SURGICAL PATHOLOGY Formalin-free surgical spec imen m ana gem ent: tran sforming the workflow

An innovative vacuum packing solution has been adopted theatres where formalin was manually decanted into specimen buckets. in order to reduce formalin use and exposure throughout The amount of NBF placed onto specimens by theatre staff varied widely the Cwm Taf Morgannwg University Health Board in Wales, according to the bucket size and the person performing the decanting. As PCH as the following overview of progress illustrates. is situated approximately 20 miles from the RGH main processing laboratory, NBF was decanted to a minimum level to Cwm Taf Morgannwg UHB, South Wales, permit safe transportation (by hospital provides healthcare services for the van/porters) and then topped up once population of Merthyr Tydfil County received in the laboratory at RGH. Borough, Rhondda Cynon Taf and Typically, the recommended volume-to- Bridgend County Borough. The United weight ratio (10:1) was not adhered to, Kingdom Accreditation Service (UKAS)- with samples being received into the accredited cellular pathology department RGH laboratory with too little NBF for is split over two sites, one large the specimen size. Often specimens were laboratory at the Royal Glamorgan also placed into containers that were too Hospital (RGH), and a smaller ‘satellite’ small, and they had to be transferred to laboratory for specimen receipt at Prince a larger container. Charles Hospital (PCH). Both sites have Upon receipt in the RGH laboratory, theatres that send surgical specimens for specimens would be checked to ensure histological analysis. Concerns about the they were in an appropriately sized health effects of formalin (formaldehyde) container and NBF added if levels were exposure, reclassified as a Class 1 too low. Larger specimens were sliced or carcinogen to humans (IARC) prompted opened to allow NBF to penetrate the the Health Board to assess ways to tissue adequately. Specimens would reduce staff exposure. Critical exposure remain in formalin until they were points for hospital personnel were examined by a biomedical scientist/ identified as the theatre area and during pathologist. Any remaining wet tissue not transfer of specimens to the pathology continuing down the diagnostic pathway laboratory. would then be transferred to a ‘BiTran’ bag for storage. The bag would be Situation before adoption of labelled manually with the laboratory vacuum packing solutions accession number and minimum Prior to adoption of vacuum packing, identifiers before being stored numerically 10% neutral buffered formalin (NBF) in a designated store area by laboratory was made up in 50-L batches from staff. Tissues were not stored in their concentrate as and when required in the originating pots/bucket due to space cellular pathology specimen reception constraints and the requirement to areas of RGH and PCH. Theatre staff retrieve archived tissue rapidly on a would replenish NBF by bringing empty regular basis. carboys to the laboratory area and Dirty buckets were either washed Fig 1. Surgical specimens sealed in a dedicated refilling. The filled carboys would be and recycled or discarded and replaced vacuum bag are placed in a refrigerator at 4˚C carried back to the theatre area and kept depending on condition. It was not until transport to the laboratory takes place. in sluice rooms near to the operating uncommon for staff to be offered

WWW.PATHOLOGYINPRACTICE.COM AUGUST 2019 45 SURGICAL PATHOLOGY overtime to perform bucket washing, as dispenses a fixed volume of formalin into often there was no time to perform this the bag depending on the weight of the duty during the normal working day. specimen, and reseals (Fig 3). At RGH clean buckets were stored in a Specimens requiring opening/cleaning cupboard for collection by theatre staff or slicing are held in a refrigerator until an when required. Cleaned buckets for PCH appropriate member of staff is available were transported back to theatres via van to deal with them. Typically, a 2:1 volume- for storage and use. There were repeated to-weight ratio is employed by the issues with buckets and lids not matching, laboratory. Bagged specimens (with which led to formalin spillages and leaks. formalin) are then placed into a dedicated At times, PCH experienced supply issues area to fix until the next working day. as the stock levels were not monitored At the time of examination/dissection effectively. long-cuffed gloves are worn and the All wet tissue was disposed of six wet specimen is removed from the bag. weeks post-authorisation of reporting. Fig 2. Specimens are transported in a cool box Appropriate blocks are prepared and the Laboratory staff would use a generated and are tracked using a temperature monitoring remaining specimen is returned to the list to select the relevant specimens from system supplied with the TissueSAFE. same bag used earlier in the process. the store and transfer them to heavy-duty If the remaining specimen does not clinical waste bags for clinical waste TissueSAFE/SealSAFE: require further fixation post-dissection, disposal. an innovative solution the used formalin is discarded and the To address all the key issues identified, bag is resealed on the SealSAFE Drivers for implementing change the TissueSAFE and SealSAFE by instrument and stored in the specimen The following were the key issues that Menarini Diagnostics were installed in the archiving room (Fig 4). Cwm Taf Morgannwg University Health operating theatres and cellular pathology If further fixation is required, then Board identified and required to be laboratories (Table 1). formalin used previously for fixation (as addressed during the transformation TissueSAFE instruments were installed left remaining in the bag) is used again. of the surgical specimen management in sluice rooms in the named theatre The bag is resealed on the SealSAFE workflow: location at each site. Final locations were instrument and then stored in a dedicated n staff formalin exposure in theatres, decided based on those sluice rooms that area for one to two days. Subsequently, during transport and in the laboratory were adjoining theatres that generated the bag is opened along the appropriate n staff manual handling risks – carrying the highest number of surgical specimens. marked line and the formalin is poured heavy containers, formalin carboys Using the TissueSAFE, all surgical away, the bag is resealed and then sent to and twisting caps on bulk formalin specimens which require collection into storage. This practice has been adopted containers containers larger than 60-mL prefilled by the Health Board to minimise the n staff time in preparation, collection pots are sealed (without formalin) in a amount of formalin used in the laboratory and tracking of formalin dedicated vacuum bag and placed into and to recycle the solution wherever n non-standardised formalin addition a refrigerator at 4˚C until transport takes possible. to specimens place (Fig 1). Fresh vacuum packed The cellular pathology laboratory at n risk of formalin spillage during specimens (without formalin) can be RGH receives approximately 20,000 preparation, decanting, collection stored at 4˚C for up to 24–72 hours specimens per annum for processing, and transportation (depending on specimen type). All of which 7000 surgical specimens are n delays to fixation of specimens when vacuum bags are labelled with the received in vacuum bags. The remaining being transported patient’s addressograph and a label specimens are either too large to fit in n no audit trail of the fixation process generated by the TissueSAFE instrument a dedicated vacuum bag or are smaller before the specimen enters the documenting the date and time of biopsies and are received in 60-mL laboratory sealing, and which member of theatre prefilled containers. It is estimated that n use of formalin inhibiting markers for staff performed the action. 5% of surgical cases are too large to fit downstream molecular genetic testing The cellular pathology request form is into a dedicated vacuum bag and, in this n use of buckets – risk of inadequate placed in the sealable document pouch scenario, a large bucket is used and the supply to PCH theatres, risk of leaking, on the front of the bag. Specimens are specimen is stored in the refrigerator with no room to archive dirty or clean pots, transported in a cool box (Fig 2) and are the TissueSAFE samples and transported time-consuming to wash/dry/stack, lids tracked using a temperature monitoring fresh to the laboratory. do not fit, cost of replacing buckets system supplied with the TissueSAFE. n use of ‘BiTran’ bags – very good Upon receipt in the laboratory, Key benefits of TissueSAFE to the theatre storage solution but extremely temperature monitoring data are retrieved and transport departments: time-consuming to transfer/label and specimens are placed into the n reduced exposure to formalin specimens and carried a risk of SealSAFE instrument. The SealSAFE n reduced manual handling of heavy transcription error. is a closed system that automatically containers.

Table 1. Number of TissueSAFE and SealSAFE instruments installed at the Cwm Taf Morgannwg University Hospital Department Instrument Quantity Royal Glamorgan Hospital Main theatres TissueSAFE 2 Royal Glamorgan Hospital Cellular pathology laboratory SealSAFE 1 Prince Charles Hospital Main theatres TissueSAFE 1

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Key benefits of TissueSAFE and SealSAFE to Cwm Taf Morgannwg University Health Board: n compliance with health and safety (H&S) and UKAS guidelines n reduction of formalin-related incidents and associated costs/downtime n reduction of environmental concerns n reduction in formalin use and lower disposal costs.

Key benefits of TissueSAFE and SealSAFE to the patient: n guaranteed specimen collection facilities at both sites to ensure optimal Fig 3. The SealSAFE automatically dispenses a fixed volume of formalin into the bag tissue viability for histological depending on the weight of the specimen, and reseals. processing and diagnosis.

Key benefits of TissueSAFE and SealSAFE n reduction of manual handling of heavy Impact on the surgical to the cellular pathology laboratory: containers specimen workflow n full audit trail of tissue storage and n improved working conditions and By installing the system at the Health transport conditions capacity in cut-up areas Board, formalin usage has been reduced n full control over the fixation process n reduced exposure to toxic fumes dramatically and has made it financially n optimal preservation of tissues: n cost-saving on use of excess formalin viable for the cellular pathology delivered to the laboratory ‘fresh’ with n reduced staff time on cleaning of laboratory to purchase commercially original colours preserved, elimination buckets/pots available formalin. This has allowed time of drying, reduced autolysis n reduced staff time on transfer of to be saved on formalin preparation and (particularly for larger specimens that specimens to ‘BiTran’ bags removed any associated issues with require opening) and rapid cooling n reduced risk of transcription errors for H&S risks and batch-to-batch variation. of tissue due to vacuum eliminating storage The TissueSAFE and SealSAFE system insulating air n better preservation of specimens for has permitted the formalin batch used n standardised fixation according to potential molecular testing and tissue onboard the system to be tracked, weight of specimen banking. allowing the laboratory to have full

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WWW.PATHOLOGYINPRACTICE.COM AUGUST 2019 47 SURGICAL PATHOLOGY transparency over which batch of formalin has been used with which individual specimen, should any issues arise. Turnaround times have been unaffected by the introduction of TissueSAFE and SealSAFE. In over two years since installation there has been no issues raised with respect to diagnostic reporting, degradation of tissue and fixation quality. Time savings have been realised with respect to formalin and bucket collection by theatres, as well as for the laboratory for bucket washing. As vacuum bags are labelled with identifiers from the TissueSAFE and SealSAFE, specimen disposal is improved as staff are not struggling to identify cases by deciphering differing handwriting, as well as transcription error risks being eliminated. Time taken to dispose of vacuum bags compared to ‘BiTran’ bags remains unchanged; however, there have been no reported leakages since the new system was employed, and space has been Fig 4. Bags are resealed on the SealSAFE instrument and stored in the specimen archiving room. reduced as the bags are vacuum sealed. The laboratory acknowledges that and to ensure everyone involved was n volume of formalin added there is an increased amount of time fully onboard and aware of the change n time sample examined/dissected required for formalin addition on the in process in line with local policies and n time elapsed between formalin SealSAFE instrument as the specimen procedures. addition and examination enters the laboratory; however, this has Go live took place one week from n biomedical scientist/pathologist had no overall impact on the time taken training at each theatre site to ensure scoring for cutting for the specimen to be processed through the information given stayed fresh in n pathologist scoring for reporting – the laboratory as there have been time everyone’s mind. Gareth Llewellyn (Main H&E, IHC, FISH (where applicable) saving gains further downstream. Theatres Coordinator and Team Leader n pathologist overall comments. By taking full control of the fixation at RGH) commented that the system is process, staff in the laboratory are able to easy to use and safer as theatre staff Conclusions and lessons learned manage work and pathologist time more are no longer handling bulk formalin. The recommended model for installing effectively, as they are better placed to Throughout the installation process and TissueSAFE in the theatre and SealSAFE indicate when a specimen will be ready beyond there has been good support in the laboratory has brought major for examination/dissection. from Menarini Diagnostics and the cellular process and safety benefits as described Another recognised cost benefit to pathology team. above, effectively limiting the distribution the Health Board is that transport runs Verification of samples took place and management of formalin within the from the PCH site have been able to be thereafter and data from the first 100 laboratory. A thorough implementation reduced from three to two collections samples from each site were captured for plan was key to the project’s success, per day. This is due to specimens being auditing purposes. Based on the workload considering the many ‘human factors’ preserved more optimally when vacuum of the laboratory at RGH, data were required to enable a smooth transition packed compared to only being covered collected for the specimens processed of processes. with the minimum volume of formalin during the first week of go live for each According to Rhianon Webb (Cellular before entering the laboratory at RGH. site. A verification log was created which Pathology Healthcare Science Service captured details such as: Manager). The role of the change Installation, training n theatre site from which specimen management team was vital, supported and verification collected by Menarini to handle any questions from The vast majority of specimen types are n case ID theatre staff regarding the new pathology collected by theatres at RGH and PCH, n laboratory accession number process. Theatre and laboratory staff feel including mastectomies, bowel resections, n vacuum bag ID that the change in process has brought the ovarian cysts, gall bladders and prostate n specimen type two departments closer together, rather chippings. The key to a successful n date/time of vacuum sealing in than working in ‘silos’, which has had an installation and training lies in clear and theatres overall positive impact on their working open communication with all interested n user performing operation on environment and the patient receiving a E C I T C A R P

N I

Y G O L O H T A parties, says Gerrard Fletcher (Cellular TissueSAFE or SealSAFE timely and accurate diagnosis. PP iP Pathology Lead Medical Laboratory n collection time from theatres Assistant). It is important to ensure dates n temperature monitoring data Further information is available from: are arranged well in advance with clear n date/time of receipt of specimen in A. Menarini Diagnostics start/finish times. Prior to installation, laboratory 405 Wharfedale Road, Winnersh Wokingham RG41 5RA meetings were held between theatres, n date/time of formalin addition Tel: +44 (0)118 944 4100 the laboratory and Menarini Diagnostics n time elapsed before formalin addition Web: www.menarinidiag.co.uk to address concerns about the system from receipt of specimen in laboratory

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