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29509

Based on interview and record review, the facility failed to implement their plan of correction which was submitted and approved on 11/19/15.

During a re-visit survey conducted on 12/14/15 through 12/15/15, the facility failed to ensure:

The governing body was responsible for services furnished in the hospital, whether or not the services are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. (A-0083)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated compliance with Federal regulations for Governing Body.

29509

Based on interview and record review the facility failed to ensure that contracted services were identified as clinical, non-clinical, and other contracted services. In addition, the facility failed to ensure which of the contracted services required a patient health information confidentiality agreement. These issues were identified during a complaint validation conducted on 10/1/15. The facility submitted a plan of correction which involved oversight by the Board of Directors and Quality Assessment and Performance Improvement Program (QAPI), and was received and accepted by the Department on 11/19/15.

As a result, the facility was unable to identify their total number of facility contracted services, nor consistently identify and determine the contracts which were clinical, non-clinical, and define the other category, nor ensure whether the contracted services had access and or utilized patient health information.

Findings:

On 12/14/15 at 1:50 P.M., a concurrent interview and record review was conducted with the Compliance Officer (CO 1), Co-Compliance Officer (CO 2) and Regulatory Director (RD).

CO 1 presented the Master List of the facility's contracted services dated and printed on 12/11/15 at 12:55 P.M. CO 1 stated there were 848 contracted services for the facility. CO 2 interjected, "No...there's 650." At which point the facility's plan of correction was reviewed, which identified a total of 413 contracted services. The RD stated, "Three weeks ago, we found the categories were miscoded." CO 1 stated the facility was in the process for correcting the list and did not have a correct list or correct total number of contracted services. She further stated, she had started the review of the process "Last week."

On 12/14/15 at 2:30 P.M., a concurrent interview and record review was conducted with the Compliance Officer (CO 1), Co-Compliance Officer (CO 2), and Regulatory Director (RD).

A review of the Cancer Registry contract was reviewed on the Master List of the facility's contracted services dated and printed on 12/11/15 at 12:55 P.M. The CO 1 confirmed the Cancer Registry contract was not defined on the Master List as clinical, non-clinical, other or Patient Health Information (PHI) required. According to the facility's POC, the Cancer Registry Contract was updated and completed by 11/19/15. The CO 1 and RD confirmed the information was not entered into the facility's database and/or entered on the Master List.

A review the facility's Quality Assurance/Performance Improvement Committee Minutes dated 11/10/15 were reviewed. The RD confirmed the minutes from the meeting did not provide a full detail of the results from the 10/1/15 complaint validation survey which resulted in Conditions of Participation non-compliance in the areas of Governing Body and QAPI.

In addition, the RD confirmed there was no evidence of Quality Assurance/Performance Improvement Committee Meeting minutes after approval of their plan of correction by the Department on 11/19/15.

29509

Based on interview and record review, the facility failed to implement their plan of correction which was submitted and approved on 11/19/15.

During a re-visit survey conducted on 12/14/15 through 12/15/15, the facility failed to ensure:

The governing body must ensure that the program reflects the complexity of the hospital's organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement)...the hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. (A-0308)

The cumulative effect of these systemic practices resulted in the failure of the facility to deliver statutorily mandated compliance with Federal regulations for QAPI.

29509

Based on interview and record review the facility failed to ensure the following:

1. Contracted services were identified as clinical, non-clinical, and other contracted services and which of the contracted services required a patient health information confidentiality agreement; and

2. Patient Health Information (PHI) was secured in the Radiology Department.

These issues were identified during a complaint validation conducted on 10/1/15. The facility submitted a plan of correction which involved oversight by the Board of Directors and Quality Assessment and Performance Improvement Program (QAPI), and was received and accepted by the Department on 11/19/15.

As a result, the facility was unable to identify their total number of facility contracted services, nor consistently identify and determine the contracts which were clinical, non-clinical, and define the other category; nor ensure whether the contracted services had access and/or utilized protected patient health information

Findings:

1. On 12/14/15 at 1:50 P.M., a concurrent interview and record review was conducted with the Compliance Officer (CO 1), Co-Compliance Officer (CO 2), and Regulatory Director (RD).

CO 1 presented the Master List of the facility's contracted services dated and printed on 12/11/15 at 12:55 P.M. CO 1 stated, there were 848 contracted services for the facility. CO 2 interjected, "No...there's 650". At which point the facility's plan of correction was reviewed, which identified a total of 413 contracted services. The RD stated, "Three weeks ago, we found the categories were miscoded." CO 1 stated, the facility was in the process for correcting the list and did not have a correct list or correct total number of contracted services. She further stated, she had started the review of the process "Last week."

On 12/14/15 at 2:30 P.M., a concurrent interview and record review was conducted with the Compliance Officer (CO 1), Co-Compliance Officer (CO 2) and Regulatory Director (RD).

A review of the Cancer Registry contract was reviewed on the Master List of the facility's contracted services dated and printed on 12/11/15 at 12:55 P.M. The CO 1 confirmed the Cancer Registry contract was not defined on the Master List as clinical, non-clinical, other or Patient Health Information (PHI) required. According to the facility's POC, the Cancer Registry Contract was updated and completed by 11/19/15. The CO 1 and RD confirmed the information was not entered into the facility's database and/or entered on the Master List.

A review the facility's Quality Assurance/Performance Improvement Committee Minutes dated 11/10/15 were reviewed. The RD confirmed the minutes from the meeting did not provide a full detail of the results from the 10/1/15 complaint validation survey which resulted in Conditions of Participation non-compliance in the areas of Governing Body and QAPI.

In addition, the RD confirmed there was no evidence of Quality Assurance/Performance Improvement Committee Meeting minutes after approval of their plan of correction by the Department on 11/19/15.

2. On 12/14/15 at 11:50 A.M., a joint observation and interview was conducted with the Radiology Director.

An opened computer was observed unlocked and unattended, in the Women's Center Radiology mammography examination room. The Radiology Director stated, the room was utilized for a patient to dress/undress, and to have their procedure. The Radiology Director was able to demonstrate on the unlocked computer a patient's name, date of birth, and type of procedure performed on the patient.

On 12/15/15 at 10:15 A.M., the Women's Center Radiology Supervisor was interviewed. The same mammography examination room was entered. She stated, a patient stayed in the examination room throughout the procedure and waited in the examination room until the staff member confirmed the film cassettes were developed. The Women's Center Radiology Supervisor demonstrated the mammography procedure process by walking outside of the room to the film cassette processor, which was approximately 20 feet outside of the examination room. This demonstration illustrated the patient would be left alone in the examination room. The supervisor further stated, a film cassette development took 5-7 minutes.

A further review of the computer screen showed icons which allowed a user to have access to other patients' PHI. The Women's Center Radiology Supervisor confirmed the information included the following: patient's name, date of birth, medical record number, type of procedure and the actual film. The Women's Center Radiology Supervisor acknowledged, "Yes it's PHI, but the system now locks since last night."

The Radiology Director stated persons who had access to the examination rooms were, patients (unattended), staff, housekeepers, and maintenance.

The facility's POC indicated the monitoring process to prevent re-occurrence of PHI risk was to conduct Environment of Care rounds monthly and to report to the Quality Assurance/Performance Improvement Committee on a monthly basis.

A review the facility's Quality Assurance/Performance Improvement Committee Minutes dated 11/10/15 were reviewed. The RD confirmed the minutes from the meeting did not provide a full detail of the results from the 10/1/15 complaint validation survey which resulted in Conditions of Participation non-compliance in the areas of Governing Body and QAPI.

In addition, the RD confirmed there was no evidence of Quality Assurance/Performance Improvement Committee Meeting minutes after approval of their plan of correction by the Department on 11/19/15.