State Operations Manual - CMS

1 State Operations Manual Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services Table of Contents (Rev. 166, 02-03-17) Transmittals for Appendix C SURVEY PROTOCOLS Introduction The Outcome-Oriented Survey Process I. Identifying Sources of Information A. Scheduling Surveys B. Announced and/or Unannounced Surveys C. Pre-Survey Preparation II. Entrance Interview III. Information Gathering A. Organizing the Survey B. Observation of Facilities and Processes C. Interviews D. Record Review IV. Assessing Outcome or Potential Outcome V. Regulatory Compliance Decision VI. Exit Conference VII. Development of the Statement of Deficiencies A. Citing Standard-Level Deficiencies B. Citing Condition-Level Deficiencies C. Choosing the Appropriate Citation D. Mandatory Citations E. Allegation of Compliance/Plan of Correction VIII. Survey Report Documentation and Data Entry IX. Additional Information A. Counting Tests B. Conducting Surveys of Multiple Testing Sites under One Certificate C.

2 Conducting Surveys of Waived Tests D. Conducting Surveys of Certificate for PPM Procedures X. Reporting Complaints B. INDEX REGULATIONS AND INTERPRETIVE GUIDELINES FOR LABORATORIES AND LABORATORY SERVICES Subpart A--General Provisions Basis and Scope Definitions Applicability Categories of Tests by Complexity Laboratories Performing Waived Tests Test Categorization Provider-Performed Microscopy (PPM) Procedures Provider-Performed Microscopy (PPM) Procedures Laboratories Performing Tests of Moderate Complexity Laboratories Performing Tests of High Complexity Subpart B--Certificate of Waiver Application for a Certificate of Waiver Requirements for a Certificate of Waiver Notification Requirements for Laboratories Issued a Certificate of Waiver Subpart C--Registration Certificate, Certificate for Provider-Performed Microscopy Procedures, and Certificate of Compliance Application for Registration Certificate, Certificate for Provider-Performed Microscopy (PPM)

3 Procedures, and Certificate of Compliance Requirements for a Registration Certificate Requirements for a Certificate for Provider-Performed Microscopy (PPM) Procedures Requirements for a Certificate of Compliance Notification Requirements for Laboratories Issued a Certificate of Compliance Notification Requirements for Laboratories Issued a Certificate for Provider-Performed Microscopy (PPM) Procedures Subpart D--Certificate of Accreditation Application for Registration Certificate and Certificate of Accreditation Requirements for a Registration Certificate Requirements for a Certificate of Accreditation Notification Requirements for Laboratories Issued a Certificate of Accreditation Subpart H--Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing Condition: Enrollment and Testing of Samples Condition: Successful Participation Condition: Reinstatement of Laboratories Performing Nonwaived Testing Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Non-waived Tests Condition: Microbiology Standard: Bacteriology Standard: Mycobacteriology Standard: Mycology Standard: Parasitology Standard: Virology Condition: Diagnostic Immunology Standard: Syphilis Serology Standard: General Immunology Condition: Chemistry Standard: Routine Chemistry Standard: Endocrinology Standard: Toxicology Condition: Hematology Standard: Hematology Condition: Pathology Standard: Cytology: Gynecologic Examinations Condition: Immunohematology Standard: ABO Group and D (Rho) Typing Standard: Unexpected Antibody Detection Standard: Compatibility Testing Standard: Antibody Identification Subpart J--Facility Administration for Nonwaived Testing Condition: Facility Administration Standard: Facilities Standard.

4 Requirements for Transfusion Services Standard: Retention Requirements Subpart K--Quality System for Nonwaived Testing Introduction Condition: Bacteriology Condition: Mycobacteriology Condition: Mycology Condition: Parasitology Condition: Virology Condition: Syphilis Serology Condition: General Immunology Condition: Routine Chemistry Condition: Urinalysis Condition: Endocrinology Condition: Toxicology Condition: Hematology Condition: Immunohematology Condition: Histopathology Condition: Oral Pathology Condition: Cytology Condition: Clinical Cytogenetics Condition: Radiobioassay Condition: Histocompatibility General Laboratory Systems Condition: General Laboratory Systems Standard: Confidentiality of Patient Information Standard: Specimen Identification and Integrity Standard: Complaint Investigations Standard: Communications Standard: Personnel Competency Assessment Policies Standard: Evaluation of Proficiency Testing Performance Standard: General Laboratory Systems Quality Assessment Preanalytic Systems Condition: Preanalytic systems Standard: Test Request Standard: Specimen Submission, Handling, and Referral Standard: Preanalytic Systems Quality Assessment Analytic Systems Condition: Analytic Systems Standard: Procedure Manual Standard: Test Systems, Equipment, Instruments, Reagents, Materials, and Supplies Standard: Establishment and Verification of Performance Specifications Standard: Maintenance and Function Checks Standard: Calibration and Calibration Verification Procedures Standard: Control Procedures Standard: Bacteriology Standard: Mycobacteriology Standard: Mycology Standard: Parasitology Standard: Virology Standard: Routine Chemistry Standard: Hematology Standard: Immunohematology Standard.

5 Histopathology Standard: Cytology Standard: Clinical Cytogenetics Standard: Histocompatibility Standard: Comparison of Test Results Standard: Corrective Actions Standard: Test Records Standard: Analytic Systems Quality Assessment Postanalytic Systems Condition: Postanalytic Systems Standard: Test Report Standard: Postanalytic Systems Quality Assessment Subpart M--Personnel for Nonwaived Testing General Laboratories Performing Provider-Performed Microscopy (PPM) Procedures Scope Condition: Laboratories Performing PPM Procedures; Laboratory Director Standard; Laboratory Director Qualifications Standard; PPM Laboratory Director Responsibilities Condition: Laboratories Performing PPM Procedures; Testing Personnel Standard; PPM Testing Personnel Qualifications Standard; PPM Testing Personnel Responsibilities Laboratories Performing Moderate Complexity Testing Condition: Laboratories Performing Moderate Complexity Testing; Laboratory Director Standard; Laboratory Director Qualifications Standard; Laboratory Director Qualifications On or Before February 28, 1992 Standard; Laboratory Director Responsibilities Condition: Laboratories Performing Moderate Complexity Testing; Technical Consultant Standard; Technical Consultant Qualifications Standard; Technical Consultant Responsibilities Condition: Laboratories Performing Moderate Complexity Testing; Clinical Consultant Standard; Clinical Consultant Qualifications Standard; Clinical Consultant Responsibilities Condition: Laboratories Performing Moderate Complexity Testing; Testing Personnel Standard; Testing Personnel Qualifications Standard.

6 Testing Personnel Responsibilities Laboratories Performing High Complexity Testing Condition: Laboratories Performing High Complexity Testing; Laboratory Director Standard; Laboratory Director Qualifications Standard; Laboratory Director Responsibilities Condition: Laboratories Performing High Complexity Testing; Technical Supervisor Standard; Technical Supervisor Qualifications Standard: Technical Supervisor Responsibilities Condition: Laboratories Performing High Complexity Testing; Clinical Consultant Standard; Clinical Consultant Qualifications Standard; Clinical Consultant Responsibilities Condition: Laboratories Performing High Complexity Testing; General Supervisor Standard; General Supervisor Qualifications General Supervisor Qualifications On or Before February 28, 1992. Standard; General Supervisor Responsibilities Condition: Laboratories Performing High Complexity Testing; Cytology General Supervisor Standard; Cytology General Supervisor Qualifications Standard; Cytology General Supervisor Responsibilities Condition: Laboratories Performing High Complexity Testing; Cytotechnologist Standard; Cytotechnologist Qualifications Standard; Cytotechnologist Responsibilities Condition: Laboratories Performing High Complexity Testing; Testing Personnel Standard; Testing Personnel Qualifications Technologist Qualifications On or Before February 28, 1992 Standard.

7 Testing Personnel Responsibilities Subpart Q--Inspection Condition: Inspection Requirements Applicable to All CLIA-Certified and CLIA-Exempt Laboratories Standard: Basic Inspection Requirements for All Laboratories Issued a CLIA Certificate and CLIA-Exempt Laboratories Standard: Inspection of Laboratories Issued a Certificate of Waiver or a Certificate for Provider-Performed Microscopy Procedures Standard: Inspection of Laboratories That Have Requested or Have Been Issued a Certificate of Compliance Standard: Inspection of CLIA-Exempt Laboratories or Laboratories Requesting or Issued a Certificate of Accreditation The items listed below replace the current Publication 7, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services. This material was rewritten due to publication of CMS-2226-F: 42 CFR 493 Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications; Final Rule on January 24, 2003, with an effective date of April 24, 2003.

8 1. Policy for Conducting Surveys 2. Subparts A-H - General Provisions, Certificates and Proficiency Testing of the CLIA regulations - Sections through 3. Subpart J - Facility Administration - Sections through 4. Subpart K, Part 1 - Quality System for Nonwaived Testing; General Laboratory Systems, Preanalytic Systems & Analytic Systems (general requirements) - Sections through 5. Subpart K, Part 2 - Quality System for Nonwaived Testing; Analytic Systems (specialty and subspecialty requirements) and Postanalytic Systems - Sections through 6. Subpart M - Personnel - Sections through 7. Subpart Q - Inspection - Sections through A. SURVEY PROTOCOLS Introduction (Rev. 140, Issued: 05-29-15, Effective: 05-29-15, Implementation: 05-29-15) Survey protocols and interpretive guidelines are established pursuant to pertinent sections of the Social Security Act, the Public Health Service Act, the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and the CLIA regulations at 42 CFR Part 493 to provide guidance to personnel conducting surveys of laboratories.

9 The protocols and guidelines clarify and/or explain the Federal requirements for laboratories and are required for use by all surveyors assessing laboratory performance based on these Federal requirements. The same survey protocols are used by the Centers for Medicare & Medicaid Services (CMS) Regional Office (RO) and/or State Agency (SA) surveyors. The following protocols represent an outcome-oriented method to be used to conduct the survey. The focus of the survey is to assess how the laboratory monitors its Operations and ensures the quality of its testing. The intended use of these protocols is to promote consistency in the approach to the survey process, and to ensure that a laboratory s Operations are reviewed in a practical, efficient, and effective manner so that at the completion of the survey there is sufficient information to make compliance determinations. While the purpose of the protocols and guidelines is to provide direction in preparing for the survey, conducting the on-site survey, analyzing, evaluating, and documenting survey findings, the surveyor s professional judgment is the most critical element in the survey process.

10 CMS s objective is not only to determine the laboratory s regulatory compliance but also to assist regulated laboratories in improving patient care by emphasizing those aspects of the regulatory provisions that have a direct impact on the laboratory s overall test performance. CMS promotes the use of an educational survey process, especially on initial laboratory inspection, to help laboratories understand and achieve the quality system concepts. It is the surveyor s objective, using professional judgment, to determine, based on observation of the laboratory s (past and current) practices, interviews with the laboratory s personnel, and review of the laboratory s relevant documented records, whether it is producing quality test results ( , accurate, reliable, and timely). The primary objective of the survey process is to determine whether or not the laboratory meets the CLIA requirements. The surveyor meets this objective by employing an outcome-oriented survey process or approach, the intent of which is to focus the surveyor on the overall performance of the laboratory and the way it monitors itself, rather than on a methodical evaluation of each standard-level regulatory requirement.