On-Site Survey Process

Laboratories seeking a permit must have an initial on-site survey before a permit is issued and before patient testing can be performed. A surveyor from the Department will contact the laboratory to schedule an initial on-site survey. Out-of-state surveys are announced but subsequent routine surveys of in-state laboratories are unannounced. Please note that a survey cannot be scheduled until the laboratory has participated in any required proficiency testing and has submitted validation in accordance with our Submission Guidelines_[1], if required.

The purpose of the survey is to ensure that the premises, laboratory practice, equipment, personnel, and record-keeping meet state requirements. These requirements are outlined in Article 5, Title V of the New York State Public Health Law, Parts 19, 58, 63 and 70 of Title 10, New York Code of Rules and Regulations (10NYCRR)_[2], and in the New York State Clinical Laboratory Standards of Practice_[3].

New York State Public Health Law requires that out-of-state laboratories seeking or reapplying for a clinical laboratory permit pay the travel expenses related to the on-site survey. Travel expenses are based on the number of surveyors involved in the survey, the number of days required for the survey, and the number of facilities surveyed. Laboratories are sent a bill for these expenses after the survey is completed. Survey expenses for in-state laboratories are included in the annual permit fees.

Preparing for your Survey

Facility Personnel Form

This form has been revised and updated to be more informative, current, and user-friendly (drop-down menus). We have transitioned to the use of this form as a required component of the New York State survey process. Laboratories should complete this form in preparation for their New York State survey. Surveys occurring after November 11, 2017 must provide their technical personnel data on this form to meet on-site survey requirements. Please complete all columns for each of your laboratory personnel. The laboratory must complete and submit only one FPF file. Please refer to the instructions for additional information.

Risk Assessment

Educational Materials

Additional Materials and Policies

NYS Cytogenetics Quality Assurance Program Chromosome Microarray Analysis policy_[11]

On-Site Survey Process

Entrance conference

The clinical laboratory consultant will explain the survey and Recreation of the Test Process tool to laboratory personnel. The Recreation of the Test Process Form_[12] is designed to recreate the entire path of testing for specific patient results. The clinical laboratory consultant and laboratory staff will agree on the tests to be used for the Recreation of the Test Process survey tool.
Key staff should attend, including the director and owner/administrator (by phone if necessary).
The surveyor and laboratory staff will review findings from previous surveys and identify any areas of concern, discuss survey objectives, agree upon a survey schedule, discuss any documents that will be required, and identify contacts for the QMS portion of the survey.
Laboratory personnel present changes in operations since the last survey, including new equipment, staffing, client base, additions and deletions to the test menu, and outreach services.
Laboratory personnel explain lines of authority and review the organizational chart.

Recreation of the Test Process Form_[13]

Laboratory orientation

The clinical laboratory consultant will tour the facility while the laboratory assembles the Recreation of the Test Process packages.
Laboratory personnel will demonstrate the path of a specimen through the laboratory, starting with the point of collection/accession.
Specimen handling and the integrity and proper identification of samples throughout the test process will be evaluated through a review of rejection logs, problem samples, STATs, etc.
Safety practices, laboratory workflow, organization and data entry will also be observed.
Surveyors may have informal discussions with laboratory personnel staff.

Survey portion for all categories

The survey will then be conducted in each testing area, centered on the sample patients used for the Recreation of the Test Process review. Particular attention will be paid to new methods and new instruments and to those analytes with poor history in proficiency testing, across permit categories. This part of the survey incorporates the following items:
- Pre-Analytic: requisition with authorized order source, specimen identity and integrity
- Analytic: quality control, calibration, reagent, and validation verification
- Personnel: verify training, competency, education, experience, job descriptions, duties, and continuing education. Laboratories will be required to complete a Facility Personnel Form_[14] for each on-site survey.
- Post-Analytic: reporting with all required elements, timeliness, and notification of critical values
- Process Review: evaluation of proficiency test performance
The clinical laboratory consultant will review the laboratory Quality Manual and determine if procedures need to be created or updated to conform to QMS Standards. Full QMS compliance will be evaluated for the probes of personnel, specimen integrity, proficiency test enrollment and handling, non-conformities, and complaints.
The Specialty Standards of Practice will be surveyed for compliance using Recreation of the Test Process packages. This may be done only for selected specialties, based on the samples selected. Employees involved in the processing of samples selected for the Recreation of the Test Process packages may be interviewed and assessed for knowledge.
The clinical laboratory consultant will perform direct observation of specific test processes that include, but are not limited to, transfusions, distribution of blood products from the pharmacy, radioactive labeling of blood components in nuclear medicine, blood salvage programs in the surgical area, and/or point of care testing, including limited service laboratory registration locations.
The clinical laboratory consultant will verify compliance with the Department's requirements for reporting reportable diseases and conditions as per Communicable Diseases Reporting Guidelines 2020:
- Guidelines for New York City_[15]
- Guidelines for New York State_[16]
During the survey the laboratory will be expected to complete forms to document reporting for the following programs: Communicable Disease, Blood Lead, Cancer Registry, and Heavy Metals.
The surveyor will review procedures for preparedness.

Exit conference

The director and any assistant directors are expected to attend. Other attendees are at the discretion of the laboratory, but it is strongly recommended that representatives from laboratory administration and the laboratory testing staff attend.
Areas of concern will be discussed, and findings will be reviewed.
The clinical laboratory consultant will provide a preliminary assessment of the laboratory's level of compliance with General Standards of Practice as well as any applicable Specialty Standards of Practice. This provides the opportunity for the laboratory to begin developing a plan of correction to the deficiencies identified while waiting for the LER to arrive via email.

Post Survey

Laboratory Evaluation Report

The clinical laboratory consultant submits the survey report to the Program.
Program reviews the report and issues a Laboratory Evaluation Report (LER) to the laboratory.
Laboratories must respond to deficiencies identified in the LER using the Plan of Correction (POC) Form within fourteen days of receipt of the LER. The laboratory will be notified if there are any concerns with the POC or requested to submit a revised POC if the plan is found unacceptable.
The Plan of Correction Worksheet_[17] provides the elements of the plan of correction your facility will receive in response to the findings identified in your Laboratory Evaluation Report. This document is a worksheet and is not to be submitted as your plan of correction. If this document s submitted, it will be returned.
The Plan of Correction Guidance Document_[18] provides instruction for completion of the Plan of Correction template the laboratory will receive with the Laboratory Evaluation Report.