Taiwan Society of Sleep Medicine

Regulations for Certification of Professional Sleep Institutions

Enacted on March 17, 96, and approved by the General Assembly on March 25, 96.

Amended on June 24, 100, by the Board of Directors.

Chapter 1: General Provisions

1. The Taiwan Society of Sleep Medicine (hereinafter referred to as "TSSM") establishes these "Professional Sleep Institution" certification regulations to enhance the development of sleep medicine and the quality of medical services.
2. The application procedure, review steps, and scoring criteria are detailed in the implementing rules.

Chapter 2: Certification and Audit Steps for Taiwan Sleep Institutions

1. The executing unit for these regulations is the Certification and Audit Committee of the Taiwan Society of Sleep Medicine.
2. Application and Approval:

• The applying unit must be established in a medical institution accredited by the Ministry of Health and Welfare.
• TSSM will annually announce and send notices to medical institutions, recommending them to apply for certification.
• The responsible person for the certified sleep institution must be a physician and a member of TSSM. After the establishment of the specialist physician system, the qualification of the responsible person for professional sleep institutions will be revised.
• Written Application: Institutions wishing to participate in certification must first complete the basic qualification evaluation form and submit it to the Certification Committee for initial written review, along with the required fees. The results of the written review will be communicated in writing.
• On-Site Audit: Those who pass the written review will be notified by TSSM, and a visit and on-site certification audit will be scheduled. The committee will arrange professional audit committee members to conduct on-site certification audits according to agreed-upon times and locations, evaluating various scoring criteria.
• Those who pass both the written review and on-site visit will be submitted to the Audit Committee for a resolution of qualified names.
• Certified professional sleep institutions will be notified and announced in writing by the Taiwan Society of Sleep Medicine, along with the issuance of a valid certificate for two years.

Chapter 3: Loss of Qualification for Professional Sleep Institutions

1. The responsible person for the professional sleep institution loses membership in TSSM.
2. A previously qualified professional sleep institution that fails recertification will lose its qualification.
3. Any behavior that violates the purpose of the Taiwan Society of Sleep Medicine and affects the reputation of TSSM, as proposed by TSSM's Audit Committee.

Chapter 4: Recertification of Professional Sleep Institutions

1. Every two years, professional sleep institutions must submit a written recertification.
2. Sleep institutions, when applying for recertification for the first time, will undergo an on-site audit. After two years, when the certification expires, recertification can be done through a written review only, without an on-site audit, until the fourth time, which is six years after the initial review when another on-site audit is required. The Audit Committee may conduct additional on-site audits if deemed necessary (based on the resolution of the 5th and 6th Board of Directors' meeting).
3. Sleep institution recertification that does not pass can reapply for recertification the following year after addressing identified issues.
4. Sleep institution recertification will be conducted annually.

These regulations, after discussion and approval by the board of directors, will be announced and implemented at the General Assembly. Any additions or modifications will follow the same process.

Taiwan Society of Sleep Medicine

Implementation Rules for Certification of Professional Sleep Institutions

Enacted in July 96.

Amended by the General Assembly on March 30, 103.

Amended by the General Assembly on March 13, 105.

Chapter 1: General Provisions

In accordance with the provisions of Chapter 2, Article 1 of the Taiwan Society of Sleep Medicine's "Regulations for Certification of Professional Sleep Institutions," these implementation rules are established.

Chapter 2: Establishment of the Certification Committee

1. According to the provisions of Chapter 1, Article 1 of the Regulations for Certification of Professional Sleep Institutions of the Taiwan Society of Sleep Medicine, the President shall appoint appropriate personnel from the following organizations:

1. Directors of the Taiwan Society of Sleep Medicine.
2. Technical personnel with expertise in polysomnography from major teaching hospitals.
3. Experts in sleep medicine from major universities.
4. Experts with expertise in sleep-related medicine from the community.

2. The Taiwan Society of Sleep Medicine Certification Committee shall appoint one convenor, elected by the committee members, responsible for handling committee affairs and executing committee decisions.
3. The term of office for members of the Taiwan Society of Sleep Medicine Certification Committee is two years, with the possibility of reappointment, but it is a non-remunerated position.

Chapter 3: Implementation Rules According to the Provisions of Chapter 2, Article 2 of the Regulations for Certification of Professional Sleep Institutions of the Taiwan Society of Sleep Medicine

1. Certification Qualifications:

• Professional sleep institutions must meet the personnel configuration, facilities and equipment, operational processes, and quality control standards specified by the Taiwan Society of Sleep Medicine before applying.
• Personnel Configuration:

• The professional sleep institution must have specialized physicians with knowledge and capabilities in diagnosing sleep-related diseases. The physician must be a member of the Taiwan Society of Sleep Medicine and a specialist in sleep medicine.
• Technicians in professional sleep institutions must have backgrounds in medical laboratory science, nursing, psychology, or respiratory therapy. Over 50% of technicians must hold the Association's issued Sleep Technician Certificate. They should possess knowledge and skills in treating sleep disorders and be capable of providing emergency care. Sleep technicians are limited to practicing in one location.
• The ratio of night technicians to patients cannot exceed 1:3.
• Technicians must have valid certification in basic life support.
• Professional sleep institutions must have dedicated staff or sleep technicians during the day to handle patient consultations, appointment scheduling, and organize patient records.
• Professional sleep institutions must ensure that over 50% of night shift technicians are full-time, without rotating to other duties (attach the schedule for the last three months as evidence).

• Facilities and Equipment:

• Private, comfortable, safe, and appropriately sized single examination rooms.
• Sleep examination equipment can use paper or digital recording.
• Rooms must have a system for controlling lighting, temperature, and air conditioning.
• Video surveillance recording equipment.
• Intercoms for two-way communication between the control room and examination room.
• Sleep examination equipment with 16 channels or more, including EEG, EOG, EMG, ECG, respiratory airflow, nasal pressure, respiratory effort (RIP), snoring, oxygen saturation, and sleep position.

• Operational Processes:

• Must have procedures for operating multi-channel sleep examinations, continuous nasal pressure assessments, and multiple sleep latency tests, including emergency response plans.
• Correct and complete signal connections (electrode placement and sensor placement).
• Perform instrument calibration and biological calibration.
• Sleep reports:

• Diagnoses of sleep disorders must be based on ICSD2/ICSD3.
• Complete reports must include patient complaints and indications for the examination.
• Sleep tracings must be manually interpreted and supervised by qualified sleep technicians.
• Original reports must be kept for at least five years.
• Reports must be signed by a qualified sleep specialist.

• Portable Multichannel Sleep Examination:

• Definition: Portable multichannel sleep examination includes levels 2 and 3 as defined by the American Academy of Sleep Medicine, including hospital and home-based multichannel sleep examinations.
• Execution: If a portable multichannel sleep examination is required, it must be conducted by certified sleep technicians and certified sleep institutions, with examination reports submitted by qualified sleep specialists.

• Quality Control:

• Must meet the education credit requirements specified by the Taiwan Society of Sleep Medicine. Physicians must earn 40 credits per year, and technicians must earn 20 credits per year.
• Professional sleep institutions must hold meetings at least once a month.
• Professional sleep institutions with two or more technicians must evaluate the reliability of technician interpretations at least once every six months.

2. Certification Process:

• Divided into two parts: the first part is the written qualification review, and the second part is the on-site visit.
• Professional sleep institutions submit a written qualification assessment form, and the Taiwan Society of Sleep Medicine arranges for committee members to review it.
• Those who pass the written review will be scheduled for an on-site visit.
• The committee will arrange for two professional auditors to conduct on-site visits.
• On-site visits include three procedures: document verification, practical review, and final discussion.

Chapter 4: Certification of Professional Sleep Institutions in Taiwan

1. The Taiwan Society of Sleep Medicine appoints two committee members to conduct on-site visits to the professional sleep institution.
2. The appointed committee members must conduct the review with a fair and transparent attitude, and they should reject any private negotiations and invitations. If such situations occur, the qualification of the committee member will be revoked.
3. After the review results are submitted to the Board of Directors for approval by the Certification Committee, formal written notifications will be sent to all applying professional sleep institutions and publicly announced. The Taiwan Society of Sleep Medicine will issue an official certification certificate.

These regulations, after discussion and approval by the board of directors, will be announced and implemented at the General Assembly. Any additions or modifications will follow the same process.