., Emergency Care and Treatment Report, SF-558, Chronological Record of Care, SF-600, Root Cause Analysis (RCA), and Potential for Compensatory Event (PCE) reporting) may be required IAW Coast Guard policy.

Routing of Form: This document should be forwarded within 14 total days through appropriate local channels and finally to the HSWL SC Quality Improvement Nurse.

Part A: Completed on the day of the event by the staff member involved in the event or who discovers the event.

a. If response “Not Applicable” or “None,” so state. If “Other” is marked for any response, please explain in the text box provided.

b. Location of event: Be specific in description (e.g., Facility name, and area such as lab, radiology, pharmacy, waiting room, treatment room).

c. Type of Event Examples: Adverse Drug Reaction, Delay in: Diagnosis/Treatment/Transfer, Equipment/Supply Related, Exposure to Blood/Body Fluids, Facility/Physical Plant Problem, Fall, Laboratory Related, Medication Related, Needle Stick/Sharp Injury, Operative/Invasive Procedure Related, Radiology Related, Pharmacy Related, Other (Specify).

d. If medication event, provide name of medication and dose.

e. Enter medication event error code or codes if applicable: type:1=Drug, 2=Staffing, 3=Double check/bagging error, 4=Sound alike/look alike, 5=Calculating/wrong strength, 6=Order entry error (e.g., patient name, drug/strength, directions) 7=Handwriting illegible, 8=Location (e.g., clinic area outside pharmacy, civilian prescription, immunizations) 9=Time of day, 10=Civilian/Military prescriber, 11= Computer system dysfunction.

f. If equipment/material involved, provide type of equipment and as much manufacturer’s information as possible. Provide disposition of defective equipment.

g. Effect on Patient: Provide a description of the effect an event had on the patient (e.g., if medication, state any effects, if a fall, state any injury, etc.).

h. Event Description: Provide the facts, what happened, where it happened, how it happened and what was going on when it happened.

In your description, omit all attempts to assign blame.

Part B: Completed by Clinic Administrator or Designee assigned within 7 days of the event.

a. The Clinic Administrator or designee most familiar with the subject and or area the event occurred in should complete Part B.

b. SAC (Safety Assessment Code) Score: See SAC MATRIX on next page for determining score. All SAC-3 events must immediately be reported within 24 hours to HSWL SC OPMED Division and require a corresponding RCA.

c. Human Factor Conditions: Investigate and include in a statement any environmental conditions, the condition of the individual(s) involved in the event, any personnel factors, organizational influences and supervision issues that may have had an effect on the event.

d. Recommendations for improvement. MUST include for each action item the What, Who, When, and Where for each recommendation.

e. Controls and Education: Describe what controls will be implemented to monitor, review, re-evaluate and what arrangements will be made to share and learn.

f. All known reporters of events should be provided feedback for submitting a PERT.

g. Note: All PERT outcomes are to be documented in the Quality Improvement Focus Group (QIFG) minutes. In addition to the QIFG minutes, medication error tracking activity will be documented in the Pharmacy and Therapeutics (PTC) minutes.

Protection: Medical quality assurance records are protected under the provisions of 14 U.S.C. Section 645, 5 USC 552a, and 10 USC 1102. Copies of this document, enclosures thereto, and information there from will not be further released under penalty of the law.

Unauthorized disclosure carries a statutory penalty of up to $3,000 in the case of a first offense and up to $20,000 in the case of a subsequent offense. In addition to these statutory penalties, unauthorized disclosure may lead to adverse actions under the UCMJ and/or adverse administrative action, including separation from military or civilian service.

Safety Assessment Code (SAC) Matrix

Adapted from Coast Guard Medical Manual, COMDINST M6000.1 (series), Chapter 13, Quality Improvement, the SAC is a risk assessment tool that considers the severity of an adverse event or near miss event together with the probability of the event’s recurrence. The score, or SAC, assigned to the event determines the type of action that should be taken, e.g., Root Cause Analysis for a score of 3.

Severity Categories:

Severity is divided into four categories: Catastrophic – Major – Moderate - Minor

The examples in the four categories below apply to events which resulted in harm. For near-miss events, where the event did not reach the patient, assign severity based on the potential for harm. For adverse events, the potential for a greater degree of harm than that experienced should be considered in determining the final severity.

Catastrophic Major Patients with Actual:

-Death or major permanent loss of function (sensory, motor, physiological, or intellectual) not related to the natural course of the patient’s illness or underlying condition (i.e., acts of commission or omission) -Suicide -Rape -Hemolytic transfusion reaction -Surgery/procedure on the wrong patient or wrong body part -Patient abduction, any age -Unintentionally retained foreign body -Prolonged Fluoroscopy (>1500 rads to single field), or radiotherapy to wrong body region or >25% above the planned radiotherapy dose.

Patients with Actual:

-Permanent lessening of bodily functioning (sensory, motor, physiologic, or intellectual) not related to the natural course of the patient’s illness or underlying conditions (i.e., acts of commission or omission) -Disfigurement -Surgical intervention required -Increased length of stay or level of care of 3 days or more

Moderate Minor Patients with Actual:

-Increased length of stay or higher level of care for less than 3 days

Patients with Actual:

-No increased length of stay or increased level of care

Probability of Recurrence:

Like the severity categories, the probability of recurrence applies to actual adverse events and near misses. In order to assign a probability rating for an adverse event or near miss, it is ideal to know how often it occurs at your facility. Sometimes, the data will be easily available because it is tracked. Sometimes, getting a feel for the probability of events which are not routinely tracked will mean asking for a quick or informal opinion from staff most familiar with those events. Sometimes it will have to be your best educated guess.

High-Likely to occur immediately or within a short period of time Medium-Likely to occur several times in 1 to 2 years Low-May happen, but with an interval of two or more years between occurrences

The SAC Matrix (Severity versus Probability):

Probability of Recurrence Severity Severity Severity Severity Catastrophic Major Moderate Minor

High 3 3 2 1 Medium 3 2 1 1 Low 3 2 1 1

How the SAC Matrix Works:

When you pair a severity category with a probability category for either an adverse event or near miss event, you will get a ranked matrix (3=highest risk, 2= intermediate risk, 1=lowest risk). These ranks, or SACs, can then be used for doing comparative analysis and for deciding who needs to be notified about an event. All SAC-3 scored events must have a corresponding RCA as outlined in Coast Guard Medical Manual, COMDINST M6000.1 (series), Chapter 13, Quality Improvement.

Cases where events reached the patient but did not result in harm and the potential for harm was low? should be scored as SAC-1 no-harm events.

Notes:

1. All known reporters of events, regardless of SAC score, should receive appropriate and timely feedback.

2. Refer all adverse events or near miss events solely related to staff, visitors or equipment/facility damage to relevant facility experts or services on a timely basis, for assessment and resolution of those situations.

Time:

Patient Event Reporting Template for Coast Guard Health Care Facilities

Part A: Completed on the day of the event by the staff member involved in the event or who discovers the event.

1. Event Information:

Date of Event: Time: Event Discovery Date:

Location of Event:

Type of Event:

Did the event reach the patient? Y or N: (Include near Misses) Medical or Dental event:

Was this a medication event? Y or N: If yes, medication name: Dose given:

For medication event error, enter the error code or codes if applicable (1-11): (See (e) medication event error code instructions)

Was equipment/material involved? Y or N if yes, type of equipment:

Disposition of equipment/material:

Effect on Patient:

Provider Contacted? Y or N Date Contacted:

2. Event Description: Facts; what, where, how it happened and what was going on:

Reporter Name (Optional): Reporter E-Mail (Optional):

Part B: Completed by Clinic Administrator or designee assigned.

1. Action Taken:

Name of Clinic Administrator or Designee assigned: Date assigned:

2. Safety Assessment Code (SAC) Matrix Number: (See SAC determination instructions for SAC score, for SAC of 3, STOP go RCA)

3. Human Factor Conditions: Include in a statement factors such as environmental conditions, conditions of the individual(s), personnel factors, organizational influences and Supervision:

4. Recommendation for Improvement/Action Plan: Provide the What, Who, When and Where for each recommendation:

5. Controls: Describe what will be implemented to monitor, review, and re-evaluate periodically:

6. Arrangements for sharing and learning: (All known reporters of events should receive appropriate and timely feedback)