ALF MAGNE HORNELAND
From time to time maritime authorities receive concerns regarding the reliability of the assessments of approved doctors. Such concerns have been based on cases where either the ship-owner or the insurer for some reason finds it peculiar that the conditions which led to diversion, hospitalisation and repatriation in a seafarer, was not revealed during the latest PEME before commencement of work on board. Sometimes seafarers ask how the doctor could possibly have done his job, when he used just a few minutes on the consultation.
During the latest decades, public and professional attention has increased regarding quality, safety and efficiency of health services. Today quality systems at different levels are necessary for clinics and single-handed practitioners that want to present themselves as running a safe and reliable service.
Audits of approved doctors have been in place in several countries having approved doctors abroad. Examples are the UK, Germany and the Netherlands.
The country having most approved doctors outside own borders, namely Norway, got this in place as mandatory after the new regulations[1] entered into force from 2014. The requirements for a quality system is described in a circular dated October 2014[2]. In this circular it is required that “the seafarer’s doctor shall have a quality system in accordance with an internationally recognised standard. This could for instance be a system based on ISO 9001[3] or IMHA Quality[4]. The Circular RSV 12-2014 from the NMA describes the minimum content of the quality system, also included in the ‘Guidance’ to the regulations[5].
C.8.1.1 The ISO Standards
The focus of the ISO 9000 family of quality management systems is to help organisations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service[6].
The ISO 9001:2015 Quality Management Systems – Requirements is a document that encompasses the following sections:
Section 1: Scope
Section 2: Normative references
Section 3: Terms and definitions
Section 4: Context of the organization
Section 5: Leadership
Section 6: Planning
Section 7: Support
Section 8: Operation
Section 9: Performance evaluation
Section 10: Continual Improvement
It is obvious that the designers of ISO 9001:2015 did not think about medical service providers when they designed the system. The system does not include aspects of sound practice assessment, and it does not check the quality of the product (e.g. medical certificates). A proper quality system for health service providers dealing with medical selection should cover all these aspects.
C.8.1.2 The IMHA Quality standards
The abstract of the article by Carter, Bell, Horneland and Idnani (2017) gives a good overview of the background for the IMHA Quality standards and is quoted below.
Standards to assess the quality of doctors and clinics performing pre-employment medical examinations (PEMEs) were developed for International Maritime Health Association (IMHA) Quality, a not for profit organisation, created to provide an ethically sound and professional accepted accreditation system that would benefit seafarers having PEMEs and employers, insurers and national maritime authorities seeking valid assessments of seafarers’ fitness for duty. These standards followed a format widely used in other healthcare settings, where assessment of clinical performance is desirable.
Uptake of these standards by doctors and clinics was not as expected, as they did not see sufficient business benefits coming from accreditation to justify the costs. This was, at least in part, because there was some antagonism to a professionally based accreditation system from commercial interest groups such as insurers, while national maritime authorities did not come forward to use the system as a recommendation or requirement for approval of doctors.
The IMHA Quality accreditation system has now been closed and for this reason and the standards are made publicly available. They are now free to use by anyone who wants, as a means of improving quality of practice when performing PEME[7].
The standards encompasses the following sections:
1. Clinic management
2. Policies and procedures
3. Staff
4. Complaints
5. Clinic facilities
6. Health and safety
7. Infection control
8. Information technology
9. Finance
10. Clinical practice
11. Health records
12. Laboratory services
13. X-ray services
14. Immunisation service
15. Pharmacy service
16. Audit and quality improvement
From our point of view, the IMHA Quality Standards are a tailored quality system for clinics and single-handed practitioners dealing with medical selection. The complete standards and criteria are available free on the ViaMedica website[8].
C.8.1.3 Audits of doctors
A quality improvement system could be an internal system, where the well-known quality circle[9] [10] is running under the management’s supervision.
It could, however, brought to a higher level including verification and validation. These independent procedures are used together for checking that the product, service or system meets the requirements and specifications and fulfils the intended purpose. Usually external auditors carry this out.
The Norwegian Maritime Authority introduced an audit system for approved doctors in their circular RSV 12-2014[11]. The inspection mainly focuses on the mentioned circular, as well as compliance with the requirements of the Public Administration Act[12] and the Health Regulations[13]. The NMA audit the administrative procedures, as well as the medical content of the assessment. The inspections commenced in 2017 and for doctors both inside Norway and abroad.
Similar arrangements have been in place for years in UK, Germany and the Netherlands.
[1] Regulations of 5 June 2014 No. 805 on medical examination of employees on Norwegian ships and mobile offshore units
[2] Norwegian Maritime Authority. RSV 12-2014 of 22 October 2014, Journal No 2014/6628. Quality System for seafarer’s doctors
[3] ISO 9001:2015 Quality management systems — Requirements. Organisation Internationale de Normalisation (ISO).
[4] Carter T, Bell SR, Horneland AM, Idnani S. Standards for quality assurance of pre-employment medical examinations of seafarers: the IMHA Quality experience. Int Marit Health. 2017;68(2):99-101.
[5] Guidance to the regulations on the medical examination of employees on Norwegian ships and mobile offshore units. Ver 2.3 of 8th June 2018, pp 18-22. Available at the NMA website: www.sdir.no.
[6] Poksinska, Bozena; Dahlgaard, Jens Jörn; Antoni, Marc (2002). "The state of ISO 9000 certification: A study of Swedish organisations". The TQM Magazine. 14 (5): 297
[7] Carter T, Bell SR, Horneland AM, Idnani S. Standards for quality assurance of pre-employment medical examinations of seafarers: the IMHA Quality experience. Int Marit Health. 2017;68(2):99-101.
[8]https://journals.viamedica.pl/international_maritime_health/article/view/IMH.2017.0018%23supplementaryFiles#supplementaryFiles
[9] Rohrbasser A, Mickan S, Harris J. Exploring why quality circles work in primary health care: a realist review protocol. Syst Rev. 2013;2:110. PMCID: PMC4029275. PMID: 24321626.
[10] Rohrbasser A, Harris J, Mickan S, Tal K, Wong G. Quality circles for quality improvement in primary health care: Their origins, spread, effectiveness and lacunae– A scoping review. PLOS ONE https://doi.org/10.1371/journal.pone.0202616 December 17, 2018
[11] Norwegian Maritime Authority. RSV 12-2014 of 22 October 2014, Journal No 2014/6628. Quality System for seafarer’s doctors
[12] Act of 10 February 1967 relating to procedure in cases concerning the public administration (Public Administration Act) with later amendments, latest by Act of 16th June 2017 No 63, in force from 1st January 2018.
[13] Regulations of 5 June 2014 No. 805 on medical examination of employees on Norwegian ships and mobile offshore units