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.

2 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.

3 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.

4 Certificate for Provider-Performed microscopy (PPM) 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.

5 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: Requirements for Transfusion Services Standard.

6 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.

7 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: Histopathology Standard: Cytology Standard: Clinical Cytogenetics Standard: Histocompatibility Standard.

8 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.

9 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; Testing Personnel Responsibilities Laboratories Performing High Complexity Testing Condition: Laboratories Performing High Complexity Testing; Laboratory Dir