ISO 15189 accredited laboratories fulfill the JCI Hospital

Iso 15189 Accredited Laboratories Fulfill The Jci Hospital-Free PDF

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426 Accred Qual Assur 2016 21 425 431, laboratories reference laboratories for tropical and infec examination or when routine examinations cannot be car. tious diseases and reference laboratories for microbiology ried out This differs from a laboratory that may include. 4 7 The molecular tests for microbiology hematology public health forensics tumor registry or a central parent. and oncology performed in a clinical pathology laboratory facility to which submission of samples is required by. also fall under a royal decree which requires ISO 15189 structure or regulation. accreditation 2 Both definitions differ slightly as the ISO 15189 defi. ISO 15189 is the gold standard for accreditation of nition distinguishes referral laboratories from national. medical laboratories 8 The ISO 15189 is an international reference laboratories to which samples are sent by struc. comprehensive standard for medical laboratories which ture or regulation. covers both Management requirements Chapter 4 and Throughout this article the authors adhere to the ISO. Technical requirements Chapter 5 The laboratory must interpretation of a reference laboratory referral laboratory. fulfill each element and must operate in complete concor i e a laboratory to which samples are sent other than the. dance Each country has its own national accreditation governmentally acknowledged national reference. body NAB which is responsible for granting accredita laboratories. tions and which operates according to ISO 17011 the In the USA the CAP Laboratory Accreditation Standard. international standard for accreditation bodies 9 is the golden standard and therefore JCI auditors may be. For hospitals on the other hand there are no specific unfamiliar with the full extent of ISO 15189 accreditation. national requirements for accreditation although over the which is much more common in Europe Hence the. last years hospitals have been increasingly encouraged by Working Group is concerned that JCI auditors may not be. the government to start the journey toward accreditation aware that ISO 15189 accreditation provides sufficient. Following international trends several hospitals have evidence for compliance with JCI requirements for the use. started international accreditation programs that are cer of referral laboratories This would result in requesting. tificated by The International Society for Quality in Health redundant proof of JCI compliance evidence This redun. Care ISQua ISQua s International Accreditation Pro dancy may put unnecessary administrative strain on. gramme IAP is a global body that provides a peer review hospitals by demanding to collect detailed documentation. accreditation framework The most frequently used hospi from the referral laboratories e g a copy of the license a. tal accreditation programs are the NIAZ QMentum 10 copy of the accreditation certificate documentation of. and the Joint Commission International JCI Accreditation EQA participation. Standards for Hospitals 5th Edition 11 The aim of this article is to clarify which JCI require. Even though most hospital laboratories offer a wide ments are covered if both the referring and referral. range of tests for patient samples they may refer a subset laboratories are ISO 15189 accredited The need for hos. of tests to external laboratories This may be the case for pitals to establish documentation records of referral. rarely performed tests for specialized analyses or due to laboratories can be moderated by supporting that JCI. organizational reasons lack of capacity infrastructure measurable elements are covered by the ISO 15189. etc Of course the quality of the services provided by accreditation scope Its aim is also to issue a best practice. these referral laboratories should be closely monitored by guideline for referral laboratories to encourage them to. the referring laboratory or should be guaranteed by the make all necessary information easily accessible for users. contract laboratory e g by means of accreditation Both of referral laboratory services. JCI and ISO 15189 state specific requirements for the use. of referral laboratories, JCI uses the term reference laboratory and defines this Methods. as a laboratory owned and operated by an organization. other than the hospital with which the hospital contacts for The initiative was taken by the Working Group for. testing The requirements for reference laboratories are Hospital Accreditation of the Belgian Zorgnet Icuro net. listed in the JCI Standards for Hospitals namely under work the University Hospitals of Leuven and the Red. Standard AOP 5 10 and AOP 5 10 1 12 These intents are Cross Zorgnet Icuro is a network that groups and repre. specified in measurable elements MEs to indicate the sents healthcare organizations in Flanders Its goal is to. requirements for full compliance with the standard MEs provide a platform for knowledge exchange and to orga. are reviewed and scored during an on site visit ISO 15189 nize high quality health care. uses the term referral laboratory which is defined as an A consensus meeting was organized in March 2015 at. external laboratory to which a sample is submitted for which a total of 21 involved stakeholders were represented. examination This is a laboratory to which laboratory quality managers of university and regional hospitals staff. management chooses to submit a sample or subsample for from medical laboratories scientific organizations the Red. Accred Qual Assur 2016 21 425 431 427, Cross the national accreditation body BELAC and the human genetics code 996 anatomopathology laboratories. Scientific Institute for Public Health WIV ISP which code 997 and clinical pathology laboratories code 998. organizes national EQA programs and is responsible for the A list of all accredited laboratories including the. licensing of Belgian medical laboratories in clinical accreditation scope can be found on the website of the. pathology and in pathology 3 4 13 national accreditation body BELAC 15 Since 2006. A comparison of JCI measurable elements of the JCI BELAC is the only Belgian accreditation organization by. Accreditation Standard for Hospitals 5th Edition royal decree 16 BELAC is internationally recognized by. AOP 5 10 and the ISO 15189 2012 Standard for Medical the European co operation for Accreditation EA the. Laboratories was discussed and best practice recommen International Laboratory Accreditation Cooperation. dations were issued ILAC and the International Accreditation Forum IAF. An overview of the number of accredited laboratories. according to laboratory type is illustrated in Fig 1 In total. there are 241 licensed medical laboratories in Belgium. Results and discussion The greater part of laboratories is situated in Flanders The. majority of medical laboratories in Belgium are clinical. A comparison of measurable elements of the JCI Accred pathology laboratories There are only eight centers for. itation Standard for Hospitals 5th Edition AOP 5 10 and human genetics which are all ISO 15189 accredited. the ISO 15189 2012 scope supports that JCI s MEs for Approximately 30 of the clinical pathology and. referral laboratories are covered if the hospital laboratory is pathology laboratories are accredited. ISO 15189 accredited Table 1 gives an overview of JCI Zorgnet Icuro as an umbrella organization for hospitals. requirements and how these are guaranteed when the lab in Flanders collects accreditation data and publishes a list. oratory is accredited of hospitals that have started the accreditation pathway on. ISO 15189 has specific requirements for the use of its website including the chosen accreditation program and. referral laboratories This implies that if the hospital lab the survey dates Table 2 gives an overview of the. oratory is accredited the quality of referral laboratories is accreditation status of hospitals in Flanders Sixty out of 65. closely monitored as specified in the ISO Standard The hospitals have chosen for accreditation One acute hospital. laboratory director is responsible for the selection of and four revalidation hospitals will not start the accredi. referral laboratories and for monitoring the quality of their tation pathway In December 2015 a total of seven. service ISO 15189 2012 4 1 1 4 Reference has to be hospitals had already obtained accreditation of which five. made to any work referred by the laboratory to a referral are accredited by JCI and two by NIAZ Another 53 hos. laboratory or consultant ISO 15189 2012 4 4 1 Fur pitals have started the accreditation process. thermore the laboratory must have a documented With regard to transparency of the quality of laborato. procedure for selecting and evaluating its referral labora ries an exemplary initiative is the Orphanet database for. tories ISO 15189 2012 4 5 The laboratory is rare diseases Orphanet offers a worldwide database of. responsible for monitoring the quality of performance and medical laboratories which can be solicited by disease or. for ensuring that referral laboratories are competent to gene name by country city laboratory or by professional. perform the requested examinations Arrangements with Interestingly search results can be filtered by accreditation. referral laboratories are periodically reviewed and a reg status and or by participation in external quality assurance. ister of all referral laboratories is maintained Results of all EQA schemes 17 This database is recommended to. samples referred are kept for a pre defined period retrieve information about accreditation and EQA partici. JCI requires that the hospital maintains a copy of the pation of laboratories performing tests in the field of rare. license JCI AOP 5 10 M1 and a copy of the accredita diseases. tion JCI AOP 5 10 M2 for all referral laboratories According to JCI the hospital must document that the. During the consensus meeting it was suggested that lab referral laboratory participates in proficiency testing pro. oratories should ideally make a copy of the license and a grams JCI AOP 5 10 M3 However this requirement is. copy of the accreditation certificate including accredita automatically fulfilled if the referral laboratory is ISO. tion scope available on their website for the users of 15189 accredited for those examinations Indeed accredi. laboratory services or provide a direct link to the official tation implies that the laboratory participates in external. websites to guarantee easy accessibility quality assessment programs 5 6 3 Moreover in Bel. In Belgium a frequently updated list of licensed labo gium participation in EQA programs is mandatory for. ratories is available on the website of the national health licensing by royal decree apart from accreditation. insurance organization RIZIV INAMI 14 The list also 2 4 18 This means that even non accredited laboratories. categorizes the different types of laboratories centers for have to participate in the EQA programs offered by the. 428 Accred Qual Assur 2016 21 425 431, Table 1 Comparison of JCI and ISO 15189 2012 elements with an explanation of compliance. JCI measur JCI ME content ISO 15189 element or other compliance Explanation of compliance. able measure, AOP 5 10 The hospital maintains a copy of the license Outcome of consensus meeting Copy should Laboratory should provide a link to a copy of.
M1 from a recognized licensing authority for be made available from the laboratory s the license on its website or a list should. all reference laboratories used by the website or a direct link to a published be available on the website of the national. hospital governmental list should be foreseen licensing organization. AOP 5 10 The hospital maintains a copy of the Outcome of consensus meeting copy Laboratory should provide a link to a copy of. M2 certificate or letter of accreditation or including the scope should be made the accreditation or to the NAB s website. certification from a recognized laboratory available from the laboratory s website or where all accredited laboratories are listed. accreditation or certification program for a direct link to a published list by the NAB including the accreditation scope. all reference laboratories used by the should be foreseen. AOP 5 10 The hospital maintains documentation that ISO 15189 2012 5 6 3 Interlaboratory If a laboratory is accredited and the test is. M3 any reference laboratory used by the comparisons included in the accreditation scope the. hospital participates in an outside laboratory must participate in proficiency. proficiency testing program testing programs, AOP 5 10 1 The frequency and type of performance ISO 15189 2012 4 2 2 2 Quality Manual The quality policy QMS and organizations. M1 expectation data from reference ISO 15189 2012 5 4 2 d 5 4 2 h 5 4 2 j structure are included in the Quality. laboratories are determined by the hospital Information for patients and users Manual. ISO 15189 2012 4 14 7 Quality indicators Information on the examinations offered are. made available for users of the laboratory,services This includes required samples. sample volumes special precautions,turnaround time biological reference. intervals and clinical decision values,Instructions for sample transportation and. the laboratory s criteria for accepting and,rejecting samples are communicated.
Quality indicators to monitor performance,throughout critical aspects of pre. examination examination and post,examination processes are established. The process of monitoring quality,indicators is planned and periodically

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