Pro-QCP SAMPLE REPORT

Transcription

1 Pro-QCP SAMPLE REPORT 2016 CarePoint Solutions, Inc. All rights reserved. General Hospital 123 N Main St New York, NY 12345

2 What is an IQCP? The Individualized Quality Control Plan (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy currently under development as an alternate QC option allowed by 42CFR The guidance and concepts for IQCP are a formal representation and compilation of many things laboratories already do to ensure quality test results. IQCP permits the laboratory to customize its QC plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing. Individualized Quality Control Plan (IQCP). (2015, November 12). Retrieved November 30, 2015, from and- Guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html About Pro-QCP by CarePoint Solutions, Inc. Pro-QCP is an online, web-based software program that facilitates the creation of Individualized Quality Control Plans (IQCP s) consistent with EP-23 guidelines. This specialized program was designed to simplify and streamline the process of developing comprehensive IQCP s with the goal of improving patient outcomes. Pro-QCP is available by annual subscription with modules specific to the risks of each test device or method. For more information on Pro-QCP visit:

3 Program Information Program Information CLIA Number Accrediting Agency Test System Consumable Analytes 12D CAP (College of American Pathologists) i-stat CG4+ ph, po2, pco2, Lac Testing Locations Locations of testing which are considered in this IQCP ED ICU NICU

4 Risk Assessment Risk Matrix Severity of Harm Probability of Harm Negligible Minor Serious Critical Catastrophic Frequent Unacceptable Unacceptable Unacceptable Unacceptable Unacceptable Probable Acceptable Unacceptable Unacceptable Unacceptable Unacceptable Occasional Acceptable Acceptable Unacceptable Unacceptable Unacceptable Remote Acceptable Acceptable Acceptable Unacceptable Unacceptable Improbable Acceptable Acceptable Acceptable Acceptable Acceptable Figure 1 Rating scale developed by the Department of Clinical Effectiveness and Quality Improvement, University of Pennsylvania Health System. "Using FMEA to Improve Patient Safety: Part II". (2013, December, 13). Retrieved November , from Tennessee Center for Patient Safety Website Severity Ratings Severity Scoring - How bad will it be if this risk occurs? 5 Catastrophic Death or serious physical or psychological injury or the risk thereof. Serious injury specifically includes loss of limb or function. Must meet two of the three criteria: 1. Results in unanticipated death or major permanent loss of function 2. Associated with a significant deviation from the usual process 3. It has the potential for undermining the public confidence 4 Critical Injury or permanent loss of bodily function (sensory, motor, physiologic, or intellectual), disfigurement, surgical intervention required, increased LOS, increased level of care. 3 Serious An event, occurrence, or situation involving the clinical care of a patient in a medical facility which could have injured the patient but did not cause an unanticipated injury or require the delivery of additional healthcare services 2 Minor Failure is not noticeable to the patient and would not affect delivery of care. Failure can be overcome with modifications to the process; failure may cause minor injury. 1 Negligible (near miss) A process variation that does not affect the outcome but for which a recurrence carries a significant chance of a serious outcome. No injury, no increased LOS or level of care.

5 Probability Ratings Probability Scoring - How often might this hazard occur? Risk Assessment 5 Frequent Once per week 4 Probable Once per month 3 Occasional Once per year 2 Remote Once every three years 1 Improbable Once in the lifetime of the test system Scoring - Will someone notice before the hazard affects the patient? Rating Absolute uncertainty Remote Low Moderately high Almost certain Detection Probability Description <10% Potential failure mode and susbsequent cannot be detected in time for adequate intervention <25% Remote chance the potential failure mode and subsequent will be detected in time for adequate intervention <50% Low chance the potential failure mode and subsequent will be detected in time for adequate intervention <80% Moderately high chance the potential failure mode and susbsequent will be detected in time for adequate intervention <99% The potential failure mode and susbsequent will be detected in time for adequate intervention

6 Risk Assessment Hazard Identification Hazard Identification is a term which encompasses activities involved in identifying hazards and evaluating risk in healthcare, throughout the continuum of care, to make certain that risks to the patient are consistently controlled within the organization s risk tolerance. These activities typically address three main risk questions to a level of detail commensurate with analysis objectives, available information, and resources at hand. The three main risk questions are: Hazard What can go wrong? Severity How bad could it be? Probability How often might it happen? Risk Categories Specimen Encompasses the order, patient id, collection, and transfer of the patient Test System Encompasses the instrument, software, data entry, accessories, and all other components not associated with the or reagents Reagent Includes the test consumable (strip, cartridge, cuvette, etc), quality control materials (liquid, optical and electronic), calibration verification or linearity materials or any other components directly tested Environment Includes the patient care and/or testing areas and all aspects of human factors which might adversely affect the test result Testing Personnel Includes personnel who perform the test, care for the patient, manage the system, or troubleshoot problems

7 Fishbone Diagram (Ishikawa) Risk Assessment The fishbone diagram identifies many possible hazards which cause an incorrect test result. It can be used to structure a brainstorming session. It immediately sorts ideas into useful categories. The problem or is displayed at the head or mouth of the fish. Possible contributing causes are listed on the smaller bones under various cause categories. A fishbone diagram can be helpful in identifying possible causes for a problem that might not otherwise be considered by directing the team to look at the categories and think of alternative causes.

8 Risk Assessment by CarePoint Solutions -QCP

9 Risk Assessment Specimen Risks Low Risk The following risks were scored as ACCEPTABLE and may or may not have a Quality Control Plan (QCP) in. S-001 Test is performed without an order Minor Improbable Acceptable Low Yes No Acceptable S-002 Test is ordered outside the Indications for Use Minor Improbable Acceptable Yes No Acceptable S-003 Test is ordered outside the Limitations of Use Minor Improbable Acceptable Yes No Acceptable S-004 Patient is injured during collection Minor Remote Acceptable Yes No Acceptable S-005 Sample is collected from the wrong patient Minor Improbable Acceptable Yes No Acceptable S-006 Wrong patient ID is entered into the handheld Serious Improbable Acceptable Yes No Acceptable S-007 Sample is mislabeled Serious Improbable Acceptable Yes No Acceptable S-008 Collection supplies are out of tolerance, misused, or expired S-009 Sample is drawn in the wrong container type (tube, syringe, capillary tube) S-010 Sample is contaminated with alcohol or cleansing agent from prep S-011 Sample quantity is insufficient due to poor circulation or access S-012 Sample quantity is insufficient due to poor technique S-013 Sample is collected by improper access method (venous, arterial, capillary) Minor Improbable Acceptable Yes No Acceptable Minor Improbable Acceptable Yes No Acceptable Minor Improbable Acceptable Yes No Acceptable Minor Improbable Acceptable Yes No Acceptable Minor Improbable Acceptable Yes No Acceptable Minor Remote Acceptable Yes No Acceptable S-014 Syringe is not evacuated of ambient air Negligible Improbable Acceptable Yes No Acceptable S-015 Wrong type of container anticoagulant is selected Minor Improbable Acceptable Yes No Acceptable S-016 Sample is diluted with IV anticoagulant or fluid Minor Remote Acceptable Yes No Acceptable

10 Risk Assessment S-017 Sample is contaminated with bubbles Negligible Remote Acceptable Yes No Acceptable S-018 Sample is clotted Minor Occasional Acceptable Yes No Acceptable S-019 Sample is not properly mixed before infusing into the cartridge S-020 Sample is transported or left sitting for an extended period of time Minor Improbable Acceptable Yes No Acceptable Negligible Improbable Acceptable Yes No Acceptable S-021 Sample is improperly iced Minor Improbable Acceptable Yes No Acceptable S-022 Patient test is not repeated when result does not match patient condition and therapy S-023 Patient is suffering from anemia or polycythemia beyond the capabilities of the test system S-024 Patient is receiving interfering drugs beyond the parameters listed in product labeling Minor Remote Acceptable Yes No Acceptable Minor Remote Acceptable Yes No Acceptable Minor Remote Acceptable Yes No Acceptable

11 Risk Assessment Test System Risks Low Risk The following risks were scored as ACCEPTABLE and may or may not have a Quality Control Plan (QCP) in. T-001 Patient is injured during the test process Minor Improbable Acceptable No No Acceptable T-002 Patient is given a nosocomial infection Serious Remote Acceptable No No Acceptable T-003 Patient is dissatisfied with test system Negligible Improbable Acceptable No No Acceptable T-004 Product recall affects test system or cartridge use Minor Improbable Acceptable No No Acceptable T-005 Handheld is not properly validated T-006 Maintenance is performed improperly Negligible Remote Acceptable No No Acceptable T-007 Handheld is not regularly cleaned Negligible Remote Acceptable No No Acceptable T-008 Thermal Probe malfunctions T-009 Handheld malfunctions or is not calibrated properly T-010 Self-test or calibration does not run or fails Negligible Remote Acceptable No No Acceptable T-011 Internal simulator is not scheduled to run frequently T-012 Software is not regularly/properly updated on the handheld T-013 Customizations are not properly programmed or transferred to the handheld T-014 Handheld is not charged or power is not available for patient testing T-015 Patient test is performed on test system which is out of control Negligible Improbable Acceptable No No Acceptable Minor Occasional Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable

12 Risk Assessment T-016 Handheld is used for patient testing after a drop or impact T-017 Sample is not run in the proper analysis mode on the handheld T-018 Sample type (venous, arterial, capillary, etc) is improper for the test or improperly identified in the handheld T-019 Incorrect or un-ordered analytes are selected on the handheld T-020 Incorrect temperature is entered into the handheld T-021 Incorrect patient hemodynamic variables are entered into the handheld T-022 Handheld is not used on a stationary, horizontal surface Negligible Remote Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable T-023 Handheld is disturbed during a patient test Negligible Improbable Acceptable No No Acceptable T-024 Patient result is clinically different on different handheld T-025 Use errors during pre-analytical or postanalytical test phases are not identified T-026 Cartridge is removed from the cartridge port before the result is reviewed T-027 Error messages which indicate bad patient result is misinterpreted T-028 Patient results are not recorded before handheld memory is exceeded T-029 Patient result is reported outside of the handheld Analytical Measurement Range (AMR) T-030 Results interface fails to transmit or corrupts results Minor Improbable Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable

13 T-031 Patient result is misinterpreted due to incorrect or incomplete demographic or clinical data T-032 Patient result is misinterpreted due to test system idiosyncrasies Risk Assessment Minor Improbable Acceptable No No Acceptable T-033 Clinician fails to act on critical results Serious Remote Acceptable Remote Yes No Acceptable

14 Risk Assessment Reagent Risks Low Risk The following risks were scored as ACCEPTABLE and may or may not have a Quality Control Plan (QCP) in. R-001 Substantial change in reagent properties or system components cause clinical errors R-002 Cartridge or reagent is not available when needed Minor Occasional Acceptable No No Acceptable R-003 Cartridge is stored improperly Negligible Remote Acceptable No No Acceptable R-004 Cartridge is used beyond manufacturer's expiration date R-005 Cartridge is used beyond the room temperature expiration date Negligible Remote Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable R-006 Cartridge is mishandled Minor Improbable Acceptable No No Acceptable R-007 Sample is forced into the cartridge Negligible Remote Acceptable No No Acceptable R-008 Cartridge is underfilled or overfilled Negligible Improbable Acceptable No No Acceptable R-009 Cartridge is inserted into the cartridge port with blood on the outside Negligible Remote Acceptable No No Acceptable R-010 Cartridge is reused R-011 Liquid control is used as a calibrator R-012 Liquid control is not properly refrigerated R-013 Liquid control is used beyond the manufacturer's expiration date R-014 Liquid control is used beyond the room temperature expiration date R-015 Liquid control is not properly brought to room temperature before use Negligible Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable

15 Risk Assessment R-016 Liquid control is not properly mixed Minor Improbable Acceptable No No Acceptable R-017 Liquid control results fall outside of expected values range for each lot R-018 Liquid control limits do not test an instrument malfunction which affects patient results R-019 Calibration verification controls are not properly refrigerated R-020 Calibration verification controls are used beyond the manufacturer's expiration date R-021 Calibration verification controls are used beyond the room temperature expiration date R-022 Calibration verification controls are not properly brought to room temperature before use R-023 Calibration verification controls are not properly mixed R-024 Calibration verification controls results fall outside of expected values range for each lot R-025 Calibration verification controls do not verify the entire patient result range R-026 Internal simulator Is not performed on every day of patient testing R-027 External simulator is not performed on every day of patient testing R-028 External simulator results fall outside of expected values range R-029 Reagent or cartridge was exposed to improper environmental conditions during shipment Negligible Improbable Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable

16 Risk Assessment Environment Risks Low Risk The following risks were scored as ACCEPTABLE and may or may not have a Quality Control Plan (QCP) in. E-001 Handheld is not used within expected temperature and humidity range E-002 Noise affects test personnel concentration during testing E-003 Poor lighting or glare affects data entry or result interpretation E-004 Workplace clutter affects test personnel concentration or test process E-005 Inadequate workspace affects test personnel concentration or test process E-006 Personal devices affect test personnel concentration during testing E-007 Conversation affects test personnel concentration during testing E-008 Short staffing affects test personnel concentration during testing E-009 Interruptions affects test personnel concentration during testing E-010 Fibers, fluids, dust, or debris affect the test system E-011 Test system is subjected to unexpected barometric pressure Minor Improbable Acceptable No No Acceptable Negligible Remote Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable Serious Improbable Acceptable No No Acceptable Minor Improbable Acceptable No No Acceptable Negligible Improbable Acceptable No No Acceptable

17 Risk Assessment Testing Personnel Risks Low Risk The following risks were scored as ACCEPTABLE and may or may not have a Quality Control Plan (QCP) in. P-001 Unqualified or expired test personnel perform patient testing P-002 Test personnel are not equipped to perform necessary troubleshooting Minor Improbable Acceptable No No Acceptable

18 Quality Control Plan Quality Control Plan The following risks are mitigated through positive action by policy, training, quality control, surveillance, calibration, and other activities which increase detection of hazards and improve prevention. This section explains the actions taken to mitigate or detect each risk. Specimen Risks S-001 Test is performed without an order Minor Improbable Acceptable Low Yes No Acceptable Chart audit Consistent implementation of the error detection system(s) defined in the procedure Track percent of ordered tests with patient identification errors Track percent of results with identification errors Track percent of patient results which are corrected Written or electronic orders are required Verbal test are followed up with a written or electronic order Every patient test Within 30 days Verbal orders are read back Immediately Entire order is read back Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant This risk is covered by our Written Policy This risk is covered during our Quiz

19 Quality Control Plan S-002 Test is ordered outside the Indications for Use Minor Improbable Acceptable Yes No Acceptable Retesting by a different method or device Unusual patient results Expected clinical results Exceptional bodily fluids d for a clinically unique situation are properly reported Each patient result outside of expected specimen types e.g. The reference range and other method performance specifications have not been established for this body fluid. The test result must be integrated into the clinical context for interpretation. S-003 Test is ordered outside the Limitations of Use Minor Improbable Acceptable Yes No Acceptable Retesting by a different method or device Unusual patient results Expected clinical results Exceptional bodily fluids d for a clinically unique situation are properly reported Each patient result outside of expected specimen types e.g. The reference range and other method performance specifications have not been established for this body fluid. The test result must be integrated into the clinical context for interpretation.

20 Quality Control Plan S-004 Patient is injured during collection Minor Remote Acceptable Yes No Acceptable Allen's Test is performed Per radial artery puncture Collateral circulation is verified and documented Device-related adverse events are reported By January 1st Per FDA mandatory reporting guidelines on Form 3419 or Form 3500 Care is provided to patients who experience adverse reactions from blood-letting Immediately Fainting, seizures, or injuries S-005 Sample is collected from the wrong patient Minor Improbable Acceptable Yes No Acceptable Track percent of patient wristbands with errors Track percent of ordered tests with patient identification errors Track percent of results with identification errors Track percent of patient results which are corrected

21 Quality Control Plan Two patient identifiers are checked Before collecting patient specimen Name and unique hospital number; outpatient name and date of birth S-006 Wrong patient ID is entered into the handheld Serious Improbable Acceptable Yes No Acceptable Track percent of patient wristbands with errors Track percent of ordered tests with patient identification errors Track percent of results with identification errors Track percent of patient results which are corrected Identifying labels are attached to the container At time of collection Accuracy of manual entry is monitored Manual result, demographics, and other data entry Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant S-007 Sample is mislabeled Serious Improbable Acceptable Yes No Acceptable

22 Quality Control Plan Track percent of ordered tests with patient identification errors Track percent of results with identification errors Track percent of accepted for testing Two patient identifiers are checked Identifying labels are attached to the container Before collecting patient specimen At time of collection Name and unique hospital number; outpatient name and date of birth Patient are positively identified Always Barcoded or manually labeled containers which track patient identification, collection date/time, and specimen type S-008 Collection supplies are out of tolerance, misused, or expired Minor Improbable Acceptable Yes No Acceptable Collection supplies are stored and used properly All supplies Per manufacturer's instructions and within expiry Specimen integrity is evaluated by Test personnel Every patient test

23 Quality Control Plan S-009 Sample is drawn in the wrong container type (tube, syringe, capillary tube) Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Specimen containers are evaluated to reduce or eliminate analytic interference Specimen integrity is evaluated by Test personnel Initial system implementation Every patient test Direct testing, clinical literature, or manufacturer information S-010 Sample is contaminated with alcohol or cleansing agent from prep Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test

24 Quality Control Plan S-011 Sample quantity is insufficient due to poor circulation or access Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant S-012 Sample quantity is insufficient due to poor technique Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing

25 Specimen integrity is evaluated by Test personnel Every patient test Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant Quality Control Plan S-013 Sample is collected by improper access method (venous, arterial, capillary) Minor Remote Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test S-014 Syringe is not evacuated of ambient air Negligible Improbable Acceptable Yes No Acceptable

26 Quality Control Plan System to prevent ambient air contamination Per blood gas Follow established procedures Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test S-015 Wrong type of container anticoagulant is selected Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Specimen containers are evaluated to reduce or eliminate analytic interference Specimen integrity is evaluated by Test personnel Initial system implementation Every patient test Direct testing, clinical literature, or manufacturer information

27 Quality Control Plan S-016 Sample is diluted with IV anticoagulant or fluid Minor Remote Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test S-017 Sample is contaminated with bubbles Negligible Remote Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant

28 Quality Control Plan S-018 Sample is clotted Minor Occasional Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant S-019 Sample is not properly mixed before infusing into the cartridge Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test

29 Quality Control Plan S-020 Sample is transported or left sitting for an extended period of time Negligible Improbable Acceptable Yes No Acceptable Track percent of accepted for testing Track collection-to-reporting median turnaround time Track turnaround time outliers Specimen integrity is evaluated by Test personnel Every patient test S-021 Sample is improperly iced Minor Improbable Acceptable Yes No Acceptable Track percent of accepted for testing

30 Specimen integrity is evaluated by Test personnel Every patient test Quality Control Plan S-022 Patient test is not repeated when result does not match patient condition and therapy Minor Remote Acceptable Yes No Acceptable Retesting by a different method or device Unusual patient results Expected clinical results Hook or sampling/dilution errors are eliminated Per patient results Outside Analytical Measurement Range (AMR) Track percent of patient results which are corrected S-023 Patient is suffering from anemia or polycythemia beyond the capabilities of the test system Minor Remote Acceptable Yes No Acceptable Retesting by a different method or device Unusual patient results Expected clinical results

31 Track percent of accepted for testing Quality Control Plan Specimen integrity is evaluated by Test personnel Every patient test Handheld configuration option or forcing function is in place At all times Verified by the Technical Consultant S-024 Patient is receiving interfering drugs beyond the parameters listed in product labeling Minor Remote Acceptable Yes No Acceptable Retesting by a different method or device Unusual patient results Expected clinical results Track percent of accepted for testing Specimen integrity is evaluated by Test personnel Every patient test

32 Test System Risks Quality Control Plan T-033 Clinician fails to act on critical results Serious Remote Acceptable Remote Yes No Acceptable Track percent of critical results reported to caregivers Track percent of critical results for which the primary caregiver cannot be contacted in a reasonable period of time Critical results are reported to the caregiver Immediately Outside critical or alert limits Critical results are read back Immediately When communicated verbally This risk is covered by our Written Policy This risk is covered during our Quiz This risk is covered by our Monitoring of Results

33 Quality Assessment Quality Assessment The Code of Federal Regulations (42 CFR 493) states laboratories must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process. The QA program must: Assess the iveness of the lab s policies and procedures. Identify and correct problems. Assure the accurate, reliable, and prompt reporting of test results. Assure the adequacy and competency of the staff. CLIA Standards for Quality Assurance The regulations specify ten different standards to be included in a laboratory s quality assurance program. 1 The first standard emphasizes having a system in place for monitoring and evaluating the procedures for Patient Test Management, including: Patient preparation Specimen collection Labeling Preservation and transportation Test requisition completeness Relevance and necessity for testing Use of appropriate criteria for specimen rejection Test report completeness Relevance and accuracy Timely reporting of results Accuracy and reliability of test reporting systems Storage and retrieval of result

34 2 The second standard is quality control. The lab is to have systems in place to evaluate the iveness of corrective actions in regard to the QC program, including: Quality Assessment Problems identified during the evaluation of calibration and QC Problems identified during the evaluation of patient test results (to verify the reference range of a test method) Errors detected in results The third standard is proficiency testing. The lab is to assess the iveness of corrective action taken to address any unacceptable, unsatisfactory, or unsuccessful PT results. The fourth standard is a comparison of test results. If a laboratory has more than one method of performing the same test, the lab must (twice a year) evaluate and define the relationship between the two methods (i.e., run the same specimen by each method and check for comparable results). If the lab performs testing on non-regulated analytes, the lab must have a method for verifying the accuracy of its test results. Proficiency testing or split sampling may be used. The fifth standard involves the relationship of patient information to patient test results. This is an internal quality assurance function. The lab must have a system in place to identify and evaluate patient test results when they appear inconsistent such criteria as the patient's age, sex, diagnosis, and the relationship with other test results. The sixth standard involves personnel assessment. The laboratory must have a system in place to evaluate the iveness of its policies and procedures for assuring employee competence. If the lab has an outside consultant, the lab should have a method for evaluating his/her iveness, also. The seventh standard involves communications. The lab must have a mechanism for documenting problems arising as a result of a breakdown in communication. Corrective actions must be taken to both resolve the problem and minimize future communication breakdowns.

35 8 The eighth standard addresses complaint investigations. The lab must have a system to assure that all complaints and problems are documented. Investigations must be made and corrective action taken. Quality Assessment 9 10 The ninth standard is quality assurance review with staff. In addition to documenting and assessing problems identified in QA reviews, the lab personnel must discuss the issues and take corrective action to prevent recurrences. The tenth standard addresses QA records. Documentation of all QA activities must be made available to the Department of Health and Human Services. Certification All 10 Quality Assurance measures are employed by this laboratory

36 Quality Management Software for the clinical laboratory Designed to simplify and streamline the process of developing comprehensive IQCPs, Pro-QCP assists in meeting your goal of improving patient outcomes. Pro-QCP is an online, web-based software application which facilitates the creation of Individualized Quality Control Plans (IQCPs) consistent with CLSI EP-23 guidelines. Pro-QCP is available by annual subscription with specialized modules specific to the risks of each test device or method. Inspection-ready IQCP s Easy-to-use Saves time Fully customizable Comprehensive: Pre-analytical Analytical Post-analytical I love Pro-QCP; it s wonderful! CarePoint has done all the work in gathering the manufacturer s information. I wouldn t do my IQCP s any other way! toll free PO Box 900 Westford, MA 01886