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Based on interview and document review, the Governing Body (GB) failed to ensure that appropriate written agreements had been written, properly approved and correctly utilized in order to assure that telemedicine health care providers, caring for patients of the Critical Access Hospital (CAH), were qualified, competent and that their care was regularly reviewed for professional proficiency, as evident by the following:

1.-- For 2 of 3 contracted telemedicine organizations (aka: distant-site telemedicine entities or DSTEs) (specifically DSTE-1 & DSTE-2) the GB failed to ensure that the CAH had a written agreement which specified that the services provided would be compliant with state and federal, laws and regulations;

2.-- For 1 of 3 contracted entities (DSTE-2) the GB failed to ensure that the CAH had a written agreement for credentialing and privileging of the telemedicine providers furnished by DSTE-2;

3.-- For 2 of 3 contracted entities (DSTE-1 & DSTE-3); although credentialing and privileging agreements had been written for each, the GB had not obtained and reviewed information about the DSTEs' processes and standards for credentialing and privileging in order to assure that those were compliant with regulations and consistent with the CAH's own credentialing and privileging requirements;

4.-- For 2 of 3 contracted entities (DSTE-1 & DSTE-2) the CAH had a means to receive "performance" data reports, however the CAH had not always been requesting reports and reports received had not been interpreted or utilized;

5.-- For 3 of 3 contracted entities (DSTEs-1,2 and 3), the CAH had no evidence of any internal performance reviews of the distant-site practitioners' services provided.

These failures exposed patients to the potential of being treated by practitioners with questionable qualifications or competency.

Findings:

On 12/15/14 the names of all telemedicine practitioners were requested and provided. Also the names and contracts of any Hospitals or Distant-Site Telemedicine Entities that furnished telemedicine providers were requested and received. Review of this data followed and continued until 12/18/15.

On 12/15/14, at 3:15 p.m. the Administrative Assistant (EA-1) was also asked to provide the Bylaws, Rules, policies, procedures and other information that the various distant site telemedicine entities, which were used by the CAH's GB to review and approval in the process of establishing arrangements for credentialing, privileging and Ongoing Professional Proficiency Evaluation processes of the telemedicine consultants. On 12/16/14 beginning at 9:00 a.m. these same documents were again requested and EA-1 participated in an extended interview and concurrent documents review. This interview and concurrent document review continued until approximately 2:15 p.m. with intermittent breaks. During that time the above requested documents were not available, and EA-1 stated she was not aware of the CAH ever requesting or receiving such documents. Also requested and reviewed, EA-1 provided agreements and related documents concerning the three organizations utilized to provide access to physicians and/or other healthcare providers located outside of the local community. Such organizations are known as Distant-Site Telemedicine Entities (DSTE or entities). Below is a list of the three (3) entities that provide telemedicine practitioners to the CAH, and findings relative to each:

* DSTE-1 is a nationwide provider of radiological consultants. On 12/16/14 two (2) written agreements between the CAH and DSTE-1 were provided for review; each agreement concerned only credentialing and privileging of their practitioners. The CAH did not have an agreement concerning the services provided by DSTE-1 or the practitioners furnished by DSTE-1. The first agreement was initiated in December 2007 and the more recent agreement was signed on 7/11/2011. Neither agreement contained language stipulating that DSTE-1 or their telemedicine providers would perform services in a manner so as to assure the CAH could remain compliant with state and federal, laws and regulations.

The more recent agreement, (signed into effect 7/11/11) contained at Section 5 that stated: "Decision of Governing Body: Hospital's (CAH's) governing body has chosen to rely on Practice's (DSTE-1's) credentialing and privileging decisions for purposes of Hospital's medical staff determining whether or not to issue privileges to the Physician." Section 8 stipulated exchange of "Provision and Confidentiality of Quality Related Data" and specified the CAH's duties to "provide DSTE-1 evidence of its internal review of each (DSTE-1) affiliated physician's (performance) ..." It went on to state: "The CAH) is responsible for periodic evaluation and quality assurance reviews ..."

On 12/16/14 during the extended interview and document review, EA-1 first explained some of her extensive duties and functions. Her title was Executive Assistant to the CAH Administrator. She did all of the filling of documents coming into the Administrative Office, was the custodian of the credential files, custodian of the Ongoing Professional Proficiency Evaluations (OPPE or Peer Review) Files, served as the scribe for both the Medical Executive Committee (MEC) and the Governing Body (GB), and she was assigned to be in charge of organizing and recording all of the CAH's contracts and written agreements. She acknowledged that prior to the current week, the CAH had not previously requested or received any bylaws, rules, policies, procedures or other documentation concerning how the three distant-site telemedicine entities (DSTEs) used (DSTE-1, DSTE-2 and DSTE-3) for making credentialing and privileging decisions or conducting Ongoing Professional Proficiency Evaluations (OPPE) of their medical staff members. She also stated the CAH had no documentation to show that the GB had knowledge concerning the credentialing and privileging processes used by DSTE-1, DSTE-2 or DSTE-3. She was unaware of any evidence to show that the GB had actively participated in a decision to rely on either DSTE-1's or DSTE-3's credentialing / privileging decisions for the purposes of determining whether or not to issue privileges to the telemedicine members on staff, as was stated the respective credentialing and privileging agreements.

EA-1 also provided an undated list which contained a listing the tele-radiologists on staff at CAH who were associated with DSTE-1. The list contained 27 names, 26 were typed with 1 hand written name added at the bottom. The Ongoing Professional Proficiency Evaluation (OPPE) reports for these radiologists were requested.

EA-1 provided a 3 page report titled "Quality; Report - Prelims" which contained performance data for 44 providers from 12/1/12 to 11/30/14. This report indicated it was generated (printed) that same day, 12/16/14. It indicated that the 44 providers listed on the report had done 962 studies over the 23 month date range. The number of "observations" for each physician ranged from only 1 observation to a maximum of 132 observations. The average was (962 / 44) 21.86 observations per physician. EA-1 could not explain why 44 names appeared on the report, when only 27 radiologists were on staff at CAH. The one physician chosen for review (MD-G) had 19 observations. The report contained no information on how to interpret the results. It contained 5 columns labeled, "No Discrepancy", "Slight Discrepancy", "Minor Discrepancy without effect", "Minor Discrepancy with effect", and "Major Discrepancy." In every case all of the reported results were "0". EA-1 could not explain why the report showed for each of the 44 radiologists, the results were always zeros; or how it was possible that zeros appeared in the columns for "No Discrepancy" and also zeros in each of the 4 columns for the 4 different levels of "Discrepancy." She also could not explain why the report was labeled as a preliminary report: "Quality Report - Prelims."

During that interview, EA-1 explained the reason that the report provided had been run on 12/16/14, just before our review, was that the CAH had not previously collected any similar reports. The CAH did not have such information in any of the various medical staff credential files, OPPE files or in any other files available to her. She could not say for sure that the CAH had never before requested, received or reviewed similar reports, but she had no evidence to demonstrate that staff members or committees at the CAH had worked with these reports. EA-1 also acknowledged that the CAH had no system for conducting OPPE for any of the telemedicine staff and had not been reporting metrics to DSTE-1, DSTE-2 or DSTE-3.

On 12/16/14 at 4:15 p.m., after EA-1 had completed an exhaustive search, she stated that the CAH did not currently have a Services Agreement with DSTE-1 which addressed the services to be provided by DSTE-1 or the radiologists that they provided.

Later on 12/17/14 at 2:40 p.m., EA-1 provided documents from DSTE-1 which EA-1 stated she had just received, via internet, for the first time. Included were "Medical Practice Bylaws," policies concerning "medical staff appointment", and "Quality Assurance Process."

* DSTE-2 is a regional provider of radiological telemedicine consultants. On 12/16/14 a written agreement between the CAH and DSTE-2 was provided for review. This agreement was titled "Service Agreement." It was signed by two individuals in November 2005 and December 2005. The agreement contained no language concerning credentialing, privileging, evaluations of professional proficiency or compliance with state and federal, laws and regulations. The agreement had no language stipulating that DSTE-2 was to provide any form of quality review data.

EA-1 was unable to provide documentation which described the processes by which DSTE-2 conducted their credentialing, privileging and their OPPE processes for the radiologists on staff at the CAH. She stated that the CAH had never requested or received any such information.

EA-1 also provided an undated list which contained a listing of the tele-radiologists on staff at the CAH who were associated with DSTE-2. EA-1 also provided and concurrently reviewed examples of the available OPPE reports provided by DSTE-2. A random example of the radiologists on staff who were associated with DSTE-2 was chosen by EA-1. The name of the individual chosen was (MD-H), whose name did not appear on the above referenced list of DSTE-2 radiologists, however EA-1 stated that was an oversight, MD-H was a radiologists provided by DSTE-2.

Concurrently reviewed was an OPPE report for MD-H provided by DSTE-2. This document comprised four pages, each page containing a table, of 20 rows and 6 columns filled out with hand written entries. The first 2 pages contained information for "Jan-March" 2014 and the second 2 pages contained information for "April-June" 2014. The first column was labeled "MR #" (medical record), the second was labeled "Case Description", and the third column was labeled "Concur". The medical record numbers ranged from 5 to 7 digits. In the Case Description column was a single word or phrase describing a part of anatomy, such as "knee," "foot" or "c-spine." Each page had at the bottom the name of the physician being reviewed (MD-H) and a physician doing the review. For this one physician, 40 cases were reviewed over the six months from January through June, 2014. There was no data to indicate the number of cases MD-H did during that time and essentially no data to qualify the results. During concurrent review of this document, EA-1 was unable to state that the report had been reviewed by other medical staff members and was unable to provide any evidence to show the information from DSTE-2 in similar "reports" had been reviewed, tabulated or otherwise utilized by CAH staff, the Medical Executive Committee (MEC) or the GB in deciding about privileges.

* DSTE-3 is a regional provider of a broad range of clinical telemedicine consultants. On 12/16/14 two (2) written agreements between the CAH and DSTE-3 were provided for review, each initiated in January 2014. The "Tele-health Service Agreement" contained Section 2.5 which stated "(DSTE-3) shall cooperate with (CAH) so that (CAH) may meet and satisfy any requirements imposed on it by applicable state and federal law ..." The "Physician Credentialing and privileging agreement" contained Section 4, which stated: "Decision of Governing Body: (CAH's) governing body has chosen to rely on Practice's (DSTE-3's) credentialing and privileging decisions for the purposes of (CAH's) medical staff determining whether or not to issue privileges to the Provider." Section 8 stipulated exchange of "Quality Related Data" and specifically to the CAH's obligation to be "responsible for periodic evaluation and quality assurance review ..."

During the 12/16/14 interview and concurrent record review, EA-1 stated that only 3 relatively recently appointed medical staff members were affiliated with DSTE-3, and their credential files and OPPE files were requested and concurrently reviewed. During the review, it was observed that the documents for these three MS members (MD-I, MD-J and Psy-K) were not housed in the same formal credential file folders used for most other MS members. When asked, EA-1 acknowledged that she had not had sufficient time to complete much of the work on these three relatively new telemedicine providers or other credentialing activities. She also stated that the CAH had not received any OPPE reports from DSTE-3 and she was unaware of any current plan to be conducting OPPE for MD-I, MD-J or Psy-K.

Later on 12/16/14 during a joint interview beginning at 2:30 p.m. and concluding at 3:15 p.m.: The Clerk of the Board (Clerk-GB), the CNO and EA-1 were interviewed. During the meeting, Clerk-GB stated that he had very little knowledge of any specific plans for correcting findings from the recent CMS survey and the GB had not been involved with or approved the Plan of Corrections. He also acknowledged that the GB had not been involved in causing the CAH to correct findings from the May QIO review. He had little information about the specific finding from either.

All three of CAH attendees attending the interview/meeting that afternoon agreed that:
* The GB had little general knowledge about the federal requirements for agreements with distant-site telemedicine entities;
* The GB did not understand that the GB had specific obligations for such agreements;
* The GB had not seen any information about the credentialing and privileging process and standards of the three distant-site telemedicine entities and had not knowingly made a deliberate choice to rely on the DSTE's credentialing and privileging decisions for the purpose of determining whether or not to issue privileges to the tele-physician.
* The GB did not know that the CAH and DSTE's were obligated to exchange OPPE information about their mutual medical staff members.
* The GB had not been involved in designing or implementing the recently approved Plan of Corrections (PoC) for the most recent federal survey.
* The CAH did not currently have a system in place to capture OPPE metrics (data), either reviews done by the CAH or meaningful collection of the data supplied by the DSTEs.