Documenting Complaint Information WI-0007, Rev AB

Transcription

1 1.0 Purpose The purpose of this work instruction is to describe the requirements related to documenting a suspected complaint electronically using the company s complaint handling system (Argos Global Sentinel Software), or manually using form F-00211, Complaint Notification Form. It also provides directions for completing a good faith effort (GFE) to obtain additional information where required. 2.0 Definitions & Acronyms Definitions and acronyms for the terms used in this procedure can be found in FM-0005, Glossary. 3.0 Responsibilities All employees are responsible for reporting complaints to Quality Assurance. Quality Assurance (QA) is responsible for documenting suspected complaints. QA is responsible for reviewing the Complaints@Argos-Global.com mailbox each working day and transferring new information into the complaint handling system. QA is responsible for periodically updating data in Sentinel, including classification codes. 4.0 References / Tools / Equipment Complaint Notification Form... F Complaints... SOP Glossary of Terms... FM-0005 Good Documentation Practices... SOP Records Management... SOP WI for Investigation in Sentinel... WI WI for Overview & General Use of Sentinel Software System... WI Procedure General Requirements All employees are required to report complaint events or suspected complaint events to Quality Assurance (QA) immediately but not later than 1 business day of becoming aware of the event. It is preferable that complaint reports be submitted electronically using the complaint handling system ( Sentinel ). However, if the system is not available or an employee does not have access to the system, they may submit the report using another method. Page 1 of 18

2 1. Employees can submit complaint reports by completing F-00211, Complaint Notification Form, and ing the completed form to 2. If the form and the system are not available, employees can send an to with relevant information. 3. If an employee becomes aware of a complaint and does not have access to any company systems, they should call any QA employee and provide the report. When submitting a complaint report, employees should include all available information, including: o How and when the employee became aware of the event; o A complete event description, including date and location, how the device was involved, and any outcomes attributed to the issue; o A description of any relevant tests or laboratory data available; o Relevant patient history and concurrent medical products (not including those used to treat the event); and o Copies of any supporting data reports that may be available (e.g. photographs). All employees who handle complaint data must comply with the applicable local and regional privacy acts. These acts require employees to protect and maintain the privacy of patient information. Any employee not familiar with these requirements should contact QA for training. QA is responsible for reviewing all s in the Complaints@Argos-Global.com mailbox each working day and transferring new information into the complaint handling system within 1 working day of being received. o The person entering the information should not change the description of reported events based on their interpretation. The information should simply be transferred from the to the electronic system. o If F-00211, Complaint Notification Form, has been used to document the event, QA will copy the information into the Sentinel system and attach a copy of the Complaint Notification Form. o Once the has been processed, it will be moved from the Inbox to indicate it has been entered. o When there is doubt about whether an issue is new, QA will create a new event since all issues are investigated to ensure they are not duplicated during the complaint investigation steps per WI-00010, WI for Investigation in Sentinel. QA is responsible for documenting complaint reports delivered verbally within 1 working day. Page 2 of 18

3 If information is missing from the complaint report, QA will work with the reporter to make a good faith effort (GFE) to collect the required information. A GFE requires at least three attempts to obtain additional information, one of which must be a written communication. All GFE attempts must be documented. Additional information is included in Section 5.10, Completing a Good Faith Effort to Obtain Additional Information. Note: A customer response letter does not constitute a GFE. Field names in Sentinel are identical to the field names on F-00211, Complaint Notification Form. Therefore, the directions in this WI apply to Sentinel and F-00211, Complaint Notification Form, unless otherwise indicated. When processing an event in the Sentinel system, users should complete as many of the fields as possible. When completing Intake in Sentinel, users should refrain from clicking Save unless an RGA number will be issued (refer to Section 5.7, Completing Return Tracking Information). It is preferred that users submit the module ( Submit as Author button) rather than saving it and returning to complete it at a later time. Submitting the Intake module ensures others can begin reviewing and processing the event quickly, which is important given the short timelines required of complaint processing. Voiding the Intake module ( Void Module button) is not permitted. Once Intake is submitted in Sentinel, the Investigation module, the Device Evaluation module, and the Response Communication module will automatically open. WI-00006, WI for Overview & General Use of Sentinel System, provides general information on use of the Sentinel software system. Fields that are blank in the Sentinel software are not applicable (N/A) to the event. 5.1 Documentation Method Determine the method for documenting the complaint: If The event has not yet been documented AND Sentinel is available Then Complete the following: 1. Log into Sentinel per WI-00006, WI for Overview & General Use of Sentinel System. 2. Click on New Event. The New Event: page will appear. 3. Proceed to the next section. Page 3 of 18

4 If The event has not yet been documented AND Sentinel is not available The event has been documented via F-00211, Complaint Notification Form, AND you need to enter the information from the completed form into Sentinel Intake has already been completed in Sentinel and additional information is required Then Complete the following: 1. Obtain F-00211, Complaint Notification Form, from Document Control. 2. Proceed to the next section. Note: If you are unable to obtain F-00211, Complaint Notification Form, document the complaint information in an and send to Global.com. Proceed to Section 5.9, Entering Information From F Into Sentinel. Proceed to Section 5.10, Completing a Good Faith Effort to Obtain Additional Information. 5.2 Completing Record Information QA will complete the Record Information section in Sentinel or using F-00211, Complaint Notification Form, Section 1, by following the directions below. Note: F-00211, Complaint Notification Form, may be completed electronically or manually. Field Intake Date For Sentinel: The system will automatically input the date and time the record was created as the intake date. For F-00211: Enter today s date, ensuring proper format is used per SOP-00095, Good Documentation Practices. Intake Operator For Sentinel: The system will automatically populate the name of the system user. Intake Channel For F-00211: Enter your name. Select the intake channel. Intake channel refers to how the complaint was communicated. Note: Sentinel will default to Telephone. Verify the selection and change it, if applicable. Page 4 of 18

5 5.3 Completing Reporter Information The reporter of a complaint is the person that initially reported the complaint to the company. Generally, this is a patient or physician, but in some cases the reporter may be a company employee (e.g. if the event was initially recognized by a company employee). QA will complete the Reporter Information section in Sentinel or using F-00211, Complaint Notification Form, Section 2, by following the directions below. Field Reporter ID Code For Sentinel: Enter a Reporter ID Code, if available, and hit the Tab button (e.g. ERF-118 or TXX-217). The system may automatically populate information that is available in the fields in the section. Alternatively, you can search for the Reporter ID Code by clicking on the Find Reporter icon. Title Proceed to the Other Contact Information field. Note: If Reporter ID Code is not available, leave blank and proceed to the next field. Contact QA if you need to add a new Reporter ID Code. For F-00211: Enter the Reporter ID Code, if available. Otherwise, check the N/A box. Enter the reporter s title, if available. First Name Enter the reporter s first name. Last Name Enter the reporter s last name. Phone Number Address Enter the reporter s business phone number, if available. Enter the reporter s address, if available. All employees should use their work address. Page 5 of 18

6 Field Facility Name For Sentinel: Enter the reporter s facility name (e.g. hospital name), if available. Other Contact Information For F-00211: Enter the reporter s facility name (e.g. hospital name). If not applicable, check the N/A box. For Sentinel: Enter any other applicable contact information for the reporter. If the Reporter is a hospital, consider entering the department that was involved here. 5.4 Completing Patient Information For F-00211: Enter any other applicable contact information for the reporter. If the Reporter is a hospital, consider entering the department that was involved here. If not applicable, check the N/A box. QA will complete the Patient Information section in Sentinel or using F-00211, Complaint Notification Form, Section 3, by following the directions below. Field Patient ID Code For Sentinel: Enter the patient s ID code, if available (e.g. ERF-812). Note: If a patient code is entered, the remaining fields in this section may automatically populate. Confirm the information in the fields, and if applicable, update. If a patient ID code is not available or does not include correct information, send an to Complaints@Argos-Global.com. The QA Team periodically updates the data and will make the required updates. Note: To view a patient s event history, click the View Patient Event History button after entering the patient s ID code. For F-00211: Enter the patient s ID Code, if available (e.g. ERF- 812). If not available, check the N/A box. Page 6 of 18

7 Field Study ID, if applicable For Sentinel: Enter the Study ID, if applicable (e.g. AST-0001). If the patient is not involved in a study, click the N/A button and N/A will automatically populate in the field. Do not enter the patient s ID code here (e.g. STR-8102). 5.5 Completing Products For F-00211: Enter the Study ID, if applicable (e.g. AST-0001). If the patient is not involved in a study, check the box indicating that Patient is not in a study. Do not enter the patient s ID code here (e.g. STR-8102). QA will complete the Products section in Sentinel or using F-00211, Complaint Notification Form, Section 4, by following the directions below. If additional products needs to be added, click the Add Another Product button in the Sentinel software and repeat the steps below as many times as required. Field Model # Select the product involved in the report. In Sentinel, click on the pull down menu to display the model numbers available to select. The following selections are also acceptable: Other: If the device or material involved in the issue is not available in the list, select Other and explain what device or material was involved in the Event Description field. No Product: If the event does not require a product entry, enter No Product. Use this for events which are not product specific (i.e. service complaints, requests for general training or information) or are related to a product not manufactured or distributed by. Unknown: If the product associated with the event is unknown, enter Unknown in the field. Page 7 of 18

8 Field Expiration Date Enter the product s expiration date, if available, ensuring proper format is used per SOP-00095, Good Documentation Practices. In Sentinel, click on the calendar icon to the right of the field to select the expiration date. Lot # For Sentinel: Enter the product s lot number, if available. Serial # For F-00211: Enter the product s lot number, if available. If not available, check the N/A box. For Sentinel: Enter the product s serial number, if available. Usage of the Medical Device For F-00211: Enter the product s serial number, if available. If not available, check the N/A box. Note: For implantable devices without Serial Numbers or in case of a clinical event, which cannot be assigned to a specific product it is allowed to enter the Serial Number of the implanted pump. Select the usage of the medical device, if available. If the problem was identified prior to use, indicate that here. Otherwise, select the appropriate usage. If you are unsure of the usage, leave this field blank. In Sentinel, click on the pull down menu to display the usage choices available to select. Usage of Device if Other For Sentinel: If Other was selected for Usage of Device field, enter the applicable information. Will Device be Returned? For F-00211: If Other was selected for Usage of Device field, enter the applicable information. Otherwise, check the N/A box. Select Yes or No to indicate if device will be returned to Argos Global. Page 8 of 18

9 Field Other Product Information For Sentinel: Enter any other applicable product information. 5.6 Completing Event Information For F-00211: Enter any other applicable product information. Otherwise, check the N/A box. QA will complete the Event Information section in Sentinel or using F-00211, Complaint Notification Form, Section 5, by following the directions below. Field Date of Event Enter the date the event occurred for the patient, using format DDMMMYYY. This is typically the day the patient first experienced symptoms or an issue. In Sentinel, click on the calendar icon to the right of the field to select the date of the event. Is Event Date Approximate? Note: Event date cannot be after the Aware Date. Select Yes or No. Select Yes if the actual date of event is not known. Aware Date For Sentinel: The aware date is the date an employee became aware of the event. The aware date will default to the date the record is created. Confirm the date, and update if required. For F-00211: The aware date is the date an employee became aware of the event. Enter the aware date, ensuring proper format is used per SOP-00095, Good Documentation Practices. Note: The Aware Date cannot be before the Event Date. Page 9 of 18

10 Field Event Description, including how the device was involved and any outcomes attributed to the issue Description of any Relevant Tests or Laboratory Data Record all facts related to the event, including troubleshooting steps. The most effective reports include a chronological (timebased) description of the event. If applicable and possible, ask the involved clinician whether the device is suspected to be a contributory cause of the event. Do not speculate or provide opinion when recording the event description. In Sentinel, do not delete information recorded in the Event Description field once the issue has been saved or submitted. In some instances where it is deemed necessary to add or delete from this field in Sentinel, a statement recording the reason for the change must be entered (e.g. Issue Updated 15May2013 with the following information: ). These instances would include: o When the Complaint Handling Unit requests additional information from the reporter. o Correcting data entry errors made in the initial report. Enter any relevant patient test or laboratory data, if applicable. In Sentinel, if there is no information to enter, click the N/A button and N/A will automatically populate in the field. Note: This field should not include device failure analysis or investigation activity performed at the company. This information is captured in the Device Evaluation module. Page 10 of 18

11 Field Relevant Patient History including Preexisting Medical Conditions Enter any relevant patient history and/or preexisting medical conditions, if applicable. In Sentinel, if there is no information to enter, click the N/A button and N/A will automatically populate in the field. Concurrent Medical Products and Therapy Dates (not including products that were used to treat the event) Enter any concurrent medical products and therapy dates for the patient, if applicable. Examples include an implanted cardiac resynchronization device (CRD; pacemaker). Do not include products that were used to treat the event. If the patient is on anticoagulation therapy, an attempt should be made to document the details of this treatment if it is relevant to the complaint (e.g. if the complaint is related to thrombus). If the patient is not on anticoagulation therapy, that should also be documented. In Sentinel, if there is no information to enter, click the N/A button and N/A will automatically populate in the field. Operator of the Device Operator of the Device if 'Other' Select the device operator. For Sentinel: If Other was selected for Operator of Device field, enter the applicable information. Date of Device Implantation, if applicable For F-00211: If Other was selected for Operator of Device field, enter the applicable information. Otherwise, check the N/A box. For Sentinel: If applicable, enter the date of device implantation. Click on the calendar icon to the right of the field to select the implantation date. For F-00211: If applicable, enter the date of device implantation, ensuring proper format is used per SOP-00095, Good Documentation Practices. Otherwise, check the N/A box. Page 11 of 18

12 Field Date of Device Explantation, if applicable For Sentinel: If applicable, enter the date of device explantation. Click on the calendar icon to the right of the field to select the explantation date. Country where the event occurred Do you want a Response Letter Generated for this Issue? For F-00211: If applicable, enter the date of device explantation, ensuring proper format is used per SOP-00095, Good Documentation Practices. Otherwise, check the N/A box. Select or enter the country where the event occurred. Verify the selection and change it, if applicable. Select Yes or No to indicate if the reporter requested follow-up information or a response to the complaint report (e.g. select Yes if the reporter is a physician who wants to understand whether is able to confirm an issue). Note: Sentinel will default to No. Verify the selection and change it, if applicable. 5.7 Returning Product and Completing Return Tracking Information Where possible, devices should be collected and returned to the company for analysis. Bio-hazardous materials (e.g. explants) must be placed in a durable, leak proof container for transport. offers special return kits to facilitate return of bio-hazardous materials and electronic components. These materials are available by sending a request to Complaints@Argos-Global.com. Return Goods Authorization (RGA) numbers should be marked on packages that are returned. o If an event ID has already been issued for a complaint report, the RGA number is the same as the event ID. o Otherwise RGA numbers are available by sending an request to Complaints@Argos-Global.com. If there is indication that the product will be returned, the reporter shall: o Make a Good Faith Effort to obtain the product, o Ask that it be sent back to as soon as possible, o Issue an RGA number, and; Page 12 of 18

13 o Provide the patient with the return shipping address below:, Inc. Logistics Department [Insert RGA Number Here] 56 Charles St, Suite 2 New York, NY If the product will not be returned, this section will not be completed in Sentinel or on F-00211, Complaint Notification Form. If using F-00211, Complaint Notification Form, check the N/A box in Section 6. If product will be returned, QA will complete the Return Tracking Information section in Sentinel or using F-00211, Complaint Notification Form, Section 6, by following the directions below. Field RGA Number Enter the complaint number, if applicable. To obtain the complaint number, click the Save button that appears at the top of the page. The complaint number is the Event Number that appears at the top of the Intake screen when the record is saved (e.g. PR000035). Courier Courier Tracking Number Return Tracking Comments Enter the courier name (e.g. DHL, FedEx, UPS, TNT). Enter the courier tracking number. Enter any applicable comments related to the return. 5.8 Submitting Intake Module in Sentinel Submit Intake by following the directions below. If Using Sentinel Then Attach any relevant information (photographs, etc) to the event record by completing the following steps: Click the Add Attachment button at the top of the page. If this button does not appear, click the Save button on the bottom of the page, and the Add Attachment button will appear. Page 13 of 18

14 If Then Note: Name the scanned form prior to uploading into the system (e.g. PR Complaint Notification Form) Click Browse. Locate your file and click Open. Using F-00211, Complaint Notification Form The File Name field will automatically populate based on the file name (e.g. PR Complaint Notification Form). Modify the file name if required. Enter a brief description of the file in the File Description field (e.g. PR Complaint Notification Form). Click Submit. The system will upload the file. Click Close Window once the Successfully uploaded file. Click close window to continue message appears. You will return to the Intake page. Complete the following: 1. Enter any additional comments in the Comments field in the Close Task section. 2. Enter your system password in the Password field. 3. Click Submit as Author. 4. Confirm your action by clicking OK. Note: Clicking the Void Module button to void intake is not permitted. This button is not always visible. Complete the following: 1. Enter any additional comments in Section 7: Comments. Otherwise, check the N/A box. 2. If F-00211, Complaint Notification Form, was completed on paper, scan it. 3. the scanned form to Complaints@Argos-Global.com. You may also send scans of any relevant information (photographs, etc). 4. The process continues in Section 5.9, Entering Information From F Into Sentinel. Page 14 of 18

15 5.9 Entering Information From F-00211, Complaint Notification Form Into Sentinel QA will enter information from F-00211, Complaint Notification Form, into the Sentinel system by following the directions below. Information from F-00211, Complaint Notification Form, must be entered into the Sentinel system within 1 day of receipt of the form. A copy of the Complaint Notification Form must be attached to Intake in Sentinel. The Complaint Notification Form must be retained per SOP-00005, Records Management In applicable, print the F-00211, Complaint Notification Form, from the Complaints@Argos-Global.com mailbox Log into Sentinel per WI-00006, WI for Overview & General Use of Sentinel System Click on New Event. The New Event: page will appear Copy the information from F-00211, Complaint Notification Form, into the system Click the Save button that appears at the top of the page. The complaint number ( Event Number ) will appear at the top of the Intake screen when the record is saved (e.g. PR000035) Record the event number in Section 8, Intake Completion in Sentinel, of F-00211, Complaint Notification Form Print your name, sign, and enter today s date in Section 8, Intake Completion in Sentinel, of F-00211, Complaint Notification Form, ensuring proper GDP is used per SOP-00095, Good Documentation Practices Scan F-00211, Complaint Notification Form Attach the scanned form to Intake by clicking the Add Attachment button at the top of the page. If this button does not appear, click Save. Note: Name the scanned form prior to uploading into the system (e.g. Complaint Notification Form) Click Browse Locate your file and click Open The File Name field will automatically populate based on the file name (e.g. Complaint Notification Form). Modify the file name if required Enter a brief description of the file in the File Description field (e.g. Complaint Notification Form for PR000035) Click Submit The system will upload the file. Click Close Window once the Successfully uploaded file. Click close window to continue message appears You will return to the Intake page. Enter your system password in the Password field Click Submit as Author Confirm your action by clicking OK. Note: Clicking the Void Module button to void intake is not permitted. Page 15 of 18

16 File the completed F-00211, Complaint Notification form, in the complaint file Completing a Good Faith Effort to Obtain Additional Information In some instances, a Quality Engineer or another investigator may require additional information to be documented in Intake when completing other modules (i.e. Investigation). In those instances, the Quality Engineer or another investigator will reopen Intake and indicate what additional information is required. The event will appear in the Available Worklist showing Intake is waiting to be completed. Once the event is opened, the additional information being requested will appear at the bottom of the page under the Task History audit trail. The reporter will process a re-opened Intake module following the directions below Review the Available Worklist items. If Intake has been reopened, the item s task status will indicate Re-opened and the item will appear at the top of the worklist and be marked as late (if worklist is sorted by the column Time Remaining ) Click Claim under the Actions column to claim the first reopened Intake item. The item will disappear from the group worklist and appear in your personal worklist In your personal worklist, click Process under the Actions column for the item claimed The Intake module will open. Note: Two circular blue arrows will appear on the Intake button at the top, indicating that the module has been reopened Navigate to the Task History audit trail at the bottom of the page. The Re-open Comment field will indicate what additional information is required Obtain the information required and update the Intake fields as required In the Comments field at the bottom of the page, indicate what fields were updated and/or what new information was provided. If a good faith effort to obtain the information was made, enter the details of this attempt in the Comment field and click Save. A GFE requires at least three attempts to obtain additional information, one of which must be a written communication. The written communication (generally an or a letter) should be attached to the complaint record. If the information required could not be obtained, enter the reason for this in the Comment field and click Save Enter your system password in the Password field Click Submit as Author Confirm your action by clicking OK. Page 16 of 18

17 6.0 Appendices Not Applicable 7.0 Revision History Note: Clicking the Void Module button to void Intake is not permitted You will return to the Intake page (view only). Navigate to the Task History audit trail at the bottom of the page The Close Comment field will be populated with the information you entered in the Comments field at the bottom of the page. This information will be viewable to the person who requested the additional information. Revision CCR Effective Date Description of Change AA Jan2013 Initial release AB Mar2014 Updating procedure to align with Sentinel system changes being performed. Page 17 of 18

18 Disclaimer Federal law requires that you develop, maintain, and implement written medical device reporting procedures. This procedure is a general template used by and is customized to meet the unique needs of our individual clients. About is a specialty Quality System services firm focused on providing comprehensive complaint-handling services to the medical device industry. We offer expert consulting, software solutions, and turnkey functional outsourcing. Through our end-to-end solution, we can manage your complaint intake, documentation, follow-up, and regulatory reporting. Our innovative functional outsourcing services allow small and medium-sized medical device firms to free themselves from the burden of routine reporting. We enable maximum efficiency and ensure regulatory compliance, so your team can focus on developing the best medical devices available. Typical client results include a 45% reduction in complaint-handling costs while achieving increased levels of regulatory compliance. We guarantee better than 99% compliance to regulatory reporting timelines. Call us today to discuss any additional concerns and understand how can help you maximize your compliance position while minimizing complaint handling related costs. Be sure to visit for more helpful analysis and content. Page 18 of 18