Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 670029 (X3) Date Survey Completed 03/15/2011
Name of Provider or Supplier First Surgical Hospital Street Address, City, State 4801 Bissonnet Blvd, Bellaire, TX
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
A0576 LABORATORY SERVICES
CFR(s): 482.27

The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter.


This CONDITION is not met as evidenced by:
Based on observation, interview, and record review the Hospital failed to ensure 1of 7 out-patient emergency departments had a CLIA certificate (Clinical Laboratory Improvement Amendments) prior to performing laboratory studies onsite. (Bellaire Emergency Center) Findings include: Observation 3/10/11 at 3 p.m. at Bellaire Emergency Center revealed a laboratory with testing equipment. No CLIA certificate was posted. The Medical Director (ID# 58) of Bellaire Emergency center acknowledged 3/11/11 at 8:50 a.m. the center did not have a CLIA certificate. The Medical Director stated that the center performs laboratory work onsite for "Internal reasons only." The Medical Director further stated that all laboratory studies are sent out to Hospital ID# 90. The Chief Executive Officer (CEO) acknowledged 3/10/11 at 3 p.m. the hospital just realized two weeks ago that Bellaire Emergency Room did not have a CLIA certificate. The CEO could not locate a contract with Hospital ID# 90 to perform laboratory studies for Bellaire emergency center. Interview 3/11/11 at 9 a.m. with the Medical Laboratory Director (ID# 82) revealed he was aware that Bellaire emergency center did not have a CLIA certificate. The Laboratory Director stated he was not really aware of the arrangements between the out-patient emergency rooms and the hospital because he primarily oversees the Hospital laboratory. Record review of a policy titled "Clinical Laboratory Scope of Services" dated 11/30/06 stated "The responsibilities of the Medical Laboratory Director will include: assuring compliance with the applicable regulations." The Centers for Medicare and Medicaid web page regarding "Clinical Laboratory Improvement Amendments (CLIA)" stated "CLIA requires all entities that perform even one test, including waived tests.......to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program." Record review of patient ID# 48 revealed he was treated at Bellaire emergency room on 3/9/11. The record revealed laboratory studies were performed at Bellaire emergency center without a CLIA certificate. Laboratory studies included Comprehensive Metabolic panel, complete blood count, and a urinalysis.