lab general checklist Flashcards
GEN.13806, Documented QM Program
The laboratory has a documented quality management (QM) program., NOTE: There must be a document that describes the overall QM program. The document need not be detailed, but should spell out the objectives and essential elements of the QM program. The QM plan may be based upon some reference resource such as CLSI QMS01-04; the ISO 9000 series or ISO 15189; AABB’s quality program; CAP’s quality management publications; or it may be of the laboratory’s own design. If the laboratory is part of a larger organization, the laboratory QM program is coordinated with the organization’s QM plan.,
GEN.16902, QM Implementation
“For laboratories that have been CAP accredited for more than 12 months, the QM plan is implemented as designed and is reviewed annually for effectiveness., NOTE: Appraisal of program effectiveness may be evidenced by an annual written report, revisions to laboratory policies and procedures, or revisions to the QM plan, as appropriate., Evidence of Compliance:
- Evidence that the plan has been implemented as designed requires all of the following:
- quality measurements/assessments specified in the plan are being substantially carried out;
- there is evidence of active review of quality measurements;
- if target performance levels are specified in the plan and the targets are not being met, there is documented follow-up action;
- any interventions/changes to operations that are specified in the plan have been carried out as scheduled, or the reason for delay documented; AND
- any communication of information that is required by the plan have taken place”
GEN.20100, QM Extent of Coverage
The QM program covers all areas of the laboratory and all beneficiaries of service., NOTE: The QM program must be implemented in all areas of the laboratory (e.g. chemistry, anatomic pathology, satellite, point-of-care, consultative services, etc.). The program must include all aspects of the laboratory’s scope of care, such as inpatient, outpatient, and reference laboratory services.,
GEN.20208, QM Patient Care Services
The QM system includes a program to identify and evaluate errors, incidents and other problems that may interfere with patient care services., NOTE: There must be an organized program for documentation of problems involving the laboratory that are identified internally, as well as those identified through outside sources such as complaints from patients, physicians or nurses. The program must be implemented in all sections of the laboratory, and on all shifts. Any problem that could potentially interfere with patient care or safety must be addressed. Clinical, rather than business/management issues, should be emphasized. The laboratory must document investigation and resolution of these problems. Laboratories must perform root cause analysis of any unexpected event involving death or serious physical or psychological injury, or risk thereof (including “near misses” and sentinel events). Laboratories must be able to demonstrate appropriate risk-reduction activities based on such root cause analyses.,
GEN.20316, QM Indicators of Quality
“The QM program includes monitoring key indicators of quality in the pre-analytic, analytic, and post-analytic phases., NOTE: Key indicators should monitor activities critical to patient outcome and/or affect many patients. The laboratory must document evaluation of indicators by regularly comparing performance against available benchmarks. The number of monitored indicators should be consistent with the laboratory’s scope of care. Special function laboratories may monitor fewer indicators; full-service laboratories should monitor multiple aspects of the testing process appropriate to their scopes of service.
While there is no requirement to monitor any specific laboratory monitor, the following key quality indicators listed below have been commonly used to measure laboratory performance in a consistent manner and are important to clinicians and patients as indices of care.
- Patient/Specimen Identification: Percent of patient wristbands with errors, percent of ordered tests with patient identification errors, or percent of results with identification errors
- Test Order Accuracy: Percent of test orders correctly entered into a laboratory computer
- Specimen Acceptability: Percent of specimens accepted for testing
- Stat Test Turnaround Time: Collection-to-reporting turnaround time or receipt-in-laboratory-to-reporting turnaround time of tests ordered with a “stat” priority (e.g. emergency department or intensive care unit specimens), mean or median turnaround time, or the percent of specimens with turnaround time that falls within an established limit
- Critical Value Reporting: Percent of critical results with documentation that results have been reported to caregivers; percent of critical results for which the primary clinician cannot be contacted in a reasonable period of time
- Customer Satisfaction: Standardized satisfaction survey tool with a reference database of physician, nurse, or patient respondents
- Corrected Reports – General Laboratory: Percent of reports that are corrected
- Corrected Reports – Anatomic Pathology: Percent of reports that are corrected
- Surgical Pathology/Cytology Specimen Labeling: Percent of requisitions or specimen containers with one or more errors of pre-defined type
- Blood Component Wastage: Percentage of red blood cell units or other blood components that are not transfused to patients and not returned to the blood component supplier for credit or reissue
- Blood Culture Contamination: Percent of blood cultures that grow bacteria that are highly likely to represent contaminants
Performance of indicators should be compared with benchmarks, preferably from multi-institutional studies conducted within ten years of the laboratory’s use of the monitor, where such surveys are available.
Both the College of American Pathologist’s Q-TRACKS Program itself and publications of Q-TRACKS studies in the Archives of Pathology provide information regarding definitions of quality indicators and demonstrate statistically valid peer-group performance standards.
For benchmark information on commonly used quality indicators, please refer to the Quality Management Quality Indicator Monitoring Guidance Document posted on the CAP Website at the following link: http://www.cap.org/apps/docs/laboratory_accreditation/qim.pdf, Evidence of Compliance:
- Listing of quality indicators that include the following:
- indicators for pre-analytic, analytic, and post-analytic phases AND
- indicators to address the scope of testing and laboratory services AND
- frequency for monitoring each indicator AND
- defined benchmarks for the performance of each indicator AND
- Quality management data and reports for quality indicator monitoring and evaluation, including, comparison against benchmark data, and corrective action when targets are not met”
GEN.20325, Employee and Patient Quality Communication
“The laboratory has a procedure for employees and patients to communicate concerns about quality and safety to management., NOTE: The investigation and analysis of employee and patient complaints and suggestions, with corrective and/or preventive action as appropriate, should be a part of the laboratory quality management plan and specifically addressed in laboratory quality management records., Evidence of Compliance:
- Records of employee and patient complaints (if any) with appropriate follow up”
GEN.20330, CAP Sign
“The laboratory posts the official CAP sign regarding reporting of quality concerns., NOTE: The laboratory must prominently post the official CAP sign regarding the reporting of quality concerns to CAP.
While personnel should report concerns to laboratory management, the laboratory must ensure that all personnel know that they may communicate with CAP directly if they have a concern not addressed by laboratory management, and that CAP holds such communications in strict confidence. In addition, the laboratory must have a policy prohibiting harassment or punitive action against an employee in response to a complaint or concern made to CAP or other regulatory organization regarding laboratory quality or safety.
GEN.20335, Customer Satisfaction
“Referring physicians’/clients’ or patients’ satisfaction with laboratory service was measured within the past 2 years., NOTE: For patients, satisfaction with the phlebotomy service may be measured., Evidence of Compliance:
- Records of physician/client satisfaction survey OR referral statistics OR complaint rates”
GEN.20340, Notifications From Vendors
“The laboratory manages notifications from vendors of defects or issues with supplies or software that may affect patient care., NOTE: Notifications may take the form of product recalls, market withdrawals, or software patches and upgrades. The laboratory should take action on those that have the potential to affect testing results or laboratory services., Evidence of Compliance:
- Records of manufacturer’s recalls received AND
- Follow-up documentation”
GEN.20371, Adverse Patient Event Reporting
“The laboratory has a procedure for reporting device-related adverse patient events, as required by FDA., NOTE: This checklist item does NOT apply to laboratories accredited under the CAP Forensic Drug Testing program. Non-US laboratories are encouraged to comply with this checklist item, either through reporting to the FDA in the US or to their national equivalent.
When information reasonably suggests that any laboratory instrument, reagent or other device (including all instruments in the central laboratory, satellite laboratories, point-of-care testing programs, and accessory devices used for phlebotomy or specimen collection) has or may have caused or contributed to a patient death or serious patient injury, the FDA requires hospitals and outpatient diagnostic facilities, including independent laboratories, to report the event. If the event is death, the report must be made both to FDA and the device manufacturer. If the event is serious patient injury, the report may be to the manufacturer only, unless the manufacturer is unknown, in which case the report must be submitted to FDA. Reports must be submitted on FDA Form 3500A (or an electronic equivalent) as soon as practical but no later than 10 days from the time medical personnel become aware of the event.
FDA defines “serious patient injury” as one that is life threatening; or results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Device malfunctions or problems that are reportable may relate to any aspect of a test, including hardware, labeling*, reagents or calibration; or to user error (since the latter may be related to faulty instrument instructions or design). An adverse patient event that may have resulted from inherent limitations in an analytic system (e.g. limitations of sensitivity, specificity, accuracy, precision, etc.) is not reportable.
The laboratory should have written procedures for 1) the identification and evaluation of adverse patient events, 2) the timely submission of MDR (medical device reporting) reports, and 3) compliance with record keeping requirements. Laboratories that are part of a larger organization (e.g. hospital laboratories) should document participation in the overall institutional MDR process.
The laboratory should educate its personnel in the FDA MDR requirements.
The laboratory (or parent institution, as appropriate) must submit an annual report of device-related deaths and serious injuries to FDA, if any such event was reported during the previous year. Annual reports must be submitted on Form 3419 (for hospital-based laboratories only, or an electronic equivalent) or Form 3500 (for non-hospital-based laboratories) by January 1 of each year. The laboratory or institution must keep records of MDR reports for 2 years.
Additional information is available on the FDA website, at http:/www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
- In this context, “labeling” refers to all user instructions provided by the manufacturer. , Evidence of Compliance:
- Records of MDR reports for reportable events, if applicable”
GEN.20374, Federal/State/Local Regulations
“The laboratory has a policy for ensuring compliance with applicable federal, state and local laws and regulations., NOTE: Applicable federal, state and local requirements may include but are not limited to the following areas: handling radioactive materials, shipping infectious or diagnostic materials, personnel qualifications, retention of specimens and records, hazardous waste disposal, fire codes, medical examiner or coroner jurisdiction, legal testing, acceptance of specimens only from authorized personnel, handling controlled substances, patient consent for testing, confidentiality of test results, and donation of blood. The checklists contain specific requirements on these areas.
The laboratory may obtain information on applicable federal, state and local laws and regulations from multiple sources, including hospital management, state medical societies and state departments of health., “
GEN.20375, Document Control
“The laboratory has a document control system to manage policies, procedures, and forms., NOTE: Document control applies to all policies, procedures and forms (including quality management documents) for all processes and activities that are subject to CAP accreditation. The document control system must ensure that only current policies, procedures, and forms are in use.
It is recommended that the laboratory maintain a control log listing all current policies, procedures, and forms with the locations of copies (including derivative documents such as card files and summary charts). The control log may contain other information as appropriate, such as dates when policies/procedures were placed in service, schedule of review, identity of reviewer(s), and dates when policies/procedures were discontinued/superseded.
Additional requirements regarding procedure manuals are found in the All Common Checklist, and in this checklist in the Collection Manual, Computer Services and Safety sections., “
GEN.20377, Record/Specimen Retention
“Laboratory records and materials are retained for an appropriate time., NOTE: The following records must be retained for at least 2 years: specimen requisitions (including the patient chart or medical record only if used as the requisition), patient test results and reports (both original and corrected), instrument printouts, accession records, quality control records, instrument maintenance records, proficiency testing records, and quality management records. Competency assessment records must be retained for at least 2 years, except in transfusion medicine, which must be retained for at least 5 years. Personnel training records must be retained for the time period in which the method/test system is in use or length of employment (whichever is shorter), plus 2 years (or 5 years for transfusion medicine).
Specimens of serum, heparinized plasma, EDTA plasma, CSF, and body fluids (except urine) should be retained for 48 hours. (The 48 hour retention requirement does not apply to whole blood samples; for example, samples collected for blood gas testing.) Urine specimens should be retained for 24 hours; exceptions may be made at the discretion of the laboratory director. Blood films, permanently stained body fluid slides, and permanently stained microbiology slides prepared from clinical specimens (including blood culture bottles) should be retained for 7 days.
Specimens must be kept under appropriate storage conditions.
Laboratories may wish to retain instrument maintenance records for longer than the 2-year requirement (e.g. for the life of the instrument), to facilitate trouble-shooting.
Records of method performance specifications must be retained while the method is in use, and for at least two years afterwards. For requirements on retaining records of changes to software, the test library, and major functions of laboratory information systems, please refer to the Software section of the Laboratory Computer Services section of this checklist.
More stringent requirements for certain laboratory records (e.g. in anatomic pathology, cytopathology, transfusion medicine) may be found in the discipline-specific checklists.
For data directly transmitted from instruments to the laboratory computer system via an interface (on-line system), it is not necessary to retain paper worksheets, printouts, etc., so long as the computer retains the data for at least two years. Manual computer entry of patient result data from worksheets, print-outs, etc. requires retention of all worksheets, printouts, etc. for at least two years (digitized or photographic images are acceptable). For results that are manually entered into the computer from 1) observation of an electronic display, with no paper print-out available, or 2) manually performed test methods without worksheets, the two-year retention requirement applies to the data within the computer.
In establishing retention requirements, care should be taken to comply with state and federal regulations., Evidence of Compliance:
- Written policy for retention of records, specimens and slides”
GEN.20425, Record Retention
The laboratory has a policy to ensure that all records, slides, blocks, and tissues are retained and available for appropriate times should the laboratory cease operation., ,
GEN.23584, Interim Self-Inspection
“The laboratory conducts an interim self-inspection and documents efforts to correct deficiencies identified during that process., NOTE: The interim self-inspection is an important aspect of continuing education and laboratory improvement. The use of a variety of mechanisms for self-inspection (residents, technologists or other inspectors) is strongly endorsed. Self inspection by personnel familiar with, but not directly involved in, the routine operation of the laboratory section to be inspected is a best practice. Documentation of performance of the interim self-inspection with correction of deficiencies is a requirement for maintaining accreditation. The laboratory must document that personnel responsible for each laboratory section have reviewed the findings of the interim self-inspection., Evidence of Compliance:
- Written evidence of self-inspection findings with records of corrective action”
GEN.26791, Terms of Accreditation
“The laboratory has a policy that addresses compliance with the CAP terms of accreditation., NOTE: The CAP terms of accreditation are listed in the laboratory’s official notification of accreditation. The policy must include notification of CAP regarding the following:
- Investigation of the laboratory by a government entity or other oversight agency, or adverse media attention related to laboratory performance; notification must occur no later than 2 working days after the laboratory learns of an investigation or adverse media attention. For laboratories subject to US regulations, this notification must include any complaint investigations conducted or warning letters issued by any oversight agency (i.e. CMS, State Department of Health, The Joint Commission, FDA, OSHA). For non-US laboratories, this notification must include discovery of actions by laboratory personnel that violate national, state or local regulations.
- A facility must notify the CAP as soon as it finds itself to be the subject of a validation inspection
- Discovery of actions by laboratory personnel that violate national, state or local regulations
- Change in laboratory test menu (notification must occur prior to starting new patient testing)
- Change in location, ownership or directorship of the laboratory; notification must occur no later than 30 days prior to the change(s); or, in the case of unexpected changes, no later than 2 working days afterwards
In addition, the policy must address:
- Provision of an inspection team comparable in size and scope if requested by CAP
- Cooperation with CAP when the laboratory is subject to a CAP investigation or inspection
- Adherence to the Terms of Use for the CAP Certification Mark of accreditation, Evidence of Compliance:
- Records of notification, if applicable”
GEN.30000, Monitoring Analytic Performance
There is a written quality control program that clearly defines policies and procedures for monitoring analytic performance., NOTE: The overall quality control program for the entire laboratory must be documented. It must include general policies and assignment of responsibilities. There must be clearly defined, written procedures for ongoing monitoring of analytic performance, including (1) number and frequency of controls; (2) establishment of tolerance limits for control testing; and (3) corrective actions based on quality control data. Quality control records should be well-organized with a system to permit regular review by appropriate supervisory personnel (laboratory director, supervisor or laboratory quality control coordinator).,
GEN.30070, Validation of Accuracy
“If the laboratory performs test procedures for which neither calibration nor control materials are available, procedures are established to validate the reliability of patient test results., NOTE: ““Reliability”” includes elements of accuracy, precision, and clinical discriminating power.
This checklist requirement does not apply to waived tests., “
GEN.40016, Collection Manual Biennial Review
There is documentation of at least biennial review of the specimen collection/handling procedure manual by the current laboratory director or designee., ,
GEN.40032, New Specimen Collection Procedure Review
The laboratory director reviews and approves all substantial changes to the specimen collection/handling procedure manual before implementation., NOTE: Current practice must match policy and procedure documents.,
GEN.40050, Distribution of Manuals
The specimen collection manual is distributed to all specimen-collecting areas within the hospital (nursing stations, operating room, emergency room, out-patient areas) AND to areas outside the main laboratory (such as physicians’ offices or other laboratories)., NOTE: It is acceptable for this information to be electronically available to users rather than in book format; there is no requirement for a paper-based specimen collection manual. Indeed, electronic manuals have the advantage of more accurately reflecting current requirements.,
GEN.40100, Specimen Collection Manual Elements
“The specimen collection manual includes instructions for all of the following elements, as applicable.
- Preparation of the patient
- Type of collection container and amount of specimen to be collected
- Need for special timing for collection (e.g. creatinine clearance)
- Types and amounts of preservatives or anticoagulants
- Need for special handling between time of collection and time received by the laboratory (e.g. refrigeration, immediate delivery)
- Proper specimen labeling
- Need for appropriate clinical data, when indicated, NOTE: Because of the importance of clinical information in the practice of surgical pathology and cytopathology, requisitions for such specimens should include pertinent clinical data, as well as pre-operative and/or post-operative diagnosis. Instructions should be documented for all applicable tissue and cytologic specimens, including biopsies, resections, PAP tests, sputum washings, brushings, body fluids, fine needle aspirations, etc. These instructions must be included in the procedure or user manuals at all sites where specimens are collected (e.g. nursing stations, clinics, physicians’ offices). Instructions must include proper fixation of slides and tissue specimens. A variety of tests in clinical pathology also require specific clinical information (e.g. maternal AFP screening, TDM peak and trough measurements, antibiotic therapy, etc.) or special instructions for collection, preservation, and storage (e.g. timed or 24-hour urine specimens)., “
GEN.40125, Referral Laboratory Specimen Handling
“For specimens sent to reference laboratories, the referring laboratory properly follows all requisition, collection and handling specifications of the reference laboratory., NOTE: Pre-analytic variables must be closely controlled to maintain specimen integrity. These include specimen temperature, transport time, and the interval before separation of blood cells from serum/plasma. For coagulation tests, important considerations include proper filling of the collection tube, the use of waste tubes, and, if blood must be drawn through an indwelling line, flushing of the line. For surgical pathology and cytopathology, specimens must be preserved by proper fixation or refrigeration. Twenty-four-hour urine specimens may require special preservatives for specific tests. Also, it may be necessary to collect specific patient information required by the testing laboratory (e.g. menstrual history for cytopathology, gestational age for prenatal neural tube defect screening, preoperative diagnosis for surgical pathology, bleeding history for specialized coagulation assays, etc.).
For newborn screening specimens, the specimen collection, application and drying of blood spots, and submission of specimens to the reference laboratory must follow the reference laboratory instructions and be in compliance with the most recent edition of the CLSI Document NBS01 and state or local regulations., Evidence of Compliance:
- Written procedure for submission of specimens to referral laboratories, consistent with the referral laboratory collection and handling requirements”
GEN.40460, Specimen Collection Supplies
Specimen collection supplies such as blood collection tubes and collection devices (e.g. heel lancets, culture swabs, and transport media) are used within their expiration date and stored per manufacturer’s instructions., NOTE: For newborn screening collection cards, if the expiration date is not printed on the individual cards, another mechanism, such as serial number, may be used for tracking.,