(1) Upon receipt of an application for a licence under section 12, at least two authorized officers shall inspect—
(a) the premises of the pathology laboratory to ascertain that it complies with the site plan, building layout plan, design, construction material and any other prescribed requirements;
(b) any equipment, material or any other thing found in the pathology laboratory to ascertain that it complies with the requirement or standard as may be prescribed; and
(c) any record, policy, standard operating procedure, clinical practice guideline, document pertaining to quality management system, manpower requirement, organizational structure or any other matters connected therewith.
(2) Where the authorized officers find that the pathology laboratory does not comply with any of the matter specified under subsection (1), they shall give a written notice to the applicant of the non-compliance and any rectification which shall be made within a specified time and re-inspect the pathology laboratory after the expiry of that period.
(3) The authorized officers shall submit a report of the inspection to the Director General as soon as practicable.
Malay text (authoritative)
Pemeriksaan premis
(1) Apabila menerima suatu permohonan bagi lesen di bawah seksyen 12, sekurang-kurangnya dua orang pegawai yang diberi kuasa hendaklah memeriksa—
(a) premis makmal patologi itu bagi memastikan bahawa makmal patologi itu mematuhi pelan tapak, pelan susun atur bangunan, reka bentuk, bahan binaan dan apa-apa kehendak lain yang ditetapkan;
(b) apa-apa kelengkapan, bahan atau apa-apa benda lain yang dijumpai dalam makmal patologi itu untuk memastikan bahawa makmal patologi itu mematuhi kehendak atau piawaian sebagaimana yang ditetapkan; dan
(c) apa-apa rekod, dasar, tatacara pengendalian piawaian, garis panduan amalan klinikal, dokumen mengenai kualiti sistem pengurusan, keperluan tenaga manusia, struktur organisasi atau apa-apa perkara lain yang berkaitan dengannya.
(2) Jika pegawai yang diberi kuasa itu mendapati bahawa makmal patologi itu tidak mematuhi apa-apa perkara yang dinyatakan di bawah subseksyen (1), pegawai yang diberi kuasa itu hendaklah memberikan notis bertulis kepada pemohon tentang ketidakpatuhan itu dan apa-apa pembetulan yang hendaklah dibuat dalam masa yang ditetapkan dan memeriksa semula makmal patologi itu selepas tamat tempoh itu.
(3) Pegawai yang diberi kuasa hendaklah mengemukakan laporan pemeriksaan kepada Ketua Pengarah secepat yang dapat dilaksanakan.
Text as at 1 November 2017 (LOM reprint); amendments made after that date may not be incorporated.
Source: Laws of Malaysia, Attorney General's Chambers of Malaysia (lom.agc.gov.my). Not a copy of the Gazette printed by the Government Printer (Interpretation Acts 1948 and 1967, s 61).
