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Based on review of records, observation, and interview, the facility failed to protect and promote the patient's right to receive care in a safe setting. The facility failed to ensure proper applications, inspections, and approval for use were obtained from regulatory agencies prior to constructing and operating a new cardiac catheterization lab at Facility #3. Review of patient records showed 4 out of 4 patients (Patient #5, #6, #7, and #8) who received cardiac catheterization procedures at Facility #3, received care in a setting that had not been inspected and approved for occupancy to ensure that it meets the LSC requirements for the provision of safe care of patients.

This deficient practice was determined to place all patients who received care in the newly constructed cardiac catheterization lab at risk of potential harm.

Cross Refer to Tag A0144 for specific findings.

Based on review of records, observation, and interview, the facility failed to ensure proper applications, inspections, and approval for use were obtained from regulatory agencies prior to constructing and operating a new cardiac catheterization lab at Facility #3. Review of patient records showed 4 out of 4 patients (Patient #5, #6, #7, and #8) who received cardiac catheterization procedures at Facility #3, received care in a setting that had not been inspected and approved for occupancy to ensure it meets the LSC requirement for the provision of safe care to patients.

This deficient practice was determined to place all patients who received care in the newly constructed cardiac catheterization lab at risk of potential harm.


(Explanation of Cardiac Catheterization - Per the National Institute of Health's National Heart, Lung, and Blood Institute, "during cardiac catheterization, a long, thin, flexible tube called a catheter is put into a blood vessel in your arm, groin or upper thigh, or neck. The catheter is then threaded to your heart. Your doctor may use it to examine your heart valves or take samples of blood or heart muscle. Your doctor also may use ultrasound or inject a dye into your coronary arteries to see whether your arteries are narrowed or blocked. Cardiac catheterization may also be used instead of some heart surgeries to repair heart defects and replace heart valves.")


Findings:

During pre-survey preparation, an search was made of public information and advertising for the facility. A public Internet site for the hospital included an advertisement for a Ribbon Cutting Ceremony and Health Fair Event to be held on 2-26-2020 at Facility #3. The advertisement indicated that Facility #3 had a Cardiac Catheterization Lab which was a new service.

On 2-24-2020 during the entrance conference, Staff #1 was asked about this new service. Staff #1 stated that they were very excited to be offering Diagnostic Cardiac Catheterization at the new Cath Lab they had built. When asked how long the Cath Lab had been opened, Staff #1 stated it was opened at the beginning of December 2019.

When asked to provide copies of notification to the state regulatory agency of the addition of new services, change functional operation, and approval for construction, Staff #1 stated they did not have that information. Staff #1 stated later in the day on 2-24-2020 that the architect employed by the hospital said they did not need to contact the state regulatory agency for approval of construction of the cardiac catheterization lab at Facility #3.

Because there was no notification to the regulatory agency with approval of architectural plans, inspection of construction at the required phases of build, and final inspection for approval, patients being treated in the Cardiac Catheterization Lab have the potential for being treated in an unsafe setting.

Review of the Cardiac Catherization Lab logs showed that the temperature and humidity for the rooms and temperature for the medication storage refrigerator were first monitored starting on December 1, 2019. This was consistent with Staff #1's statement that the Cardiac Catheterization Lab was completed and opened for services in December.

Review of the hospital's form titled Infection Control Construction Permit showed that the Infection Control Preventionist conducted an infection control risk assessment for the construction project on 1-19-2019. Construction Activity was classified as "Type D: Major duration and construction activities. Requiring consecutive work shifts". The Infection Control Risk Group was classified as "Group 3: Medium/High Risk". The Project Start Date was listed as 1-19-2019 with the estimated duration listed as "Long Term".

Review of the Governing Body meeting minutes for 7-31-2019 showed that the former CEO had reported to the board "that the Fire Marshall had approved the Cath Lab at the ________ (Facility #3) location". Review of Governing Body meeting agendas and minutes for the 10-2-2019 and 12-17-2019 meetings did not include any information on the construction completion, opening, or operation of a Cardiac Catheterization Lab at Facility #3.

Review of the Procedure Log for the Cardiac Catheterization Lab at Facility #3 showed that Patient #5 had a Left Heart Catheterization performed in the Cardiac Catheterization Lab at Facility #3 on 10-29-2019. This date was over a month before the December date that Staff #1 had reported the Cath Lab was completed and opened for procedures. This was over a month before the temperature and humidity for the rooms and temperature for the medication storage refrigerator were first monitored. Because there were no records of inspections, it was unknown as to the stage of completion of the construction project. The next procedure was not performed until 12-2-2019. This was consistent with date that had been reported for construction completion and opening of the Cardiac Catheterization Lab, as well as documentation of monitoring of temperatures and humidity necessary for maintaining a safe environment. It was unknown what the temperature and humidity in the procedure room and supply room was on 10-29-2019 to ensure a safe environment for the procedure.

Patient #6 had a Left Heart Catheterization performed at Facility #3 on 12-2-2019. Patient #7 had a Left Heart Catheterization performed at Facility #3 on 12-18-2019. Patient #9 had an Abdominal Aortogram with Runoff (a procedure to find areas of blood vessels where they may be narrowing or closing) performed at Facility #3 on 12-18-2019.

All four patients had procedures performed in an area that had not been inspected by the state regulatory agency and approved as safe for patient care.


Review of the Texas Administrative Code, Title 25 Health Services, Part 1 Department of State Health Services, Chapter 133 Hospital Licensing, Subchapter I Physical Plant And Construction Requirements, RULE §133.161 Requirements for Buildings in Which Existing Licensed Hospitals and RULE §133.168 Construction, Inspections, and Approval of Project Are Located were as follows:

"§133.161 (a) Compliance. All buildings in which existing hospitals licensed by the Department of State Health Services (department) are located shall comply with this subsection.

(1) Minimum fire safety and construction requirements.

(A) Existing licensed hospitals shall meet the requirements for health care occupancies contained in the 1967, 1973, 1981, 1985, 1991, 1997, 2000, or 2003 editions of the National Fire Protection Association 101, Life Safety Code, (NFPA 101), the Hospital Licensing Standards/Rules (1969, 1985, or 1998 editions as amended), and the hospital licensing rules under which the buildings or sections of buildings were constructed. All documents published by NFPA as referenced in this section may be obtained by writing or calling the NFPA at the following address or telephone number: National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.

(B) Existing hospitals or portions of existing hospitals constructed prior to the adoption of any of the editions of NFPA 101, the Hospital Licensing Standards, and the hospital licensing rules listed in subparagraph (A) of this paragraph, shall comply with this section and Chapter 19, NFPA 101, 2003 edition.

(C) Compliance with the requirements of Chapter 4 of the National Fire Protection Association 101A, Alternative Approaches to Life Safety, 2001 edition, (relating to Fire Safety Evaluation System for Health Care Occupancies) will be acceptable in lieu of complying with the requirements of Chapter 19, NFPA 101, 2003 edition.

(2) Remodeling of existing facilities. All requirements listed in this chapter relating to new construction are applicable to renovations, additions and alterations unless stated otherwise.

(A) Alteration or installation of new equipment. Any alteration or any installation of new equipment shall be accomplished as nearly as practicable with the requirements for new construction, except that when existing conditions make changes impractical to accomplish, minor deviations from functional requirements may be permitted if the intent of the requirements is met and if the care and safety of patients will not be jeopardized.

(B) Installation, alteration, or extension approval. No new system of mechanical, electrical, plumbing, fire protection, or piped medical gas system may be installed or any such existing system may be replaced, materially altered or extended in an existing building licensed as a hospital, until complete plans and specifications for the replacement, installation, alteration, or extension have been submitted to the department, reviewed and approved in accordance with §133.167 of this title (relating to Preparation, Submittal, Review and Approval of Plans, and Retention of Records).

(C) Minor remodeling or alterations. All remodeling or alterations which do not involve alterations to load bearing members or partitions, change functional operation, affect fire safety (e.g. modifications to the fire, smoke, and corridor walls), add or subtract beds or services for which the hospital is licensed, and do not involve changes listed in subparagraph (B) of this paragraph, shall be submitted for approval without submitting contract documents. Such approval shall be requested in writing with a brief description of the proposed changes in accordance with §133.167(f)(3) of this title.

(D) Major remodeling or alterations. Plans shall be submitted in accordance with §133.167 of this title for all major remodeling or alterations. All remodeling or alterations which involve alterations to load bearing members or partitions, change functional operation, affect fire safety (e.g. modifications to the fire, smoke, and corridor walls), or add beds or services over those for which the hospital is licensed are considered as major remodeling and alterations.

(E) Phasing of construction in existing facilities.

(i) Projects involving alterations of and additions to existing buildings shall be programmed and phased so that on-site construction will minimize disruptions of existing functions.

(ii) Access, exit access, and fire protection shall be maintained so that the safety of the occupants will not be jeopardized during construction.

(iii) A noncombustible or limited combustible dust and vapor barrier shall be provided to separate areas undergoing demolition and construction from occupied areas. When a fire retardant plastic material is used for temporary daily usage, it shall be removed at the end of each day.

(iv) The air inside the construction area shall be protected by mechanical filtration that recirculates inside the space or is exhausted directly to the exterior.

(v) The area shall be properly ventilated and maintained. The area under construction shall have a negative air pressure differential to the adjoining areas and shall continue to operate as long as construction dust and odors are present.

(vi) Temporary sound barriers shall be provided where intense prolonged construction noises will disturb patients or staff in the occupied portions of the building.

(F) Nonconforming conditions. When doing renovation work, if it is found to be infeasible to correct all of the nonconforming conditions in the existing hospital in accordance with these rules, a conditional approval may be granted by the department if the operation of the hospital, necessary access by the handicapped, and safety of the patients are not jeopardized by the nonconforming condition.

(b) Previously licensed hospitals. Buildings which have been licensed previously as hospitals but have been vacated or used for purposes other than as hospitals and which are not in compliance with the 1967, 1973, 1981, 1985, 1991, 1997, 2000, or 2003 editions of the NFPA 101, the Hospital Licensing Standards/Rules (1969, 1985, or 1998 editions as amended), and hospital licensing rules under which the building or sections of buildings were constructed shall comply with the requirements of §133.162 of this title (relating to New Construction Requirements), §133.163 of this title (relating to Spatial Requirements for New Construction), §133.165 of this title (relating to Building with Multiple Occupancies), §133.167 of this title, and §133.168 of this title (relating to Construction, Inspections, and Approval of Project)."

"§133.168 (c) Approval of project. Patients and staff shall not occupy a new structure or remodeled or renovated space until approval has been received from the local building and fire authorities and the department."