SOM - Chapter 6

State Operations Manual: Chapter 6 - Special Procedures for Laboratories-Lab Services

 
 Date PostedPublication
8/13/2009 §6000 - Background 
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8/13/2009 §6002 - CLIA Applicability 
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8/13/2009 §6004 - Consultative CLIA Activities 
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8/13/2009 §6006 - Application & Certificate Process 
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8/13/2009 §6007 - CLIA Certificate Status Changes 
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8/13/2009 §6008 - Criteria for One Certificate for Multiple Sites 
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8/13/2009 §6010 - Assignment of CLIA Identification Numbers 
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8/13/2009 §6012 - CLIA Information in OSCAR System 
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8/13/2009 §6014 - CLIA Data System 
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8/13/2009 §6016 - Revised Certificates 
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8/13/2009 §6018 - Fee Adjustments 
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8/13/2009 §6020 - Regional Office (RO) Role 
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8/13/2009 §6022 - Laboratories Under Direct RO Jurisdiction 
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8/13/2009 §6024 - RO Review of SA Certification Activities 
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8/13/2009 §6026 - State Agency (SA) Role 
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8/13/2009 §6028 - CLIA Laboratories - Compliance With Civil Rights Requirements 
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8/13/2009 §6030 - Referrals to the Office of Inspector General (OIG) 
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8/13/2009 §6032 - Notification of Change in Laboratory Operations 
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8/13/2009 §6034 - Mobile Laboratories 
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8/13/2009 §6036 - Facilities With Multiple Sites 
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8/13/2009 §6038 - Transfusion Services Covered by CMS/FDA (MOU) 
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8/13/2009 §6040 - Transfusion-Related Fatalities 
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8/13/2009 §6042 - Proficiency Testing (PT) 
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8/13/2009 §6044 - Enrollment Information 
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8/13/2009 §6046 - PT for Non-Accredited and Non-CLIA Exempt Labs 
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8/13/2009 §6048 - PT Enrollment, Participation, and Testing Requirements 
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8/13/2009 §6050 - Monitoring of PT Scores 
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8/13/2009 §6052 - PT Monitoring System Reports 
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8/13/2009 §6054 - Unsuccessful Performance in Proficiency Testing 
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8/13/2009 §6056 - Excused Failure to Participate in Testing Event for Particular Analyte 
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8/13/2009 §6058 - Unsuccessful Participation in PT 
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8/13/2009 §6060 - Reinstatement After Failure to Successfully Participate in PT 
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8/13/2009 §6061 - PT Referral 
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8/13/2009 §6062 - Onsite Observation of Proficiency Testing 
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8/13/2009 §6063 - Survey Protocols for Compliance with Cytology PT 
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8/13/2009 §6100 - The Survey Process - Emphasis, Components, & Applicability 
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8/13/2009 §6102 - Scheduling Surveys 
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8/13/2009 §6106 - Policy on Announcing Surveys 
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8/13/2009 §6108 - Survey Responsibilities 
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8/13/2009 §6110 - Survey Team Size and Composition 
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8/13/2009 §6112 - Laboratory Self-Assessment 
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8/13/2009 §6114 - AQAS Verifications and Summaries 
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8/13/2009 §6116 - Laboratory Refuses to Allow Survey 
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8/13/2009 §6118 - During the Survey 
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8/13/2009 §6120 - Completing the Survey Report (Form CMS-1557) 
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8/13/2009 §6122 - Credentialing of Foreign Trained Laboratory Personnel 
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8/13/2009 §6124 - Preparation for Exit Conference 
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8/13/2009 §6126 - Exit Conference 
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8/13/2009 §6128 - Certification Actions Performed After Survey 
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8/13/2009 §6130 - Statement of Deficiencies and Plan of Correction, Form CMS-2567 
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8/13/2009 §6132 - Follow-Up on PoCs 
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8/13/2009 §6134 - Evaluation of Compliance 
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8/13/2009 §6135 - Data Management 
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8/13/2009 §6136 - Complaints Involving Laboratories 
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8/13/2009 §6138 - Retention of CLIA Certification Records 
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8/13/2009 §6139 - Media Representatives Referred by the CMS Press Office 
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8/13/2009 §6150 - Background - CMS Approval of Accreditation Organizations 
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8/13/2009 §6151 - Accredited Laboratories - Deemed Status 
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8/13/2009 §6152 - Accreditation Validation Surveys - Citations and General Description 
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8/13/2009 §6154 - Objective of Validation Surveys of Accredited Laboratories 
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8/13/2009 §6156 - Selection of Sample for Validation Surveys of Accredited Labs 
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8/13/2009 §6158 - Preparing for Validation Surveys of Accredited Labs 
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8/13/2009 §6162 - Accredited Labs Refusal to Permit a Validation Survey 
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8/13/2009 §6164 - Conducting Validation Surveys of Accredited Labs 
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8/13/2009 §6166 - Results of Validation Surveys of Accredited Labs 
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8/13/2009 §6170 - Forwarding Completed Validation Survey Info to CO 
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8/13/2009 §6172 - Notification Requirements of Approved Accreditation 
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8/13/2009 §6174 - Basis for Validation Survs of Accredited Labs 
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8/13/2009 §6200 - CMS Approval of State Lab Licensure Programs  
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8/13/2009 §6202 - Validation Survs of CLIA-Exempt Labs - Citations & Objectives 
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8/13/2009 §6204 - Number & Criteria for Selection of CLIA-Exempt Labs for Valid Survs 
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8/13/2009 §6206 - Preparing Sample Validation Survey of CLIA-Exempt Labs 
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8/13/2009 §6208 - Conducting Validation Surveys of CLIA-Exempt Labs 
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8/13/2009 §6210 - Results of CLIA-Exempt Validation Survey - RO & SA Respon 
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8/13/2009 §6212 - Processing Validation Survey Records 
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8/13/2009 §6214 - Evaluation of Approved State Licensure Program 
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8/13/2009 §6216 - Onsite Visit to State Laboratory Program 
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8/13/2009 §6218 - Notification Responsibilities of Approved State Licensure Program 
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8/13/2009 §6226 - Simultaneous Validation Surveys - General 
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8/13/2009 §6227 - Scheduling Simultaneous Valid Survs & Coor Pre-Surv Arrangements 
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8/13/2009 §6228 - Onsite Activities - Simultaneous Validation Surveys 
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8/13/2009 §6230 - CLIA State Agency Performance Review (SAPR) 
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8/13/2009 §6232 - CLIA Federal Monitoring Survey (FMS) Selection 
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8/13/2009 §6234 - FMS of Laboratories - Definitions & Purpose 
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8/13/2009 §6236 - CLIA-FMS Procedures 
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8/13/2009 §6238 - Completion of FMS Workload & Time Expenditures 
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8/13/2009 §6240 - Other Special Purpose Federal Surveys - Definitions 
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8/13/2009 §6250 - Purpose of and Basis for Enforcement Action 
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8/13/2009 §6252 - Definitions/Terminology - Enforcement 
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8/13/2009 §6254 - Denial of Form CMS-116 from Prospective Lab 
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8/13/2009 §6256 - Voluntary Withdrawal from CLIA Program 
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8/13/2009 §6260 - Requests to Change Cert Type When Enforce Action is Pending 
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8/13/2009 §6262 - CLIA Conditions Not Met - Enforce Options for All Labs 
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8/13/2009 §6264 - CLIA Conditions Not Met 
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8/13/2009 §6266 - Failure to Furnish Notification of Changes 
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8/13/2009 §6270 - Enforce Based on Actions of Labs Owner, Operator, or Employees 
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8/13/2009 §6272 - Sanction(s) - Factors Considered 
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8/13/2009 §6274 - Principal Sanctions 
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8/13/2009 §6276 - Alternative Sanction: Directed PoC & Directed Portion of PoC 
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8/13/2009 §6278 - Alternative Sanction: State Onsite Monitoring 
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8/13/2009 §6280 - Alternative Sanction: Civil Money Penalty 
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8/13/2009 §6282 - Noncompliance With One or More Conditions - IJ Exists 
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8/13/2009 §6284 - Noncompliance With One or More Conditions - No IJ 
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8/13/2009 §6286 - Ensuring Timely Correction of Condition-Level Defs 
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8/13/2009 §6288 - Procedures for Noncompliant Fed and State Operated Labs 
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8/13/2009 §6289 - Withdrawal or Denial of Laboratory Accreditation 
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8/13/2009 §6290 - Proc for Labs Found Out of Compliance During a Surv of Accred Lab 
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8/13/2009 §6292 - Deficiencies That Are Not at Condition Level 
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8/13/2009 §6293 - Intervening Actions That Do Not Postpone or Delay Enforce Time 
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8/13/2009 §6294 - Duration of Alternative Sanctions 
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8/13/2009 §6295 - Lifting of Alternative Sanctions 
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8/13/2009 §6296 - Sanction Imposed on Any Type of CLIA Certificate 
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8/13/2009 §6297 - Summary of RO Respon During CLIA Adverse Action Process 
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8/13/2009 §6298 - Limitation on Medicaid Payment 
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8/13/2009 §6299 - CLIA Violations 
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8/13/2009 §6300 - Application of Appeals Procedures 
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8/13/2009 §6302 - Reconsideration 
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8/13/2009 §6304 - RO Notice of Reconsidered Determination 
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8/13/2009 §6306 - Administrative Hearing 
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8/13/2009 §6308 - Processing of Hearing Requests 
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8/13/2009 §6310 - Scheduling of the Hearing 
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8/13/2009 §6312 - Adverse Hearings Decisions by ALJ 
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8/13/2009 §6314 - Readmission to CLIA Program 
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8/13/2009 §6316 - Laboratory Registry 
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8/13/2009 §6400 - The CLIA Fed/State Relationship 
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8/13/2009 §6402 - Federal Administrative Responsibilities 
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8/13/2009 §6404 - Nature and Source of Payments to States 
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8/13/2009 §6406 - State Agency Administrative Responsibilities 
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8/13/2009 §6408 - State Agency Responsibility for Records & Reports 
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8/13/2009 §6410 - State Agency Respon for Staff Training & Dev 
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8/13/2009 §6412 - Role of the CMS RO With State Agency Prog Admin 
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8/13/2009 §6414 - CLIA Budget - RO Procedures 
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8/13/2009 §6416 - Budget Call - RO Procedures 
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8/13/2009 §6418 - Regional Allocations 
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8/13/2009 §6420 - The SA Agency Annual Activity Plan 
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8/13/2009 §6422 - Planning the Annual Workload - SA Procedures 
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8/13/2009 §6424 - Elements in the Annual Activity Plan 
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8/13/2009 §6426 - Format for the Annual Activity Plan - SA Procedures 
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8/14/2009 §6428 - Survey Team Composition and Workload Report 
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8/14/2009 §6430 - Basis for Determining CLIA-Related Costs - SA Procedures 
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8/14/2009 §6432 - Promotional & Public Inform Activities - SA Procedures 
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8/14/2009 §6434 - The State Budget Request 
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8/14/2009 §6436 - State Budget Request, CLIA, Form CMS-102 
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8/14/2009 §6438 - Form CMS-105, Planned Workload Report - CLIA 
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8/14/2009 §6440 - Form CMS-1466, State Agency Schedule for Equip Purch 
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8/14/2009 §6442 - Form CMS-1465A, State Agency Bud List of Positions 
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8/14/2009 §6444 - State Budget Request Submittal - CLIA 
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8/14/2009 §6446 - Developing Budget Approval - RO Procedures 
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8/14/2009 §6448 - RO State Agency Budget Review - Form CMS-102 
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8/14/2009 §6450 - Employee Salaries & Wages - RO Procedures 
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8/14/2009 §6452 - Retirement Contributions & Fringe Benefits - RO Procedures 
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8/14/2009 §6454 - Travel - RO Procedures 
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8/14/2009 §6456 - Communications & Supplies - RO Procedures 
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8/14/2009 §6458 - Office Space - RO Procedures 
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8/14/2009 §6460 - Equipment - RO Procedures 
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8/14/2009 §6462 - Training - RO Procedures 
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8/14/2009 §6464 - Consultants - RO Procedures 
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8/14/2009 §6466 - Subcontracts - RO Procedures 
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8/14/2009 §6468 - Miscellaneous - RO Procedures 
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8/14/2009 §6470 - Indirect Costs - RO Procedures 
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8/14/2009 §6472 - Hourly Rate Requested - RO Procedures 
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8/14/2009 §6474 - Planned Workload Report - Form CMS-105 - RO Procedures 
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8/14/2009 §6476 - Schedule of Equip Purch - Form CMS-1466 - RO Procedures 
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8/14/2009 §6478 - Prep of List of Positions - Form CMS-1465A - RO Procedures 
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8/14/2009 §6480 - Line Item Approval for Personal Services - RO Procedures 
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8/14/2009 §6482 - Need for Additional Funds - RO Procedures 
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8/14/2009 §6484 - Need for Additional Funds - SA Procedures 
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8/14/2009 §6486 - State Agency Accounts & Reporting 
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8/14/2009 §6488 - Support for Expenditures - SA Procedures 
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8/14/2009 §6490 - Certificate of Authority - SA Procedures 
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8/14/2009 §6492 - Cash Basis - SA Procedures 
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8/14/2009 §6494 - Limit on Expenditures - SA Procedures 
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8/14/2009 §6496 - Periodic Analysis of Accounts - SA Procedures 
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8/14/2009 §6498 - Cash Balances & Expenditure Authority - SA Procedures 
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8/14/2009 §6500 - Unliquidated Obligations - SA Procedures 
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8/14/2009 §6502 - Nothing to Report on a Given Line - SA Procedures 
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8/14/2009 §6504 - SA Forwarding Materials to the RO 
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8/14/2009 §6506 - State Agency Files Used for Case Control & Reporting 
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8/14/2009 §6508 - SA Establishment of Case Controls 
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8/14/2009 §6510 - Payment by Electronic Transfer of Funds - SA Procedures 
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8/14/2009 §6512 - State Expense Reporting 
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8/14/2009 §6514 - Employee Salaries & Wages - Distrib of Staff Time for Prog Purp 
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8/14/2009 §6516 - Determination of Necessary Staff - SA Procedures 
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8/14/2009 §6518 - Retirement Contributions & Fringe Benefits - SA Procedures 
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8/14/2009 §6520 - Travel - SA Procedures 
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8/14/2009 §6522 - Communications & Supplies - SA Procedures 
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8/14/2009 §6524 - Office Space - SA Procedures 
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8/14/2009 §6526 - Privately-Owned Space - SA Procedures 
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8/14/2009 §6528 - Space in Publicly-Owned Buildings - SA Procedures 
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8/14/2009 §6530 - Repairs & Alterations - SA Procedures 
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8/14/2009 §6532 - Identifiable (Direct) Costs - SA Procedures 
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8/14/2009 §6534 - Office Maintenance - SA Procedures 
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8/14/2009 §6536 - Equipment - SA Procedures 
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8/14/2009 §6538 - Retirement & Social Security - SA Procedures 
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8/14/2009 §6540 - Other Expenses - SA Procedures 
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8/14/2009 §6542 - Consultants - SA Procedures 
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8/14/2009 §6544 - Training of State Agency Personnel - SA Procedures 
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8/14/2009 §6546 - Miscellaneous - SA Procedure 
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8/14/2009 §6548 - Goods, Facilities, Services From Other Staff or Local Agencies 
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