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An experience with the accreditation of private laboratories

Jegathesan M, De Witt GF

Med J Malaysia, 1978 Jun;32(4):331-5.
PMID: 732634
Matched MeSH terms: Laboratories/standards*
Fulltext Health laboratory services in Malaysia

Chandrasekharan N

Med J Malaysia, 1982 Sep;37(3):197-204.
PMID: 7176996
Matched MeSH terms: Laboratories/standards*
Fulltext Evaluation of the performance of a micromethod for measuring urinary iodine by using six sigma quality metrics

Hussain H, Khalid NM, Selamat R, Wan Nazaimoon WM

Ann Lab Med, 2013 Sep;33(5):319-25.
PMID: 24003421 DOI: 10.3343/alm.2013.33.5.319

BACKGROUND: The urinary iodine micromethod (UIMM) is a modification of the conventional method and its performance needs evaluation.
METHODS: UIMM performance was evaluated using the method validation and 2008 Iodine Deficiency Disorders survey data obtained from four urinary iodine (UI) laboratories. Method acceptability tests and Sigma quality metrics were determined using total allowable errors (TEas) set by two external quality assurance (EQA) providers.
RESULTS: UIMM obeyed various method acceptability test criteria with some discrepancies at low concentrations. Method validation data calculated against the UI Quality Program (TUIQP) TEas showed that the Sigma metrics were at 2.75, 1.80, and 3.80 for 51±15.50 µg/L, 108±32.40 µg/L, and 149±38.60 µg/L UI, respectively. External quality control (EQC) data showed that the performance of the laboratories was within Sigma metrics of 0.85-1.12, 1.57-4.36, and 1.46-4.98 at 46.91±7.05 µg/L, 135.14±13.53 µg/L, and 238.58±17.90 µg/L, respectively. No laboratory showed a calculated total error (TEcalc)

Matched MeSH terms: Laboratories/standards
Guidelines on sample management (version 1/2004)

College of Pathologists, Academy of Medicine of, Malaysia

Malays J Pathol, 2005 Jun;27(1):73-4.
PMID: 16676699
Matched MeSH terms: Laboratories/standards*
Fulltext The use of immunohistochemistry in an oral pathology laboratory

Ajura AJ, Sumairi I, Lau SH

Malays J Pathol, 2007 Dec;29(2):101-5.
PMID: 19108402 MyJurnal

Immunohistochemistry has become part of normal routine diagnostic work in the Stomatology Unit, Institute for Medical Research, Kuala Lumpur. Of 9523 cases received from the year 2000 to 2005, 197 cases (2.1%) required immunohistochemical staining. These cases ranged from benign to malignant lesions. They include lymphomas (n=41), epithelial tumours (n=29), neural lesions (n=21), fibroblastic/myofibroblastic tumours (n=16), small round cell tumour (n=11), vascular tumours (n=4), smooth muscle tumours (n=4), myxomatous tumours (n=4) and skeletal muscle tumours (n=1). In most of the cases (69.5%), immunohistochemical staining was mandatory to reach a definite diagnosis, while 60 cases (30.5%) required immunohistochemistry in confirming the diagnosis. In 32 cases (16.2%), definitive diagnosis could not be made due to the small size of the specimens received or the results of immunohistochemistry were inconclusive. Standardization of techniques, competent medical laboratory technologists and sufficient budget allocation are important in producing a high quality immunohistochemistry service.

Matched MeSH terms: Laboratories/standards*
Guidelines on laboratory construction and design (version 1/2004)

College of Pathologists, Academy of Medicine of Malaysia

Malays J Pathol, 2005 Jun;27(1):63-7.
PMID: 16676696
Matched MeSH terms: Laboratories/standards*
Experience of the first survey of the pilot project of Asian Quality Assurance Survey program

Lee KN, Yoon SY, Cho HI

Southeast Asian J. Trop. Med. Public Health, 2002;33 Suppl 2:30-43.
PMID: 12755265

The Asian Network for Clinical Laboratory Standardization (ANCLS) decided to start her First Inter-laboratory Quality Assurance survey at the business meeting during the Second Asian Colloquium on October 21-22, 2000 in Kobe, Japan. The first survey materials of Asian Quality Assurance Survey (AQuAS) were distributed in July 2001 to 21 hospitals in the field of chemistry and 22 hospitals in the field of hematology among total 24 participating laboratories from seven Asian countries: Indonesia, Japan, Korea, Malaysia, Philippines, Singapore and Thailand. The survey methods in chemistry and in hematology were somewhat different. In chemistry the survey material was considered as unknown but handled similarly to the sample from the patient. Nineteen routine tests were performed only once. The hematology samples were considered as unknown but handled similarly to control or calibration material. Five parameters were tested five times repetitively and their average for each parameter was calculated. All the results were supposed to be sent back to the office within two weeks. Although it took more than two weeks, the return rate was 100%. The analysis was performed in several ways such as all the results together, by instruments and by methods. Mean, standard deviation (SD), standard deviation index (SDI), coefficient of variation (CV) and variance index score (VIS) were to be calculated in chemistry, and in hematology the same parameter were to be calculated except CV and VIS. In the first survey, the CV in chemistry was not calculated and the analysis by instrument or by methodology was also not attempted since there were not enough participating hospitals to do such analysis. In hematology the analysis was done by instrument only. The survey process was carried out successfully though there were some difficulties in communication tools, transportation methods and handling of specimens due to different weather conditions, and returning the report in the correct unit and to the correct place. The submitted data were acceptable for analysis. There were some differences in the units of measurement in different countries or laboratories. It was necessary to convert some of the units. Some laboratories apparently do not perform certain tests such as calcium, potasium and gamma-glutamyltransferase (gamma-GT). The gamma-GT is the most frequently not performed test. With the experience of this first survey, all the members involved in the survey have been trained well to do future surveys.

Matched MeSH terms: Laboratories/standards*
Fulltext The Pathology Laboratory Act 2007 explained

Looi LM

Malays J Pathol, 2008 Jun;30(1):1-10.
PMID: 19108405 MyJurnal

The past century has seen tremendous changes in the scope and practice of pathology laboratories in tandem with the development of the medical services in Malaysia. Major progress was made in the areas of training and specialization of pathologists and laboratory technical staff. Today the pathology laboratory services have entered the International arena, and are propelled along the wave of globalization. Many new challenges have emerged as have new players in the field. Landmark developments over the past decade include the establishment of national quality assurance programmes, the mushrooming of private pathology laboratories, the establishment of a National Accreditation Standard for medical testing laboratories based on ISO 15189, and the passing of the Pathology Laboratory Act in Parliament in mid-2007. The Pathology Laboratory Act 2007 seeks to ensure that the pathology laboratory is accountable to the public, meets required standards of practice, participates in Quality Assurance programmes, is run by qualified staff, complies with safety requirements and is subject to continuous audit. The Act is applicable to all private laboratories (stand alone or hospital) and laboratories in statutory bodies (Universities, foundations). It is not applicable to public laboratories (established and operated by the government) and side-room laboratories established in clinics of registered medical or dental practitioners for their own patients (tests as in the First and Second Schedules respectively). Tests of the Third Schedule (home test blood glucose, urine glucose, urine pregnancy test) are also exempted. The Act has 13 Parts and provides for control of the pathology laboratory through approval (to establish and maintain) and licensing (to operate or provide). The approval or license may only be issued to a sole proprietor, partnership or body corporate, and then only if the entity includes a registered medical practitioner. Details of personnel qualifications and laboratory practices are left to be specified by the Director-General of Health, providing for a formal recognition process and room for revision as pathology practices evolve. Encompassed in the responsibilities of the licensee is the requirement that samples are received and results issued through, and management vested in, a registered medical or dental practitioner. This effectively prohibits "walk-ins" to the laboratory and indiscriminate public screening. The requirement for a person-in-charge in accordance with class and speciality of laboratory ensures that the laboratory is under the charge of the pathology profession. Examined carefully, the requirements of the Act are similar to laboratory accreditation, but are backed by legislation. Many of these details will be spelt out in the Regulations, and these in turn are likely to fall back on National professional guidelines, as accreditation does. Although not at first obvious, enforcement of the Act is based on self-regulation by pathology laboratory professionals. Sincere professional input is thus required to embrace its philosophy, ensure rational and transparent enforcement of legislation, and develop National guidelines for good pathology practices upon which enforcement may be based.

Matched MeSH terms: Laboratories/standards*
Guidelines on safe laboratory practice (version 1/2004)

College of Pathologists, Academy of Medicine of, Malaysia

Malays J Pathol, 2005 Jun;27(1):71-2.
PMID: 16676698
Matched MeSH terms: Laboratories/standards*
Sunway Medical Laboratory Quality Control Plans Based on Six Sigma, Risk Management and Uncertainty

Jairaman J, Sakiman Z, Li LS

Clin. Lab. Med., 2017 Mar;37(1):163-176.
PMID: 28153364 DOI: 10.1016/j.cll.2016.09.013

Sunway Medical Centre (SunMed) implemented Six Sigma, measurement uncertainty, and risk management after the CLSI EP23 Individualized Quality Control Plan approach. Despite the differences in all three approaches, each implementation was beneficial to the laboratory, and none was in conflict with another approach. A synthesis of these approaches, built on a solid foundation of quality control planning, can help build a strong quality management system for the entire laboratory.

Matched MeSH terms: Laboratories/standards*
Formulation variables affecting drug release from xanthan gum matrices at laboratory scale and pilot scale

Billa N, Yuen KH

AAPS PharmSciTech, 2000;1(4):E30.
PMID: 14727895

The purpose of this research was to study processing variables at the laboratory and pilot scales that can affect hydration rates of xanthan gum matrices containing diclofenac sodium and the rate of drug release. Tablets from the laboratory scale and pilot scale proceedings were made by wet granulation. Swelling indices of xanthan gum formulations prepared with different amounts of water were measured in water under a magnifying lens. Granules were thermally treated in an oven at 60 degrees C, 70 degrees C, and 80 degrees C to study the effects of elevated temperatures on drug release from xanthan gum matrices. Granules from the pilot scale formulations were bulkier compared to their laboratory scale counterparts, resulting in more porous, softer tablets. Drug release was linear from xanthan gum matrices prepared at the laboratory scale and pilot scales; however, release was faster from the pilot scales. Thermal treatment of the granules did not affect the swelling index and rate of drug release from tablets in both the pilot and laboratory scale proceedings. On the other hand, the release from both proceedings was affected by the amount of water used for granulation and the speed of the impeller during granulation. The data suggest that processing variables that affect the degree of wetness during granulation, such as increase in impeller speed and increase in amount of water used for granulation, also may affect the swelling index of xanthan gum matrices and therefore the rate of drug release.

Matched MeSH terms: Laboratories/standards*
Fulltext External quality assessment of dengue and chikungunya diagnostics in the Asia Pacific region, 2015

Soh LT, Squires RC, Tan LK, Pok KY, Yang H, Liew C, et al.

Western Pac Surveill Response J, 2016 04 22;7(2):26-34.
PMID: 27508088 DOI: 10.5365/WPSAR.2016.7.1.002

OBJECTIVE: To conduct an external quality assessment (EQA) of dengue and chikungunya diagnostics among national-level public health laboratories in the Asia Pacific region following the first round of EQA for dengue diagnostics in 2013.
METHODS: Twenty-four national-level public health laboratories performed routine diagnostic assays on a proficiency testing panel consisting of two modules. Module A contained serum samples spiked with cultured dengue virus (DENV) or chikungunya virus (CHIKV) for the detection of nucleic acid and DENV non-structural protein 1 (NS1) antigen. Module B contained human serum samples for the detection of anti-DENV antibodies.
RESULTS: Among 20 laboratories testing Module A, 17 (85%) correctly detected DENV RNA by reverse transcription polymerase chain reaction (RT-PCR), 18 (90%) correctly determined serotype and 19 (95%) correctly identified CHIKV by RT-PCR. Ten of 15 (66.7%) laboratories performing NS1 antigen assays obtained the correct results. In Module B, 18/23 (78.3%) and 20/20 (100%) of laboratories correctly detected anti-DENV IgM and IgG, respectively. Detection of acute/recent DENV infection by both molecular (RT-PCR) and serological methods (IgM) was available in 19/24 (79.2%) participating laboratories.
DISCUSSION: Accurate laboratory testing is a critical component of dengue and chikungunya surveillance and control. This second round of EQA reveals good proficiency in molecular and serological diagnostics of these diseases in the Asia Pacific region. Further comprehensive diagnostic testing, including testing for Zika virus, should comprise future iterations of the EQA.

Matched MeSH terms: Laboratories/standards*
Fulltext Haemoglobin A1c: comparing performance of two point of care devices with laboratory analyser

Wan Mohd Zin RM, Ahmad Kamil ZI, Tuan Soh TR, Embong M, Wan Mohamud WN

BMC Res Notes, 2013 Dec 18;6:540.
PMID: 24344903 DOI: 10.1186/1756-0500-6-540

BACKGROUND: Measurement of HbA1c has been widely used for long-term monitoring and management of diabetes control. There is increasing use of point-of-care (POC) devices for measuring HbA1c where quicker results would allow immediate clinical management decisions to be made. Therefore, it is important to evaluate and compare the performance of such devices to the reference laboratory method.
FINDINGS: A total of 274 venous blood was collected from normal healthy adults during the community screening programmes. The performance of POC devices, Afinion and Quo-test were compared to central laboratory HPLC method; Adams A1c HA 8160. Both POC devices showed good correlation to HA 8160 with r = 0.94 (p < 0.001) and r = 0.95 (p < 0.001) for Afinion and Quo-test respectively. The means difference were statistically higher between POC and HA 8160 with 0.23% (95% CI 0.19-0.26, p < 0.001) and 0.29% (95% CI 0.24-0.34, p < 0.001) for Afinion and Quo-test respectively.
CONCLUSIONS: Both POC devices could be considered in health clinics for diabetes management but not to be used for the diagnostic purposes.

Matched MeSH terms: Laboratories/standards