Document Control Practices in 120 Clinical Laboratories

2009 ◽  
Vol 133 (6) ◽  
pp. 942-949
Author(s):  
Paul N. Valenstein ◽  
Ana K. Stankovic ◽  
Rhona J. Souers ◽  
Frank Schneider ◽  
Elizabeth A. Wagar
Keyword(s):  
Patient Outcomes ◽  
Clinical Laboratory ◽  
Standard Setting ◽  
Clinical Laboratory Improvement Amendment ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Laboratory Results ◽  
Control Failures

Abstract Context.—A variety of document control practices are required of clinical laboratories by US regulation, laboratory accreditors, and standard-setting organizations. Objective.—To determine how faithfully document control is being implemented in practice and whether particular approaches to document control result in better levels of compliance. Design.—Contemporaneous, structured audit of 8814 documents used in 120 laboratories for conformance with 6 generally accepted document control requirements: available, authorized, current, reviewed by management, reviewed by staff, and archived. Results.—Of the 8814 documents, 3113 (35%) fulfilled all 6 document control requirements. The requirement fulfilled most frequently was availability of the document at all shifts and locations (8564 documents; 97%). Only 4407 (50%) of documents fulfilled Clinical Laboratory Improvement Amendment requirements for being properly archived after updating or discontinuation. Policies and procedures were more likely to fulfill document control requirements than forms and work aids. Documents tended to be better controlled in some laboratory sections (eg, transfusion service) than in others (eg, microbiology and client services). We could not identify document control practices significantly associated with higher compliance rates. Conclusions.—Most laboratories are not meeting regulatory and accreditation requirements related to control of documents. It is not clear whether control failures have any impact on the quality of laboratory results or patient outcomes.

scholarly journals Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Mᵃ Liboria López Yeste ◽  
Silvia Izquierdo Álvarez ◽  
Antonia R. Pons Mas ◽  
Luisa Álvarez Domínguez ◽  
Fernando Marqués García ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Test Results ◽  
Correct Interpretation ◽  
Laboratory Management ◽  
Iso 15189 ◽  
Effective Implementation ◽  
Clinical Laboratories ◽  
Global Trend ◽  
Laboratory Results ◽  
Critical Results

Abstract The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

scholarly journals Analisis Penerapan Keselamatan Kerja Pada Petugas Laboratorium Klinik di Kota Pekanbaru

2016 ◽  
Vol 3 (1) ◽  
pp. 33
Author(s):  
Ismulyati Ismulyati ◽  
Rahman Karnila ◽  
Elda Nazriati
Keyword(s):  
Clinical Laboratory ◽  
Behavioral Assessment ◽  
Design Data ◽  
Clinical Laboratories ◽  
Measurement Results ◽  
Laboratory Workers ◽  
Potential Risks ◽  
Observational Design ◽  
Knowledge Attitude And Practice

Abstrak: The workers in clinical laboratories were suspected to always threatened a number of risks and potential accidents due to the interaction between the labor, equipment, materials and labor and environmental situation in it. In addition, the lack of understanding and awareness of companies/agencies and workers to anticipated and managed the potential risks in the laboratory in accordance with established standards. Research has been conducted in nine private clinical laboratories from February to December 2014 with 39 respondents of laboratory workers. This research was a quantitative study which using observational design. Data collection techniques in this research was using interviews, direct observation and questionnaires which distributed to the management of clinical laboratory and clinical laboratory workers. The quality of the clinical laboratory in Pekanbaru city of fair quality were three of eight laboratories. The results of clinical laboratory management signified the majority of fair quality that five of the eight laboratories in Pekanbaru city. The results of behavioral assessment of clinical laboratory workers were not well behaved. Measurement of behavior consists of knowledge attitude and practice of clinical laboratory workers. The measurement results of clinical laboratory workers were moderate categorized, nice attitudes, but the practice was not well categorized.

History of NIST's contributions to development of standard reference materials and reference and definitive methods for clinical chemistry

1995 ◽  
Vol 41 (9) ◽  
pp. 1306-1312 ◽  
Author(s):  
R Schaffer ◽  
G N Bowers ◽  
R S Melville
Keyword(s):  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Standard Reference Materials ◽  
National Bureau ◽  
Serum Samples ◽  
Clinical Laboratories ◽  
History Of ◽  
Primary Standards ◽  
Definitive Methods

Abstract The issuance of cholesterol as a Standard Reference Material (SRM) in 1967 started the National Institute of Standards and Technology (NIST; then named the National Bureau of Standards) on a major effort to help clinical laboratories establish and improve the quality of measurements they make. NIST now issues three kinds of SRMs for that purpose: analyte samples of certified purity as primary standards, serum samples having certified analyte concentrations as accuracy controls, and materials certified for calibrating instruments. In working with clinical laboratory scientists to establish Reference Methods (RMs) for measuring the analytes, NIST developed Definitive Methods (DMs) to use for evaluating RM accuracy and then used the DMs for assigning analyte values to its SRMs. The development of SRMs and DMs is discussed.

Assessing Clinical Laboratory Quality: A College of American Pathologists Q-Probes Study of Prothrombin Time INR Structures, Processes, and Outcomes in 98 Laboratories

2015 ◽  
Vol 139 (9) ◽  
pp. 1108-1114 ◽  
Author(s):  
Peter J. Howanitz ◽  
Theresa P. Darcy ◽  
Frederick A. Meier ◽  
Christine P. Bashleben
Keyword(s):  
Adverse Drug Events ◽  
Clinical Laboratory ◽  
International Normalized Ratio ◽  
The United States ◽  
Time Frame ◽  
Critical Value ◽  
Clinical Laboratories ◽  
Policies And Procedures ◽  
Emergency Department Patients ◽  
Critical Results

Context The anticoagulant warfarin has been identified as the second most frequent drug responsible for serious, disabling, and fatal adverse drug events in the United States, and its effect on blood coagulation is monitored by the laboratory test called international normalized ratio (INR). Objective To determine the presence of INR policies and procedures, INR practices, and completeness and timeliness of reporting critical INR results in participants' clinical laboratories. Design Participants reviewed their INR policies and procedure requirements, identified their practices by using a questionnaire, and studied completeness of documentation and timeliness of reporting critical value INR results for outpatients and emergency department patients. Results In 98 participating institutions, the 5 required policies and procedures were in place in 93% to 99% of clinical laboratories. Fifteen options for the allowable variations among duplicate results from different analyzers, 12 different timeliness goals for reporting critical values, and 18 unique critical value limits were used by participants. All required documentation elements were present in 94.8% of 192 reviewed INR validation reports. Critical value INR results were reported within the time frame established by the laboratory for 93.4% of 2604 results, but 1.0% of results were not reported. Although the median laboratories successfully communicated all critical results within their established time frames and had all the required validation elements based in their 2 most recent INR calculations, those participants at the lowest 10th percentile were successful in 80.0% and 85.7% of these requirements, respectively. Conclusions Significant opportunities exist for adherence to INR procedural requirements and for practice patterns and timeliness goals for INR critical results' reporting.

Cognitive Impairment and Dementia in Geriatric Population: Role of Clinical Laboratory

2019 ◽  
Vol 15 (2) ◽  
pp. 79-82
Author(s):  
Abhik Banerjee ◽  
Gopa Haldar Das ◽  
Rajarshi Sil
Keyword(s):  
Cognitive Impairment ◽  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Intermediate Stage ◽  
The Elderly ◽  
Geriatric Population ◽  
Clinical Laboratories ◽  
Normal Ageing

Mild cognitive impairment is an intermediate stage between the expected cognitive decline of normal ageing and the more serious decline of dementia. Dementia is typically diagnosed when acquired cognitive impairment has become severe enough to compromise social and/or occupational functioning. The elderly are at much greater risk for cognitive impairment. Unfortunately, most cases of cognitive impairment without apparent dementia go undetected and thereby untreated in primary care. Clinical diagnosis supported by appropriate use of diagnostic tests and biomarker is essential to improve the quality of life in these patients. In this article, we discussed the role of clinical laboratories in the diagnosis of cognitive impairment and dementia in the geriatric population.

How Good are Clinical Laboratories? An Assessment of Current Performance

1992 ◽  
Vol 38 (7) ◽  
pp. 1210-1217 ◽  
Author(s):  
R Rej ◽  
R W Jenny
Keyword(s):  
New York ◽  
Proficiency Testing ◽  
Failure Rate ◽  
Clinical Laboratory ◽  
New York State ◽  
Performance Standards ◽  
Performance Criteria ◽  
York State Department ◽  
Clinical Laboratories

Abstract The Clinical Laboratory Improvement Act of 1967 and Amendments of 1988 (CLIA '67 and CLIA '88) were enacted to ensure that clinical laboratories within the U.S. provide a quality of service that meets clinical needs for good patient care. Approved proficiency-testing programs are to judge the quality of laboratory testing by promulgated performance criteria. We examine the quality of analytical results reported in 1991 to the New York State Department of Health Proficiency Testing program in light of these criteria and analytical goals, based on medical usefulness. Analytical performance is examined for cholesterol, potassium, sodium, calcium, glucose, aspartate aminotransferase, digoxin, and theophylline. In general, proposed CLIA '88 performance standards are compatible with the current state of practice for the population of laboratories examined. Exceptions appear to be digoxin and sodium (failure rate exceeding average) and most therapeutic substances (low failure rate). Sources of analytical bias relative to an accuracy-based target value must be characterized as method-, laboratory-, or matrix-dependent if regulatory programs are to achieve the objective of improving analytical accuracy across all testing sites.

scholarly journals Role and Responsibilities of Laboratory Medicine Specialists in the Verification of Metrological Traceability of in Vitro Medical Diagnostics / Uloga I Odgovornosti Specijalista Laboratorijske Medicine U Verifikaciji Metrološke Sledljivosti In Vitro Medicinske Dijagnostike

2015 ◽  
Vol 34 (3) ◽  
pp. 282-287 ◽  
Author(s):  
Federica Braga ◽  
Ilenia Infusino ◽  
Mauro Panteghini
Keyword(s):  
Quality Control ◽  
Measurement Uncertainty ◽  
Clinical Laboratory ◽  
Metrological Traceability ◽  
Uncertainty Budget ◽  
Medical Diagnostics ◽  
Internal Quality ◽  
Clinical Laboratories ◽  
Laboratory Results

Summary To be accurate and equivalent, laboratory results should be traceable to higher-order references. Furthermore, their quality should fulfill acceptable measurement uncertainty as defined to fit the intended clinical use. With this aim, in vitro diagnostics (IVD) manufacturers should define a calibration hierarchy to assign traceable values to their system calibrators and to fulfill during this process uncertainty limits for calibrators, which should represent a proportion of the uncertainty budget allowed for clinical laboratory results. It is therefore important that, on one hand, the laboratory profession clearly defines the clinically acceptable uncertainty for relevant tests and, on the other hand, endusers may know and verify how manufacturers have implemented the traceability of their calibrators and estimated the corresponding uncertainty. Important tools for IVD traceability surveillance are quality control programmes through the daily verification by clinical laboratories that control materials of analytical systems are in the manufacturer’s declared validation range [Internal Quality Control (IQC) component I] and the organization of Exter nal Quality Assessment Schemes meeting metrological criteria. In a separate way, clinical laboratories should also monitor the reliability of employed commercial systems through the IQC component II, devoted to estimation of the measurement uncertainty due to random effects, which includes analytical system imprecision together with individual laboratory performance in terms of variability.

scholarly journals ISO 15189:2012 Accreditation and Certification: Are You Ready?

2015 ◽  
Vol 1 (2) ◽  
pp. 42-43
Author(s):  
Rajendra Dev Bhatt ◽  
Raj Kumar Shrestha ◽  
Dhruba Acharya
Keyword(s):  
Clinical Laboratory ◽  
Modern Medicine ◽  
Quality Service ◽  
Iso 15189 ◽  
Laboratory Results ◽  
Recent Advancement ◽  
The Status ◽  
Treatment Prognosis ◽  
Huge Investment

“The quality of shoes reflects the status of man and standard of toilets reflect the status of family”: we mean to say- quality matters in day-to-day living. Despite less recognition and prioritization of clinical laboratory in former years, the recent advancement in modern medicine has compelled the health professionals to intensify its importance in diagnosis, treatment, prognosis and management of diseases. It is estimated that 70-80% of clinical decisions are based upon information derived from laboratory results. The simultaneous concern on quality of clinical diagnosis has been noted in developing country like Nepal. A huge investment in automation for the sake of quality services has also justified the fact that quality definitely matters. However, the enigma of quality service in clinical laboratory still exists in our health environment. Hence, we attempted to poke a part of the process of developing quality services in diagnostic fraternity. 

scholarly journals Patient Experiences with the Transition to Telephone Counseling during the COVID-19 Pandemic

Healthcare ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 663
Author(s):  
Augustine W. Kang ◽  
Mary Walton ◽  
Ariel Hoadley ◽  
Courtney DelaCuesta ◽  
Linda Hurley ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Interrater Reliability ◽  
Telephone Counseling ◽  
Patient Experiences ◽  
Opioid Use Disorder ◽  
Opioid Use ◽  
Therapeutic Experience ◽  
Perceived Impact

Background: To identify and document the treatment experiences among patients with opioid use disorder (OUD) in the context of the rapid move from in-person to telephone counseling due to the COVID-19 pandemic. Methods: Participants (n = 237) completed a survey with open-ended questions that included the following domains: (1) satisfaction with telephone counseling, (2) perceived convenience, (3) changes to the therapeutic relationship, (4) perceived impact on substance use recovery, and (5) general feedback. Responses were coded using thematic analysis. Codes were subsequently organized into themes and subthemes (covering 98% of responses). Interrater reliability for coding of participants’ responses ranged from 0.89 to 0.95. Results: Overall, patients reported that telephone counseling improved the therapeutic experience. Specifically, 74% of respondents were coded as providing responses consistently indicating “positive valency”. “Positive valency” responses include: (1) feeling supported, (2) greater comfort and privacy, (3) increased access to counselors, and (4) resolved transportation barriers. Conversely, “negative valency” responses include: (1) impersonal experience and (2) reduced privacy. Conclusions: Telephone counseling presents its own set of challenges that should be investigated further to improve the quality of care and long-term patient outcomes.

scholarly journals Diagnostic Challenges on the Laboratory Detection of Lupus Anticoagulant

Biomedicines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 844
Author(s):  
Armando Tripodi
Keyword(s):  
Lupus Anticoagulant ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
State Of The Art ◽  
Diagnostic Procedures ◽  
External Quality ◽  
Glycoprotein I ◽  
Current State ◽  
Clinical Laboratories

Lupus anticoagulant (LA) is one of the three laboratory parameters (the others being antibodies to either cardiolipin or β2-glycoprotein I) which defines the rare but potentially devastating condition known as antiphospholipid syndrome (APS). Testing for LA is a challenging task for the clinical laboratory because specific tests for its detection are not available. However, proper LA detection is paramount for patients’ management, as its persistent positivity in the presence of (previous or current) thrombotic events, candidate for long term anticoagulation. Guidelines for LA detection have been established and updated over the last two decades. Implementation of these guidelines across laboratories and participation to external quality assessment schemes are required to help standardize the diagnostic procedures and help clinicians for appropriate management of APS. This article aims to review the current state of the art and the challenges that clinical laboratories incur in the detection of LA.

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