Laboratory Testing Requirements Sample Clauses

The Laboratory Testing Requirements clause sets out the standards and procedures that must be followed when conducting laboratory tests related to the agreement. It typically specifies the types of tests required, the methods or protocols to be used, and any necessary certifications or accreditations for the testing facility. By clearly defining these requirements, the clause ensures that all parties rely on consistent, reliable, and verifiable test results, thereby reducing disputes and ensuring compliance with regulatory or contractual standards.
Laboratory Testing Requirements. 1. This part sets forth the conditions that all laboratories shall meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Except as specified in paragraph (2) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it: i. Has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory. ii. Is CLIA-exempt. 2. These rules do not apply to components or functions of: i. Any facility or component of a facility that only performs testing for forensic purposes. ii. Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients. iii. Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed which meets SAMHSA guidelines and regulations. However, all other testing conducted by a SAMHSA-certified laboratory is subject to this rule. 3. Laboratories under the jurisdiction of an agency of the Federal Government are subject to the rules of this part, except that the Secretary may modify the application of such requirements as appropriate.
Laboratory Testing Requirements. A. This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Except as specified in paragraph (B) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it: 1) Has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for Provider Performed Microscopy (PPM) procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory; or 2) Is CLIA-exempt. B. Exception. These rules do not apply to components or functions of: 1) Any facility or component of a facility that only performs testing for forensic purposes; 2) Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; or 3) Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed which meets SAMHSA guidelines and regulations. However, all other testing conducted by a SAMHSA-certified laboratory is subject to this rule. C. Federal laboratories. Laboratories under the jurisdiction of an agency of the Federal Government are subject to the rules of this part, except that the Secretary may modify the application of such requirements as appropriate.
Laboratory Testing Requirements. CFR Part 493 sets forth the conditions that all laboratories shall meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Except as specified in paragraph (2) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it:
Laboratory Testing Requirements. A. This part sets forth the conditions that all laboratories must meet to be certified to perform testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Except as specified in paragraph (B) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it: 1) Has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for Provider Performed Microscopy (PPM) procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory; or 2) Is CLIA-exempt.‌ B. Exception. These rules do not apply to components or functions of:‌ 1) Any facility or component of a facility that only performs testing for forensic purposes;‌ 2) Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients; or

Related to Laboratory Testing Requirements

  • Testing Requirements 12.1. Workplaces - 12.2. On workplaces where the value of the Commonwealth’s contribution to the project that includes the building work is at least $5,000,000, and represents at least 50% of the total construction project value or the Commonwealth’s contribution to the project that includes the building work is at least $10,000,000 (irrespective of its proportion of the total construction project value) the following minimum testing requirements must be adhered to.

  • Screening Requirements LFAC shall ensure that all prospective and current Covered Persons are not Ineligible Persons, by implementing the following screening requirements. a. LFAC shall screen all prospective Covered Persons against the Exclusion List prior to engaging their services and, as part of the hiring or contracting process, shall require such Covered Persons to disclose whether they are Ineligible Persons. b. LFAC shall screen all current Covered Persons against the Exclusion List within 30 days after the Effective Date and on a monthly basis thereafter. c. LFAC shall require all Covered Persons to disclose immediately if they become an Ineligible Person. LFAC shall maintain documentation (i.e., a print screen of the search results) in order to demonstrate that LFAC: (1) has checked the Exclusion List and determined that its Covered Persons are not Ineligible Persons; and (2) has required its Covered Persons to disclose if they are an Ineligible Person. Nothing in this Section III.D affects LFAC’s responsibility to refrain from (and liability for) billing Federal health care programs for items or services furnished, ordered, or prescribed by an excluded person. LFAC understands that items or services furnished by excluded persons are not payable by Federal health care programs and that LFAC may be liable for overpayments and/or criminal, civil, and administrative sanctions for employing or contracting with an excluded person regardless of whether LFAC meets the requirements of Section III.D.

  • Forecasting Requirements 19.5.1 The Parties shall exchange technical descriptions and forecasts of their Interconnection and traffic requirements in sufficient detail necessary to establish the Interconnections necessary for traffic completion to and from all Customers in their respective designated service areas.

  • Training Requirements Grantee will: A. Authorize and require staff (including volunteers) to attend training, conferences, and meetings as directed by DSHS. B. Appropriately budget funds to meet training requirements in a timely manner, and ensure staff and volunteers are trained as specified in the training requirements listed at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇▇▇.▇▇▇/hivstd/training/ and as otherwise specified by DSHS. Grantee shall document that these training requirements are met. C. Follow the appropriate DSHS POPS by funding opportunity (as per Section I: General Requirements for All Grantees) for training and observation requirements.

  • Child Abuse Reporting Requirement Grantee will: a. comply with child abuse and neglect reporting requirements in Texas Family Code Chapter 261. This section is in addition to and does not supersede any other legal obligation of the Grantee to report child abuse. b. develop, implement and enforce a written policy that includes at a minimum the System Agency’s Child Abuse Screening, Documenting, and Reporting Policy for Grantees/Providers and train all staff on reporting requirements. c. use the System Agency Child Abuse Reporting Form located at ▇▇▇▇▇://▇▇▇.▇▇▇▇.▇▇▇▇▇.▇▇.▇▇/Contact Us/report abuse.asp as required by the System Agency. d. retain reporting documentation on site and make it available for inspection by the System Agency.