Accreditation systems ensure that pathology laboratories provide a service to its users while meeting a minimum standard of quality and safety. This ensures customers that the laboratory and its staff are adequate to carry out specific duties at a set standard, therefore allowing them to confidently judge which laboratory to invest their time and resources in. A failure to meet the standards provided by an accredited system can lead to the removal of the accreditation as well as informing other members of the accreditation system and potential service users.
The clinical pathology accreditation Ltd (CPA) acts as a voluntary accreditation system within the UK for pathology laboratories. To be accredited, laboratories must follow standards arranged into eight different categories:
A. Organisation and
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The Evaluation and Quality Assurance category ensures that evaluation and improvement processes are made available to staff, and to users as required. The Laboratory management shall establish an internal audit of the quality management system.
In 2009 the CPA became a subsidiary of the United Kingdom Accreditation System which now acts as the sole accreditation body of the UK. The main goal of UKAS is to “provide an assurance of the competence, impartiality and integrity of conformity assessment bodies. UKAS accredited certification, testing, inspection and calibration reduces the need for suppliers to be assessed by each of their customers” as stated on their website (https://www.ukas.com/about/our-role/).
UKAS also has a series of standards that must be met by accredited laboratories such as the ISO 15189:2012 standard which is used to determine if the quality and competence of medical laboratories is met. This standard is also used to develop the quality management standard of the laboratory. ISO/IEC 17025:2005 provides the requirements to carry out sampling, calibrations and tests with the use of lab-developed methods, standard methods and non-standard
Many preparations need to be taken into consideration by the EQA before external quality assurance activities may commence and take hold. These include: , including: information collection, communications, administrative arrangements and resources. The specific sequence of these preparations are also important due to the necessitates of a systematic framework for success. These arrangement can occur in a few ways but these regulations must include ideas or plans on how to collect information, communicate with the client, administer arrangements and allocate resources. Once these basic and preliminary ideas are covered in this particular stage, a holistic and total approach has arrived to
These are the day to day quality standards of the organisation where detailed analysis of quality is measured.
When an individual is seeking medical care they expect the highest quality of care. Accreditation of a facility or department is a way to obtain the confidence of a patient. When a facility does obtain accreditation they are officially being recognized as being qualified to perform studies that will yield diagnostic images as well as provide quality patient care. The department who hold the accreditation status will then be held to minimum standards and or requirements in order to maintain the status. Any facility or department seeking accreditation is eligible under the guidelines of the different accreditation agencies (Intersocietal Accreditation Commission (IAC), 2015). On the other hand if a facility fails
Today she learns, on one day’s notice, that the College of American Pathologists (CAP) will be onsite for the annual laboratory accreditation audit. She’ll need to provide a copy of each security policy and address any questions raised by the auditor.
The ONC does not perform the assessment or issue any certifications itself, but collaborates with other organizations that perform these functions. The National Voluntary Laboratory Accreditation Program [NVLAP] has been designated by the ONC to oversee the Healthcare Information Technology Testing Laboratory Accreditation Program. After accreditation from the NVLAP and authorization from the ONC has been received, a laboratory can become an ONC-Authorized Testing Laboratory [ONC-ATL]. Then, the ONC-ATL can begin testing health IT modules for functionality and conformity. The ONC also selects ONC-Approved Accreditors [ONC-AAs] to accredit and oversee certification bodies. Once applications for accreditation have been approved by the ONC, ONC-Authorized Certification Bodies [ONC-ACBs] are tasked with certifying electronic health technology in accordance with the Program guidelines and
With BioReference Laboratories, Inc. impact of being the third largest integrated clinical diagnostic laboratory in the United States, they have inherited excellent customers satisfaction from their clients over the years for the services they provide by the leadership management of organization promoting quality services at reduced cost along with speedy and flexible overall performance (BioReference Laboratories, Inc.,
In the diagnostic laboratories, different operation methods and evaluation standards would result in the limitations of the experimental results, thus, accreditation is important for diagnostic laboratories to manage the quality, resources, quality assurance and other pre examination, examination and post examination operations. It is important having a unified standard in the laboratory field to meet the needs and requirement of all the users. (2) The Clinical Pathology Accreditation (CPA) is a laboratory accreditation service, which is a part of UK Accreditation Service (UKAS), provides the strict guidelines of all laboratory procedures (including external quality assessment and internal quality control) and personal training. The laboratory must apply annually to ensure that they maintained the standards.
The Clinical Laboratory Improvement Amendments (CLIA) established a program to regulate any size and all “laboratories that test patient specimens to ensure the labs produce accurate and reliable test results”, CLIA was passed in 1988 to establish quality standards and regulations on all non-research laboratory test, and they must meet applicable Federal requirements and have a CLIA certificate to operate.
Guides clinicians in identifying appropriate testing panels based on medical necessity, patient’s family history, suspected syndrome, and
The Codes specified the typical requirements for laboratory activities which included laboratory examinations, sampling and test as well as the provision of expert testimony.
Medical laboratory assistants (MLA’s) play a key role in pathology by aiding the biomedical scientist in the pre-analytical stage of sample processing. They are also responsible for starting up and maintaining equipment within the laboratories which are used by the biomedical scientists. In the case of the Flow Cytometry department, the MLA was responsible for preparing bone marrow aspirates and bone marrow smears when they arrived at the laboratory, allowing biomedical scientists to carry out diagnostic tests and at a much faster rate by mainly focusing on the analytical and post-analytical stages of the sample. The MLA was also responsible for maintaining the laboratory environment by keeping the equipment clean and making sure that consumable stocks were at a suitable level.
A pathology laboratory is a type of lab which specialises in medical science which concerns the examination of organs, blood and bodily fluids in order to make the diagnosis of disease. The main branches of pathology are clinical pathology, anatomical pathology. This type of lab takes privacy very seriously; whether its data of an examination or personal data of patients, they will routinely analyse various pieces of personal data and they’re legally required to securely store and transmit electronic patient data. The information in relation to analysis and examinations will likely be stored on documents on a PC, yet patients have personal paper files which the pathologists will also handle and will have to handle the folders and store safely in a secure filing cabinet. I think the pathology laboratory will assess its information very frequently as material will change constantly so documents will have to be updated. I think it’s important to keep this type of pathology data stored as its involves people health and its very effective in diagnosing
A pathology laboratory uses analysis to detect diseases and their progression through examining bodily fluids; such as blood, urine and tissue. Pathologists look for abnormalities within samples, yet tests are usually done to guarantee that everything is okay within the body. The design of a pathology lab needs to be safe for researching many different samples, work surfaces need to be strong to deal with various strengths of chemicals. The services required include; power, portable distilled water, many sinks and drainage. Ventilation will be needed as chemicals may cause fumes and heat dissipation. These labs need to be flexible and adaptable, they need to accommodate different activities without needing to rearrange the layout, it also needs to be able to standardise mechanical and electrical systems. The equipment used within this lab type may include; a flow cytometer is used for automated counting of total blood count, the sahli haemoglobinometer is needed to effectively and quickly estimate haemoglobin levels. Tissue paraffin blocking techniques are used to make thin slices of tissues which are needed for microscopy. A trephine biopsy needle is used for taking a biopsy of hard material such as bone marrow; also a spirometer is needed to test lung
Five years has passed since I graduated from GMU College of Science with Medical Technology bachelor degree, right after I graduated I was recruited by Quest Diagnostics to join their Flow Cytometry department as Medical Technologist II. My daily tasks were; preparing and analyzing samples to test lymphocyte subsets surface markers to monitor HIV+ Patients, HLA B27 antigen, leukemia/ lymphoma, and lime disease, I also ran miscellaneous surface markers using flow cytometry methodology. I routinely performed stem cell viability assays to assist in stem cells transplant procedure. Additionally, I maintained all reagents and test kits to comply with all quality assurance procedures as well as regulations such as CAP, CLIA, NAACLS, and FDA. I also conducted daily operation which includes, calibration, maintenance, and troubleshooting of FACS Sample Prep Assistant (SPA III), FACS Lyse Wash Assistant, FACSCanto, and FACSCanto II by Becton Dickinson Biosciences.
The standard is ISO 9001:2000 which is concerned about the QMS. The company needs to understand the requirement and be familiar with it.