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.,
GEN.40470, Specimen Collection Training
“There is documentation that all personnel collecting patient specimens have been trained in collection techniques and in the proper selection and use of equipment/supplies., NOTE: This applies to laboratory employees, including those at remote sites that are owned and operated by the laboratory.
It applies to all personnel who collect and test samples under the laboratory’s CAP number, such as for point-of-care testing and for blood gas analysis. It does not apply to the collection of specimens sent to the laboratory by hospital personnel or from outside sources. All types of specimen collection techniques (e.g. phlebotomy, capillary, arterial, in-dwelling line, phlebotomy during intravenous infusion), as well as non-blood specimens, must be included in the training in accord with the individuals’ duties. If the laboratory uses prepackaged kits for specimen collection, any special instructions that accompany the kit must be part of the training., “
GEN.40490, Patient Identification
“The individual collecting the specimen positively identifies the patient before collecting a specimen., NOTE: Personnel must confirm the patient’s identity by checking at least two identifiers before collecting a specimen. For example, an inpatient’s wristband may be checked for name and unique hospital number; an outpatient’s name and birth date may be used. The patient’s room number may not be used as an identifier. The patient’s identity should be verified by asking the patient to identify him- or herself, when it is practical to do so*. The identifying label must be attached to the specimen container(s) at the time of collection. The intent of this requirement is to ensure a documented, consistently followed system for correct patient sample identification at the point of collection.
- For example, verbal verification is not necessary if obtaining the services of a translator would delay specimen collection., Evidence of Compliance:
- Written collection procedure defining criteria for patient identification”
GEN.40491, Specimen Labeling
“Primary specimen containers are labeled by at least 2 identifiers., NOTE: All primary specimen containers must be labeled with 2 identifiers at the time of collection. Submitted slides may be labeled with a single identifier, but two identifiers are preferred. Examples of acceptable identifiers include but are not limited to: patient name, date of birth, hospital number, social security number, requisition number, accession number, unique random number. A location (e.g. hospital room number) is not an acceptable identifier.
The ‘primary’ specimen container is the innermost container received by the laboratory that actually holds the specimen.
Obtaining uniform compliance with this requirement may be difficult when specimens are collected by non-laboratory personnel. The laboratory should 1) Provide a list of acceptable identifiers to all specimen collectors; 2) Communicate with specimen collectors regarding the importance of this requirement; and 3) Have a procedure for following up with specimen collectors when inadequately labeled specimens are received. Communication and follow-up may be through QM reports, written memoranda, phone calls, visits by client service personnel, or other means of disclosure., Evidence of Compliance:
- Written collection procedure defining criteria for labeling of primary specimen containers”
GEN.40492, Specimen Label Correction
“The laboratory has a written policy regarding correction of information on specimen labels., NOTE: If laboratory personnel become aware of a potential error in patient identification or other information (e.g. initials of individual collecting the specimen, date/time of collection) on a specimen label, best practice is to recollect the specimen. However, there may be circumstances when recollection is not possible or practical (e.g. for specimens that are impossible or difficult to recollect, such as cerebrospinal fluid, etc.). The laboratory should define the circumstances under which correction of the information on specimen labels is permitted. A record of all such corrections should be maintained. The laboratory should investigate errors in specimen labeling, and develop corrective/preventive action as appropriate, including education of personnel who collect specimens., Evidence of Compliance:
- Records of corrections to specimen labels and corrective action”
GEN.40493, Compatibility Specimen Labeling
“All blood specimens collected for compatibility testing are labeled at the time of specimen collection in the presence of the patient with:
- Patient’s first and last name
- Unique identification number
- Date of collection
- A method to identify the individual collecting the specimen, NOTE: Blood specimens collected for compatibility testing must be positively and completely identified and labeled before leaving the patient. Acceptable practices for positive identification of patient and blood specimen labels must be defined in the procedure manual and may include visual inspection and/or an electronic system to read the identifying information contained in bar codes or radio-frequency identification (RFID) microchips or the patient’s wristband. Acceptable practices for generating specimen labels must be defined in the procedure manual and may include electronic devices utilizing information encoded in bar codes or RFID microchips. There must be a dependable method to identify the individual who collected the blood specimen, such as initials or another identifier on the tube, or an electronic record., Evidence of Compliance:
- Written procedure defining labeling requirements of specimens for compatibility testing AND
- Written procedure defining system identifying the individual collecting compatibility testing specimens”
GEN.40497, Paternity/Forensic Data
“If the laboratory collects specimens for paternity/forensic identity testing, the following data are obtained:
- Place and date of specimen collection
- Identity of person collecting the specimen
- Photograph, or photocopy of a picture identification card for each individual tested
- Signed record of information (including name, race, relationship) for each individual tested
- Date of birth of child
- Synopsis of case history/investigation, sample source
- Documentation of informed consent, NOTE: If the laboratory uses prepackaged kits for specimen collection, any additional instructions that accompany the kit must be followed., “
GEN.40498, Specimen Labeling - Paternity/Forensic ID
“For paternity/forensic identity testing, the information about each individual and the accuracy of the specimen label is verified by that individual or the legal guardian., , Evidence of Compliance:
- Records of information and label verification by patient or legal guardian”
GEN.40505, Specimen Collection Feedback
“There is a mechanism to provide feedback to the collectors of specimens on issues relating to specimen quality and labeling., NOTE: The accuracy of an analytic result depends upon the initial quality of the specimen. Proper collection techniques are essential., Evidence of Compliance:
- Written policy defining methods for providing feedback to specimen collectors AND
- Records of specimen collection issues communication such as QM reports, staff meeting minutes OR records of employee counseling”
GEN.40508, Phlebotomy Adverse Reaction
“The laboratory has procedures to care for patients who experience adverse reactions from phlebotomy., NOTE: Minor adverse reactions include hematomas, abrasions, nausea, and fainting. Serious injuries include vomiting, nerve damage, seizures and injuries. Training of phlebotomists should emphasize injury prevention. Serious reactions must be recorded in an incident log., Evidence of Compliance:
- Written instructions to phlebotomists AND
- Training records”
GEN.40511, Specimen Tracking/Labeling
“All specimens are properly packaged and labeled to indicate the general nature of the materials transported., , Evidence of Compliance:
- Written procedure defining criteria for packaging and labeling”
GEN.40512, Infectious Material Packing/Shipping
“The laboratory packages and ships infectious material in accordance with applicable federal, state and local regulations., , Evidence of Compliance:
- Records of review of applicable regulations”
GEN.40515, Transport Personnel Training
“Transport personnel are trained in appropriate safety and packaging procedures suitable to specimen type and distances transported, including certified training for personnel involved in packaging and shipping infectious substances., NOTE: Training should include issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc.
All personnel who package infectious specimens for shipment must satisfactorily complete certified training in these requirements. Federal and international regulations mandate the proper packaging and transportation of infectious substances, also termed ““etiologic agents.”” It is the laboratory’s responsibility to determine whether specimens that are to be shipped are subject to the regulations, or are exempt. For US laboratories, specific requirements are set forth by the US Public Health Service, the US Department of Transportation and the US Postal Service. These apply to domestic transportation by land, air or sea, and to international air transportation. Recurrent training is required every 3 years. The laboratory should check with its local department of transportation or state health department for any recent revisions to these requirements.
Laboratories outside of the US must comply with their national regulations.
These requirements for packaging and shipping of infectious substances do not apply to private couriers.
The laboratory may send personnel to courses for certified training, or may obtain materials to train its personnel in-house. Resources for certified training are available from many sources, including state health departments, vendors of shipping materials, and the CDC National Laboratory Training Network (NLTN).
- Records of training for all personnel involved in transport of specimens”
GEN.40530, Specimen Tracking
“For specimens submitted to the laboratory from remote sites, there is a documented tracking system to ensure that all specimens are actually received., NOTE: Documentation should include time of dispatch and receipt, as well as condition of specimens upon receipt. An example of an acceptable tracking system is submission of a packing list (prepared by the client or courier) with each batch of client specimens, which may be checked against the specimens received by the laboratory. Some laboratory tests (e.g. coagulation assays) have limitations on time and temperature conditions between collection and analysis. This requirement applies to couriers/transportation systems that are part of the laboratory organization, not to outside courier systems., Evidence of Compliance:
- Specimen shipping/transport logs AND
- Records of follow up for specimens not received”
GEN.40535, Specimen Transport QM
“There is an adequate process for monitoring the quality of submitted specimens, correcting problems identified in specimen transportation, and improving performance of clients or offices that frequently submit specimens improperly., , Evidence of Compliance:
- Records of corrective action OR communications with clients that frequently submit specimens incorrectly”
GEN.40545, Newborn Screening Specimen Tracking
“For specimens being submitted to a remote testing laboratory for newborn screening for congenital disorders, there is a documented tracking system to ensure that all specimens are submitted in compliance with timing requirements and that a result or other appropriate notification is received indicating that the specimens were actually received., NOTE: Tracking documentation should include time of dispatch and condition of specimens upon submission. An example of an acceptable tracking system is the use of a packing list (prepared by the submitting site or courier) with each batch of specimens that is checked against the specimens received by the remote testing laboratory. Newborn screening laboratory specimens have limitations with time and humidity conditions between collection and analysis. This requirement applies to couriers/transportation systems that are part of the laboratory organization and to outside courier systems., Evidence of Compliance:
- Records showing results/notifications received on all specimens AND
- Records of follow up for specimens not received at the remote laboratory”
GEN.40700, Requisitions
All specimens are accompanied by an adequate requisition., NOTE: In computerized settings, there may not be a paper requisition that is physically attached to the specimen container.,
GEN.40725, Requisition Data Entry
Test requisition data elements are entered accurately into the laboratory information or record system., NOTE: Data elements include patient demographic data; the name and location of the individual or entity ordering the test, as well as other elements needed for the final report (see GEN.41096). The laboratory must have an ongoing mechanism to ensure the accuracy of manual entries. For test orders crossing an interface to the LIS, requirements for interface integrity apply.,
GEN.40750, Requisition Elements
“The paper or electronic requisition includes all of the following elements, as applicable.
- Adequate patient identification information (e.g., name, registration number and location, or a unique confidential specimen code if an alternative audit trail exists)
- Patient sex
- Patient date of birth or age
- Name and address (if different than the receiving laboratory) of the physician, legally authorized person ordering the test, or name and address of the laboratory referring the specimen
- Tests requested
- Last menstrual period (for gynecologic specimens)
- Time and date of specimen collection when appropriate
- Source of specimen, when appropriate
- Clinical information, when appropriate, NOTE: Specimen source may be particularly important for microbiology, surgical pathology, and cytopathology specimens. Surgical pathology specimens must be labeled and requisitions prepared in the room where the surgical procedure is performed. The patient’s chart or medical record may be used as the test requisition or authorization., “
GEN.40825, Specimen ID
There is a system to positively identify all patient specimens, specimen types, and aliquots at all times., NOTE: Each specimen container must identify the patient uniquely. This may be text-based, numeric, bar-coded, etc. The form of this system is entirely at the discretion of each laboratory, so long as all primary collection containers and their aliquots have a unique label which one can audit back to full particulars of patient identification, collection date, specimen type, etc. Practical considerations of container size may limit the extent of such details. There must be an appropriate, consistently applied accessioning system.,
GEN.40900, Specimen Date Received
The date (and time, if appropriate) that the specimen was received by the laboratory is recorded., ,
GEN.40930, Authorized Requestor
“The laboratory has a mechanism to ensure that specimens are analyzed only at the request of an authorized person., NOTE: The laboratory must perform tests only at the written or electronic request of an authorized person. In some US states and other countries, individuals may order some laboratory tests without a physician’s referral (direct-to-consumer testing)., Evidence of Compliance:
- Written policy requiring test orders by authorized persons, if applicable in the jurisdiction in which the laboratory is located”
GEN.40932, Verbal Test Authorization
“For laboratories subject to US regulations, the laboratory solicits written or electronic authorization for verbal orders within 30 days., NOTE: The laboratory must retain the written authorization or documentation of efforts made to obtain a written authorization. In a managed office where the staff assistants are not employees of the physician/clinician, the staff should not sign a test requisition for the physician without some type of provider services agreement. This agreement must specify how the clinician has accepted responsibility for the tests ordered from the off-site laboratory. (This situation is different from the hospital environment, where the physician has personally signed the order sheet.), Evidence of Compliance:
- Records of follow-up to obtain written order”
GEN.40935, Test Order Read Back
The laboratory has a policy that personnel receiving verbal or phone orders read back the entire order to verify accuracy of transcription., ,
GEN.40938, Unclear Test Order
The laboratory has a policy on confirmation of test orders that may be unclear (e.g. orders using non-standard or non-specific terms). , ,
GEN.40942, Specimen Container Analytic Interference
“The laboratory evaluates its specimen containers to ensure that they do not contribute to analytic interference in the assays to be performed., NOTE: This may be done through some combination of direct testing by the laboratory, review of the clinical literature, and evaluation of information from manufacturers. It does not mandate exhaustive testing by each laboratory. ““Inertness”” of blood collection containers and specimen-contacting transfer devices and aliquot tubes cannot be assumed, as materials within these containers may lead to erroneous test results with medical consequences. Also, over- or underfilling vacuum tubes may lead to error., Evidence of Compliance:
- Records of specimen container evaluation for analytic interference”
GEN.41017, Centrifuge Operating Speeds
“The operating speeds of centrifuges are checked at least annually as needed for the intended use, and this is done in a safe manner., NOTE: For centrifuges having a safety mechanism preventing the opening of the lid while in operation, the checks of rpm should be performed only by an authorized service representative of the manufacturer or an appropriately trained clinical engineer., Evidence of Compliance:
- Records of verification of operating speeds documented at least annually”
GEN.41042, Refrigerator/Freezer Temperatures
“Refrigerator/freezer temperatures are checked and recorded daily using a calibrated thermometer., NOTE: This checklist requirement applies to refrigerators/freezers containing reagents or patient/client specimens. “Daily” means every day (7 days per week, 52 weeks per year). The laboratory must define the acceptable temperature ranges for these units. If temperature(s) are found to be outside of the acceptable range, the laboratory must document appropriate corrective action, which may include evaluation of contents for adverse effects.
The two acceptable ways of recording temperatures are: 1) recording the numerical temperature, or 2) placing a mark on a graph that corresponds to a numerical temperature (either manually, or using a graphical recording device). The identity of the individual recording the temperature(s) must be documented (recording the initials of the individual is adequate).
The use of automated (including remote) temperature monitoring systems is acceptable, providing that laboratory personnel have ongoing immediate access to the temperature data, so that appropriate corrective action can be taken if a temperature is out of the acceptable range. The functionality of the system must be documented daily.
Patient samples may be stored in frost free freezers only if protected from thawing. The laboratory must be able to document that the temperatures stay within the defined range., “
GEN.41067, Content/Format Report Review
An individual meeting CAP laboratory director qualifications reviews and approves the content and format of paper and electronic patient reports at least every two years., NOTE: The laboratory director (or a designee who meets CAP qualifications for laboratory director) must review and, at least every two years, approve the content and format of laboratory patient reports (whether paper or computer screen images) to ensure that they effectively communicate patient test results, and that they meet the needs of the medical staff. Further details on review of electronic reports are given in GEN.48500.,
GEN.41077, Reporting Outside Results
“There is a policy for laboratory director input regarding whether outside laboratory results are reported through the primary reporting system (i.e. the laboratory information system or the institution’s electronic medical record)., NOTE: At times patients may bring test results from outside laboratories to their physicians. Patients’ physicians may request, or institutional policy may dictate, that such results (or other test results from outside laboratories) be integrated into the laboratory’s primary reporting system (i.e. the LIS or the institution’s electronic medical record). The laboratory director should be aware of whether results from outside laboratories are reported through the laboratory information system or the electronic medical record system. It is recognized that the laboratory director may not be in a position to prohibit entry of outside laboratory results into the electronic medical record system.
However, if such results are integrated, the name and address of the outside laboratory must be available in the primary reporting system, and there must be an indication available to the person viewing such results that the results originated from an outside laboratory. Criteria for inclusion of such results might include whether the quality of the outside laboratory has been evaluated by the laboratory director; CLIA licensure or equivalent; whether reference ranges and/or units of measurement differ from in-house tests; whether units of measurement and reference range are included; and possession of an official report.
If the laboratory director believes that certain test results should not be integrated into the primary reporting system, one option is to include such results in a section of the electronic medical record other than the laboratory database., “
GEN.41096, Report Elements
“The paper or electronic report includes the following elements.
- Name and address of testing laboratory (see note below)
- Patient name and identification number, or unique patient identifier
- Name of physician of record, or legally authorized person ordering test, as appropriate
- Date and time of specimen collection, when appropriate
- Date of release of report (if not on the report, this information should be readily accessible)
- Time of release of report, if applicable (if not on the report, this information should be readily accessible)
- Specimen source, when applicable
- Test result(s) (and units of measurement, when applicable)
- Reference intervals, as applicable
- Conditions of specimen that may limit adequacy of testing, NOTE: All of the above data elements, as applicable, must be available in the laboratory information system or in paper records, and must be in the report that is available/sent to the clinician, whether electronic or paper, including electronic reports in systems interfaced to the laboratory information system directly or through middleware or an interface engine. (For electronic reports, data elements need not all be present on one screen, but must be readily available.)
The paper or electronic report must include the name and address of reference laboratories where patient testing was performed. For laboratories subject to US regulations, a “reference laboratory” includes outside reference laboratories as well as any affiliated or special function laboratory that is separately accredited and has a different CLIA registration number than the referring laboratory. For electronic reports, the name and address of reference laboratories need not all be present on the same screen(s) as the results but must be available in the information system.
Under some circumstances it may be appropriate to distribute lists or tables of reference intervals to all users and sites where reports are received. This system is usually fraught with difficulties, but if in place and rigidly controlled, it is acceptable.
Patient reports must state the name of the physician (or other legally authorized person) ordering the test(s) or a physician of record. In those institutions where there are multiple ordering physicians and/or frequent changing of attending physicians, the ordering physician should be easily identifiable through a computer audit trail or other records of the test order.
Reference laboratories accredited by the CAP must send a copy of the results to the referring laboratory (Exceptions to this requirement may be made under special circumstances or for special categories of testing, such as drugs of abuse or employee drug testing. The laboratory director may make these exceptions.). Results may be reported to the ordering physician of record (or other legally authorized person) by either the reference laboratory or the referring laboratory., “
GEN.41300, Report Retention and Retrieval
Copies or files of reports are legible and retained by the laboratory in a manner that permits prompt retrieval of the information., NOTE: The length of time that reported data are retained in the laboratory may vary; however, the reported results must be retained for that period encompassing a high frequency of requests for the data. In all circumstances, a hospital laboratory must have access to the patient’s chart where the information is permanently retained.,
GEN.41303, Patient Confidentiality
“The laboratory has a policy in place to protect patients’ health care information., NOTE: The policy must include a method for maintenance of confidentiality when patient data are transmitted between two organizations. Also, organizations must establish appropriate relationships between sender and receiver of patient data to ensure that the information will be used as intended.
For laboratories subject to US regulations, the laboratory should have policies and procedures delineating Health Insurance Portability and Accountability Act (HIPAA) compliance. HIPAA is a federal law requiring protection of patients’ health care information.
The laboratory must at least annually monitor compliance with the patient privacy policy., Evidence of Compliance:
- Records of HIPAA audit”
GEN.41304, Patient Data Accessibility
There is a documented protocol in place to ensure that patient data are accessible only to those individuals who are authorized to review test results., NOTE: Only those healthcare personnel authorized to review a patient’s test results should have access to those results. Laboratories subject to US regulations must provide final test results to the patient or the patient’s personal representative upon request.,
GEN.41306, Analyst Tracking ID
There is a system whereby the identity of the analyst performing or completing the test and the date of the test can always be established., NOTE: The system should also be capable of identifying those test results that have been autoverified.,
GEN.41307, Report Errors
“When errors are detected in patient test reports, the laboratory promptly notifies responsible clinical personnel or reference laboratory as applicable and issues a corrected report., NOTE: Notification should include the department of health or other legal entity as required by local regulations., Evidence of Compliance:
- Records of report error notification and corrected report”
GEN.41310, Revised Report
“All revised reports of previously reported, incorrect patient results are identified as revised, and both the revised and original data are clearly identified as such., NOTE: 1. ““Revised”” means changes to patient results, accompanying reference intervals and interpretations, or patient identifiers, but not to minor typographical errors of no consequence. As clinical decisions or actions may have been based on the previous report, it is important to replicate previous information (test results, interpretations, reference intervals) for comparison with the revised information. The previous information and the revised information must be identified as such, and the original data must be present in the revised report (for paper reports), or linked electronically or logically to the revised information (in electronic reports).
- This requirement applies to electronic reports in the laboratory information system and to the data systems interfaced to the laboratory information system either directly or through middleware or an interface engine (but not to systems that are further downstream in the interface chain).
- The format of corrected reports is at the discretion of the laboratory. For extensive interpretive or textual data (e.g. surgical pathology reports), replicating the entire original and corrected pathology reports may be cumbersome and render the revised report format difficult to interpret. In such cases, a comment in the corrected report summarizing the previous information and the reason for the correction may be provided.
- Displays in an electronic medical record (EMR) downstream from the laboratory should include the original report as well as the revised report. The report elements listed in GEN.41096 should be included in the EMR.
- The revision should add explanatory language if an explanation would be helpful to the user. For example, a comment about transport or sample storage conditions uncovered post-analysis can help frame an original, invalid result., “
GEN.41312, Multiple Revisions
When there are multiple sequential corrections of a single test result, all corrections are referenced in sequential order on subsequent reports., NOTE: When there are multiple sequential corrections of a previously reported result, it is considered inappropriate to note only the last correction made, as the clinician may have made a clinical decision based upon erroneous data rather than the “true” result. All corrections should be referenced in the patient report.,
GEN.41316, Infectious Disease Reporting
“There is a policy regarding the timely communication, and documentation thereof, of diagnoses of infectious diseases of particular significance (e.g. human immunodeficiency virus, tuberculosis, etc.)., NOTE: The laboratory should have a policy to ensure that diagnoses of human immunodeficiency virus infection, and other serious infections (for example, tuberculosis) are communicated to the responsible clinician in a timely manner.
The intent of this checklist item is NOT to require that these diagnoses be treated as critical results (this decision is up to the laboratory director); rather, the intent is that the laboratory assure that its reporting system is effective., “
GEN.41325, Newborn Screening Results
There must be a procedure for handling invalid and positive newborn screening results for samples submitted to other laboratories for testing., NOTE: This requirement applies to the testing of whole blood heel stick samples from the newborn after birth on filter paper collection devices for the routine screening of congenital disorders. Positive results include those results that are outside of the expected range of testing results established for a particular condition. Invalid results include situations where the laboratory is unable to complete the screening process due to an unsuitable specimen, test, or incomplete information. Due to the urgent nature of newborn screening test results, procedures must include a process to track requests for repeat testing so that repeat specimens are submitted within the follow-up/recollection timeframe specified by the testing laboratory.,
GEN.41345, Turnaround Time
“The laboratory has defined turnaround times (i.e. the interval between specimen receipt by laboratory personnel and results reporting) for each of its tests, and it has a policy for notifying the requester when testing is delayed., NOTE: This does NOT imply that all instances of delayed reporting for all tests must lead to formal notification of clinical personnel. Rather, clinicians and laboratory must have a jointly agreed upon policy for when such notification is important for patient care., Evidence of Compliance:
- Written policy defining test reporting turnaround time and process for communication of delays in turnaround time”
GEN.41350, Reference Laboratory Selection
“The laboratory has a documented process to select and evaluate reference laboratories., NOTE: The laboratory director, in consultation with the institutional medical staff or physician clients (where appropriate), is responsible for selecting referral laboratories.
- Selection of reference laboratories must be based primarily upon the quality of performance of such laboratories
- "”Referred Specimens”” includes any for which intermediate processing is performed at another facility, such as histopathology/cytology preparation or nucleic acid sequencing
- For laboratories subject to US regulations: for tests in disciplines covered by CLIA, specimens must be referred only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.* With respect to patients on research protocols, whose tests are referred to a research laboratory: if those test results are used for patient management decisions, the research laboratory must be CLIA-certified, or meet equivalent requirements as determined by CMS.
- For disciplines not covered by CLIA (e.g. histology), laboratories subject to US regulations must refer specimens to a laboratory accredited by CAP or a CAP-accepted organization.*
- For non-US laboratories, whenever possible, referral specimens should be sent to a laboratory accredited by CAP; accredited to an established international standard from a recognized organization; or certified by an appropriate government agency. The inspector may need to exercise judgment with respect to determining if a referral laboratory is acceptable.
- It is the responsibility of the laboratory director or designee to monitor the turnaround time and quality of test results received from reference laboratories.
The laboratory director should ensure that the reference laboratories provide turnaround times that meet clinical needs.
*For overseas US military laboratories only, an exception to this requirement is acceptable if both of the following conditions are met:
- Rapid turnaround time (TAT) is required to prevent either a delay in patient treatment/diagnosis or specimen degradation, and an acceptable TAT cannot be provided by a CAP-accredited or CLIA-certified laboratory.
- The laboratory director has determined that the alternative testing site meets requirements that are equivalent to those of a CLIP (Clinical Laboratory Improvement Program) or CLIA-certified laboratory as stipulated in the CLIP/CLIA Manual (11-32(8)c). This assessment must be documented., Evidence of Compliance:
- Records of the monitoring of reference laboratory services (e.g. problem log, review of reports)”
GEN.41430, Reference Laboratory Report Retention
“For samples referred to another laboratory, the original or an exact copy of the testing laboratory’s report is retained by the referring laboratory., NOTE: The report may be retained on paper or in electronic format. Exceptions to this requirement may be made under special circumstances or for special categories, such as drugs of abuse or employee drug testing. The laboratory director may make these exceptions., Evidence of Compliance:
- Retained original reference laboratory reports OR direct access to reference laboratory reports via electronic transmission from the reference laboratory”
GEN.41440, Reference Laboratory Results Reporting
“The essential elements of referred test results are reported by the referring laboratory as received from the reference laboratory, without alterations that could affect clinical interpretation., NOTE: If the laboratory transcribes results from the reference laboratory report, the test result(s), interpretation, and information directly related to the interpretation must be copied as reported by the reference laboratory This does not mandate that the referring laboratory report every word nor retain the exact format of the reference laboratory report. There is no requirement to fully replicate the complete content of the reference laboratory report beyond the results and interpretation. Suggestions for follow-up testing may, for example, be omitted at the discretion of the laboratory director., Evidence of Compliance:
- Patient results from the reference laboratory consistent with laboratory-issued patient reports”
GEN.41460, DTC Jurisdiction
“The laboratory performs DTC testing and reports results of DTC tests only in jurisdictions where such testing is lawful., NOTE: No less than every 2 years, the laboratory must verify which jurisdictions permit DTC testing., Evidence of Compliance:
- Documentation that the laboratory has reviewed applicable laws/regulations”
GEN.41475, DTC Report
The test report includes test results, reference range, interpretation as applicable, and limitations of the test, as applicable, in language readily understandable by a lay person., ,
GEN.41485, DTC Report
“The test report includes information that enables the consumer to contact a licensed heath care professional about the clinical significance of the test result., NOTE: This information may consist of the name, phone number, and email address of a health care professional. Alternatively, it may be the phone number of an office at the laboratory or medical center that can provide contact information to the consumer.
The practitioner or designee should be reasonably available during normal business hours., “
GEN.41497, DTC Result Retention
The laboratory retains the results of DTC tests and reference ranges for at least 10 years after testing., NOTE: This requirement applies only to DTC tests performed after June 15, 2009.,
GEN.41500, Defined Water Types
“The laboratory defines the specific type of water required for each of its testing procedures and water quality is tested at least annually., NOTE: The laboratory should define the type of water necessary for each of its procedures, and should have an adequate supply of same. The current edition of CLSI Guideline C3-A4 defines the following grades of water: Clinical Laboratory Reagent Water (CLRW), suitable for most laboratory procedures; Special Reagent Water (SRW), defined by a laboratory for procedures that need different specifications than CLRW; Instrument Feed Water, specified by IVD manufacturers as suitable for use with their measurement systems; and Commercially Bottled Purified Water that may be suitable for certain laboratory procedures. CLRW is similar to the Type I reagent water defined in earlier editions of this guideline.
CLRW is not required if the laboratory is able to document reliable results with an alternate grade of water.
The following specification for CLRW is adapted from this guideline and should be met at time of in-house production:
Bacteria may inactivate reagents, contribute to total organic contamination, or alter optical properties of test solutions. Resistivity provides a nonspecific measure of the ion content. Particulate matter includes organic carbon from biofilms and inorganic aggregates that can vary over time both in nature of the contamination and the effect on the laboratory use.
The CLSI Guideline provides testing information for microbial content, and resistivity, as well as total organic carbon; earlier specifications for silicates have been removed. It gives instructions for the preparation of the various types of water. It also addresses the use of purchased water, the effects of storing water, and the monitoring of stored water.
The quality (specifications) of the laboratory’s water, whether prepared in-house or purchased, must be checked and documented at least annually. The frequency and extent of checking may vary, according to the quality of source water and specific laboratory needs. Corrective action must be documented if water does not meet acceptability criteria.
For CLRW, minimum monitoring includes resistivity and microbiology cultures. Other criteria, such as pH, endotoxin/pyrogens, silicates and organic contaminants are at the discretion of the laboratory, testing for these substances must be documented only if the laboratory finds that they adversely affect specific test methods.
The laboratory must determine the level of testing necessary for other grades of water in use.
Typically, ““sterile (pharmaceutical) water”” is not manufactured to meet the specifications of CLRW, and should not be used as its equivalent.
For commercial instrument-reagent systems, the laboratory must use a specific type of water recommended by the manufacturer. Although routine commercial methods are typically designed to work with laboratory reagent grade water, higher-quality water systems exist and may be required for specific methods or if analytical imprecision or inaccuracy has been traced to the quality of in-lab water., Evidence of Compliance:
- Documentation of corrective action when water quality does not meet specifications”
GEN.41770, Glassware Cleaning
“There are appropriate documented procedures for handling and cleaning glassware, including methods for testing for detergent removal., NOTE: Special instructions for micropipettes, cuvets, acid washing, etc. must be included.
A simple procedure to check for detergent residue uses bromcresol purple (0.1 g bromcresol purple in 50 mL ethyl alcohol). Pipette approximately 5 cm (2 inches) distilled water into a representative, washed, glassware item. Add two to three drops bromcresol solution. A purple color reveals residual detergent. A yellow color indicates satisfactory rinsing., Evidence of Compliance:
- Records of detergent residue testing”
GEN.42195, Remote LIS
If components of the LIS are located at a facility other than the one under this CAP accreditation number, there is evidence that the remote facility complies with CAP requirements for host LIS functions., NOTE: This requirement does not apply if all components of the LIS are under the laboratory’s CAP number. This requirement may be addressed by a copy of the CAP accreditation certificate from other sites, or evidence that the computer facility has been provided a copy of this Checklist, and has satisfactorily addressed the contents of the Computer Facility section, and all other pertinent items, with documentation provided to the laboratory director and the CAP inspector.,
GEN.42750, Computer Facility Maintenance
The computer facility and equipment are clean, well-maintained and adequately ventilated with appropriate environmental control., NOTE: The computer facilities should be clean, well maintained and in a location that is environmentally controlled, as required by the most restrictive vendor specifications. ,
GEN.42800, LIS Fire Equipment
“Fire-fighting equipment (extinguishers) is appropriate for electrical components available., NOTE: Acceptable fire-fighting equipment/extinguishers in areas with information technology equipment may include:
- Automatic sprinkler systems that are valved separately from other systems
- Gaseous clean agent extinguishers systems
- Listed portable fire extinguishers of carbon dioxide or halogenated agent type
- Listed extinguishers with a minimum rating of 2-A for ordinary combustible material (paper and/or plastics)
- Gaseous agent inside units or total flooding systems when there is critical need, e.g. to protect data in process, reduce equipment damage and to facilitate a return to service
Dry chemical extinguishers are not recommended because of the corrosive damage they cause. In the instance where no other extinguisher is available and there is imminent danger to personnel or property however, a dry extinguisher may be used., “
GEN.42900, LIS Power
The computer system is adequately protected against electrical power interruptions and surges., NOTE: Protection from electrical surges and interruptions must be adequate to prevent loss of data. An uninterruptible power system (UPS) or similar protective device (e.g. isolation transformer) must be considered. Periodic testing of this protective equipment to ensure protection of data and proper shutdown of computer equipment is considered best practice.,
GEN.43022, LIS Testing
There is documentation that programs are adequately tested for proper functioning when first installed and after any modifications, and that the laboratory director or designee has approved the use of all new programs and modifications., NOTE: Computer programs must be checked for proper performance when first installed and after any changes or modifications. Any changes or modifications to the system must be documented, and the laboratory director or designee must approve all changes, additions and deletions in programs, the test library, and major computer functions before they are released. Documentation must be retained for at least two years beyond the service life of the system. ,
GEN.43033, Custom LIS
Customized programs are appropriately documented., NOTE: The purpose of the computer program, the way it functions, and its interaction with other programs must be clearly stated. The level of detail should be adequate to support trouble-shooting, system modifications, or additional programming.,
GEN.43044, Software Modification Tracking
“There is an adequate tracking system to identify all persons who have added or modified software., , Evidence of Compliance:
- Records of individuals adding or modifying software”
GEN.43055, LIS Training
There is documentation that all users of the computer system receive adequate training initially, after system modification and after installation of a new system., ,
GEN.43066, Computer Malfunction Notification
“There is a written policy with instructions for contacting a responsible person (e.g. Computer System Manager) in case of computer malfunction., , Evidence of Compliance:
- Written LIS policy with instructions for contacting a responsible person in case of system malfunction”
GEN.43088, LIS Integrity
“There is a documented process to verify the integrity of the system (operating system, applications and database) after restoration of data files., NOTE: The computer system must be checked after restoration of data files to ensure that no inadvertent alterations have occurred that might affect clinical result reporting. The integrity of the system may be verified, for example, by review of a representative number of computer-generated patient reports, or by generating test (“dummy”) patient reports for review. The laboratory director is responsible for determining verification procedure(s) appropriate to the laboratory. Whether or not the data center is located on site, all facilities served by the data center must participate in the verification of the system(s) integrity following a hardware or software failure., Evidence of Compliance:
- Records of verification after a hardware or software failure”
GEN.43150, Access Patient Data
There are explicit documented policies that specify who may use the computer system to enter or access patient data, change results, change billing or alter programs., NOTE: Policies must define those who may only access patient data and users who are authorized to enter patient results, change results, change billing, or alter computer tables or programs. If data in other computer systems can be accessed through the LIS (e.g. pharmacy or medical records), policies must prevent unauthorized access to the data through the LIS.,
GEN.43200, Computer Access Codes
Computer access codes (security codes, user codes) are in place to limit individuals’ access to those functions they are authorized to use, and the security of access codes is maintained (e.g. inactivated when employees leave, not posted on terminals)., NOTE: The laboratory should establish security (user) codes to permit only specifically authorized individuals to access patient data or alter programs. A system that allows different levels of user access to the system based on the user’s authorization is desirable and usually provides effective security. Examples of best practices include these requirements: periodic alteration of passwords by users; minimum character length for passwords; password complexity requirements (e.g. a combination of alphanumeric characters); recording of failed log-on attempts with user lock-out after a defined number of unsuccessful log-on attempts. ,
GEN.43262, Unauthorized Software Installation
Policies and procedures are in place that govern installation of software on any computer used by the laboratory., NOTE: Laboratory computers often serve multiple functions. Many of these computers are connected in a network. The security of the system should be sufficient to prevent the casual user from installing software. Such unauthorized installation may cause instability of the operating system or introduce other unwanted consequences. Many operating systems allow procedures to restrict certain users from installing software.,
GEN.43325, Public Network Security
“If the facility uses a public network, such as the Internet as a data exchange medium, there are adequate network security measures in place to ensure confidentiality of patient data., NOTE: Information sent over a public domain such as the Internet is considered in the public domain. Thus it is potentially accessible to all parties on that network. Systems must be in place to protect network traffic, such as ““fire walls”” and data encryption schemes. , Evidence of Compliance:
- Written policy defining mechanism for data protection”
GEN.43450, Calculated Patient Data Verification
“Calculated values reported with patient results are reviewed every two years or when a system change is made that may affect the calculations., NOTE: This checklist requirement applies only to calculations based on formulas modifiable by the user.
Errors can be inadvertently introduced into established computer programs. Calculations involving reportable patient results must be rechecked and documented to ensure accuracy. This requirement applies to laboratory information systems, middleware, and analyzers. More frequent checks may be required for certain specific calculations, as delineated elsewhere in the checklists (for example, INR).
When calculations are performed by an LIS shared by multiple laboratories, this review only needs to be done at one location and each individual laboratory must have a copy of the review documentation. However, any calculations specific to an individual laboratory’s methodology must be reviewed by that laboratory and the documentation of that review must be available., Evidence of Compliance:
- Records of validation of calculated test results”
GEN.43750, Specimen Quality Comment
“The system provides for comments on specimen quality that might compromise the accuracy of analytic results (e.g. hemolyzed, lipemic)., , Evidence of Compliance:
- Patient reports “
GEN.43800, Data Input ID
“There is an adequate system to identify all individuals who have entered and/or modified patient data or control files., NOTE: When individual tests from a single test order (e.g. multiple tests with same accession number) are performed by separate individuals and the test result is entered into the LIS, the system must provide an audit trail to document each person involved. For example, a single accession number having orders for electrolytes and a lipid panel may have testing done by two or more individuals. The laboratory should be able to identify the responsible personnel who performed each test and posted the data. This includes sequential corrections made to a single test result. If autoverification is used, then the audit trail should reflect that the result was verified automatically at a given time.
With point-of-care testing, if the individual performing the test is different than the individual entering test data into the LIS, both should be uniquely identified by the system and retrievable by audit trail., “
GEN.43812, Test Result Routing
“The laboratory has a process to ensure appropriate routing of patient test results to physicians., NOTE: During the course of their medical care in a health care system, the location of a patient may change multiple times; i.e. from various inpatient locations, to outpatient, to physician office patient. The intent of the requirement is to ensure that patient test results are routed to the responsible physician(s) regardless of patient location. For example, after a patient is discharged from the hospital test reports should be routed to the physician as well as the hospital medical record., Evidence of Compliance:
- Written policy defining process for routing of patient results”
GEN.43825, Result Verification
“Manual and automated result entries are verified before final acceptance and reporting by the computer., NOTE: Data entered into the computer system either manually or by automated methods must be reviewed by an authorized individual who verifies the accuracy of the input data before final acceptance and reporting by the computer. An example of best practices for this step is checking the result against the reportable range and critical results for the test. Depending on the local environment, this may or may not require a second person. Verification procedures must generate an audit trail.
This checklist requirement does not apply to autoverification procedures (see below)., “
GEN.43837, Downtime Result Reporting
There are documented procedures to ensure reporting of patient results in a prompt and useful fashion during partial or complete downtime and recovery of the system., ,
GEN.43850, Autoverification Approval
There is a policy signed by the laboratory director approving the use of autoverification procedures., ,
GEN.43875, Autoverification Validation
There is documentation that the autoverification process was validated initially, and is tested at least annually and whenever there is a change to the system that could affect the autoverification logic., NOTE: The range of results for which autoverification is acceptable must be defined for all patient tests subject to autoverification.,
GEN.43878, Autoverification QC Samples
“For all test results subject to autoverification, the laboratory ensures that applicable quality control samples have been run within an appropriate time period, with acceptable results., NOTE: This requirement may be met by, 1) the computer system automatically checking quality control status prior to autoverification, or, 2) manually disabling autoverification after any unacceptable QC result, or when QC has not been run within the required time interval., Evidence of Compliance:
- Procedure defining the QC process AND
- QC data to show that QC was performed at defined intervals”
GEN.43881, Autoverification Result Comparability
“Results are compared with an appropriate range of acceptable values prior to autoverification., NOTE: Appropriate comparisons include checking patient results against absurd and critical results requiring manual intervention (repeat testing, dilution, telephone notification of results, etc.), Evidence of Compliance:
- Records of system rules including comparison of patient results against absurd and critical values”
GEN.43884, Result Flags
Results are checked for flags or warnings prior to autoverification., NOTE: The mere presence of a flag may not disqualify a result from autoverification, but any flag that is not specifically recognized by the autoverification program must cause the flagged result to be held for manual review.,
GEN.43887, Autoverification Audit Trail
The audit trail in the computer system identifies all test results that were autoverified, and the date/time of autoverification., ,
GEN.43890, Autoverification Delta Checks
“The autoverification process includes all delta checks that the laboratory performs prior to manual release of test results., NOTE: This requirement does not require delta-checking for all autoverified results, but the laboratory’s delta-checking procedures should be the same for manually released and autoverified test results., Evidence of Compliance:
- Records of system rules including the use of delta checks when appropriate”
GEN.43893, Autoverification Suspension
The laboratory has a procedure for rapid suspension of autoverification., NOTE: Laboratory personnel should be able to suspend autoverification in the event of a problem with a test method, analytic instrument or the autoverification program.,
GEN.43900, Archived Test Result
A complete copy of archived patient test results can be retrieved, including original reference ranges and interpretive comments, including any flags or footnotes that were present in the original report, and the date of the original report., NOTE: Stored patient result data and archival information must be easily and readily retrievable within a time frame consistent with patient care needs.,
GEN.43920, Multiple Analyzer ID
When multiple identical analyzers are used, they are uniquely identified such that a test result may be appropriately traced back to the instrument performing the test., NOTE: Best practice is to store these data in the LIS.,
GEN.43946, Data Preservation/Destructive Event
“There are documented procedures for the preservation of data and equipment in case of an unexpected destructive event (e.g. fire, flood), software failure and/or hardware failure, and these procedures allow for the timely restoration of service., NOTE: Policies and procedures must 1) Be adequate to address scheduled and unscheduled interruptions of power or function; 2) Be tested periodically for effectiveness; 3) Include systems to backup programs and data; and 4) Include a written plan.
These procedures can include (but are not limited to) steps to limit the extent of the destructive event, protocols for periodic backing up and storing of information, procedures for off-site storage of backup data, and protocols/procedures for restoring information from backed up media. The procedures should specifically address the recoverability of patient information. Changes to hardware and software commonly require review and reevaluation of these documented procedures. These procedures must specifically address the physical environment and equipment. This checklist requirement is often addressed by the organization’s disaster plan., “
GEN.46000, Reference Range/Units Transmission
As applicable, reference ranges and units of measure for every test are transmitted with the patient result across the interface., NOTE: The reference range, including units of measure, may be specific for a given patient result and should be attached to that result such that it will be displayed along with the patient result.,
GEN.48500, Interface Result Integrity
“There is a procedure to verify that patient results are accurately transmitted from the point of data entry (interfaced instruments and manual input) to patient reports (whether paper or electronic)., NOTE: Verification must be performed prior to implementation of an interface (i.e. pre go-live), and every 2 years thereafter. This includes evaluation of data transmitted from the LIS to other computer systems and their output devices. Reference ranges and comments, as well as actual patient results and report formats, must be evaluated.
Verification of accurate data transmission from the LIS to other systems must be performed by reviewing data in the first downstream (or interfaced) system in which the ordering clinician/client (e.g. referring laboratory) may be expected to routinely access patient data. This requirement can be met by printing screen shots or by other methods that document that a verification procedure has been performed. If the LIS has separate interfaces to multiple receiving systems in which patient data can be accessed by clinicians, then reports from each receiving system must be validated. However, where multiple sites use the same recipient system (e.g. the same installed instance of an electronic medical record system), validation need only occur for the interface (i.e. at one of the sites) and not for each individual site that is served by that single installed system.
At implementation of a new interface, or change to an existing interface, validation of at least 2 examples of reports from each of the following disciplines, where applicable, satisfies the intent of this checklist requirement. Subsequently, at least 2 examples of reports from at least 4 of these disciplines should be validated every 2 years. Not all of these report types will be applicable to every laboratory:
- Surgical pathology reports
- Cytopathology reports (preferably gynecologic and non-gynecologic)
- Clinical laboratory textual reports (e.g. molecular, protein electrophoresis, coagulation panel interpretation)
- Quantitative results (e.g. chemistry, hematology, or coagulation)
- Qualitative or categorical results (e.g. serology)
- Microbiology reports (e.g. culture and antimicrobial sensitivity)
- Blood bank reports (e.g. type and screen)
Interface validation should include examples of individual results, test packages or batteries, abnormal flags, and results with comments/footnotes. Initial interface validation should include verification that corrected results for clinical laboratory and anatomic pathology results are handled accurately in the receiving system., Evidence of Compliance:
- Records of verification”
GEN.48750, LIS Interface Shutdown/Recovery
There are procedures for changes in laboratory functions necessary during partial or complete shutdown and recovery of systems that interface with the laboratory information system., NOTE: These procedures must ensure integrity of patient test data. Procedures must include verifying recovery of interfaced systems, and replacement or updating of data files, as necessary.,
GEN.50057, Slide/Image ID
“There is a method for the individual reviewing cases to ensure that correct patient identification and slides/images are submitted for review., NOTE: There are multiple ways to accomplish positive patient identification, including verbal communications, images of slide identifier, etc., Evidence of Compliance:
- Written procedure defining mechanism to positively identify slides/images”
GEN.50614, Clinical Information Access
The individual reviewing cases has access to pertinent clinical information at the time of slide/image(s) review., NOTE: Typically this information includes at least the information on the surgical pathology or cytology requisition form.,
GEN.51171, Telepathology Appropriate Use
The methods and systems in place ensure that the system used for telepathology is appropriate for its intended clinical use., NOTE: There should be a policy statement in the procedure manual that identifies appropriate and inappropriate use cases. For example, if a dynamic telemicroscopy system is installed on a microscope in the frozen section suite, the manual might state that this system is intended for use in intra-operative consultation and is not intended for second opinion consultation from pathologists at outside institutions.,
GEN.51728, Telepathology Training
“The lab has a procedure addressing training requirements for all users of the telepathology system., , Evidence of Compliance:
- Records for telepathology training in personnel files”
GEN.52842, Telepathology and Patient Confidentiality
“There are procedures in place to ensure that sites engaging in telepathology provide reasonable confidentiality and security., NOTE: Procedures might include message security, system and user authentication, activity logs, encryption, and access restrictions.
For laboratories subject to US regulations, the procedures must be in conformance with HIPAA requirements., “
GEN.52850, Telepathology Result Documentation
“Diagnostic and specimen adequacy of telepathology results are documented., , Evidence of Compliance:
- Reports generated from reviews of images/slides performed by telepathology”
GEN.52860, Quality Management Program
Telepathology services are included in the laboratory’s quality management plan., NOTE: For example, the laboratory might monitor the frequency of deferral cases, comparison to on-site evaluation, or consultation using traditional glass slide microscopy.,
GEN.52900, Whole Slide Imaging User Training
GEN.52900, Whole Slide Imaging User Training
GEN.52920, Whole Slide Imaging System Validation
“The laboratory validates whole slide imaging systems used for clinical diagnostic purposes by performing its own validation studies, including approval for use by the laboratory director (or designee who meets CAP director qualifications) before the technology is used for the intended diagnostic purpose(s)., NOTE: The specific components of the validation study are left to the discretion of the laboratory.
As general guiding principles, the validation process should:
- Closely emulate the real-world clinical environment and involve specimen preparation types and clinical settings relevant to the intended use(s);
- Be carried out by a pathologist(s) adequately trained to use the system;
- Assess intraobserver concordance between digital and glass slides;
- Encompass the entire whole slide imaging system, with reevaluation if a significant change is made to a previously validated system., Evidence of Compliance:
- Records of completed validation study with review and approval”
