Laboratory Consulting

Focused on clincial laboratory

Expertise and Experience

Laboratory Consulting Services

To learn more about our consulting services please expand the boxes related to the services your wanting to learn more about. If you need to contact a consultant to setup a consultation there is a consultation request at the end of the page.

New Lab Setups

Xmacode, LLC offers assistance in setting up new laboratories. This service includes:

  • preparation of CMS-116 (CLIA application) and other required forms, as applicable
  • evaluation of laboratory director and other personnel qualifications
  • enrollment in an appropriate proficiency testing program
  • assistance with instrument validation / performance specifications
  • support / education of applicable CLIA requirements

In addition, Xmacode, LLC provides the laboratory with a complete policy / procedure manual (including quality assurance policies / procedures) and all forms needed to maintain CLIA compliance. Xmacode, LLC also provides assistance with the initial CLIA inspection, either on-site or by phone, depending on the laboratory’s needs.

This service is provided through an initial on-site consultation with the laboratory director (and laboratory representative, if applicable). Subsequent contact with the laboratory director and / or laboratory representative may be electronic, via phone, or face-to-face, according to the laboratory’s needs.

Any documents developed may be delivered to the laboratory electronically or in the form of a hard copy (additional printing fee may apply).

Regulatory Compliance

Staying abreast of laboratory compliance and billing industry practices is a challenge for most hospitals, independent commercial laboratories, and contract billing companies. Having an ongoing relationship with a qualified industry expert results in proper regulation application and integration, and prevents organizational misinterpretations, which often leads to management team paralysis, unnecessary costs, loss of revenue and legal exposure

Our compliance and billing advisory services are designed to meet the immediate and long-term needs of each individual client. This flexibility allows our clients to focus on areas of greatest concern to improve services and profitability and maintain an effective compliance program at a reasonable cost.

Laboratory Compliance Audit Assessment

Our laboratory compliance audit assessment is a prospective review of 135 regulatory issues. Our approach is comprehensive, participative, and geared to withstand federal scrutiny.

We focus on all aspects of compliance issues, including not only coding and billing practices, but also all marketing and operational interfaces between referring physicians, contract hospitals, and pathology billing areas, which have traditionally been overlooked.

Mock Laboratory CLIA / CAP / The Joint Commission Inspection

The purpose of our mock laboratory inspection is to prepare clients for a successful outcome in their mandatory CLIA / CAP / The Joint Commission inspection (required every two years). Laboratories that are either ill-prepared or have had deficiencies in past inspections could jeopardize losing their licensure in one or more testing areas; severely hindering service and patient care. The objectives of Xmacode’s mock inspection are to:

  1. Identify any areas of laboratory operation that do not meet the standards required for CAP accreditation (e.g., compliance deficiencies).
  2. Identify areas of laboratory operation that are marginal and in jeopardy of failing accreditation standards.
  3. Provide recommendations to meet CAP accreditation standards.

Our audit assessment includes interviews with selected staff, a review of selected policies and procedures, and an evaluation of CAP laboratory-related practices in the laboratory departments approved for testing. The results of our inspection and recommendations are presented to our clients in a unique ‘report card’ format designed to measure against levels of compliance with accreditation and regulatory standards.

Lab Management

Interim Management

Xmacode, LLC employs industry experts with years of experience in the day-to-day management of complex laboratory operations. For organizations facing critical gaps in personnel, Xmacode,LLC can provide the following interim management – even on short notice – until permanent personnel can be identified, hired, and trained:

  • Compliance Officer
  • Lab Manager
  • Billing Manager
  • Outreach management
  • Controller
  • CFO
  • IT Manager

Staffing & Benchmarking

One of the most significant fixed costs to in a clinical or hospital-based laboratory is the labor component. The way in which this valuable commodity is used (or underused) dramatically impacts the margins and financial health of the laboratory. Xmacode, LLC appreciates the critical importance of the labor component and has developed a number of proprietary tools – using industry benchmark information – to maximize full-time equivalent (FTE) employees while maintaining high quality results. These proprietary tools also assist with pathology staffing and compensation.

Xmacode, LLC uses these tools extensively in our operational assessments and provides impactful results to our clients when advising them upon their particular labor requirements.

Compensation Analysis

Without question, Pathologist compensation is one of the most highly controversial issues impacting employee satisfaction in laboratories today. Xmacode, LLC has been called upon on a number of occasions to analyze and assist in the design of compensation and productivity models for all types of physician specialties.

Quality Assurance

After Xmacode, LLC has performed an initial assessment of the laboratory’s quality assurance program for compliance with CLIA regulations and provided our client with a “Report of Laboratory Assessment”, the laboratory director may recognize a need for assistance with the quality assurance program and monitoring.

Xmacode, LLC offers quality assurance (QA) services to assist the laboratory with establishing, maintaining, and monitoring quality assurance activities in accordance with CLIA regulations. This service includes:

  1. development / revision of QA policies and procedures;
  2. development / revision of QA documentation forms;
  3. gathering and monitoring QA data.

This service is further augmented by educating the laboratory director and key personnel about CLIA’s QA requirements, and their responsibilities per CLIA regulations.

Xmacode, LLC will assist the laboratory director in determining how often QA activities need to be performed and may provide QA monitoring services for the laboratory director (however, CLIA requires the laboratory director to sign and date all QA reports).

Procedure Manual Assistance

After Xmacode, LLC has performed an initial assessment of the laboratory’s policy / procedure manual(s) for compliance with CLIA regulations, and provided our client with a “Report of Laboratory Assessment”, the laboratory director may recognize a need for assistance with establishing and / or revising policies and procedures to meet applicable CLIA regulations.

Xmacode, LLC offers “Procedure Manual Assistance” to help the laboratory establish or revise policies and procedures to meet applicable CLIA regulations. Any policies / procedures (or required elements of a policy / procedure) which are missing are created and provided to the laboratory either electronically or in the form of a hard copy (may be subject to additional printing fee). Once the laboratory has received their new or revised policies and procedures, Xmacode, LLC can performs an on-site visit at the laboratory location to provide any support and educational services needed to implement the new procedures.

Xmacode, LLC is not responsible for any revision of policies / procedures made by the laboratory without the knowledge, consultation, and approval of Xmacode, LLC.

Instrumentation Validation

Xmacode, LLC offers assistance with instrument validation (termed “performance specifications” in CLIA) whenever a new instrument is placed into use, or an existing instrument is moved from one location to another. This service requires the laboratory staff to perform the testing (per CLIA regulations), but Xmacode, LLC offers educational support and an interpretation of the data collected by the laboratory.

Performance specifications generally include:

  1. accuracy
  2. Precision
  3. reportable range
  4. reference ranges

Xmacode, LLC provides the laboratory with all the documentation needed to show instrument validation was performed in accordance with CLIA regulations.

Xmacode, LLC will inform the laboratory director and staff of their responsibilities and how Xmacode, LLC can assist. If subsequent information is needed, Xmacode, LLC may provide that electronically, or face-to-face, depending on the needs of the laboratory.

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