Inspection Report We are the regulator: Our job is to check whether hospitals, care homes and care services are meeting essential standards. The Doctors Laboratory - Whitfield Street 60 Whitfield Street, London, W1T 4EU Tel: 02073077373 Date of Inspection: 14 June 2013 Date of Publication: July 2013 We inspected the following standards as part of a routine inspection. This is what we found: Care and welfare of people who use services Cleanliness and infection control Safety, availability and suitability of equipment Supporting workers Assessing and monitoring the quality of service provision Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 1
Details about this location Registered Provider Registered Manager Overview of the service Type of service Regulated activities The Doctors Laboratory Mr. Tim Herriman The Doctors Laboratory is an independent healthcare organisation offering diagnostic and screening services within the United Kingdom. It provides laboratory information needed for the diagnosis and treatment of medical disorders to a range of people using the service that includes GP's, occupational health services, medical consultants in the NHS and private sector, insurance sector, fertility centres. Diagnostic and/or screening service Diagnostic and screening procedures Management of supply of blood and blood derived products Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 2
Contents When you read this report, you may find it useful to read the sections towards the back called 'About CQC inspections' and 'How we define our judgements'. Summary of this inspection: Page Why we carried out this inspection 4 How we carried out this inspection 4 What people told us and what we found 4 More information about the provider 5 Our judgements for each standard inspected: Care and welfare of people who use services 6 Cleanliness and infection control 8 Safety, availability and suitability of equipment 9 Supporting workers 10 Assessing and monitoring the quality of service provision 12 About CQC Inspections 14 How we define our judgements 15 Glossary of terms we use in this report 17 Contact us 19 Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 3
Summary of this inspection Why we carried out this inspection This was a routine inspection to check that essential standards of quality and safety referred to on the front page were being met. We sometimes describe this as a scheduled inspection. This was an unannounced inspection. How we carried out this inspection We looked at the personal care or treatment records of people who use the service, carried out a visit on 14 June 2013, observed how people were being cared for and talked with people who use the service. We talked with staff and were accompanied by a specialist advisor. What people told us and what we found This report relates to The Doctors Laboratory at Northwick Park Hospital which is registered at 60 Whitfield Street, London. This laboratory consists of four smaller laboratories. This inspection was prompted by a complaint received by the Care Quality Commission on samples being lost and inaccurate results being provided. People who use the service told us that it had improved since the beginning of the year. One person told us that they had "low confidence" in the provider. This was relating to lost samples and errors in reporting results which occurred during the transition period. We found that the provider met needs of the people who use the service. The provider took account of published research and guidance and had arrangements for dealing with foreseeable emergencies. The service was provided in clean and hygienic environment. There were systems in place for assessing and preventing the risk of a health care associated infection. There was suitable equipment available for the purpose of carrying out the regulated activity and the equipment was maintained and used correctly. Staff had been supported well in performing their job. We found that the provider had systems in place which helped to prevent incidents and protect staff and people who use the service from risk. You can see our judgements on the front page of this report. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 4
More information about the provider Please see our website www.cqc.org.uk for more information, including our most recent judgements against the essential standards. You can contact us using the telephone number on the back of the report if you have additional questions. There is a glossary at the back of this report which has definitions for words and phrases we use in the report. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 5
Our judgements for each standard inspected Care and welfare of people who use services People should get safe and appropriate care that meets their needs and supports their rights Our judgement The provider was meeting this standard. People experienced care, treatment and support that met their needs and protected their rights. Reasons for our judgement Staff told us that since the provider took over management of the laboratories "specimen transit goes smoothly and work flow is easier." Another person told us that "at the beginning using new systems was very difficult, samples were lost." We noted that samples arrived in the lab through a pneumatic tube system or were delivered by porters within the hospital and by courier from other hospitals. Samples were sorted and separated as urgent and non-urgent in the reception area. They were then booked into an information management system by medical laboratory assistants. This meant that the provider had system in place to prevent errors. The provider had a protocol for receiving specimens which included formal criteria for acceptance. A member of staff told us that testing was prioritised by clinicians or senior biomedical scientist based on urgency. Another person said that "as we got used to new systems, we know how to track samples and the process and systems have improved." We were told that results were sent electronically to clinicians in the blood sciences department, who had requested tests and in paper form to the histology laboratory. Laboratories used internal quality control samples, audits and double reporting to make sure that the results were accurate. The manager told us that turnaround times were monitored in each laboratory based on a target set internally or as agreed with clinicians. For example, in one laboratory, a one hour target was set for samples which arrived from the accident and emergency department, a four hour target was set for inpatients and a forty hours turnaround time was agreed for general practitioners. A member of staff told us that "turnaround times work well, it has improved." Records were kept orderly and secure. A member of staff told us that the laboratory used secure storage facilities where archived document were kept. Staff we spoke with were Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 6
aware of the records retention period. A member of staff told us that in event of emergency, for example equipment failure, samples received could be sent to another laboratory managed by the provider. Staff could use some spare equipment which was available at the location. The laboratory had a plan in place to deal with disruptions to the service and ensure the needs of the people who use the laboratory would continue to be met. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 7
Cleanliness and infection control People should be cared for in a clean environment and protected from the risk of infection Our judgement The provider was meeting this standard. People were protected from the risk of infection because appropriate guidance had been followed. Reasons for our judgement Some of the laboratories had been recently refurbished. They were bright and clean and appeared generally well-organised. We noted that laboratories were secure and each visitor to the laboratory was required to sign the visitors' book. The provider informed us that there were plans for the refurbishment of the cellular pathology laboratory within the next few months. The provider may find it useful to note that some areas of the cellular pathology laboratory appeared cluttered and had poor ventilation. We could smell strong fumes of formalin and xylene in two of the rooms used. The manager told us that they had clinical waste disposal contract with The Northwick Park Hospital. We saw that the waste containers were suitably labelled and had not been overfilled. There were separate secure areas where clinical waste was kept before it was removed by a contractor. Staff we spoke with knew how to prevent and control risks relating to cross-contamination. We saw that a health and safety policy and local induction procedures were in place to minimise risk of accidents and cross-contamination and to protect the staff. Most of the laboratory staff were wearing appropriate white coats in specimen handling areas. The provider may find it useful to note that staff occasionally disregarded dress code policy. We also saw two external contractors in their regular clothing in areas where lab coats were required. We noted that suitable guidance on how to deal with exposure to blood and other bodily fluids was displayed. A member of staff described procedures for cleaning up spills of blood and blood products. Specimens were kept in the refrigerators as necessary and the temperature of these refrigerators was checked and recorded daily. Hand washing facilities and hand sanitizers were provided and were easily accessible to all staff and visitors. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 8
Safety, availability and suitability of equipment People should be safe from harm from unsafe or unsuitable equipment Our judgement The provider was meeting this standard. People were protected from unsafe or unsuitable equipment. Reasons for our judgement Equipment was calibrated in accordance with protocols in the lab and testing was a subject to internal quality control samples. We saw a periodic preventative maintenance schedule for equipment in the clinical biochemistry lab and accompanying engineer's reports which was recent. This meant that the equipment was checked by a qualified external professional and was working properly. We noted the laboratory used an automated microbiology testing system for scanning and reading culture plates. A member of staff told us that this system was regularly maintained by an external company. The provider employed a technician who was able to deal with minor repairs. An engineer was available on call for urgent repairs. We noted that most of the equipment used was new and still under warranty. Other than the cellular pathology lab, all laboratories had recently upgraded their equipment. The manager told us that the cellular pathology equipment and laboratory information management system will be upgraded commencing July 2013. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 9
Supporting workers Staff should be properly trained and supervised, and have the chance to develop and improve their skills Our judgement The provider was meeting this standard. People were cared for by staff who were supported to deliver care and treatment safely and to an appropriate standard. Reasons for our judgement Staff told us that they were well supported and enabled to acquire new skills and qualifications. One member of staff told us that training was good and they felt "able to contribute." Another person said they had "fantastic team, they [other team members] are all very dedicated." We were also told that the provider "listens and answer questions." The provider employed a total of 165 staff, with 45 in cellular pathology, 40 in microbiology and 80 in the blood sciences laboratories. Some staff were biomedical scientists, registered with the Health and Care Professions Council, others were non-registered medical laboratory assistants. We noted that some clinical scientists and office staff were also working at the laboratory. Staff had job descriptions and person specification and we saw that copies of it were kept in their individual records. The provider had not fully implemented a staff appraisal system. The manager told us that staff would be appraised annually and competency assessed every two years. Other staff would be re-assessed earlier, if returning from extended leave or if they were required to work with new equipment. A member confirmed that this had been discussed with them, saying "I was told I will have my appraisal soon." We saw that competency assessments were completed for staff that needed to learn how to operate new equipment. We noted that there were two vacant posts in the cellular pathology laboratory. The manager told us that vacant posts were expected to be filled shortly. We were told that there was no backlog of work, as it was completed by staff working extra hours on weekends. We were told that there are good arrangements in place for staff to receive on-going training. Some lunch time seminars were organised. There was a suitable induction procedure for new staff. We saw certificates of induction that was issued by the provider to some staff. The provider may find it useful to note that induction checklists and audit of staff knowledge forms kept in individual records were not completed. Staff told us that they had induction shortly after the provider took over. The induction included health and safety, fire safety, and how to comply with the provider's quality management systems. The provider may find it useful to note that not all staff had received regular supervision. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 10
Team meetings were held fortnightly and senior staff meetings were held monthly. We saw records related to these meetings. The manager told us that operational management committee, which discussed governance and strategic issues and was chaired by a general practitioner or Trust's pathology manager, also met monthly. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 11
Assessing and monitoring the quality of service provision The service should have quality checking systems to manage risks and assure the health, welfare and safety of people who receive care Our judgement The provider was meeting this standard. The provider had an effective system to regularly assess and monitor the quality of service that people receive. Reasons for our judgement We were told that 17 complaints about missing specimens and 30 complaints regarding results not being received or being delayed or inaccurate were made in December 2012.. These were recorded, with actions being taken to prevent further occurrence and analyse root causes. We noted that number of complaints and errors had decreased in the first half of 2013. People who use the service told us that the service had improved since the beginning of the year. One person told us, "It will take a long time to have the confidence back, I always double and triple check each of the results received." Staff told us that they were occasionally involved in internal quality audits. Staff felt the provider had systems in place which helped to prevent incidents and protect staff and people who use the service from risk. They were positive about changes and told us that the service had improved since the provider had taken over the management of laboratories. One person said, "changes were good", "we have good recording [systems], improvements are dealt with immediately." At the beginning of 2013 some of the doctors using the laboratory raised concerns regarding the analysis undertaken by the provider. More than the average number of blood tests was either abnormal or missing. In other cases, blood tests had been taken, but results were not reported back. Some results were being sent back in a different format, which some doctors found difficult to understand. The provider took over the management and delivery of pathology service in May 2012. A manager told us that the laboratory had undergone a significant investment and a new laboratory information management system (LIMS) was implemented. The laboratory had been refurbished with new equipment. Initially, the blood transfusion service commenced, which was followed in December 2012 by the blood sciences service (clinical biochemistry and haematology) using the new equipment and LIMS. It was noted that complaints received were due to problems with integration of new equipment and LIMS. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 12
We noted that the provider identified the root causes of problems in March 2013. The provider found that poor communication had contributed to complaints being made about the service. The manager told us that the doctors and other service users had not been informed of changes in pathology service. We saw an action plan prepared in May 2013 which addressed the issues of communication. The provider had allocated staff responsible for communicating with and engaging stakeholders, analysing errors, and preventing samples or results getting lost. We were told that some of the problems that led to complaints were linked to a five day power cut at the laboratories. During this period cellular pathology work was referred out to another hospital. We were informed that the Northwick Park Hospital had since invested in new power generator and was planning to connect the laboratories to this power supply, which would not be interrupted. This meant that the provider improved the service by learning from adverse events, incidents, errors, and near misses. We noted that the provider had a quality audit programme in place. Staff told us that 1% of tests were repeated to ensure accuracy of results. We noted that all laboratories participated in relevant external quality assessment schemes. All laboratories were performing satisfactorily in these schemes. The laboratories were last inspected by Clinical Pathology Accreditation (CPA) assessors in August 2011, following which, the CPA's accreditation was confirmed. However, due to changes in the organisation and management structure of the laboratories the CPA removed the accreditation. The provider informed us that the application for CPA accreditation was submitted for all laboratories at the beginning of the year and they are currently awaiting inspection. We noted that incidents were recorded and actions were set in response to them. The provider may find it useful to note that some of these were not completed in a timely manner in accordance with the set timescales. In addition, the provider may find it useful to note that feedback from people who use the service had not been obtained for the past two years. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 13
About CQC inspections We are the regulator of health and social care in England. All providers of regulated health and social care services have a legal responsibility to make sure they are meeting essential standards of quality and safety. These are the standards everyone should be able to expect when they receive care. The essential standards are described in the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. We regulate against these standards, which we sometimes describe as "government standards". We carry out unannounced inspections of all care homes, acute hospitals and domiciliary care services in England at least once a year to judge whether or not the essential standards are being met. We carry out inspections of other services less often. All of our inspections are unannounced unless there is a good reason to let the provider know we are coming. There are 16 essential standards that relate most directly to the quality and safety of care and these are grouped into five key areas. When we inspect we could check all or part of any of the 16 standards at any time depending on the individual circumstances of the service. Because of this we often check different standards at different times. When we inspect, we always visit and we do things like observe how people are cared for, and we talk to people who use the service, to their carers and to staff. We also review information we have gathered about the provider, check the service's records and check whether the right systems and processes are in place. We focus on whether or not the provider is meeting the standards and we are guided by whether people are experiencing the outcomes they should be able to expect when the standards are being met. By outcomes we mean the impact care has on the health, safety and welfare of people who use the service, and the experience they have whilst receiving it. Our inspectors judge if any action is required by the provider of the service to improve the standard of care being provided. Where providers are non-compliant with the regulations, we take enforcement action against them. If we require a service to take action, or if we take enforcement action, we re-inspect it before its next routine inspection was due. This could mean we re-inspect a service several times in one year. We also might decide to reinspect a service if new concerns emerge about it before the next routine inspection. In between inspections we continually monitor information we have about providers. The information comes from the public, the provider, other organisations, and from care workers. You can tell us about your experience of this provider on our website. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 14
How we define our judgements The following pages show our findings and regulatory judgement for each essential standard or part of the standard that we inspected. Our judgements are based on the ongoing review and analysis of the information gathered by CQC about this provider and the evidence collected during this inspection. We reach one of the following judgements for each essential standard inspected. This means that the standard was being met in that the provider was compliant with the regulation. If we find that standards were met, we take no regulatory action but we may make comments that may be useful to the provider and to the public about minor improvements that could be made. Action needed This means that the standard was not being met in that the provider was non-compliant with the regulation. We may have set a compliance action requiring the provider to produce a report setting out how and by when changes will be made to make sure they comply with the standard. We monitor the implementation of action plans in these reports and, if necessary, take further action. We may have identified a breach of a regulation which is more serious, and we will make sure action is taken. We will report on this when it is complete. Enforcement action taken If the breach of the regulation was more serious, or there have been several or continual breaches, we have a range of actions we take using the criminal and/or civil procedures in the Health and Social Care Act 2008 and relevant regulations. These enforcement powers include issuing a warning notice; restricting or suspending the services a provider can offer, or the number of people it can care for; issuing fines and formal cautions; in extreme cases, cancelling a provider or managers registration or prosecuting a manager or provider. These enforcement powers are set out in law and mean that we can take swift, targeted action where services are failing people. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 15
How we define our judgements (continued) Where we find non-compliance with a regulation (or part of a regulation), we state which part of the regulation has been breached. Only where there is non compliance with one or more of Regulations 9-24 of the Regulated Activity Regulations, will our report include a judgement about the level of impact on people who use the service (and others, if appropriate to the regulation). This could be a minor, moderate or major impact. Minor impact people who use the service experienced poor care that had an impact on their health, safety or welfare or there was a risk of this happening. The impact was not significant and the matter could be managed or resolved quickly. Moderate impact people who use the service experienced poor care that had a significant effect on their health, safety or welfare or there was a risk of this happening. The matter may need to be resolved quickly. Major impact people who use the service experienced poor care that had a serious current or long term impact on their health, safety and welfare, or there was a risk of this happening. The matter needs to be resolved quickly We decide the most appropriate action to take to ensure that the necessary changes are made. We always follow up to check whether action has been taken to meet the standards. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 16
Glossary of terms we use in this report Essential standard The essential standards of quality and safety are described in our Guidance about compliance: Essential standards of quality and safety. They consist of a significant number of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. These regulations describe the essential standards of quality and safety that people who use health and adult social care services have a right to expect. A full list of the standards can be found within the Guidance about compliance. The 16 essential standards are: Respecting and involving people who use services - Outcome 1 (Regulation 17) Consent to care and treatment - Outcome 2 (Regulation 18) Care and welfare of people who use services - Outcome 4 (Regulation 9) Meeting Nutritional Needs - Outcome 5 (Regulation 14) Cooperating with other providers - Outcome 6 (Regulation 24) Safeguarding people who use services from abuse - Outcome 7 (Regulation 11) Cleanliness and infection control - Outcome 8 (Regulation 12) Management of medicines - Outcome 9 (Regulation 13) Safety and suitability of premises - Outcome 10 (Regulation 15) Safety, availability and suitability of equipment - Outcome 11 (Regulation 16) Requirements relating to workers - Outcome 12 (Regulation 21) Staffing - Outcome 13 (Regulation 22) Supporting Staff - Outcome 14 (Regulation 23) Assessing and monitoring the quality of service provision - Outcome 16 (Regulation 10) Complaints - Outcome 17 (Regulation 19) Records - Outcome 21 (Regulation 20) Regulated activity These are prescribed activities related to care and treatment that require registration with CQC. These are set out in legislation, and reflect the services provided. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 17
Glossary of terms we use in this report (continued) (Registered) Provider There are several legal terms relating to the providers of services. These include registered person, service provider and registered manager. The term 'provider' means anyone with a legal responsibility for ensuring that the requirements of the law are carried out. On our website we often refer to providers as a 'service'. Regulations We regulate against the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 and the Care Quality Commission (Registration) Regulations 2009. Responsive inspection This is carried out at any time in relation to identified concerns. Routine inspection This is planned and could occur at any time. We sometimes describe this as a scheduled inspection. Themed inspection This is targeted to look at specific standards, sectors or types of care. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 18
Contact us Phone: 03000 616161 Email: enquiries@cqc.org.uk Write to us at: Care Quality Commission Citygate Gallowgate Newcastle upon Tyne NE1 4PA Website: www.cqc.org.uk Copyright Copyright (2011) Care Quality Commission (CQC). This publication may be reproduced in whole or in part, free of charge, in any format or medium provided that it is not used for commercial gain. This consent is subject to the material being reproduced accurately and on proviso that it is not used in a derogatory manner or misleading context. The material should be acknowledged as CQC copyright, with the title and date of publication of the document specified. Inspection Report The Doctors Laboratory - Whitfield Street July 2013 www.cqc.org.uk 19