Section 216-RICR-60-05-4.9 - Quality Assurance Program4.9.1General RequirementsEach clinical laboratory or station shall have clearly established internal and external quality control programs to ensure high standards of performance and reliability of test results. These programs shall consider such factors as preventive maintenance, periodic inspection, testing for proper operation of equipment and instruments as may be appropriate, validation of methods, evaluation of reagents and volumetric equipment, surveillance results, remedial action taken to correct deficiencies and such other relevant factors as required in these rules and regulations and as may be deemed necessary.
4.9.2Procedural ManualA. Each clinical laboratory shall have available at all times in the immediate bench area of personnel engaged in conducting clinical laboratory testing, a procedure manual that includes a detailed compilation of all automated and manual methods and procedures for all clinical tests that are performed by the laboratory and for which it is licensed. Furthermore, such manual shall: 1. Contain information concerning preparation and storage of reagents, control and calibration procedures and pertinent literature references;2. Describe the laboratory's technical procedures for the collection, processing and examination of specimens based on current standards of practice;3. For those tests that are normally performed on automated test equipment, provide for alternate methods or for storage of the test specimens, in the event the automated equipment becomes inoperable; and4. Procedures shall be approved, signed, and dated by the laboratory director. Procedures shall be re-approved, signed and dated if the directorship of the laboratory changes. Each change in a procedure shall be approved, signed, and dated by the current director of the laboratory.B. Each station shall have available at all times a procedure manual that includes a detailed compilation of methods and procedures for the collection, processing, and transmission of specimens including preparation of patients, based on current practices.4.9.3Collection, Identification and Examination of SpecimensA. No specimen shall be examined if unsuitable for testing as a result of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection and examination, or for such other reason(s) that would render findings of doubtful validity.B. Specimens shall be examined only at the documented request of a licensed physician or other authorized medical personnel, pursuant to statutory provisions of this state.C. Clinical laboratories in state and out of state may receive reference specimens for examination provided the reference laboratory is licensed in this state, pursuant to R.I. Gen. Laws Chapter 23-16.2 and this Part.D. Whenever a clinical laboratory licensed by the state of Rhode Island isolates any one of the specified microorganisms identified in the rules and regulations pertaining to Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title), the original culture or a subculture shall be submitted to the Rhode Island Department of Health Laboratory for confirmation, typing, or banking in accordance with the aforementioned regulations. 1. All specimens shall be accompanied by identifying data such as name of the patient, physician or other authorized medical personnel, and laboratory.E. A clinical laboratory collecting blood for lead analysis and/or performing blood lead analyses shall do so in accordance with the regulations of Reporting and Testing of Infectious, Environmental and Occupational Diseases (Part 30-05-1 of this Title) and Lead Poisoning Prevention (Part 50-15-3 of this Title).4.9.4Radiobioassay, Pathological, and Cytological ExaminationsA. A clinical laboratory licensed in the category of radiobioassay shall comply with the applicable rules and regulations for Radiation (Chapter 40 Subchapter 20 of this Title).B. Pathological examination of specimens of excised tissue(s) shall be performed only by a physician licensed in this state who is either qualified for certification, or is certified in anatomic pathology by the American Board of Pathology.C. Cytological examination of specimens shall be performed only under the supervision of a physician licensed in this state who is either qualified for certification, or is certified in anatomic pathology or cytopathology by the American Board of Pathology.4.9.5Methodologies for Quality ControlA. Each clinical laboratory shall establish an internal program of quality control covering each type of analysis performed for the verification and assessment of accuracy, measurement of precision, and detection of error. The factors that constitute the quality control provisions shall be based on current acceptable standards of practice such as those promulgated in the most current version of the rules and regulations of the Department of Health and Human Services' "Clinical Laboratory Improvement Amendments of 1988."B. Each clinical laboratory shall furthermore be required to participate in an external proficiency testing program to assess the accuracy and reliability of testing performance for each category and subcategory of clinical specialties for which the laboratory is licensed. 1. Appropriate proficiency testing programs shall be those approved by the U.S. Department of Health and Human Service or such as those the Director may deem appropriate based upon national standards.2. A determination of satisfactory performance on proficiency testing shall be made by the licensing agency based on the passing score for each analyte as established by the proficiency testing program.216 R.I. Code R. 216-RICR-60-05-4.9