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Based on interviews and document review, the Governing Body (GB) failed to ensure for each utilized, qualified Distant-Site Telemedicine Entity (DSTE: a group of medical care providers, at distant locations and providing care through a telephone/television system) [and only with those DSTEs which the Critical Access Hospital (CAH) intended to utilize] there was a written agreement which had been written, approved and utilized in accordance with Federal Regulations, and in a manner which assured telemedicine health care providers caring for patients of the CAH were qualified, competent and their care was regularly reviewed for professional competency and performance, as evidenced by the following findings. These failures permitted the possibility of telemedicine providers, caring for patients in the CAH, may not be properly reviewed, credentialed, and privileged (overview past performance, inspecting qualifications and given permission to treat patients in a specific manner) causing sub-optimal care, unfavorable outcomes and potential harm to patients.

Findings:

Prior to the survey the deficiency reports of the two recent CMS surveys concluding on 9/11/14 & 12/17/14, and the 2014 Annual Credentialing Review and Quality/Performance Assurance Review conducted in May 2014 by the CAH's contracted Quality Improvement Organization (QIO-1), were reviewed. The deficiency reported from the 12/17/14 CMS survey and the May 2014 report from QIO-1 of the 2014 annual review, supplied the CAH with very similar lists of specific regulatory noncompliance issued that needed to be corrected. The CMS finding from the December 2014 survey caused the CAH to write Plan of Correction (PoC) which they submitted on 1/27/15. The PoC was also reviewed prior to the current survey. The PoC contained a specific plan of correction for each section of the federal regulations which was found to be deficient, with completions dates for each task required to achieve correction. The last of these completions dated for this section concerning Agreements was 2/28/15.

On 4/2/15 the CAH's Executive Assistant (EA-1) participated in an extensive and wide ranging interview and concurrent records/documents review beginning at 9:45 a.m. and extending until 2:15 p.m., with intermittent breaks in order for EA-1 to accomplish her regular executive functions. The documents concurrently reviewed were provided by EA-1 and included the minutes of the Medical Executive Committee (MEC, the main committee of the Medical Staff), the Governing Body (GB) meeting minutes, contracts and other written agreements, credential files, Professional Performance Evaluation (PPE) reviews, forms and metrics reports, and other documents used and managed by EA-1's in conducting her duties as custodian of the Medical Staff (MS) credentials, MS Coordinator, and scribe for the MEC and GB meetings. During this interview, EA-1 stated the CAH used the services of three (3) Distant-Site Telemedicine Entities (DSTEs: DSTE-1, DSTE-2 & DSTE-3) and for each the CAH had granted clinical privileges to the DSTEs' respective telemedicine physicians. EA-1 stated that she was given the PoC assignments and tasks to amend or supplement the written agreements with the three DSTEs and related documentation for credentialing, privileging and PPE review in order and fully compliant with the federal regulations. EA-1 also was assigned the task of collecting and compiling all information regarding all other contracts for services provided by outside entities and used in the CAH. EA-1 stated that the volume and extent of her PoC assignments was very large, so large that she did not accomplish all of the tasks.

DSTE-1: On 4/2/15, review of the CAH's current Medical Staff Directory (roster) showed it documented 47 telemedicine physicians associated with DSTE-1 listed and indicating they had Telemedicine clinical privileges. Concurrent review of the agreement between DSTE-1 and the CAH (dated 7/11/11) verified it gave the CAH an option to utilize DSTE-1's credentialing information, data from Professional Performance Evaluations (PPE) and lists of granted privileges, to be used by the CAH when considering granting similar privileges to provide clinical services in the CAH. However the agreement did not contain language specifying the services to be provided or the type, nature, quality and other needed safeguards for the quality or other specifics of any services provided.

PoC relative to DSTE-1: The PoC developed by the CAH, did not specifically address the lack of a Service Agreement between CAH and DSTE-1. During the interview and concurrent record/document review, on 4/2/15 between 9:45 a.m. and 2:15 p.m. EA-1 stated the CAH did not have a Service Agreement with DSTE-1, to specify the services or quality of services to be provided by DSTE-1. EA-1 state she did not know when DSTE-1 began providing telemedicine services at CAH, but DSTE-1 was providing services as a sub-contractor for DSTE-2. EA-1 stated DSTE-2 had a contract with DSTE-1 to provide after hour services in the evenings after DSTE-2 closed for the day. EA-1 stated the PoC to modify the DSTE contracts to be in compliance with regulations was her assignment and she had not complete the assignment. She stated the CAH had obtained DSTE-1's "Medical Staff bylaws, and their credentialing and privileging process and standards." EA-1 was unable to provide any written documentation showing the GB had received and reviewed DSTE's Bylaws or their processes and standards of credentialing and privileging their Medical Staff (MS) members, as required to meet the Federal Regulations at 42 CFR §485.616(c)(1)(i) through (c)(1)(vii).

On 4/2/15 during interview and concurrent document review, EA-1 did provided a copy of DSTE-1's quality assessment metrics (data) for their MS members' professional performance for the 2 years beginning February 2013 and ending January 2015. EA-1 stated she was unable explain how to interpret the PPE metrics (data) supplied by DSTE-1. EA-1 stated the CAH had not obtained from DSTE-1 an explanation of how the data was obtained or how to interpret the data. EA-1 also stated she did not have written evidence to show the GB had reviewed DSTE-1's "Medical Staff credentialing and privileging process and standards." EA-1 stated she was unable to locate any record of the GB's decision to utilize DSTE-1's credentialing and privileging information when granting or renewing MS membership and privileges at the CAH. EA-1 stated she was unable to locate a record of the decision. EA-1 stated she attended all GB meetings because she was the scribe and typed all of the GB minutes. The GB meeting minutes are public records and available through the internet. Review of all the available GB minutes for 2014 and 2015 show no record of GB review or actions taken concerning any DSTE matters.

DSTE-2: Review of the CAH's current Medical Staff Directory (roster) documented 16 telemedicine physicians with clinical privileges associated with DSTE-2. EA-1 provided a written service agreement between CAH and DSTE-2, signed 11/27/15, which contained language specifying the teleradiology (reading of x-ray and related studies, by a radiologist from a distant site) services to be provided. EA-1 stated this agreement was the only contract with DSTE-2 and there were no addendums or modifications. EA-1 also stated there was no agreement between CAH and DSTE-2 concerning credentialing, professional performance evaluations or privileging. Review of the 2005 services contract between CAH and DSTE-2 specifies (among other things) telemedicine physicians provided by DSTE-2 will "provide timely written and ... (reports) ..." Also stated: "(Telemedicine Physicians) will be available for telephone consultation 24 hours per day." Also in section "5 - SUBCONTRACTING: The Provider (DSTE-2) shall not subcontract nor assign any portion of the work required by the Agreement without prior written approval of Hospital (CAH) except for any subcontract work identified herein." On 4/2/15 during interview and concurrent record review at 1:40 p.m., EA-1 stated she had not arranged an addendum to this contract and there were no other written agreements between CAH and DSTE-2.

PoC related to DSTE-2: Review of the CAH's PoC (dated 1/27/15) showed the plans was not to obtain a Credentialing and Privileging (C&P) contract because "those physicians submit an applications and are processed through our credentialing process ... (therefore) ... an agreement (was) not needed for credentialing." During the interview and concurrent record review at 1:40 p.m. on 4/2/15, EA-1 stated the physicians provided through DSTE-2 were not credentialed & privileged exactly like all non-telemedicine Medical Staff members, because their ongoing and periodic Professional Performance Evaluations (PPE) were not done by MS members at the CAH. For the most recent reappointment of DSTE-2 associated MS physicians the CAH had used "Performance" data generated and reported by DSTE-2 in the report titled "(Telemedicine) Performance Improvement January through December 2014." This report was provided by EA-1 and concurrently reviewed with EA-1. It consisted of one page, with 8 columns, 5 rows of titles, number and % values, without other explanation. EA-1 stated she was unable to explain what was being reported and how it could be used in place of the similar PPE for other MS members. EA-1 acknowledged the report did not contain information about individual teleradiologists; rather, it appeared to be an overall report of the cumulative performance for all of DSTE-2 affiliated teleradiologists. EA-1 stated DSTE-2 was not structured like most DSTE's because did not have a Medical Staff with bylaws and DSTE-2 did not credential or privilege the physicians. EA-1 stated, because of DSTE-2's different organizational structure and not conducting credentialing or privileging of the physicians DSTE-2 was incapable of entering into a Credentialing and Privileging agreement.

DSTE-3: During an interview and concurrent document review on 4/2/15, at 3:45 p.m., EA-1 stated the CAH had both a Services contract and a Credentialing and Privileging (C&P) contract with DSTE-3, each dated 1/27/14. Review of this document (provided by EA-1) revealed an addendum which listed 14 tele-medicine physician providers. Review of the CAH's Medical Staff Directory showed only 2 physicians from DSTE-3 on staff (Physician 2 & Physician 3). The other 12 of the 14 listed practitioners had not yet applied for MS membership or clinical privileges. EA-1 stated plans and contracts were in place in the event so if other specialties were needed in the future the CAH was ready for their application. EA-1 stated the CAH had on PPE information for Physicians 2 or Physician 3; the CAH did not obtained documentation from DSTE-3 concerning Medical Staff bylaws or the procedures and standard for credentialing, privileging or their processes/standards for professional performance evaluations. EA-1- 1 stated the CAH did not have documentation or protocols established for local (in the CAH) PPE of DSTE-3's telemedicine providers. The tasks related to achieving compliance for credentialing, privileging and PPE of DSTE-3 physicians had been her assignment and she had not accomplished those PoC tasks.

Based on staff interview and document review, the Governing Body (GB) and Critical Access Hospital (CAH) Administrative staff failed in their Organizational Structure obligations as evidenced by the following:

1. The GB failed to assume responsibility for and to ensure effective corrective actions were designed and properly implemented to a) achieve compliance with federal regulations, b) establish and follow procedures and programs for to achieve quality, were implemented and administered to provide quality health care delivered in a safe environment. (Refers to C-241)

2. The GB failed to assume and exercise full responsibility in: a) providing overview and approval of agreements for telemedicine services; b) assuring proper credentialing and privileging processes of telemedicine providers, and c) directing the development of a functioning system for professional proficiency evaluations and review of quality assurance reports. (Refer to C-197 and C-331)

3. The GB failed to ensure the CAH had taken action to correct deficiencies as planned and to set in motion a functional system for timely and properly executed professional performance evaluations so the yearly Periodic Evaluation and Quality Assurance Review, by the contracted Quality Improvement Organization, currently scheduled to occur during the week of 1/5/15, would have sufficient staff or previously properly reviewed medical records. (Refer to C-330 and C-331)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Organizational Structure, 42 CFR §485.627.

Based on interview and document review the Critical Access Hospital's Chief Executive Officer (CEO) and its Governing Body (GB) failed to assume responsibility for and ensure effective corrective actions were designed, properly implemented and satisfactory achieved in order to:
a) Correct deficiencies presented to the CAH after the 2014 annual periodic credentialing evaluation and quality assurance review conducted by the CAH's contracted Quality Improvement Organization (QIO-1) in May 2014
b) Correct deficiencies presented to the CAH after the 12/17/14 CMS survey; and
c) Promptly initiate preparations for corrective actions when the 2015 annual review by QIO-1 was provided to the CEO on 3/10/15 and the CEO presented the report to the GB on 3/18/15.

These failures left the CAH incapable of effectively resuming the CAH's part in resuming the federally required Annual Periodic Evaluations and Quality Assurance Reviews, incapable of establishing effective credentialing and ongoing professional performance evaluations of the healthcare providers delivering services to patients, left the CAH out of compliance for multiple federal requirements, and left questions remaining about the quality and safety of services provided to patients in the hospital.

Findings:

In a joint interview, on 4/2/15 beginning at 2:30 p.m., the CEO, Chief Nursing Officer (CNO) and Executive Assistant (EA-1) were unable to provide documentation showing all portions of facility's Quality Assessment and performance Improvement plan (QAPI: also known as Continuous Quality Improvement or CQI) had been fully enacted; unable to provide documentation corrective action for the most recent Annual Credentialing and Performance Review conducted by the CAH's contracted Quality Improvement Organization (QIO-1) on 2/24/15 to 2/26/15 with a report of the findings returned to the CAH on 3/10/15, had been addressed and corrections designed and completed; and unable to provide documentation showing the 1/28/15 Plan of Correction (PoC) for the most recent CMS survey (December 2015) had been fully enacted and accomplished. Each administrative staff member present during the interview (CEO, CNO & EA-1) acknowledged major aspects of the CQI, plans for correcting findings of the QIO-1 reports and PoC had not been enacted and fulfilled.

Additional supporting findings:

A. The GB failed to ensure the Critical Access Hospital (CAH) had followed its plans for correction and taken all appropriate remedial action to address and correct deficiencies found through prior surveys and quality assurance reviews done by their contracted Quality Improvement Organization (QIO-1). (Refers to Q-341)

B. The GB failed to assume and exercise full responsibility in: 1) providing overview and approval of agreements for telemedicine services; 2) assuring proper credentialing and privileging processes of telemedicine providers, and 3) directing the development of a functioning system for professional proficiency evaluations and review of quality assurance reports. (Refer to Q-197 and Q-331)

C. The GB failed to ensure the CAH had taken action to correct deficiencies as planned and to set in motion a functional system for timely and properly executed professional proficiency evaluations for the yearly Periodic Evaluation and Quality Assurance Review, by the contracted Quality Improvement Organization, currently scheduled to occur during the week of 1/5/15, would have sufficient staff or previously properly reviewed medical records. (Refer to Q-331)

28650

Based on observation, interview and document review, the facility failed to ensure the provision of services was in accordance with appropriate written policy, procedures and standards of practice as evidenced by:

1. Failure to ensure that nutritional needs of inpatients were met in accordance with recognized dietary practices and facility policy (Refer to C 279);

2. Failure to provide nutritional oversight to all patients, in the form of a Registered Dietician (Refer to C 279).

3. Failure to compile a complete listing of all contracted services utilized in the CAH, with which the CAH could track the performances of contracted service providers. This failure could potentially expose staff or patients to harmful effects from poor quality, unsafe or inefficient products or services. (Refer to C 291)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality care in a safe environment, and ensure provisions of services were in compliance with the statutorily-mandated Condition of Coverage: Provision of Services.


28773

Based on staff interview, medical record review, and facility document review, the hospital failed to ensure the implementation of effective systems to ensure the nutritional needs of inpatients were met in accordance with recognized dietary practices and policy, as evidenced by:

1. Registered Dietitian (RD) and licensed staff did not assess, reassess and screen for nutritional risk according to their policy, for patients who were high risk for compromised nutritional status for one of 16 sampled patients (Patient 1);

2. The facility failed to provide nutritional oversight in the form of an RD, for all patients in the facility, per their policy, from 3/22 through present (4/2/15).

These failures resulted in the inability of the hospitals' food and nutrition services to direct and staff in a manner to ensure that the nutrition needs of the patients were met in accordance with their policy and current standards of practice.

Findings:

1. The hospital's policy and procedure titled, "Nutrition Screening - Med Surg" dated 12/14, indicated a licensed nurse would complete the Nutritional Risk Screening Form (NRSF) and the nutrition risk screening section of the patient's medical record on each acute care patient and fax to the RD within 24-hours of admission. It indicated the risk level was determined by the total number of conditions that exist (number of yes answers), and patients at no or low risk (risk level of 0-1) would be re-evaluated in one week by a member of nursing staff via completion of a new NRSF and would fax the updated NRSF to the RD within 24-hours. It indicated for patients at moderate or high risk (risk level of 2 or more) referral to the RD via fax within 24-hours of admission and re-evaluated in three days by completion of a new NRSF. The re-evaluation NRSF would be faxed to the RD within 24-hours of the third day. The RD would complete a nutrition assessment on all patients referred with a Nutrition Risk Level of 2 or above and make recommendations within 24-hours of receiving the NRSF. The RD would complete initial assessments on patients found to be at nutritional risk from the NRSF within 48-hours of admission. The RD was to complete re-evaluation within 24-hours of receiving the fax. All patients followed by a RD would receive ongoing nutrition follow up care. The frequency of follow-up would be based on the patient's NRSF completed by a licensed nurse and/or within five days of the initial nutrition assessment unless the patient had been discharged.

A review of Patient 1's medical record was conducted on 4/1/15. Patient 1 was admitted with a diagnosis of dehydration and a large facial cancerous lesion on 2/10/15.

A review of the NRSF, dated 2/10/15, indicated Patient 1 had a nutrition risk score of a six. The form had been faxed to the RD on 2/10/15. A Nutrition Assessment from the RD was received on 2/11/15, and indicated that if the patient remained hospitalized, nursing would need to re-evaluate Patient 1's nutritional risk in three days, per hospital policy. The next NRSF was completed by the nursing staff on 2/14/15. There was no re-evaluation by the RD per the hospital policy. The next NRSF was completed on 2/26/15 (a new NRSF should have been completed on 2/17, 2/20 and 2/23, per policy with associated RD assessments).

The next NRSF was completed by the nursing staff on 2/26/15. A Nutrition Assessment from the RD was received on 2/27/15, and indicated that if the patient remained hospitalized, nursing would need to re-evaluate Patient 1's nutritional risk in three days, per hospital policy. The next NRSF was completed on 3/1/15. There was no further re-evaluations completed by the RD. Resident 1 expired on 3/3/15.

On 4/1/15 at 4:45 pm, a concurrent interview and record review was conducted with the Chief Nursing Officer (CNO). The CNO stated they had in-serviced the nursing staff multiple times regarding the timely completion of the NRSF. The CNO stated the NRSF should be done within 24-hours of admission and then in three days or seven days depending on the risk level. The CNO acknowledged that Patient 1 had multiple missed and/or late NRSF, which lead to missing RD evaluations. This failure could have put Patient 1 at risk for nutritional decline.

2. During this same interview with the CNO, she reported that the outside agency that had been providing Dietary Consultant Services had terminated their contract with the facility, effective 3/21/15. The CNO acknowledged that the facility currently had no nutritional oversight in the form of an RD, and so although the NRSF was completed on patients admitted after 3/22/15, they had no RD to fax it to and therefore no RD evaluations had been received per facility policy.


28773

Based on interview and document review, the Critical Access Hospital (CAH) had not compiled a complete listing of all contracted services utilized in the CAH, with which the CAH could track the performances of contracted service providers. The available partial list did not describe the nature, scope or any quality-performance indicators with which the CAH could evaluate the quality, safety or effectiveness of the services or products provided. This failure could potentially expose staff or patients to harmful effects from poor quality, unsafe or inefficient products or services supplied by contracted vendors or providers.

Findings:

On 4/1/2015 the facility's Executive Assistant (EA-1) was asked to provide the CAH's list of all services or products utilized under agreement with outside vendors; and to provide the Quality or Performance Indicators (QI, PI or Q-PI) that had been selected for each written contract. "A 'Quality or Performance Indicator' is a description of a quantitative or qualitative measurement, or any other criterion, by which the performance, efficiency, achievement, etc. of a person or organization can be assessed, often by comparison with an agreed standard or target." On 4/1/2015 a two page list of 69 contracts, which ranged from physician and other practitioners that cared for patient to banking services or office supply vendors. The list did not contain any descriptions of the nature, scope or Q-PIs used to evaluate the contracted providers.

On 4/1/15 at 1:50 p.m. during an interview the Chief Executive Officer (CEO) stated he had only recently taken the CEO position and acknowledged the current list of contracted services was incomplete. It did not contain all of the services utilized at the CAH and the list did not contain all of the elements required by regulation (scope and nature). He stated he was in the process of personally reviewing each contract, but his current focus was not on individual contract specific Quality Indicators (QIs) or Performance Indicators (PIs) which would insure quality, safety and effectiveness. His focus was on the cost aspects of the contracts. The CEO was receptive to the idea of developing and tracking QIs or PIs for quality, safety and effectiveness, specifically tailored for each contract individually. He was also receptive to the concept of ranking the contracts in order of priority for the frequency and rigor of review. He acknowledged the CAH still had considerable improvements to make before being compliant with this section of CMS regulations.

On 4/2/15 during an interview beginning at 9:45 a.m., the EA-1 stated the list of contracted services was incomplete and did not have the required data, and the list had no performance indicators which the CAH could use to evaluate the services provided. She state the Plan of Correction (PoC) for contracts was her assignment and she did not completed her PoC tasks.

Based on staff interviews and document review, the Critical Access Hospital (CAH) failed to establish and maintain a functional Periodic Evaluation and Quality Assurance Review Program which had annually assessed the CAH's total program, as evidenced by the following:

1. The CAH failed to effectively design and properly execute Plans of Correction (PoC) to correct the deficiencies noted in the most recent CMS survey concluding on 12/17/14. (Refer to C-197 & C-331)

2. The CAH failed to effectively establish and properly utilize agreements with Distant-Site Telemedicine Entities (DSTE: an entity [group] of physician or other healthcare providers that provide medical care from a distant location [other cities] to patients via telephone and television communication equipment) and failed to develop a uniform, functional system for Professional Performance Evaluations (PPEs) for all of the CAH's Medical Staff (MS) members, including the Telemedicine MS members. The CAH did not established written protocols, procedures or standards for PPE, Credentialing and Privileging which were commensurate with the Medical Staff Bylaws and could be used in a uniform manner for each class (specialty & location) of MS members. The CAH had not established written protocols, procedures or standards for PPE which were commensurate with the Medical Staff Bylaws and which could make possible an effective, fair and uniform quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. (Refer to C-197, C-331 & C-336)

3. The Governing Body (GB) and Medical Executive Committee (MEC) failed to document their deliberate consideration, evaluation and approval or disapproval of the following:

a. -- Contracts for Services and Contracts for Credentialing & Privileging provided by Distant-Site Telemedicine Entities (DSTEs) or other Telemedicine Organizations (TM-Org) utilized to provide Telemedicine Provider services in the CAH. (Refer to C-197 & C-331)

b. -- The documentation provided or not provided by DSTEs or Telemedicine Organizations concerning these organizations' Bylaws and the processes and standards used for credentialing and privileging Medical Staff members. (Refer to C-197, C-331 & C-336)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Periodic Evaluation and Quality Assurance Review, 42 CFR §485.641.

Based on document review and staff interviews the Critical Access Hospital (CAH) failed to effectively plan and carry-out corrective actions in order for the CAH to resume annual periodic comprehensive evaluation of its total program. The CAH failed to develop a uniform, functional system for Professional Performance Evaluations (PPE) of all Medical Staff (MS) members and other healthcare professionals providing care in the CAH.

The CAH did not established written protocols, procedures or standards for PPE which were commensurate with the Medical Staff Bylaws and to facilitate an effective, fair and uniform PPE program for all practitioners, to be used in the annual or ongoing professional performance evaluation.

The CAH had allowed two (DSTE-1 & DSTE-2) of three (DSTE-1, DTSE-2 & DSTE-3) groups of Telemedicine Physicians (T-M Physicians: physicians at a distant location who provide services via audio/visual communications) to conduct PPE among themselves at their distant-sites. The CAH allowed this without first obtaining information from the distant-site organizations to explain how these evaluations were conducted. The CAH received and accepted performance reports from the distant-site organizations, without understanding how the data was collected, without a means to interpret the report data, and no documented plan for how the data could be used by the CAH. The CAH granted clinical privileges to a third group of T-M physicians (DSTE-3) without developing a PPE process for evaluation of affiliated physicians' professional performances. A fourth group of MS members for which the CAH did not develop a PPE process, were the local pathologists, physicians who perform or interpret laboratory studies in the CAH. These pathologists were permitted to evaluate themselves without the CAH obtaining information about their PPE processes or standards without a means for the CAH to interpret or influence the results.

These failures permitted questionable quality, safety and effectiveness of the care provided by distant-site and local MS members, which could potentially expose patients to substandard care.

Findings:

Documentation provided and reviewed prior to the survey included the CMS Statements of Deficiencies from CMS surveys conducted in September and December 2014 and the Plans of Corrections (PoC) dated 1/27/15 for the December 2014 CMS survey. Also provided and reviewed prior to the survey was the 2014 Annual Periodic Comprehensive Evaluation Review conducted by the Quality Improvement Organization (QIO-1) in May 2014 and the subsequent "Credentialing and Performance Report" provided to the CAH. Each of the CMS Statements of Deficiencies and the Credentialing and Performance Report from QIO-1 found significant regulatory deficiencies related to the credentialing, privileging and performance review of telemedicine physician and other local physicians and other practitioners in the CAH. Review of the PoC of 1/27/15 and related documents showed the PoC many specific tasks or process to achieve compliance for the many regulatory deficiencies. Each with one or more dates by which the corrections were to be satisfactory completed. Review of the PoC showed planned tasks for the CAH to achieve correction for the Condition of Participations: Periodic Evaluation and Quality Assurance had to involve correcting two key deficiencies. 1.) One was related to the Credentialing and Professional Performance Evaluation (PPE) reviews of Medical Staff members which provided telemedicine in the CAH and the written agreements required to govern the services they provided and the manner in which their credentials, privileges and PPE processes were done. 2.) The other was the overall process by which all medical care professionals providing services in the CAH had their ongoing record reviews and Professional Performance Evaluation (PPE) reviews conducted to ensure each provided high quality care and safe services were being provided by all of those caring for patients in the CAH. In the recent past OIG-1 annual reviews in 2014 and 2015 and in the most recent 2 CMS surveys of 12/17/14 and 9/11/14, the CAH had consistently high level deficiencies in these areas. The overall plan for these corrections was to write a workable Plan of Correction (PoC) and carefully execute it to demonstrate successful completions of the PoC, and to achieved that success early enough in 2015 so when OIG-1 returned in the first quarter of 2015, to conduct the annual Evaluation and Quality Assurance Review, the resulting report would show these essential key areas had been successfully accomplished showing results demonstrating the CAH's Medical Staff members, Administrative staff, Governing Body members all CAH staff members assigned tasks for the PoC had done their part and the CAH would have demonstrated the processes and systems were in place and functioning for credentialing, PPE, Quality Improvement, thus demonstrating the CAH's annual summary review of the quality, performance and review process had been reestablished.

1.) Review of the 1/27/15 PoC showed the plan for achieving regulatory compliance for the agreements related to the telemedicine services provided by DSTE-1, DSTE-2 and DSTE-3 was to amend the current agreements or establishing new agreements in a manners which were consistent with the federal regulation at [Q-197 or 42CFR§485.616(c)(3&4)] for such agreements. Not stated, but implied was the intent to use the contracts in a manner consistent with the regulation. The time of completion for this was 2/28/15.

2.) Review of the 1/27/15 PoC showed the plan for achieving regulatory compliance for the overall ongoing quality and performance reviews of practitioners and services provided was to improving the overall PPE processes by which all medical care professionals providing services in the CAH would have each of their Professional Performances and each of their services evaluated and reviewed in a uniform, consistent manner and measurable manner in order to generate metrics (data) to be use over time in comparing the performance of various MS members, etc. These goals and tasks were less specifically defined. The times of completion for these were 2/28/15.

Another document reviewed prior to the survey was the Medical Staff Bylaws and Rules. Review showed bylaws recorded they had been recently been amended and approved by the Governing Body (GB) on 12/3/14. In the bylaws beginning on page 23 the section numbered and titled "5.3-2 Basis for Privilege Determinations" states: "Requests for privileges shall be evaluated on the basis of the hospital's needs and ability to support the requested privileges and assessment of the applicant's general competencies with respect to the requested privileges, as evidenced by the applicant's license, education, training, experience, demonstrated professional competence, judgment and clinical performance, (as confirmed by peer knowledge of the applicant's professional performance), health status, the documented results of patient care and other quality improvement review and monitoring, performance of a sufficient number of procedures each year to develop and maintain the applicant's skills and knowledge, and compliance with any specific criteria applicable to the privileges requested. Privilege determinations shall also be based on pertinent information concerning the clinical performance obtained from other sources, especially other institutions and health care settings where an applicant exercises privileges."

On 4/1/15 at 1:30 p.m. the Executive Assistant (EA-1) was interviewed and stated QIO-1 had conducted its 2015 Annual Periodic Comprehensive Evaluation Review from 2/24/15 to 2/26/15 and its 2015 Credentialing and Performance Report arrived at the CAH on 3/10/15.

On 4/2/15 at 9:45 a.m. the facility's protocols, policies, procedures, standards or other directives for how the CAH conducted PPE of practitioners were requested from Executive Assistant (EA-1), but none were unavailable. Throughout 4/2/15 EA-1 was intermittently available for interviews and concurrent records/documents reviews. At 2:10 p.m. after searching extensively EA-1 stated the CAH had no written policies, procedures, rules or other written descriptions of protocols or processes used for PPE of MS members (physicians) or other practitioners [Physician Assistances, Nurse Practitioners, Certified Register Nurse Anesthetists (CRNA) or other healthcare providers] providing care to patients in the CAH. EA-1 state the CAH had no documentations to show a means had been developed to ensure PPEs were conducted to fulfill the stated intent (standard) specified in section 5.3-2 of the Medical Staff Bylaws for the "Basis for Privilege Determinations."

Earlier on 4/2/15, at 10:30 a.m., during interview and concurrent documents/records review EA-1 stated the CAH had recently developed a number of clinical chart review forms to assist with peer review (PPE) of Medical Staff (MS) members by MS members of various types (specialties and locations). These new PPE forms were provided by and concurrently reviewed with EA-1. These PPE forms included: "CAH Clinical Pertinence"; "CAH Medical Staff Continuous Quality Improvement"; and "CAH Emergency Physician Pertinence." EA-1 provided examples of completed PPE forms, concurrent review of these, demonstrated the various forms were completed in a variety of manners. The forms generally "screened" for a set list of subjective questions with response options of "yes", "no" and "comments." EA-1 stated the CAH had not written instructions or process protocols to assist reviewers to use the forms in a consistent and reproducible manner. EA-1 stated the CAH had not developed a means of testing the validly and usefulness of the metrics gathered from these various PPE forms. Review of the Medical Staff Directory (roster or list of Medical Staff members and their specialties) showed one Active Staff member (Physician-1) who had privileges to performed and interpreted cardiac (heart) studies: ECG (electrocardiograms) and other cardiac diagnostic procedures. The CAH's PPE form for reviewing physicians' performance when conducting and interpreting ECGs and other cardiac studies was requested, and EA-1 stated the CAH had not developed a form or other means to evaluate performance of physicians who perform or interpret ECG studies or other cardiac services or procedures.

During the interviews and concurrent documents/records review with EA-1 on 4/2/15, EA-1 stated the CAH had not developed PPE forms or clinical chart review forms similar to those listed above which were for the performance of 1) Radiologists (physicians who interpret X-ray studies), 2) Pathologists (physicians who perform and interpret laboratory studies), 3) Telemedicine or 4) other unique specialties (infrequently used medical specialties, not available in the CAH). EA-1 state the CAH had a contract for outside PPE review, by a surgeon from another hospital, to evaluate the performance of the general surgeon (Physician 6) on staff at CAH. EA-1 also stated the CAH had developed PPE forms for the few CRNA (Certified Registered Nurse Anesthetist) on staff. EA-1 stated the pathologists and tele-radiologists were conducting their own PPE within their respective departments. Examples of these departmental PPE reviews and resulting metrics were requested and those provided were reviewed. EA-1 stated no PPE data or reports were available for the pathologists, and no documentation was available to show PPE plans for pathologists had been developed or approved by the GB.

Teleradiologists Agreements and Performance Evaluations: During the interviews and concurrent documents/records review with EA-1 on 4/2/15, EA-1 stated the CAH used the services of 2 different distant-site telemedicine groups (DSTE-1 and DSTE-2) to provide X-ray study interpretations by teleradiologists and the concurrent document review for each revealed the following:

DSTE-1: Concurrent review of the performance report from DSTE-1 showed a table similar to a spreadsheet: On the left of the table were 42 random and unpronounceable sets of 5-letters used to identify the individual radiologists without revealing their names. Across the top were labels for 15 columns across the page. In the table were various numbers and percentages (%). EA-1 stated she was unable to explain the meaning of the information in the report and the CAH had no information to explain how the data was obtained. EA-1 stated she was unable to show how the CAH was using the data to evaluate the tele-radiologists' respective performances. EA-1 acknowledged the CAH had not obtained from DSTE-1 information explaining their PPE processes or standards. EA-1 could not provide documentation showing the CAH's Governing Body (GB) had reviewed the processes or standards used by DSTE-1 for PPE, credentialing or privileging of their Medical Staff members. EA-1 stated the 1/27/15 PoC tasks relating to correcting the agreements with DSTE-1 had been assigned to her, and she had not achieved the task of amending the DSTE-1 agreement to include a services agreement and compliance with federal regulations.

DSTE-2: Concurrent review of the PPE metrics report from DSTE-2 also showed a spreadsheet type table: At the left were 4 categories of radiological studies [Diagnostic, CT (aka: CAT scan or computerized axial tomographic scan), Ultrasound (studies done using high frequency sound), and MRI (magnetic resonance imaging)]; across the top were labels for 7 columns across the page. However the table did not indicate data for separate individual radiologists, only general date form the group of radiologists together. EA-1 stated she was unable to explain the meaning of the information in the report from DSTE-2 and had no information to explain how the data was obtained, or how the CAH was using the data to evaluate the tele-radiologists' respective and individual performances. EA-1 stated the CAH did not have a credentialing and privileging contract with DSTE-2 or any other written agreement with DSTE-2 to warrant or explain using the self-evaluation of performances by the DSTE-2 group. EA-1 stated the 1/27/15 PoC tasks relating to correcting the agreements with DSTE-2 had been assigned to her. EA-1 stated she had exchanged one set of e-mail messages with DSTE-2 but had not achieved an amendment for their agreements, because of DSTE-2's organizational structure. EA-1 stated DSTE-2 was not structured as other Distant-Site Telemedicine Entities. DSTE-2 did not have member bylaws and no written processes for evaluating, credentialing or privileging the group members; because the group did not credential or grant privileges to its members. The CAH had not obtained from DSTE-2 information explaining their PPE processes or standards. EA-1 stated she could not provide documentation showing the CAH's GB reviewed the processes or standards DSTE-2 used for performance evaluation of their group at large.

DSTE-3: During an interview and concurrent document review on 4/1/15, at 3:45 p.m., EA-1 stated the CAH had both a Services contract and a Credentialing and Privileging (C&P) contract with DSTE-3, each dated 1/27/14. Concurrent review of this document (provided by EA-1) showed an addendum which listed 14 tele-medicine physician providers. Review of the CAH's Medical Staff Directory showed only 2 (Physician 2 & Physician 3) of these 14 were currently on staff (MS members) with clinical privileges. EA-1 stated currently only 2 members had become MS members with privileges, but plans and contracts were in place in the event the other specialties were needed in the future. PPE metrics for Physician 2 & Physician 3 were requested, and EA-1 stated the CAH had no metrics for either physician. EA-1 stated the 1/27/15 PoC tasks relating to correcting the agreements with DSTE-3 had been assigned to her, and she had not achieved the task of obtaining PPE and credentialing specifics in order to achieved compliance with federal regulations. EA-1 stated, as a result the CAH had no documentation provided by DSTE-3 concerning the specifics of credentialing and ongoing PPE procedures and standard used for review of the group's telemedicine physicians. EA-1 stated the CAH had not received from DSTE-3 information about the procedures or performance of Physician 2 or Physician 3. EA-1 stated the CAH did not have any PPE information for Physician 2 and Physician 3 and the CAH had no plan for PPE of telemedicine physicians provided by DSTE-3 or others for their performance within the CAH.

On 4/2/15 at 2:30 p.m. a joint interview with the CEO, the Chief Nursing Officer (CNO) and EA-1 was conducted. The three (3) administrative staff members present (CEO, CNO & EA-1) acknowledged the CAH did not achieve completion of the 1/27/15 PoC, and although they were proud of the achievements they had made with their overall Quality Improvement Program, they had not satisfactory achieved completing the 1/27/15 PoC. The CAH had not established the required agreements for credentialing and professional review of telemedicine physicians. The CAH still had improvements to be made to achieve a uniform and functional PPE processes for all MS members and AHP which provide care services in the CAH, especially for telemedicine providers and pathologists. The CEO and other administrative staff present acknowledged that after the 2015 Credentialing and Performance Report from QIO-1 arrived on 3/10/15, showing continued noncompliance in credentialing and performance review, the CAH's Administration, MEC and GB reviewed the finding but took no immediate action to initiate any corrections. The CEO and other administrative staff present expressed frustration and disappointment for not achieving regulatory compliance before the 2015 Annual review be QIO-1 and during the current survey. They resolutely stated their commitment to make the needed corrects to complete the PoC and establish 100% compliance and continue with making improvements.

Based on interview and document review, the Critical Access Hospital (CAH) failed to consider and take needed corrective action related to the findings of the "2015 Annual Quality Assurance and Credentialing Review" conducted by a Quality Improvement Organization (QIO-1) from 2/24/2015 to 2/26/2015. On 3/10/2015 the findings of this evaluation, included the findings and recommendations for achieving regulatory compliance were reported to the CAH's Chief Executive Officer (CEO). The CEO presented this report to the Medical Executive Committee (MEC) and the Governing Body (GB), but neither took any corrective action. This failure permitted the continuation of multiple quality assessment and credentialing deficiencies which dated back to early 2014; and left in place the possibility that staff or patients could be exposed to harmful effects from poor quality, unsafe or inefficient staff, products or services.

Findings:

On 4/1/15 the CAH's Executive Assistant (EA-1) provided the 3/10/15 report from QIO-1 detailing the findings and recommendations for needed action from its 2/24-2/26/15 Annual Quality Assurance and Credentialing Review (2015 QIO Review). During an interview, 4/1/15 at 1:40 p.m. the CEO acknowledged receipt of the 2015 QIO Review report on 3/10/15. He stated he had presented the report informally to the MEC members and formally to the GB at their most recent meeting. He provided the GB meeting packet outlining the report. He stated the CAH had not yet initiated any corrective action, and specifically stated neither the MEC nor the GB had called for corrective action to begin.

Based on document review and staff interview, the Critical Access Hospital (CAH):

A. Failed to take the appropriate remedial actions that the CAH wrote into the 1/27/15 Plan of Correction (PoC) to correct deficiencies found during the prior CMS certification survey concluding on 12/17/14;

B. Failed to initiate appropriate remedial actions when on 3/10/15 the CAH received finding of the 2015 Annual Credentialing and Performance Review conducted by the CAH's contracted Quality Improvement Organization (QIO-1) which again found the CAH had not corrected credentialing, contracting and professional performance evaluations for the Medical Staff members and other healthcare providers and substantiating the CAH had failed to achieve its planned corrective actions for the 12/17/14 CMS survey and the 2014 Annual Credentialing and Performance Review conducted in 5/2014.

These failures left in place multiple deficiencies in standards of operation and regulations which could potentially expose staff and patients to harmful outcomes.

Findings:

Before to the CMS survey began on 4/1/15 documents related to prior surveys of the CAH were reviewed. These documents included the deficiency statement from the 12/17/14 CMS survey, the required Plan of Correction (PoC) for that survey and a prior report from May 2014 when the CAH's contracted Quality Improvement Organization (QIO-1) conducted an annual review.

The PoC referenced above was required to have details of specific corrective actions with completion dated to bring the CAH back into compliance for multiple federal regulation deficiencies from the 12/17/14 CMS survey. This documents was signed and submit on 1/27/15 and it contained completion dates for each of the many deficiencies, the latest date for completion was 2/28/15.

Review of the prior CMS findings and the CAH's 1/27/15 PoC revealed the following:

1. The PoC contained a plan to have all corrective actions completed in an expedient and efficient manner in order to have compliance achieved with correction of for deficiencies related to contracted services, telemedicine, credentialing and uniform, consistent review of all healthcare providers completed before the next annual credentialing and performance review by QIO-1 occurred at some time the first quarter of 2015.

2. One aspect of the PoC was to have all agreements related to provision of care by Telemedicine physicians amended so that they were compliant with federal regulations. The completion date to have these amendments completed was 2/28/15. The plan detailed having each of three contracts with Distant Site Telemedicine Entities (DSTE-1, DSTE-2 & DSTE-3) amended, to have each of the telemedicine physicians' credential files in order and to have reviewed and approved plans for Professional Performance Evaluation (PPE) reviews and the processes and standards for credentialing and PPE by the DSTEs to be reviewed and approved by the CAH's Governing Body (GB).

3. Another aspect of the PoC was to have the Professional Performance Evaluations of each of the Medical Staff (MS) members and Allied Health Practitioners (AHP: Certified Registered Nurse Anesthetist [CRNA], Physician Assistants and Nurse Practitioners) uniformly and consistently begun and documented with sufficient data collected so that when QIO-1 returned during the first quarter of 2015 there would be sufficient data (metrics) compiled that QIO-1's report would show the CAH had achieved regulatory compliance and verification that the CAH was conducting credentialing and PPE in an appropriate manner.

On 4/1/15 at 1:30 p.m. the Executive Assistant (EA-1) was interviewed and stated QIO-1 had conducted its 2015 Annual Periodic Comprehensive Evaluation Review from 2/24/15 to 2/16/15 and its 2015 Credentialing and Performance Report arrived at the CAH on 3/10/15.

On 4/2/15 beginning at 9:45 a.m. and completing at 2:10 p.m. EA-1 participated in an extensive interview and concurrent record review with intermittent interruptions throughout the day. EA-1 stated she had been given the PoC assignment to have the three DSTE agreements (DSTE-1, DSTE-2 & DSTE-3) amended to achieve compliant with federal regulations, and she had not been able to achieve that task for any (0/3) of the three contracts. EA-1 also stated it had been her PoC assignment to assist with the design of forms to assist with the Professional Performance Evaluation process for MS members and AHP staff. She had been able to make some forms but the process had been incomplete and PPE forms and processes had not been developed for the pathologists on staff, for the performance of Physician 1 who performed and interpreted various cardiac diagnostic studies such as Electrocardiograms (ECGs: used to evaluate the electrical pattern and rhythm of patients' hearts.) (Refer to C-331)

On 4/2/15 at 2:30 p.m. during a joint interview with the CEO, the Chief Nursing Officer (CNO) and EA-1, they agreed the CAH did not achieve completion of the 1/27/15 PoC and as a result the CAH remained out of compliance for credentialing, PPE review of physicians and other practitioners, and the contracts for telemedicine providers still had not been amended to comply with federal regulations.