4 PRINCE FAISAL BIN KHAT!D CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY ltF 6tc ii -''"-'I| fi1ljg \lni\lr\ 1)i ll('rlth 1. Policy Number Number of Pages DPPILABIOO4 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE tANl2O2O FEBI2O2O FEBl2023 0 P F,X,C,C PURPOSE: 1.1. The policy identifies and outlines the orientation and re-contracting activities required when staff are hired, re-contracted or terminated by the Laboratory department . The requirements identified in the policy also apply to those individuals scheduled to spend a limited amount of time in the trainees, volunteers and authorized visitors. 1.2. Toassurethatall staffare knowledgeable with each procedure they are expected to perform and practice each procedure according to written instructions in the department policy and procedure manuals. 2. DEFINITIONS: 2.1. Personnel Training: The intent oftraining is to provide the individual with the knowledge and skills necessary to be competent in their assigned duties and responsibilities. 2.2. Competency Assessment: Competency Assessment is the means to confirm that training is effective and that personnel are capable of following established procedures to accurately perform laboratory testing that produces quality results. 2.3. Continuing Education: Continuing Education important for all laboratory employees to ensure knowledge ofthe latest health care trends, which in turn, allows for continual interest in day-to-day responsibilities. lt is a good way for employees to become aware ofthe latest developments in medical laboratory practices, and can help PFKCC lab provide better patient (CE) is care more efficiently. 3. RESPONSIBILITIES: 3.1. Quality Supervisor 3.1.1 Ensures implementation of training procedure. 3.1.2 Maintains employee training records 3.1.3 Responsible for the evaluation, training and growth of the technical and quality related skills of employees by establishing training schedule and rotation for all new employees and by ensuring personnel receive training and demonstrate competence. i1.} STAMP Page 1 of 14 PRINCE FAISAL BIN KHATID CARDIAC CENTER TITLE: TRAINING ORIENTATION POtICY aic 4tF ri rnll <iy I Policy Number Number of Pages -----+ L4 DPPILABIOO4 ljg ISSUE DATE \trnr\tr\ ol llcirllh JAN/2020 EFFECTIVE DATE REVIEW DATE FEBI2O2O FEBl2023 I P.F.r{.C.C 3.1.4 Ensures proper supervision oftrainees until training completed. 3.1.5 Ensures training records are complete. 3.1.6 Monitors employee performance to identify the need for retraining or additional continuing education 3.1.7 Ensures and records continued competency of employees. 3.1.8 Has relevant knowledge of the technology, methods and procedures used, purpose of each test, and an understanding of the significance of deviations found with regard to the normal use of the items, materials, products, etc. concerned within their area of responsibility 3.2. Laboratory medical director: Ensures training is conducted and recorded for quality management system policies and procedures. 3.3. Staff: 3.3.1 Completes required training within specified timeframe 3.3.2 Becomes and stays knowledgeable in procedures and methods performed, NOTE: Employees are responsible for self-training, throuBh reading current literature, technical papers, publishing technical papers 3.3.3 Ensures all FDA mandated training, i.e. annual ethics, computer security, etc., is completed and certificate submitted to local training coordinator 3.3.4 Reads and complies with standards, regulations, policies, procedu res, and work instructions 4. POLICY: 4.1 Personnel Training: Accurate and reliable test results are achieved when a test is performed as per manufacturer guidelines. Proper training and ongoing competency assessment will help to ensure the test is being performed correctly every time. a\i o STAMP ?age 2 of L4 PRINCE FAISAL BIN KHATID CARD]AC CENTER TITLE: TRAINING ORIENTATION POLICY 4F atc ii -r "r \lirri\u I I <i1 Ijg \ ol ll.,rllh Policy Number Number of Pages DPPILABIOO4 t4 ISSUE DATE EFFECTIVE DATE JAN/2020 FEBI2O2O REVIEW DATE P,F,H,C.C FEBl2O23 All new employees need orientation and training for lab. Every facility is regardless of how much laboratory experience an different, and individual has, new employees must be trained in the following areas: 4.1.1 Their assigned duties and responsibilities 4.1.2 Laboratory policies 4.1.3 Laboratory procedure manual(s) 4.1.4 Procedures for all of the tests the individual will be authorized to perform 4.1.5 Laboratory quality assessment plan 4.1.6 Safety practices 4.1.7 Computer system (LlS), records, and reports 4.2 Current employees need continuous trainint: 4.2.1 When new processes and test procedures are implemented 4.2.2 When current processes and test procedures are changed 4.2.3 Whenever the need for additional training is identified (e.g., a failed competency assessment, proficiency testing failure, identified problem) The intent of training is to provide the individual with the knowledge and skills necessary to be competent in their assigned duties and responsibilities. Additional training may be necessary to ensure ongoing competency. The training program should have defined objectives, methods, and tra ining materials. 4.3 Quality Test Performance: training must ensure that all testing personnel are familiar with the following for each test procedure: 4.3.1 The test name and purpose ofthe test 4.3.2 The equipment necessary to perform the test 4.3.3 Specimen collection and handling 4.3.4 Preparation, labeling, use, and storage of reagents, standards, and controls 4.3.5 Special requirements, safety procedures, etc. 4.3.6 lnstrument maintenance, function checks, and calibration, when applicable 4.3.7 Step-by-step performance ofthe test procedure \___ STAM P Page 3 of 14 PRINCE FAISAL BIN KHAIID CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY 4n atc ci:.,all<illjg \lrnr\tr\ (,i llcirllh Policy Number Number of Pages DPPILABIOO4 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE JAN/2020 FEBI2O2O FEBl2023 e P.F.X.C.C 4.3.8 Quality control procedures including what constitutes acceptable results and when to report patients 4.3.9 How to recognize and interpret inconsistent results and test system problems and perform troubleshooting 4.3.10 Recommended corrective action when controls are unacceptable 4.3.11 Necessary calculations and derivation of results, when applicable 4.3.12 4.3.13 4.3.14 4.3.15 Reference ranges and critical values Result reporting Quality assessment procedures important that personnel do not report test results on patient specimens until training is completed and competency is verified for each specific test procedure. 4.3.16 A basic protocol for test procedure training could include having the trainee: 4.3.L6.1 entire package insert and/or test procedure to become familiar with the items Read the listed above 4.3.16.2 Observe the specimen collection, handling, and processing steps used to obtain the specimen and get it ready for testing 4.3.16.3 Observe as the trainer performs and documents all applicable maintenance, startup and function checks, calibration, and quality control procedures 4.3.16.4 Observe as the trainer tests specimens 4.3.16.5 Observe and discuss the evaluation of quality control result acceptability and interpretation of specimen results 4.3.16.6 Perform all quality control procedures 4.3.16.7 Perform the test using previously tested specimens and compare the results obtained su ,r/*', "t,/ ,-\ li STAM P Page 4 of 14 PRINCE FAISAT BIN KHATID CARD]AC CENTER TITtE: TRAINING ORIENTATION POtICY atc 4tF ri -'',n ll 6il ljg \1ini\rr\ ()l lle lth Policy Number Number of Pages DPPILp.B/OO4 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE tANl2O2O FEBI2O2O FEBl2023 4.4 Continuing Education: Continuing Education P.F.(.C.C important for all laboratory employees to ensure knowledge of the latest update. lt is a good way for employees to become aware of (CE) is the latest developments in medical laboratory practices, and can help the lab provide better patient care more efficiently. 4.4.1 There are many sources for laboratory continuing education, including: 4.4.1.1 Conferences, seminars, workshops, and meetings 4.4.1.2 Presentation and review of case studies 4.4.1.3 Training on instruments or kits by the manufacturer 4.4.1.4 Annual required training (safety, lnfection) 4.4.1.5 Document all continuing education activities with the date, topic, source, and 4.5 CE. Professional Development: Laboratory professionals should look for opportunities ongoing professional growth and for development including: 4.5.1 Explore any continuing education opportunities that the organ ization offers 4.5.2 Attend a regional or national meeting or conference ffi 1 STAM P Page 5 of 14 ;*$ PRINCE FAISAL BIN KHAIID CARDIAC CENTER TITtE: TRAINING ORIENTATION POLICY atc 4ltr ci-:,all<illjq Policy Number Number of Pages DPPI1,.BIOO4 t4 ISSUE DATE \1ini\tr\ ()t llcirlth EFFECTIVE DATE REVIEW DATE FEBI2O2O FEBl2023 T JAN/2020 5. e P.f.t{.c.c PROCEDURES: 5.1. Training Requirements: Before starting any work-related duties, the employee will be familiar with work related documents. These documents include procedures, work instructions, applicable manuals and regulations. Employees undergoing training are supervised until training is completed and competency demonstrated. 5.1.1 Training requirements are outlined and documented on the basis of the position description of duties and respon sib ilities. 5.1.2 Training is determined by the employee's educational qualifications, experience, complexity of the test method, and knowledge of the test method performed. 5.1.3 The employee will not perform any procedure, inspection, or method until all applicable training has been completed and competency demonstrated. 5.1.4 Employees may request training related to their duties. 5.2 5.1.5 Training and competency records shall be maintained according to local policy. 5.1.6 The effectiveness of training is evaluated by reviews & evaluate the employees performance Training Technique: 5.2.1. The training process for technical procedures such as laboratory analysis consists of the following steps: 5.2.1.1 Trainee reads the laboratory procedures, work instructions, or other applicable documents. 5.2.1.2 Trainee observes demonstration ofthe procedure by a trainer. 5.2.1.3 Trainee performs the procedure under observation by a trainer. 5.2.1.4 Trainee successfully completes the procedure independently. \r.E "::) STAMP Pa 6of14 .lp PRINCE FAISAL BIN KHALID CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY 4tF Number of Pages Policy Number atc L4 DPP/LA8/004 ci-:,all<jlljg \1rnr\lr\ (Ji llcirlrll EFFECTIVE DATE ISSUE DATE REVIEW DATE FEBI2O2O JAN/2020 5.2.2. T tEBl2O23 I P.f.(.c.c The training process for non-technical procedures includes, but is not limited to: 5.2.2.1 5.2.2.2 5.2.2.3 5.2.2.4 5.2.2.5 5.2.2.6 5.2.2.7 5.2.3 5.3. Reading laboratory procedures. lnstructions. Demonstrations. Lectures and discussions. Self-study. Computer-based training. Manufacturer's training or demonstration An employee's performance is verified by measurement against a defined performance standard. The measures used to verify an employee's performance are assessment tools. Assessment tools: 5.3.1 Administration of a Written Evaluation: Written evaluations can be used in areas where verification of a participant's knowledge is desired. Knowledge of theory or principles, problem-solving ability, logical sequence used, and independent or group decision making may be established. 5.3.2 Observation of Procedure, Process, or Outcome: Observation by a trainer of an employee performing or demonstrating a procedure. 5.3.3 Response to OralQueries Related to a Step or Procedure: Answers provided by the employee to questions asked by trainer. 5.3.4 Testing Blind QC Samples: Employees are unaware when blind test samples are assigned. They appear identical to other samples, are in routinely used containers, and are from a similar source. The intent is to provide simulated samples to measure realistic analytic conditions. This tool assesses all phases of laboratory performance. STAMP Page 7 of L4 PRINCE FAISAL BIN KHALID CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY atc 4tF ci-:.,all<illjg \1inr\rr\ (rl Hcul{h Policy Number Number of Pages DPP/rA8/004 t4 ISSUE DATE EFFECTIVE DATE !AN/2O2O FEBI2O2O REVIEW DATE FEBl2023 e P.r.(.c.c 5.3.5 Testing of Known Samples: Participants know and often plan for known testing events, such as external proficiency surveys and commercially prepared quality control samples. Samples for quality assurance or quality control purposes are identified immediately upon receipt in the laboratory. lt is considered a waste of time and resources to conduct more careful handling and analysis on these samples or perform duplicate testing. This tool assesses the analytical phase only. 5.3.6 Testing Previously Analyzed Samples: Duplicate or replicate testing provides accessible internal comparisons and contributes to the validation of the analytic phase. These sources may be previously tested samples, samples of known constituents, and already reported proficiency testing samples. This tool assesses the analytical phase only. 5.4. Authorization of Personnel: 5.4.1 Laboratory management authorizes personnel to perform specific laboratory Training in each section. 5.4.2 When personnel are authorized to be trainee, the training records must indicate which parts of the method the employee has received training. 5.5. Training Records 5.5.1 Training and competency records are maintained 5.5.2 Training records should include a description ofthe training, the trainee name, the trainer, dates of training, and indication of successful completion. Training records are archived for exiting employees. Examples of training records: 5.5.2.1 Completed training checklist prepared internally for procedure. 5.5.2.2 Completed blind quality control (QC) samples, proficiency surveys, acceptable preparation and analysis of QC samples. 5.5.2.3 Completed written evaluations. 5.5.2.4 Signed acknowledgment of reading assigned procedural documents. STAM P Page 8 of 14 PRINCE FAISAL BIN KHATID CARDIAC CENTER TITLE: TRAINING ORIENTATION POtICY 6tc 4tF -.' I I <i1 lj g "-' ()l ll('irllh \irrn\tr\ ai Policy Number Number of Pages oPPILABIOO4 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE JAN/2020 FEBI2O2O FEBl2023 P,F,R.C,C 5.5.2.5 Attendance sign-in sheets for in-house training. 5.5.2.6 A certificate from manufacturer's training courses. 5.6 Orientation Plan: Covers all the areas mentioned below: 5.6.1. The Section Head and Supervisor of the 5.6.2. 5.6.3. applicable laboratory section are responsible for ensuring that all new staff, trainees, locums, volunteers have been appropriately oriented and complete the necessary checklist items. All new staff must go through the orientation process and complete the New Employee Checklist Hospital Checklist and the applicable section specific orientation and training checklists. Departments & Location: The section supervisor shall provide orientation to new staff about the laboratory departments/section, with respect to their location, heads, supervisors and technical staff. He/she also provide information about the other related departments like Biomedical and general maintenance 5.6.4. with their contact information. Policy & Procedure: All new employees read the appropriate departmental policies, the section supervisor and head of the department will provide all the related information either the hard copies or electronic copies of these policies or procedure to the staff and staff should sign that they have read and understood them, they should be informed about the 5.6.6. Laboratory Mission, Vision and Values. Safety:(Refer to lab. Safety policy and Lab. (safety manual) 5.6.7. Employee should inform about their roles & responsibility in different adverse event. <i;!)b LE i -o./S ptovear/ r,,y *---.-' .*1-f,.'I, ,';r,et4 STAMP Pa e9of14 PRINCE FAISAL BlN KHATID CARDIAC CENTER TITLE: TRAINING ORIENTATION POI-lCY 6tc 4tF a r,nll \linist^ 6illjg (rf llcrhh Policy Number Number of Pages DPPILABIOO4 L4 ----T--- ISSUE DATE tANl2O2O EFFECTIVE DATE e REVIEW DATE FEBl2O23 FEBI2O2O 5.6.7.1 tn case of fire: P.F.X.C.C When there is a fire in your immediate work area. 5.6.7.t.L Fire's point of origin. 5.6.7 .1.2 Where location of pull stations, fire doors, fire extinguishers, evacuation routes, and procedures. How to use fire extinguisher. 5.6.7.1.3 How to Use and functioning of fire alarm systems 5.6.7.1.4 Fire exit plan 5.6.7.1.5 RACE & PASS 5.6.7.1.6 Disaster plan and their codes- Yellow , Red etc. 5.6.7.1.7 Electrical Safety 5.6.8. Flammable, Chemical and Corrosives Liquids: Supervisor and safety officer provide information about the following points: 5.6.8.1 Storage -Store only in approved safety cans or storage cabinets. Be sure they are labeled. 5.6.8.2 How to clean different type of spills 5.6.8.3 Clean up spills right away. 5.6.9. Other Situations: 5.6.9.1 lnformation about hazardous materials including material safety datasheet (MSDS). .t\ STAMP Page 10 of 14 PRINCE FAISAT BIN KHALID CARD]AC CENTER TITLE: TRAINING ORIENTATION POtICY atc ,TIF ci-:,all<illjg \1irr\lr\ r,l ll('irlrh Policy Number Number of Pages oPPILA.Bloo4 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE tANl2O2O FEBI2O2O FEBl2023 P.F.l{.C.C 5.6.9.2 lnformation on lnfection Control and Sharp disposal. How to report adverse event including. 5.6.9.2.7 When to complete an Occurrence Variance Report - OVR. 5.6.9.2.2 Where to route the Occurrence variance Report - OVR. 5.6.9.2.3 General lnformation about the Lab Quality Management Program 5.6.10 Orientation: All staff required to use the Laboratory lnformation System (LlS) must be granted the appropriate access and receive training in the appropriate LIS applications. LIS The LIS Manager/LlS coordinator are responsible to provide unique access and the training about the LIS and LIS orientation form should be filled and copy will kept in the employee file. Both the staff member and the Laboratory LIS Coordinator must sign the access form. The staff member will be instructed in the train domain using a generic password. 5.6.11 Personal: The section supervisor provides information about the laboratory team, Administrative, technical, Operational with their designation and contact information. He / She also inform about the organizational chart and chain of command. 5.6.12 Work process: Provide basic information about the laboratory working and ground rules in the laboratory. Keeping in mind the main phases of work flow (Pre analytical, Analytical and the post analytical). General lnformation on Communication devices: Telephone System. <(t;") \.1\ STAM P Pa e11 of 14 PRINCE FAISAL BIN KHATID CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY atc ?IF <i-:.,all <il \l[]r\lr\ {)l l ljg Number of Pages Policy Number DPP/rAB/004 L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE tANl2O2O FEBI2O2O FEBl2023 lc'irlth 5.6. 13.Staff e P.F.l(C.C Evaluation Process: The following steps shall be followed: 5.6.13.1 All new employees receive an assessment of the knowledge, skills and attitude required of the employee to function successfully in his/her position. 5.6.13.2 All new employees receive education on the proper use of equipment including troubleshooting and reporting malfunctions. 5.6.13.3 All new employees receive more clarification as needed on all topics provided in the general orientation and this is signed by the employee and immediate supervisor. 5.6.13.4 Orientation for new employees is located in the employee's personnel file. 5.6. 14. Re-contracting 5.6.14.1 At time of employee re-contractin8. the activities and requirements outlined on the Employee Reconstructing Checklist must be complete. 5.6.14.2 The re-contracting package should be completed, signed by the Laboratory Director and submitted to hospital committee of at least 3 months prior to the end of contract date. 5.6.14.3 Updated BLS (Basic Life Support) and participating in Continuing education Programs in the laboratory are needed 5.6.L4.4 Completing Competency assessment. flR STAMP Page 12 of 14 PRINCE FAISAT BIN KHALID CARDIAC CENTER TITLE: TRAINING ORIENTATION POLICY 4tF ctc ,i-r"rll Policy Number oPPILABIOO4 aiyljg \lIn\lr\ ol llcrlth J T Number of Pages L4 ISSUE DATE EFFECTIVE DATE REVIEW DATE JAN/2020 FEBI2O2O FEBl2023 P.F.t(.C.C --J 5.6.15 Accountability: 5.6.15.1 The section supervisor must ensure that the staff member has successfully completed the training. 5.6.15.2 The staff member must complete the Confidentiality Agreement. 5.6.15.3 Arrange for additional training employee has not successfully if the completed the training. 5.6.15.4 Visitors, volunteers and trainees who are expected to spend more than one working day in the laboratory must undergo an abbreviated orientation process. The Section Head and Supervisor ofthe section visited are responsible for ensuring visitors, volunteers and trainees have been appropriately oriented completely. 6. REFERENCES: 6.1. Clinical and Laboratory Standards lnstitute (CLSI), Training and 6.2.Competence Assessment, Approved Guideline-Third Edition 6.3.CLSl Document GP-21-A3 (ISBN 1-56238-691-3) 7. ATTACHMENTS: 7.1 Orientation check list form (PFKCC/LAB/FO15 7c, lit ,t STAM P Page 13 of 14 r PRINCE FAISAL BIN KHALID CARDIAC CENTER ar atc ci-:,alldlljq \lrrr\la\ )l ll.:rlll) TITLE: TRAINING ORIENTATION POtICY Policy Number Number of Pages oPPILABIOO4 L4 ISSUE DATE r I EFFECTIVE DATE !ANl2O2O 8. FEBI2O2O l l REVIEW DATE FEBl2023 e P.F.X.C.C APPROVAT: Prepared By Na me Title Hanadi AL-Yenbawi Laboratory Quality Signature Date Coordinator Mr. lbrahim ALWadie Laboratory Director Dr. Eisa Assiri QIPS Director 1-z-n>o -(,--raf?o l-t-u"r" Reviewed By Dr. Amer Hassan Medical Director (for Assiri Medical PP's) Mr. Ali Al Qarnie Nursing Director (for b/e/?oh lt1lllotu Nursing PP's) Approved By Dr. Adel Maswary Center Director t r lL/tob, STAMP Pa L4 of t4