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1) The Governing Body (Board of Directors) failed to ensure that in all instances, the determination whether to grant, continue, limit or revoke a practitioner's privileges and Medical Staff membership, was consistent with established Medical Staff criteria, as well as with Federal and State law and regulations.

2) The Governing Body (Board of Directors) failed to ensure the granting of Medical Staff membership or professional privileges, both new and renewal, is based upon an individual practitioner meeting the Medical Staff's membership/privileging criteria and in accordance with the Medical Staff Bylaws.

Findings include:

Cross reference to findings at A 046, A 050, A 340, A 341, A 353 and A 357.

The Governing Body (Board of Directors) failed to ensure that in all instances, the determination whether to grant, continue, limit or revoke a practitioner's privileges and Medical Staff membership, was consistent with established Medical Staff criteria, as well as with Federal and State law and regulations.

Findings include:

Cross reference to findings at A 341. In addition, the SA asked for additional information regarding the election process of the current Chief of Staff (Physician #7) who had not been an Active member of the medical staff, but of Provisional Active status, when he/she was elected. In an 11/14/11 email by the previous hospital Chief Executive Officer (CEO), he/she stated, "For at least 8 years, we have not been following a little known provision in the NHCH Hospital Bylaws which requires that the NHCH Board of Directors approves the slate of candidates for Medical Staff Officers prior to the slate being submitted to the Medical Staff. I ran across the provision in our Bylaws and thus we will be following the provision in the future. Below, please find the slate of candidates that have been recommended by MEC..."

The SA's review of the Medical Staff (MS) Bylaws, Policies, And Rules And Regulations did not have this provision included within the current Bylaws nor the set which preceded it. Interview with the Vice President of Patient Care Services and Chief Nursing Officer (CNO) on 6/7/13 revealed it was another set of hospital bylaws referenced in the email, and stated that although the hospital governance was to follow the Board approved MS Bylaws and Rules & Regulations, it did not always work that way. The CNO affirmed the SA's survey findings were reflective of the hospital's governance system and that it was "broken" in many ways.

The Governing Body (Board of Directors) failed to ensure the granting of Medical Staff membership or professional privileges, both new and renewal, is based upon an individual practitioner meeting the Medical Staff's membership/privileging criteria and in accordance with the Medical Staff Bylaws and Rules and Regulations.

Findings include:

Cross reference to findings at A 340 and A 341.

1) Based on record reviews, interviews, and review of policies and procedures, the Medical Staff (MS) failed to ensure it conducts appraisals of its members, such that each individual practitioner is evaluated based on his/her qualifications and demonstrated competencies to perform each task or activity within the applicable scope or privileges for which the practitioner has been granted privileges. The MS also failed to ensure components on practitioner qualifications and competencies such as special training, quality of specific work, patient outcomes, adherence to MS rules, certifications, and currency of compliance with licensure requirements were enforced and followed for 28 of 30 practitioners' credentials that were reviewed.

2) Based on record reviews, review of policies and procedures and interviews, the Medical Staff (MS) failed to comprehensively examine the credentials of candidates for MS membership prior to making recommendations to the Governing Body (Board) for 28 of 30 practitioners' credentials that were reviewed.

3) Based on record review and interviews, the facility failed to ensure the Medical Staff enforced its Bylaws to carry out its responsibilities, as evidenced by failing to adhere to and enforce its provisions along with Department specific Rules and Regulations.

4) Based on record review and interviews, the facility failed to ensure that the granting of Medical Staff membership or privileges was based upon an individual practitioner meeting the Medical Staff's membership/privileging criteria in accordance with the Medical Staff Bylaws and Department specific appointment criteria.

Findings include:

Cross reference to findings at A 046, A 050, A 340, A 341, A 353 and A 357.

Based on record reviews, interviews, and review of policies and procedures, the Medical Staff (MS) failed to ensure it conducts appraisals of its members, such that each individual practitioner is evaluated based on his/her qualifications and demonstrated competencies to perform each task or activity within the applicable scope or privileges for which the practitioner has been granted privileges. The MS also failed to ensure components on practitioner qualifications and competencies such as special training, quality of specific work, patient outcomes, adherence to MS rules, certifications, and currency of compliance with licensure requirements were enforced and followed for 28 of 30 practitioners' credentials that were reviewed.

Findings include:

1. There was a failure to ensure practitioners were qualified and competent in their current work practice, as evidenced by numerous expired Neonatal Resuscitation Program certifications. On 6/6/13, a review of the facility's Department of Women & Children's Services Rules & Regulations revealed that specific to Newborn Resuscitation at WCS/11.0, "Any practitioner who participates in the care of newborns must be NRP (Neonatal Resuscitation Program) certified. Personnel who satisfy NRP guidelines, shall be solely responsibility [sic] for newborn care..." The SA's review of the department's 19 practitioners required to have NRP certifications found that 14 of 19 practitioners' NRP certifications were expired, with some practitioners having expired certifications from 2011.

In addition, at WCS/1.0 of the Rules & Regulations, the department members included pediatrics, obstetrics and other subspecialties and, "...The general policies stated herein will be adhered to in a manner consistent with ACOG Guidelines,...NRP Program..." At WCS/2.0, "Privileges in the Department...are granted based on a practitioner's education, training, current competence, and scope of licensure. The department has established privilege criteria for each speciality within its jurisdiction...privilege forms cover these categories: Obstetrics, Certified Nurse Midwifery, Pediatrics."

During an interview with licensed nurse #1 (LN #1) on 6/6/13, LN #1 stated the physicians and midwives had to be current with their NRP certification. LN #1 did not track their certifications however, but stated the obstetricians, pediatricians and midwives, just like the licensed staff, were required to have valid, current NRP certifications. LN #1 was not aware that 14 of their practitioners had expired NRP certifications. LN #1 said NRP certification classes were offered monthly. A review of the 2013 class schedule showed the NRP classes were offered monthly.

During an interview with Physician #5 on the morning of 6/7/13, it was found the practitioners within the department were individually responsible to maintain his/her own current valid NRP certification. During an interview on 6/7/13 at 12:10 P.M. with the CNO, she verified each individual practitioner in the Women's and Children's Department had to maintain a current NRP certification. She stated if a practitioner was not current on his/her certification, this was unacceptable practice as it did not meet what was outlined in the department's Rules & Regulations.

2. The appraisal/review process failed to ensure each practitioner's requested privileges included evidence of qualifications and competencies demonstrated by the practitioner, specific to the nature of his/her request (for renewal or as a new member) before being granted privileges and appointment to the Medical Staff.

a) Record review found Physician #11's reappointment period to the Active Medical Staff with privileges in teleradiology was approved from 11/4/11 to 11/4/13. The Privileging for Diagnostic Radiology (Teleradiology only) stated under, "Required Previous Experience" that this practitioner needed to have performed and interpreted at least 1,000 radiologic tests or procedures during the 12 months prior to the reappointment, in addition to three letters of reference from his/her affiliates.

Physician #11 signed the Privileging form on 9/1/11 and the department chair approved it on 9/27/11. The Medical Staff Credentialing and Privileging Credentials Report of October 2011 listed Physician #11, but there was no comment about whether the practitioner met the requirement as outlined in Privileging form. Additionally, review of Physician #11's Activity/Case Log in his/her medical credentials file revealed a single case log summary during the period from 9/1/09 to 8/30/11 for a total of only 11 cases. The Reappointment Evaluation, signed by the Department Chair, Credentials Committee, Medical Executive Committee (MEC) and the Board, noted Physician #11's request for clinical privileges was granted and that he/she was, "Qualified for the privileges as requested/delineated." The SA queried the facility's privileging process regarding how the appraisals/reviews were being conducted as Physician #11 did not meet the "Required Previous Experience," and yet was reappointed with core privileges.

The SA requested the production of policies and procedures (P/P) related to the privileging process and on 6/6/13, the CNO produced, "The Medical Staff's Policy for Ongoing Professional Practice Evaluation (OPPE)" (approved 6/11/10 by the MEC). This P/P delineated the privileging process and it was applicable to "...all practitioners privileged through the medical staff appointment and re-appointment process..." at the hospital. The OPPE was to ensure there was, "...ongoing evaluation of each practitioner's professional performance and to identify professional practice trends that impact on quality of care and patient safety. The information gathered during this process will be relevant in decisions to maintain, revise, or revoke existing privilege (s) prior to or at the time of reappointment. Findings that indicate potential negative trends or raise concerns about the quality of care or patient safety may require intervention by the medical staff and a Focused Professional Practice Evaluation (FFPE) implemented...The Credential Committee will use OPPE information, along with other pertinent data/information, to consider whether to grant, continue, limit or revoke any existing privilege(s). The Credentials Committee will report results of their review to the Medical Executive Committee (MEC). The MEC will report relevant findings and recommendations to the Board of Trustees. The Board of Trustees has final authority for privileging decisions." The SA found no documentation to show this was being done in Physician #11's credentials file or in the MEC Minutes.

Upon further inquiry as to where the OPPE information could be found for Physician #11, the CNO stated, "It is not being done here." Also, during an interview with Physician #8 on 6/6/13 at 1:50 P.M., he/she was asked what the OPPEs were and asked to describe how the OPPE was applicable to him/herself. Physician #8 stated in this advanced technological age, there should be reason why this type of information could not be obtained, and that an OPPE was about "outcomes and performance...you got to have it." Physician #8 acknowledged that an OPPE should be in each practitioner's credentials file if they were up for reappointment. Physician #8 stated if it was not there, "then it's not there."

b) Similar to Physician #11, Physician #12's reappointment to the Active Medical Staff with privileges in Internal Medicine (IM) was granted from 4/25/13 to 4/25/15. A review of this practitioner's credentials file revealed there was no OPPE for him/her. Physician #12's core privileging requirements stated he/she was to have demonstrated having provided inpatient care to at least 30 patients during the past 12 months (from 4/25/12 to 4/25/13). Physician
#12 also had the burden of producing the information, "...deemed adequate by the Hospital for a proper evaluation of current competence, and other qualifications and for resolving any doubts." In addition, Physician #12 requested Special Procedures in ICU Management, and per the Privileging for ICU Management, he/she, "...must meet criteria for Internal Medicine Core and demonstrate evidence of ICU medical management to at least 12 patients during the last 12 months..."

The SA's review of a 2/1/11 - 2/1/13 Medical Records Procedure Index (MRPI) for Physician #12, noted 9 different procedure codes but had no patients' names, level of care or medical record number. In addition, the MRPI outlined procedures such as Packed Cell Transfusion, Continuous Mechanical Ventilation, Serum and Platelet Transfusion, Parenteral Nutrition, etc., with a total case count of 34, yet there was no evidence to show there were 42 inpatients (12 of which had to be ICU) that were medically managed by this practitioner from 4/25/12 to 4/25/13. The practitioner's MRPI had been extended to include inpatient care activity from February 2011, which did not meet the privileging requirement time period of "...during the last 12 months." There also was no additional documentation found in his/her credentials file to show that an OPPE was done, in accordance with the MS policy.

Furthermore, Physician #12's Delineation of Privileges for the Application for Special/Invasive Procedures showed that he/she on 4/7/13 requested privileges for CVP Line Placement, Emergency Cardioversion, Endotracheal Intubation and Hyperalimentation. Although the Department Chair signed it on 4/12/13, there was no indication on whether it reviewed as the columns for "Recommended, Not Recommended, Recommended W/modification" were all blank and unmarked. Interview with the CNO on 6/7/13 revealed this was unacceptable and the CNO confirmed this practitioner's privileging application/review was incomplete and thus, should not have been approved nor considered for reappointment to the Active Medical Staff by the Board.

c) Physician #13's reappointment to the Active Medical Staff with privileges in General Surgery was granted from 11/1/12 to 11/1/14. As part of this practitioner's general surgery clinical privileges under the "Required Previous Experience," he/she had to demonstrate performance of at least 100 general surgical procedures during the past 12 months for clinical core privileges. Additionally, for Special Non-Core Privileges, of which Physician #13 requested Sentinel Lymph Node Biopsy, albeit stating he/she had performed this procedure since 2001, had to have, "...successfully provided patient services to at least 24 patients in the last 24 months." However, he/she had no MRPI that documented the criteria was met as part of his/her OPPE.

d) Physician #1's appointment was as Provisional Active staff with privileges in obstetrics and gynecology (OB/GYN) on 5/7/13 by the current Interim CEO. The approval and decision was granted from a review of the practitioner's credentials file by the Department Chair, Credentials Committee, MEC and the Board. However, it was found Physician #1 was one of the practitioners who did not have a current valid NRP certification.

The SA queried the credentialing and approval process for Physician #1 as he/she initially was hired as a locum tenens (LT), with privileges granted by the past CEO for the period of 11/9-12/31/12, and again from 1/2/13 to May 2013 due to a coverage need related to Physician #2's vacation. It also was found that an Independent Contractor agreement was entered between Physician #1 and the past CEO (Admin person #1) which became effective 11/6/12 for one year. This agreement was entered into during the time Physician #1 was granted to be a LT in Nov 2012. Within Section 6 of this agreement, Active Medical Staff Appointment and Clinical Privileges, it stated, "The Physician shall obtain and maintain active medical staff appointment and clinical privileges at NHCH commensurate with the clinical services that the Physician is required to perform pursuant to this Agreement. Application for the same shall be processed pursuant to the applicable bylaws and policies of the Hospital and its medical staff."

A review of Physician #1's credentials file however, revealed a 2/22/13 memo stating he/she was credentialed as a LT provider, but, "...there is inconsistency with dates regarding the recruitment..." It was noted Physician #1 was granted LT privileges by the CEO due to a need for speciality services, and thus, the practitioner's file had not reviewed/approved by the Credentials Committee, MEC or the Board of Directors (Board), before the start of Physician #1's first shift on 11/11/12.

It was noted thereafter, Physician #1's file was to be submitted to the Credentials Committee on 3/14/13, then forwarded to the MEC and the Board. The Board then approved Physician #1's privileges in OB/GYN on 5/17/13 as Provisional Active for two years. Review of the MEC Meeting Minutes of 9/9/11 noted that the Medical Staff Office personnel, "...stressed the importance of taking the necessary time needed when credentialing a physician. There is no such thing as 'emergency' credentialing unless our disaster drill has been activated." Interview with the CNO on 6/7/13 revealed that at times contracts were entered into as a means of hiring practitioners before they were fully reviewed.

Interview with the current Interim CEO on the morning of 6/10/13 prior to the exit conference revealed that although he/she may have signed one of the Independent Contract agreements, he/she did not have the full background on it. He/she affirmed the agreements were already in place and preceded him/her, so he/she could not give a concise explanation as to why these agreements were being entered into.

e) Physician's #2's reappointment with privileges in OB/GYN to the Active Medical Staff was approved from 2/24/12 - 2/24/14. Although a Delineation of Privileges in Category I for OB/GYN privileges and Category II were requested and marked with an "X" by the practitioner along with a request for repair of bladder, endometrial ablation and TVT (mid-urethral sling) procedures, the columns for "Approve, W/consult, Denied" were left blank; yet, the Department Chairman signed the form on 2/28/12.

In addition, the privileging in Category I for OB/GYN required Physician #1 to be board eligible or board certified by the American Board of Obstetrics and Gynecology, of which this physician was not. Physician #2 also did not meet the privileging criteria for Category I Obstetrical as he/she had an expired NRP certification and the criteria indicated at, "d. Obstetricians/ob practitioners are required to maintain current NRP certification." The Department Chairman also signed the form on 2/28/12, which was after the practitioner's reappointment. There was no OPPE contained within this practitioner's credentials file as well.

f) Physician #14's reappointment to the Active Medical Staff was approved from 10/22/12 - 10/22/14. Similar to Physician #11, Physician #14 had to demonstrate performance and interpretation of at least 1,000 radiologic tests or procedures during the past 12 months, along with 3 letters of reference. The Department Chair approved the privileging form on 9/27/12, with the practitioner signing and requesting core privileges on 9/15/12. He/she also was required to, "...provide evidence of patient activity (i.e. admissions/consultations/surgeries/procedures) during the past 24 months to demonstrate current clinical competency," per a 9/17/12 reappointment verification form.

However, Physician #14's MRPI dated from 9/1/10 through 9/10/12 was a listing of diagnosis and procedure summaries, which showed a patient count of 282, total days of 1,139 with an average length of stay of 4 and a total revenue exceeding $5 million. However, there was no documentation in the MRPI to show how this correlated to patient activity as described in the reappointment verification form. The CNO verified that it showed, along with the other physicians' credentials the SA reviewed, that the OPPEs were not being done as part of the reappraisal process of their physicians.

g) Physician #15's credentials file revealed he/she was approved for Provisional Community-Based staff. The MS Bylaws for the category of Community Based Staff, 1.8-1 Qualifications stated, "The Community-Based Staff shall consist of medical staff appointees who do not actively practice at the Hospital but are deemed deserving of membership by virtue of their qualifications and their contributions to the health of the community, or their previous long-standing service to the Hospital, and who continue to exemplify high standards of professional and ethical conduct. Community-Based staff shall be recommended by a member of the medical staff and approved by the Medical Executive Committee and Board of Directors. 1.8-2 Prerogatives: Community-Based staff members are not eligible to exercise clinical privileges in the Hospital, or to vote or hold office in this medical staff organization, but they may serve on committees without vote at the discretion of the Chief of Staff."

On 6/7/13 at 11:55 A.M., the CNO was queried about Physician #15's category status as he/she was approved for privileges in Adult Family Medicine on 1/29/13 by the Department Chair, but was a Community-Based staff. The CNO verified the SA's finding that this practitioner was approved as a Provisional Community-Based staff by the Board, but according to the MS Bylaws, was not eligible to have clinical privileges. The physician also was granted core in-patient privileges per the hospital's privileging form for Family Medicine. The CNO verified this practitioner was an employed physician of the hospital, but practiced in the outpatient clinic setting and "does not do any in-patient work." The SA further queried the CNO as to how Physician #15 was then credentialed when his/her category status did not match the privileging he/she was granted. The CNO shook her head, and stated the credentialing process/review failed and there should be different sets for in-patient and out-patient privileging review, "but it's not there."

In addition, the 2/8/13 letter to Physician #15 granting his/her appointment was initially for temporary privileges in family medicine until the Board was to meet on 2/22/13. Then a second letter dated 2/19/13 letter to Physician #15 confirmed his/her status as "Provisional Community staff," and he/she was granted privileges without having met the "Required Previous Experience" of, "...provided inpatient care to at least 12 patients as the attending physician or senior resident during the past 12 months..." The letter also mentioned the physician was to be monitored in accordance with the Focused Professional Practice Evaluation (FPPE) policy, which was not in the credentials file. The CNO affirmed this was similar to the OPPE, but used for new provisional staff members. The CNO stated even the FPPEs were not being done, similar to the OPPEs.

h) Physician #16 was approved by the Board in the category of Provisional Courtesy staff with privileges in Family Medicine. An 11/4/11 letter to this practitioner stated, "This decision was based on your qualifications and review of the information in your credentials file, including the recommendations forwarded from the Department Chair, the Credentials Committee and the Medical Executive Committee. Your initial appointment and clinical privileges are for the period November 4, 2011 - November 4, 2013. The first twelve (12) months of your appointment is considered provisional. During that time, you will be monitored in accordance with the Focused Professional Practice Evaluation (FPPE) policy, which is attached, for your review," and was signed by the previous CEO.

Physician #16's privileging for Family Medicine included the "Required Previous Experience" in which he/she was to demonstrate that he/she had provided inpatient care to at least 12 patients as the attending physician or senior resident during the past 12 months, or be able to produce evidence of comparable clinical competence through the credentialing process. Review of the practitioner's credentials file however, revealed that he/she did not meet the privileging criteria. The records showed Physician #16 did not perform any procedures during the time he/she was at Facility A from April 2010 to January 2011. Physician #16 also had no provider activity listed at Facility B for Family Practice from September 2007 to September 2011 as the inquiry showed zero "0" inpatient/observation provider activity. At Facility C, their credentialing department returned the Appointment Verification Form documenting that Physician #16, "has not been working here within the past 24 months." The verification form was dated 10/31/11 from Facility C's Human Resources officer.

The CNO verified the SA's inquiry regarding what was found in Physician #16's credentials file which showed that he/she did not meet the qualifications to be credentialed and privileged as the requirements were not met. The CNO also verified the FPPEs were usually chart reviews, and did not include the monitoring, proctoring, external review, etc. as outlined in the MS Bylaws and the MS's FPPE policy of 3/11/11.

i) Physician #17, similar to Physician #1, entered into an Independent Contractor agreement with the current Interim CEO effective 5/20/13 for one year. Physician #17 had been recruited as a LT with temporary privileges granted for 6 days from 5/21/13 through 5/26/13, which was documented on the Delineation of Privileges for OB/GYN and signed by Physician #17 on 9/26/12. The Department Chairman signed it on 5/23/13; however, did not approve the requested privileges by Physician #17, as the columns for "Approve, W/consult, Denied" were left blank.

During the interview with the CNO on 6/7/13, the CNO stated regarding the credentialing/privileging process, it was not being done in accordance with the MS Bylaws, and revalidated the SA's findings as evidenced in the multiple random practitioner's credentials files reviewed during the validation survey.

Based on record reviews, review of policies and procedures and interviews, the Medical Staff (MS) failed to comprehensively examine the credentials of candidates for MS membership prior to making recommendations to the Governing Body (Board) for 28 of 30 practitioners' credentials that were reviewed.

Findings include:

1. Cross-reference to relevant findings in A 340. Concomitantly, several physicians' request for clinical privileges were not approved and marked (i.e., w/consult, denied, recommend all, recommend privileges with the following conditions modification, do not recommend), by respective Department Chairs (or designees) for Physicians #2, 7, 10, 12, 13 and 17. Moreover, the Credentials Committee failed to review and examine the credentialing details of the candidates, and thus, did not follow the requirements of their MS Bylaws nor the Rules and Regulations, prior to making recommendations to the MEC and the Board.

2. On 6/4/13, the SA reviewed selected medical staff credentials files and one review included the Chief of Staff (COS). Review of Physician #7's credentials file, as the COS, revealed his/her "New Appointment Request For Privileges" was approved by the Surgical Department Chair, Credentials Committee, Medical Executive Committee (MEC) and Board of Trustees, and given a "Provisional Active" status in Orthopedic Surgery. The president/CEO's 5/5/11 appointment letter to Physician #7 confirmed his/her Provisional Active status with clinical privileges in orthopedic surgery from 5/5/11 - 5/5/13.

On 6/5/13 at 9:00 A.M., the SA queried the CNO whether Physician #7 was a member of the Active medical staff, after reviewing his/her credentials file. The SA found his/her appointment was "Provisional Active." A concurrent review of the facility's 2/4/13 Medical Staff Bylaws, Policies and Rules and Regulations (revised from 2/2/11), found in Part I Organization, Medical Staff Bylaws (MS Bylaws), Definitions, that, "4. Chief of Staff (COS) means the chief officer of the medical staff elected by members of the medical staff...8. Medical Executive Committee means the committee of the medical staff which shall constitute the decision making body of the Medical Staff as described in these bylaws. 9. Medical Staff or Staff means those physicians; MD or DO...meeting the qualifications of Part II and who have been granted recognition by the Board of Directors as members of the medical staff pursuant to the terms of these bylaws." Within Article II, 2.1-1, "The officers of the medical staff shall be the chief of staff, vice chief of staff...2.1-2 Qualifications - Officers must be members of the active medical staff at the time of their nominations and election, and must remain in good standing during their term of office. Failure to maintain such status shall create a vacancy in the office involved." Of note, the MS Bylaws was adopted by the MS on 12/20/12, signed by Physician #7 as the COS, who was not an Active member of the MS, and was approved by two members of the Board of Directors (Board) on 2/4/13.

From the review, the CNO confirmed that Physician #7 was not a member of the Active medical staff. In addition, a concurrent review of the MS Bylaws found at section "2.B.3 Provisional Period: (a) Initial appointment to the Medical Staff (regardless of the staff category) and all initial grants of clinical privileges or scope of practice, whether at the time of appointment, reappointment, or during the term of an appointment, shall be provisional." The CNO verified that Physician #7, being Provisional Active, was not qualified to be the COS according to the MS Bylaws.

On 6/5/13 at 4:21 P.M., during an interview with Physician #7, he/she explained that prior to returning to the facility in 2011, he/she had been practicing in two other States for approximately 2-3 years. Physician #7 said he/she was given a provisional active status from 5/5/11 to 5/5/13, and in January 2012, was elected to be the COS. Physician #7 said as a Provisional member, the MS Bylaws stated one could not be the COS. Physician #7 said, "I got elected Chief of Staff." SA asked if the Board (Governing Body) knew his/her status prior to election, and Physician #7 replied, "I was asked to be Chief of Staff. The intent of this was because I knew how to be chief versus someone else who would be new. It would take two years to train someone into the position if they were new." Physician #7 stated he/she was aware of the MS Bylaws, but the Board wanted him/her to be the COS, so he/she took the position and did what the Board told him/her to do. "It's hard work and it's free time (without pay)." Physician #7 also submitted a 6/6/13 letter to the SA stating, "In adition to our previous discussion, there was no individual willing to the take the position of Chief of Staff. Requests for a replacement candidate were repeatedly asked for, but no one was willing to step into this role."

During an interview with Physician #8 on 6/6/13 at 1:50 P.M., he stated the COS should not have been elected as an officer because Physician #7 was still provisional during the first year of his appointment. Physician #8 stated he was uncertain when Physician #7 had been appointed as the Medical COS, but then acknowledged it was 1/1/12, which would have been during Physician #7's provisional period and thus, not as an Active member of the Medical Staff when appointed.

Review of the Bylaws at "Article II - Officers, 2.1 Officers of the Medical Staff, 2.1-2 Qualifications, Officers must be members of the active medical staff at the time of their nominations and election, and must remain members in good standing during their term of office. Failure to maintain such status shall create a vacancy in the office involved," was read to Physician #8. Physician #8 affirmed the Bylaws have to be followed, and stated to be an officer, the qualification was to be an Active member of the MS. He confirmed Physician #7 was not in such standing because all new physicians were given a "'provisional" status and retained the "provisional active" status until the end of the second year. Physician #8 verified this was true for Physician #7, whose Provisional Active period was from 5/5/11-5/5/13.

Both Physicians #7 and #8 stated during their interviews that there was a need to fill the COS position as there was no other physician willing or available to take it. However, during a review of the 10/14/11 MEC Minutes, it was revealed an initial slate of the 2012 Medical Staff officers had included the acting COS at that time, Physician #9, who was an Active member of the MS, and met the criteria for appointment. However, in the 11/11/11 MEC Minutes, Physician #8 "...recommended (Physician #7) as Chief of Staff for 2012." The past CEO then presented the revised slate to the Board for approval, which the Board approved, albeit Physician #7 being a Provisional Active member.

In addition, the SA asked for additional information regarding the election process for Physician #7 who had not been an Active member of the medical staff, but of Provisional Active status, when he/she was elected. In an 11/14/11 email by the previous hospital Chief Executive Officer (CEO), he/she stated, "For at least 8 years, we have not been following a little known provision in the NHCH Hospital Bylaws which requires that the NHCH Board of Directors approves the slate of candidates for Medical Staff Officers prior to the slate being submitted to the Medical Staff. I ran across the provision in our Bylaws and thus we will be following the provision in the future. Below, please find the slate of candidates that have been recommended by MEC..."

The SA's review of the Medical Staff (MS) Bylaws, Policies, And Rules And Regulations did not have this provision included within the current Bylaws nor the set which preceded it. Interview with the Vice President of Patient Care Services and Chief Nursing Officer (CNO) on 6/7/13 revealed it was another set of hospital bylaws referenced in the email, and stated that although the hospital governance was to follow the Board approved MS Bylaws and Rules & Regulations, it did not always work that way. The CNO affirmed the SA's survey findings were reflective of the hospital's governance system and that it was "broken" in many ways.

Based on record review and interviews, the facility failed to ensure the Medical Staff enforced its Bylaws to carry out its responsibilities, as evidenced by failing to adhere to and enforce its provisions along with Department specific Rules and Regulations.

Findings include:

Cross-reference to findings at A 340 and A 341.

Based on record review and interviews, the facility failed to ensure that the granting of Medical Staff membership or privileges was based upon an individual practitioner meeting the Medical Staff's membership/privileging criteria in accordance with the Medical Staff Bylaws and Department specific appointment criteria.

Findings include:

Cross-reference to findings at A 340 and A 341.

Based on record review, staff interviews and policy review, the hospital failed to develop nursing care plans with interventions and measurable objectives, whenever possible, and to keep current the nursing care plans for 8 of 30 patient records reviewed. There was 1 record (Patient #7) without a care plan and 7 records with care plans without measurable goals or without updates (Patients #1, 2, 3, 4, 6, 15, and 16).

Findings include:

1. Record review of P#1 in the afternoon of 6/3/13 revealed a 51 year old patient admitted that day at 10:30 am with diagnosis of left diabetic foot ulcer. Patient had left leg swelling for five (5) days with redness and the possibility of infection. Laboratory results showed elevated blood sugar level of 280 mg/dl and white blood cell count of 11.6. The physician ordered IV antibiotics (Vancomycin 1 gm every 12 hrs and Piperacillin-Tazobactam 3.375 gm every 6 hrs IV piggy back), Enoxaparin 40 mg subcutaneously every 12 hours, insulin on a sliding scale basis - low dose regimen before meals and at bedtime. The orders also included elevate leg, contact precautions for possible MRSA, consult wound nurse and tepid showers. Morphine 2 mg IV was ordered as needed for pain every 4 hours.

P#1's care plan included one problem - "altered comfort level with goal of optimal comfort level will be achieved. Patient will report changes in comfort level." Patient was given Norco for pain at that time. On 6/5/13, review of the care plan noted that the patient had complained of pain to left foot when ambulating . However, the care plan did not reflect specific and measurable goals for the pain based on the Wong-Baker Face Pain Scale the hospital utilized in order to define patient comfort level stated in the problem. (Pain scale of 1-10 with 10 being the highest level of pain). The patient's unstable blood sugars due to diabetes and wound care were still not included as problems in the care plan.

Therefore, P#1's Care Plan was not updated to include diabetes and wound care and did not include measurable objectives/goals for his/her pain so that maximal patient comfort and care could be achieved.

2. Record review of P#2 in the afternoon of 6/4/13 revealed a 64 year old patient admitted on 5/27/13 with diagnoses of elevated troponin levels, altered mental status and diabetic ketoacidosis. Insulin (Levemir) pen 100 units/ml 6 units subcutaneously was being administered every 12 hours. The patient's transfer to a skilled nursing facility was held due to elevated blood sugar levels. Review of the care plan revealed problems listed were (1) altered blood sugar, goal of adequate blood sugar and (2) altered comfort level, goal of optimal comfort level. There were no measurable goals for the blood sugar levels or definition for comfort level and no specific interventions on how the goals were going to be achieved.

3. Record review of P#3 on 6/3/13 revealed a 92 year old patient admitted with diagnoses of acute diastolic heart failure, diabetes type II, hypertension, and congestive heart failure with diastolic dysfunction. The patient was admitted under observation status but was not doing well. His/her main complaint was shortness of breath, respiratory congestion and weakness. P#3 was then admitted to inpatient acute status to the medical/surgical unit for stabilization. P#3's Care Plan listed (1) impaired gas exchange as problem, goal was optimal gas exchange and (2) altered fluid volume deficit excess, goal of adequate fluid volume, electrolyte balance maintained. Again, there were no specific interventions and measurable goals for both problems.

4. Record review of P#4 on 6/3/13 revealed a 31 year old patient admitted on 5/30/13 with diagnoses of pancreatitis, history of diabetes type I with insulin pump, traumatic brain injury, post traumatic stress disorder (PTSD), severe esophagitis, and diabetic ketoacidosis (DKA). Patient had just been discharged the day before this admission for DKA. P#4's main complaint on this admission was epigastric abdominal pain. The physician ordered IV fluids, NPO (nothing by mouth), Morphine and Zofran as needed. Patient's diabetes was uncontrolled so insulin through his/her pump was to be continued. The physician's note stated that P#4 also had a non-obstructing renal stone so a urinalysis was ordered to check for infection or hematuria.

Although there were multiple concerns for this patient, the care plan listed only one problem - alteration in comfort level, goal optimal comfort for patient with medications. The patient's diabetes type I with insulin pump and recent discharge for DKA, PTSD, and renal stone were not addressed in the care plan together with applicable interventions. Also, the goal for "optimal comfort" was not defined so that appropriate clinical assessments/interventions could be made.

5. Record review of P#6 revealed a 79 year old patient admitted with diagnoses of weakness due to dehydration, diabetes type II, history of COPD (chronic obstructive pulmonary disease), congestive heart failure, hypertension and an unspecified psychiatric disorder. Patient's blood sugars were generally elevated in the 200-300 mg/dl range. Levemir 20 units subcutaneous at bedtime and Novolog was being administered on a sliding scale basis. Review of the care plan revealed the elevated blood sugars and diabetes care was not included. An interview was conducted with LN#3 on 6/6/13 at 9:45 A.M. regarding a care plan for diabetes. LN#3 stated that a care plan for P#6's elevated blood sugars should have been added to the existing care plan.

6. Record review of P#15 revealed a 47 year old patient admitted on 6/3/13 with diagnoses of medication overdose, history of opiate addiction due to chronic pain to lower back and right knee, hepatitis C, mixed anxiety (depressed mood, adjustment disorder) and sleep apnea. One of problems listed in the care plan was altered thought process, with the goal as disorientation "will be minimized." However, there were no specific interventions on how this goal was to be met.

7. Record review of P#16 on 6/4/13 revealed a 72 year old patient admitted on 6/1/13 with diagnoses of syncope, bradycardia with prolonged sinus pauses, on narcotics due to chronic pain, history of depression multiple back surgeries, and status post (s/p) ventriculoperitoneal shunt placement five (5) years ago and s/p angioplasty. While the patient was attempting to taper off narcotics, he/she experienced nausea, vomiting and syncope. He/she was brought into the emergency room where the patient had an episode of bradycardia and asystole for a short period of time. Patient had been on Subutex and was trying to decrease the dosage by 2 mg every 9 days. The patient was concurrently on Levaquin for left lower extremity cellulitis, Lexapro, lasix, Lipitor and potassium. Physician's note stated the prolonged QT intervals was possibly from drug interaction of the Levaquin and Lexapro. The care plan listed altered comfort level - patient will report changes in comfort level. Patient was monitored in the intensive care unit until stabilized. The care plan did not include additional nursing interventions or goals for the altered comfort level which was also not defined.

8. Record review of P#7 revealed there was no care plan for this patient. P#7 was admitted on 5/26/13 with a primary diagnosis of cellulitis, which the patient was being treated for. However, there was no nursing care plan developed for wound/skin integrity. The only care plan for P#7 was for pain management. During a concurrent clinical record review on 6/4/13 with LN#3, she confirmed there was no care plan for the patient 's cellulitis. LN #3 said the expectation was for a care plan to have been developed.

Interview was conducted with Licensed Nurse #5 on 6/3/13 concurrently with record reviews. LN#5 stated that the computer lists problems and goals that the nurses can select from, or could formulate his or her own care plan for patients. Another interview was conducted with LN#3 on 6/7/13 regarding the care plans. LN#3 agreed the nurses can select from a list of problems and goals that was "generically" on the computer or write a care plan. However, LN#3 also agreed that a more specific care plan with measurable goals and interventions would better assist the Interdisciplinary Team (IDT) in evaluating the patients.

Policy review of the hospital's "Organizational Plan for Provision of Patient Care Services" found that part of the patient care process and services was the provision of a care plan. The plan stated, "Individualized plans for care, treatment, and services to meet the patient's unique needs are developed based on initial assessments, re-assessments, goals set, and patient's responses...North Hawaii Community Hospital encourages participation and includes patient and family in decisions related to their care."

Based on active and closed patient record reviews, staff interview and policy review, the hospital failed to complete 14 of 30 patient medical record entries with dates and/or times to accompany the authenticating signatures. Twelve records lacked the dates and/or times on the Conditions of Registration and two records did not have dates and times on the discharge instructions. Signatures with dates and times validate that all the conditions provided by the hospital are agreed upon prior to care, whenever possible. Timing and dating of entries also establishes a timeline of events and is necessary for patient safety and quality of care.

Findings include:

Record reviews conducted from 6/3/13 through 6/10/13 found that the Conditions of Registration presented to patients on admission did not have dates and times on the signed agreement. The Conditions of Registration included medical and surgical consent, nursing care, legal relationship between hospital and physician, maternity consent of newborns, and release of information. Patients #1, 4, 5, 7, 9, 20, 22, 23, 24, 25, 27, and 29 were found to lack the necessary dates and/or times on their Conditions of Registration forms. Records of Patients #17 and 28 did not have the date and time on their discharge instructions.

Interview was done on 6/6/13 with the Health Information Management Director (HIMS #1) who confirmed that all record entries should have the signature, date and time to ensure completeness of the legal medical record.

Policy review of hospital's "Legal Medical Record Standards" dated 4/11/12 stated for completion, timeliness and authentication of medical records, "all medical record entries are to be dated, the time entered and signed." (Page 4, VI. C.).

Based on observation, record review and interview, the facility failed to ensure the temperature logs of the walk-in refrigerator and walk-in freezer were accurately recorded by the dietary staff.

Findings include:

During an initial tour of the kitchen on 6/5/13 at approximately 2:15 P.M., it was found the walk in refrigerator and walk-in freezer's temperature logs did not indicate which log sheet it belonged to. For example, the 5/1/13 6:00 AM temp was "13," the 12:00 noon temp was "23" and the 6:00 PM temp was "2." A kitchen staff (KS #1) confirmed the temperatures for both units were taken three times a day as shown on the log sheet. However, KS #1, KS #2 (cook) and the Registered Dietitian (RD) had differing versions about how to read the temperatures in addition to which log sheet belonged to the refrigerator walk-in versus the freezer. On the bottom of the Temperature Log sheet, it noted, "Equipment: Refrigerator *Standard Temperature: 35-40 F (Any out of range temps should be documented on Service Requisition Form and reported to Engineering Department Immediately); Equipment: Freezer *Standard Temperature: Below -0 F (Any out of range temps should be documented on Service Requisition Form and reported to Engineering Department Immediately)."

The kitchen staff were asked about the temperature reflecting the "13" as well as other recorded temperatures such as the "23" recording. The RD stated the log sheet belonged to the Walk-In Freezer and then circled it. However, when he/she was asked if the "13" meant Fahrenheit (F), he/she was uncertain as well as the other staff. It was noted that if it was Celsius, then at 13 degrees, that would be 55 degrees F and the freezer items would have melted. If it was 13 F, it still would not have met the standard temperature for the freezer at "Below -0 F" per their log sheet. The SA asked for a policy and procedure on the recording of temperatures, and although the RD looked for it, stated he/she could not find one. The SA was also informed the Director of Dietary Services was out on leave.

Based on surveyor observation on 6/4/13 at approximately 10:30A, the facility failed to maintain the fire alarm system in accordance with Section 9.6.1.4 and the NFPA 72, National Fire Alarm Code.

The annunciator panel for the facility's fire alarm system indicated a supervisory system trouble signal. This is not a normal condition for a fire alarm system annunciator panel.

Based on observation, record review and interview, the facility failed to ensure the infection control program was implemented with collaboration that included individuals clinically responsible for the surgical department and the housekeeping staff, so as to prevent and control infections and communicable diseases.

Finding includes:

During a tour with Environmental Services (EVS) on 6/7/13 at 9:10 A.M., and the housekeeping department, it was revealed the terminal cleaning of the facility's surgical operating suites (OR) occurred on Monday-Thursday. Although surgical cases were performed on Fridays, Housekeeper #1 (HK #1) confirmed the terminal cleaning was not done on Fridays. "We would do it on Sunday nights," before the scheduled OR cases on Monday. Upon query as to why a terminal cleaning was not done after surgical cases on Friday, HK #1 said housekeeping was just not scheduled to do it.

The SA asked to review a policy and procedure on terminal cleaning and Admin #1, who copied policies from his/her computer onto a flash drive and gave it to the SA. He/she said, "it would all be here," but did not state whether a policy existed. The SA returned the flash drive to the CNO, and asked to have it perused for a policy on terminal cleaning. The CNO viewed the policies copied by Admin #1, and informed the SA that there was no policy and procedure on terminal cleaning.

Interview with LN #4 on 6/7/13 at approximately 10:15 A.M. revealed that best practice was to ensure terminal cleaning was done after the surgical cases were completed on Friday as well. LN #4 confirmed it was not being done, and stated there was no policy and procedure on the terminal cleaning of the OR. The SA asked for the AORN or similar standards of practice, and at 10:50 A.M., LN #4 provided the 2012 Perioperative Standards and Recommended Practices. At Recommendation IV it stated, "Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily. Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day. IVa. Terminal cleaning and disinfection of operating and invasive procedure rooms should be done - when the scheduled procedures are completed for the day, and each 24-hour period during the regular work week. IV.a.1. Unused rooms should be cleaned once during each 24-hour period during the regularly scheduled work week. Personnel enter unused rooms and move equipment and supplies in and out of the room...IV.b. Equipment is cleaned to prevent the growth of microorganisms during storage and to prevent subsequent contamination of the periooperative area...Recommendation V. All areas and equipment in the surgical practice setting should be cleaned according to an established scheduled. A clean environment will reduce the numbers of microorganisms present."

LN #4 verified that after the Friday surgical cases, the terminal cleaning was not done until Sunday night. LN #4 agreed that best practice was to ensure terminal cleaning was done after the Friday OR cases as well. Terminal cleaning was meant to assure a clean surgical environment, reducing the potential for transmission of diseases.