Preparing for a CAP Inspec1on

Transcription

1 Preparing for a CAP Inspec1on Jacqueline Brooks, HTL, SCT, MB (ASCP) Q IHC 5/9/2017 1

2 Thank you for agending Preparing for a CAP InspecKon. This is a reminder that to receive a contact hour cerkficate for the meekng you must report your agendance to NSH through the NSH Contact Hour Portal - ce.nsh.org. InstrucKons for adding your hours to your account are located below. If you have any queskons, please contact the NSH office, Kind regards, INSERT NAME Direc&ons for Submi0ng Your Hours to the NSH Contact Hour Portal 1. Login to NSH Contact Hour Portal ce.nsh.org (do not use www prior to the web address) a. First Time to the Site? complete the Not Yet Registered form to create your contact hour portal user account. Once you have created a user account you will be asked to complete the user profile form (your name, address etc). To complete the profile and access hours from previous events you will need your NSH Customer ID number in the first step. b. Finding or Gecng an NSH Customer ID# - You can log into My NSH from nsh.org and find your Customer ID # on the profile page. You can access a short video that explains where to find the number. If you are not a member of NSH or have not agended an event or purchased a book from NSH in the past you may need to create an account through the My NSH portal on nsh.org to get your Customer ID#. Here is a short video to explain the process: 2. Once you are logged in select Session Tracker from the top naviga&on 3. Add your Contact Hours for an event a. Step 1: Year: Select the year in which the event was held. b. Step 2: Event Title: All events approved in a specific year for contact hours by NSH are available to you to in this drop down list. Select the name of the event you agended: Aurora Diagnos,cs Webinar Series. c. Step 3: Session Title: Select the workshop or webinar you agended: Preparing for a CAP Inspec,on. The number of contact hours awarded for this session is preset and cannot be edited. d. Step 4: Add: Click on Add and your workshop or webinar will appear in your session log listed below. 4. Print your contact hour cer&ficate a. Click on the box next to each session you would like to appear on your cerkficate. b. Make sure you click all of the sessions from one event if you want them to appear on one cerkficate. c. If you want all of your hours for a specific year you will need to click on all of the sessions from that year. 5/9/2017 2

3 Cunningham Pathology, Your CEU approval documents (Certificate, Approval Letter, and Invoice) have been uploaded to your CEU Vendor Information page. All documents will be available until the listed expiration date. You can access these documents with the following username and password: Username: cunninghampathology Password: Filter your Recent Activity to approved titles only; your most recent approvals will be at the bottom of the list. If you login via any other AAPC page, you will need to hover over My AAPC (top right, in the blue bar) and click on Overview under CEU Vendor to see the Recent Activity. Please give all attendees a copy of the original PDF CEU certificate. This is the only certificate AAPC will accept from a member for CEUs. The PDF is not to be altered, other than adding the name of the recipient and the date of the course. Please see AAPC CEU Vendor Guidelines for additional information. Thank you! AAPC CEU Vendor Department 5/9/2017 3

4 AAPC Approved CEUs Recent Activity Title SubmiGed ExpiraKon Approval Documents Status Lung Cancer Laboratory Tests 05/02/16 05/31/17 Communica&on 06/01/16 06/30/17 Breast Cancer 06/21/16 06/30/17 Understanding Regulatory Requirements in the Laboratory The Adventurous Travels of Specimen HPV (Human Papillomavirus) Processing and Instrumenta&on For Every Specimen There is a Pa&ent 07/20/16 07/31/17 08/19/16 08/31/17 09/27/16 09/30/17 10/19/16 10/31/17 11/29/16 11/30/17 Tuberculosis 12/22/16 12/31/17 Microscopic Tissue Iden&fica&on STI cytology and Molecular Tes&ng with associated CPT codes 02/08/17 02/28/18 03/09/17 03/31/18 Gene&c Tes&ng 03/28/17 03/31/18 Preparing for a CAP Inspec&on Breast Cancer Breast CAncer Processing and Instrumenta&on Quality withing the Laboratory 04/28/17 04/30/18 5/9/2017 4

5 Health Informa1on Privacy The Office for Civil Rights enforces the HIPAA Privacy Rule, which protects the privacy of individually idenkfiable health informakon; the HIPAA Security Rule, which sets nakonal standards for the security of electronic protected health informakon; and the confidenkality provisions of the PaKent Safety Rule, which protect idenkfiable informakon being used to analyze pakent safety events and improve pakent safety. It is required by law to provide HIPAA educakon and training to individuals working in the healthcare industry to ensure accountability for the privacy and security of protected health informakon. Covered enkkes must train all members of the workforce on HIPAA policies and procedures. 5/9/2017 5

6 Clinical Laboratory Improvement Amendments From Wikipedia, the free encyclopedia Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory teskng performed on humans in the United States, except clinical trials and basic research. 5/9/2017 6

7 CLIA Program In accord with the CLIA, the CLIA Program sets standards and issues cerkficates for clinical laboratory teskng. CLIA defines a clinical laboratory as any facility which performs laboratory teskng on specimens derived from humans for the purpose of providing informakon (1) for the diagnosis, prevenkon, or treatment of disease or impairment, and (2) for the assessment of health. An objeckve of the CLIA is to ensure the accuracy, reliability and Kmeliness of test results regardless of where the test was performed. 5/9/2017 7

8 Centers for Medicare and Medicaid Services (CMS) (CMS) has the primary responsibility for the operakon of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State OperaKons, Survey and CerKficaKon Group, Division of Laboratory Services. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory teskng (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 254,000 laboratory enkkes. The Division of Laboratory Services, within the Survey and CerKficaKon Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implemenkng the CLIA Program. The objeckve of the CLIA program is to ensure quality laboratory teskng. Although all clinical laboratories must be properly cerkfied to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilikes. 5/9/2017 8

9 The CLIA Program The CLIA Program is funded by user fees collected from approximately 250,000 laboratories, most located in the United States. Clinical Laboratory Improvement Amendments (CLIA) 5/9/2017 9

10 DO I NEED TO HAVE A CLIA CERTIFICATE? CLIA requires all facilikes that perform even one test, including waived tests, on materials derived from the human body for the purpose of providing informakon for the diagnosis, prevenkon, or treatment of any disease or impairment of, or the assessment of the health of, human beings to meet certain Federal requirements. If a facility performs tests for these purposes, it is considered a laboratory under CLIA and must apply and obtain a cerkficate from the CLIA program that corresponds to the complexity of tests performed. 5/9/

11 WHAT ARE THE DIFFERENT TYPES OF CLIA CERTIFICATES AND HOW LONG ARE THEY EFFECTIVE? All types of cerkficates are effeckve for two years and the different types of cerkficates are: COW (CERTIFICATE OF WAIVER) PPM (PROVIDER PERFORMED MICROSCOPY) COR (CERTIFICATE OF REGISTRATION) COC (CERTIFICATE OF COMPLIANCE COA (CERTIFICATE OF ACCREDITATION) 5/9/

12 Cer1ficate of Waiver (COW): Issued to a laboratory that performs only waived tests. TESTS GRANTED WAIVED STATUS UNDER CLIA This list includes updates from Change Request FFS9797 * Newly added waived test system 2 CPT CODE(S) TEST NAME MANUFACTURER USE 80047QW, 82330QW, 82374QW, 82435QW, 82565QW, 82947QW, 82950QW, 82951QW, 82952QW, 84132QW, 84295QW, 84520QW, 85014QW Abbott i-stat Chem8+ Cartridge {Whole Blood} i-stat Corporation Measures ionized calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, urea nitrogen, and hematocrit in whole blood 80048QW 1. Abaxis Piccolo Blood Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood} Abaxis, Inc Measures total calcium, carbon dioxide, chloride, creatinine, glucose, potassium, sodium, and urea nitrogen in whole blood 2. Abaxis Piccolo xpress Chemistry Analyzer (Basic Metabolic Reagent Disc){Whole Blood} Abaxis, Inc 80051QW 1. Abaxis Piccolo Blood Chemistry Analyzer (Electrolyte Metabolic Reagent Disc){Whole Blood} Abaxis, Inc. Measures carbon dioxide, chloride, potassium, and sodium in whole blood 2. Abaxis Piccolo xpress Chemistry Analyzer (Electrolyte Metabolic Reagent Disc){Whole Blood} Abaxis, Inc QW 1. Abaxis Piccolo Blood Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood} Abaxis, Inc. Measures alanine amino transferase, aspartate amino transferase, albumin, total bilirubin, total calcium, carbon dioxide, chloride, creatinine, glucose, alkaline phosphatase, potassium, total protein, sodium, and urea nitrogen in whole blood 2. Abaxis Piccolo xpress Chemistry Analyzer (Comprehensive Metabolic Reagent Disc){Whole Blood} 5/9/2017 Abaxis, Inc. 12

13 Cer1ficate for Provider Performed Microscopy (PPM) procedures: Issued to a laboratory in which a physician, midlevel prackkoner or denkst performs specific microscopy procedures during the course of a pakent s visit. A limited list of microscopy procedures is included under this cerkficate type and these are categorized as moderate complexity. The PPM-certified testing site is restricted to nine specific microscopic examinations using bright-field or phase-contrast microscopy: All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements All potassium hydroxide (KOH) preparations Pinworm examinations Fern tests Post-coital direct, qualitative examinations of vaginal or cervical mucous Urine sediment examinations Nasal smears for granulocytes Fecal leukocyte examinations Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility) Under PPM, the testing site may also perform all waived testing. 5/9/

14 Cer1ficate of Registra1on: Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) teskng unkl the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulakons. Only laboratories applying for a cerkficate of compliance or a cerkficate of accreditakon will receive a cerkficate of registrakon. 5/9/

15 Cer1ficate of Compliance (COC): Issued to a laboratory once the State Department of Health conducts a survey (inspeckon) and determines that the laboratory is compliant with all applicable CLIA requirements. This type of cerkficate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) teskng. 5/9/

16 Cer1ficate of Accredita1on (COA): Issued to a laboratory on the basis of the laboratory s accreditakon by an accreditakon organizakon approved by CMS. This type of cerkficate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) teskng. 5/9/

17 There are Six CMS-approved accredita1on organiza1ons 1. AABB 2. American Osteopathic AssociaKon (AOA) 3. American Society of HistocompaKbility and ImmunogeneKcs (ASHI) 4. COLA 5. College of American Pathologists (CAP) 6. American AssociaKon for Laboratory AccreditaKon 7. AccreditaKon of Healthcare OrganizaKons (JCAHO) 5/9/

18 CERTIFICATE OF ACCREDITATION If you apply for accreditakon by one of the CMS-approved accreditakon organizakons, you must also apply to CMS for a COA concurrently. 5/9/

19 WHAT IS A WAIVED TEST? As defined by CLIA, waived tests are categorized as simple laboratory examinakons and procedures that have an insignificant risk of an erroneous result. The Food and Drug AdministraKon (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer s applicakons for test system waiver. 5/9/

20 HOW CAN I FIND A LIST OF WAIVED TESTS? For a list of waived tests sorted by analyte name, visit the FDA website at hgp:// analyteswaived.cfm For a list of waived tests sorted by the test categorizakon date and by the test system name, visit the FDA website at hgp:// 5/9/

21 WHERE CAN I FIND INFORMATION ABOUT TESTS CATEGORIZED AS NONWAIVED (I.E., MODERATE AND/OR HIGH COMPLEXITY)? To determine which tests are categorized as waived or nonwaived (i.e., moderate or high complexity), refer to the lists of tests online at hgp:// 5/9/

22 Tes1ng Classifica1on You may also contact the local survey agency at your State Health Department for categorizakon informakon concerning tests that you may be performing in your laboratory. A list of State Agency addresses, phone numbers and contact persons is available online under the heading State Survey Agencies (CLIA Contact List) at the CMS CLIA website. If you do not have online access or have queskons concerning cerkficakon, you may contact the CMS CLIA Central Office at for the address and phone number of your local State Agency. 5/9/

23 ARE THERE ANY STATES THAT EXEMPT ME FROM HAVING TO APPLY FOR A CLIA CERTIFICATE? Any laboratory located in a state that has a CMS approved laboratory program is exempt from CLIA cerkficakon. Currently, there are two states with approved programs: Washington and New York. New York has a parkal exempkon; therefore, if your laboratory is located in that state, contact the New York State Agency concerning your need for a CLIA cerkficate. 5/9/

24 IF I HAVE MORE THAN ONE LABORATORY LOCATION, DO I NEED A CLIA CERTIFICATE FOR EACH LOCATION? You will need a CLIA cerkficate for each locakon where you perform teskng unless you qualify for one of the excepkons listed below. Laboratories that are not at a fixed locakon; that is, laboratories that move from teskng site to teskng site, such as mobile units providing laboratory teskng, health screening fairs, or other temporary teskng locakons may be covered under the cerkficate of the designated primary site or home base, using its address. Not-for-profit or Federal, State or local government laboratories that engage in limited public health teskng, may file a single applicakon. Laboratories within a hospital that are located at conkguous buildings on the same campus and under common direckon may file a single applicakon for the laboratory sites within the same physical locakon or street address. Contact your State Agency if you have queskons or you are filing a single applicakon for more than one teskng site. 5/9/

25 WHAT KIND OF FEES DO I HAVE TO PAY TO CMS FOR A CLIA CERTIFICATE? If you apply for COW or a PPM cerkficate, you will pay a minimal cerkficate fee every two years. There are no registrakon or compliance fees. 5/9/

26 COST If you apply for a COC, you will pay a one Kme minimal registrakon fee that covers the cost of the CLIA enrollment in addikon to a compliance fee that covers the cost of the inikal inspeckon by the State Agency. CMS will send you a CerKficate of RegistraKon. Once compliance has been determined by your inspeckon, you will pay a cerkficate fee to CMS and CMS will send you a COC. A two-year cerkficate cycle is then established, and you will pay a cerkficate fee and a compliance fee every two years. CMS will send you a COC as long as your laboratory is in compliance. 5/9/

27 COST If you apply for a COA, you will pay a minimal registrakon fee that covers the cost of the CLIA enrollment. Once CMS receives verificakon from the accreditakon organizakon that you have selected, you will pay a cerkficate fee and validakon fee to CMS and CMS will send you a COA. A two year cerkficate cycle is then established and you will pay a cerkficate fee and a validakon fee every two years. CMS will send you a COA as long as your laboratory remains compliant. You will pay survey and any other fees to the accreditakon organizakon. 5/9/

28 COST You can obtain more informakon concerning the amount of cerkficate fees from the CMS CLIA website under CLIA CerKficate Fee Schedule or from your State Agency. For informakon concerning compliance (survey) fees, you may contact your State Agency or accreditakon organizakon. These fees are based on the number and types of teskng you perform and must cover the cost of the CLIA program because CLIA is enkrely user fee funded. 5/9/

29 WILL I RECEIVE AN IDENTIFYING CLIA NUMBER? You will receive a ten-digit number on the CLIA cerkficate. This number will be uklized to idenkfy and track your laboratory throughout its enkre history. You should use this number when making inquiries to the State Agency and CMS about your laboratory. 5/9/

30 WHEN CAN I BEGIN TESTING? Arer you apply for your cerkficate, you will receive a coupon nokfying you of the corresponding fee. Follow the instruckons on the fee coupon for payment. Arer CMS receives your payment, your cerkficate will be mailed to you. You may begin teskng once you have received your cerkficate containing your CLIA number. However, you need to check with your State Agency since some states have addikonal requirements. 5/9/

31 NONWAIVED TESTING If your laboratory performs any nonwaived teskng, the laboratory may have either a COC or COA. All laboratories with either of these cerkficate types must meet all nonwaived teskng requirements and are subject to biennial surveys, by CMS or a CMS agent (such as a surveyor from the State Agency) or by a CMS-approved accreditakon organizakon, if the laboratory is accredited. COA laboratories must also meet the requirements of their accreditakon organizakon. CAP INSPECTIONS 5/9/

32 UNEXPECTED CLIA INSPECTIONS AddiKonally, a limited percentage of laboratories with a COA will receive a validakon survey by CMS or a CMS agent. This is a survey performed by CMS or a CMS agent to evaluate the results of the most recent survey performed by an accreditakon organizakon. NOTE: If CMS or the State Agency receives a complaint against your laboratory, you may receive an unannounced on site survey, even though you only perform waived tests or PPM procedures. 5/9/

33 Requirements IF I HAVE A COA OR A COC, CAN I ALSO PERFORM PPM PROCEDURES? Yes, these cerkficates permit laboratories to perform PPM procedures as well as waived tests. The cerkficate you obtain should be for the highest (most complex) category of teskng you perform. 5/9/

34 CHANGES DO I NEED TO NOTIFY ANYONE IF I MAKE ANY CHANGES IN MY LABORATORY? For all types of CLIA cerkficakon, you must nokfy the State Agency or your accreditakon organizakon within 30 days of any changes in: Ownership Name LocaKon Director Technical supervisor (for high complexity teskng only) 5/9/

35 ADDING PROCEDURES If you perform only waived tests and wish to add PPM procedures or other nonwaived (moderate or high complexity) teskng to your menu, you must reapply for the appropriate cerkficate using the same form (Form CMS-116) you used for your inikal CLIA cerkficakon. However, you cannot begin nonwaived teskng unkl you have paid the appropriate fee, and have received the appropriate cerkficate. If you perform PPM procedures and wish to add other nonwaived (moderate or high complexity) teskng, you must first apply for the appropriate cerkficate. 5/9/

36 NEW TESTING If you have a COC or COA and wish to add tests categorized under a different laboratory specialty or subspecialty than those on your current cerkficate or that employ a different test method from those you are already performing, you must nokfy the State Agency or the accreditakon organizakon of the new teskng. 5/9/

37 QUESTIONS IF I HAVE ANY QUESTIONS ABOUT MY CERTIFICATE OR CHANGES IN MY TEST MENU, WHO SHOULD I CONTACT? You should contact the State Agency where your laboratory is located. You can find this informakon as well as other informakon about CLIA at or you may contact the CMS CLIA Central Office at /9/

38 CAP The CAP Laboratory AccreditaKon Program is an internakonally recognized program and the only one of its kind that uklizes teams of prackcing laboratory professionals as inspectors. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to posikvely impact pakent care. 5/9/

39 CAP The program is based on rigorous accreditakon standards that are translated into detailed and focused checklist requirements. The checklists, which provide a quality prackce blueprint for laboratories to follow, are used by the inspeckon teams as a guide to assess the overall management and operakon of the laboratory. 5/9/

40 CAP The CAP Laboratory AccreditaKon Program meets the needs of a variety of laboratory secngs from complex university medical centers to physician office laboratories. The program also covers a complete array of disciplines and teskng procedures. Because of its comprehensive nature, CAP accreditakon can help achieve a consistently high level of service throughout an insktukon or healthcare system. 5/9/

41 CAP The Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory AccreditaKon Program deeming authority. It is also recognized by the Joint Commission, and can be used to meet many state cerkficakon requirements. The CAP also provides laboratory accreditakon to forensic urine drug teskng and reproduckve laboratories, co-sponsored with the American Society for ReproducKve Medicine (ASRM). CAP 5/9/

42 What is an accredited laboratory? An accredited laboratory is one that is inspected by a private not-forprofit accredikng organizakon that has been approved by the Centers for Medicare and Medicaid Services (CMS) and its requirements deemed as equivalent to or more stringent than CMS's regulatory requirements. An approved accredikng organizakon can inspect a laboratory in lieu of CMS. 5/9/

43 What is CAP accredita1on? The goal of the CAP Laboratory AccreditaKon Program is to improve pakent safety by advancing the quality of pathology and laboratory services through educakon, standard secng, and ensuring laboratories meet or exceed regulatory requirements. Upon successful complekon of the inspeckon process, the laboratory is awarded CAP accreditakon and becomes part of an exclusive group of more than 7,000 laboratories worldwide that have met the highest standards of excellence. 5/9/

44 Benefits of CAP Accredita1on Comprehensive Evalua,ons All test results need to be accurate-every Kme-no mager where they are performed. The CAP accommodates all different types of labs so that you can maintain a consistently high level of service across your enkre organizakon Expert Inspec,on Teams The CAP Laboratory AccreditaKon Program is the only one of its kind that uklizes mulk-disciplinary teams of prackcing lab professionals as inspectors. Because they deal with lab issues on a daily basis, these inspectors are uniquely qualified to provide you with a thorough inspeckon that is specific for each seckon of the lab. 5/9/

45 CAP Compliance with Regula,ons The CAP Laboratory AccreditaKon Program helps you meet and exceed requirements of the Centers for Medicare and Medicaid Services (CMS) as well as those of other nakonal and state regulatory bodies. Unparalleled Educa,onal Opportuni,es Lab professionals are involved on both sides of the inspeckon process, so there is always a healthy exchange of ideas and discussion of the latest lab techniques that goes beyond regulatory requirements. There is something valuable to take away from every inspeckon. 5/9/

46 CAP Useful Inspec,on Tools The InspecKon Checklists constantly evolve to reflect current prackces and technologies and therefore serve as living documents on good laboratory prackce. Adhering to the Checklists provides assurance that your lab is doing all it can to produce the highest quality test results. Recogni,on as a Top Performer Over 83% of the top major teaching and large community hospitals* choose the CAP as their accredikng agency. By achieving the highest standards in the industry you not only gain the confidence and trust of your community but also disknguish yourself as a leader who is commiged to quality pakent care. 5/9/

47 CAP The CAP AccreditaKon Checklists include many valuable features: Incorporate the development and support of board-cerkfied pathologists and conknually evolve to reflect current technology. Provide a solid foundakon for ensuring excellence in pakent safety and compliance. Specify detailed requirements that inspectors use to conduct the inspeckon. Serve as a tool used by an inspector to evaluate the inspected laboratory against the Standards for Laboratory AccreditaKon. Act as guidelines for development of policies, procedures, and processes to help ensure accurate, reliable laboratory test results. 5/9/

48 CAP EOC Using Evidence of Compliance (EOC) This component, which appears with several checklist requirements, is intended to: 1 Assist a laboratory in preparing for an inspeckon and managing ongoing compliance 2 Drive consistent understanding of requirements between the laboratory and the inspector 3 Provide specific examples of acceptable documentakon (policies, procedures, records, reports, charts, etc.) In addikon to the Evidence of Compliance listed in the checklist, other types of documentakon may be acceptable. Whenever a policy/procedure/process is referenced within a requirement, it is only repeated in the Evidence of Compliance if such statement adds clarity. All policies/procedures/ processes covered in the CAP checklists must be documented. A separate policy is not needed for each item listed in EOC as it may be referenced in another policy. 5/9/

49 CAP CAP has streamlined the inspeckon approach used during onsite inspeckons and is now offering guidance to inspectors by providing assessment techniques to facilitate a more efficient, consistent, and effeckve inspeckon process. Specific inspector instruckons are listed at the beginning of a grouping of related requirements. Rather than reviewing each individual requirement, CAP inspectors are encouraged to focus on the Inspector InstrucKons for a grouping of related requirements. Once an area of concern has been idenkfied through "Read," "Observe," "Ask," "Discover," or a combinakon thereof, inspectors are encouraged to "drill down" to more specific requirements, when necessary and review more details outlined in the Evidence of Compliance statements. If a requirement is non-compliant, circle the requirement number to later list on the Inspector SummaKon Report. Inspectors may also make notes in the margins of the checklist document. Inspector InstrucKons and Icons used to evaluate a laboratory's performance now appear in several areas throughout the Inspector Checklists. Please note that all four R.O.A.D elements are not always applicable for each grouping, or seckons of related requirements. 5/9/

50 CAP Inspector InstrucKons: READ/review a sampling of laboratory documents. InformaKon obtained from this review will be useful as you observe processes and engage in dialogue with the laboratory staff. (Example of the complimentary inspector instruckons for Quality Management/Quality Control General Issues seckon appearing across checklists): Sampling of QM/QC policies and procedures Incident/error log and correckve ackon OBSERVE laboratory prackces by looking at what the laboratory personnel are actually doing and note if prackce deviates from the documented policies/procedures. (Example) Observe the secngs/qc range limits established in the laboratory LIS/HIS to ensure that the laboratory's stated ranges are accurately reflected ASK open-ended, probing queskons that start with phrases such as "tell me about..." or "what would you do if..." This approach can be a means to corroborate inspeckon findings that were examined by other techniques, such as Read & Observe. Ask follow-up queskons for clarificakon. Include a variety of staff levels in your communicakon process. (Example) As a staff member, what is your involvement with quality management? How do you detect and correct laboratory errors? 5/9/

51 CAP DISCOVER is a technique that can be used to "drill down" or further evaluate areas of concern uncovered by the inspector. "Follow the specimen" and "teach method" are two examples of Discovery. UKlizing this technique will allow for the discovery of pre-analykc, analykc, and post-analykc processes while reviewing mulkple requirements simultaneously. (Example) Select several occurrences in which QC is out of range and follow documentakon to determine if the steps taken follow the laboratory policy for correckve ackon 5/9/

52 CAP An inspeckon of a laboratory seckon, or department will include the discipline-specific checklist(s), the Laboratory General Checklist, and the All Common Checklist. In response to the ongoing request to reduce the redundancy within the AccreditaKon Checklists, the CAP accreditakon program is introducing the All Common Checklist (COM). The purpose of the All Common Checklist is to group together those requirements that were redundant in Laboratory General and the discipline-specific checklists. Therefore, the CAP centralized all requirements regarding: proficiency teskng, procedure manuals, test method validakons, and crikcal results into one checklist, the COM checklist. 5/9/

53 TEAM LEADER SUMMARY OF CHANGES UNDERSTAINDING THE CAP ACCREDITATION CHECKLIST COMPONENTS INSTRUCTIONS DEFINITION OF TERMS LABORATORY DIRECTOR ASSESSMENT QUALIFICATIONS AND GENERAL REQUIREMENTS DIRECTOR RESPONSIBILITY AND OVERSIGHT DIRECTOR NOT ON-SITE FULL TIME 5/9/

54 ALL COMMON SUMMARY OF CHANGES UNDERSTANDING THE CAP ACCREDITION CHECKLIST COMPONENTS INTRODUCTION DEFINITION OF TERMS ALL COMMON CHECKLIST PROFICIENCY TESTING QUALITY MANAGEMENT GENERAL ISSUES SPECIMEN COLLECTION AND HANDLING PROCEDURE MANUAL RESULTS REPORTING REAGENTS INSTRUMENTS AND EQUIPMENT Instrument and Equipment Maintenance/FuncKon Checks Thermometers Temperature-Dependent Instruments, Equipment, and Environments -TEST METHOD VALIDATION METHOD PERFORMANCE SPECIFICATIONS- NON-WAIVED TESTS REFERENCE INTERVALS - INDIVIDUALIZED QUALITY CONTROL PLAN (IQCP) 5/9/

55 LABORATORY GENERAL CHECKLIST SUMMARY OF CHANGES UNDERSTANDING THE CAP ACCREDIATION CHECKLIST INTRODUCTION DEFINITIAON OF TERMS QUALITY MANAGEMENT 5/9/

56 Lab General Specimen CollecKon, Handling, and ReporKng Specimen CollecKon InstrucKons Specimen CollecKon and Labeling Specimen Transport and Tracking RequisiKons and Specimen Receipt/Handling/Processing Results ReporKng and Referral of TesKng 5/9/

57 Lab General Quality of Water and Glassware washing Laboratory Computer Services Computer Facility Hardware and Sorware System Security PaKent data Auto-verificaKon Date Retrieval and preservakon Interfaces 5/9/

58 Lab General Personnel SecKon Directors(Technical Supervisors)/General Supervisors Technical and Clinical Consultant All Personnel Physical FaciliKes Space Environment CommunicaKons Inventory and Storage of Supplies Power 5/9/

59 Lab General Laboratory Safety Safety Policies, Procedurs and Records Bloodborne Pathogens Other InfecKous Hazards Fire PrevenKon and ProtecKon Electrical Safety Compressed Gases RadiaKon Safety Environmental Safety Other Hazards Waste Disposal 5/9/

60 Lab General BIOREPOSITORY ACCREDITTION PROGRAM (BAP) ONLY A Biorepository is a biological materials repository that collects, processes, stores, and distributes biospecimens to support future scienkfic inveskgakon Biorepositories can contain or manage specimens from animals, including humans, and many other living organisms. Vertebrates, invertebrates, arthropods, and other lifeforms are just a few of the many classes of living organisms which can be studied by preserving and storing samples taken. 5/9/

61 ANATOMIC PATHOLOGY SUMMARY OF CHANGES INTRODUCTION General Anatomic Pathology..Safety 5/9/

62 ANATOMIC PATHOLOGY SURGICAL PATHOLOGY QUALITY MANAGEMENT QUALITY CONTROL SURGICAL SPECIMEN EXAMINATION INTRA-OPERATIVE CONSULTATION (RAPID DIAGNOSIS) FINE NEEDLE ASPIRATE (FNA) SPECIMENS SURGICAL PATHOLOGY REPORTS 5/9/

63 ANATOMIC PATHOLOGY HISTOLOGY LABORATORY GENERAL QUALITY CONTROL 5/9/

64 ANATOMIC PATHOLOGY IMMUNOLOGIC AND MOLECULAR METHODS IMMUNOFLUORESCENCE MICROSCOPY IMMUNOHISTOCHEMISTRY FLUORESCENCE AND NON-FLUORESCENCE INSITUHYBRIDIZATION (FISH, ISH) PREDICTIVE MARKERS DIGITAL IMAGE ANALYSIS VALIDATION AND CALIBRATION QUALITY CONTROL SPECIMEN ANALYSIS DNA STAINING REPORTS PERSONNEL -INSTRUMENTS AND EQUIPEMNT EQUIPMENT MAINTENANCE PIPETTES AND THERMOMETERS TISSUE PROCESSOR FLOATION BATHS MICROTOMES 5/9/

65 ANATOMIC PATHOLOGY PHYSICAL FACILITIES STORAGE AND SUPPLY AUTOPSY LABORATORY SAFETY QUALITY MANAGEMENT AUTOPSY CONSENT PROCEDURES AUTOPSY ROOM AUTOPSY PERFORMANCE AND DOCUMENTATION AUTOPSY SAFETY 5/9/

66 ANATOMIC PATHOLOGY ELECTRON MICROSCOPY QUALITY CONTROL ELECTRON MICROSCOPY SAMPLE PREPARTION INSTURMENTS AND EQUIPMENT REPORTS RECORDS, FILES AND PHOTOGRAPHS LABORTORY SAFETY 5/9/

67 CYTOPATHOLGY SUMMARY OF CHANGES INTRODUCTION DEFINITION OF TERMS 5/9/

68 CYTOPATHOLOGY GENERAL CYTOPATHOLOGY INTERLABORATORY COMPARISONS QUALITY MANAGEMENT QUALITY CONTROL SPECIMEN COLLECTION AND RECEIPT CYTOLOGY STAINS AND SLIDE PREPARTIONS ON-SITE MICROSCOPIC REVIEW INSTRUMENTS AND EQUIPMENT RECORDS AND REPORTS RETENTION OF SLIDES STATISTICAL RECORDS 5/9/

69 CYTOPATHOLOGY GENECOLOGIC CYTOPATHOLOGY NON-GENECOLOGIC CYTOPATHOLOGY PERSONNEL PHYSICAL FACILITIES LABORATORY SAFETY 5/9/

70 MICROBIOLOGY GENERAL MICROBIOLOGY BACTERILOGY MYCOBACTERILOGY MYCOLOGY PARASITOLOGY VIROLOGY MOLECULAR MICROBIOLOGY 5/9/

71 MOLECULAR MICROBIOLOGY GENERAL REQUIREMENTS QUALITY MANAGEMENT QUALITY CONTROL PROCEDURE MANUAL SPECIMEN HANDLING & PROCESSING RESULTS REPORTING REAGENTS PROCEDURES AND TESTS INSTRUMENTS LABORATORY SAFETY PERSONNEL 5/9/

72 MOLECULAR MICROBIOLOGY FDA CLEARED/APPROVED NON-AMPLIFICATION METHODS QUALITY CONTROL ASSAY VERIFICATION FDA CLEARED/APPROVED TARGET & SIGNAL AMPLIFICATIN METHODS & SEQUENCING QUALITY CONTROL SEQUENCING ASSAY VERFICATION 5/9/

73 MOLECULAR MICROBIOLOGY LABORATORY-DEVELOPED OR MODIFIED FDA CLEARED / APPROVED TESTS QUANTITATIVE ASSAYS; CALIBRATION & STANDARDS QUALITY CONTROL SEQUENCING TEST PROCEDURES ASSAY VALIDATION 5/9/

74 FLOW CYTOMETRY QUALITY MANAGEMENT AND QUALITY CONTROL SPECIMEN COLLECTION AND HANDLING RAGENTS RECORDS AND REPORTS CONTROLS AND STANDARDS INSTRUMENTS AND EQUIPMENT FLOW CYTOMETERS TEMPERATURE-DEPENDENT EQUIPMENT THERMOMETERS AUTOMATIC PIPETTING DIVICES PROCEDURES AND TEST SYSTEMS IMMUNOPHENOTYPING BLOOD LYMPHOCYTE SUBSET ENUMERATION CD34 STEM CELL ENUMERATION LEUKEMIC AND LYMPHOMA DNA CONENT AND CELL CYCLE ANALYSIS PERSONNEL 5/9/

75 Team Leader and All Common Table of Contents CAP # Page TEAM LEADER Laboratory Director QualificaKons and ResponsibiliKes CPA.GEN TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC TLC /9/

76 Title of Manual: Team Leader All Common Document Number: CPA.GEN Version No: 1.0 Effec&ve Date: Revised Date: Revised: Revised: Title: Laboratory Director Qualifica&ons and Responsibili&es Page 1 of 5 I. PURPOSE To assure that: 1. Individuals serving as Laboratory Director possess the appropriate licensure and board certification in accordance with federal regulatory agencies and corporate requirements. 2. The responsibilities associated with serving as Laboratory Director are specified. II. MATERIALS Reagents Supplies Equipment A N/A N/A III. PROCEDURE QUALIFICATIONS 1. Licensure: Be an MD or DO licensed to practice (if required) in the jurisdiction where the laboratory is located, and Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or American Osteopathic Board of Pathology, or possess qualifications equivalent in those required for certification. 2. OR Be an MD, DO or DPM licensed to practice (if required) in the jurisdiction where the laboratory is located, and Have at least one year of laboratory training during residency, or at least two years of experience supervising high complexity testing. 3. OR Hold an earned doctoral degree in chemical, physical, biological, or clinical laboratory science from an accredited institution, and Be certified and continue to be certified by a board approved by HHS 4. A single individual may direct no more than 5 laboratories 5. Credential for all personnel trained outside the US must be reviewed and documented to ensure that their training and qualifications are equivalent to CLIA requirements. 5/9/2017 PROVISION OF AP SERVICES 76 Anatomic pathology services are provided by a pathologist certified in an anatomic pathology or possessing qualifications equivalent to those required for certification.

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78 THE END Tips for Performing Your CAP Self-Inspection Performing your CAP self-inspection will help you achieve: Ongoing compliance with the CAP Checklist Requirements Improved preparedness for your next unannounced inspection Improved laboratory performance and better patient care 1 2 PREPARE Have your self-inspection simulate a real inspection event. - Formalize a self-inspection procedure. View the Laboratory Data Report on e-lab Solutions for accuracy. - Notify the CAP of any demographic changes. Confirm that proficiency testing (PT) is being performed for each required analyte. - View the Laboratory Activity Menu with PT Options (or the Missing PT Enrollment) Report online. - The 2010 CAP Surveys catalog, Tab 21, can provide you with a list analytes for which PT is required. - Notify the CAP of any changes to your Activity Menu that might affect PT enrollment. Determine the date that the inspection will occur. (Remember that this should be unannounced.) Select a team to perform the unannounced inspection. - Involve a variety of staff levels to prepare and cultivate new team members. - Include a mix of supervisory staff, non-supervisory staff, residents, and fellows. - Consider using a sister facility and cross discipline lines for a fresh, unbiased perspective. Encourage staff and inspectors to complete inspector education. Available courses include: - Accreditation Education Activities at - Virtual library of audioconferences from the CAP home page, click on the Accreditation and Laboratory Improvement tab; under CAP Accreditation and Inspection Information, choose Virtual Library of Past Audioconferences; then choose Performing Effective Self-Inspections - Laboratory Accreditation Manual and Checklist Activities from the CAP home page, click on the Education Programs tab; under Course Catalog, choose CONDUCT Review previously cited deficiencies and proficiency testing performance. Check deficiency responses against current practice. Ensure compliance with each checklist question including any new CAP requirements. Communicate with a variety of staff levels. As you experience the self-inspection consider how you would respond to the following if the supervisor or laboratory director was not present: - Are you prepared to explain a certain procedure or practice? - Are you aware where various policies are located? - Are you aware where quality control and instrument maintenance records are located? 3IMPROVE Conduct a summation conference. Review cited deficiencies. Develop a corrective action plan with appropriate staff members. Implement the plan to review corrections and ensure compliance. Retain self-inspection documentation for the next onsite inspection team to review. Return the Self-Inspection Instructions and Verification Form to the CAP within 60 calendar days. Need assistance? Call the CAP at or or us at accred@cap.org. 5/9/