8 PMLS1 Nature of the Clinical Laboratory PDF

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THE CLINICAL LABORATORY➢ Is an Essential Component of Health Institution. ➢ Its main task is to provide accurate and reliable information to Medical doctors for Diagnosis, Prognosis, Treatment, and Management of disease. ➢ 70% of all decisions Performed by medical Doctors are based on laboratory and...

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PRINCIPLES OF MEDICAL LABORATORY SCIENCE 1 Nature of the Clinical Laboratory THE CLINICAL LABORATORY ➢ Is an Essential Component of Health Institution. ➢ Its main task is to provide accurate and reliable information to Medical doctors for Diagnosis, Prognosis, Treatment, and Management of disease. ➢ 70% of all decisions Performed by medical Doctors are based on laboratory and test result, thus the need for accurate and reliable test result ➢ Also actively involved in research, community outreach programs, surveillance, infection control in the hospital and community setting, information dissemination, and evaluation of the applicability of current and innovative diagnostic technologies. ➢ Is the Place where specimens (e.g., Blood and not her Body Fluids, Tissues, Feces, Hair, and Nails) Collected from individuals are Processed, Analyzed, Preserved, and properly disposed. ➢ Clinical laboratories vary according to size, function, and the complexity of tests Performed What is the Role of Clinical Laboratory to a Medical Technologist? ➢ It plays a Very Significant Role in the Performance of Laboratory Testing and Ensuring the reliability of Test Result. ➢ Assays undertaken in the Clinical Laboratory in the Past were Described as a manual, taxing, labor-intensive, and time consuming. ➢ Currently w/ the advent of automatation, Assays are less Laborious, with shortened turnaround time (TAT). ➢ Also, test procedures are ensured to produce more reliable result.

Challenges in Clinical Laboratory ➢ In the near future, there will be more changes in the Clinical Laboratory. ➢ Changes may be Due to Shifting demographics, Emergence of a new and re-emergence of infectious and noninfectious disease, demand for a more efficient and efficient workflow, and new government institutional policies. ➢ These factors can usher in change in the activities done in the laboratory. CLASSIFICATION OF CLINICAL LABORATORIES According to Function 1. Clinical Pathology ➢ It is concerned w/ the diagnosis and treatment of diseases Performed through laboratory testing of Blood and other Body Fluids ➢ Is a Clinical Laboratory that focuses on the areas of; ➢ Clinical Chemistry ➢ Immunohematology and Blood Banking ➢ Medical Microbiology ➢ Immunology and Serology ➢ Hematology, Parasitology ➢ Clinical Microscopy ➢ Toxicology ➢ Therapeutic Drug monitoring, Endocrinology 2. Anatomic Pathology ➢ is concerned w/ the Diagnosis of diseases Through Microscopic examination of tissues and Organs ➢ Is a Clinical laboratory that focuses on the areas of; ➢ Histopathology ➢ Immunohistopathology ➢ Cytology ➢ Autopsy

➢ Forensic Pathology According to Institutional Characteristic 1. Institution-Based ➢ Is a Clinical laboratory that operates within the premises or part of an institution such as; ➢ Hospital ➢ School ➢ Medical Clinic ➢ Medical Facility for overseas workers and seafarers ➢ Birthing Home ➢ Psychiatric Facility ➢ Drug Rehabilitation Center. 2. Free-Standing ➢ Clinical Laboratory is not part of an established institution. The most common example is a Free- Standing out-patient Clinical Laboratory According to Ownership 1. Government- owned ➢ Owned by National or Local Government Units, Wholly or Partially Examples: DOH Run Government Hospitals ➢ San Lazaro Hospital ➢ Jose R. Reyes memorial Medical Center ➢ University of the PhilippinesPhilippine General Hospital Local Government Run Hospital-Based ➢ Ospital ng Maynila Medical Center ➢ Sta. Ana Hospital ➢ Bulacan Medical Center 2. Privately-Owned ➢ Clinical laboratories are Owned, Established, and operated by an Individual, Corporation, Institution, Association, or Organizations.

Examples: ➢ St. Luke’s Medical Center ➢ Makati Medical Center ➢ MCU-FDTMF Hospital According to Service Capability 1. Primary Category ➢ Liscened to perform basic; ➢ Routine Laboratory Testing ➢ Routine Analysis ➢ Routine stool Examination ➢ Routine Hematology or CBC that includes Hemoglobin ➢ Hematocrit, WBC and RBC Count ➢ WBC differential Count and Qualitative Platelete Count ➢ Blood Typing ➢ Gram Staning (if hospital based). ➢ Equipment requirements are, but not limited to; ➢ Microscopes ➢ Centrifuge ➢ Hematocrit centrifuge. ➢ Space requirement is at Least 10 Sq meters. 2. Secondary category (Hospital and Non-Hospital-Based) ➢ Are also Liscened to perform Laboratory Test being done by the Primary section clinical labortories alonside with routine clinical chemistry test like; ➢ Blood glucose concetration ➢ blood urea nitrogen ➢ Blood ➢ uric acid ➢ blood creatinine ➢ cholesterol determination qualitative ➢ Platelet count ➢ Gram Stain ➢ KOH Mount ➢ Crossmatching. ➢ A minimum requirement of 20 square meters is needed for the floor area of this type of Laboratory.

➢ Personnel Requirement depends on the workload. ➢ Minimum equipment requirements; ➢ Microscopes ➢ Centrifuge ➢ Hematocrit Centrifuge ➢ Semi-Automated Chemistry analyzers ➢ Incubator ➢ Oven. 3. Tertiary Category (Hospital and Non-Hospital-Based) ➢ Are Liscened to perform all laboratory test performed in the Secondary category laboratory Additional Performances: ➢ Immunology and serelogy ➢ Microbiology, Bacteriology, and Mycology ➢ Special Clinical Chemistry ➢ Special Hematology ➢ Immunohematology and Blood-banking ➢ Floor area at least 60 Square Meters. ➢ Equipment Requirementd include those seen in Seconday category Laboratories along with; ➢ automated chemistry analyzer ➢ biosafety cabinet ➢ class II ➢ serofuge NATIONAL REFERENCE LABORATORY ➢ Is a Laboratory in a Government Hospital Designated by the DOH to provide special Diagnostic funnctions and Services for certain diseases. ➢ These functions include referral services, provision of Confirmatory Testing, Assitance for research activities, Implementaton of External Quality Assurance Program (EQAP) of the Government, resolution of clonflicts regarding test Results of Different

laboratories, and training of medical technologist on certain Specialized Procedures that require Standardization. LAWS ON THE OPERATION, MAINTENANCE, AND REGISTRATION OF CLINICAL LABORATORIES IN THE PHILIPPINES REPUBLIC ACT NO. 4688 ➢ An Act regulating the operation and maintenance of Clinical laboratories and Requiring the registration of the same with the DOH (Department of Health), providing penalty for the Violation thereof, and for other Purposes ➢Approved: June 18,1966 Section 1 ➢ Any person, firm or corporation, operating and maintaining a clinical laboratory in w/c body fluids, tissues, secretions and radio activity from beings or animals are analyzed for the determination of the presence of patthologic organism, Processes and/or conditions in the persons or animals from w/c they were obtained, shall register and secure a licence annually at the office of the Secretary of Health: provide, that Government Hospital Laboratories doing routine or minimum laboratory examinations shall be exempt from the Provision of this section if thier services are extensions of government regional or central Laboratories. Section 2 ➢ It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he/she is a licensed physician duly qualified in the laboratory medicine and authorized by Secretary of Health, such authorization to be renewed annually.

➢ No License shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration, direction and supervision of an authorized physician, as provided for in the Preceding Paragraph. Section 3 ➢ the Secretary of Health, through the Bureau of research and laboratories shall be charged with the responsibility of strictly enforcing the provisions of this act and shall be authorized to issue such rules and regulations as may be necessary to carry out its provision Section 4 ➢ any person, firm or corporation who violates any provisions of this act or the rules and regulation issued the reunder by Secretary of Health shall be punished w/Imprisonment for not less than 1 month but not more than 1 year, or by a fine of not less than P1, 000 nor more than P5, 000, or both such fine and imprisonment, at the discretion of the court. Section 5 ➢ If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be invalid, the judgement shalll not affect, impair, or invalidate the remainder thereof. Section 6 ➢ the sum of P50,000 or so much thereof as may be Necessary, is hereby authorized to be appropriated, out of any funds in the National treasury not otherwise appropriated, to carry into effect the provisions of this act.

Section 7 ➢ All Acts or parts of Acts w/c are inconsistent w/ the provisions of this Act are hereby repealed ADMINISTRATIVE ORDER NO. 59 S. 2001 “Rules and Regulation Governing the establishment, Operation and Maintenance of Clinical Laboratories in the Philippines.” Section 1: Title ➢ This Administrative Order shall be known as the “Rules and Regulation Governing the Establishment, Operation and Maintanance of clinical laboratories in the Philippines.” Section 2: Authority ➢ these rules and regulation are issued to implement R.A.4688: Clinical Laboratory Law consistent w/ E.O. 102 series1999: Redirecting the Functions and Operations of the Department of Health (DOH), through the Bureau of Health Facillities and Services (BHFS) in the Health Regulation cluster, shall Exercise the regulatory functions under these rules and regulations. Section 3: Purpose ➢ These rules and regulations are promulgated to protect and promote the health of the people by ensuring Availability of clinical laboratories that are properly managed w/ adequate resources w/ effective and efficient performance through compliance w/ quality standards. Section 4: Scope ➢ these Regulations shall apply to all entities performing the activities and functions of clinical laboratories w/c shall include the examination and analysis of any or all samples of human and other

related tissues, fluids, secretions, radioactive, or other materials from human body for the determination of the existence of pathogenic organisms, pathologic processes or conditions in the person from whom such samples are obtained. ➢ These regulations do not include government laboratories doing in the laboratory examinations limited to acid fast bacilli microscopy, malaria screening and cervical cancer screening, provide their services are declared as extension of a licensed government clinical laboratory. Section 5: Classification of Laboratories Classification by Functions 1. Clinical Pathology ➢ Hematology ➢ Clinical Chemistry ➢ Microbiology ➢ Parasitology ➢ Mycology ➢ Clinical Microscopy ➢ Immunology and Serology ➢ Immunohematology ➢ Toxicology ➢ Therapeutic Drug Monitoring 2. Anatomic Pathology ➢ surgical pathology ➢ Immunohistopathology ➢ Cytology ➢ Autopsy and Forensics Pathology Classification by Institutional Character 1. Hospital-Based Laboratory ➢ a Laboratory that operates w/in a Hospital 2. Non-Hospital-Based Laboratory ▪ a Laboratory that operates on its own Classification by Service Capability 1. Primary Provides the minimum services capabilities such as:

Routine Hematology (CBC) ➢ Hemoglobin Mass Concertation, ➢ Erythrocyte Volume Fraction (Hematrocrit) ➢ Leucocyte Number Concentration (WBC Count) ➢ Leucocyte Type Number Fraction (Differential Count), Qualitative Platelet Determination. Routine Urinalysis Routine Fecalysis Blood typing-Hospital-Based Quantitative Platelet Determination-Hospital-Based 2. Secondary ➢ Provides the Minimum services Capabilities of a Primary category and the following: ➢ ➢ ➢ ➢

Routine Clinical Chemistry

3.

➢ ➢ ➢ ➢

➢ blood Glucose Substance Concentration ➢ Blood ➢ Urea Nitrogen Concentration ➢ Blood Uric Acid Substances Concentration ➢ Blood Creatinine Concentration ➢ Blood total Cholesterol Concentration ➢ Crossmatching Tertiary ➢ Provides the Secondary Services Capabilities and the following: Special Chemistry Special Hematology Immunology/ Serology Microbiology

Section 6: Policies 1. An approved permit to construct and design layout of a Clinical laboratory shall be secured form the BHFS prior to submission of an Application for a Petition to Operate.

2. No Clinical Laboratory shall be constructed unless plans have been approved and construction permit issued by the BHFS. 3. A Clinical Laboratory shall operate w/ a Valid License issued by BHFS/ CHD, based on Compliance w/ the minimum Licensing Requirements (Annex A). 4. The Clinical laboratory shall be Organized and Managed to provide effective and efficient Laboratory services. 5. The Clinical Laboratory Shall Provide Adequate and Appropriate safety Practices for its Personnel and Clientele. Section 7: Requirements and Procedures for Application of Permit to Construct and License to Operate 1. Application for Permit to Construct The Following are the Documents Required: ➢ Letter of Application to the Director of BHFS ➢ 4 sets of Site Development Plans and Floors Plan approved by an architect ➢ DTI/SEC Registration (for Private Clinical Laboratory) 2. Application for New License ➢ a Duly notarized Application “Petition to Establish, Operate and Maintain a Clinical Laboratory”, shall be filed by the Owner or his/ her Duly authorized representative at the BHFS ➢ a Duly notarized Application form “Application for Renewal License to Establish, Operate and Maintain a Clinical Laboratory ” Shall be filled by the owner or his/her duly authorized representative at the respective CHD 3. Renewal of License ➢ application for Renewal of license shall be filed w/in 90days before the expiry date of the license describes as follows:

Region

NCR

Schedule of Application for Renewal of License January to March

1,2,3, & CAR

February to April

4,5,&6

March to May 7,8,&9 April to June

7,8,&9 10,11,12,CARAGA ARMM

& May to July

4. Permit and License Fees ➢ A non-refundable license fee shall be charged for application for permit to construct, and for license to Operate a Government and private clinical laboratory ➢ A non-refundable fee shall be charged for application for renewal of license to operate ➢ All fees shall be paid to the cashier of the BHFS/CHD ➢All fees shall follow the Current Prescribed schedule of fees of the DOH. 5. Penalties ➢ A penalty of P1,000 for late Renewal shall be Charged in addition to the renewal fee for all Categories if the application is filed during the next 2 months after the expiry. ➢ An Application received more than 2 months after expiry shall be fined P100 for each month thereafter in addition to the P1,000 Penalty. 6. Inspections ➢ Each license shall make available to the director of the BHFS/CHD or his duly authorized representative(s) at any Reasonable time, the premise and facilities where the laboratory examinations are being performed for Inspection.

➢ Each license shall make available to the Director of the BHFS/CHD or his/her duly authorized representative(s) all performed records. ➢ Clinical Laboratories shall Inspected every two 2 years oras necessary 7. Monitoring ➢ All clinical laboratories shall be monitored regularly and the records shall be made available to determine Compliance w/ these rules and regulation ➢ The Director of the BHFS/CHD or his authorized representative(s) shall be allowed to monitor the clinical laboratory at any given time ➢ All clinical laboratories shall make available to the director of the BHFS or his/her duly authorized representative(s) records for monitoring. 8. Issuance of License ➢ The license shall be issued by the director of the CHD or his authorized representative, if the application is found to be meritorious. 9. Terms and Conditions of License ➢ The license is granted upon compliance w/ the Licensing requirements ➢ The license is non-transferable. ➢ The owner or authorized representative of any clinical laboratory desiring to transfer a licensed clinical laboratory to another location shall inform the CHD in writing at least 15 days before the actual Transfer. ➢ the laboratory in its new location shall be subject to re-inspection and shall comply w/ the licensing requirements ➢ An extensions laboratory shall have a separate license. ➢ Any change affecting the substantial conditions of the license to operate a laboratory shall be reported w/in 15 days in writing by the person(s) concerned, to the BHFS/CHD for notation and approval. ➢ Failure to do so will cause the revocation of the License of the clinical laboratory.

➢ The clinical laboratory is license must be placed I a conspicuous location/area w/in the laboratory. Section 8: Violations ➢ The license to operate a clinical laboratory shall be suspended or revoked by the Secretary of Health upon Violation of R.A. 4688 or the Rules and Regulations issued in pursuance thereto. ➢ The following acts committed by the Owner, President, Managers, Board of Trustees/Directors, Pathologist or its personnel are considered Violations. ➢ Operation of a Clinical Laboratory w/o a certified pathologist or w/o a registered medical technologist ➢ Change of ownership, location, and head of laboratory or personnel w/o informing the BHFS/CHD. ➢ Refusal to allow inspection of the clinical laboratory by the person(s) authorized by the BHFS during reasonable Hours. ➢ Gross negligence ➢ Any act or omission detrimental to the public ➢ The provincial, City of Municipal Health Officers are authorized to report to the CHD and BHFS the existence of unlicensed clinical laboratories or any Private party performing laboratory examinations w/o proper license and/or Violations to these rules and regulations. Section 9: Complaints

Investigation

of

Charges

and

➢ The BHFS/CHD or his/her duly authorized representatives shall investigate the compliant and verify if the laboratory concerned or any of its personnel is guilty of the charges.

1.

If upon investigation, any person is found violating the provision of R.A. 4688, or any of these rules and regulations, the BHFS/CHD or his/her duly authorized representative(s) shall suspend, cancel or revoke for a determined period of time the license, as well as the authority of the offending person(s), w/o prejudice to taking the case to judicial authority for criminal action. 2. Any person who operate a clinical laboratory w/o the proper license from the Department of Health shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1year or a fine of not less than P1, 000 and not more than P5, 000 or both at the discretion of the court provided. However, that if the offender is a firm or corporation, the Managing Head and/or owner/s there of shall be liable to the penalty imposed herein. 3. Any clinical laboratory operating w/o a valid license or whose license has been revoked/cancelled shall be summarily closed upon order issued by the BHFS/CHD or his/her duly authorized representative. The BHFS/CHD may seek the assistance of the law enforcement agency to enforce the closure of any clinical laboratory. 4. The closure order issued by the DOH (Department of Health) shall not be rendered ineffective by any restraining order and injunction order issued by any court, tribunal or agency or instrumentalist. Section 10: Modification and Revocation of License 1. A License may be revoked, suspende or modified in full or in part for any material false statement by the applicant, or as shown by the record of inspection ofr for a violation of, or failure to comply w/ any other of the terms and conditions and provision of these rules and regulations 2. No License shall be modified, suspended or revoked unless prior notice has been made and the corresponding investigation

conducted expect in cases of wilful, or repeated violations hereof, or where public health interest or safety requires otherwise Section 11: Repealing Clause ➢ These rules and regulations shall supersede all other previous official issuances hereof. Section 12: Publication and List of Licensed Clinical Laboratory ➢ A list of Lice...