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G0862: Laboratory Services/Clia Waivers

CMS level: Standard Moderate. On this site, a condition-level citation is labeled Serious, a standard-level citation Moderate, and an element-level citation Minor. What the labels mean · How to choose an agency

62times cited
60agencies
17states
2018-01-26 – 2026-08-07survey dates

Data from CMS inspection reports (Form 2567), 2018-01-02 to 2026-10-15, downloaded 2026-10-21; CMS agency list file dated 2026-09-21. CMS source file. What the labels mean

Where it was cited

Most recent citations

The 20 most recent of 62 citations. Newest inspection first.

Mission Minded Home Healthcare

Inspection 2026-08-07

The agency failed to, when engaging in laboratory testing outside of the contact of assisting a patient in in self-administering a test with an appliance that had been cleared for that purpose of the Food and Drug administration, ensure the testing was in compliance with all applicable federal…

Happy Visit Home Health

Inspection 2026-07-28

Therapy services directly inside patients' homes) failed to obtain a current Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver while performing point-of-care blood glucose testing (finger sticks) for one of 8 patients (Patient 8).

All Americans Choice Home Health Inc

Inspection 2026-06-04

The agency failed to maintain and keep current a Clinical Laboratory Improvement Amendment (CLIA—a federal certification that allows healthcare facilities to legally perform simple, low‑risk diagnostic tests) certificate for 132 patients (Patients 1 through 132) during the three‑year period…

Just for Kids Inc

No longer in CMS list
Inspection 2026-03-11

The Home Health Agency (HHA) failed to obtain a CLIA (Clinical Laboratory Improvement Amendment) certificate as required.

Unity Home Health LLC

Inspection 2026-02-25

The agency failed to maintain a current CLIA (Clinical Laboratory Improvement Amendment) certificate as required to conduct laboratory testing.

Ls Healthcare Services LLC

Inspection 2026-01-02

The agency failed to ensure the laboratory testing conducted by HHA employees was in compliance with all applicable requirements of chapter 42 of the Code of Federal Regulations part 493, in that: the agency’s CLIA Certification of (CLIA 1988) for providing waived laboratory services was expired…

New Horizon Home Care, LLC

Inspection 2025-04-25

The facility failed to have a valid Clinical Laboratory Improvement Amendments (CLIA) certificate.

Care Plus Home Health Agency Inc

Inspection 2025-04-23

The agency failed to ensure their Clinical Laboratory Improvement Amendment Certificate (CLIA) was current.

Para Ninos del Valle Pediatric Home Health,PLLC

Inspection 2025-04-16

The agency failed to maintain a CLIA waiver to make sure the laboratory services provided by the agency met certain federal laboratory standards in that the agency's CLIA waiver expired on 07/19/24. This failure could place potential patients at risk of harm due to unregulated laboratory practices.

Golden Care of Northeast PA, Inc

Inspection 2025-02-21

The agency failed to maintain a CLIA Certification of Waiver for 6 of 6 months after expiration of the CLIA Certification of Waiver.

Angel's Hope Home Health, Inc.

Inspection 2025-02-07

The facility failed to maintain a current Clinical Laboratory Improvement Amendments (CLIA) waiver for laboratory testing performed by the Home Health Agency (HHA).

247 Allstaff West LLC

No longer in CMS list
Inspection 2025-01-29

The Home Health Agency (HHA) failed to obtain a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver when employees conducted blood glucose meter testing (test to measure amount of sugar in the blood) for two out of seven sampled patients (Patient 2 and Patient 4).

Good Neighbor Hhc of Brainerd

Inspection 2024-12-17

The facility failed to maintain a CLIA waiver and continued to engage in laboratory testing outside of the context of assisting an individual in self-administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration.

Angels on Earth Home Health Inc

Inspection 2024-11-22

The facility failed to ensure the Clinical Laboratory Improvement Amendments waiver (CLIA waiver - allows a facility to legally perform waived tests to diagnose, treat, and assess a patient's health, and to perform testing of blood sugar levels) was not expired.

Traditions Health of Stigler

Inspection 2023-11-08

The Agency failed to conduct waived testing quality controls and maintain waived testing quality controls records for blood glucose testing for one (#2) of ten (#1-#10) records reviewed.

Beneficial Home Health Services, Inc

Inspection 2023-10-31

The HHA failed to ensure the CLIA waiver certificate was current when conducting the blood glucose testing for two of nine sampled resident (Patients 2 and 8) creating the risk of not meeting the regulatory standards related to laboratory testing.

John C Fremont H C Dist HHA

No longer in CMS list
Inspection 2023-09-25

The agency failed to provide reliable laboratory test for seven of seven sampled patients when the agency collect the laboratory specimen without CLIA (Clinical Laboratory Improvement Amendment - federal regulatory standards that applied to all clinical laboratory testing performed on humans in the…

Emerest Home Health Care of Long Island

Inspection 2023-09-01

The agency failed to ensure the CLIA Certificate of Waiver was kept current.

Golden Home Healthcare Pittsburgh

Inspection 2023-08-23

The agency administrator the agency failed to maintain a Clinical Laboratory Improvement Amendments (CLIA) waiver in order to perform laboratory blood draws within the home as prescribed by the physician for one (1) of three (3) home visits observed.

Oasis HH Operations LLC

No longer in CMS list
Inspection 2023-08-23

The Home Health Agency failed to ensure the agency's appliance for conducting testing had been cleared for that purpose by the Food and Drug Administration.

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