Title: Recording Patient and Specimen Information on the Inventory System Serial Number: OMB-LSOP 005 Version Number: 2.0 Version Approver: James Edwards Version Approval Date: 25/04/2012 Version Effective: On release Version Author: Huma Zafar (BMS) Version Date: 06/03/2012 Area of Application: Research Laboratories Relevance: Research Staff Date Details of Review Version number No. of pages Name of Reviewer Next Review 28/10/09 (25/01/10) 10/08/11 New SOP by Matthew Burgess (Changes in Pro-curo software, conversion to new SOP template, changes to Biobank terms; version not completed) Added induction section, corrected workflow to current practice re: parent/child samples 1.0 11 Karolina Kliskey 28/10/10 2.0 18 Gareth Bicknell March 2013 YOU ARE INSTRUCTED TO READ THE FOLLOWING THOROUGHLY BEFORE PROCEEDING TO UNDERTAKE THE METHODS DESCRIBED. UNDER NO CIRCUMSTANCES ARE THESE INSTRUCTIONS TO BE AMENDED OR ALTERED IN ANY WAY OTHER THAN BY THE AUTHOR / APPROVER. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 1 of 18
Table Of Contents 1 PURPOSE... 3 2 SAFETY INFORMATION... 3 3 DEFINITIONS... 3 4 REQUIREMENTS & RESPONSIBILITIES... 3 4.1 GENERALLY... 3 4.2 SPECIFICALLY... 3 5 REFERENCES & RELATED DOCUMENTS... 4 6 PROCEDURE... 4 6.1 OPENING PRO-CURO... 4 6.2 NAVIGATING PRO-CURO... 5 6.3 ENTERING RELEVANT MATERIAL INTO PRO-CURO... 8 6.4 EDITING AND SPLITTING SAMPLES IN THE PRO-CURO SOFTWARE... 12 6.5 PRINTING LABELS IN PRO-CURO... 14 6.6 SEARCHING FOR SAMPLES IN PRO-CURO... 14 6.7 HOW THE USE OF PRO-CURO RELATES TO THE HUMAN TISSUE ACT AND OMB... 15 7 IMPLEMENTATION... 16 8 TRAINING REQUIREMENTS... 17 9 STAFF RECORD OF ACKNOWLEDGEMENT... 18 Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 2 of 18
1 Purpose 1.1 This SOP details the use of the Pro-curo sample tracking system to log relevant material. 1.2 The Human Tissue Act requires the traceability of all relevant material held under OMB jurisdiction. This extends to the ability to withdraw from use and storage all samples donated by a patient upon their request. 2 Safety Information 2.1 Specific reference should be made to the University Occupational Health Service and their advice on Display Screen Equipment use with respect to eye strain and ergonomics. 3 Definitions 3.1 Not applicable. 4 Requirements & Responsibilities 4.1 Generally 4.1.1 The Designated Individual is responsible and accountable for all activities relating to the logging, storage, use and disposal of all OMB controlled relevant materials. 4.1.2 Research projects receiving tissue from the OMB are expected to keep accurate logs of all tissue in their use and the disposal of any specimen. Tissue use and disposal is required to be reported to the OMB annually. 4.1.3 Inventory personnel are responsible for ensuring the Pro-curo software is maintained and ensuring records are kept for all movements of samples within the system. 4.2 Specifically Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 3 of 18
4.2.1 Researchers using OMB samples are responsible for ensuring that all tissue received from OMB (including subsequent splitting) is tracked promptly and accurately until the moment of: physical disposal, or being rendered acellular, or passage in culture, or return to OMB 4.2.2 OMB Team members are responsible for ensuring that all tissue received by the OMB (including subsequent splitting) is tracked promptly and accurately until the moment of: physical disposal, or transfer by approved means to a third party 5 References & Related Documents 5.1 OMB-LSOP 008 Set-up of Laboratory Printer Labels 5.2 OMB-LSOP 042 Writing SQL Queries for the Sample Inventory Database 5.3 OMB-F 003 Sample Tracker and Laboratory Checklist 5.4 OMB-F 009 Sample Tracker and Laboratory Checklist (Externally Approved Projects) 5.5 OMB-F 014 OMB Sample Transfer Register 6 Procedure 6.1 Opening Pro-curo 6.1.1 The Pro-curo software can be found on the desktop, once installed on a machine. It is also located in the Pro-Curo folder of the start menu. 6.1.2 OMB PCs with the Pro-curo software installed are: Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 4 of 18
OMB laboratory x2, with Brady label printer connected OMB office x2 Room F18 of the Botnar Research Centre, with Brady label printer connected. 6.1.3 Pro-curo can also be installed onto any departmental computer with access to the network through a Novell client log-in, through application to the OMB. 6.1.4 To log into Pro-curo, the individual must be added to the user list. This will happen once the individual has been satisfactorily trained through this SOP. A new user will default to have their password set as their Pro-curo user name; they will be prompted to change this upon the first log-in. 6.1.5 The user will only have access to projects and software functions specified for their user. The OMB administration team set these access rights. 6.1.6 Pro-curo will auto log out if left idle for 15 minutes; the timer for this is displayed in the top right corner of the Pro-curo window. 6.2 Navigating Pro-curo 6.2.1 On the left of the screen is the location hierarchy. Looking at the testing location shows that this goes through Pro-curo, Building, Room, Freezer, Shelf, Rack, Draw and Box. A location can be opened to the next sub-location with the + button and similarly closed with the button. Double-clicking the location will also open and close it. 6.2.2 When a location is highlighted, all samples stored in it, and in projects to which the user has access, are displayed in the sample window on the right. 6.2.3 Normally, only samples within the highlighted location will be displayed in the sample window. To view all samples in a selected location and all its sublocations, tick the include sub-locations box at the bottom of the screen. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 5 of 18
6.2.4 The sample window shows all the details entered for each sample. The samples on display are, by default, ordered by ascending sample number. You can sort by any of the data fields by clicking on its column header. A second click will sort in the opposite order. Double-clicking a sample will open its details window for editing. 6.2.5 Right clicking on a location brings up the full menu for its use. New sample will open the window for entering a new sample within the highlighted location. Add location will open the window for adding a new sublocation within that location. Duplicate location will copy the location to the same layer in the hierarchy. Move location opens a window identical to the location hierarchy that can be navigated in the same fashion. Highlighting a location will move the original location within this new one, providing that it fits the hierarchy. Rename location allows the user to change the name of the selected location. Remove location will remove the location from the hierarchy. Any samples within the location will move to the next higher location within the hierarchy. However, any of its own respective sub-locations, and their samples, will remain in position. Print location label will open the printing window where you can print a label with the details of that location. 6.2.6 Right clicking on a sample in the sample window will open the full menu for that sample. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 6 of 18
New sample opens the sample entry window with the location field pre-filled as the current location. Edit sample opens the current sample s details for alteration (equivalent to double-clicking the sample). Split sample opens the sample splitting window for generating new child samples from the current sample. Move sample opens a new window with the same location hierarchy, allowing selection of a new location for the highlighted sample(s). Print label opens the printing window for printing a label with the details of the selected sample. Book in and Book out are used to identify samples that have been sent to an external facility. Set date check will define an audit date for the sample. View history shows every interaction with the sample that has occurred in Pro-curo. Retire sample and Dispose of sample are ways to tag a sample as removed from the Pro-curo database (though actual deletion of data does not occur). Disposal is much harder to reverse, requiring help from the Pro-curo Superuser (the highest level of user), whereas a retired sample can be retrieved by any Pro-curo administrator. For this reason, it is recommended that samples that have ceased to exist, because they have been split or rendered acellular or cultured beyond first passage, should be retired. Samples that have been physically disposed of may be retired, providing a note is included detailing the reason for disposal. If disposing of a sample via Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 7 of 18
Dispose of sample, you will be prompted to choose a reason for disposal from a drop down menu. Print grid will print the current sample window table; ensure this is sent to a paper printer and not a label printer! Export grid will export the current sample window table in a format suitable for other database and spreadsheet programs. 6.2.7 It is possible to select multiple samples in the sample window with Shift or Ctrl clicking. Multiple samples can then be processed with most of the options detailed above. 6.2.8 Some key actions are available from the toolbar at the top of the screen. These will all perform the same functions as previously described. 6.2.9 When a new location is created the name is entered in the Enter the new location name box and the location type selected from the visual menu. If a box is being created, a second window will ask for the dimensions of the box with respect to how many samples it can hold. Either a one dimension rack (e.g. or slides) or a two dimensional grid can be entered. For a two dimensional box, the X dimension will default to alpha for easy differentiation between the two axes. 6.3 Entering Relevant Material into Pro-curo 6.3.1 Open the new sample window in one of the ways described above. Within this window all details for an individual sample can be entered. Fields with an asterisk are required for Pro-curo to log the sample. Fields in bold are mandatory for OMB samples. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 8 of 18
The Project name* is the ethically approved research project (or biobank) that the sample will be held under, or has been (pre-) allocated to. A user can only see and select projects that they have been granted access to in the database. Projects (whether internal or external) must contact the OMB to have the project added to the project list. Sample type* is the type of material the sample is. New sample types can be added to the list by administrators. The Batch number should be an identifier for the donor of the sample. For all samples collected under the OMB ethics since 1st March 2010, this is the OMB number. An OMB number is generated by the OMB team when a patient is consented for research and it will be associated with all relevant material collected during that period of care. External samples should use their own suitable identifier. Samples that were collected before the formal incorporation of the OMB and are part of the OMB collection will have an NHS or MRN number, or a Pre 2010 number, in this field. The External reference is a unique identifier for the sample. If used, this must be unique throughout the whole database. A user can only see projects they have access to, so being unable to see a sample with an external reference does not mean that it is not used elsewhere in the database. Due to this and Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 9 of 18
other complications (described later), use of this field is not recommended. It must not be used for Pathology numbers, which have their own field. Mass* is the unit measurement of the sample. This can be in either fluid volume or weight mass. An estimated mass is acceptable if measuring the exact mass would be detrimental to the quality of the sample. Re-agent % is the percentage of the sample that is re-agent. Location* is the location of the sample. This will default to the location that was selected when the new sample option was chosen. To view the hierarchy to select a different location, click the dot button. Sub-location is only available if the location type is a box. A sample can only be placed in a box if there are sub-locations still empty in it. If Sub-location is not filled, Pro-curo will place the sample in the next free space. It is advised that you check that the automatic assignment is correct. The Sample document links will display any supported documents linked to this particular sample. New documents can be added to this list with the Add button and removed with the Remove button. View will open the highlighted document. The Batch document links will display any supported documents linked to this batch number. Again, new documents can be added to this list with the Add button and removed with the Remove button. View will open the highlighted document. Documents linked in this way will be in the list for all samples with this batch number. Notes is a space for any details that may be useful for the researcher that do not fit the available fields. OMB samples should put relevant extra details of processing/storage here (e.g. Snap frozen + the date of snap freezing). Patient gender is the gender of the patient. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 10 of 18
Diagnosis or Surgery is the medical condition of the patient, or the intended surgery, as relevant to the sample. More items can be added to the list by an administrator. Origin is the place where the sample was generated (e.g. NOC Wards). Again more options can be added. Patient type is the treatment status of the patient, whether private, NHS or European Union hospital. Consultant is the consultant responsible for the patient care. Affected side is the side of the patient being treated by surgery or affected by the condition. Prosthesis is the type of operation/prosthetic device used if relevant. Project of origin is the project from which a sample was sourced (e.g. a project with external ethics that has donated the samples to the OMB). It therefore serves a different purpose from Project name (which identifies the project that the sample is held under, or is allocated to). Consent Form Version is the code for the consent form linked to the donor of this sample. New codes can be added by the administrators. Surgical Procedure is the actual surgical procedure performed on the donor. This may indicate a different intervention from that originally intended, or it may be a specific description of the techniques used. Date of birth is the date of birth of the patient. Use the European dating convention dd/mm/yyyy. Pathology number is the code used for samples originating from a histopathology department. Origin if other can be used if the hospital is not available in the Origin field. IHC or staining tech can be filed with any histological analysis performed on that sample. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 11 of 18
Trial number can be used for any trial numbering system used for patients. It is recommended that these are identified with a letter code to avoid confusion between trials. Age at diagnosis is the age of the donor when the information given in the diagnosis field was ascertained. Random numbers is a field for linking to randomly generated numbers used in research studies. Consent date is the date that consent was obtained for the storage and research use of the sample. This is filled using a visual calendar to avoid confusion. Collection date is the date the sample was collected from the donor. Again this is filled using a visual calendar. 6.3.2 A Sample number* will be assigned automatically when the sample is added to the database. Each new sample is given the next available sample number in ascending numerical value. 6.3.3 Once confident that all required data fields, and any others desired, are entered correctly, add the sample to the specified location using the main Add button at the bottom of the window. 6.3.4 Pro-curo will offer to open the printing window. Once printed or declined the software will return to the sample window. NB the Add and duplicate button allows a sample to be added and duplicated simultaneously. It will present a prompt asking how many duplicates you wish to create. Each duplicate will have the same field entries and the next available sample number. Exceptions to this are the External reference that will be blank, due to its unique entry requirement, and Sub-location that will have turned over to the next empty slot (if in a box). The Cancel button will close the window without entering the sample into the database. 6.4 Editing and Splitting Samples in the Pro-curo Software Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 12 of 18
6.4.1 The edit window for a sample is nearly identical to the new sample window. Any field bar the Sample number can be edited as required. The Save button will apply the changes, then close the window, whilst the Cancel button will close the window without applying any changes. All saved edits are logged into the sample s history. 6.4.2 The splitting window is similar to the edit sample windows. The Original sample tab shows the details of the original sample, whilst the Split parameters tab outlines how the split will occur. The Split into field defines how many new samples are generated. This does not include the original sample as that is specified in a different field. A new mass and sample type for the child samples must be input. 6.4.3 Any changes to other data fields in the Split parameters tab will be applied to all new child samples, but not to the original parent sample. What happens to the parent sample is selected at the bottom of the window. The new estimated mass must be entered, and it must be specified if the sample is to be kept, retired or disposed. It is recommended that samples are retired, not disposed of, if they need to be removed by virtue of being split. 6.4.4 Current OMB practice is to retire the parent of inbound child samples. For example, if a urine specimen is split into 8 aliquots upon receipt, the Split into is set as 8, and the Original sample is retired (rather than splitting into an extra 7 samples and keeping the original). This ensures a more consistent, and therefore more easily remembered, approach to splitting particularly when some samples are necessarily split in such a way that the original sample cannot exist (e.g. EDTA samples being split into plasma and buffy coat). It also makes audit of samples easier a search for a particular sample number only has to look in Sample number or Parent fields, not in both. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 13 of 18
6.4.5 The Generate split button will create all new child samples required and edit the original sample as requested. The history of the child samples will include that they were generated by a splitting operation, and the split will form part of the original samples history. 6.5 Printing Labels in Pro-curo 6.5.1 The printing window can be used for either location labels or sample labels, depending on how it was entered. The correct printer should be already be selected, but take care not to change it accidentally using the scroll wheel of your mouse! For the OMB Laboratory, the correct printer is the OMB Brady IP300. 6.5.2 The label template used should reflect the intended purpose of the label, otherwise error messages will occur. Unfortunately, all label templates are available in both cases. 6.5.3 Label templates relevant to the user will be identified or set up by the member of staff performing the induction. For basic use BASIC will print sample labels and location will print location labels. OMB samples currently use OMB Blood New. 6.5.4 Guidance on setting up a new label may be found in OMB-LSOP 008. 6.6 Searching for Samples in Pro-curo 6.6.1 The search bar can be opened using the Search button on the top toolbar, and it replaces the location hierarchy. A search is initiated by using the Search button at the bottom of the bar. A search can include multiple terms and it will bring up results containing the search term, even if it is part of the data field. For example, searching for ham will find a data field containing hamstring. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 14 of 18
6.6.2 The Include sub locations tick box will extend the search to the samples within all sub-locations of the selected location. The Include retired samples tick box will make the search also find samples that are retired and match the search criteria. The Display retired samples tick box at the bottom of the screen should not be used it is a known bug (it serves the default navigation panel and it is supposed be hidden during searching). 6.6.3 More complicated searches may be performed by typing SQL queries into the box marked SELECT * FROM SAMPLES WHERE. A basic guide to SQL queries is given in OMB-LSOP 042. 6.6.4 To close the search bar select the close search button. 6.7 How the Use of Pro-curo Relates to the Human Tissue Act and OMB 6.7.1 The Human Tissue Act requires the traceability of relevant material and that such material is consented. Some consent exceptions exist, but within the OMB the only ones that apply are samples collected before the 1st September 2006 or excess tissue kept in a pathology archive for a project with ethical approval. 6.7.2 To adhere to these requirements all samples must be registered in the Pro-curo database as soon as acquired. Bar the exceptions described above, the person logging the sample must be assured that consent has been obtained for the sample storage and use. This is usually the responsibility of the surgeon or identified individuals trained in the consent procedure. Where samples are deemed to be OMB samples, a copy of the consent form must have been lodged with the OMB. 6.7.3 The collection date must be entered, as required by the OMB, and where possible the consultant s name should also be entered with the sample. This provides another safeguard to identifying that consent has been obtained from the patient. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 15 of 18
6.7.4 Researchers must not see the personal details of a patient, such as name or address. This means that a researcher cannot see the patient s consent form and must accept the consent collector s word that consent exists. 6.7.5 The patient may withdraw consent for use at any time. Hence it is essential to keep the Pro-curo database up to date with the movements, conversions, and splitting of all samples such that all relevant material from the patient may be identified and disposed of within the required one week period. 6.7.6 One individual donor s relevant material does not equate to one Pro-curo sample. As the original piece of relevant material is split and converted to other relevant samples, each new sample must also be recorded into the database to ensure traceability. Some exceptions for rapid conversion can be arranged with the database administrators, but this is agreed on a case by case consultation and should not be assumed. 6.7.7 Samples must be labelled in a manner such that they can be identified in the Pro-curo database as part of traceability requirements. Ideally this will take the form of the Pro-curo sample number for that sample. In most cases the label generated by Pro-curo is ideal for this purpose. A trial number or hospital number for a patient is not sufficient for this, because it does not differentiate between multiple samples that may have been split from the original. 7 Implementation 7.1 This SOP is more a description of the Pro-curo software than an instruction set on entering sample data. This is because the data needed may vary greatly from sample to sample. 7.2 This SOP does not therefore have a direct impact on the rest of the quality system, other than by its use to link individual samples to consent (via batch numbers) and its use to record tissue storage positions and tissue disposal. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 16 of 18
7.3 Although it does effectively record transfer of tissue within and without the OMB, such transfer is currently better recorded on paper records (e.g. OMB-F 003, OMB-F 009, OMB-F 014). 8 Training Requirements 8.1 Basic computers skills. These may be enhanced by attending courses provided by the University and/or NHS. Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 17 of 18
9 Staff Record Of Acknowledgement 9.1 I understand the contents of this document. 9.2 I have received the training appropriate to the procedures and feel competent to undertake them. 9.3 My supervisor agrees that I am able to perform the work covered by this SOP. 9.4 I understand that further on the job or other training supervision may be required before working independently. 9.5 I understand that I may discuss my needs with my manager. Trainee Trainer (if applicable) Name Position Signature Date Signature Date Approved 25/04/2012 OMB-LSOP 005 Version 2.0 Page 18 of 18