Board Approved: 01/05/ /08/ /01/15 01/16/15 Responsible Party: Director of Compliance/QA

Transcription

1 POLICY & PROCEDURE TITLE: Variance Reporting Scope/Purpose: The purpose of Variance Reporting is provide a systematic method for reporting adverse events in order to improve systems and processes in an effort to promote a safe environment for all patients. Division/Department: All HealthPoint Policy/Procedure #: Original Date: 08/22/2013 New _X Replacement for: Same Date Reviewed: Date Revised: Implementation: CPIC Approved: Board Approved: 01/05/ /08/ /01/15 01/16/15 Responsible Party: Director of Compliance/QA DEFINITIONS: Adverse event or incident Near miss an undesired outcome or variance, not expected within the normal course of care or treatment, disease process, condition of the patient, or delivery of services. an event or situation that could have resulted in an accident, injury, or illness but did not, either by chance or through timely intervention (e.g., a procedure almost performed on the wrong patient due to lapse in verification of patient identification but caught at the last minute by chance). POLICY: HealthPoint endorses and supports a culture of safety and views adverse-event reporting as a means of improving systems and processes in providing healthcare services to all patients. In a continuing effort to promote a safe environment for patients, HealthPoint will conduct a systematic program of adverse-event reporting. Reporting is non-punitive, and all providers, employees, and volunteers are encouraged to report all patient and visitor events. HealthPoint encourages open and honest reporting of actual or potential injuries or hazards to patients, visitors, and employees at all sites and services and at all levels of care throughout the organization. HealthPoint aims to limit disciplinary action to only those individuals that engage in willful or malicious misconduct or exhibit continued noncompliance in following established policies and procedures relating to patient care and/or safety or continued failure to follow recommendations to improve skills. : 1 / 12

2 HealthPoint strives to facilitate education and problem resolution through forthright disclosure of process failure and/or human error. Providers, employees, and volunteers are not subject to disciplinary action EXCEPT as follows: a. The event is not reported as soon as possible after discovering that the event has occurred and in accordance with event-reporting procedures. b. Providers, employees, or volunteers are directly involved in sabotage; malicious behavior; patient mistreatment, abuse, or neglect; chemical impairment; or criminal activity. c. False information is provided on the event report or in the follow-up investigation. d. A provider, employee, or volunteer fails to respond to educational efforts and/or to participate in the education process or other preventive plan. Providers, employees, or volunteers who meet any of the exceptions listed above will be subject to disciplinary action. Variance reporting is an essential component of the risk management program and is considered part of the performance and quality improvement process. All event reports shall be privileged and confidential to the extent provided by state and federal law. Confidentiality protections can include attorney client privilege, attorney work product, and peer review protections. Variance reports may not be copied or otherwise disseminated. The circumstances surrounding an event, all information contained in the Variance Report, and any follow-up reports are confidential, HealthPoint fully supports that patients and family members or designated representatives be fully informed of errors that reach patients under one or both of the following circumstances: a. When some unintended act or substance reaches the patient and results in harm b. When there is potential clinical significance of the event to the patient In addition, consideration should be given to disclosing errors that reach patients and do not result in harm. The decision to disclose these errors will depend on the circumstances of the event and the patient. Responsibility for disclosing the error usually rests with the provider who has overall responsibility for the patient s care; however, the Chief Medical Officer and Chief Operations Officer should be consulted regarding approaches for appropriate communication of the variance of adverse events or errors to patients Examples of situations to be reported include, but are not limited to, the following: 1. Any happening that could have caused or did cause injury to a patient (e.g., a medication error or adverse reaction, fall, delay in delivery of needed care, unexpected death) : 2 / 12

3 2. Any condition or situation that could or did result in an injury to a patient (e.g., misfiling diagnostic test results, failure to follow up on abnormal test results, scheduling problem, equipment malfunction) 3. Failure to comply with established policy or protocol, with or without patient, provider, employee, or visitor injury 4. Any injury, potential injury, or unusual variance involving a patient, visitor, or employee on the facility grounds (e.g., due to a fall, falling object) 5. Any suggestion or threat of lawsuits, contacting legal counsel, or claims for restitution 6. Anything unusual or not in compliance with everyday activities 7. Unauthorized release of protected health information, intentional or inadvertent 8. Equipment failures resulting in, or could have resulted in, harm to patient, harm to user, abnormal results, loss of medicines or supplies, or other unexpected results PROCEDURE: A Variance Report should be completed by any individual who has first-hand information regarding a reportable variance. Variance reports will be submitted immediately to the manager of the department in which the variance happened for review and completion of documentation. Please note that all variance reports are private and confidential reports of the Compliance and Quality Improvement Committee and the Professional Review Committee. Each provider, employee, or volunteer shall be responsible to report all adverse events, incidents, and near misses at the time they are discovered to his or her immediate supervisor and/or Director of QA/Compliance. Immediate evaluation and stabilization of the patient or other individual involved in the event should be carried out. After any needed intervention has been provided to the patient or other involved individual, the HealthPoint Variance Report should be completed. Persons knowledgeable about the event should complete the Variance Report objectively, accurately, and without conclusions, criticisms, or placement of blame. The manager of the department where the variance happened will forward the Variance Report and the investigative form in a sealed envelope to the Director of QA/Compliance for review. The Director of QA/Compliance will determine if further documentation is needed and report to the Compliance and Performance Improvement Committee (CPIC). All Variance Reports will be forwarded as soon as possible, preferably within 24 business hours, to the Director of QA/Compliance for review and further investigation. Serious injuries and deaths resulting from an adverse event should also be reported immediately by telephone to the Director of QA/Compliance, Chief Clinical Operations Officer, and Chief : 3 / 12

4 Medical Officer. Per HealthPoint policy, the Executive Director and medical director should be notified within 24 hours of any events: a. requiring hospitalization; b. contributed to or resulted in permanent injury or harm; c. resulted in near-death circumstances or required intervention necessary to sustain life; d. or, contributed to or resulted in patient or visitor death. On receipt of a Variance Report the Director of QA/Compliance logs each variance into a tracking log. Variance reports and investigative forms are reviewed by the Director of QA/Compliance. If further information is needed the Director of Compliance/QA will contact the Manager for further information related to the variance. A report is made to the Compliance and Performance Improvement Committee (CPIC) at least quarterly. The information provided on the variance report will be used for trend analysis, loss control purposes and risk management. The CPIC may refer areas of concern to the individual Administrators or Managers to promote problem-solving/investigation, initiate changes that lead to improvements in the clinic systems and to document this process and the outcomes. NOTE: No copies of the Variance Report should be made. The original variance reports are maintained in the Quality Management Department. EXCEPTIONS: 1) In the event of an Occupational Accident claim involving an employee a copy of the original Variance Report can be forwarded to the Administrator handling the Occupational Accident. A copy of the request for the Variance Report from the Administrator involved with the Occupational Accident claim will be maintained with the Variance Report to document that the information was released and is no longer covered as Private and Confidential. 2) In the case of theft, property, or vehicle damges a copy of the original Variance Report is sent to the CFO of BVCAA. The Administrator or Director of QA/Compliance will notify external regulatory or accrediting agencies of the event as required in accordance with state and federal statutes and regulations or accreditation standards. Examples of external reporting requirements may include reporting to the U.S. Food and Drug Administration under the Safe Medical Devices Act or to state agencies. Designated BVCAA or HealthPoint administrator will notify insurers (e.g., liability, property, Workers Compensation) in accordance with established notification procedures. Director of QA/Compliance will preserve, secure, and inspect before putting back into service all equipment (e.g., blood glucose monitors, steam sterilizers), assistive or transport devices (e.g., wheelchairs), accessories (e.g., electrocardiography electrodes), packaging, or any other items that may have been involved in the event. : 4 / 12

5 ROOT-CAUSE ANALYSIS: Root-cause analysis is a process for identifying the basic or causal factor(s) that underlie the variance or possible variance of an adverse event or error. A root-cause analysis should be conducted for the following events or errors or near misses: a. An event occurred that may have contributed to or resulted in temporary harm, required treatment and/or intervention, or required increased observation or monitoring with changes in vital signs, mental status, or laboratory values. Examples: A patient fall results in a scalp laceration that requires suturing; the patient is also sent for a CT of the head to rule out further injury. An incorrect dose of a medication causes ototoxicity or nephrotoxicity b. An event occurred that may have contributed to or resulted in temporary harm to a patient or visitor and required initial or prolonged hospitalization. Examples: During the flushing of a patient s ear canal, the tympanic membrane is damaged, requiring a visit to the emergency department and subsequent treatment. Group B streptococcus status of mother is not documented, and infant does not receive appropriate treatment. c. An event occurred that may have contributed to or resulted in permanent injury or harm to a patient or visitor. Examples: Patient is given an injection with a contaminated needle and acquires hepatitis C. Falls or other events result in bone fractures (e.g., broken hip, jaw, arm). Patient sustains a fourth degree laceration during vaginal delivery. : 5 / 12

6 d. An event occurred that resulted in near-death circumstances or required intervention necessary to sustain life. Examples: Patient has an anaphylactic reaction to medication requiring treatment and transfer to a hospital. e. An event occurred that contributed to or resulted in patient or visitor death. Examples: Patient s prescribed medication dose results in an overdose and the patient's death. Patient sustains a hip fracture or closed head injury as a result of a fall and later dies in surgery. Neonatal resuscitation attempts are ineffective, and the infant is declared dead. The information and learning from the root-cause analysis should be used to facilitate systems improvements to reduce the probability of variance of future related events. INVESTIGATIONS: The Director of QA/Compliance, in conjunction with the Clinic/Practice Manager (as applicable), is responsible for conducting follow-up investigations. The manager's investigation is a form of self-critical analysis to determine the cause of the incident, analyze the process, and make improvements. The individual conducting the investigation will complete an event follow-up investigation form. All event follow-up reports will be completed within seven working days from the date of the initial event report. Depending upon the type of event, the investigation and report addresses patient- or visitorspecific factors (e.g., physical harm, immediate and ongoing treatment required), external factors (e.g., lighting, flooring, clutter, distractions), witnesses statements, staffing, communication flow, construction or design factors, human or ergonomic factors, signage, equipment factors, and any other factors or conditions believed to be relevant to the cause of the event. An investigation will be conducted, at minimum, for any of the following: 1. Any incident or adverse event that may have contributed to or caused temporary or permanent patient or visitor harm, initial or prolonged hospitalization, or death. 2. Any serious patient or family written or verbal complaint or verbalization that a lawsuit will be brought against the provider or the facility. 3. Any significant adverse drug reaction or significant medication error. A significant medication error is defined as unintended, undesirable, and unexpected effects of a prescribed medication or medication error that requires discontinuing a medication or modifying the dose, initial or prolonged hospitalization, or treatment with a prescription medication; results in disability, cognitive deterioration or impairment, congenital anomalies, or death; or is life-threatening. 4. Any unplanned instance of a patient being hospitalized, or transferred to the emergency department or other higher level of care, directly from the health center or clinic. : 6 / 12

7 5. Any incident involving police contact or reporting to external agencies or accreditors. 6. Any near miss with the potential to have been an event with harm. DOCUMENTATION: A Variance Report should meet the following criteria: Report should be able to stand alone on the information being reported. Report should contain pertinent negatives (i.e., if patient falls the report should have an assessment of the surrounding area. Floors dry, no obstacles, etc.). A root cause analysis (RCA) should be performed. Contain recommendations Information should be disseminated to all clinic staff (if applicable) A Variance Report should contain the following information: Date and time of the report Date and time of the event Location of the event Identification of people affected (e.g., patient, visitor, employee) Names of people witnessing the event Name of the physician to whom the event was reported (if applicable) and the physician s response (e.g., orders given) Brief, factual description of the event Key observations of the event scene (e.g., if event was a fall, was there water on the floor or ice on the sidewalk?) Manufacturer, model, and lot (or batch) number of any medical device involved Condition of the people affected (including any complaints of injury, observed injuries, and a brief comment on any follow-up care) Documentation in the patient's chart or medical record shall include: Date and time of the event A factual account of what happened Name of provider notified and time of notification (if applicable). Patient s condition after the event Any treatment or diagnostic tests rendered to the patient Documentation should not reflect that a Variance report was completed. The report should not be filed in the patient s medical record HOW TO COMPLETE A VARIANCE FORM 1. Check the type of variance you are reporting. If you do not feel it falls into one of the categories listed check Other, please specify and document what happened. : 7 / 12

8 a. Injury bodily injury b. Medication error incorrect medication given to a patient c. Theft d. Body Fluid Exposure for both BVCAA employees and non BVCAA employees e. Damage property damage f. Collision vehicle damage g. Staff Complaint h. Client Complaint i. Other provide detail 2. List the clinic site involved. a. ABC Women s and Children clinic b. Bryan/College Station Clinic c. Caldwell d. Centerville e. Hearne f. Hearne Dental g. Hempstead h. Madisonville i. Mary Lake Dental j. Navasota k. Memorial l. Somerville m. Other site 3. Collect data about the person involved in the incident a. Name the person involved in the incident (Do not forget to check whether they are an employee below the name line.) b. Birth date of the person involved c. SSN Social Security Number of the person involved d. Address, City, ST and Zip Code - complete address of the person involved e. Phone home number of the person involved f. Cell Phone mobile number g. contact of the person involved h. Worker s Comp provider name and address of worker s comp provider 4. Variance Date the date the variance happened. 5. Time the time the variance occurred. 6. Location the physical location in the clinic site where the variance occurred. 7. Details of Variance this is a comprehensive narrative description of what happened including a description of the actions of all parties involved in the event. It is a factual account with no opinions or impressions from the writer of the document. Pertinent : 8 / 12

9 negatives should be included. The following specific details should be included pending the type of variance a /EMS call for chest pain- Chest pain protocol should be followed. i. Pulse oximetry on room air (RA) ii. Vital signs iii. Time EMS called iv. Time EMS arrived v. Use of O2 vi. Use of Aspirin (ASA), Nitroglycerin (NTG) and other meds vii. Patient description with pain scale. Example: Patient presents with shortness of breath, diaphoretic, c/o mid sternal chest pain. Patient states pain is 8 on a scale of viii. EKG done with results b. Patient/visitor fall i. What caused the fall? ii. What was the scene around the area of fall (i.e. equipment in way, wet floors, surface was unstable, patient s mental activity, did they use any device to help them ambulate). iii. iv. Assess patient for possible injuries, do neuro check and assess vital signs. If injury is suspected call 911 (i.e. broken bone, neck injury) don t attempt to move the patient until EMS arrives. c. Break in i. Take pictures ii. Video surveillance available? iii. Footprints around scene? iv. Damage? v. What was taken? vi. If appropriate, police notified? 8. Police notified if the police department was notified check yes, and obtain the following information from the responding officer or officers. a. Case number b. Responding Officer s name c. Responding Officer s badge number d. Responding Officer s contact phone number If the police department was not notified check no. 9. Name of physician seen If it is deemed necessary or the person involved in the incident requests to be seen by a physician, this is the name of the physician who examined the person(s) involved in the variance. 10. Hospital seen at this is the name of the healthcare facility where the person(s) involved in the variance was evaluated. : 9 / 12

10 11. Witnesses/Participants, Address and Phone Number this information is provided by anyone who saw the variance, heard the variance or was involved in the variance. A statement from each witness to the event should be obtained. 12. Supervisor Notification a. Supervisor Notified (Name) this is the name of the supervisor of the employee who was involved in the variance/reporting the variance. b. Date this is the date that the supervisor was informed of the variance. c. Time this is the time that the supervisor was informed of the variance. 13. Informant Information a. Informant name the name of the person reporting the incident or who informed the supervisor of the variance. b. Signature the signature of the person reporting the incident or who informed the supervisor of the variance. c. Date the date the informant signed this form. d. Time the time the informant signed this form. 14. Administrative Intervention a. CPIC Coordinator signature the CPIC Coordinator documents he/she received the variance report. The CPIC Coordinator signs the form and dates and times his/her signature. b. Administration signature this is where the Administrator/Medical Director documents the Variance Report is sent to the CPIC Committee. The Administrator signs the form and dates and times his/her signature 15. The Compliance and Performance Improvement Committee reviews and dates their review of the variance. The CPIC documents any recommendations/actions that are recommended by the committee RETENTION OF INCIDENT REPORTS: Variance reports shall be maintained in accordance to HealthPoint Record Retention Policy. RELATED POLICY: REFERENCES: HealthPoint Record Retention Policy ECRI Institute Texas Association of Community Health Centers (TACHC) OC3 Manual : 10 / 12

11 REQUIRED BY: PHS/Federal Tort Claims Act (FTCA) Claim Liability ATTACHMENTS/ENCLOSURES: Variance Report Form Variance Report Investigative Form : 11 / 12

12 TITLE: Variance Reporting Scope/Purpose: The purpose of Variance Reporting is provide a systematic method for reporting adverse events in order to improve systems and processes in an effort to promote a safe environment for all patients. Division/Department: All Clinics/Dept Policy/Procedure #: Original Date:08/22/2013 New _X Replacement for: Same Date Reviewed: Date Revised: Implementation: CPIC Approved: Board Approved: 01/08/ /01/15 01/16/15 Date of Revision Description of Changes 01/08/2015 Reformatted; addition of investigative form; change in terminology from occurrence report to variance report : 12 / 12