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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.

Based on food storage observations, dietary staff interview, and dietary document review, the hospital failed to ensure the development of a mass disaster menu that had adequate amounts of food for the designated number of people that would be fed during a potential disaster.

Findings:

On 12/15/14, beginning at 11:30 am, food service for disaster preparedness was reviewed with the Dietary Manager (DM). A concurrent review of the hospital's disaster menu noted the plan included the provision to provide meals for 75 people (combined patients and staff) for three days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as Nutri-grain bars (1 case short), graham crackers (1 case short), and canned low sodium tuna (4 cans short).

In a concurrent interview, the DM stated she would need to order those items and look at her inventory again. Upon further review, in the disaster preparedness binder there were two inventory lists with different amounts of food supplies on them. The DM acknowledged this was confusing and only the correct one should be in the binder.

A review of the Registered Dietitian's (RD) monthly sanitation and food safety checklist dated 11/11/14, indicated she would check to see if disaster supplies are stored in a designated area with a can opener and flashlight and if the disaster menus, spreadsheets, and inventory sheet were visible.

On 12/16/14 at 1:30 pm, an interview was conducted with the RD regarding how she monitors the disaster food supplies. The RD acknowledged that she would check to see if it was present but not if it was adequate.

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

1. 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)

2. The GB failed to ensure that 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 so that 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-330 and Q-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.

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Based on observation, interview and document review, the facility failed to ensure the provision of services were 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 (Refer to C 279);

2. Failure to develop a disaster plan to ensure that they had enough food supplies on hand in the event of a disaster (Refer to C 230);


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.

Based on observation, staff interview, medical record review, and 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 as evidenced by:

1. The hospital did not develop a disaster preparedness plan to ensure that they had enough food supply on hand in the event of a disaster;
2. 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 5 of 5 sampled patients (Patients 6, 7, 8, 9, and 10);
3. Ensure that performance improvement activities demonstrated opportunities for improvement and the development of an action plan for areas identified as requiring improvement.

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 practitioners' orders and current standards of practice.

Findings:

1. On 12/15/14, beginning at 11:30 am, food service for disaster preparedness was reviewed with the Dietary Manager (DM). A concurrent review of the hospital's disaster menu noted the plan included the provision to provide meals for 75 people (combined patients and staff) for three days. A random comparison of the hospital developed inventory and available food supplies revealed there was inadequate supplies of items such as Nutri-grain bars (1 case short), graham crackers (1 case short), and canned low sodium tuna (4 cans short).

In a concurrent interview, the DM stated she would need to order those items and look at her inventory again. Upon further review, in the disaster preparedness binder there were two inventory lists with different amounts of food supplies on them. The DM acknowledged this was confusing and only the correct one should be in the binder.

A review of the Registered Dietitian's (RD) monthly sanitation and food safety checklist dated 11/11/14, indicated she would check to see if disaster supplies were stored in a designated area with a can opener and flashlight and if the disaster menus, spreadsheets, and inventory sheet were visible.

On 12/16/14 at 1:30 pm, an interview was conducted with the RD regarding how she monitors the disaster food supplies. The RD acknowledged that she would check to see if it was present but not if it was adequate.

2. A review of the hospital's policy and procedure titled, "Nutrition Screening - Med Surg" dated 2014, indicated a licensed nurse would complete the Nutritional Risk Screening Form 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 (# 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 Nutrition Risk Screening Form and would fax the updated Nutritional Screening Form 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 (3) days by completion of a new Nutrition Risk Screening Form. The re-evaluation Nutritional Screening Form 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 Nutritional Screening Form. The RD would complete initial assessments on patients found to be at nutritional risk from the Nutrition Risk Screening Form 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 Nutrition Risk Screening Form completed by a licensed nurse and/or within five days of the initial nutrition assessment unless the patient had been discharged.

a. Patient 9 was admitted with diagnoses that included inanition (the exhausted condition that results from lack of food and water) and protein malnutrition on 11/30/14. Patient 9 was discharged on 12/8/14. A review of the physician orders dated 11/30/14 indicated a regular diet and mightyshakes (nutrition supplement) with meals. A review of physician orders dated 12/5/14, indicated a low sodium diet, dated 12/6/14 indicated Megace (appetite stimulant) 800 milligrams once daily, and dated 12/8/14 yogurt daily.
A review of the Nutrition Risk Screening Form dated 11/30/14, indicated the risk level was a six (6) for oral liquid supplement (mightyshake with meals), skin breakdown/decubs, serum albumin (made by the liver, amount of protein in the blood) less than 3 grams (g) per deciliter (dL), weight loss greater than 5% times one month, constipation greater than three days and meal intake less than 50%. It indicated it was faxed on 11/30 at 6:50 pm, to the RD.
A review of the Nutrition Assessment dated 12/1/14, indicated the current diet with at least 50% consumed would meet Patient 9's estimated needs of 1200-1350 calories and 35-45 grams of protein per day. It indicated Patient 9's meal intake was 40% for breakfast and 15% for lunch that day. The RD's plan was to continue with the current diet and mightyshakes with meals and to continue to monitor the oral intake and medical plan of care. It indicated if the patient remained hospitalized, then nursing to re-evaluate nutrition risk in three days per policy.
A review of the Diet Assessments for the following: dated 12/1/14, indicated Patient 9 meal intake percentages were 40% for breakfast and 15% for lunch. There was no intake recorded for supper; dated 2/2/14, indicated 25% for breakfast and 5% for lunch. There was no meal intake recorded for supper; dated 12/3/14, was 25% for breakfast, 15% for lunch, and 10% for supper. There was no meal intakes recorded for 12/4/14; dated 12/5/14, indicated 25% for breakfast and lunch. There was no meal intake recorded for supper; dated 12/6/14, indicated 25% for breakfast and 15% for lunch. There was no meal intake recorded for supper; dated 12/8/14, indicated 10% for breakfast, and 5% for lunch.
There was no other Nutrition Risk Screening Form or RD Nutrition Assessment for Patient 9 in the medical record.
On 12/15/14 at 4:05 pm, an interview was conducted with Registered Nurse (RN) 2. RN 2 stated the hospital policy was for the nurse to do a nutrition risk screening form within 24 hours of admission then fax to the RD. If the score was a 2 or higher then the RD was to fax back a RD nutrition assessment and then a re-screen would be done every 3 days. If the score was a 0 or 1 then they would re-screen within a week. The RN 2 stated this was done for all acute patients and swing patients.
On 12/16/14 at 9:25 am, an interview was conducted with Certified Nursing Assistant (CNA) 1 regarding recording meal intake percentages. The CNA 1 stated they put all the intakes on a paper in the room and at the end of their shift they enter those into the electronic medical record. CNA 1 stated they do this each day.
On 12/16/14 at 1:30 pm an interview was conducted with the RD. The RD stated they do an assessment after receiving a fax from nursing if the nutrition risk was a 2 or higher, then every three days nursing should do a re-screen if the patient was still admitted. If it was again higher than a 2 then the RD would do another assessment. The RD stated they also monitor each patient that they did an assessment on and will check the computer or call the nurse to see if the patient is still there after 5 days and would do a reassessment. The RD stated they now keep track on a calendar with the patient names so they can make sure they follow up. The RD was not aware Patient 9's reassessment was missed.
A review of the hospital's policy and procedure titled, "CNA Responsibilities on the Medical/Surgical Unit", dated 9/10, indicated the CNA performs responsibilities that include passing the meal trays and recording the percent intake.

b. A review of the clinical record was conducted on 12/16/14. Patient 10 was admitted with a diagnosis of dehydration on 12/13/14. A review of the Nutrition Risk Screening Form, dated 12/13/14, indicated Patient 10 had a nutrition risk score of a two (2) for oral supplement and receiving a complex modified diet. The form had a faxed stamp on it with no date or time. There was no Nutrition Assessment found in the clinical record by the RD.

On 12/16/14 at 8:40 am, an interview was conducted with RN 1. RN 1 stated the RD had called last evening but there was never an assessment that was faxed over as of yet.
c. Patient 6 was admitted on 11/8/14 with diagnoses that included hematoma (localized swelling that is filled with blood), contusion (bruise), and low back pain. Patient 6 was discharged on 11/14/14.
A review of the Nutrition Risk Screening Form, dated 11/11/14, indicated the risk level was a two for being on a diabetic diet and the serum albumin was less that 3 g per dL at 2.6 g per dL. This was not done within 24 hours of admission.
On 12/15/14 at 4:05 pm, an interview was conducted with RN 2. RN 2 stated they do a nutrition risk screen on admission within 24 hours and then fax over to the RD.
d. Patient 8 was admitted to the general acute hospital on 11/25/14 with diagnoses that included constipation. Patient 8 was admitted to swing bed status (patient receives skilled nursing services instead of acute care services) on 11/29/14 with diagnoses that included abdominal pain. Patient 8 was discharged on 12/5/14.
A review of the Nutrition Risk Screening Form dated 11/29/14, indicated a risk level of a three for NPO (nothing by mouth) and clear liquid greater than three days, oral liquid supplement and meal intake less than 50%.
A review of Nutrition Assessment dated 11/30/14 indicated that Patient 8 had 0-45% meal intake likely due to nausea because of constipation. The RD stated the current diet with good intake would meet the estimated nutrition needs. The RD indicated Patient 8 was 64 inches and 115 pounds and the estimated nutrition needs were 1300-1560 calories per day and 52-68 grams of protein per day. The RD plan was to continue with the regular diet and mightyshakes three times a day, replete fluids and electrolytes as medically appropriate as needed, and to adjust the bowel regimen as needed to promote optimal bowel function. The RD indicated will re-evaluate per the Nursing Nutrition Risk Screen.
There was no re-evaluation per the hospital policy for the Nutrition Risk Screening Form.
On 12/15/14 at 4:05 pm, an interview was conducted with RN 2. RN 2 stated they do a nutrition risk screen on admission within 24 hours and then fax over to the RD. RN 2 stated for a risk of 2 or higher they will do a re-screen every three days.
A review of the Diet Assessment for the following dates: 12/1/14 indicated 15% for breakfast, 50% for lunch and there was no record for the supper meal; 12/2/14 indicated 10% for breakfast and 100% for lunch and there was no record for the supper meal; 12/3/14 indicated 50% for breakfast and supper and there was no record for the lunch meal; 12/4/14 there was no record for any meal; and 12/5/14 indicated 75% for breakfast and the lunch meal. There was no record for any meal on 11/29/14 or 11/30/14.
On 12/16/14 at 9:25 am, an interview was conducted with CNA 1 regarding recording meal intake percentages. The CNA 1 stated they put all the intakes on a paper in the room and at the end of their shift they enter those into the electronic medical record. CNA 1 stated they do this each day.
A review of the hospital's policy and procedure titled "CNA Responsibilities on the Medical/Surgical Unit", dated 9/10, indicated the CNA performs responsibilities that include passing the meal trays and recording the percent intake.
e. Patient 7 was admitted on 12/2/14, with diagnoses that included hyponatremia (low sodium levels) and generalized weakness. Patient 7 was discharged on 12/10/14.
A review of the Nutrition Risk Screening Form dated 12/2/14, indicated the nutrition risk level was zero. The form indicated to have a re-evaluation in one week dated 12/9/14. There was no re-evaluation of the Nutrition Risk Screening Form in the medical record.
A review of the Diet Assessment for the following: dated 12/3/14, indicated 100% for clear liquids and 50% for lunch for low fat diet and there was no record for the supper meal; there was no meal intake record for 12/4/14; dated 12/5/14, indicated 50% for breakfast and lunch meal and there was no supper meal intake recorded; there was no meal intake record for 12/6/14 and 12/7/14; dated 12/8/14, indicated 50% for breakfast and the lunch meal and there was no meal intake record for the supper meal; dated 12/9/14, indicated 25% for breakfast and 50% for the lunch meal and there was no supper meal intake recorded.
On 12/16/14 at 9:25 am, an interview was conducted with CNA 1 regarding recording meal intake percentages. The CNA 1 stated they put all the intakes on a paper in the room and at the end of their shift they enter those into the electronic medical record. CNA 1 stated they do this each day.
A review of the hospital's policy and procedure titled, "CNA Responsibilities on the Medical/Surgical Unit", dated 9/10, indicated the CNA performs responsibilities that include passing the meal trays and recording the percent intake.
On 12/16/14 at 1:15 pm, an interview was conducted with the Chief Nursing Officer (CNO). The CNO stated they in-serviced the nursing staff multiple times since 10/2014 regarding the nutrition risk screening forms. The CNO stated for both the acute hospital and the swing status the nutrition risk screening form should be done within 24 hours of admission then in three days or seven days depending on the risk level. The CNO stated the CNAs should document, in the medical records, the percentage of meal intakes.
3. On 12/16/14 beginning at 1:15 pm, the department's performance improvement plan was evaluated with the CNO. The CNO stated part of the plan of correction included that they would be monitoring the nursing nutrition screens and the RD assessments being done timely. The CNO stated they would not start to pull the data to evaluate these indicators for Quality Assurance Performance Improvement until the end of the month.

On 12/16/14 at 1:55 pm an interview was conducted with the Quality/Risk Manager (QRM). She stated she had been working with the DM regarding her review of the RD assessments being timely. The QRM stated upon further review of the report there was no recent data that had been collected at this time but she was to get that data towards the end of the month. The QRM stated she would get the data from the nursing side of things as well but right now the managers are just submitting their templates. The QRM stated they would be reporting on this last quarter but they just did not have the data in at this time.

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

1. The CAH failed to effectively establish and properly utilize agreements with Distant-Site Telemedicine Entities (DSTE) and failed to develop a functioning system for professional proficiency evaluations for telemedicine Medical Staff. (Refer to Q-197)

2. The CAH failed to effectively design and properly execute plans of correction for the most recent CMS survey. (Refer to Q-331)

3. The CAH's Governing Body (GB) and Medical Staff (MS) failed to take appropriate corrective action, when a contracted qualified Quality Improvement Organization made recommendations concerning needed improvements to achieve regulatory compliance. (Refer to Q-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: Periodic Evaluation and Quality Assurance Review, 42 CFR 485.641.

Based on document review and staff interview the Critical Access Hospital (CAH) and the Governing Body (GB) of the CAH:
1. Failed to effectively design and implement corrective actions so that resumption of annual periodic comprehensive program evaluations and quality assurance reviews could be successfully initiated and completed as planned.
2. Failed to follow through with a stated plan of correction of CMS deficiencies so the planned comprehensive evaluation and review could be effectively resumed and would find that planned improvements in quality and compliance had been accomplished.

These failures could potentially permit patients to receive substandard care.

Finding:

On 12/15/14 and previously the performance of the CAH during a May 2014 review by a contracted Quality Improvement Organizations (QIO-1) and the recent CMS survey conducted in September 2014 were reviewed and considered. Two documents from QIO-1 dated 5/16/14 and 5/20/14 documented that QIO-1 had not done a comprehensive review of the CAH's total program and had not reviewed a representative sample of the CAH's medical records. Rather, only 20 medical records (charts) had been reviewed. This small number of charts is less than 1% of percent of the patients seen in the prior year. Despite that small percentage of charts reviewed, the QIO had significant findings which generated a number of recommendations for needed improvements, only some of these are partially recounted below:

In the two above referenced QIO-1 Reports finding included:
QIO-1 Report #1: The CAH had insufficient staff to maintain the Medical Staff Credential files and other records to support adequate credentialing and privileging of the medical staff.
QIO-1 Report #2: The medical staff credential files, in particular those for telemedicine providers were not being kept current and complete.
QIO-1 Report #3: The contracts with telemedicine providers were critiqued and suggestions were made.
QIO-1 Report #4: The medical staff privileges lists were critiqued and suggestions were included.
QIO-1 Report #5: The process for medical staff peer review was critiqued and significant improvement suggested, which included the development of a "process for review of at least 10% of the Hospital records for each provider."


During September the CAH had undergone a full CMS validation survey for recertification, which resulted in many findings which were similar to those found in the May QIO review. There were also other significant findings. As a result the CAH was required to write a Plan of Correction which was finally approved on 12/9/14. That plan contained numerous segments, the following partial list (3 of many) are relevant to this section of the regulations:

PoC #1: The "QIO-1 has been retained and scheduled for a full (Critical Access Hospital) facility-wide (name of CAH) survey the week of 1/5/15 to include a total quality program assessment. A 10% minimum of facility-wide charts ... and other documentation will be utilized during the survey to assure compliance with (regulations)." This was to be completed by 11/24/14.

PoC #2: "The survey report, along with ... will be presented to the MEC (Medical Executive Committee) and Board of Directors (Governing Body or GB) for review ..." This was to be completed by 11/24/14.

PoC #3: "At least 10% of Emergency Department charts are continuously reviewed by Emergency Room physicians for ..." "Clinical charts are reviewed by members of the Medical Staff. 10% of charts are reviewed monthly ..." These and many other goals to assure full review were to be completed by 12/5/14.


On 12/16/14 beginning at 9:00 a.m. and continuing into the mid-afternoon with intermittent breaks, the Executive Assistant (EA-1) was interviewed and documents were concurrently reviewed. Records requested included any evidence that the PoC had been carried out and evidence of the results. Also the following were requested:

Request #1: A request was made for the memorandum of understanding or other documentation showing that the full system-wide periodic evaluation and quality assurance review had been scheduled with QIO-1 for the week of 1/5/15. Also requested was any evidence that preparations had been started in preparation for that review.

Request #2: A request was made for the current policies, procedures, plans or other documentation directing the CAH's annual total system evaluation and quality assessment review process.

Request #3: A request was made for documentation to show that the GB had had been involved with and approved the CAH's Plan of Corrections current quality assessment and performance improvement program and plan (titled Organizational Performance Improvement Plan), and the Plans of Correction for the May QIO-1 review findings and the September CMS survey findings.

Request #4: A request was made for evidence that Ongoing Professional Proficiency Evaluations (OPPE or Peer Review) that were being done for all medical staff members. Selected OPPE files were also requested and concurrently reviewed.

Request #5: A request was made for the contracts or other written agreements with any providers of telemedicine practitioner (reference in CMS regulations as Distant-Side Telemedicine Entities or DSTE). A list of all medical staff members with telemedicine privileges so they could provide care from a distant site. Selected credential files and OPPE were requested and concurrently reviewed. Also the CAH's complete list of all contracted service agreements was requested.


During the 12/16/14 extended interview and concurrent review beginning at 9:00 am, the following observations and interview statements were noted relative to the above 5 requests:

During that interview EA-1 commented about her wide ranging list of assignments and lack of assistance, which made it very difficult for her to effectively and completely keep the credential files and other governance documents current. During the subsequent interview and concurrent document review, it became clearly evident that the tasks assigned to EA-1 were exceedingly numerous and that many of her custodial tasks pertaining to Medical Staff (MS) credential files had not been accomplished in a timely manner, thus indicating that the suggested and needed improvement referenced above at QIO-1 Report #1 had not yet been achieved.

Concerning Request #1: Documentation showing preparations for scheduled review by QIO-1: At 9:00 am on 12/16/14, the requested documents were not readily available and EA-1 called for assistance from the Chief Nursing Officer (CNO).

At 9:30 am, some documentation and information about the scheduled review by QIO-1 was available and provided by the CNO. The CNO reported that there had been no memorandum of understanding or a written agreement of any type with QIO-1. Arrangements had been made only by phone but 2 available related email messages were provided for review. These messages, both dated 11/24/14 document an exchange of phone messages in an effort to establish phone communication. The CNO reported that she had called a representative of QIO-1 and scheduled the review by phone and she provided a copy of the purposed agenda.

The agenda titled "Quality and Credentialing Review January 6 -8" included comments relative to material needed from the CAH for the review to occur. On the second page (first after the cover page with title), under the section titled "Focus - Record Review" was the following comment. "Emergency Department: 10% of annual visits or approximately 440. Given that this is such a large number I think we should include any internal reviews that you have done and/or we need a team to review this many!" This same statement was repeated at the top of the fourth page titled "Audit Form - Service: Emergency Department. The CNO was asked: what had been planned in response to this comment? Had the CAH made arrangements for a team from QIO-1? If so, did the CAH have documentation of that arrangement? She stated that the CAH had not made arrangements for a team of reviewers from QIO-1. She also indicated that preparations for an internal audit of Emergency Departments, using the Audit Form provided by QIO-1, had not yet been arranged. A discussion of the relative costs of each alternative plan followed.

During the morning of 12/16/14 after the information from CNO was provided, EA-1 opened the drawer containing Medical Staff (MS) Peer Review (OPPE) files and the file of a randomly selected Emergency Physician was pulled for concurrent review. The OPPE file for MD-L contained multiple forms titled "Emergency Department Physician Review Worksheet" but none of the forms were filled out with relevant information. When asked, EA-1 indicated that the forms had not been used properly. She also said that no data had yet been tabulated or reported to the MEC or GB. She stated that the CAH had not yet come close to the target of 10% review for emergency room charts or other types of charts.

Beginning at 2:30 pm on 12/16/14, a subsequent joint interview with 3 CAH members, included a member of the GB (Clerk-GB), the CNO and EA-1: During that interview the CAH members acknowledged that CAH did not yet have in place a system of OPPE that did the 10% review of all charts, as the Plan of Correction as referenced in PoC #3 above.

At the conclusion of the survey at 12:00 noon on 12/18/14 at the CAH administrative staff had not provided any documentation to demonstrate that action had planned or begun to facilitate the comprehensive program evaluations and quality assurance review by QIO-1 currently scheduled for the week of 1/5/15. There was no evidence of plans for QIO-1 to bring a full team to review charts, nor was there evidence to demonstrate actions planned or begun in the CAH to initiate an effective internal 10% review of charts.

Thus the CAH had not accomplished the stated Plans of Correction specified at PoC #1 or PoC #3 referenced above. Nor had the CAH accomplished improvements suggested in the May QIO-1 Reports, referenced above at QIO-1 Report #1, #2 or #5.

Concerning Request #2: In addition to policies and plans for the 1/5/15 review by QIO-1, all current policies, procedures, plans or other documentation directing the CAH's annual total system evaluation and quality assessment review process was requested. There were no available documents detailing a current plan of action for the total system review scheduled for the week of 1/5/15. The only relevant policy came from the "CAH Manual" and was titled, "Critical Access Hospital: Periodic Evaluation and Quality Assurance Review," originating in 3/2013, last revised 3/2012 and last reviewed 8/2013. It was a 2 page document stating the general intent as outlined in CMS regulations. It contained no specific processes or procedures and dis not address any of the recently identified deficiencies, thus showing that the CAH had failed to change policies or make plans to correct the CAH's failure to conduct a yearly Periodic Evaluation and Quality Assurance Review.

Concerning Request #3: Review of the GB minutes showed that the only minutes completed since last reviewed, were from the meeting of 10/29/14. A report titled "Annual Critical Access Hospital Evaluation for 2013" was presented by the Chief Executive Officer (CEO). The report, dated 10/22/14 did not call attention to the finding from the May review by QIO-1 or the September CMS survey. Rather, it stated "Medical Record Review - Reviews of medical records were completed at part of ongoing performance improvement and peer review processes. A total of 10% of records were reviewed which is 10% of total inpatient and outpatient records." This statement in the report was contrary to the finding of both the May QIO-1 review and the September CMS survey.

During a telephone interview, on 12/18/14 at approximately 10:30 am, the CAH's Administrator (CEO) stated that he had not fully informed the GB of the details in the QIO-1 reports for the May 2014 review and the GB had not been significantly involved in any related corrective action. He also stated that he had not fully informed the GB about the details of the September CMS survey, and the GB had not been informed of or involved with the resulting Plan of Correction (PoC). Thus the CAH had not accomplished the stated Plan of Correction specified at PoC #2 referenced above. Nor had the CAH involved the GB in seeking to accomplish the improvements suggested in the May QIO-1 Reports, referenced above at QIO-1 Report #1, #2, #3, #4 or #5.

Concerning Request #4 and #5: The available OPPE reports for Telemedicine medical staff members affiliated with DSTE-1 were incomplete and could not be interpreted. The example credential file pulled of a medical staff member affiliated with DSTE-1 and reviewed was that of MD-G. EA-1 had no documentation to show that the MEC or GB had reviewed or addressed the OPPE irregular reports from DSTE-1, thus demonstrating that the statements in PoC #1 & #3 were not correct and neither had not yet been achieved. (Refer to Q-197)

The available OPPE reports for Telemedicine medical staff members affiliated with DSTE-2 were incomplete and could not be interpreted. The example credential file pulled of a medical staff member affiliated with DSTE-2 and reviewed was that of MD-H. EA-1 had no documentation to show that the MEC or GB had reviewed or addressed the irregular OPPE reports from DSTE-2, thus demonstrating that the statements in PoC #1 & #3 were not correct and neither had not yet been achieved. (Refer to Q-197)

There were no OPPE data or reports available for the 3 medical staff members (MD-I, MD-J & PhD-K) affiliated with DSTE-3. None of these three credential files had been assembled and the documentation available for review was incomplete, thus demonstrating that the statements in PoC #1 & #3 were not correct and neither had not yet been achieved. (Refer to Q-197)

Concerning Request #5: Documents concurrently reviewed with EA-1 on 12/16/14 included information about the contracts related to telemedicine medical staff members on staff: The CAH had written agreements with three (3) different Distant-Site Telemedicine Entities (DSTE-1, DSTE-2 and DSTE-3). Only two of these three organizations had contracts recorded on the CAH's list of all contracted services. DSTE-3 was not on the list provided for review and EA-1 acknowledged that she needed to add it. The various contracts for these DSTEs were incomplete and did not meet all of the requirements specified at §485.616. EA-1 had no documentation to show that the GB had knowingly approved the credentialing and privileging agreements. (Refer to Q-197)

The Reports after the May QIO-1 review pointed out that the requirements for credentialing and privileging for telemedicine medical staff was irregular and not in keeping with requirements. Had the suggested improvement recommended by QIO-1 been addressed, it is very likely that the deficient contracts would have also been corrected. Without these contracts in place, the affiliated medical staff members would not be properly credentialed or privileged.

Thus demonstrating that the statements in PoC #1 & #3 were not correct and neither had not yet been achieved.

Interview statement relating to QIO-1 Report #1: During the extended interview beginning at 9:00 am on 12/16/14, EA-1 commented that her wide ranging list of assignment and lack of assistance, made it very difficult to effectively and completely keep the credential files and other governance documents current, thus demonstrating that the suggested improvement referenced above at QIO-1 Report #1 had not been achieved.