Appendix B_HSWLSCTD 2016-008_PERT.pdf

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NON-STANDARD DISTRIBUTION: HSWL SC and components

HSWLSCTD 2016-008

20 December 2016

HEALTH, SAFETY, AND WORK-LIFE SERVICE CENTER TECHNICAL DIRECTIVE 2016-008

Subj: PATIENT EVENT REPORTING TEMPLATE (PERT) FOR COAST GUARD HEALTH CARE

FACILITIES

Ref: (a) Commandant Operating Facility Change Order (OFCO) Number 040-10

(b) VCG memo 5400 of 26 OCT 2012 Organizational Modification Request: Health, Safety, and Work-Life Service Center

(c) DCMS Field Support Concept of Operations 21 Oct 2011

(d) CGTTP 1-01B, Coast Guard Tactics, Techniques, and Procedures 1-01B

(e) Coast Guard Medical Manual, COMDTINST M6000.1(series)

1. PURPOSE. A Technical Directive (TD) is authoritative guidance issued by Health, Safety and Work- Life Service Center (HSWL SC) to maintain control and standardize HSWL systems of service delivery. A TD is used to clarify complex, overlapping, or conflicting organizational relationships and policy that fall under the responsibilities and authorities of HSWL SC.

2. ACTION. All personnel assigned to clinics for which the HSWL SC exercises technical and professional direction shall be familiar with and abide by the content of this directive. This technical directive and enclosure serve as enterprise-wide documents for understanding, completing, and reporting effectively a Patient Event Reporting Template (PERT). Enclosure (1) Patient Event Reporting Template for USCG Health Care Facilities provides step-by-step instructions for completing and reporting a PERT and incorporates the concepts, tenets and objectives of Coast Guard Medical Manual, COMDTINST M6000.1 (series) and current accreditation standards. Internet release authorized.

3. DIRECTIVES AFFECTED. None

4. DISCUSSION. This TD applies to all Coast Guard health care facilities, Coast Guard health care personnel, and all personnel employed by or detailed to the Coast Guard for the purpose of delivering health care. This TD is intended to encourage and standardize reporting of incidences, adverse events and near misses, and to discuss the reporting template and user instructions.

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) 628-4324

5. DISCLAIMER. This guidance is not a substitute for applicable legal requirements, nor is it itself a rule. It is intended to provide operational guidance for Coast Guard personnel and is not intended to nor does it impose legally-binding requirements on any party outside the Coast Guard.

6. IMPACT ASSESSMENT. The PERT provides a non-punitive method of documenting medical and dental incident events, adverse events and near miss events that may have quality assurance/risk management implications involving patients, visitors, or others. Type of event examples include: Adverse Drug Reactions, Delay in Diagnosis, Treatment, Transfer, Equipment/Supply Related, Exposure to Blood/Body Fluids, Facility/Physical Plant Problem, Falls, Laboratory Related, Medication Related, Needle Stick/Sharp Injury, Operative/Invasive Procedure Related, Radiology Related, Pharmacy or Vaccine Related.

7. ENVIRONMENTAL ASPECT AND IMPACT CONSIDERATIONS. Environmental considerations were examined in the development of this TD and have been determined to be non-applicable.

8. DISTRIBUTION. No paper distribution will be made of this TD. An electronic version will be located on the Health, Safety, & Work Life SharePoint site:

https://cgportal2.uscg.mil/units/hswlsc/SitePages/Unit%20Directives.aspx

9. PROCEDURE. This responsibility falls to the appropriate Staff Member, Clinic Administrator, Quality Improvement Coordinator, Regional Practice Manager and Quality Improvement Nurse at

HSWL SC.

(a) Part A is completed by the staff member involved in the event or by a staff member who discovers the event. The PERT is then forwarded to the Clinic Administrator.

(b) Part B is to be completed by the Clinic Administrator or designee within 7 days of the event. Within

14 days of the event, the PERT is forwarded through the appropriate channels to include the Clinic Quality Improvement Coordinator, the Regional Practice Manager, and lastly the Quality Improvement Nurse, HSWL SC Operational Medicine Division.

(c) Quality Improvement Nurse, HSWL SC Operational Medicine Division, will review all PERTs for completion, and assign a control number for tracking and trending purposes.

(d) PERT outcomes are to be reported in the clinics Quality Improvement Focus Group (QIFG) minutes.

(e) The reported data are to be used to monitor, evaluate, and improve functional processes, and human factors to include environment of care, as well as the quality and safety of patient care and services.

10. RECORDS MANAGEMENT CONSIDERATIONS. This TD has been reviewed through the directives clearance process, and it has been determined there are not 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. AUTHORITIES. References (a) through (d) establish the responsibilities and authorities of HSWL SC to provide authoritative guidance. Reference (a) designates HSWL SC as the Military Treatment Facility (MTF) Commander and Intermediate Service Representative for all USCG medical and dental practice locations. Reference (b) states, that HSWL SC retains the authority to provide technical direction over HSWL organizational elements at all types of CG units. Reference (c) establishes that Logistics and Service Centers provide technical and professional guidance and direction. In other words, they oversee the systems https://cgportal2.uscg.mil/units/hswlsc/SitePages/Unit%20Directives.aspx used, services rendered, techniques and practices followed, as well as the utilization and prioritization of resources in the field in the delivery of services/support. Reference (d) establishes the configuration and employment of HSWL systems, processes and resources in and around the CG and describes how health services shall be delivered. Reference (e) establishes Coast Guard Medical Manual policy regarding adverse event reporting.

12. FORMS/REPORTS. See listed enclosure.

13. REQUEST FOR CHANGES. Individuals may recommend changes by writing via the chain of command to: HSWL SC (om); 300 E. Main Street; Suite 1000; Norfolk, Virginia 23510-9109.

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

Encl: (1) Patient Event Reporting Template (PERT) for Coast Guard Health Care Facilities

Enclosure (1) TO HSWLSCTD 2016-008

Patient Event Reporting Template (PERT) For Coast Guard Health Care Facilities

Privacy Act of 1974, 5 USC 552a governs access to this document. Quality Management Document under 10 USC 1102. Copies of this document, enclo-sures 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.

This Quality Assurance Document Is Protected Under the Provisions of 14 U.S.C. SEC 645

Purpose: To provide an effective non-punitive method of documenting incident, adverse, and near miss events that may have quality assurance/risk man-agement 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)) may be required IAW USCG policy.

Routing of Form: This document should be forwarded within 14 total days through appropriate channels to include the Clinic Quality Improvement Coor-dinator, the Regional Practice Manager, and 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 “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, 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, ward, 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 manufactures 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.

1. Patient Information:

Date of Event: Time: Event Discovery Date: Time:

Location of Event: (i. e. Facility Name, Specific Area Event Occurred):

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 instruc-tions)

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

Disposition of equipment/material:

Effect on Patient:

Patient Provider: 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 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 Score: See SAC MATRIX below for determining score, all SAC-3 events must immediately be reported within 24hrs to HSWL SC OPMED Divi-sion. All SAC-3 events will require a corresponding Root Cause Analysis.

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 your QIFG minutes.

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)

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

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

5. Describe what controls 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)

7. NOTE: All PERT outcomes are to be documented in the clinics QIFG minutes.

HSWL SC Use Only:

Date PERT received and logged by HSWL SC: Event Tracking Log Number Assigned:

Harm Scale assigned:

Potential Compensatory Event?

* If the Harm Scale is between1-4, and or the SAC score is a 3, the event needs to be reported to legal for their situational awareness.

Date Follow-Up Requested by HSWL SC:

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 con-siders the severity of an adverse or near miss event together with the probability of the events recurrence. The score, or Safety Assessment Code, assigned to the event determines the type of action that should be taken, e.g., Root Cause Analysis (score 3).

Severity Categories:

Severity is divided into four categories:

1. Catastrophic

2. Major

3. Moderate

4. Minor

The examples in the four categories below apply to events which resulted in harm. For near-misses, where the event did not reach the patient, assign severity based on the potential for harm. However, many cases that reach the patient also have the potential for greater degrees of harm than that experienced and 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.

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

Moderate Minor

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

-No increased length of stay or increased level of care

Probability of Recurrence:

Like the severity categories, the probability 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 actual or near miss, you will get a ranked matrix (3=highest risk, 2- intermediate risk, 1 = lowest risk). These ranks, or Safety Assessment Codes (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 (se-ries), Chapter 13, Quality Improvement. Cases where events reached the patient but did not result in harm 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 close calls 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.