Subpart K or the Quality System of Non waived Testing is organized into five Conditions (Introduction, General Laboratory Systems, Pre-Analytic Systems, Analytic Systems and Post Analytical Systems). Each condition has a set of Standards. Standards are “designed to define component criteria constituting a Condition”. Condition-level deficiencies associated with proficiency testing performance, enrollment, personnel qualifications and responsibilities are mandatory citations. Condition-level deficiencies are considered to be serious and may lead to sanctions and revocation of a CLIA certificate.
Introduction
This section of the regulation defines the laboratory quality system for all laboratory specialties and sub specialties. Laboratories must establish and maintain policies and procedures to monitor a quality system for all phases of testing (pre-analytic, analytical and post analytical). There must also be procedures for monitoring, continuous improvement, and evaluate, identify and resolve problems in the quality systems.
General Laboratory Systems
The laboratory is required to “monitor and evaluate the overall quality of the general laboratory systems and correct identified problems … for each specialty and sub-specialty of testing performed”. There are seven standards under this condition.
- Confidentiality of patient information
- Specimen identification and integrity
- Complaint investigations
- Communications – identifies and documents problems that occur due to a lack of communications between the lab and the authorized person ordering the testing
- Personnel competency assessment policies
- Evaluating proficiency testing performance
- General laboratory systems quality assessment
Pre-Analytic Systems
The pre-analytical system sets the standards for all the processes the laboratory does prior to analysis of the sample which include test requisitions, specimen submission and handling, and referral. A written or electronic request for patient testing from an authorized person must be in the laboratory’s possession within 30 days of an oral request.
There are six mandatory items that must be in every test requisition. Patient’s name or unique identifier; sex; age or date of birth, test to be performed, source of specimen, date and time of specimen collection. You may also include any additional information that may be relevant for a specific test to ensure accurate and timely testing and reporting.
The laboratory must also have policies and procedures that defines proper patient preparations, specimen collection and identification, transportation and labeling, to name a few. Any change in policies and/or procedures must be approved, signed and dated by the laboratory director prior to being implemented.
Analytical Systems
The following standards apply to all specialties and sub-specialties:
- Procedure manual – written procedures for all testing performed by the laboratory. It must be followed by and accessible to all testing personnel.
- Testing system – properly following manufacture’s instructions for equipment and reagents, documenting water quality, temperature and humidity, labeling of reagents, solutions and culture media, as well as control and calibration materials, documenting expiration dates and ensuring that materials are not used when expired.
- Establishment and verification of performance specifications – the laboratory must demonstrate the testing accuracy, precision, sensitivity, reportable range, reference intervals, and any other performance characteristics.
- Maintenance and function checks – document equipment maintenance and function check as defined by the manufacturer
- Calibration and calibration verification procedures –procedures that substantiate the continued accuracy of the test system throughout the laboratory’s reportable range of tests results for the test system
- Control procedures:-these procedures must be developed so that errors are immediately detected and to monitor accuracy and precision over time
Each specialty or sub-specialty must follow additional requirements set forth by the standards under this condition.
For Cytogenetics the laboratory must document
- Media uses, reactions observed, #of cells counted, number of cells karyotyped, number of chromosomes counted for each metaphase spread and quality of banding
- Document resolution appropriate for type of tissue or specimen and the type of study required based on clinical information
- Have an adequate number of karyotypes
- Determination of sex must be performed by full chromosome analysis
- A prepared report must include a summary and interpretation of the observations, number of cells counted and analyzed, and the use of ISCN
Post Analytical Systems
This condition sets the standards for reporting test results. The laboratory must have adequate manual or electronic system in place to ensure test results and other patient specific information in order to accurately send to the authorized person at the final report destination.
The report must include:
- Patient’s name and ID number or unique identifier and ID number
- Name and address of the laboratory performing the test
- Report date
- Test performed
- Specimen source
- Test results
The lab must notify the authorized person requesting the test when any test indicates an imminently life-threatening condition, when the laboratory cannot report results within its established time frames and whenever there has been a reporting error. If there are changes to a report, the laboratory must keep a copy of the original report as well as the amended report.
It’s at the laboratory’s discretion as to how they set up their quality system. However, these regulations are at a minimum of what each lab must have in place and communicate to their employees in order to ensure testing accuracy. Continuous monitoring and documentation and personnel training ensure that your laboratory keeps a rigorous quality management program. It’s vital to our patients!