The document discusses good laboratory practices (glp) and Good Laboratory Practice (GLP). It defines the three main notions of glp/GLP as: 1) general, everyday laboratory practices without formal regulations; 2) technical laboratory practices or guidelines; 3) strict adherence to protocols and standards required for regulatory purposes, especially in the pharmaceutical industry. The goals of glp are to ensure safety, timeliness, and accuracy in the laboratory through proper documentation, training, equipment, and prevention of accidents, delays, and errors.

1. good laboratory practice or glp Noel C. Santos, MD,MPH Fellow, Phil. Society of Pathologists

7. 3 Different Notions of GLP

16. good laboratory practice = SAFE TIMELY ACCURATE

18. Accidents

19. THE HAZARDOUS ENVIRONMENT IN THE LABORATORY “ THE PERFECT SET UP FOR AN ACCIDENTS” Toxic and Hazardous waste Inadequate training/ Do not follow procedure high stress, overworked laboratory staff high turnover laboratory staff infectious environment potent body fluids Toxic and flammable chemicals dangerous equipment

20. LABORATORY HAZARD PREVENTION STRATEGIES (WORK PRACTICE CONTROLS) Handwashing after each patient contact Cleaning surface with disinfectants Orientation training and continuing education Warning signages No eating drinking or smoking in laboratory Immunization for Hepatitis Job rotation to Minimize repetitive Task

21. LABORATORY HAZARD PREVENTION STRATEGIES ( ENGINEERING CONTROLS) Kneel/elbow or foot Controlled faucets Puncture-resistant containers for disposal and transport of needles Mechanical pipetting Device Sufficient supply of wall electric points to avoid “octopus” extensions Biohazard bags Bench space and floor non-slip resistant to reagents and disinfectants used Biological safety Cabinets

22. LABORATORY HAZARD PREVENTION STRATEGIES (PERSONAL PROTECTIVE EQUIPMENTS) Non latex gloves Mask including respirators Protective eye wear Gowns and laboratory coats Face shield Eye station

23. Delays

24. “ WHAT TIME WILL BE THE RELEASE OF MY LABORATORY RESULTS?”

25. DELAYS = LOST REVENUES A tertiary laboratory calculated that it took almost 2 hours to do a CBC blood test that can be done in 7 minutes. Another laboratory calculated that it took almost a month to release a biopsy result

28. Patient Process Flow Analysis in the laboratory LOS (length of stay) reduction

29. admitted patient discharged patient PATIENT FLOW “ PROCESS ORIENTED APPROACH” Hospital Management ER MEDICINE ANCILLARY FINANCE

30. Conventional Process (batch processing) Lean Process (one piece flow)

31. “ Batch Production Method” in the Clinical Laboratory

33. Using the principles of Kaizen and the Toyota Production System, Virginia Mason Medical Center increased the number of patients it treats in its 40-foot-long hyperbaric chamber by adding dressing, toilet and treatment space, which allowed some patients to prepare while others are being treated.

34. (LABORATORY HOSPITAL LABORATORY REQUEST PROCESS) PATIENT ARRIVES AT THE LAB 1 ST FLOOR WAIT GIVE LAB REQUEST USE OF PROCESS FLOW ANALYSIS ASSESSEMENT RETURN TO LAB GIVE RECEIPT PAY AT 2 ND FLOOR ACCOUNTING BEFORE IMPROVEMENT RETURN TO 2 ND FLR TO COLLECT URINE PATIENT ARRIVES AT THE LAB GIVE REQUEST ASSESSEMENT PAYMENT SPECIMEN COLLECTION ALL IN THE SAME FLOOR AFTER IMPROVEMENT

35. ONE-STOP-SHOP PROCESSING

36. Errors

37. THE HIGH RISK ENVIRONMENT OF HEALTH CARE “ THE PERFECT SET UP FOR MAKING MISTAKES” high volume prescription high volume MD orders high volume patients high speed emergencies high stress, overworked medical staff highly sensitive impatient patients high turnover medical staff illegible, unclear orders MD high variety, myriad cases, symptoms

38. DANGEROUS ABBREVIATIONS- INSTRUCTIONS .5 mg 5 mg U/A (urinalysis) UA (uric acid) 10 % formalin 10 mL formalin µL mL 5.0 mg 50 mg 1:10,000 mg/mL 1:1,000 mg/mL X (yes) X (no) HBsAg HBsAb

39. LOOK-ALIKE PRODUCTS AND PACKAGING water alcohol A B KCl distilled water

40. 1 million hospitalized patients in the U.S. 6 laboratory request daily each 6 million request per day 5% mislabeling of specimen 300,000 mislabeled specimen daily

41. Six Sigma Quality 99.9999997% “ 3 defects per million (DPM)” WORLD CLASS MANUFACTURERS 230 DPM HOSPITALS 6,000 - 300,000 DPM

42. Mistake-proofing

43. WRONG SITE SURGERY IMPOSSIBLE EVENTS UNDER TOYOTA’S MISTAKE PROOFING SYSTEM WRONG BLOOD TYPE

44. MISLABELING OF SPECIMEN MISLABELING – 50% OF ALL REPORTED LABORATORY ERRORS IMPOSSIBLE EVENTS UNDER TOYOTA’S MISTAKE PROOFING SYSTEM

45. ROBUST PROCESS DESIGN “ SMART MACHINES” cannot be set nor operated beyond normal, safe, or maximum levels (volume, intensity or time)

46. ROBUST PROCESS DESIGN (INFORMATION SYSTEM DATA ENTRY) abnormal values cannot be entered N.R. 0.001 gram to 0.01 gram [ 0 .1 gram will be rejected ]

47. VISUAL CONTROL 35% ERROR REDUCTION HBs Ag Anti -HBs

48. STANDARDS MEASURES What is not measured cannot be improved.

53. Thank you very much for listening....

54. Good day!!!