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Based on observation, review of Surgical Airflows Analysis Report Results, standards for Airflow in the surgical areas, and Manufacture's instructions for the use of Enzymatic and interviews, it was determined the facility failed to ensure:

1. The Airflow in the Surgical Areas met ASHRAE (American Society of Heating, Refrigeration, and Air-Conditioning Engineers) guidelines.

2. The Semi-Critical Equipment was cleaned according to the Manufacture instructions.

This had the potential to affect all patients served by this facility who underwent a cardiac catheterization and endoscopy.

Findings include:

Guidelines for Design and Construction of Health Care Facilities 2006

Chapter 2.1 General Hospitals

Table 2.1-2 Ventilation Requirements for Areas Affecting Patient Care in Hospitals and Outpatient Facilities

X-ray (surgical/critical care and catheterization) Minimum total air changes per hour = 15.

Enzymatic cleanser instruction:

1 to 2 ounces of Enzymatic to a gallon of water.

Review of the Surgical Airflows Analysis Report Results dated 10/21/11 revealed the following air changes per hour:

Cath Lab ( Cardiac Catheterization Laboratory) # 1 = 9.98
Cath Lab # 2 = 10.81
Cath Lab # 3 = 6.40
Cath Lab # 4 = 6.72

Review of the Surgical Airflows Analysis Report Results dated 1/11/12 revealed the following air changes per hour:

Cath Lab # 1 = 14.42
Cath Lab # 2 = 14.25
Cath Lab # 3 = 7.73
Cath Lab # 4 = 12.58

Review of the Surgical Airflows Analysis Report Results dated 4/20/12 revealed the following air changes per hour:

Cath Lab # 1 = 9.98
Cath Lab # 2 = 12.47
Cath Lab # 3 = 7.50
Cath Lab # 4 = 10.34

Review of the Surgical Airflows Analysis Report Results dated 7/9/12 revealed the following air changes per hour:

Cath Lab # 1 = 6.74
Cath Lab # 2 = 10.74
Cath Lab # 3 = 6.30
Cath Lab # 4 = 7.90

An interview was conducted on 8/1/12 at 10:15 AM with Employee Identifier (EI) # 1, the Facility Manager. The surveyor asked what the action plan was for the decreased air exchanges in the cath labs and the response was that an air conditioner was being built to meet the requirements and the Infection Control Coordinator was monitoring the Cardiac cath patients for infections.

An interview was conducted with EI # 2 , the Infection Control Coordinator on 8/1/12 at 10:50 AM. The surveyor asked how they were monitoring the patient who received a cardiac cath at the facility and the response was, " We have a good rapport with the physicians and they let us know if there is an infection".

EI # 2 submitted a list of patients who developed an infection after a procedure in the cath lab and that included 4 patients from 2011 and one patient from January to June 2012.

A tour of the Endoscopy Department was conducted on 8/1/12 at 11:45 AM with EI # 3, an Endoscopy staff member. EI # 3 discussed the cleaning of the scopes to include 6 gallons of water and 3 pumps of Enzymatic cleaner. One pump of Enzymatic was measured and equaled 1 ounce which equaled 3 ounces of Enzymatic to 6 gallons of water (below the manufactures instructions).

An observation was conducted on 8/1/12 at 2:00 PM with EI # 4, the Endoscopy Tech cleansing an endoscope. EI # 4 filled the sink to the 6 gallon mark and place 3 pumps of enzymatic into the water to clean the scope.

An interview was conducted on 8/1/12 at 2:30 PM with EI # 5, a Quality Coordinator who verified EI # 4 did not use the manufacture required amount of enzymatic to clean the scope.