--- title: "Laboratory Quality & Compliance Guide | WCGTX" description: "Explore 30 laboratory quality topics and a 56-item readiness checklist for Texas freestanding ERs, with searchable guidance and a fillable PDF checklist." image: "https://wcgtx.com/og-cover-v2.jpg" url: "https://wcgtx.com/facility-resources/laboratory-quality-compliance/" --- Facility Resources · Laboratory Source Review: September 2026 # Laboratory Quality *& Compliance Guide* A practical reference for Texas freestanding emergency rooms. Explore laboratory quality, testing processes, personnel competency, and survey readiness. Browse topics Use readiness checklist Download Fillable PDF Checklist **Educational Resource, Not a Compliance Certification.** Adapted from the supplied laboratory guide and checklist, which state a review date of September 2026. Confirm current requirements with the applicable regulator or accreditor, your laboratory director, and manufacturer instructions. Checklist selections are self-reported, not an assessment by WCGTX. Start Here ## Every Result Should Be Traceable. Browse 30 guide topics, review 56 readiness items, or download the fillable PDF checklist for your team. The full guide is available on this page. The Laboratory Quality Standard Accurate · Reliable · Timely · Traceable · Clinically Communicated Review the five readiness questions About This Guide and Its Scope A Practical Resource Based on CLIA, COLA, Texas HHSC, and Joint Commission Quality Expectations Laboratory testing is an essential component of emergency care. In a Texas Freestanding Emergency Room, laboratory services must support rapid clinical decision-making while meeting overlapping federal, state, accreditation, patient-safety, and quality-assurance requirements. A strong laboratory program should ensure that every result used in patient care is: Accurate • Reliable • Timely • Traceable • Clinically Communicated This resource provides a practical framework for Freestanding Emergency Rooms operating in Texas and incorporates major expectations from: - Clinical Laboratory Improvement Amendments (CLIA) - Centers for Medicare & Medicaid Services (CMS) - Texas Health and Human Services Commission (HHSC) - 26 Texas Administrative Code Chapter 509 - COLA laboratory accreditation - Joint Commission Ambulatory Health Care and laboratory quality expectations Browse the Guide ## Find a Laboratory Topic Search laboratory topics Search the full guidance inside all 30 topics. All Regulatory Foundations Oversight & Personnel Patient Safety Testing Quality Operations & Equipment Quality Improvement & Readiness 30 topics Clear filters Expand all Jump to a Topic Readiness checklist Fillable PDF checklist Reference library 01 Regulatory Foundations ### Texas Requirements for Freestanding Emergency Rooms Texas regulates Freestanding Emergency Medical Care Facilities under 26 Texas Administrative Code Chapter 509. Read Guidance Texas regulates Freestanding Emergency Medical Care Facilities under 26 Texas Administrative Code Chapter 509. Section 509.49 — Laboratory and Pathology Services contains specific requirements for laboratory operations in Texas Freestanding Emergency Rooms. Texas requires a Freestanding Emergency Room to maintain directly, or have immediately available on the premises, laboratory services adequate to meet the needs of its patients. Laboratory services must comply with CLIA requirements under 42 CFR Part 493. #### Minimum Emergency Laboratory Capability Under 26 TAC §509.49, emergency laboratory services must be available on the premises during the facility's hours of operation and must include: - Cardiac marker assays - Hematology - Chemistry - Pregnancy testing For a Freestanding Emergency Room operating 24 hours per day, this effectively means these capabilities must remain available whenever the facility is open. Source: Supplied Laboratory Quality & Compliance Guide, Section 1. 02 Regulatory Foundations ### CLIA Certification The Clinical Laboratory Improvement Amendments regulate laboratories testing human specimens for diagnosis, prevention, treatment, or health assessment. Read Guidance The Clinical Laboratory Improvement Amendments regulate laboratories testing human specimens for diagnosis, prevention, treatment, or health assessment. CMS states that the purpose of CLIA is to ensure laboratory test results are: - Accurate - Reliable - Timely CLIA requirements vary according to the complexity of the testing being performed. Every Freestanding ER performing patient laboratory testing should ensure that: - The facility has the correct CLIA certificate. - The certificate reflects the level of testing actually being performed. - The laboratory does not perform testing beyond the complexity permitted by its certificate. - Changes in laboratory director, ownership, location, test complexity, or other required information are reported appropriately. - CLIA certification remains current. CMS currently operates CLIA certification electronically and requires laboratories to maintain a valid email address for certificates and related communications. Source: Supplied Laboratory Quality & Compliance Guide, Section 2. 03 Regulatory Foundations ### Know the Complexity of Every Test Laboratory tests generally fall into categories such as: Read Guidance Laboratory tests generally fall into categories such as: #### Waived Testing Tests determined to be relatively simple with low risk of erroneous results when performed according to FDA-cleared instructions. Examples commonly encountered in emergency facilities may include selected: - Urine pregnancy tests - Glucose testing - Rapid infectious-disease testing - Urinalysis systems The specific FDA classification of each testing platform must be confirmed. #### Moderate Complexity Testing Many automated hematology, chemistry, blood gas, and other analyzer-based tests may fall into this category depending upon the specific instrument and test system. #### High Complexity Testing More complex methods, modified testing procedures, and certain laboratory-developed tests may fall into high complexity. A Freestanding ER should maintain a current test menu identifying: Test → Instrument → FDA Complexity → CLIA Authorization → QC Requirements → Competency Requirements Source: Supplied Laboratory Quality & Compliance Guide, Section 3. 04 Regulatory Foundations ### Never Modify a Waived Test without Understanding the Consequences Waived testing must be performed according to the manufacturer's required Instructions for Use. Read Guidance Waived testing must be performed according to the manufacturer's required Instructions for Use. Joint Commission specifically warns that modifying a waived test outside the manufacturer's FDA-approved instructions can cause that testing to become high complexity. Examples can include changes involving: - Specimen type - Reagents - Instrument components - Procedural steps - Testing conditions A facility performing such modified testing may consequently need an appropriate high-complexity CLIA certificate and laboratory accreditation requirements applicable to that testing. This is an important survey-readiness issue for point-of-care testing. Source: Supplied Laboratory Quality & Compliance Guide, Section 4. 05 Oversight & Personnel ### Laboratory Director Oversight The Laboratory Director plays a central role in laboratory quality. Read Guidance The Laboratory Director plays a central role in laboratory quality. Depending upon the complexity of testing performed and accreditation structure, responsibilities generally include oversight of: - Laboratory policies and procedures - Testing systems - Personnel qualifications - Staff competency - Quality control - Proficiency testing - Corrective actions - Quality assessment - Test performance - Result reporting - Regulatory compliance CMS maintains specific educational resources concerning Laboratory Director responsibilities and personnel competency. The laboratory should have documentation showing who is responsible for laboratory oversight and that those duties are actively performed rather than merely assigned on paper. Source: Supplied Laboratory Quality & Compliance Guide, Section 5. 06 Oversight & Personnel ### Laboratory Policy and Procedure Manual Every Freestanding ER laboratory should maintain an organized laboratory manual. Read Guidance Every Freestanding ER laboratory should maintain an organized laboratory manual. Recommended sections include: #### Administration - Laboratory scope of services - CLIA certificate - Laboratory director designation - Testing personnel responsibilities - Organizational structure - Approved testing menu #### Specimen Management - Patient identification - Specimen labeling - Specimen collection - Acceptable specimens - Rejection criteria - Transportation - Storage - Stability requirements #### Testing Procedures A procedure should be available for every test system. Procedures should identify: - Specimen requirements - Reagents - Test steps - Calibration - Quality control - Reference ranges - Critical values - Limitations - Interferences - Troubleshooting - Result reporting Joint Commission expects waived-testing policies to be current, approved, readily available, and consistent with required manufacturer instructions. Source: Supplied Laboratory Quality & Compliance Guide, Section 6. 07 Oversight & Personnel ### Manufacturer Instructions for Use Current manufacturer Instructions for Use should be readily available for every instrument, reagent, cartridge, or testing kit. Read Guidance Current manufacturer Instructions for Use should be readily available for every instrument, reagent, cartridge, or testing kit. Staff should not rely solely on informal training or memory. Laboratory leadership should periodically confirm that: - Current IFUs are available. - Testing procedures match required manufacturer instructions. - Reagent storage matches manufacturer requirements. - QC frequency meets applicable requirements. - Calibration requirements are followed. - Maintenance is performed appropriately. In 2026, Joint Commission clarified that surveyors evaluate compliance with manufacturer requirements, rather than treating advisory manufacturer recommendations as mandatory unless the organization has incorporated those recommendations into its own policy. Source: Supplied Laboratory Quality & Compliance Guide, Section 7. 08 Patient Safety ### Patient Identification and Specimen Labeling Specimen errors can produce clinically dangerous laboratory results even when the analyzer functions perfectly. Read Guidance Specimen errors can produce clinically dangerous laboratory results even when the analyzer functions perfectly. Laboratory quality therefore begins before the test reaches the instrument. Recommended controls include use of at least two patient identifiers and verification during: - Specimen collection - Labeling - Point-of-care testing - Result entry - Result communication Labels should support traceability between: Patient → Specimen → Test → Operator → Result The organization should monitor: - Mislabeled specimens - Unlabeled specimens - Wrong-patient specimens - Recollection rates - Specimen contamination - Improper containers - Insufficient specimens Source: Supplied Laboratory Quality & Compliance Guide, Section 8. 09 Testing Quality ### Quality Control Quality Control demonstrates that a testing system is functioning properly before patient results are relied upon. Read Guidance Quality Control demonstrates that a testing system is functioning properly before patient results are relied upon. The laboratory should establish QC requirements for every applicable testing system. Records may include: - QC date and time - QC material - Lot number - Expiration date - Expected range - Actual result - Acceptability - Operator - Corrective action when QC fails Patient testing should not proceed when required QC is unacceptable unless the issue has been resolved according to applicable requirements. A key principle should be: Do not report patient results when the testing system has not demonstrated acceptable performance. Source: Supplied Laboratory Quality & Compliance Guide, Section 9. 10 Testing Quality ### Individualized Quality Control Plans For eligible nonwaived testing systems, laboratories may use an Individualized Quality Control Plan (IQCP) where permitted. Read Guidance For eligible nonwaived testing systems, laboratories may use an Individualized Quality Control Plan (IQCP) where permitted. CMS provides specific guidance for developing IQCPs. An IQCP generally incorporates: #### Risk Assessment Evaluation of risks involving: - Specimen - Environment - Reagents - Testing system - Personnel #### Quality Control Plan Controls designed to reduce identified risks. #### Quality Assessment Ongoing monitoring demonstrating whether the plan remains effective. IQCP should not be treated merely as a way to perform less QC. It should be a documented risk-management process. Source: Supplied Laboratory Quality & Compliance Guide, Section 10. 11 Testing Quality ### Calibration and Calibration Verification Applicable laboratory analyzers should undergo calibration and calibration verification according to CLIA requirements and manufacturer requirements. Read Guidance Applicable laboratory analyzers should undergo calibration and calibration verification according to CLIA requirements and manufacturer requirements. Documentation should demonstrate: - Required frequency - Results - Acceptability - Corrective actions - Personnel performing the activity CMS maintains specific guidance on calibration and calibration verification. Source: Supplied Laboratory Quality & Compliance Guide, Section 11. 12 Testing Quality ### Proficiency Testing Proficiency Testing is an external mechanism used to evaluate laboratory testing accuracy and reliability. Read Guidance Proficiency Testing is an external mechanism used to evaluate laboratory testing accuracy and reliability. CMS requires laboratories performing applicable nonwaived testing on regulated analytes to participate in an approved proficiency-testing program. PT samples should be handled similarly to patient specimens. The laboratory should maintain documentation of: - PT enrollment - Testing dates - Personnel performing testing - Results - Scores - Investigation of failures - Corrective actions PT materials must not be improperly referred or handled in violation of CLIA rules. #### Waived Tests Joint Commission does not generally require formal proficiency testing for FDA-waived tests. However, organizations may voluntarily use proficiency testing, split samples, or similar mechanisms as part of quality assessment or competency programs. Source: Supplied Laboratory Quality & Compliance Guide, Section 12. 13 Oversight & Personnel ### Staff Training and Competency Initial training alone is not sufficient to demonstrate continuing competency. Read Guidance Initial training alone is not sufficient to demonstrate continuing competency. Personnel should be trained and competent for each test they are authorized to perform. Joint Commission's waived-testing expectations call for training to be documented and competency to be assessed according to organizational policy, including at orientation and at least annually thereafter for applicable waived-testing personnel. Multiple methods should be used when required. Competency methods may include: - Direct observation of routine testing - Observation of specimen handling - Review of result reporting - Review of QC performance - Blind sample testing - Problem-solving assessment - Written examination - Instrument troubleshooting A useful staff competency matrix can track: Employee | Test | Initial Training | Initial Competency | Annual Competency | Due Date Source: Supplied Laboratory Quality & Compliance Guide, Section 13. 14 Testing Quality ### Quality Assessment Quality Assessment evaluates the entire laboratory system rather than only the analyzer. Read Guidance Quality Assessment evaluates the entire laboratory system rather than only the analyzer. COLA emphasizes that laboratories should evaluate quality across all phases of testing: #### Preanalytic Before testing. Examples: - Patient identification - Test ordering - Specimen collection - Labeling - Transportation - Specimen rejection #### Analytic During testing. Examples: - QC - Calibration - Instrument performance - Reagent integrity - Personnel competency - Proficiency testing #### Postanalytic After testing. Examples: - Result reporting - Critical results - Turnaround time - Corrected reports - Physician communication - Medical-record documentation COLA describes comprehensive Quality Assessment as an ongoing process designed to identify gaps and improve the reliability, relevance, and reproducibility of laboratory results. Source: Supplied Laboratory Quality & Compliance Guide, Section 14. 15 Patient Safety ### Critical Laboratory Results Critical-value management is especially important in emergency medicine. Read Guidance Critical-value management is especially important in emergency medicine. Texas specifically requires the facility to establish a mechanism ensuring that the patient's physician or other licensed healthcare professional is made aware of critical-value laboratory results established by the medical staff, including results identified before or after discharge. Texas also requires laboratory reports to be read, dated, signed, and authenticated by a physician. The medical staff should approve a written critical-value list. Examples may include critical: - Potassium - Sodium - Glucose - Hemoglobin - Platelet count - Troponin - Blood gas values - Other clinically significant results The notification process should document: Patient → Result → Date/Time → Person Notified → Person Communicating → Read-back/verification when applicable → Clinical follow-up Source: Supplied Laboratory Quality & Compliance Guide, Section 15. 16 Operations & Equipment ### Laboratory Turnaround Time In emergency medicine, laboratory quality includes speed as well as accuracy. Read Guidance In emergency medicine, laboratory quality includes speed as well as accuracy. Facilities should establish realistic turnaround-time goals for key emergency tests. Potential metrics include: - CBC turnaround - CMP/BMP turnaround - Troponin turnaround - Pregnancy testing turnaround - Lactate turnaround - Blood gas turnaround Review: Order → Collection → Analyzer → Result → Clinical acknowledgement Delays should be investigated when they affect clinical decision-making. Source: Supplied Laboratory Quality & Compliance Guide, Section 16. 17 Testing Quality ### Corrected and Amended Results The laboratory should have a clear process for corrected reports. Read Guidance The laboratory should have a clear process for corrected reports. Documentation should identify: - Original result - Corrected result - Reason for correction - Date/time - Person making correction - Physician notification when clinically significant Original information should remain traceable according to record-retention requirements. Source: Supplied Laboratory Quality & Compliance Guide, Section 17. 18 Testing Quality ### Reference Ranges Reference ranges should be accessible to clinicians interpreting laboratory results. Read Guidance Reference ranges should be accessible to clinicians interpreting laboratory results. Joint Commission permits reference ranges to be maintained elsewhere within the permanent medical record when they cannot practically appear directly beside the result, provided the result directs the clinician to their location. Source: Supplied Laboratory Quality & Compliance Guide, Section 18. 19 Testing Quality ### Laboratory Result Traceability For waived testing, Joint Commission does not specifically require a traditional paper testing log. Read Guidance For waived testing, Joint Commission does not specifically require a traditional paper testing log. However, the organization must be able to correlate QC information with individual patient test results. A strong electronic or manual system should allow the organization to determine: - Which patient was tested - Date and time - Instrument - Operator - Reagent or cartridge lot - QC status - Final result Traceability becomes particularly important during recalls or quality investigations. Source: Supplied Laboratory Quality & Compliance Guide, Section 19. 20 Operations & Equipment ### Reagent and Supply Management Laboratory supplies should be monitored for: Read Guidance Laboratory supplies should be monitored for: - Expiration - Lot numbers - Storage conditions - Open-vial stability - Temperature requirements - Manufacturer recalls - Inventory levels Expired reagents should not be used. The laboratory should maintain sufficient emergency inventory to support uninterrupted ER operations. Source: Supplied Laboratory Quality & Compliance Guide, Section 20. 21 Operations & Equipment ### Temperature Monitoring Temperature-controlled laboratory materials may include: Read Guidance Temperature-controlled laboratory materials may include: - Reagents - Controls - Specimens - Blood products - Certain testing cartridges Logs should identify: - Acceptable temperature range - Actual temperature - Date/time - Staff initials - Corrective action for excursions Excursions should be evaluated for their effect on reagent or specimen integrity rather than merely documented. Source: Supplied Laboratory Quality & Compliance Guide, Section 21. 22 Operations & Equipment ### Instrument Maintenance Every analyzer should have a defined maintenance program based on applicable requirements. Read Guidance Every analyzer should have a defined maintenance program based on applicable requirements. Records may include: - Daily maintenance - Weekly maintenance - Monthly maintenance - Preventive maintenance - Manufacturer service - Repairs - Software updates - Instrument downtime When equipment fails, the facility should have contingency arrangements to maintain emergency laboratory capability. Texas governing-body requirements also specifically contemplate arrangements for obtaining emergency laboratory services when services are unavailable because of system failure. Source: Supplied Laboratory Quality & Compliance Guide, Section 22. 23 Operations & Equipment ### Downtime and Backup Plan A Freestanding ER should maintain a written laboratory downtime plan. Read Guidance A Freestanding ER should maintain a written laboratory downtime plan. The plan should address: - Analyzer failure - Power loss - LIS/EMR failure - Internet outage - Refrigerator failure - Reagent shortage - Staffing disruption Backup processes may include: - Secondary analyzers - Approved alternate testing - Contract laboratory services - Courier procedures However, Texas requires certain emergency laboratory services to remain available on the premises, so contingency planning should be designed around continued compliance with §509.49. Source: Supplied Laboratory Quality & Compliance Guide, Section 23. 24 Regulatory Foundations ### Contract and Reference Laboratories Texas permits laboratory services to be provided through contractual arrangements but requires contracted laboratory services to be performed by laboratories appropriately certified under CLIA for the specialties and subspecialties provided. Read Guidance Texas permits laboratory services to be provided through contractual arrangements but requires contracted laboratory services to be performed by laboratories appropriately certified under CLIA for the specialties and subspecialties provided. Facilities should maintain: - Contract - Current CLIA certificate - Accreditation documentation when applicable - Test menu - Courier procedures - Critical-result procedures - Turnaround expectations Source: Supplied Laboratory Quality & Compliance Guide, Section 24. 25 Patient Safety ### Blood and Blood Components If blood or blood components are stored at the Freestanding ER, Texas requires written procedures addressing appropriate storage temperatures and actions during refrigeration or power failures. Read Guidance If blood or blood components are stored at the Freestanding ER, Texas requires written procedures addressing appropriate storage temperatures and actions during refrigeration or power failures. Texas also establishes requirements related to transfusion protocols, personnel training, patient observation, vital signs, and transfusion documentation. Blood-management systems therefore warrant dedicated policy and quality oversight when applicable. Source: Supplied Laboratory Quality & Compliance Guide, Section 25. 26 Patient Safety ### Laboratory Safety Texas requires Freestanding ER laboratories to implement written policies that manage, minimize, or eliminate risks from hazardous chemical exposure. Read Guidance Texas requires Freestanding ER laboratories to implement written policies that manage, minimize, or eliminate risks from hazardous chemical exposure. Laboratory safety programs should also address applicable: - PPE - OSHA Bloodborne Pathogens requirements - Sharps - Biohazard waste - Chemical hygiene - Safety Data Sheets - Spill response - Exposure management - Eyewash availability - Infection prevention - Equipment cleaning Source: Supplied Laboratory Quality & Compliance Guide, Section 26. 27 Quality Improvement & Readiness ### Laboratory Quality Dashboard for a Freestanding ER The following measures can provide a practical monthly dashboard: Read Guidance The following measures can provide a practical monthly dashboard: #### Patient Identification - Mislabeled specimens - Unlabeled specimens - Wrong-patient events #### Specimen Quality - Rejected specimens - Hemolyzed samples - Recollections #### Quality Control - QC failures - QC corrective actions - Missed QC #### Proficiency Testing - PT score - PT failures - Corrective actions #### Turnaround Time - Troponin - CBC - Chemistry - Pregnancy - Lactate #### Critical Values - Number of critical values - Notification compliance - Notification turnaround #### Personnel - Competency compliance - Training deficiencies - Expired competency #### Equipment - Analyzer downtime - Maintenance completion - Temperature excursions #### Safety - Exposure incidents - Chemical incidents - Safety audit findings Source: Supplied Laboratory Quality & Compliance Guide, Section 27. 28 Quality Improvement & Readiness ### Recommended Monthly Laboratory Quality Review The laboratory should provide a standing report to the facility Quality/QAPI Committee. Read Guidance The laboratory should provide a standing report to the facility Quality/QAPI Committee. A practical review can include: #### Quality Control Were required QC procedures completed and acceptable? #### Proficiency Testing Were results satisfactory? #### Competency Are all testing personnel current? #### Critical Results Were critical results communicated within policy? #### Turnaround Time Did emergency laboratory tests meet targets? #### Specimens Were there labeling, rejection, contamination, or collection problems? #### Equipment Were there significant analyzer failures or downtime? #### Safety Were there exposures, spills, or other incidents? #### Corrective Action Were prior laboratory findings resolved and effectiveness verified? Source: Supplied Laboratory Quality & Compliance Guide, Section 28. 29 Quality Improvement & Readiness ### Laboratory QAPI Model A practical laboratory quality-improvement cycle is: Read Guidance A practical laboratory quality-improvement cycle is: IDENTIFY → INVESTIGATE → CORRECT → MEASURE → SUSTAIN #### Example: - Finding: Troponin turnaround averages 38 minutes. - Goal: ≤25 minutes. - Investigation: Delay between specimen collection and analyzer placement. - Corrective Action: Revised specimen transport workflow. - Follow-Up: Average turnaround reduced to 22 minutes. - Effectiveness: Performance maintained for three consecutive months. - Status: Closed. Texas governing-body requirements specifically call for a facility-wide QAPI program and quarterly governing-body review and monitoring of QAPI activities. Laboratory services are expressly included among areas for which governing bodies must adopt and enforce policies. Source: Supplied Laboratory Quality & Compliance Guide, Section 29. 30 Quality Improvement & Readiness ### Survey-Ready Laboratory Binder A Freestanding ER should be able to rapidly produce documentation such as: Read Guidance A Freestanding ER should be able to rapidly produce documentation such as: #### Section 1 — Regulatory - CLIA certificate - COLA or other accreditation certificate - Texas facility license - Laboratory Director documentation - Test menu #### Section 2 — Policies - Laboratory manual - Specimen collection - Critical values - QC - PT - Competency - Corrected reports - Safety - Downtime #### Section 3 — Personnel - Qualifications - Training - Competency assessments - Continuing education #### Section 4 — Quality Control - QC records - Calibration - Maintenance - Temperature records #### Section 5 — Proficiency Testing - Enrollment - PT results - Investigations - Corrective actions #### Section 6 — Quality Assessment - Monthly laboratory dashboard - QA studies - QAPI reports - Corrective-action tracking #### Section 7 — Equipment - Analyzer records - Preventive maintenance - Service records - Manufacturer instructions #### Section 8 — Safety - Chemical inventory - SDS - Exposure plans - Safety audits Source: Supplied Laboratory Quality & Compliance Guide, Section 30. Quick Reference ## Five Questions Every Laboratory Should Be Able to Answer Use these questions to guide a discussion with laboratory leadership. They do not replace the detailed review or applicable requirements. 1. What testing do you perform? 2. How do you know the testing is accurate? 3. How do you know staff are competent? 4. What happens when something goes wrong? 5. How do you know your corrective action worked? During a survey, leadership should be able to explain: A laboratory that can clearly demonstrate these five elements is much better positioned for regulatory and accreditation review. Review Your Readiness ## Laboratory Survey Readiness Checklist Review all 56 items from the supplied checklist. Select a status for each item. The CLIA, COLA, HHSC, and TJC labels reproduce the source checklist’s reference columns; they are not independently verified regulatory determinations. **Session-Only Tool.** Selections stay in this page and are not saved or submitted. They reset when you reload or leave. Do not enter patient information. Use the downloadable fillable PDF checklist for facility details, findings, due dates, and sign-off. Search Checklist Items Filter by Status Reset selections 0 of 56 reviewed · 0 marked deficient 56 checklist items shown ### Regulatory & Technical Readiness Item 01 Current CLIA certificate is available and displayed/maintained as required. Certificate type matches actual testing complexity. Source References: CLIA · COLA · HHSC · TJC Review Status Item 02 Laboratory does not perform testing exceeding the complexity authorized by its CLIA certificate. Source References: CLIA · COLA · HHSC · TJC Review Status Item 03 Current COLA accreditation certificate/status is available when COLA is the laboratory accreditor. Source References: COLA Review Status Item 04 Laboratory Director designation is current and qualifications are documented for the testing performed. Source References: CLIA · COLA · TJC Review Status Item 05 Current laboratory test menu identifies test, method/instrument, specimen, and CLIA complexity. Source References: CLIA · COLA · HHSC · TJC Review Status Item 06 FSER has required emergency laboratory capability available on premises, including cardiac markers, hematology, chemistry, and pregnancy testing. Source References: CLIA · COLA · HHSC Review Status Item 07 Current written procedure is available for every laboratory test performed. Source References: CLIA · COLA · TJC Review Status Item 08 Procedures have appropriate Laboratory Director/authorized approval and review documentation. Source References: CLIA · COLA · TJC Review Status Item 09 Current manufacturer Instructions for Use are readily accessible to personnel. Source References: CLIA · COLA · TJC Review Status Item 10 Testing is performed according to required manufacturer IFU instructions; unauthorized modifications are not being made. Source References: CLIA · COLA · TJC Review Status Item 11 Patient identification process uses required identifiers before specimen collection/testing. Source References: CLIA · COLA · TJC Review Status Item 12 Specimens are labeled accurately and traceable to the correct patient. Source References: CLIA · COLA · TJC Review Status Item 13 Written specimen collection, handling, transport, storage, stability, and rejection criteria are available and followed. Source References: CLIA · COLA · TJC Review Status Item 14 Required Quality Control is performed at the correct frequency and documented. Source References: CLIA · COLA · TJC Review Status Item 15 QC results are reviewed for acceptability before affected patient results are released. Source References: CLIA · COLA · TJC Review Status Item 16 Failed/out-of-range QC is investigated and corrective action is documented before patient testing resumes. Source References: CLIA · COLA · TJC Review Status Item 17 Calibration/calibration verification and required function checks are current for applicable analyzers. Source References: CLIA · COLA · TJC Review Status Item 18 Required analyzer maintenance and preventive maintenance are current and documented. Source References: CLIA · COLA · TJC Review Status Item 19 Reagents, controls, cartridges, and kits are within expiration date and stored according to requirements. Source References: CLIA · COLA · TJC Review Status Item 20 Refrigerator/freezer/room-temperature logs are current; excursions have documented investigation and disposition. Source References: CLIA · COLA · TJC Review Status Item 21 Lot numbers and expiration dates can be correlated with QC and/or patient testing when required. Source References: CLIA · COLA · TJC Review Status Item 22 Laboratory can trace patient testing to operator, instrument/method, date/time, result, and associated QC. Source References: CLIA · COLA · TJC Review Status Item 23 Proficiency Testing enrollment covers applicable regulated nonwaived analytes. Source References: CLIA · COLA · TJC Review Status Item 24 PT samples are tested appropriately, with attestations and required records maintained. Source References: CLIA · COLA · TJC Review Status Item 25 Unacceptable/unsatisfactory PT performance receives documented investigation, corrective action, and follow-up. Source References: CLIA · COLA · TJC Review Status Item 26 IQCP is complete and current for any eligible test system operating under an Individualized Quality Control Plan. Source References: CLIA · COLA · TJC Review Status Item 27 Reference/contract laboratories have current appropriate CLIA certification and applicable credentials. Source References: CLIA · COLA · HHSC · TJC Review Status Item 28 Laboratory downtime plan addresses analyzer failure, LIS/EMR failure, power failure, reagent shortage, and backup testing. Source References: CLIA · COLA · HHSC · TJC Review Status ### Personnel, Patient Safety, Quality & QAPI Item 29 Qualifications of all laboratory/testing personnel are documented and appropriate for tests performed. Source References: CLIA · COLA · TJC Review Status Item 30 Testing personnel receive documented training before independent testing. Source References: CLIA · COLA · TJC Review Status Item 31 Initial and ongoing competency assessments are current and documented as applicable to test complexity. Source References: CLIA · COLA · TJC Review Status Item 32 Competency assessments use the required number and types of assessment methods for applicable testing. Source References: CLIA · COLA · TJC Review Status Item 33 Staff performing instrument-based waived testing have documented training and required ongoing competency. Source References: COLA · TJC Review Status Item 34 Only authorized and competent personnel have access to perform/report laboratory tests. Source References: CLIA · COLA · TJC Review Status Item 35 Critical-value list is formally established/approved by medical staff or appropriate leadership. Source References: CLIA · COLA · HHSC · TJC Review Status Item 36 Critical laboratory values are communicated promptly to the physician/LIP and communication is documented. Source References: CLIA · COLA · HHSC · TJC Review Status Item 37 Process addresses critical results discovered after patient discharge. Source References: COLA · HHSC · TJC Review Status Item 38 Laboratory reports contain required patient/result information and are integrated into the medical record. Source References: CLIA · COLA · HHSC · TJC Review Status Item 39 Corrected/amended result process preserves the original result and documents reason, date/time, and notification when applicable. Source References: CLIA · COLA · TJC Review Status Item 40 Appropriate reference intervals/ranges are available to clinicians interpreting results. Source References: CLIA · COLA · TJC Review Status Item 41 Laboratory turnaround time is monitored for key emergency tests. Source References: COLA · TJC Review Status Item 42 Delays in critical/emergency testing are analyzed and corrected when performance falls outside facility goals. Source References: CLIA · COLA · TJC Review Status Item 43 Mislabeled, unlabeled, rejected, contaminated, hemolyzed, and recollected specimens are tracked. Source References: CLIA · COLA · TJC Review Status Item 44 Laboratory-related incidents, errors, near misses, and complaints are reported and investigated. Source References: CLIA · COLA · TJC Review Status Item 45 Laboratory Quality Assessment addresses preanalytic, analytic, and postanalytic processes. Source References: CLIA · COLA · TJC Review Status Item 46 Laboratory QA/QAPI activities identify measurable problems, interventions, responsible owners, and outcomes. Source References: CLIA · COLA · HHSC · TJC Review Status Item 47 Previous corrective actions are followed through to determine whether they were effective and sustained. Source References: CLIA · COLA · HHSC · TJC Review Status Item 48 Monthly laboratory quality indicators are reported to facility Quality/QAPI leadership as applicable. Source References: COLA · HHSC · TJC Review Status Item 49 Chemical safety policies, SDS access, PPE, exposure response, and hazardous-material practices are current. Source References: CLIA · COLA · HHSC · TJC Review Status Item 50 Sharps/bloodborne-pathogen practices and biohazard-waste handling are compliant with facility policy and applicable requirements. Source References: COLA · HHSC · TJC Review Status Item 51 Emergency eyewash/safety equipment is accessible and checked according to policy when required by laboratory hazards. Source References: COLA · HHSC · TJC Review Status Item 52 Blood/blood components, if maintained, meet required storage, temperature, emergency power, transfusion, and documentation requirements. Source References: CLIA · COLA · HHSC · TJC Review Status Item 53 New instruments/test methods receive required verification/validation before reporting patient results. Source References: CLIA · COLA · TJC Review Status Item 54 New reagent/kit lots receive required verification before routine use where applicable. Source References: CLIA · COLA · TJC Review Status Item 55 Records are retained for the required period and can be produced promptly during a survey. Source References: CLIA · COLA · HHSC · TJC Review Status Item 56 Previous CLIA/COLA/HHSC/Joint Commission laboratory citations have documented correction and evidence preventing recurrence. Source References: CLIA · COLA · HHSC · TJC Review Status Monthly Laboratory Quality Dashboard For each indicator, the source worksheet provides fields for Current, Goal, Prior, and Trend / Action. Goals below are copied from that worksheet; they are not universal regulatory thresholds. Use the fillable PDF checklist to record your facility’s measurements. | Indicator | Source Worksheet Goal | | --- | --- | | Specimen identification errors | 0 | | Specimen rejection/recollection rate | Facility Goal | | QC failures | Facility Goal | | Unresolved QC failures | 0 | | PT score / deficiencies | 100% / 0 | | Critical-value notification compliance | 100% | | Critical-value notification turnaround | Facility Goal | | Troponin turnaround time | Facility Goal | | CBC turnaround time | Facility Goal | | Chemistry turnaround time | Facility Goal | | Analyzer downtime | Facility Goal | | Temperature excursions | 0 unresolved | | Staff competency compliance | 100% | | Expired reagent/supply findings | 0 | | Laboratory incidents / near misses | Trend review | Corrective Action and Leadership Review ### Corrective Action & Effectiveness Tracker The supplied worksheet tracks each Finding, Immediate action, Root Cause, Corrective Action, Owner, Due date, Effectiveness, and Status. **Closing Standard:** Finding → Immediate Correction → Root Cause → Corrective Action → Measurement → Effectiveness Verified → Closed. ### Monthly Leadership Review - **High:** What went well? - **Low:** What did not meet expectations? - **Blocker:** What is preventing compliance or improvement? - **Decision Needed:** What requires Medical Director or Administrator action? ### Survey-Readiness Sign-Off The fillable PDF checklist includes name, signature, and date fields for the Laboratory Lead / Manager, Laboratory Director, Facility Administrator, and Medical Director. Signing the source worksheet is an internal review step, not a certification by WCGTX. “Reviewed” means a status has been selected, including Not Applicable. No overall “Survey Ready” or compliance score is generated. Keep a Working Copy ## Download the Fillable PDF Checklist Read the guide on this page. Download the checklist to record and save your facility’s review. Fillable PDF ### Laboratory Survey Readiness Checklist The complete 56-item checklist, with editable review statuses, a monthly quality dashboard, corrective actions, and leadership review fields. [Download Fillable PDF Checklist](https://wcgtx.com/resources/laboratory-survey-readiness-checklist-fillable.pdf) Open in a PDF reader that supports fillable forms and save your completed copy securely. Website selections are not transferred to the PDF. Do not enter patient information. Keep the Source in View ## References & Regulatory Resources These links and reference notes come from the supplied guide. Requirements may depend on testing complexity, the facility’s certificate, accreditation, manufacturer instructions, and current regulations. 1. [Clinical Laboratory Improvement Amendments (CLIA) (opens in a new tab)](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments) CMS overview of laboratory certification, testing complexity, and laboratory quality requirements. 2. [CLIA Regulations & Compliance (opens in a new tab)](https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/clia-regulations-compliance) CMS guidance regarding quality control, proficiency testing, IQCP and regulatory compliance. 3. [CLIA Resources & Support (opens in a new tab)](https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/resources-support) Includes Laboratory Director responsibilities, personnel competency, IQCP, calibration and performance-verification materials. 4. [CLIA Proficiency Testing Requirements (opens in a new tab)](https://www.cms.gov/medicare/health-safety-standards/clinical-laboratory-improvement-amendments-clia/clia-regulations-compliance/proficiency-testing-program-requirements-general-cytology) 5. [COLA Laboratory Accreditation (opens in a new tab)](https://cola.org/accreditation/) COLA is a CMS-approved laboratory accreditation organization that assists laboratories in meeting CLIA and applicable state requirements. 6. [COLA Primers and Educational Resources (opens in a new tab)](https://cola.org/training-development/cola-primers-notes/) Includes resources addressing: Quality Assessment Proficiency Testing Personnel Training and Competency Procedure Manuals COLA emphasizes continuous evaluation of preanalytic, analytic, and postanalytic laboratory processes. 7. [Joint Commission — Waived Testing (opens in a new tab)](https://www.jointcommission.org/en-us/standards/national-performance-goals/waived-testing) Joint Commission quality expectations address: Policies and procedures Manufacturer instructions Staff training Competency Quality control Result reliability 8. [Waived Testing — Modified Methods (opens in a new tab)](https://www.jointcommission.org/en-us/knowledge-library/support-center/standards-interpretation/standards-faqs/000001467) 9. [Waived Testing — Testing Logs and Traceability (opens in a new tab)](https://www.jointcommission.org/en-us/knowledge-library/support-center/standards-interpretation/standards-faqs/000001468) 10. [Proficiency Testing — Waived Testing (opens in a new tab)](https://www.jointcommission.org/en-us/knowledge-library/support-center/standards-interpretation/standards-faqs/000001393) Source Reference Notes ### Texas Health and Human Services Commission 26 TAC Chapter 509 — Freestanding Emergency Medical Care Facilities Key laboratory section: ### 26 TAC §509.49 — Laboratory and Pathology Services This section establishes Texas requirements involving: - On-premises emergency laboratory capability - CLIA compliance - Contract laboratory certification - Cardiac markers - Hematology - Chemistry - Pregnancy testing - Critical-value communication - Blood and blood-component requirements - Chemical safety Texas Freestanding Emergency Medical Care Facilities are licensed by HHSC under Texas Health and Safety Code Chapter 254 and applicable provisions of 26 TAC Chapter 509. Important Disclaimer This document is intended as an educational and quality-improvement resource for Freestanding Emergency Rooms and is not an official interpretation of CMS, CLIA, COLA, Texas HHSC, or Joint Commission requirements. Regulations, accreditation standards, manufacturer requirements, testing classifications, and interpretations may change. Each facility should verify requirements against: Its current CLIA certificate Testing complexity Current manufacturer Instructions for Use Current 42 CFR Part 493 requirements Current COLA accreditation criteria, if applicable Current Joint Commission standards, if applicable Current Texas Health and Human Services requirements 26 TAC Chapter 509 The facility's actual laboratory test menu and scope of services **Sources:** Laboratory Quality & Compliance Guide for Texas Freestanding Emergency Rooms and Texas FSER Laboratory Survey Readiness Checklist. Source-stated review: September 2026. Presented as an interactive web reference. These educational resources are not official interpretations of CMS, CLIA, COLA, Texas HHSC, or Joint Commission requirements. 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