Recommendation

Actions Taken / Next Steps

Status

01

As testing methodology and "best practice" continue to evolve as a result of improvements in technology and advances in research, it would not be appropriate to dictate how testing should be performed. The creation of the policies and procedures currently in place at Eastern Health was an important first step towards ensuring that its estrogen and progesterone hormone receptor testing systems and processes, and quality assurance systems reflect "best practice." Eastern Health must identify who is responsible for continual monitoring of consensus statements issued on and research in the area of immunohistochemistry and ensuring appropriate modifications are made to the testing protocols. 

Eastern Health's immunohistochemistry laboratory has a committee consisting of three pathologists that has assumed responsibility for laboratory procedures, protocols and quality control.  Eastern Health has engaged the University Health Network to, among other things, provide specialist services in immunohistochemistry.

Completed

02

It is recommended that the Government of Newfoundland and Labrador create a position of Provincial Director of Pathology and Laboratory Services for the province. This position should exist within the Department of Health and Community Services and be independent of the regional health authorities. The Department should create a job description for this position that clearly outlines the duties and responsibilities, which should include: 

i. assisting the regional health authorities in development of policies and procedures; 

ii. encouraging a collaborative culture of quality within laboratory medicine; 

iii. coordinating efforts amongst regional health authorities to ensure adequate pathology locums are available; 

iv. facilitating the regional health authorities' preparation for accreditation of laboratories; 

v. coordinating educational opportunities and dissemination of information amongst pathologists throughout the province; 

vi. coordinating educational opportunities and dissemination of information amongst laboratory staff throughout the province, including technologists and pathology assistants; 

vii. promoting a high quality of pathology and laboratory services throughout the province; 

viii. creating a strategic plan for provincial recruitment and retention of pathologists and laboratory medicine technologists.

The position of Provincial Director of Pathology and Laboratory Medicine has been created and the position has been advertised.  The provincial director will be located within the Department of Health and Community Services (the department) and will report directly to the medical consultant. This position is also affiliated with Memorial University School of Medicine.

Substantially complete

03

In recognition of the critical importance of "quality," it is recommended that in each regional health authority there be a separate quality portfolio. A separate position of Vice-President Quality must be created to manage this portfolio. The individual in this position would have a multi-functional role that includes providing assistance to all departments in areas of quality assurance and quality control, and ensuring all policies and procedures relating to quality are being fully complied with. While risk management might fit within this portfolio, claims management should not be included.

Each Regional Health Authority (RHA) has created a position of Vice-President (VP) Quality whose main responsibility is quality. The VP Quality is responsible at the senior management level for implementing the Cameron recommendations. Claims management is not a responsibility of persons occupying the VP Quality position.

Completed

04

It is recommended that the Government of Newfoundland and Labrador require each regional health authority to obtain a license in order to operate a laboratory. It is further recommended that as a condition of licensure, each regional health authority must participate in a recognized accreditation program for laboratories. A national program would raise the standard of practice across the country. A national accreditation program, therefore, is the optimum method of accreditation. I recommend that the Government of Newfoundland and Labrador utilize best efforts to work with other provinces towards establishing a national accreditation program. In the interim, it is recommended that the province require, as a condition of license, that each regional health authority participate in a recognized laboratory accreditation program to ensure that the laboratories within this province operate at the standard required for accreditation. All regional health authorities should have support for meeting these standards. Examples of support required are funding to bring the laboratories up to accreditation standards and assistance, the preparation of manuals and policies for practice. It is important to note here that the external laboratory accreditation program should be a complement to other external and internal approaches to proficiency testing and quality assurance.

The minister has informed CEOs that all RHAs must participate in mandatory laboratory accreditation. Quality Management Program - Laboratory Services (QMP-LS) has been identified as the preferred vendor to conduct this laboratory accreditation. QMP-LS offers accreditation services based upon standards specified by the International Standards Organization (ISO).    

Partially complete

05

Reports were prepared by Mr. Williams Parks and Mr. Bryan Hewlett on review of laboratories at each regional health authority. It is recommended that each regional health authority implement the recommendations contained in the report related to that health authority. It is further recommended that each regional health authority examine the reports relating to other health authorities and implement any recommendations also relevant to their laboratories. For example, implementing a practice of further separating cassettes in the tissue processor as done at the Charles S. Curtis Memorial Hospital may be appropriate for laboratories at other regional health authorities.

RHAs have made significant progress in implementing Hewlett-Parks recommendations. 

Western Health — 12 of 14 Hewlett-Parks recommendations from the October 2, 2008 review are in place. The two remaining recommendations are in progress and refer to continuing professional development and the hiring of a Technologist III position who would be assigned responsibility for processing quality control information.  

Eastern Health — Seven of 11 recommendations are in place, two recommendations are in progress, another is implemented using another process, and one is outstanding.   The outstanding recommendation involves slides and blocks being brought together for comparison after staining.  

Labrador-Grenfell Health - 20 of 24 Hewlett-Parks recommendations are in place. Four recommendations are in progress.  

Central Health — 16 of 18 Hewlett-Parks recommendations from the October 3, 2008 visit to James Paton Memorial Regional Health Centre, Gander, have been completely implemented at James Paton and Central Newfoundland Regional Health Centres. The remaining two recommendations are in progress.   

RHAs have shared and reviewed each others' reports and are in the process of determining which recommendations targeted for specific RHAs might also be applicable to them.

Substantially complete

06

It is recommended that each regional health authority establish morbidity and mortality (quality assurance) rounds for pathology; Eastern Health should also establish such rounds for medical oncology. Both Dr. McCarthy and Dr. Laing, in their testimony before the Commission, discussed the importance of these rounds to quality assurance. All pathologists and oncologists should be required to participate in such rounds as a condition of continued employment with the regional health authority; accommodations need to be made to allow participation by pathologists and oncologists who work in areas that would prevent them from physically attending. These accommodations could include the use of teleconference or videoconference technology. Best practices for these rounds should be developed as soon as is practicable.

Eastern Health pathologists now participate in patient specific (tumor board) rounds, grand rounds (educational — around specific topics) and morbidity and mortality rounds with oncologists. The oncology program at Eastern Health is developing provincial multidisciplinary morbidity and mortality rounds with pathologists and oncologists.  

While historically morbidity and mortality rounds have worked under an informal structure, a template for such rounds, developed by Eastern Health has been shared with each RHA. RHAs are now in the process of adapting this tool for implementation and pathologists will be active participants in these rounds.

Many of the rounds mentioned above are, by their nature, multidisciplinary in their format.  The department is about to engage an individual to research, recommend, implement, and evaluate best practice in multidisciplinary rounds for Newfoundland and Labrador which include oncology rounds.

Partially complete

07

Pathologists and oncologists should be required to participate in multidisciplinary rounds. The regional health authority should be responsible for ensuring the development of best practices for these rounds. Quality assurance and quality control must be considered a mandatory part of the job of all clinicians.

08

Time required for participation in rounds should be considered when determining the number of pathologists and oncologists required for each institution so that physicians do not have to choose between day-to-day tasks and participation in the quality assurance process. This is consistent with the report of Dr. Maung to the Government of Newfoundland and Labrador in 2007.

The appropriate number of oncologists and pathologists in the province has been allocated as recommended in Dr. Raymond Maung's report of 2007.  Dr. Maung is an expert in the field of pathology workload assessment. The time required for quality assurance, research, continuing medical education, teaching and administration has been factored into the RHA allocation for pathologists and oncologists.

Completed

09

It is highly desirable to collect all data required to maintain laboratory metrics for estrogen receptor and progesterone receptor test results. It is therefore recommended that each regional health authority designate a staff person who is responsible for tracking ER and PR metrics within the regional health authority. It is recommended that Eastern Health track metrics not only for its own patients, but also for results of all tests completed at the IHC laboratory. These numbers should be compiled, at a minimum, on an annual basis. All regional health authorities should provide reports containing this data to the Department of Health and Community Services. This data would be a valuable tool for detecting potential problems, although it is important to point out that, as Dr. Mullen told the Commission, waiting for a deviation from an expected percentage would not be the most prudent or expeditious way to detect problems. Investigations should still be triggered based on individual cases that deviate from the norm, since to misdiagnose or misinterpret one test result affects patient care substantially.

Each RHA has designated a staff person for tracking ER/PR metrics. When Eastern Health does resume ER/PR testing it will be tracking ER/PR metrics for the province.  The review of daily quality control checks will enable identification of cases that deviate from the norm and clinicians are to discuss such deviations with laboratory personnel. The Minister of Heath and Community Services has notified RHAs that ER/PR metric reports are to be submitted to the department semi-annually.

Completed

10

It is recommended that information collected by regional health authorities relating to quality control and quality assurance within their laboratories be used appropriately to take corrective actions to prevent occurrences from happening. This information should be kept in electronic format for more effective usage and analysis of the information.

Quality management is a critical issue for RHAs and the department and quality control / assurance are essential elements of a quality management system.; Budget 2009-10 committed $1 million for laboratory accreditation and $1.3 million for additional laboratory staff. RHAs continue their work to ensure that information collected relating to quality control / assurance within their laboratories is used appropriately to take corrective actions and therefore prevent occurrences.

Central Health has initiated phase one of QMS development and has hired two quality managers and an IT specialist for laboratory services.  

Western Health has implemented a protocol for corrective action from a quality control aspect and has hired a quality assurance manager and a clinical IT specialist.  

Eastern Health has created a new Quality Management Division in Laboratory Medicine. Eight quality coordinators are assigned to this department. Eastern Health is developing and implementing its laboratory QMS in compliance with ISO 15189 for medical laboratories.  

Labrador-Grenfell Health has quality management policies in place and has created two laboratory quality assurance positions and an IT laboratory administrative position.  

The department will continue to work with RHAs to ensure greater standardization of their quality management systems. 

With the exception of Labrador-Grenfell Health, much of the RHA quality control information is already captured in electronic format.  All RHAs, using the Meditech Laboratory Information System, are moving toward electronic capture for the majority of quality control information.

Partially complete

11

It is recommended that all regional health authorities utilize proficiency testing within their laboratories. The quality and safety framework within each regional health authority should include a regular schedule of internal and external audits, and these audits must cover all aspects of work being performed in the pathology laboratories. Internal reviews, such as the exchanges that have been conducted between Grand Falls and Gander, and Carbonear and Clarenville, should be encouraged and continued. Other regions should consider setting up similar exchanges.

All RHAs utilize proficiency testing within their laboratories. Currently, RHAs engage in internal and external auditing, to varying degrees. When the Provincial Director of Pathology and Laboratory Medicine is in place, the director will be tasked with ensuring there is a standardized program of internal and external audits.  Target completion date for standardization is April 2011.

Substantially completed

12

I note that Eastern Health is in the process of implementing an electronic occurrence reporting system. All other regional health authorities should implement a similar system, with co-operation and coordination among all four regional health authorities to ensure the system is utilized to its full potential and that information gained within each authority can benefit all health authorities and prevent the repeating of similar adverse events.

In Budget 2009, the Provincial Government committed $3 million to expand Eastern Health's Clinical Safety Reporting System to all RHAs.  NLCHI is responsible for this expansion and has released a request for proposals to implement this project. Target completion date for all RHAs is March 2012.

Partially complete

13

Eastern Health, as mentioned above, has created standard operating policies and procedures for their laboratory. All other regional health authorities should ensure that standard laboratory operating procedures are in place, That staff are made aware of these procedures, and that a process is in place to ensure compliance. These policies should also contain provisions to ensure they are regularly reviewed and updated.

RHAs are ensuring that all standard operating procedures are in place and documented, that personnel are aware of these procedures and that a process is in place to ensure compliance. Eastern Health alone reports over 700 standard operating procedures for their laboratories.  This work will be completed by March 2011.

Partially complete

14

It is recommended that there be an assessment to identify upgrades required to the laboratory premises and laboratory equipment within the Central, Western, and Labrador-Grenfell Regional Health Authorities. Resources needed to complete required expansion or upgrades to prepare these laboratories for the accreditation processes should be provided.

As RHAs go through the ISO laboratory accreditation process, a formal assessment to identify upgrades required to laboratory premises and equipment will be conducted.  This assessment will be additional to the department's annual RHA needs assessment in terms of facilities and equipment. In 2009-10 the Provincial Government invested $4.7 million to upgrade laboratory equipment and facilities. Additional resources needed to complete required expansions or upgrades indicated in the laboratory accreditation process will be allocated as necessary.   

Partially complete

15

At the time of the review of Mr. Parks and Mr. Hewlett, a noticeable disconnect existed between individual work areas within the histology laboratory at Eastern Health and the management goals. Dr. Banerjee also noted in his initial report that "superior outcomes could be achieved by ensuring better linkages between technical, managerial and medical leadership." Accountability has to be clear; the reporting structure within the Laboratory Medicine Program of Eastern Health must reflect the requirement of interaction between technologists and physicians to ensure best possible quality assurance outcomes. I recommend leadership training for management within the pathology division of the Laboratory Medicine Program.

Since the release of the Cameron Report, the reporting structure at Eastern Health has changed significantly. The Chief of Laboratory Medicine now has the overall authority and accountability for the Laboratory Medicine Program. This is reflected in Eastern Health's revised organizational chart.  The Chief of Laboratory Medicine and other management staff will continue to participate in leadership training.

Completed

16

As noted in the report of Mr. Hewlett and Mr. Parks, staff in the laboratory is in constant flux, which is counterproductive to a motivated, highly skilled, and productive technologist work force. While Eastern Health has dedicated three technologists to the IHC service, a succession plan should be implemented to minimize future attrition problems. The Canadian Society for Medical Laboratory Science states that a shortage of medical laboratory technologists will occur as large numbers of medical laboratory technologists retire over the next five to ten years. This shortage must be addressed so that patient waiting times, and therefore timely access to appropriate treatment, are not adversely affected. The Department of Health and Community Services should carry out an analysis of requirements for medical laboratory technologists within the province for the foreseeable future and take steps to address any potential shortage. Addressing any potential shortage of medical laboratory technologists must not be accomplished by lowering the standards for admission into the training program.

A Laboratory Human Resources Planning Committee has been formed at Eastern Health, chaired by the Director of Laboratory Medicine. This committee comprises staff from the Human Resources Program and Policy Development Department, as well as laboratory technologists from city hospitals and outside-city laboratories at the regional level. A department-led Cameron Provincial Working Group is preparing a medical laboratory technologist workforce model, with a draft report expected by May 2010.

Partially complete

17

With advances in technology and knowledge in the area of immunohistochemistry, highly skilled laboratory staff will be required to implement successfully new protocols and procedures. Eastern Health must develop, maintain, and update as appropriate all job descriptions for both technical and medical staff working in the IHC laboratory.

Eastern Health is updating job descriptions for all laboratory positions including Immunohistochemistry laboratory positions. This work will be completed by September 2010. 

Substantially complete

18

Eastern Health should develop formal in-house training programs for new immunohistochemistry technologists. Until these training programs are developed and implemented, Eastern Health should retain outside expertise to attend at its IHC laboratory to train the new staff. As a less desirable alternative, new staff could be sent for training to a laboratory that already has an acceptable training program in place. It is helpful to refer to the testimony of Ms. Maria Tracey on orientation and training for operating room nurses. The strict approach developed and followed for the nursing peri-operative program should be applied to laboratory technology staff, as these positions are also extremely important to safe and accurate patient care. Reference should also be made to the testimony of Ms. Patricia Wegrynowski, Mr. William Parks, and Mr. Bryan Hewlett relating to training required for laboratory staff at their respective institutions.

Eastern Health continues to work to develop standardized training and educational programs throughout its laboratories.  Eastern Health is in the process of developing its own in-house training program for immunohistochemistry technologists.

Substantially complete

19

To ensure continuing quality within pathology laboratories, it is recommended that histology and IHC laboratory technologists be required to demonstrate their competency, at a minimum, on an annual basis. All regional health authorities must conduct annual performance evaluations of histology and IHC technical staff and managers.

RHAs have policies that require either annual or bi-annual performance evaluations. RHAs that have not already done so will amend policies as necessary, to ensure performance evaluations of histology and IHC technical staff and managers occur annually. These policy amendments will be competed by May 30, 2010. Some RHAs have already completed this round of performance evaluations; the remaining RHAs will complete evaluations by August 2010.

Substantially complete

20

All immunohistochemistry and histology laboratory technologists should be required to complete mandatory continuing education each year. Continuing education is vital in any area that continues to have new developments, particularly laboratory medicine. Regional health authorities should work cooperatively on this to ensure resources are maximized. Technologists should also be encouraged to complete online courses. Regional health authorities should support this effort by providing staff with the time required to complete the courses and the funding to pay for them.

The Health Professions Act (umbrella legislation) will mandate continuing education for all professions governed under it.  This legislation will be ready for the spring 2010 sitting of the House of Assembly.  Currently, RHAs support and actively encourage continuing education programs (for example, Canadian Society for Medical Laboratory Science education modules) and provide opportunities for personnel to attend external professional development sessions.

Substantially complete

21

The Laboratory Medicine Program at Eastern Health in setting its annual goals and objectives should place a greater emphasis on investment in human resources. This would assist in creating an environment that attracts and maintains highly qualified staff, and encourage their ongoing professional growth. In their review of Eastern Health laboratories, Mr. Parks and Mr. Hewlett noted that implementing new technologies requires not only purchasing new equipment, but also a "strong core group of experienced technologists with intimate knowledge and deep understanding of the current technology and willingness to learn and apply the new technology. The application of any new technology without this experience, knowledge and understanding can have dire consequences."

The laboratory operational plan includes a goal and objectives to enable achievement of this recommendation: 

Partially complete

22

It is recommended that the legislation currently being developed for licensing and regulation of medical laboratory technologists be completed as soon as is practicable.

Umbrella legislation will be introduced in the spring 2010 sitting of the House of Assembly. Licensing of medical laboratory technologists will occur following the passing of the legislation.

Substantially complete

23

While the province has substantially increased the benefit package available to pathologists in this province, there must be a plan developed to ensure the sustainability of this professional group. With respect to recruitment, the Department of Health and Community Services should develop a contingency plan for the establishment of pathology services in the event that an adequate number of qualified pathologists cannot be recruited and retained in all provincial hospital laboratories. Particular emphasis should be given to recruitment efforts in rural areas to allow "respite" for pathologists who work alone in institutions and have no colleague to relieve them. To this end, the Department of Health and Community Services should develop and implement a system to ensure adequate locums are available for pathologists. The Department of Health and Community Services should also implement a system to assess pathology manpower requirements on an ongoing basis. The regional health authorities must also continue to ensure recruitment and retention of pathologists is given high priority.

The province has a strategy to recruit and retain physicians, including pathologists.  This year, as part of the strategy, the department has funded recruitment officers for each RHA; these officers will be appropriately trained. The process to assess human resource requirements for pathology is included in a report completed by Dr. Raymond Maung. The current allocation of pathologists to RHAs was based upon Dr. Maung's assessment using a workload measurement tool.  The tool will guide the department in the ongoing assessment of pathologist requirements for the province. The department is examining best practices nationally and internationally with a view to developing a provincial locum registry for physicians. Target completion date for the provincial locum registry is May 2010.

Completed

24

The Department of Health and Community Services and the regional health authorities should work together to explore alternative means of providing pathology services within the province and assistance to pathologists in their practice. It is recommended that a program be implemented to provide pathologists who work alone with a means for receiving feedback, advice, and interaction from colleagues. The Department of Health and Community Services should also ensure that adequate resources are available to fund technical resources such as telemedicine technology, particularly for pathologists who work alone, as well as new technology in the field of pathology digital imaging and computer transmission.

In 2009, Canada Health Infoway officially approved a proposal submitted by a Tri-Provincial partnership including Newfoundland and Labrador, Manitoba, and Ontario for a multi-jurisdictional telepathology network planning project.  The intention of this project is to replicate the Northern Ontario telepathology project whereby provincial hubs are created in Newfoundland and Labrador and Manitoba.  Once fully operational, all three participating jurisdictions will benefit from the ability to remotely engage pathologists to support local workload management issues and to access sub-specialty pathology services. This will result in earlier completion of expert pathology review and diagnosis, and expediting treatment decisions including timely access to surgery where appropriate. At present solo pathologists in Newfoundland and Labrador have linkages developed with colleagues internal and/or external to the province so that feedback, second opinions, and further advice can be provided.  The department will make continued funding available as necessary to support this recommendation.

Substantially complete

25

The Department of Health and Community Services should investigate and study the potential for the expansion of services that could be provided by pathology assistants to laboratories in the province.

The department has determined there is a role for pathology assistants within the province; however, some RHAs report limited availability of trained people to fill these positions. Furthermore, contact was made with the Canadian Society for Medical Laboratory Science (CSMLS) who indicated it would not be developing IHC and pathology assistant training programs.  Discussions are on-going with Eastern Heath to examine the possibility of developing a provincial training program for pathology assistants.

Completed

26

Pathologists should have a positive obligation to identify and inform their superiors when they have inadequate experience or any limitation in their ability or expertise with respect to performing a particular test or in assessing any particular case.

Pathologists have an ethical obligation as part of licensure to identify professional limitations and report the same to their superiors.

Completed

27

Continuing medical education for pathologists and oncologists must be mandatory and funded.  Each regional health authority should develop a written protocol for continuing education for pathologists and oncologists in accordance with the requirements of the region. Each regional health authority has the responsibility to ensure the protocol is followed, and that adequate protected time and resources for these physicians is provided to allow them to participate.

The department provides annual continuing medical education funding to pathologists and oncologists. The minister has written RHA CEOs directing them to make continuing education for pathologists and oncologists mandatory.  RHAs will complete written protocols for continuing education for pathologists and oncologists by June 30, 2010.

Substantially complete

28

It is recommended that the appropriate person within each regional health authority complete an annual performance review of the work of each pathologist and oncologist. The regional health authority is responsible for ensuring these reviews are completed.

The majority of these annual performance reviews are complete.  Two RHAs will have this year�s performance reviews of the work of each pathologist and oncologist completed by March 31, 2010.  The other two RHAs will have this work completed by August 2010.

Substantially complete

29

It is recommended that the Royal College of Physicians and Surgeons of Canada consider expanding opportunities for sub-specialization within pathology.

The Director of Education at the Royal College of Physicians and Surgeons Canada (RCPSC) has been contacted. Currently there are no plans for further sub-specialization in pathology. The RCPSC does have in place a diploma program so that additional skills can be developed in a particular field.  This allows local expertise to be developed under national standards while the overall function of the pathologist as a generalist continues.

In addition, the minister has written the RCPSC to request that they consider expanding opportunities for sub-specialization within pathology.

Completed

30.

Given the shortage of pathologists, faculties of Medicine are encouraged to promote interest in pathology as a specialty by exposing students to pathology in the early years of their program. Faculties of Medicine are also encouraged to expand their curriculum to ensure all medical students are educated as to the important, underlying role of pathology in the practice of medicine.

The Acting Dean of Memorial University's Faculty of Medicine reports that at Memorial University all specialties are promoted in the Medical School. In addition, the acting dean confirms the new curriculum to be introduced in 2012 will be much more clinically relevant for pathology beginning in the first month of medical school.  The Undergraduate Office of the Medical School is exploring the possibility of offering a four to six month longitudinal experience in pathology during the final year of medical school.

Completed

31

Each regional health authority must develop and maintain a crisis management plan. Elements of a crisis management plan must include:

i. a clear articulation of the roles of those managing the crisis;

ii. information management and record keeping;

iii. the role of the Board of Trustees;

iv. identification of special skills required to manage the crisis;

v. provision for notification of the Minister responsible   under the Regional Health Authorities Act;

vi. a plan for communications, which would include with whom one should communicate, when communications should occur, and the method used to communicate;

vii. a conflict of interest policy.

Three RHAs have finalized draft crisis management plans that include the "core elements" as specified in the Cameron Report.  A fourth RHA's crisis management plan is complete with the exception of a crisis communications component. All four RHA crisis management plans will be finalized by April 2010.

Substantially complete

32

Regional health authorities should develop a protocol for management of multi-regional crises.

The department will be engaging a facilitator to meet with RHAs once their individual crisis management plans have been finalized (April 2010). The facilitator will work with RHAs to develop a multi-regional protocol, consistent with RHAs' individual crisis management plans. Target completion date is June 2010.

Partially Complete

33

It is recommended that the Government of Newfoundland and Labrador consider whether section 8.1 of the Evidence Act remains relevant.

Recommendations 33, 34 and 35 are under active consideration and because of their complexity and the level of public interest will be placed on the agenda for the national meeting of health ministers in September 2010.

The department will explore the possibility of retaining an expert in the area to review these issues in further detail.

Partially complete

34

It is recommended that any conflict between section 8.1 of the Evidence Act and section 12 of the Public Inquiries Act, 2006 be resolved in favour of permitting Commissions of Inquiry to have access to peer review and quality assurance reports.

35

It is further recommended that legislation be enacted to specify that adverse event disclosure to patients include an explanation of why the adverse event occurred and what is being done to ensure that a similar event does not occur in the future.  Disclosure should also involve providing the patient with a copy of any peer review or quality assurance report respecting the adverse event. As explained in this Report, the names of the individuals who participated in the peer review or quality assurance may be removed prior to disclosure. I recommend that these rights be entrenched in legislation and that they be given priority over any prohibition contained in section 8.1 of the Evidence Act.

36

It is recommended that the Government of Newfoundland and Labrador adopt apology legislation. While in many cases professionals do not need the protection of legislation to allow them to apologize, many experts have recognized the importance of apologies to both the care provider and the patient.

The Apology Act was passed in the spring 2009 sitting of the House of Assembly.

Completed

37

The Department of Health and Community Services should conduct a province-wide assessment of the information management needs of the regional health authorities. The communication problems that became evident during the ER/PR issue demonstrate why it is essential that this be done on a province-wide basis. Following this assessment of information management needs, any system chosen for data management should be capable of such things as:

i. ensuring that the results and reports of all diagnostic and treatment services referred by a physician to a regional health authority laboratory are transmitted to the treating physician in a timely manner;

ii. creating reminders within the laboratory when requested work has not been completed on a timely basis;

iii. tracking reports back to the physician who requisitioned them and confirming that reports are received and opened. If reports are not opened within a set period of time, the system should flag the report and send it back to the originating laboratory for follow-up;

iv. creating a reminder, after a certain period of time passes, that a report has not been returned when a consult was sent to an external institution;

v. communicating amongst regional health authorities.

This initiative is being combined with an already existing e-health strategic planning process.  At the request of the Cameron Provincial Working Group responsible for actioning this recommendation, NLCHI is to "prepare a high level compilation of the existing information systems, identify those that are standardized or capable of presently sharing information between and among RHAs and between RHAs and physician offices. Where deficits exist, NLCHI will identify what needs to be done to correct omissions." A high level approach for the revised planning process has been prepared and detailed planning continues. To engage the required range of stakeholders as effectively as possible and deliver results sooner, a phased approach is being utilized. A consultant team has been engaged for the first phase of the planning and assessment and the process has begun.

Partially complete

38

The Cancer Care Program must develop and implement policies and procedures to ensure treating physicians receive all information concerning their patients in order to ensure timely and safe patient care.

The Cancer Care Program, Eastern Health, is in the process of purchasing a new oncology patient information system.  A request for proposals is being completed in which one of the specific requirements outlined includes capacity of interface with the Meditech system.  Once the new system is in place, new policies and processes will be developed and implemented.

Partially complete

39

A province-wide electronic medical record system must be developed and implemented, including support for all regions and positions to have appropriate access to the system. 

This is a complicated piece of work that will take years to complete. The development of an Electronic Health Record (EHR) has been underway for a number of years. The following three components are complete: client registry, provider registry and the Picture Archiving and Communications System (PACS) for digital images. The Pharmacy Network went live (November 2009) and further rollout is ongoing. This system will be rolled out across the province through fiscal year 2010-11. In March 2009, the Provincial Government announced approval of the iEHR / labs project which will provide the lab module, along with improved information sharing between all EHR components. The Lab/iEHR project is currently at the planning and request for proposal (RFP) development stage. Budget 2009 also approved funding for development of a provincial vision/plan for the consolidation of patient information systems (Meditech) within regional health authorities. This planning effort has started. 

Partially complete

40

When one regional health authority is performing work referred from another regional health authority, there must be an obligation to share any information relevant to that work. The Provincial Director for Pathology and Laboratory Medicine should coordinate collaboration amongst laboratories to enhance overall quality of service.

Under the circle of care model, all RHAs agree that sharing of information with the appropriate health care provider must occur, regardless of which health authority performed the work. While systems are in place for sharing information across RHAs, the Integrated Electronic Health Record system will allow all of the functionality required.

The position description for the Provincial Director of Pathology and Laboratory Medicine includes coordination and collaboration amongst laboratories as one of the director's key responsibilities.

Partially complete

41

Each regional health authority is responsible for the maintenance of a record-keeping system which enables responsible physicians to easily access and search all information required for safe and timely patient care. As valuable as the Cancer Registry is for the functions for which it was established, health authorities cannot abrogate responsibility for information management by virtue of the fact that the Cancer Registry exists.

The Provincial Records Management Committee continues to support provincial consistency and ongoing improvement with records management. The RHAs, NLCHI and the department are in the process of developing an Integrated Electronic Health Record System. This will provide a province-wide, patient-centric view of lab results, medical images, and related reports, drug information, admissions history, various medical reports and other elements yet to be identified.  The planned Electronic Medical Record, as a component of the Electronic Health Record System, will have enhanced search functionality. This will enable responsible physicians to easily access and search all information required for safe and timely patient care.

Partially complete

42

I agree with the review of positive cases currently being undertaken by Eastern Health where re-test results could potentially change a patient's original decision relating to the use of anti-hormonal therapy. A similar review should be undertaken in each of the other regional health authorities.

Oncologists, external to the province, have been contacted to review this recommendation and provide an opinion as to the value of its actioning. Terms of reference have been provided to the oncologists. The department is currently receiving opinions and once all reports are available it will make a final determination around recommendation 42.

Partially complete

43

It is recommended that the Department of Health and Community Services engage consultants external to the regional health authorities to assist with the investigation and decision as to what action, if any, is required for the remaining patients who originally had ER positive test results and, to date, have not been re-tested. This analysis should be undertaken with a view both to patient care and to obtaining as much information as possible about the circumstances which gave rise to the ER/PR problem. The decision as to whether further testing is required rests with the Department of Health and Community Services upon receipt of the consultant's report.

Oncologists, external to the province, have been contacted to review this recommendation and provide an opinion as to the value of its actioning. Terms of reference have been provided to the oncologists. The department is currently receiving opinions and once all reports are available it will make a final determination around recommendation 43.

Partially complete

44

It is recommended that the regional health authorities identify all patients who have already been re-tested and whose hormone receptor status changed from "positive" to "negative" on re-test, and that an analysis be conducted to ensure that each such individual case has been reviewed to determine whether patients were appropriately treated and have been advised of their changed hormone receptor status.

There are 11 patients in this cohort. An analysis of each case has been conducted and has revealed that all patients were appropriately treated. Seven of the 11 patients have been appropriately notified of their re-tested hormone receptor status. Two of these 11 were deceased prior to re-testing and as such their next-of-kin were appropriately notified. One patient under the jurisdiction of Central Health and one under the jurisdiction of Eastern Health were also deceased prior to re-testing and the next-of-kin of these patients are being contacted as part of the next-of-kin follow-up related to recommendation 48.

Completed

45

Given the ambiguity surrounding the contact of the patients from Saint-Pierre and Miquelon, it is recommended that further investigation be undertaken by Eastern Health to ensure that all patients have been contacted.

The final listing of patients identified to be from St. Pierre et Miquelon is complete. All involved patients (9) and/or their next-of-kin have been contacted regarding the initial and re-test ER/PR results. The administration of St. Pierre et Miquelon acknowledges that all patients have been appropriately contacted.

Completed

46

It is recommended that an audit be conducted of the work of the pathologists who were identified through the ER/PR re-testing process as having interpreted background staining incorrectly as nuclear staining.  Dr. Dabbs and Dr. Torlakovic recommended that an audit occur in such circumstances.

Eastern Health reports that it was informed by the Cameron commission staff that the work referenced in this recommendation relates only to pathologists' ER/PR testing. Before any decision is made regarding re-starting ER/PR testing at Eastern Health, external expert opinions will be obtained pertaining to the appropriate policies, procedures and audits.

Partially complete

47

Only specimens from patients with primary breast cancer were candidates for the re-testing process commenced in 2005. There were non-primary breast cancer patients who had ER/PR testing performed between 1997 and 2005 and therefore did not have their specimens re-tested. It is recommended that a review be undertaken by an external expert to determine what the ER/PR test was utilized for in those cases and whether, in the best interest of these patients, re-testing of their specimens is warranted. If the expert recommends re-testing of those specimens, the regional health authority responsible for each patient must arrange for the re-testing at the earliest possible time.

Non-primary breast cancer refers to cases where the origin of the cancer is not the breast. The specific circumstance where the ER/PR test is used is for patients presenting with metastatic cancer and the source of the primary cannot be found. In these situations the patient would undergo a multitude of diagnostic testing including ER/PR testing in an attempt to determine the etiology of their metastatic disease. Correspondence is ongoing with Dr. Nevin Murray, medical oncologist with the British Columbia Cancer Agency, and the department is seeking further clarificationon re-testing of specimens. This group of patients would be very small in number.

Substantially completed

48

It is recommended that all reasonable efforts be made to identify and contact next of kin of the deceased patients whose specimens were re-tested as part of the ER/PR review. The regional health authority responsible for each of these patients should send letters to the next of kin advising that re-testing results are available and   providing contact information to obtain the results should they wish to do so.

The RHAs and the department collaborated closely to develop a work plan around this recommendation. Letters to next-of-kin have been released indicating that re-test results for their family member are available upon request.

Completednt>

49

It is recommended that the Department of Health and Community Services engage the Newfoundland and Labrador Centre for Health Information to undertake further investigation as to whether any other use could or should be made of the data that was retrieved by the Commission from the DAKO Autostainer. As well, an analysis should be undertaken to determine whether the data can provide any useful information on the cause of the changed results, such as whether there is any correlation between changed test results and particular runs or particular dates.

In March 2009, the Newfoundland and Labrador Centre for Health Information (NCHLI) contracted Patricia Wegrynowski, Mount Sinai Hospital, to extract the data from the DAKO system and provide NLCHI with a usable database for analysis.  Ms. Wegrynowski reported that only 230 out of an expected 3,000 ER/PR records were found on the DAKO files provided to the NLCHI by the Commission of Inquiry.  NLCHI determined that further analysis of 230 files recovered would not provide any added value as the files contained very little information. NLCHI considered the gold standard was to conduct a review of paper charts and the RHAs' hospital information systems.

Completed

50

It is recommended that data from the ER/PR re-testing review, including any subsequent reviews carried out pursuant to these recommendations, be collected and analyzed to obtain all useful information from this event. As there is a dearth of studies on this issue, review and analysis of available data presents an opportunity for research to be carried out. For example, patients who were placed on anti-hormonal treatment following changes in their ER/PR results should be followed and data collected to determine the efficacy of treatment initiated at various times post-diagnosis.

The department has formally accepted a proposal to partner with Eastern Health and the Dr. H. Bliss Murphy Cancer Care Foundation to create an ER/PR research fund. Details on this fund will be announced shortly by the three partners.

Substantially complete

51

All regional health authorities should have a policy to deal with disclosure of adverse events. Disclosure relating to adverse events should include:

i. the facts;

ii. the actual or potential impact of the event on the patient;

iii. an expression of sympathy or regret;

iv. an overview of the process that will follow;

v. an explanation of why the event occurred;

vi. what is being done to ensure that a similar event does not occur in the future;

vii. whether a review has been conducted: if so, the patient is to be provided with a copy of any reports emanating from the review, if requested;

viii. an offer of future meetings;

ix. time for questions;

x. offers of support.

All RHAs have a policy in place to deal with disclosure of adverse events which includes the elements outlined in the Cameron Report.

Completed

52

The skills for communicating with patients about adverse events can be learned. Physicians should be trained in disclosure of adverse events. The training of physicians should include not only patient disclosure, but also patient safety and quality assurance practices. This training should be part of continuing medical education.

Phase one of training, which included physicians, was conducted by the Institute Healthcare Communications in St. John's in October 2009.  Phase two training will be conducted at the RHA level in the spring 2010.   At the end of phase two, staff within RHAs will be certified to conduct training sessions. Funding is being provided by the department for phases one and two training.

Substantially Complete

53

It is also important that staff involved in disclosure of adverse events to patients have the skill and knowledge to do so. The regional health authorities should identify the appropriate persons to conduct disclosure, what support these individuals need, how best to educate them as to the particulars of occurrences, what they should convey to the patients, and the health authority's disclosure policy.

RHAs have identified appropriate persons to conduct disclosure. Training sessions referred to in recommendation 52 are designed to educate staff as to the particulars of occurrences, what they need to convey to patients, and health authority disclosure policies.  RHA disclosure policies also address what support these individuals need.

Completed

54

It is recommended that for ethics consultations occurring within regional health authorities, priority be given to ensuring there is balance of perspectives amongst those participating. If the consultation is dealing with disclosure to patients, the presence of a person or persons who can articulate and advocate for the position of patients is required.

Currently each RHA has an ethics committee set up under a framework designed to ensure a balance of perspectives.  Western Health, Central Health, and Labrador-Grenfell Health currently have an informal process for accessing Eastern Health's ethicists.   The department is facilitating discussions between Eastern Health and the other RHAs with a view to formalizing the participation of Eastern Health's ethicists as needed / upon request.

Substantially complete

55

It is recommended that each regional health authority's disclosure policies be reviewed periodically to ensure compliance with current standards. Audits should be undertaken by each regional health authority to ensure that policies are current and that staff are aware of and comply with policies.

As part of its commitment to assist RHAs in providing quality health care services the department is in the process of establishing a provincial coordinating office for adverse health event management. The coordinating office will ensure that RHA policies pertaining to disclosure are in place, current, reviewed periodically and complied with. Additionally, an efficiency and effectiveness evaluation of the provincial occurrence information system will be conducted every three years. The department has initiated recruitment of the coordinator for the provincial coordinating office.

Completed

56

It is recommended that the regional health authorities post policies and procedures relevant to disclosure and patient safety on their respective websites and make them available to the public on request. To demonstrate their commitment to the principle of transparency and to assist in rebuilding public confidence in the healthcare system, any assessment or accreditation of the regional health authority relating to patient safety indicators should also be posted on the website and made available to the public.

All RHAs have posted their disclosure policy on their respective websites.  The RHAs are undergoing accreditation in 2010, through Accreditation Canada, and patient safety is one of eight quality dimensions measured. Once this process is completed and reports received, the accreditation results will be posted to RHA websites.  As well, assessments or accreditation of the regional health authorities relating to patient safety indicators, collected outside of the Accreditation Canada process, will be posted.

Completed

57

All regional health authorities must preserve communications related to an adverse event, including all forms of electronic communication. Each regional health authority should develop a policy to that effect and educate its staff as to the importance of adhering to the policy.

Three RHAs are revising existing policies to incorporate all elements of this recommendation.  These RHAs will finalize their policies by March 2010. A fourth RHA will finalize its policy by August 31, 2010. All RHAs will preserve electronic communications related to an adverse event.  Staff will be educated as to the importance of adhering to the policy.

Substantially complete

58

"Patient navigator" positions should be created within each hospital. The primary responsibility of the patient navigator would be to communicate with and on behalf of the patient. These individuals would, among other things, assist patients and/or their families in dealing or communicating with the hospital.

The department has initiated implementation of patient navigators with a focus on cancer care.  As a first step, six patient navigator positions have been approved as part of budget 2009-10.  Three positions have been allocated to Eastern Health and one to each of Central Health, Western Health and Labrador-Grenfell Health.  These positions will be evaluated to ensure they are adequately responding to patient demand and need, and if required, the department will provide funding for more positions. The department has assigned the provincial chief nursing officer with responsibilities for leadership of implementing patient navigators throughout the province.  A provincial coordinator will be in place in the coming weeks and recruitment for patient navigators is underway.

Substantially complete

59

The Government of Newfoundland and Labrador should provide sufficient funding to implement the recommendations contained in this report.

Completed

60

The Minister of Health and Community Services should report to the House of Assembly on the status of implementation of the recommendations contained in this report by March 31, 2010.

Completed