Conducting Surveys of Multiple Testing Sites under One

6140.2 - Conducting Surveys of Multiple Testing Sites under One Certificate (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) 1. Multiple sites are permitted to operate under a single certificate when the sites meet one of the multiple site exceptions at 42 CFR §§ 493.35(b), 493.43(b), or 493.55(b). Each site performing testing under a single certificate must meet all applicable requirements of 42 CFR Part 493. Each site is subject to a survey; however, the primary site or home base, as applicable, should be one of the locations included in the initial CLIA certification survey. Select a representative portion of the remaining locations for onsite survey. When choosing the representative sample for multiple site surveys, consider the following: a. Types of testing performed; b. Types of clients and/or facilities served, e.g., pediatric, geriatric, residential/emergency care, or health assessment screens; c. Location(s) participating in PT; and d. Problems or complaints identified either at the primary or other testing sites. 2. Temporary testing sites, including mobile units, should be inspected using the criteria listed above. Refer to the SOM Chapter 6, §6010.1 to assist with determining what constitutes a mobile unit and for temporary testing sites. Every effort should be made to schedule the survey to coincide with testing at temporary locations. (Refer to 42 CFR §§493.35(b)(1), 493.43(b)(1), 493.55(b)(1)) a. Home Health and Hospice laboratory testing with multiple sites should generally be inspected using the criteria listed above (Refer to CFR §§493.35(b)(1), 493.43(b)(1), 493.55(b)(1)) Refer to SOM Chapter 6 § 6010.1.2.1. Many Home Health Agencies (HHAs) may be certified with multiple sites under one certificate. A parent HHA may apply for one CLIA certificate as long as these sites meet the applicable requirements. Medicare designates these multiple locations using the term “parent location” for the main location and the term “branches” for the additional sites. Hospices may also be certified with one certificate for multiple sites. Refer to the SOM Chapter 6, §6010.1.2.1 for additional information on HHAs and hospices. 3. Refer to the SOM Chapter 6, §6010.2 for additional information on laboratories performing limited public health testing. These entities should be inspected using the above criteria (Refer to 42 CFR §§ 493.35(b)(2), 493.43(b)(2), 493.55(b)(2)) 4. In a hospital laboratory, multiple test sites under one certificate should generally be inspected using the criteria listed above. (Refer to 42 CFR §§ 493.35(b)(3), 493.43(b)(3), 493.55(b)(3)). Refer to SOM Chapter 6 §6010.3. A laboratory having multiple sites under one certificate is required to enroll in only one PT program(s) for the primary test system/procedure for each specialty, subspecialty, analyte or test used under that certificate even though the same specialty, subspecialty, analyte or test may be used at multiple locations using different test systems or procedures and different personnel. Ensure that PT records indicate the location at which the tests were performed, and that all other locations have been compared with the system selected for PT, as specified in 42 CFR §493.1281(a). A condition may be considered out of compliance even if deficiencies are only found at a subset of the sites operating under the single certificate.