Introduction to Total Quality Management (TQM) in a microbiology laboratory:
There are all the activities that effort to establish and maintain continued improvement in lab to do what it is intended to do i.e. clinical relevance achievement by delivery of high quality services to customer aiding in patient management.
Lab organization:
Organization is one of the pivotal element of Quality management system that indicates the management and supporting organizational structure of the lab. Management at all levels should fully supports the quality management activities. It ensures decision making level of organization.
Organizations structure ensures that quality goals of lab is met.
Peripheral lab is located at point of first contact of patients with health care services. Intermediate lab is located at district or regional headquarters and act as clinical as well as public health lab.
Providing a manual that outlines the Quality Management System (QMS) is the responsibility of the management function. Establishing the organization is primarily the duty of the lab directors. They create policies and serve in administrative and instructional capacities. Quality managers support MS planning, implementation, and policy development. He or she must be strategic, adept at solving problems, and able to explain every facet of the QMS to the lab director. When doing their everyday tasks, lab employees should adhere to all quality policies.
Documentation:
Any information can be found in a document, including reports, specs, job descriptions, lab policies, quality manuals, procedures, and more. It might be a tangible copy or an electronic one. Documentation acquires thorough records for each aspect of lab activities for the purposes of validation and traceability. Document structure includes the distribution list, document number, style, and format.
The majority of documents are examined once a year. Wherever an operation is conducted, the lab should make sure that only the most recent versions of the pertinent documentation are available. The majority of documentation are on paper. Computer use improves data retrieval and storage. Generally speaking, records are kept for two years.
Records in lab can be accession list that records all specimens received in lab, requestion form containing name, age, and sex of patient, source and type of specimen, antibiotic therapy, and vaccine history. Work card including name, age, and sex of patient, source and type of specimen, procedures, AST etc. and test report including physician’s name who ordered the test, specimen source and type, Name of test, date of specimen receipt and processed.
The most crucial document in a laboratory is the Standard Operating Procedure (SOP). It describes the entire test-taking procedure. A copy of the SOP should be in every lab area, and it should be reviewed once a year. Organization name, SOP title, revision number, pagination, and the date the SOP went into effect are all included in the SOP.
Quality assessment:
Laboratory personnel or an impartial outside organization can do both periodic and retroactive quality assessments.
External quality assessment (EQA) uses data with known but secret results to evaluate quality by an outside organization.
EQA supports accreditation, enhances GLPs, and guarantees the lab’s trustworthiness. For a fair comparison, the provided material should be uniform and EQA should be flexible. The more collaborating labs there are, the more beneficial the system is. If the quality is not up to par, there should be a short turnaround time so that appropriate action can be taken. Experts approved by the national health authority should be organizers. Lab improvement might be encouraged by using a scoring system.
Internal quality assessment (IQA): The procedures are identical to those of EQA, except the material is made, disseminated, and the outcomes assessed in the laboratory. IQA has access to statistical analysis, confidence limit testing, and test variability. In the referral lab, confirmation can be completed.
EQA ensures credibility of lab, improved Good Laboratory Practices, support accreditation. EQA should be versatile and the supplied material should be homogenous for fair comparison. Greater the participating lab, greater is the usefulness of scheme. Turnaround time should be short to take relevant action if quality is not satisfactory. Organizers should be experts authorized by National health authority. Lab improvement might be encouraged by using a scoring system.
Internal quality assessment (IQA): The procedures are identical to those of EQA, except the material is made, disseminated, and the outcomes assessed in the laboratory. IQA has access to statistical analysis, confidence limit testing, and test variability. In the referral lab, confirmation can be completed.
Customer services:
A microbiology laboratory provides services in infectious disease diagnosiss
Identification of etiology, antibiogram, biosafety and biosecurity and it is
responsible for total testing procedures i.e. pre-analytical, analytical and post analytical processes. The result has to be communicated well and timely by effective communication strategies. Communication may be in written or electronic form. In addition to the advice provided directly to individuals, laboratory should also plan on developing new services and facilities. Laboratory in collaboration with organization’s leadership should be able to meet needs of patients, health care providers and organization. In the process, all arms such as quality I process, biosafety, biosecurity should be taken care of.
Personnel:
Personnel being one of the major arm of robustly working organization, hiring, training and staff management are key in gaining the quality. During hiring, institution should provide clear job qualification, job description and competencies. Orientation and training are vital for personnel especially new ones. This includes familiarizing new staffs with personnel policies and safety requirements. Ongoing training of personnel is important for a dynamic laboratory environment. Training should be well planned, documented and evaluated.
Competency testing of all technical staffs should be done and documented. CLIA requires annual competency testing of personnel. Blind sample testing, direct observations can be conducted. Any deficiency should be addressed with retraining. Up to date personnel records should be done with high confidentiality and storage security.
Facilities and safety:
The organization of the laboratory is determined by the location where testing is conducted, whether in a physical laboratory or at the point of care. The laboratory should assess whether there is sufficient space to accommodate both personnel and equipment appropriately.
Space should be adequate for specimen receiving, processing, microscopy, media preparation, glassware washing, AFB isolation, molecular test and specimen workup.
The lab should have a procedure in place to find a qualified source to buy equipment from. Equipment should be installed in accordance with the manufacturer’s specifications, and initial calibration and functioning verification should be carried out to qualify it for use. When a bar code label is received, it facilitates special equipment maintenance and service. Every piece of equipment should have its own file containing the model number, serial number, and bar code of the manufacturer. The calibration and verification results ought to be recorded.
Purchasing and inventory:
For high quality service, the selection and purchasing of services and supplies should be procedure oriented. The laboratory must keep track of its interactions with vendors or products. Problems detected by staff should be reported to lab supervisor and documented as non-conformity. The laboratory administration and laboratory supervisor should be agreed on approval of purchase. BSL certification, equipment maintenance, and referral lab are examples of purchased external services. Service agreements are used to document a transaction where service provider gives services like reference testing, consulting. Since a laboratory might be required to perform a wide array of test, referral lab might be required to perform tests not ordinarily performed in that lab. Referral lab accreditation is vital. The results from the referral lab should be reported as the clinical lab intended. LIS communication is preferred.
While purchasing supplies, quality requirements need to be determined and well communicated between staff and purchasing agents should exist. Cost accounting should exist for consumables and even overhead cost should be determined by the manager. Budgeting is crucial, and managers should keep an inventory ledger.
Equipment:
A laboratory should be equipped with the tools it needs to deliver services, such as software, information systems, analytical tools, and lab-specific equipment.
The laboratory should have a defined process to identify and select qualified suppliers for equipment purchases. Equipment must be installed in accordance with the manufacturer’s specifications, and an operational qualification should be carried out through initial calibration and functionality verification. A barcode label should be affixed upon receipt to facilitate unique identification for service and maintenance tracking. Separate files must be maintained for each piece of equipment, including details such as the manufacturer’s model number, serial number, and barcode. Every calibration and verification outcome needs to be accurately recorded.
Process management:
Pre examination phases are great sources of error so institutional support from various groups is required for best practices to ensure highest quality specimen. The proper method must be used to choose the right sample at the right moment. The specimens should be well’ labelled and requisition form should match the label on the specimen. In examination phase, the validity of all the equipment and reagents and choice of test should be ensured. Validation is vital and performed by authorized lab staff who are trained in the same lab. Any modifications to the validation process must be thoroughly documented and approved prior to implementation. Quality assurance should be maintained through both quality control measures and quality assessment activities. An interlaboratory comparison program may be established, and internal quality assurance procedures can also be conducted. During the post-examination phase, all test results must be carefully reviewed before being released. For instance, a result such as Neisseria gonorrhoeae isolated from a wound should be critically evaluated, as it may be questionable.
Occurrence management:
It is the process by which errors are identified and handled/ Errors could be because staff is unclear or when individual roles are not well defined. So written procedural guidelines should be provided to staffs. Proper training to staff, day to day management and timely monitoring of equipment, reagents can be preventive action. Applying corrective measures involves addressing the root cause of the issue. Example: If equipment is not functioning well, it can be recalibrated or repaired.
Continual process improvement:
Planning, checking and acting for quality improvement should be done and continual improvements can be achieved by:
- Monitoring quality indicators
- Identification and control of non-conformities,
- Root cause analysis
- Preventive and corrective action
- Accessing customer needs
Quality indicators should be measured and managed and pre analytical, analytical and post analytical remedial actions should be taken.
Information management:
Laboratory-generated data and information should be managed to guarantee traceability, security, and integrity. The majority of the data comes from patient lab reports. Both manual and electronic methods can be used to handle information. Verification is required to guarantee the accuracy of the manual. For instance, software should be monitored and calculations produced electronically should be checked on a regular basis. It should be simple to interpret lab reports. For patient care, the lab should ascertain the turnaround time that is clinically meaningful. For instance, the AFB staining report needs to be sent within 24 hours of the sample being collected. Report confidentially should be upheld by the lab, and LIS access should be restricted. There should be a procedure to recover the previous data in the event that the LIS is upgraded or replaced.