Standards for Accreditation of Sleep Disorders Centers in Austria

R. Popovic, J. Zeitlhofer, W. Mallin, B. Högl, J. Bolitschek, O. Ipsiroglu, P. Anderer, B. Holzinger, M. Lehofer, B. Saletu

Austrian Sleep Research Association (ASRA)
Österreichische Gesellschaft für Lungenerkrankungen und Tuberkulose (ÖGLUT)
Österreichische Gesellschaft für Neurologie (ÖGN)
Österreichische Gesellschaft für Psychiatrie und Psychotherapie (ÖGPP)
Österreichische Gesellschaft für Kinder- und Jugendheilkunde (ÖGKJ)
Österreichische Gesellschaft für Klinische Neurophysiologie (ÖGKN)

Introduction

The aim of the accreditation of sleep laboratories by the ASRA is to provide quality assurance in this field.



Due to the multidisciplinary character of sleep medicine, the standards at hand have been developed by a cooperation of representatives of the respective professional organizations. Moreover, a number of scientific publications in this field are referred to (1-9). The accreditation of a clinical sleep center entails examination of its structural and functional qualities and provision of a certificate. The accreditation process comprises the completion of a questionnaire as well as a site visit by three experts in the field of sleep medicine (different specialities: pulmonology, neurology, psychiatry, pediatrics).

Accreditation Process

A sleep laboratory can apply for accreditation by completing an application form and a questionnaire, which can be obtained from the ASRA or downloaded from the internet (www.schlafmedizin.at). It provides information on the equipment of the center, specifically on technical devices for evaluation of sleep (electroencephalogram, electrooculogram, electromyogram) and other vital parameters (respiration, cardio-vascular function, muscular activity, pH-value, etc.), as well as on the staff.. To cover organizational costs involved in the accreditation process, a flat application fee is charged, whose current amount can be inquired from the ASRA or seen on the homepage.



Having received an application, the ASRA summons a multidisciplinary expert panel for the site visit, which after reviewing the application package fixes a date for the visit within the next 6 months. The paying-in slip of the application fee has to be provided.



At the agreed date, the site visit is performed, the correctness of the information provided in the questionnaire is checked and the quality of the recordings is examined by a test run. Finally, a randomly selected record is reviewed by the visitors, and a physician (psychologist) entitled to compile reports is asked to interpret it. For documentation purposes, during the site visit a detailed report is produced, a fair copy of which is prepared later. At the end of the site visit, the expert panel may communicate a preliminary decision.



The head of the sleep laboratory will later be sent the report of the site visit and thus be notified of the final decision reached. If no major deficiencies are found or objections raised, the center will be accredited for a limited period of time (5 years) and receive a certificate. Should there be any major deficiencies, accreditation will only be granted after their elimination or, if considered necessary, after another site visit. Having been granted accreditation, the sleep laboratory is obliged to immediately inform the ASRA of any substantial changes concerning facility, equipment or staff since they might even entail revocation of the certificate.

Requirements

Staff

Heading a sleep laboratory is reserved to a medical specialist or clinical psychologist focusing on sleep medicine, who reports to the head of the department. Even if the laboratory is specialized in the diagnosis and/or treatment of a specific kind of sleep disorders, its head is required to be well versed in the full diagnostic spectrum of sleep disorders. If (s)he is a psychologist, there also has to be a physician in charge. In order to ensure continuous quality care for sleep disorder patients, the head of the sleep laboratory should not be holding a post limited to a certain period of time. Moreover, (s)he should be a member of the ASRA and her/his respective professional organization.


Sleep staff physicians are required to have substantial expertise in the diagnosis of sleep disorders according to the International Classification of Diseases and Related Health Problems (ICD-10) and International Classification of Sleep Disorders (ICSD) (10-13) and be familiar with diagnostic and therapeutic measures, polysomnographic investigations, tests and examinations performed during the day as well as the evaluation of sleep (and respiratory variables) (14-20). In positive airway pressure titration, a physician with expertise in sleep disorders medicine should be present until the patient reaches at least the end of the first sleep cycle (non-REM/REM) in order to monitor and supervise pressure titration.



Medical technicians have to be familiar with polysomnography, daytime investigations concerning daytime tiredness and sleepiness as well as portable studies. They should also be able to do a pre-evaluation of the recordings performed, which serves as a basis for the doctor's report. Organizational tasks (making appointments), patient care as well as training patients how to use respiratory devices (in laboratories specialized in sleep-related breathing disorders) also form part of their duties. In accordance with working hour regulations in Austria, their shift lasts from 8 p.m. to 7 a.m. (with time required for preparing the recordings and tasks subsequent to them included).



Polysomnographic technologists are envisaged to ensure the proper, artefact-free functioning of the recording devices during the recording, detect errors and repair them, which makes their presence during the entire recording an absolute necessity. They continuously monitor the patient's vital parameters and take adequate measures in case of emergency. It seems desirable for one technologist to attend to a maximum of three diagnostic polysomnographies in adults simultaneously, or to two sleep recordings with airway pressure treatment. In neonatal or pediatric patients, or problematic/more complicated cases, the technician : patient ratio should be determined according to the individual situation. Polysomnographic technologists must not be charged with any tasks other than caring for the sleep laboratory patients during the recordings. In general, the staff policy of the hospital should underline the status of the sleep laboratory as an independent entity. A "doctor with expertise in sleep medicine" should not have gained it in a purely autodidactic way, but have gathered experience by working at other centers and have participated in courses and sleep-related educational activities, and should continue to do so in the future as well. Also the non-medical staff has to be given proper training and encouraged to regularly participate in educational programs.



During the time recordings are performed at the laboratory, a doctor has to be within reach. In cases of emergency (s)he must be available at short notice. A sleep laboratory attending to a substantial number of patients should also have its own administration.



Depending on the pathogenesis of the sleep disorders diagnosed and treated at the laboratory, or its special focus, consultants from the fields of internal medicine, pulmonology, neurology, psychiatry, otolaryngology and maybe pediatrics have to be available. Having an outpatient clinic as well offers the possibility of screening patients before admission to the sleep laboratory and providing follow-up care and treatment.

Facility

The construction of the facility must allow professional diagnosis and therapy in the field of sleep medicine (21). Single bedrooms must be available. Recording and testing rooms have to be of adequate size (minimum of 10-12 m2), sound and light insulated and equipped with temperature and ventilation control. Concerning light insulation, ordinary curtains allowing some light transmission are not sufficient. Sound insulation should ensure that during recordings the noise level does not exceed 40-45 dB. The rooms should be insulated from footstep noise so that patients may also go to sleep during the day. The temperature should allow sleeping comfortably also during summer, which may require having air conditioning installed. A bathroom must be available close to the bedroom. There must be a separate control room to house equipment and monitoring staff, which has to be of adequate size and provide conditions that allow undisturbed working.

Equipment

Concerning requirements for polysomnographic equipment, please consult the relevant literature (5, 21, 22). As a minimum standard for sleep stage classification, recording of the following parameters is required: 2 EEG channels (C3 and C4 according to the international 10/20 system), 2 EOG channels, 1 mental and/or submental EMG channel. Which other channels are necessary depends on the question at hand or on the kind of sleep disorders the laboratory focuses on (17). Concerning sleep-related breathing disorders relevant measures comprise respiratory movements of the chest and abdomen, nasal and oral airflow, oxygen saturation, ECG (1 channel), snoring, EMG of both M. tibial. ant. and body position. Other diagnostic questions may require the recording of more EEG channels or other biological signals (e.g. pH monitoring, esophageal pressure).



Moreover, continuous visual monitoring and video recording of polysomnography via infrared cameras should be possible. In this case a window between the bedroom and the control room is not necessary. A remote-control zoom lens and a pan-and-tilt head are desirable since they provide pictures of individual details of interest as well as of the entire bedroom. A two-way communication system allows the patient and technologist to communicate with each other. Moreover, it can be useful for biosignal calibration.



A filing system should make it easy to access findings and original polysomnographic records for comparative purposes. Nowadays data recording and storage will mainly be digital, but paper records are acceptable as well.

Focus and daily routine of the sleep laboratory

Each sleep laboratory should be able to provide patient statistics. From the number and kind of investigations performed a special focus of the laboratory can be deduced and it should become possible to accordingly choose the optimum staff and equipment. There should be enough time and opportunities for the patient to contact the sleep laboratory staff with his problems, which requires regular office hours. During these the staff on duty should have easy access to records of patients, investigations performed and results. To allow an exchange of experiences between different laboratories and for the sake of quality assurance there should be a common data structure based on current knowledge and standards. Store-room, break area for the staff, conference room, control room and recording room should not be too far away from one another.

Details concerning completion of the questionnaire

Polysomnography

The recording rooms have to meet the above-described requirements (see Facility and Equipment) (21). Recordings can be on paper or digital. With digital recording devices there should be the possibility of providing a printout of individual epochs and going back to previous epochs during the recording (23). Screen resolution should be of such high quality that sleep stage classification can be performed on the computer screen.



Automatic computer-assisted sleep stage scoring and evaluation of respiratory parameters has to be corrected visually (24). Sleep stage classification is based on current standards (25, 26).

Additional devices

If required, polysomnographs can be equipped with other recording instruments (e.g. for determination of pressure in respiratory devices, transductors of other signals). Other equipment used may comprise portable screening devices, instruments for vigilance testing, etc.

Routine measures

During the site visit, quality and evaluation of a polysomnographic test recording subsequent to the placement of all measuring devices are assessed. Specific attention is paid to the correct placement of electrodes and measuring devices, determination of impedance, adjustment of filters and pre-amplifiers, signal quality, correct biosignal calibration and interpretation of EEG, respiratory and motor signals as well as artefact detection (5, 21, 27, 28).

Other equipment

This refers to any other devices used in a broader diagnostic context, mainly outside the field of sleep medicine, such as actigraphy, long-term ECG, portable blood pressure monitoring, pH monitoring, etc., irrespective of whether the devices are at the sole disposal of the sleep laboratory or shared with other departments.

Documentation

Polysomnographic records (raw data) have to be kept for the legally required period of time. Sleep disorders have to be diagnosed according to the ICD-10 and ICSD (10-12). Findings, especially concerning follow-up investigations or titration of positive airway pressure, have to be documented in the patient file and should be available within 2, maximally 4 weeks. A short report compiled upon the patient's discharge should specify the preliminary diagnosis as well as further proceedings. The final comprehensive report has to comprise the patient's sleep history as well as a description and interpretation of relevant sleep parameters (sleep stages, sleep latency, etc.) (29). Merely listing pathological findings and events is not sufficient.

Others

This is the place for additional remarks or explanations of deviations from the general requirements.

Diagnostic tests

Apart from a medical history and sleep history, in patients with apparent sleep disorders a sleep diary and validated sleep questionnaires should be available (29-32). There should be the possibility of performing further diagnostic tests concerning daytime tiredness (MSLT, MWT, actigraphy) (33, 34). If required, neurophysiological investigations and psychological personality diagnostics should be possible as well (34).

Site visit

(Discussion of relevant items, test recording, documentation)

Before the site visit the completed questionnaire should be available to all panel members. In the discussion of relevant items the head of the sleep laboratory as well as the medical and technical staff should participate. Already at the beginning, the diagnostic and therapeutic focus of the center should be clearly detectable. The discussion should be comprehensive and usually takes one to two hours. The beginning and end of the site visit have to be documented in the report. The panel members must be provided with detailed information concerning diagnostic and therapeutic procedures. Special attention will be paid to the handling of risk patients, the distribution of tasks and the time schedule of the staff. The test recording should not be different from daily routine. The data obtained are presented on-line and reviewed by the visitors. Subsequent to the test recording the facility is inspected. When checking some randomly selected cases, the panel attaches special importance to high quality and completeness of the investigations performed and the findings obtained as well as to differential diagnosis and comorbidity considerations. With all diagnostic steps completed, the patient file should make clear the scope of the investigations performed, the findings obtained as well as their interpretation and further proceedings.

Final discussion

At the end of the site visit the panel members should have the opportunity to deliberate in private over its course and outcome. Then one of the site visitors informs the head of the sleep laboratory of the preliminary result. Major deficiencies should be indicated on site. However, the panel can only make recommendations. Granting of accreditation is finally confirmed by the accreditation certificate and the accreditation report. A copy of both is sent to the Presidents of the professional organizations.

Accreditation categories

• Full accreditation
• Accreditation without another site visit after written notification by the sleep laboratory that minor deficiencies have been repaired
• Recommendation to repair major deficiencies and decide upon accreditation after another site visit
  
• Denial of accreditation

Report

The report is produced by one of the site visitors and should be written on ASRA stationery. It should address the same items as the questionnaire and thus should include:

Initial essential information

Place, date, expert panel, recording site visitor, duration of the site visit, demographic data of the inspected sleep laboratory, head and medical staff members

General information on

the hospital/department
laboratory staff, their positions and duties, percentage of their working hours spent in the laboratory
consultants, their specialities and availability or time devoted to this task so far
description of the sleep outpatient clinic

Sleep laboratory routine

Diagnostic and therapeutic measures
Diagnostic focus (number of patients/statistics)
Therapeutic focus (number of patients/statistics)

Equipment, facility, polysomnographic investigations, compilation of reports

Diagnostic tests performed
Documentation
Test recording
Qualification of staff (if present)
Example of a polysomnographic record (randomly selected case)
Example of a patient file/description of findings obtained/final report (randomly selected case)

Assessment and recommendation

General summary of the site visit
Point-by-point report (if required)
Final recommendation

After the site visit report has been signed by all panel members and approved by the President, it is sent to the head of the sleep laboratory together with the accreditation certificate. The President of the respective professional organization receives a copy as well.

Required alterations, improvements, notification of changes

Deficiencies stated in the report have to be taken care of. As described above, in the report alterations and improvements required by the panel may be stipulated. Any further exchange of information has to be in writing. With its application for a site visit each laboratory has agreed to be obliged to inform the ASRA Secretariat immediately of any relevant changes performed so that the necessary steps can be taken. Relevant changes refer to the head of the sleep laboratory, the minimum requirements concerning staff, equipment or the facility as well as the focus of the laboratory or diagnostic/therapeutic measures. Should due to deficiencies stated in the report a second site visit become necessary, additional costs may arise.

Re-evaluation

A re-evaluation of sleep laboratories is desirable every 5 years. It is mainly intended to take into account any changes performed in the meantime or confirm that all the points stated in the site visit report are still valid. Moreover, changes in capacities should be detected. The re-evaluation form will be sent to the laboratory by the ASRA Secretariat and has to be returned within 6 weeks. If substantial changes have been performed it is the accreditation authority's decision whether another site visit is necessary and if so whether it should be performed by a single expert or an expert panel.