Laboratory Management Information, 2023 PDF

**Information management** - Is a system that incorporates all the processes needed for effectively managing data---both incoming and outgoing patient information (WHO). - *Laboratory are loaded with information and effective communication is one of the most important skills needed...

**Information management** - Is a system that incorporates all the processes needed for effectively managing data---both incoming and outgoing patient information (WHO). - *Laboratory are loaded with information and effective communication is one of the most important skills needed in pathology, to delivered the services effectively*. Note: - As Medtech, we used Laboratory Information System (LIS) - It incorporates all data such as patient information, test requested, results inputs and output, test formation, and processes. **Communication can be defined a number of ways:** - The exchange of thoughts, messages, or information using speech, signals, writing, or behavior - The art and technique of using words effectively to impart information or ideas - A system, such as mail, telephone, television, or computer, for sending and receiving messages - The exchange or transmission of ideas, attitudes, or beliefs between individuals or groups. Note: - ***Communication*** - *[the exchange of information or messages from two individuals in effective way]* **Importance of communication in the management theories** ***1. Chester I. Barnard wrote in 1938*** in Functions of the Executive that the first executive function is to develop and maintain a system of communication. 2\. I***n the Management of Organizations***, ***Hicks*** stated, ***["Organizational interaction depends on communication"]***. - ***Communication is of prime concern to managers because it makes cooperative action possible***. 3\. ***Peters and Waterman***, In Search of Excellence, state, ***["The nature and uses of communication in excellent companies are] [remarkably different from those of their non - excellent peers".]*** Note: - *[Communication and information flow or transfer throughout the healthcare setting are very complicated ]* - *The information must be exchange between internal and external departments, the external vendors, regulatory, and laboratory clients/customers* - *Anytime the information flow will be improved and the efficiency of the laboratory will be improved (delivery of the message)* **Management communication strategy** - A plan used by the laboratory for the dissemination of information - **The appropriate utilization of laboratory services** - *[(test orders, frequency of test orders, specimen collection and transport, testing turnaround times, report formats, additional report comments, reference ranges, consultation options, and test limitations)]* - **The extent of services offered** - *[(test menu, test available for STAT testing, and comprehensive test parameters)]* - **Regulations concerning the operation of the laboratory** - *[(hours of operation, performance of tests per shift, STAT reporting, critical value reporting, and laboratory organization chart)]* **Elements of a communication plan:** - **Define objectives and purpose of the plan**. - Use a concise message - Gear communication to education level of recipient - **Identify the structure and format of written communiqués**. - Design a format and use it as a template for all written communications. - **List recipients of laboratory communication**. - Identify all stakeholders who should receive communication ***(medical staff, laboratory staff, administration, clients, computer services, patients, etc.).*** - **Identify the method(s) of communication.** - **Written *(memo, newsletter, email, specimen collection manual, etc.),*** - **Verba**l ***(phone call, intercom, etc.)*** - **Visual *(banner, poster, video, etc.)*** **Means and Mechanics of Effective Communication** ***Heller*** wrote, ***["For effective communication, you must be aware of the means and the channels with which to transmit and exchange information."]*** **Methods of communication** ***ACTION*** ***EXAMPLES*** -------------- ------------------------------------------------------------------ **Verbal** ***Telephone, intercom, face-to-face*** **Written** ***Memoranda, email, newsletter, flyer, manual*** **Visual** ***Videos, posters, presentation, personal digital assistants*** Note: - **Types of communication:** - *Intradepartmental Communication* - *Interdepartmental Communication* - *External Communication* **Documents and Records** - The management of documents and records is one of the 12 essential elements of the quality system. - The management system addresses both use and maintenance of documents and records. - *[A major goal of keeping documents and records is to find information whenever it is needed]*. What are the differences of lab docs and records? - Documents *[provide written information about policies, processes and procedures (WHO]*) - ***Records*** *[are the collected information produced by the laboratory in the process of performing and reporting a laboratory test. (WHO)]* +-----------------------------------+-----------------------------------+ | ***Characteristics of | ***Characteristics of Records*** | | Documents*** | | +===================================+===================================+ | communicate information to all | need to be easily retrieved | | | | | persons who need it | or accessed | +-----------------------------------+-----------------------------------+ | need to be updated or maintained; | contain information that is | | | permanent, and does not require | | | updating | +-----------------------------------+-----------------------------------+ | must be changed when a policy, | | | process or procedure changes | | +-----------------------------------+-----------------------------------+ | | ***Examples:*** ***completed | | | forms, charts, sample logs, | | | patient*** | | | | | | ***records, quality control | | | information and patient | | | reports***. | +-----------------------------------+-----------------------------------+ | establish formats for recording | | | and reporting information by the | | | use of standardized forms---once | | | the forms are used to record | | | information, they become records | | +-----------------------------------+-----------------------------------+ | ***Examples:*** ***quality | | | manuals, SOP (standard operating | | | procedures), job aids*** | | +-----------------------------------+-----------------------------------+ - *Information is the major product of the laboratory, so manage it carefully with a good system for the laboratory's documents and records. (WHO)* Note: - **Ongoing used:** *Documents* - **Already used:** *Records* - *These documents include all written policies, processes and procedure of laboratory.* - *In order to develop laboratory documents, it is important to understand each of these elements and how they relate to each other* **Documents** ***What is a policy?*** - A policy is "a documented statement of overall intentions and direction defined by those in the organization and endorsed by management". - ***Policies give broad and general direction to the quality system.*** ***What is a process?*** - Processes are the steps involved in carrying out quality policies (Ex. ISO 9000) - ISO 9000 - *[defines a process as a "set of interrelated or interacting activities that transform inputs into outputs"]* ***What are procedures?*** - Procedures are the specific activities of a process (ISO 9000). *Procedures are very familiar to laboratorians---a procedure is easily described as the performance of a test.* NOTE: - [*Job aids and work instructions are example of shorten version of SOP*, that can be posted at the bench for easy reference on performing a procedure that are meant to supplement and not to replace SOP's] **Quality manual** - *The quality manual is a document that describes the quality management system of an organization (ISO 15189)* **Its purpose is to:** - clearly communicate information - serve as a framework for meeting quality system requirements - convey managerial commitment to the quality system Note: - Quality manual *is the overall guiding document for the quality system and provides the framework for its design and implementation* - [A laboratory is required to have a quality manual for their ISO accreditation ] - When writing quality manual, use a steering committee because the quality manual needs to be tailored to the specific needs of the laboratory - Facility should carefully consider how to best involve to those who are needed - Involved the policy makers of the laboratory and bench technologies to take advantage of their expertise and get their buy in - [*Quality manual should state policies for each essential of the quality system.* They should describe how all the related quality processes occur and make note of all version of SOPs and where they are located ] **The key points to remember about the quality manual are:** - there is only one official version - the quality manual is never finished---it is always being improved - it should be read, understood and accepted by everyone - it should be written in clear, easily understood language - the quality manual should be dated and signed by the management **What makes a good document?** - Written clearly and concisely - it is better to avoid wordy, unnecessary explanations in the documents; - Written in a user-friendly style - it might be helpful to use a standard outline so the general structure will be familiar to staff and easily used by new personnel; - Accurate, reflecting all implemented measures, responsibilities and programs; - Maintained to ensure that it is always up to date **Standard operating procedures (SOPs)** - *[SOPs are also documents, and contain written step-by-step instructions that laboratory staff should meticulously follow when performing a procedure.]* - ***Consistency*** - ***Accuracy*** - ***Quality*** **A good SOP should be:** - ***detailed, clear and concise,*** - ***easily understood by new personnel or students in training;*** - ***reviewed and approved by the laboratory*** - ***updated on a regular basis*** **SOP should have the following:** - ***Title*** - ***Purpose Instruction*** - ***Name of Person preparing the SOP*** - ***Signatures of approving officials and dates of approval*** Note: - ***Basis to prepare your SOPs:*** - *Assess the scientific validity of the procedure* - *When writing the procedure, include all steps and details* *explaining how to properly perform the procedure* - *SOP should refer to any relevant procedures that may be written separately such as sample collection and quality control* - *Mechanism should be established for keeping the SOPs updated* **When preparing SOPs:** - **Title** *-- what is the name of the test* - **Purpose instruction** -- *include information about the test, why it is important, how it is used, and whether it is intended for screening, diagnostic, follow treatment, and for public health surveillance* - **Instructions** -- *detailed info for the entire testing process including the pre- examination, examination, and post-examination phases* - **Name of the person preparing SOP** - the one who prepare and create SOP - Signatures of approving officials and dates of approval - **Pre-Examination:** *address sample collection, transport, and conditions needed for the proper handling of the sample* - **Examination:** include the step-by-step laboratory procedures to follow and the quality control procedure needed to ensure accuracy and reliability - **Post-Examination:** *reporting of results including the unit of measurement to be used, the normal reference range, ranges that are life-threatening (panic values), and the instructions how to deal with urgent report or STAT* **Reference materials** - *good reference materials are needed in order to find scientific and clinical* *information about diseases, laboratory methods, and procedures* **Records** - *Records are laboratory information, either written by hand or computer- printed*. - They are permanent, and are not revised or modified. - **They should be complete, legible and carefully maintained, as they are used for many purposes:** - ***Continuous monitoring*** - ***Tracking of samples*** - ***Evaluating problems*** - ***Management*** Note: - **Continuous monitoring** -- *without access to all data collected as a part of a quality system process, continuous monitoring cannot be accomplished* - **Tracking of samples** -- *well kept records allow tracking of samples throughout the entire testing process so this is important when troubleshooting, looking for sources of error, and testing and investigating identified errors* - **Evaluating problems** -- *important of record keeping; allows for a thorough evaluation of many problems that arises* - **Management** - *good record serves as important management tool* - **Examples of Laboratory Records** - *sample logbook/registers* - *laboratory workbooks/ worksheets* - *Instrument printouts -maintenance records* - *quality control data;* - *external quality assessment or proficiency testing records* - *patient test reports* - *personnel records* - *results of internal and external audits* - *continuous improvement projects* - *Incident reports* - *user surveys and customer feedback* - *critical communications* - **Critical communication** -- *includes letters for or from regulatory agencies such as refence laboratories, government or administrative offices within the healthcare system* **The following is a list of test report contents required by ISO 15189** - *identification of test* - *identification of laboratory* - *unique identification and location of patient, where possible, and destination of the report* - *name and address of requestor* - *date and time of collection, and time of receipt in laboratory* - *date and time of release of report* - *primary sample type* - *results reported in Sl units or units traceable to Sl units, where applicable;* - *biological reference intervals* - *applicable comments relating to quality or adequacy of sample, methodology limitations or other issues that affect interpretation* - *identification and signature of the person authorizing release of the report* - *if relevant, notation of original and corrected results.* **Storing documents and records** - *Storage must be given careful consideration, as the main goal of documentation is finding the information when it is needed.* ***Paper system for records*** ***Using an electronic system*** -------------------------------- ---------------------------------- Permanence Permanence Accessibility Accessibility Security Security Traceability Traceability **Record retention** - *the length of time the laboratory will need to have access to its records*; - government requirements or standards that dictate record retention times; - whether the laboratory is engaged in ongoing research requiring many years of data - the time interval between the laboratory's assessments or audits Note: - *[Histopathology section have longer record retention compared to clinical results in clinical chemistry and hematology ]* - **Important elements:** - *unique identifiers for patients and samples* - *standardized test request forms (requisition)* - *logs and worksheets* - *checking processes to assure accuracy of data recording and transmission* - *protection against loss of data* - *protection of patient confidentiality and privacy* - *effective reporting systems* - *effective and timely communication* - **Common problems occur when managing laboratory information** - *incomplete data for test interpretation, or insufficient or illegible identification* - *forms that are inadequately designed to meet laboratory and client needs* - *standardized forms prepared by others that may not be suitable for all laboratories* - *Inability to retrieve data due to poor archiving processes or insufficient backup of computerized information* - *poor data organization, which may hinder later data analysis efforts to meet research or other needs* - *Incompatibility between computerized information systems and equipment or other electronic systems, resulting* - *In problems with data transmission.* **Requisition and Reporting** **Requisition** - *clearly specify the tests to be performed and the kind of service required.* - Time of collection should also be indicated - **This record should contain at least the following information:** - *Laboratory procedure* - *Identification of the patient* - *Name of the physician* - *Date and time the specimen was collected* - *Date and time the specimen was received* - *Date, time and by whom the specimen was examined* - *Condition of any unsatisfactory specimen* - *Type of test or procedure performed* - *Results and date of reporting* - ***Example of a request form:*** **Lab Reports** **General Qualities of a Laboratory Report:** 1. Compactness 2. Consistency of terminology, format and usage of understandability 3. Clear and easy to understand 4. Logical and accessible location in medical chart 5. Statement of date and time of collection 6. Gross description and source of specimen when pertinent 7. Sharp differentiation of reference or normal and abnormal values 8. Sequential order of multiple results on single specimen 9. Identification of patient, patient location and physician 10. Assurance of accuracy of transcription of request - ***Laboratory head is responsible for all laboratory reports*** **Verbal Reports** - Constitute a major problem for most laboratories - major potential source of errors and medical liability. - It is essential that verbal reports be given in order to facilitate medical care, - ***particularly in an emergency situation*** **Laboratory Information System (LIS)** - *computer network of hardware and software for receiving, processing, and storing laboratory data and information.* - It can interface with laboratory instruments to transfer data into patient records, evaluate quality control data, and store preventive maintenance records. - LIS can interface with an HIS, pathology information system, and other information systems **Components of LIS** 1. The LIS software ***user interface*** determines how the user will interact with the system. 2. ***Request entry:*** Requests for laboratory tests to be performed can be entered through clients located in the nursing units or remote primary care practitioner\'s office. 3. ***Data (results) entry*** - Electronic data interface (EDI) - Manual data entry - Release patient results 4. ***Data storage*** a. Redundant arrays of independent disks (RAID): b. System backup 5. ***System security*** 6. ***Barcoding*** 7. ***Interface*** 8. ***Manual procedures*** 9. ***System maintenance*** 10. ***Disaster recovery*** **Information Provided by an LIS** 1. ***Patient demographics*** 2. ***Work lists*** 3. ***Data retrieval (inquiry)*** a. ***Generate patient results:*** - Flag critical values, print reports if requested. b. ***Perform delta checks:*** - Results of an analyte assay are compared to the most recent previously performed results on the same patient c. ***Patient results can be retrieved electronically at a client or via the Internet with a Web browser.*** 4. ***Quality control:*** An LIS can analyze quality control specimens and prepare charts and reports (e.g., Westgard rules, Levey-Jennings charts). 5. ***Quality assurance*** can provide reports on turnaround time, documentation of critical result reporting, and corrected reports. 6. ***Management reports:*** Cost per billable test calculations, test volume, turnaround time, employee hours, workload data, etc. 7. ***Encoding systems:*** - Systemized Nomenclature of Medicine---Clinical Terms (SNOMED---CT) is a comprehensive database of standardized terminology for healthcare. - Once implemented, it will allow automatic data analysis over a wide range of clinical information systems. - Logical observation identifiers names and codes (LOINC) is another database of universal standards for healthcare Note: - **Reflex testing** -- *initial test result is positive or outside normal parameters, LIS can automatically order a second appropriate test* - **Current procedural terminology codes (CPT Codes)** -- *describe any medical, surgical, and diagnostics services which are designed to communicate information about medical services and procedures among the physicians and* *other health* *care professional. Also used for billing purposes and can be program into the LIS* **How do we select an LIS** - *The process begins with laboratory needs assessment* -- [this is where the data collected on the information needs by the laboratory ] - *Analyzed to determine the feasibility* [of a system and what is needs to get the job done ] - *Laboratory managers and administrators* [to form a committee and prepare a request for the proposal] - Vendors respond to the request for proposal describing how their system will meet the needs of the laboratory and the estimated cost of the system - *Request for proposal* -- [responses will be reviewed by the committee to prevent information overload and confusion so only few vendors only those who submitted an RFP response that will match the need should be selected to give demonstration ] - Vendor demonstrations and visits to the laboratories *using the system help narrow down the choices and the vendor demonstrator demonstration should be scheduled within a short time frame so that information is fresh in everyone's mind* - The selection which based on the system that can best meet the laboratories needs **at the lowest cost.** The cost does not outweigh the benefits if we don't get LIS **Installation** - *Installation process is important and very time -- consuming* - [Vendor representative will install the server, clients, network connections, and software] - Testing of the said laboratory system - [Training laboratory personnel and other healthcare providers on the LIS is an expensive process] - *Communication -- new system that will be used inside the laboratory, all members inside needs to know how to operate it*