The reason for the release of a new version is, among other things, that in the existing version what was previously recorded in RvA-SAP-M001 (=Point of Care Testing (POCT)) and in RvA T044 (=EN ISO 15189-scopes for medical laboratories) has been adopted. In addition, some changes have been made following the publication of a new version of EA 2/15M (=EA Requirements for the Accreditation of Flexible Scopes).
Extra attention is requested for a number of changed requirements with regard to maintaining and making available the list of transactions for transactions performed under a flexscope. In particular: outsourced research must be included in this and the list of transactions must be publicly available (§ 3.1).
With the publication of this new version of SAP-M000, the documents RvA-T044 and SAP-M001 will expire.
Click here for the latest version of SAP-M000
The main changes are listed below:
The copied texts from the T044 and the M001 (in H2)
– Further explanation fixed and flexible scope § 2.1 – § 2.5
– Further explanation of outsourced research § 2.6
Current overview of transactions with flexible scope (in § 3.1)
Nature, content and scope of assessments (in § 3.2)
– Added information regarding team reduction § 126.96.36.199
– intra and extramural blood collection § 3.2.4
– POCT § 3.2.5
– POCT in microbiology 3.2.6
– bioinformatics § 3.2.7
– legionella in water § 3.2.8
– semen banks § 3.2.9
Specific points for attention (in H4)
– donor testing labs § 4.1
– Convert fixed scope element(s) to flexible scope element(s) § 4.2