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Clinical Laboratory Standards of Practice

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Clinical Laboratory Standards of Practice New York State Department of Health Wadsworth Center Clinical Laboratory Evaluation Program Clinical Laboratory Standards of Practice Part 1 – General Systems New York State Department of Health Clinical Laboratory Standards of Practice TABLE OF CONTENTS Quality Management System 3 Human Resources 9 Facility Design and Resource Management 23 General Facilities ......................................................................................................................................................... 24 Laboratory Equipment ................................................................................................................................................. 27 Reagents & Supplies ................................................................................................................................................... 32 Laboratory Safety ........................................................................................................................................................ 37 Laboratory Information Systems (LIS) ........................................................................................................................ 50 Standard Operating Procedures and Compliance 53 Pre-Examination Procedures 58 Examination Requisition .............................................................................................................................................. 58 Specimen Processing .................................................................................................................................................. 62 Examination Procedures 67 Validation of Laboratory Procedures ........................................................................................................................... 67 Determination of Calibration and Calibration Verification Procedures ........................................................................ 71 Quality Control Procedures ......................................................................................................................................... 73 Process Quality Control ............................................................................................................................................... 78 Post-Examination Procedures 81 Process Review ........................................................................................................................................................... 81 Reporting ..................................................................................................................................................................... 83 Records & Specimen Retention .................................................................................................................................. 87 Confidentiality .............................................................................................................................................................. 90 Quality Assessment and Improvement 93 Proficiency Testing ...................................................................................................................................................... 95 Referral and Contract Laboratories ............................................................................................................................. 102 Resolution of Complaints and Identification and Control of Nonconformities ............................................................. 103 Corrective Action ......................................................................................................................................................... 106 Public Health Preparedness and Reporting 108 January 2017 Page 2 of 110 New York State Department of Health Clinical Laboratory Standards of Practice Quality Management System Standard Guidance Quality Management System Fundamental Standard of Practice 1 (QMS Laboratory compliance with the Quality Management System F1) Fundamental Standard of Practice is evaluated by review of laboratory The laboratory director and owner are jointly and separately responsible for practices using minimum requirements specified in Sustaining Standards laboratory operations and shall exercise authority for the design, of Practice 1 though 5. Your laboratory should be prepared to provide implementation, maintenance and improvement of a quality management documentation of quality goals, objectives, performance measures and system. The quality system must be designed to assess and continuously quality improvement initiatives for each of the quality system essentials improve the delivery of services to meet the needs of patients. Key system under Quality Management System Sustaining Standard of Practice 1. practices shall include periodic audits of laboratory operations for compliance with stated requirements, management review of audit findings and Quality systems are uniquely dependent on laboratory leadership and authorization for implementation of plans for operations improvement that were infrastructure. A laboratory permit becomes void upon a change in developed in concert with stakeholders. location, director or owner. Upon a change in the assistant director designated as a sole certificate of qualification holder for a category, the permit becomes void in the categories affected. The voiding of a permit, or portions of a permit, may be stayed upon receipt of timely notification, which shall serve as a new permit application. A stay of the voiding of a permit or portions of a permit shall be effective until the department issues a final determination with respect to the new application. In the case of a change in director, if a permanent new director has not been approved at the time the director listed on the existing permit ceases to function as director, a transition plan shall be submitted within Statutory Authority: Article 5, Title V Public Health Law Section 575 (2) five days nominating an individual to serve as interim director, until a and (3) permanent appointment can be made. Quality Management System Sustaining Standard of Practice 1 (QMS S1): Establishment of Specifications and Requirements Specifications and requirements established by laboratory management under Quality Management System Sustaining Standard of Practice 1 shall meet The quality management system shall establish written specifications and or exceed minimum requirements provided under applicable parts of these Clinical Laboratory Standards of Practice. In developing specifications and for the following quality system essential elements: requirements requirements for effective delivery of laboratory services, management should identify and seek input from stakeholders, i.e., those who have expectations and a) qualifications, responsibilities, authority and interrelationships of all dependencies on the quality of services provided. Specifications and personnel; requirements developed by laboratory management and stakeholders should be clearly described and presented to vendors and contractors that provide support b) adequate training and competency evaluation of all staff and and resources for laboratory operations. supervision by competent persons conversant with the purpose, References to applicable sustaining standards of practice for the establishment of specifications and requirements may include, but not limited to: January 2017 Page 3 of 110 New York State Department of Health Clinical Laboratory Standards of Practice Quality Management System Standard Guidance procedures, and assessment of results of the relevant examination a) Human Resources S1, S3, S4, S5; Director S3(f) procedures; b) Human Resources S6, S7, S8 c) management support of all laboratory personnel by providing them with the appropriate authority and resources to carry out their duties and by c) Director S3 responding to their concerns and problems; d) General Facilities S1 d) provision and maintenance of facilities as necessary to support e) Laboratory Information System S2, S4 analytical systems and to promote safety and security practices; f) Operating Procedures S2, S6 e) laboratory information system initial and periodic performance g) Requisition S3 verification; h) Processing S4 f) development, updating, approval and implementation of standard operating procedures; i) Validation S1; Laboratory Equipment S1(a) g) protocols to ensure positive identification and optimum integrity of j) Validation S5 primary and subsamples from the time of collection or receipt through k) Quality Control S1-S6 completion of testing and reporting of results, including written policies l) Process Review S2 and procedures for test request, patient preparation, specimen type, collection, labeling, handling and processing; m) Reporting S1-S6 h) specimen acceptance and rejection criteria; n) Proficiency Testing S1-S8; Quality Assurance S3 i) selection of instruments and reagents; o) Quality Assurance S3 (c)(d) j) validation or verification, as appropriate, of examination procedures’ p) Control of Non-Conformities S1 performance characteristics; q) Complaint Resolution S1 k) quality control practices that monitor the conformance of examination r) Referral S1 procedures to specified requirements; s) l) mechanisms to verify test results prior to release; t) Retention S1, Retention S3 m) timely and accurate reporting of results, including alert results; u) Quality Assurance S1, S2 n) enrollment in a CMS-approved proficiency testing program for tests c) Appropriate authority
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