2014 PT PROGRAM ENROLLEE REFERENCE MANUAL
CALIFORNIA THORACIC SOCIETY (CTS) 2014 PT PROGRAM ENROLLEE REFERENCE MANUAL Thank you for selecting the California Thoracic Society (CTS) ABG Proficiency Testing (PT) Program to help you monitor your laboratory's performance. CTS urges you to retain this document in a binder, and include your laboratory's PT Cycle Notes that will be transmitted to you after each Cycle (see this year’s CTS PT Action Calendar). — The CTS PT Program Committee QUESTIONS? PT Enrollment or administration questions may be directed to: CALIFORNIA THORACIC SOCIETY 575 Market Street, Suite 2125 San Francisco, CA 94105 Phone: 415-536-0287 / Fax: 415-764-4933 / E-mail: [email protected] Office Hours: Mon–Fri: 9:00 am – 5:00 pm Pacific Time THE CTS MISSION is to improve respiratory health in California by promoting and advancing the science and practice of pulmonary, sleep, and critical care medicine. — Executive Committee, 12/08 MARK YOUR CALENDARS [Please post in your lab] 2014 PT CALENDAR CTS PROFICIENCY TESTING PROGRAM Blood Gas/Electrolyte, Blood Gas Hgb/Hct, and CO-Ox Programs FLOW Test Event One (Cycle 2014-1) Test Event Two (Cycle 2014-2) Test Event Three (Cycle 2014-3) SAMPLES SHIPPED to Laboratories (~2 day) Mon. 3/3/2014 Mon. 7/7/2014 Mon.11/3/2014 NO SAMPLES? Call 1-888-450-4633 by noon if your samples have NOT arrived or are unacceptable for testing at Laboratories (ETA +3) By Tues. 3/11/2014 By Tues. 7/15/2014 By Tues 11/11/2014 DATA INPUT FORMS Due: Your data input forms MUST be faxed/mailed to the CTS Data Center in Wisconsin by this date. Fax: 608-265-1111 Address: 465 Henry Mall, #402 Madison, WI 53706-1578 Fri. 3/21/2014 Fri. 7/25/2014 Fri. 11/21/2014 Cycle Reports Received by Labs Mon. 5/5/2014 Mon. 9/8/2014 Mon. 1/5/2015 HHS/ State/ COLA/ CAP Reporting Deadline Tues. 5/20/2014 Tues. 9/23/2014 Tues. 1/20/2015 QUESTIONS? California Thoracic Society (CTS) 575 Market Street, Suite 2125/ San Francisco, CA 94105 ph: 415-536-0287 / fax: 415-764-4933 / e-mail: [email protected] / www.calthoracic.org CTS PT PROGRAM ENROLLEE REFERENCE MANUAL CONTENTS Program Purpose and Federal Regulations.................................................................................................................. Page 2 Cycle Timetable / PT Action Calendar .......................................................................................................................... Page 3 Cycle Shipments............................................................................................................................................................. Page 3 Replacement Samples ................................................................................................................................................... Page 3 Federal, State Regulatory Agency & Accredited Organization PT Reporting Requirements .................................... Page 3 Data Input Form.............................................................................................................................................................. Page 4 Data Analysis .................................................................................................................................................................. Page 5 Scoring ............................................................................................................................................................................ Page 6 Enrollment Changes ....................................................................................................................................................... Page 8 PT Cancellation............................................................................................................................................................... Page 8 Reports............................................................................................................................................................................ Page 9 Validated Ampules.......................................................................................................................................................... Page 9 PT Reinstatement Program.......................................................................................................................................... Page 10 Troubleshooting and CTS PT Program Reference Technicians ............................................................................... Page 10 Reenrollment ................................................................................................................................................................ Page 11 Sample Forms: Blood Gases/Electrolytes+ and Hemoglobin/Hematocrit PT Sample Handling and Reporting Instructions ............ Page 15 Shipment Cover Page – Key ....................................................................................................................................... Page 18 Evaluation Report: Interpretation Guidelines .............................................................................................................. Page 19 Sample Evaluation Report ........................................................................................................................................... Page 20 Sample Cumulative Summary Report: Interpretation Guide ..................................................................................... Page 24 Sample Cycle Notes (specific for each Cycle, accompanies Reports) ..................................................................... Page 25 CTS PT Troubleshooting and Documentation Guide ................................................................................................. Page 27 CTS PT Validated Ampule Request Form .................................................................................................................. Page 28 California Thoracic Society © 2014 PROGRAM PURPOSE AND FEDERAL REGULATIONS The California Thoracic Society (CTS) has demonstrated considerable leadership in blood gas analysis and a unique concern for the quality care of pulmonary patients. CTS initiated the Proficiency Testing (PT) Program in 1979 to serve blood gas laboratories. The Program involves establishing standards of excellence and accumulating data of important scientific interest regarding blood gas (BG) measurement techniques and equipment specifications. Prior to 1992, the CTS offered the PT Program as a voluntary program. In 1993, HCFA—which became the Center for Medicare and Medicaid Services (CMS)—issued regulations that mandated proficiency testing for all clinical laboratories. Operating under the Clinical Laboratories Improvement Amendments (CLIA) of 1988, these regulations stipulate that successful participation in a CLIA approved proficiency testing program is a prerequisite for certification, Current CLIA regulations are online at: www.cdc.gov/clia/regs/toc.aspx. California and several other states also require PT to obtain a state lab license. For participants, the PT programs are identical. CTS sends ALL scores and Cycle reports to CMS and the California Department of Health Care Services, Lab Field Services Branch (DHCS LFS) for federal regulatory purposes. For laboratories outside California, CTS sends reports to CMS, state regulatory agencies, Commission on Office Laboratory Accreditation (COLA), College of American Pathologists (CAP) or AOA (only if requested by lab on the PT Enrollment form). Laboratories DO NOT have the option of denying sending scores to CMS as part of fulfilling its regulatory requirements. Duplicate transmissions to accreditation organization (COLA, CAP) must be made if requested by the Accrediting Organization or laboratory. The CTS PT program is a CMS-approved program for pH, pCO2, pO2, Na+, K+, Cl-, glucose, and tHb. The CLIA-CMS regulations mandate specific methods for assessing laboratory PT performance, and the CTS PT Program scoring system accommodates these regulations. CTS is a CAP accepted PT-Provider for the following analytes: pH, pCO2, pO2, Na+, K+, Cl-, iCa++, lactic acid, whole blood glucose, carboxyhemoglobin, methemoglobin, oxyhemoglobin, and tHb from CO CTS PROFICIENCY TESTING PRODUCTS Blood Gas / Electrolytes+ Analytes and PT Products: The CTS Blood Gas/Electrolyte+ PT Program assesses measurement accuracy of pH, pCO2, pO2, Na+, K+, Cl-, and glucose as required by CMS. The CTS program also assesses iCa++ and lactic acid (not required by CMS); the iCa++ and lactic acid scores are released to designated state agencies. Consistent participation in this program is useful for monitoring the adequacy and effectiveness of your laboratory, preventive maintenance protocols, and overall instrument performance as compared with your peers. The CTS Blood Gas/Electrolyte+ PT Program uses a clear, aqueous, buffered solution testing material, without colored dyes (five 3 mL samples per shipment) to accommodate proficiency testing for instruments that perform Electrolyte+ analysis in conjunction with blood gas analysis. Blood Gas - Hemoglobin/Hematocrit Analytes and PT Products: The CTS Blood Gas - Hemoglobin/Hematocrit PT Program assesses measurement accuracy of hemoglobin (Hb) and hematocrit (Ht) as required by CMS. These scores are released to designated agencies. The CTS Hemoglobin/Hematocrit PT Program uses clear, aqueous, buffered solution testing material, without colored dyes (five 2.5 mL samples per shipment) to accommodate proficiency testing for instruments that perform hemoglobin/ hematocrit analysis, using the conductivity method, in conjunction with blood gas analysis. CO-Oximetry Analytes and PT Products: The CTS CO-Oximetry PT Program assesses measurement accuracy of total hemoglobin (tHb) as required by CMS. In addition to tHb, participation in this program also allows you to assess measurement accuracy of oxyhemoglobin (O2Hb %), carboxyhemoglobin (COHb %), and methemoglobin (MetHb %), which are not regulated under CLIA. These scores are released to designated state agencies. The CTS CO-Oximetry PT Program uses a bovine-based hemoglobin solution (a non-biohazardous, non-human blood-based reagent) for total hemoglobin and hemoglobin fraction testing (five 2 mL samples per shipment). These solutions are suitable for all instruments with the exception of Waters Oxicom. CYCLE TIMETABLE / PT ACTION CALENDAR The PT Action Calendar identifies specific shipping dates, data input due dates, and the dates when cycle reports will be sent to you. YOUR ADHERENCE TO THIS PT SCHEDULE IS ESSENTIAL: CMS REQUIRES THAT RESULTS RECEIVED AFTER A CYCLE DATA INPUT DUE DATE OR IS NON-PARTICIPANT MUST BE SCORED "UNSATISFACTORY” AND WITH A SCORE OF “0”. FEDERAL AND STATE SANCTIONS MAY RESULT FROM LATE SUBMISSION. CYCLE SHIPMENTS CTS PT Program materials are shipped three times a year (see PT Action Calendar for specific dates) to each enrolled laboratory via Two Day UPS delivery with signature required. The CO-Oximetry materials are shipped with an ice pack and these CO-Ox ampules require refrigeration upon receipt. The CO-Ox samples should not be used if they are left unrefrigerated for more than 24 hours. REPLACEMENT SAMPLES PT samples will be replaced at no cost to enrollees if regular samples do not arrive or are damaged during shipment. To obtain replacement samples, you must call the toll free number on the PT Action Calendar within 3 days from expected date of receipt of original shipment §493.901 (b)(6). If a lab misplaces or mishandles the samples, replacement samples can be ordered for a nominal fee. To order, call the CTS Program Manager at 415-536-0287. Any request for replacement samples must occur and be prepaid within 3 days from expected date of receipt of original shipment. FEDERAL, STATE REGULATORY AGENCY AND ACCREDITED ORGANIZATION PT REPORTING REQUIREMENTS Your laboratory’s designated instrument PT score(s) are automatically released to CMS in compliance with CLIA PT regulations, as required by HHS for Medicare and Medicaid payments. If you do not want your CTS scores sent to CMS (that is, your CTS enrollment is for internal QC purposes only and you are enrolled in another CLIA approved program that reports your lab PT results to CMS), you must advise the CTS office on your PT enrollment Regulatory Agency Reporting form—or with a written addendum by the contact person prior to a Cycle’s data input due date. For labs requesting CAP reporting: CTS will electronically transmit all scores for all PT enrolled instruments to CAP. For labs licensed in California, Pennsylvania or Washington State: CTS automatically transmits all PT scores electronically to the state agency, in the unique California record format as required (if you have provided CTS with your State ID number). If you do not want your CTS scores sent to these agencies (that is, your CTS enrollment is strictly for internal QC purposes and you are enrolled in another approved program that reports your lab PT results to LFS, California, Pennsylvania or Washington State Agencies),you must advise the CTS office by checking the appropriate box on the PT enrollment Regulatory Agency Reporting form and also submit a written statement for CTS documentation purposes. All other state regulatory agencies have access to the designated instrument results CTS submits to CMS in the CMS required format, unless you inform CTS of other state expectations. If your state regulatory agency or accredited organization has specific program requirements that need to be addressed by your PT provider, assure you notify CTS in writing. CTS sends PT Cycle reports to CMS, the state regulatory agency and/or accredited organization specified by the enrolled lab on Regulatory Agency Reporting, Part D of the CTS PT enrollment form (or as provided on a written addendum, from the contact person prior to a Cycle’s data input due date). The CTS Proficiency Testing Program is designed to satisfy the requirements of your regulatory agency. Proficiency testing combined with your daily QC procedures also is an important tool for you to maintain the quality of your clinical testing. Therefore, it is important for you to take the appropriate troubleshooting and corrective steps if your PT results fall out of limits, even if the results were obtained on a non-designated instrument, were for a non-regulated analyte, or received an 80% score. In addition, failure to respond to any out of limit result could lead to problems when your laboratory is inspected. According to a memo we received from the Joint Commission on 5/18/05, “We will review all proficiency testing performed, regardless of its classification as a regulated analyte. A laboratory would receive a finding for failing to follow-up on out of range results (whether they achieve a passing score or not), specifically, performing an investigation and implementing corrective action.” DATA INPUT FORM A Data Input Form is provided for each Blood Gas/Electrolyte +, Hemoglobin/Hematocrit and/or CO-Oximetry instrument you enrolled. To ensure proper grading of your test results, each Data Input Form submitted to the CTS PT Data Center must include: Your CTS ID Number (ie, C-123 or A-321) that we assigned to your laboratory. (Current CTS enrollees find this number on past reports, upper left corner.) Identifier that you assign, specific to each instrument. Use up to four alpha and/or numeric characters according to location, serial number, analyst, etc (ie, ER1, ER2; NICU, ICU). You must define a distinct Identifier for each enrolled instrument, and consistently match that instrument’s data with its Identifier on Data Input Forms. Method Code that is specific to your instrument model reported on that Data Input Form. Method Codes are four-digit numbers that represent your instrument system. Please verify your Blood Gas/Electrolytes+ and COOximetry Instrument Method Codes carefully on page 14 respectively; instruments are listed alphabetically by manufacturer, and new codes are added continually. If your instrument is not listed, enter 9999 for your instrument: if you use this “other” code, you must identify the instrument in the Instrument Name box or Comments section of the Data Input Form, to group your instruments appropriately before scoring and help us update the Method Code list. If you have changed an instrument model since the last testing Cycle, assure that you correctly identify the Method Code for your current instrument on the Data Input Form. If you provide CTS with the wrong method code (i.e, wrong instrument model) your result will be graded against the wrong peer group. This could increase the likelihood that your result will fall outside of the target range. Note: CMS requires that labs keep copies of all documents for at least two years. DISCONTINUE ENROLLMENT If you discontinue an enrolled analyte, be sure to notify the CTS office in writing ASAP. If you do not advise us of the change by the Cycle data input due date, a non-respondent zero score report will be generated and the unsatisfactory status will be sent to CMS, your state regulatory agency, and any accredited organization, as required by CLIA. REPORTING ERRORS BEFORE CYCLE DATA INPUT DEADLINE If you notice an error on your copy of the Data Input Form after you have transmitted it and you notify CTS of your corrected input in writing before the data input due date, this will not be regarded as a failure. After the data input due date, the reporting error is considered a failure and cannot be revised, as required by CLIA. DATA ANALYSIS CTS suggests that laboratories analyze all the samples in the same manner to minimize differences. PT Sample Handling & Reporting Instructions [see page 11] accompany each set of samples. Under CLIA Code of Federal Regulations (CFR) part H § 493.801 (b), you must handle proficiency testing specimens in the same manner as you test patient specimens. Testing PT samples in the same manner as you test patient specimens, testing the same number of times as patient specimens. and at the same time as patient specimens; Samples must be tested by personnel who routinely perform the testing in the lab; Testing must be done using the laboratory’s routine methods, using the same test system that is routinely used for the patient specimens; You cannot analyze the proficiency testing material multiple times, unless it is the laboratory's routine practice to analyze all samples multiple times; Never send proficiency testing materials out of your laboratory for any reason, never send to another laboratory for analysis, or to discuss your testing results with another laboratory until after the deadline for your Data Input. If you are contacted by another lab for this purpose, you are instructed to notify CMS immediately; If a loaner or “mothballed” operational instrument temporarily replaces your standard instrument for patient reporting, you must run the samples on it and submit Cycle data by the deadline. Mode Selection: Laboratories using instruments with both blood and aqueous (QC) sampling modes need guidance from the instrument’s manufacturer as to which mode to use when performing aqueous PT analysis. After PT sample analysis: Record your instrument results on the Data Input Form enclosed with your samples. Legibly complete all the information requested on the Form. Verify your CTS ID Number, Identifier, and Method Code, recording them correctly on the Data Input Form. Mark the designated instrument box (see below for more information about selecting a designated instrument) on the Form [see pages 15-18]. CMS scoring will be based only on the instrument you specify as the Cycle’s designated instrument. We strongly recommend that you select the designated instrument for your lab. If you do not specify your lab’s designated instrument on your Data Input Form, a random selection will be made for you. Sign and date your Data Input Form where indicated and have your Laboratory Director (or it’s designee) sign, as required by CLIA CFR § 493.801(b)5. Under CMS rules, the Laboratory Director (or it’s designee) and the analyst (i.e. testing person) must sign an attestation statement as part of each testing Cycle. In addition, per the California Thoracic Society’s proficiency testing protocol, laboratories doing moderately complex tests may have the Technical Specialist or the Medical Director sign as the designee of the Laboratory Director. This statement indicates that you used your laboratory's routine methods and protocols to analyze the proficiency testing material. Fax or mail your PT analyses data to the CTS PT Data Center at the fax number or address provided on the Form by the PT Action Calendar deadline. It is not necessary to include a cover sheet when you fax your Data Input Forms. We strongly recommend that you program your fax machine to print a journal report verifying data transmission details. Keep the fax journal report for documentation. Assure that you feed the Forms into your fax machine with the appropriate side down for correct transmission of the data, to avoid a non-respondent’s unsatisfactory report. Keep a file copy of your instrument printout (raw data) and the completed, signed Cycle Data Input Forms for a minimum of two years, as required by CLIA CFR § 493.801(b)5. Designated Instrument: Laboratories that enroll multiple instruments need to designate one of these instruments for each module, each testing Cycle, for regulatory purposes. Laboratories are required to rotate the primary testing instruments from testing Cycle to testing Cycle (§ 493.801(b)(1)). If your instrument analyzes both Blood Gas and Electrolyte+ analytes, you must indicate the designated instrument(s) for both Blood Gas analytes and Electrolyte+ analytes. It is acceptable to designate one instrument for Blood Gas analytes and a different instrument for Electrolyte+ analytes, so long as one instrument is designated for each regulated analyte. The designated instrument and only the designated instrument is used to determine whether the laboratory's performance is acceptable under the CMS guidelines. Although only the designated instrument is used to define compliance with CMS regulations, it is to your advantage to enroll all clinically used instruments in a proficiency testing program, and to involve all your techs as part of your overall quality assurance operation. Institutions are required to provide a representative sample of your twice annually ‘checks’ along with your annual review submittal (CLIA CFR § 493.1236(c)(1). Internal performance-based checks include regular use of certified reference materials and/or internal quality control using secondary reference materials; replicate tests or calibrations using the same or difference methods; re-testing of retained items. SCORING Blood Gas / Electrolyte+ and Hemoglobin/Hematocrit Analytes: You will receive a Cycle PT Evaluation Report for all instruments you enrolled. Peer group mean values and standard deviations (SD) are calculated for each comparative peer group for pH, pCO2, pO2, Na+, K+, Cl -, iCa++, glucose, and lactic acid for each coded sample. Each of your results receives a standard deviation index (SDI) score that is calculated from the difference between your result and the target value [see page 8] assigned for your peer group divided by the peer group SD. A high SDI score (greater than 3.0 in either a positive or negative direction) indicates poor performance. If the SDI is greater than 2.0 in either direction, it suggests problematic performance even if you have received an “acceptable” rating. The Evaluation Report for your designated instrument includes the relevant entries in the Regulatory Status column on the right [see sample, pages 19-21]. Your Cumulative Summary Report provides further data regarding your designated instrument in each module [see sample pages 22-23]. The CTS ABG, Electrolyte+ and CO-Ox PT Program Committee carefully reviews and monitors the PT Program results. The data are scored both by our own CTS established inter-laboratory comparison program and by the system mandated by CLIA. [Sample Reports similar to those you will receive are on pages 19-25]. Target Value: As defined in the CLIA regulations (§ 493.2) target value for quantitative tests means either the mean of all participant responses after removal of outliers (those responses greater than 3 standard deviations from the original mean) or the mean established by definitive or reference methods acceptable for use in the National Reference System for the Clinical Laboratory (NRSCL) by the National Committee for the Clinical Laboratory Standards (NCCLS). In instances where definitive or reference methods are not available or a specific method's results demonstrate bias that is not observed with actual patient specimens, as determined by a defensible scientific protocol, a comparative method or a method group ("peer" group) may be used. If the method group is less than 10 participants, "target value" means the overall mean after outlier removal (as defined above) unless acceptable scientific reasons are available to indicate that such an evaluation is not appropriate. § 493.2 CLIA Acceptable Performance: In accordance with CMS rules, the following define ACCEPTABLE performance for the analysis of a single analyte in one of the samples: pH: Target value + 0.04 pO2: Target value + 3 SD pCO2: Target value + 5 mmHg or + 8% (whichever is greater) Na +: Target value + 4 mmol/L K +: Target value + 0.5 mmol/L Cl : Target value + 5 mmol/L Glucose: Target value +6 mg/dl or +10% (whichever is greater) Ht: Target value + 6% Hb: Target value + 7% Note: Currently iCa++ and lactic acid are not regulated by CMS. These target values are: iCa++: + 0.13 mmol/L and lactic acid: + 2SD or 0.2 mmol/L (whichever is greater). Scores for Each Analyte: If at least 80% of the scores (ie, at least four of the five assays each PT Cycle) for a given analyte are ACCEPTABLE, the performance for that analyte is scored as SATISFACTORY (if less than 80%, that analyte is scored as UNSATISFACTORY). Overall Score: If at least 80% of all assays for a given specialty (eg, chemistry or hematology) within a given PT Cycle are scored as ACCEPTABLE, the overall testing score is SATISFACTORY (if less than 80%, that analyte is scored as UNSATISFACTORY). According to CMS rules, if a laboratory fails to participate or to submit results by the specified due date, a score of UNSATISFACTORY is given for the analyte's performance, with a zero (0) for the overall testing event score. Excused Non-submission: If patient testing was temporarily suspended during the time when proficiency testing samples were scheduled to be shipped (e.g. extended equipment malfunction or reagent back order of more than 2 weeks), in writing, you must notify the CTS San Francisco office that patient testing was temporarily suspended and you are requesting for an “excused non-submission” status for this Cycle and submit it along with the data input results. The excuse will be valid only if your documentation is accepted by your accrediting agency’s surveyor. UNSUCCESSFUL Performance A laboratory's performance is considered UNSUCCESSFUL if the principle/primary instrument used for Federal regulatory purposes fail to achieve SATISFACTORY performance for the same analyte or in the overall score for two consecutive testing Cycles, or in two of three consecutive testing Cycles. Under CMS rules, UNSUCCESSFUL performance may result in sanctions that could include termination, revocation, suspension, or limitation of the laboratory's Medicare-Medicaid approval and/or licensure under CLIA ’88. It may also result in intermediate sanctions that include remedial action, re-testing, and monetary fines. CO-Oximetry Analytes: All of the previous information on scoring is applicable to CO-Oximetry with one exception. In accordance with CMS rules, the following will define acceptable performance for the analysis of a single analyte in one of the samples: Hemoglobin: Note: Target value +7% Currently, only hemoglobin in the CO-Oximetry profile is regulated by CMS. All the other parameters tested (ie, O2Hb, COHb, and MetHb) are to enhance your laboratory's overall program. The target value for O 2Hb, COHb, and MetHb is +3 SD. ENROLLMENT CHANGES If there are any changes in shipping/mailing address or contact person during the year, alert the CTS San Francisco office IMMEDIATELY in writing, on official letterhead. This will assure you continue receiving PT items in a timely manner, and maintain the confidentiality of your lab’s data. Additional Instruments for a Currently Enrolled Lab: Laboratories may add an instrument to the CTS PT Program at any time, with the cost prorated accordingly. Call the CTS office to arrange adding an instrument: it will be enrolled for the next available PT Cycle shipment. If you want to add an instrument when the shipping address, CLIA and State ID numbers are not exactly the same, call the CTS office to enroll a separate lab, as described below. Any separate mailing, different contact person, or different CLIA # are charged at the first instrument rate. Funds cannot be transferable from one lab to another. New Lab Enrollments: A new lab can enroll at any time by calling the CTS office for the current Cycle enrollment forms and rates. Instrument Model Change: If you change your instrument model during the year, you need to carefully identify the correct Method Code for your current instrument on the Data Input Form. This ensures that your results are processed and scored with the appropriate comparative peer group, and it keeps your lab’s CLIA reports accurate over the next two cumulative Cycles. No additional cost is incurred for a change in instrumentation. PT CANCELLATION CLIA regulations require your lab to be enrolled with the same PT provider for three consecutive Cycles (12 months) (ie, you cannot ‘switch’ PT providers within a cumulative reporting stream, defined as a minimum of three testing events) CLIA CFR § 493.801(a)(3). Cancellation or withdrawal from the program is valid only if a lab has closed, has merged with another lab with continuing PT service, has shut down all its testing for Blood Gas/ Electrolytes+/COOximetry, or started a new laboratory or new test starts midyear, then the laboratory may enroll in another PT Program the next calendar year For the rest of the calendar year, please notify the CTS Program Manager in writing, on official letterhead, of any cancellation or withdrawal and its effective date. A $100 cancellation/processing fee is incurred. CTS issues a refund when applicable based on prorated costs of Cycle shipments consumed during the year. REPORTS Each CTS enrolled laboratory receives reports of its Blood Gas, Electrolyte+ and CO-Oximetry proficiency tests from each testing Cycle [samples, pages 19-25]. For duplicate reports, there is a prepaid $30 charge per Cycle. All CTS enrollees will receive paper cycle reports this year. Those who chose e-reports also will receive electronic reports at their current email address. Blood Gas, Electrolyte+ and Hemoglobin/Hematocrit Analytes: CTS Cumulative Regulatory Reports notify participants when an UNSATISFACTORY rating occurs. Review each Cycle report and, if you receive an UNSATISFACTORY score, take action as soon as possible to correct the situation, and to document your corrective action. Each laboratory needs to keep ALL proficiency testing reports on file for at least two years, in accordance with CLIA regulations. Any UNSATISFACTORY (individual or overall testing event score) rating needs to have prompt attention for possible analysis problems (e.g. equipment maintenance, accuracy of calibration liquids or gases, use of uncommon or inappropriate techniques). The CTS PT Troubleshooting and Documentation Guide [see page 26] is a useful tool for this process. CMS requires that, if an UNSATISFACTORY rating is received on the primary instrument for a given testing Cycle, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with this proficiency testing problem. All remedial action taken must be documented and maintained by the laboratory for two years from the date of the proficiency testing Cycle, per CLIA CFR. It is important that you INVESTIGATE, DOCUMENT, and REMEDIATE any unacceptable, unsatisfactory, and unsuccesful score(s) for an analyte over the last 2 or 3 cycles. Any UNACCEPTABLE result refers to a particular analyte that has not reached the 80th percent in scoring. These types of score(s) may result in sanctions by your inspecting agency that could include termination, revocation, suspension, or limitation of your laboratory's medicare-medicaid approval and/or licensure under CLIA '88. It may also result in intermediate sanctions that include remedial action, re-testing, and monetary fines. State sanctions may also apply. Request for Report Correction: You have 30 calendar days from the event report date (listed on the bottom left corner of your Cumulative Summary Report) to request corrections in writing from the CTS office in San Francisco. After the 30 days, scores are sent to regulatory agencies and will not be changed. If your lab receives a “No Results Received” statement on the report, and you feel it is in error, you must provide proof of timely response/data submission (eg, printed fax confirmation, fax log, telephone bill) in order to request a correction. For this reason, it is always prudent to save your fax confirmation printouts with your original result forms. VALIDATED AMPULES As a service to our subscribers, CTS offers validated ampules that are identical to the samples shipped in each testing Cycle. The use of these ampules may be employed as part of the remedial measures suggested under CMS rules pursuant to CLIA’88 when “UNACCEPTABLE,” “UNSATISFACTORY,” or “UNSUCCESSFUL” ratings are encountered. Model-specific target values for each ampule are included in each Cycle report. The validated ampules are numbered, so you will know the model-specific target values. We suggest validated ampules be utilized after a thorough check of your instrument; the results will indicate if a problem persists. As these data are part of your troubleshooting and remedial measures, you do not need to send validated ampule data back to the CTS Data Processing Center. To order validated ampules, use the enclosed order form or retrieve it from the CTS web site (www.calthoracic.org). Note that the order and accompanying payment must be made within 30 days of receipt of an “UNACCEPTABLE,” “UNSATISFACTORY,” or “UNSUCCESSFUL” rating for each testing Cycle. PT REINSTATEMENT PROGRAM As an added service to our CTS PT enrollees, we have arranged a PT Reinstatement Program as a remedial measure if your lab receives a second “UNSUCCESSFUL” PT Cycle report in the cumulative summary for the same analyte, or for overall performance. An order form and instructions will accompany relevant Cycle reports. Your regulatory agency inspector will advise you concerning the number of reinstatement set(s) needed for remedial action. The use of the PT Reinstatement Program may be employed as part of remedial measures suggested by CMS/your state or other regulatory agency to avoid penalties for any two of three cumulative UNSUCCESSFUL PT Cycles. This Reinstatement Program includes one set of reinstatement samples, with special instructions and Data Input Forms. When you receive these samples, immediately analyze the samples and return your results to the PT Data Center. The results will be scored manually and a Reinstatement Report issued to your lab and your inspecting agency(s). TROUBLESHOOTING AND CTS PT PROGRAM REFERENCE TECHNICIANS CTS has skilled Reference Laboratory Technicians to assist our enrolled laboratories with prompt PT problem analysis and resolution. Each reference technician has been selected by the CTS ABG, Electrolyte+ and CO-Ox PT Program Committee on the basis of his or her expertise in blood gas analysis, a thorough working knowledge of quality control systems, numbers theory, statistical analysis, knowledge of instruments that match with frequently enrolled models, location, and willingness to assist participating laboratories. Enrollee access to these Reference Laboratory Technicians is part of the CTS PT Program service. The technicians provide supplementary data, telephone assistance, and laboratory group review of issues that need attention and referral to the California Thoracic Society ABG, Electrolyte+ and CO-Ox PT Program Committee. These Reference Laboratory Technicians are available to answer CTS participant's questions regarding any aspect of the CTS PT Program. Feel free to contact a CTS PT Reference Technician directly with any technical questions you may have: Michael Muth, RCP RRT MBA Los Angeles, California Ph: 213-977-2210 Fx: 213-977-2262 E-mail: [email protected] Michael H. Terry, RCP RRT Loma Linda, California Ph: 909-558-4000 x46209 Fx: 909-558-4165 E-mail: [email protected] CTS PT PROGRAM REENROLLMENT CTS will mail the PT enrollment forms in September. Please watch for them. If you have not received yours by September 26, call the CTS office at 415-536-0287 to request your CTS PT enrollment forms. If you require a delivery receipt for your enrollment forms, send the forms to CTS via certified mail, receipt requested. Kindly do not request that CTS call you to confirm receipt—due to the high volume of enrollments and other patient care endeavors, CTS cannot respond to these confirmation requests. CAP Accredited Labs Blood Gas Hgb / Hct are not CAP accepted. Please call a program associate at 415-536-0287 if your menu includes one more more of these analytes. 2014 CTS PT General Instructions ***READ ALL SHIPMENT PAPERWORK as there are many significant changes.*** Inspect shipment contents immediately upon receipt: Verify the package contains the Modules and quantities (Primary and Secondary) listed on the cover page which serves as a packing slip. Verify sample integrity for all received sets/ampules. Review result forms for accurate instrument information. Note that Q products are web-only so results forms are not provided for any Secondary/additional result sets. Package discrepancies or questions? Call the CTS PT Fulfillment Center: 888-450-4633 Need to adjust your enrollment? Contact the CTS Main Office by phone: 415-536-0287. Sample Handling, Storage, and Testing Instructions: Store, handle, and test CTS PT samples according to the enclosed Supplemental Instructions for your enrolled module(s). If any Supplemental Instruction documents are misplaced, copies are available online at http://www.pt-central.com/wslhpt/cts/login.asp by logging in (Login/Password are on cover page) and clicking on the corresponding Module number. Prior to testing, review all shipment paperwork: Cover page, General Instructions, Module Supplemental Instructions, and Module result forms. [Note: result forms are now double-sided.] Test samples using routine methods, test procedures, and personnel. Report only those analytes/procedures you normally perform in-house on patient samples. DO NOT REFER PROFICIENCY TESTING SAMPLES. Note that samples within any set might have shifted in transit and it is the participant’s responsibility to match sample sets to forms, to confirm both integrity of ampules and completeness of each set, and to re-organize any shifted ampules prior to analysis. Additionally, we recommend use of the label ID as part of the specimen ID during analysis to minimize transcription errors. ***NEW*** If your lab ordered multiples of any CTS PT product(s), you will find that any additional sets were filled as “Q Product” which will arrive in the same shipment as your Primary sets. These “Q Products” are labeled with alternate testing/resulting dates on the fluorescent “Q Product” set label. To satisfy current regulatory requirements, Secondary (Q) instruments should not be analyzed prior to the Primary PT result due date. See “Testing Periods and Due Dates” section on the next page for additional information. Replacement Samples: All requests for replacements must be made by the “Call by” date of the scheduled shipment date [see “Proficiency Testing Action Calendar”]. Supplies may be limited. Requests received after the “Call by” date may incur additional fees. Failure to make timely requests for replacement samples will not be accepted or excused. Broken or missing samples? Call the CTS PT Fulfillment Center for replacements: 888-450-4633. Mishandled or lost samples? Submit payment with a “Replace Ampules Lab Order Form” (available online) to the Main Office by fax: 415-764-4933. **NEW** Testing periods and Due Dates: To comply with current CMS requirements, there are now different testing periods AND due dates for Primary and Secondary Modules. The intent is to avoid any inference of comparison or referral. Only the Primary Module samples should be analyzed and reported during the live proficiency testing cycle. See next page for details. Primary Modules: Web submission is preferred. Samples must be tested during the normal Cycle period, ship date through due date (as listed in the “Primary” section of the shipment cover page. Primary set results submitted after the Primary due date will receive a 0% score. Secondary (Q) Modules: Web submission is REQUIRED. The Q Period (for analysis and submission of these Secondary sets) is defined on a fluorescent Q Product label on each Q set sample bag. It begins the day following the Primary due date and ends at midnight central of the following Friday. Additionally, the Secondary due date is listed on the shipment cover page in the “Secondary” section. Results must be submitted online by midnight central of this date. Reporting Results: Provide a numeric result or exception code for each sample/analyte. Blank sample/analytes will receive a 0% score. Call 888-450-4633 with reporting questions. **NEW** Online Data Entry: NOTE: Do not use your browser’s back button to navigate. 1. Report your results online at www.pt-central.com/wslhpt/cts/login.asp Log in using the assigned PT Central user name and password found on the shipment cover page just under your account information. [During the Secondary (Q) period, start on this same login page but click on the blue “Secondary for Q Products” link, then log into the Q page using the same login name and password as used for the Primary site.] 2. Once logged in, verify that your modules, identifiers, and method information are correct before continuing. Notify the CTS PT Data Processing Center of any discrepancies PRIOR to any data entry/submission by phone (888-450-4633) or by clicking the CONTACT US link on the left side of the screen to send us an email. Complete all fields and include any comments. Be specific when referring to sample number, analyte or module. Click the blue NEXT link to send the message. 3. Once any needed updates (analytes, methods) have been addressed, locate the module for which you wish to enter results and click ENTER to the right of the module/instrument to enter your results. Enter the numeric result value in the appropriate box. Use the Tab button to move between fields. If your result exceeds the reportable range of your instrument, select the greater than (>) or less than (<) sign from the drop-down box above your result. A numeric value must accompany a greater than or less than sign. 4. Exception Codes: If you will not be reporting results for any reason, an exception code must be attached to either the entire module or the individual sample (example: Excuse Requested – Instrument Out of Order). NOTE: You will not be able to report a result for any sample that has an exception code. A. Global Exception Code - located above your analyte list: This exclusion will be applied to all analytes/samples listed. Click on the blue arrow next to the red box to choose from a list of exceptions; the selected code will appear in the red box. Next, click on the blue APPLY link to apply the exception code to the entire module. Click the blue REMOVE link to remove the exception code from the entire module. B. Individual Sample Exception - located next to OR below the associated result field: This exception code can be applied to an individual sample/analyte. Click on the yellow E associated with that result field, then click on the blue arrow to the right of the red box and choose from the list of exceptions. The selected exception code will appear in the red box. WARNING! Clicking the blue REMOVE link will remove all exception codes. 5. Comments/Questions: A. For individual sample/analyte comments, click on the yellow C associated with that result field to open a free text box. Such comments will be included on your Data Submission Report. B. General comments and questions may be directly submitted to CTS PT by clicking on the CONTACT US link on the left side of the data entry screen. Complete all fields and include any comments. Be specific when referring to sample number, analyte or module. Click the blue NEXT link to send the message. C. If you have a question about your results that directly impacts your submission, or if you need to have your instrument updated, CALL 888-450-4633 for assistance before you save your results. 6. Saving Results: You have the option of a TEMPORARY SAVE or FINAL SAVE. Both submit into the database. Temporary Save will submit results but keeps them available for review/edit. Final Save submits and locks your results. Be sure to carefully review your results, check for clerical errors and correct method information before selecting Final Save. No further edits are allowed without coordinator assistance. 7. CLIA Record Keeping: After saving your results, generate a Data Submission Report by clicking the REPORTS link on the left side of the screen. Select the appropriate Year and Event (i.e.; BloodGas1), click APPLY, then go to the Data Submission Report line under “Reports” and select BUILD to generate the report. Click VIEW to open the pdf, print it, and keep with your PT records including the signed Attestation Statement (found on your shipment cover page) for your records. 8. Log out of PT Central by clicking on the LOG OUT link on the left side of the screen. **NEW** Paper Result Forms (Fax) – available ONLY for Primary set results 1. The result forms enclosed with your PT samples are customized for your laboratory and pertain only to the Primary result set(s). Your account information is embedded in the barcode on each page; you MUST use these forms when reporting Primary set results by fax. Refer to the instructions at the top of each form for specific directions on how to complete correctly. A detailed form example is provided in this packet. 2. Do NOT cross out or darken the blue box/bubble outlines on the form. Use blue or black ink to record your results. Use block numbers for all results. For any Exception Codes you must fill in the bubble completely; any writing other than filling in the oval or boxes will result in read/scan errors. 3. All reporting forms are double sided. Be sure to proof BOTH SIDES and enter results for all analytes and each sample. The COMMENTS section on side two of any form should be used to add missing analytes, instruments, results or other information, as needed. 4. Fax your completed Primary result forms to (866) 240-4687 as listed in the form’s instructions at the upper right corner. We STRONGLY recommend reprogramming your fax it it has a pre-programmed button for data submission. [This is a new fax number strictly for result forms submission.] Be sure to fax all completed sides of your combined forms. If there are no analytes or comments on side 2 of any form then you do not need to fax that blank page. 5. Do NOT include a fax cover page, attestation page, or any other information to this number. Do not send duplicate faxes. 6. Keep a copy of your submitted results and proof of successful/timely fax transmission (confirmation report, daily log) for your PT records. Although you should not fax your attestation to the Data Processing Center, you must sign it and keep it with your PT records to meet CLIA requirements. Questions? Call 888-450-4633. SHIPMENT COVER PAGE - KEY NHS = Non-Hazardous Samples Shipment name = ship group + Cycle number “(18)” = Fulfillment Center shipment reference Sequence number within the shipment (for Fulfillment Center use). New web entry customer numbers; 7 digits beginning with a ‘30’ followed by the previous shipping number (i.e., 2013 shipping ID “20000” becomes 2014 paperwork/web ID# 3020000). DUE DATE for the Primary Result Set(s). The sample IDs for the included sample sets An identifying number for enrolled base product sample sets that need to be included in the package. May include: 1350 = BloodGases or BloodGases/Lytes+ 1380 = BloodGas Hgb/Hct 1390 = Co-Oximetry This section is for new ‘Q’ modules (additional sets) module numbers followed by the additional set quantity(-ies) for each enrolled module that need to be included in the package. DUE DATE for Additional Result Set(s); only available through web entry starting the date AFTER the Primary Due Date. CMS no longer allows submission of multiple result sets during the live Primary cycle. CLIA attestation and signature lines for your in-house records. CTS PT Program – Evaluation Report Interpretation Guidelines CTS ID Number Laboratory Supervisor Some Institution 9999 Some Avenue Some City, CA 99999 5 C-999 1 2 Blood Gases/Co-oximetry Shipment Date: 7/08/09 3 4 6 7 8 Event 2009-2 Evaluation Report 10 11 12 Agencies/Consultants Reported To: CMS CLIA ID: 10D0000000 CAP-LAP ID: 0000000 CA Dept of Health: CLF0000000 13 14 Analyte Sample Result Identifier pCO2 (mmHg) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 ER ER ER ER ER i-STAT i-STAT i-STAT i-STAT i-STAT 70.7 41.4 66.7 22.8 16.8 64.1 - 75.2 34.1 - 45.1 59.9 - 70.4 17.1 - 27.1 11.4 - 21.4 69.6 39.6 65.2 22.1 19.4 0.4 1.0 0.8 0.8 0.5 100% Satisfactory BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 ICU ICU ICU ICU ICU i-STAT i-STAT i-STAT i-STAT i-STAT 72.4 40.8 67.5 21.9 11.0 * 64.1 - 75.2 34.1 - 45.1 59.9 - 70.4 17.1 - 27.1 11.4 - 21.4 69.6 39.6 65.2 22.1 19.4 1.2 0.5 1.2 -0.2 -4.5 80% Non-regulated result set 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Scoring Group Your Result 9 Accepted Range Mean SDI Score CLIA Regulatory Status CTS identification number. Proficiency Testing program and shipment date. Institution name and department demographic information. CLIA and other specified accreditation organization identification numbers Analyte: Individual analyte reported and unit of measure. Sample: Identification code on each sample ampule (BG = 2-letter PT program code, 06 = year, -2 = testing event/cycle, -1 = sample number). Result Identifier: Your identification of the instrument. Your options include location, serial number, analyst, etc. Scoring Group: Scoring group used to evaluate your results. A scoring group can consist of results from a specific instrument model, results from instrument models in the same series, results from a group of instruments from the same manufacturer or results from all instruments. Your Result: The result reported by your institution. An asterisk indicates an unsatisfactory result. Accepted Range: The scoring group range of results in which your result must fall for satisfactory performance. The criteria for acceptable performance are defined by the Center for Medicare and Medicaid Services (CMS), formerly HCFA, and are published in the Federal Register, Clinical Laboratory Improvement Amendments of 1988; Final Rule, 42 CFR Part 405, February 28, 1992. Mean: The average result in the scoring group by which your result was scored. SDI: Standard deviation index is a comparison of your result to the scoring group mean, expressed in terms of the standard deviation. The SDI is calculated as follows: SDI = Individual result – scoring group mean Scoring group standard deviation Score: The percentage of your results which fall within the accepted range. It is calculated by dividing your number of satisfactory results by the total number of samples in the cycle challenge. Regulatory Status: This column indicates whether a regulated analyte score is satisfactory (≥80%) or unsatisfactory (<80%). “Non-regulated analyte” is printed for analytes not regulated by CMS. The regulatory status is shown only for the designated instrument results. “Non-regulated result set” is printed for results reported for analytes from additional instruments. Page 1 of 2 CTS Number: A-888 Event 2011-1 Evaluation Report Blood Gases/Co-oximetry Shipment Date: 03/01/11 REPORTuserIDinternalNum: SL20182 Some Community Health Center Attn: Director Lab Services Laboratory 88 Some Place Somewhere, CA 0000 Agencies/Consultants Reported To: CMS - CLIA ID: 00D0000000 Sample Scoring Group pH BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 ABL 700 series ABL 700 series ABL 700 series ABL 700 series ABL 700 series pCO2 (mmHg) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 ABL 700 series ABL 700 series ABL 700 series ABL 700 series ABL 700 series pO2 (mmHg) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 ABL 700 series ABL 700 series ABL 700 series ABL 700 series ABL 700 series Ionized calcium (mmol/L) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 Lactate (mmol/L) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 Your Result M PL E Analyte Accepted Range CLIA Mean SDI Score Regulatory Status 7.519 7.282 7.641 7.585 7.343 7.378 7.138 7.498 7.544 7.200 - 7.458 7.218 7.578 7.624 7.280 7.418 7.178 7.538 7.584 7.240 0.3 1.0 1.0 0.3 0.8 20% Unsatisfactory 36.3 61.3 26.8 23.7 51.9 31.5 56.4 21.8 18.5 46.8 - 41.5 66.4 31.8 28.5 56.8 36.5 61.4 26.8 23.5 51.8 -0.4 -0.1 0.0 0.4 0.1 100% Satisfactory 87.0 49.3 78.4 129.0 140.0 83.3 45.2 73.0 124.4 135.6 - 97.1 59.4 90.0 141.4 149.6 90.2 52.3 81.5 132.9 142.6 -1.4 -1.2 -1.1 -1.4 -1.1 100% Satisfactory ABL 700 series ABL 700 series ABL 700 series ABL 700 series ABL 700 series 1.29 1.74 0.88 0.71 1.10 1.18 1.64 0.74 0.55 1.00 - 1.44 1.90 1.00 0.81 1.26 1.31 1.77 0.87 0.68 1.13 -2.0 -1.0 0.5 1.0 -3.0 100% Non-regulated analyte ABL 700 series ABL 700 series ABL 700 series ABL 700 series ABL 700 series 6.40 7.20 9.40 1.80 5.50 5.67 6.27 8.06 1.58 4.75 - 6.71 7.57 9.93 2.00 5.71 6.19 6.92 9.00 1.79 5.23 0.8 0.8 0.8 0.1 1.1 100% Non-regulated analyte * * * SA * 8 N ! E ~ Not scored Nonconsensus Excuse requested Referred P Pass L Late result, automatic 0% score * Unsatisfactory result Report Run Date: 09/30/09 Form: PTTR0087 S Susceptible I Intermediate R Resistant Page 2 of 2 Analyte Sample Your Result Scoring Group Accepted Range CLIA Mean SDI Score Regulatory Status -2-3 BG09-2-4 BG09-2-5 130 111 133 149 116 - 138 119 141 157 124 134 115 137 153 120 -1.0 -0.8 -2.0 -1.0 -0.8 Potassium (mmol/L) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 3.7 2.6 4.3 6.1 2.1 - 4.7 3.6 5.3 7.1 3.1 4.2 3.1 4.8 6.6 2.6 0.0 0.0 0.0 0.0 0.0 Glucose (mg/dL) BG09-2-1 BG09-2-2 BG09-2-3 BG09-2-4 BG09-2-5 207 260 303 47 145 - 254 317 370 59 178 230 288 337 53 162 -0.1 -0.6 -0.3 0.8 0.4 Hemoglobin (g/dL) CO09-2-1 CO09-2-2 CO09-2-3 CO09-2-4 CO09-2-5 7.8 12.8 15.7 15.6 7.7 - 9.0 14.8 18.1 18.0 8.9 8.4 13.8 16.9 16.8 8.3 0.0 0.5 0.5 0.5 1.0 Oxyhemoglobin (%) CO09-2-1 CO09-2-2 CO09-2-3 CO09-2-4 CO09-2-5 94.0 83.0 56.5 55.0 94.2 - 97.2 85.6 58.9 57.4 97.2 95.6 84.3 57.7 56.2 95.7 -2.6 -2.8 -1.5 -1.5 -3.4 1.5 12.7 39.4 42.2 1.3 - 3.3 14.3 41.2 43.8 3.5 2.4 13.5 40.3 43.0 2.4 -1.7 -1.7 -1.7 -1.7 -0.2 0.2 0.2 2.0 1.6 0.0 - 2.0 1.9 4.2 3.4 2.0 1.1 1.1 3.1 2.5 1.0 5.3 4.0 2.8 3.7 6.0 Carboxyhemoglobin (%) CO09-2-1 CO09-2-2 CO09-2-3 CO09-2-4 CO09-2-5 Methemoglobin (%) CO09-2-1 CO09-2-2 CO09-2-3 CO09-2-4 CO09-2-5 Not scored Nonconsensus Excuse requested Referred SA M PL E Sodium (mmol/L) N ! E ~ Blood Gases/Co-oximetry Shipment Date: 07/08/08 Event 2008-2 Evaluation Report CTS Number: A-515 P Pass L Late result, automatic 0% score * Unsatisfactory result * * * * * Report Run Date: 09/30/09 CTS Number: C-999 1 Blood Gases/CO-Oximetry Event: 2011-1 Shipment Date: 03/01/11 2 Agencies/Consultants Reported To: CMS - CLIA ID: 10D0000000 CA Dept of Health Services ID: CLF0000000 CAP LAP ID: 0000000 3 Facility/Organization Contact Name Street Address City State Zip Code 4 CUMULATIVE SUMMARY REPORT 2011-1 2010-3 2010-2 Score Score Score Program(s) Analyte(s) 6 Blood Gases/Electrolytes+ (BG) pH pCO2 5 pO2 Ionized calcium Lactate Sodium Potassium Chloride Glucose Co-oximetry (CO) Hemoglobin Oxyhemoglobin Carboxyhemoglobin Methemoglobin CLIA Regulatory Cumulative Performance 8 7 80% 100% 100% 100% 100% 100% 100% 100% Dropped 60% 100% Excused 80% 100% 100% 60% Not Reported Not Reported 100% Not Reported 0% 100% 100% 60% 100% 100% 20% 100% Successful Successful Successful Insufficient Information ** Non-regulated analyte Insufficient Information ** Unsuccessful Successful Successful 0% 100% 100% 100% 100% 60% 100% 100% Successful Non-regulated analyte Non-regulated analyte Successful 100% 100% 100% 100% CURRENT EVENT UNSATISFACTORY PERFORMANCE Blood Gases/Electrolytes+ Potassium Co-oximetry (CO) Hemoglobin 99 60% 0% ** Refer to CTS PT Reference Manual if you experience an unsatisfactory (<80%) score. 11 Three events are required to assess regulatory performance. Scores marked as voluntary are not transmitted to agencies Reviewed By __________________________________________ Date_____________ Report Run Date: 09/03/10 (Lab Director / Designee) 10 Interpreting Your Cumulative Summary Report: File this report key with your proficiency testing (PT) records. NOTE: The top of this report is a summary of your laboratory’s performance over 3 events. The bottom portion lists any problem analytes on the enclosed evaluation report for the current event. Review both your current event Evaluation Report and your Cumulative Summary Status report as soon as possible after receipt. REMINDER: You are responsible for in-house maintenance of PT records. File all reports and other in-house documentation for a minimum of 2 years. Refer to your inspecting agency’s guidelines for exact requirements. CUMULATIVE SUMMARY KEY: 1. Your CTS identification number (“A” or “C” followed by the 3-digit assigned number). Refer to this number anytime you contact us to help us identify your lab. 2. Proficiency testing program/group, year, cycle number and date samples were shipped. 3. Inspecting/accrediting agency with identification numbers [if applicable]. 4. Facility/organization, contact name and mailing address for all correspondence. 5. Programs and analytes reported to us for the current and 2 previous events. 6. Analyte score is the percentage of results which fall within the accepted range. 7. Informational field indicating analyte score status. Field will be blank unless one the following apply: Dropped Lab has indicated that test is no longer performed Late Results were received after the due date Excused Patient testing temporarily suspended; excuse requested by lab No Results Results were not received for a regulated analyte; no indication from lab that testing was dropped/suspended Not Reported Lab had not previously reported a regulated analyte OR results were not received for a nonregulated analyte Not Enrolled Lab was not enrolled in this CTS PT program for event(s) specified Not Scored Labs receive automatic 100%. This may not be indicative of instrument performance. 8. CLIA performance for regulated analytes over the current and 2 previous events: Successful Analyte has acceptable scores in at least 2 of the last 3 events Unsuccessful Analyte has unacceptable scores in any 2 of the last 3 events Non-regulate Performance criteria for analyte is not defined under CLIA Voluntary Lab has indicated to us that it participates for quality assurance purposes, is not covered under CLIA, or has designated another PT provider to send analyte scores to their accreditation agency Insufficient Information Analyte scores for 3 events are needed to assess performance 9. List of all analytes with unacceptable scores for the current event. Scores of 0% due to late result submissions or missing/unreported results will not be included. More detailed information on why the failure may have occurred can be obtained by reviewing the enclosed report. These analytes will require in-house follow-up and documentation to assure accrediting agencies that failures were noted and actions were taken. 10. Legends to clarify regulatory performance status and the date that the report was generated. 11. Signature line and date for documenting in-house review of this report. Blood Gases/Electrolytes+/CO-Oximetry CTS Proficiency Testing Program Cycle 2013-1 Notes General Information This "Cycle Notes" document accompanies your Evaluation Report and Statistics Summary Report for the most recent PT cycle with a scheduled ship date of March 4th. View the footer of your reports for official report release date(s). Report Review/Request for Correction: Review your results as soon as possible after receiving reports. You have 30 calendar days from the "report run date" listed on the bottom left corner of your "Cumulative Summary Report" to request corrections. After 30 days, scores are sent to accrediting agencies and may become ineligible for correction. SA M PL E If your lab receives a “No results submitted for …” statement for any product (BG, CO, etc), proof of timely data submission (e.g. printed fax confirmation, fax log, or phone bill) must accompany your request. For this reason, it is always prudent to save your fax confirmation printouts WITH your copy of the result forms. If your fax machine is not currently set to print confirmations, we recommend resetting it. If your lab receives a 0% score for analytes that are listed with blank/missing results, it is because method information was provided without corresponding sample/analyte results. Because instructions stated that numeric data would be evaluated “as submitted” AND that unenrolled or unreported analytes should be left blank for all fields, provision of method information implies intent to report and is processed as such. Contact the CTS PT Main Office at 415-536-0287 if your enrollment requires updating. Review the paragraph “Avoid errant/stray marks on your data input forms” in Section 5 (page 3) of the 2013 instructions for details. If you note a data processing error (i.e.; numeric value error, analyte data missing, etcetera), immediately contact the CTS PT Main Office at 415-536-0287. When brought to our attention in a timely manner and IF confirmed by review of the submitted data forms, such requests will usually result in issuance of a corrected report. Failures due to clerical or handling errors by the participant(s) are not eligible for correction. They should, however, be recognized and documented with any corrective action(s) taken. If any sample was depleted or not recoverable, a replacement request should have been submitted to the CTS PT Main Office in a timely manner. Similarly, compromised forms could have been replaced by calling for a blank form. It is recommended that labs always initiate proficiency testing at least 4 days prior to the due date to allow time for any needed replacements or clarifications. Result set designation or omission errors are sometimes eligible for correction. If a result set reported by your lab is not included on your Evaluation Report, contact CTS so we can determine if it is a clerical, submission, or fax error versus a data processing error. If it is found to be a data processing error, a corrected report will be issued. Temporary Suspension of Analyte Testing: If your lab temporarily suspended patient testing [e.g. reagent/calibrator backorder or instrument malfunction/repair], you must have contacted CTS PT in writing prior to the due date to request excused status for the shipment. Requests received after the due date will not be reflected on your current Evaluation Report and are not eligible for correction without proof of timely notification. It is your responsibility to document the reasons for any unreported analyte(s) as part of your proficiency testing records. Any Excuse Requested flag/status will be valid only if your certifying agency concurs with the reason and is satisfied with your documentation. Permanent Suspension of Analyte Testing: If your lab stops in-house patient testing for any analyte(s), it is your responsibility to contact both CTS and your certifying agency. Failure to notify CTS prior to the scheduled due date will cause a "0% No Result" score for any regulated analytes and a blank score / "Not Reported" for non-regulated analytes on the reports. For regulated analytes, the 0% score will be sent to your certifying agency unless we are notified in a timely manner [see above]. For additional information please refer to the current Enrollee Reference Manual. Reports Each participant will receive three reports (defined below) with a Validated Ampules Request Form. Examples of the Evaluation and Cumulative reports, with keys to interpretation, are found in the Enrollee Reference Manual. 1. The Cumulative Summary Report presents an assessment of participant analyte performance for this cycle, the two previous cycles and your current regulatory status for each analyte. If you are a new participant, the regulatory status will state “insufficient information” until two or three cycles are completed. The CLIA ’88 regulations define analyte performance as “Successful” when the analyte score is 80% for two of three consecutive cycles. If the analyte score is <80% for two of three consecutive cycles, analyte performance is “Unsuccessful”. Analyte scores that do not meet these criteria are deemed “Unsuccessful” for regulatory purposes and documented in-house corrective action is necessary. Scores are listed only for the designated set of results regulated by CMS. 2. The current Evaluation Report includes CLIA Regulatory Status and Standard Deviation Index (SDI). SA M PL E CLIA Regulatory Status is “Satisfactory” when a regulatory analyte score is 80% and “Unsatisfactory” when it is <80%. The column will state “Non-regulated analyte” if the scoring criteria for the analyte is not listed in the CLIA regulations and “Non-regulated result set” if additional sets of results are reported from instruments other than your designated instrument. Scored results are sent to CMS and other specified agencies. Since only one set of results is sent to CMS, be sure to designate which set of results should be sent. SDI is the number of standard deviations above (+) or below (-) the target value where your reported result lies. This can help you assess your result’s difference (bias) from the scoring group mean independent of the analyte concentration of that sample. Not scored (N): The PT Program may choose to utilize this option if there are not enough participants using a specific instrument and/or method to create a statistically significant peer group and results from that instrument could not be combined with other related instruments to constitute a valid peer scoring group. Results are given an automatic 100% but the score may not be indicative of instrument performance. Affected participants must self-evaluate their performance. In this cycle, affected CTS methods (# n, CTS) was/were: RAPIDLab 1200 series (n=1) Lactate OPTI CCA-TS (n=1) Sodium cobas b 221 (n=5) Hemoglobin (CO) IL GEM 3000 (n=1) Hemoglobin (BGHN) Non-consensus: Results will be flagged as "non-consensus" if less than 80% of the results fell within the calculated range for the peer group. Affected participants receive an automatic score of 100% but are required to self-evaluate performance using the statistics summary provided. 3. The Qualitative Statistics Summary Report provides additional scoring information. Standard Deviation (SD) and scoring/peer group size (n) are listed for each peer group (both specific/direct and non-specific/composite or indirect) used for scoring purposes for all analytes by program/product. “Not Scored” peer groups are not included. Cycle Specific Information Performance Data: There was a combined total of 545 participants in this cycle, 123 labs from CTS PT and 422 from the WSLH PT program. By pooling the data from the two programs we are able to provide larger and more modelspecific peer groups with more reliable statistics. Of the 5540 analytes scored, there were 151 analyte failures experienced by 64 participants. While some failures might be attributed to sample storage and/or handling issues, it was transcription errors, late submission, and missing/unexcused data that appeared to account for the majority of the failures. These could be easily avoided through adherence to the instructions AND with consistent proof-reading of result forms prior to submission. The overall analyte passing rate was 97.3 %. Cycle 2013-2 Shipment The next Blood Gas/Electrolytes/CO-Oximetry Cycle will be shipped via 2-day carrier on July 8, 2013 with UPS as the default courier. Re-enrollment is required for continued participation. Result forms will be due at the CTS Data Center by midnight (central) of July 26th. If you have any questions/concerns OR if you need to adjust your 2013 Enrollment (number of sets, analyte content, etcetera), call the CTS PT Main Office at 415-536-0287. Have you seen CTS PT Web Education materials? Go to http://www.calthoracic.org/content/cts-proficiency-testing-web-education CTS PROFICIENCY TESTING TROUBLESHOOTING AND DOCUMENTATION GUIDE Laboratory Name: Instrument: Your Value: All Instrument Mean: Your Model Mean: Model: _______ SDI: SD: n: SD: Year: Serial#: Unsatisfactory Analyte: Ampule Code #: Cycle: Identifier: n: SUGGESTED GUIDELINE FOR TROUBLESHOOTING INVESTIGATION Directions: Review the following list of possible causes for poor Proficiency Testing (PT) performance. Check "PASS" for compliance and "FAIL" for non-compliance indicating potential problems in your lab. Summarize you findings and implement corrective action. Save this checklist with your PT records as documentation of your investigation, corrective action, and Medical Director review. PASS FAIL Results suggest the possibility of room air contamination of sample contents or other pre-analytic errors. Multiple instruments were enrolled, and all failed on the same analyte in the same direction (pos or neg). Low n. The "all-instrument" mean was used as target value instead of the "model-specific" mean. Scoring error. Scoring is inconsistent with CTS model-specific or all-instrument acceptable range. Pre-existing bias. Previous PT SDI rankings are low or unacceptable. Transcription error. Failed to transcribe PT value(s) correctly to CTS Data Input form. Storage error. Failed to store PT material according to CTS package insert instructions. Equilibration error. Failed to ensure temperature equilibration of PT material prior to sampling. Sample handling error. Analyzer mode error. Failed to introduce PT material according to instrument manufacturer's instructions. Sample introduction error. Failed to sample PT material according to instrument manufacturer’s instructions. Preventive maintenance error. Failed to follow instrument manufacturer's service interval recommendations. Sensor/electrode failure. Age and/or performance of the measurement electrode were unsatisfactory. Sample chamber temperature error. Failed to follow instrument manufacturer's recommendations. Instrument "Error Codes" displayed during PT sampling. Failed to initiate corrective action prior to sampling. Reagent expired. Failed to replace reagent when expired. Reagent contaminated. External analysis or internal swapping of buffer/gas standard confirms contamination. Compromised reagent path. Reagent path shows signs of leakage or contamination buildup. Contaminated sample path. Sample path/chamber shows signs of protein buildup or other contamination. Barometric pressure error. Instrument's barometer failed to agree with laboratory standard. Calibration error. Failed to calibrate instrument within manufacturer's specifications. Quality control error. Failed to meet laboratory quality control standards. Other error (describe): Review performed by: Name: CONSULTATION Laboratory Medical Director: Name: Analyzer Field Service Rep: Name: CTS Reference Tech: Name: Corrective Action: Corrective Action Implemented by: Name: Title: Date: Date: Date: Date: Recommendation: Recommendation: Recommendation: Title: Date: For CTS Office use: CTS PROFICIENCY TESTING PROGRAM: VALIDATED AMPULES REQUEST FORM ______ - _____ This order form is provided to all participating laboratories in conjunction with the Cycle Notes and reports. You may order any needed set(s) of five Validated Ampules by faxing this completed order form with credit card information OR sending the completed form with a check to the CTS Main Office at the address listed on the bottom of this form. Requests will be forwarded to the Order Fulfillment Center once your prepaid order/payment has been received and processed. Most requests are filled using 2-day UPS service. SEE REVERSE FOR MORE DETAILS. Routine requests received after 11:00 am Wednesday (Pacific Time) are not processed until the following Monday. Overnight delivery may be available for an additional fee. ANY requests received after 9:30AM Pacific Time on Thursday will not ship until the first business day of the following week. Requesting Account: CTS ID number ____ – __ Requestor’s Name ____________________________________ Phone ____________________________________ Ship to: Institution ____________________________________ Address ______________________________________ ______________________________________ ______________________ Zip ________-____ At this time, we are requesting the following Validated Ampule sets from the most recent PT Cycle: # of Product description Price Extended sets per set price Blood Gas / Electrolytes+ analysis (5 BG samples, including routine s/h) $100 Blood Gas – Hgb/Hct analysis (5 BGHN samples, including routine s/h) $100 CO-Oximetry analysis (5 CO samples, including routine s/h) $100 Overnight delivery $27 CALCULATED TOTAL COST: Prepayment Method (check one): Visa® MasterCard® AmEx® OR overnight check* ____ ____ ____ ____ Expiration Date: Month _ _ Year _ _ _ _ Security Code: _ _ _ Credit Card #: Authorized Signature: _________________________________________________________ PRINT name as it appears on card: ____________________________________ WRITE LEGIBLY TO EXPEDITE APPROVAL! FAX credit card order to 415-764-4933 OR mail form with check* to: CTS PT Main Office 575 Market Street, Suite 2125 San Francisco, CA 94105
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