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Based on observation, interview, and record review, the hospital failed to keep clean and sterile supplies in a clean area, which had the potential for the spread of infection to the hospital's patient population.

Findings:

1. During a concurrent observation of the Emergency Department (ED) and interview with the Chief Nursing Officer (CNO) on 5/21/12 at 10 AM, a doorless supply closet located behind the ward clerk's desk was inspected. There was a fine gray substance covering all the items found in the closet. The following was found in this closet:

A working hopper (a toilet like apparatus used for the disposal of body waste).
Cotton tipped applicators-four boxes.
Isopropyl alcohol 70% pads-six boxes (pads used to clean skin).
Sterile gloves-one box each of size 6, 7, and 8.
Syringes-13 boxes.
Gauze sponges-four boxes.
Adhesive bandages-six boxes.
Polysporin foil packs.
Temperature prob covers.
Multiple pieces of paper.
Staff drink cups (2) and jackets (2).

This was verified with the CNO. He stated the ED staff puts supplies were ever they can find a place because of the ED's limited space.

2. During a concurrent observation of the ED dirty utility room and interview with the CNO on 5/21/12 at 11:20 AM, the following was found:

A sink used to clean hands with two boxes of surgical scrub soap packets.
Employee coffee cups.
Lubricating jelly in tubes.
Multiple clean graduated cylinders.
Multiple clean specimen cups.
Hopper with a yellow liquid inside the bowl.
Hydrogen Peroxide-one bottle.
Prep solution-one bottle (a liquid used to clean skin).
Clean sharps containers-three (plastic containers used to dispose of used needles).

At this time, the CNO stated the dirty utility room was considered dirty and clean items should not be placed inside and the the surgical scrub soap packets were used to scrub out wounds when patients present to the ED with open wounds. The CNO stated the sharp containers were used to replace the full containers located in the ED.

Based on staff interview and administrative document review, the Governing Body failed to ensure the Medical Staff operated under the current bylaws when a provisional Medical Staff member (Medical Doctor [MD] 4) was allowed to engage in clinical care activities without being assessed for competence. The Governing Body failed to ensure a provisional Medical Staff member (MD 4) was proctored while engaging in clinical care activities as a means of ensuring competence of newly appointed physicians granted clinical privileges as required by the Bylaws of the Medical Staff. This failure placed patients at risk of receiving care from someone not qualified to provide those services.

Findings:

The hospital Staff Policies and Procedures, Bylaws, and Rules were reviewed on 5/22/12 at 11:30 AM. The hospital's Staff Bylaws state on page 18 "4.3-2 Basis for Appointment a. Except as next provided with respect to telemedicine practitioners, recommendations for appointment to the Medical staff and for granting privileges shall be based upon appraisal of all information provided in the application (including, but not limited to, health status and written peer recommendations regarding the practitioner's current proficiency with respect to the hospital's general competencies [as further described at Bylaws, Article 5, Section 5.2], the practitioner's training, experience, and professional performance at this hospital, if applicable, and in other settings, whether the practitioner meets the qualifications and can carry out all of the responsibilities specified in these Bylaws and the Rules, and upon the hospital's patient care needs and ability to provide adequate support services and facilities for the practitioner. Recommendation from peers in the same professional discipline as the practitioner, and who have personal knowledge of the applicant, are to be included in the evaluation of the practitioner's qualifications." Article 5, Section 5.2 states on page 23 " 5.2 Criteria for Privileges/General Competencies 5.2-1 Criteria for Privileges Subject to the approval of the medical Executive Committee and governing Body, the Medical Staff will be responsible for developing criteria for granting setting-specific privileges (including, but not limited to, identifying and developing criteria for any privileges that may be appropriately performed via telemedicine). These criteria shall address the hospital's general competencies (as described below) and assure uniform quality of patient care, treatment, and services. Insofar as feasible, affected categories of AHPs shall participate in developing the criteria for privileges to be exercised by AHPs. Such criteria shall not be inconsistent with the Medical Staff Bylaws, Rules or policies. 5.2-2 General Competencies. The Medical Staff shall assess the practitioner's current proficiency in the hospital's general competencies, which shall be established by the Medical Staff and shall include assessment of patient care, medical/clinical knowledge, interpersonal and communication skills, and professionalism. The Medical staff shall define how to measure these general competencies as applicable to the privileges requested, and shall use them to regularly monitor and assess each practitioner's current proficiency. The hospital's Medical Staff Rule state on page 21 " PROVISIONAL STAFF The Provisional Staff shall consist of the members who: 1. Are initial appointees to the Medical Staff and plan to qualify for, and seek transfer to, the Active, Consulting, or Courtesy Staff in 12 to 24 months. 2. In the ordinary course of events, are transferred to Active, Consulting, or Courtesy status after serving at least twelve but not more than 24 months on the provisional staff. Action shall be initiated by the Medical Executive Committee to terminate the privileges and membership of a provisional member who does not qualify for advancement within 36 months. The member shall not be entitled to any hearing and appeals under the Bylaws, Article 14, Hearings and Appellate Reviews, if any advancement was denied because of a failure to have a sufficient number of cases proctored or because of a failure to maintain a satisfactory level of activity. The member shall be entitled to the hearing and appeal rights under Bylaws, Article 14, Hearings and Appellate Reviews, if advancement was denied because the members clinical performance or professional conduct was unsatisfactory." The hospital's Medical Staff policy and procedure for proctoring-peer review states on page 1 "SCOPE: Medical Staff Applicants/Reapplicants/Members, Service Chiefs/Medical Directors, Governing Board, Medical Executive Committee POLICY STATEMENT: The purpose of this procedure is to observe and evaluate, concurrently and/or retrospectively, all physicians granted privileges to assure and maintain the quality and appropriateness of patient care. PROCEDURE: 1. Proctoring: All initial appointees to the Medical Staff shall be subject to retrospective and/or concurrent proctoring on a minimum of ten (10) cases for a period of (2) months or for as long as the provisional period of one year."

A total of twelve Medical Staff credential files were reviewed with the Medical Staff Coordinator (MSC) 2 on 5/21/12 at 2 PM and at 5/22/12 at 9 AM. On 5/22/12 at 10:45 AM review of MD 4's credential file revealed no evidence that the physician had been proctored in accordance with Medical Staff Bylaws, Rules, Regulations and Policies.

MSC 2 was interviewed on 5/22/12 at 10:52 AM. She agreed the credential file of MD 4 revealed no evidence of proctoring while being engaged in clinical patient care activities. She stated there was a Medical Staff policy which detailed proctoring requirements for provisional Medical Staff members. She stated the MD 4 should have been proctored concurrently while engaging in clinical care activities. She stated the failure to proctor the MD 4 while he was engaging in clinical care activities represented a violation of the proctoring-peer review Medical Staff policy. She stated MD 4 was a member of a radiology group contracted to provide service at the hospital. She stated the radiology group had a Medical Staff Liaison (MSL) 3 with responsibilities which included coordination of proctoring for provisional Medical Staff members of the group.

MSL 3 was interviewed by telephone on 5/22/12 at 11 AM. He stated he was Medical Staff liaison for the group of radiologists contracted to provide service at the hospital. He stated he could not provide any documentation to substantiate MD 4 had been proctored concurrently while engaging in clinical care activities at the hospital as required by the proctoring-peer review Medical Staff policy.

The hospital's Chief Operating Officer (CEO) 1, Medical Staff Chief (MD 5), and MSC 2 were interviewed as a group on 5/22/12 at 1:15 PM. MD 5 stated he was Chief of the Medical Staff. CEO 1 stated he was the Chief Operating Officer. Both CEO 1 and MD 5 agreed they represented the Governing Body of the hospital for the purposes of the interview. Both CEO 1 and MD 5 stated they were not aware of the fact MD 4 had not been proctored as provisional Medical Staff member while engaging in clinical care activities. Both agreed MD 4 engaging in clinical care activities as provisional Medical Staff member without concurrent proctoring represented a violation of the proctoring-peer review Medical Staff policy. Both agreed the violation of the proctoring-peer review Medical Staff policy represented a violation of the Medical Staff Bylaws, Rules and Regulations. CEO 1 and MD 5 stated they would ensure a plan was instituted to correct the ongoing situation. MSC 2 stated she would contact MSL 3 as a means of making the arrangements for the proctoring of MD 4 to be done by another radiologist in the group.

MSC 2 was interviewed on 5/22/12 at 2:30 PM. She stated she had spoken to MSL 3 and finalized arrangements to have MD 4 proctored by another radiologist in the group. She stated both CEO 1 and MD 5 were aware of the arrangement and had approved it.

Based on interview and record review, the hospital failed to develop a policy and procedure indicating the services provided by the hospital and the services furnished by other providers which had the potential for adverse patient outcomes.

Findings:

During a concurrent interview with the Chief Nursing Officer (CNO) and review of the hospital's "Scope of Services" document for the emergency department on 5/22/12 at 10 AM, he stated the hospital did not have a policy and procedure indicating the services provided by the hospital and the services provided by other providers, including the emergency department.

The "Scope of Services" undated, read "The department provides evaluation and treatment to patients of various ages and varying levels of illness from minor to critical. The patients are then evaluated for response to that treatment and are then discharged, admitted or transferred based on the level of care deemed necessary by the Emergency Department physician."

Based on observation, interview, and record review, the hospital failed to:

1. Remove expired medication from patient care areas which had the potential for adverse patient outcomes; and,
2. Failed to date irrigation solutions in the warming cabinet, which had the potential to affect the integrity of the irrigation solution.

Findings:

1. During an observation of the emergency department medication room with the Chief Nursing Officer (CNO) on 5/21/12 at 10:50 AM, the following expired medications were found:

Hespan (a medication used as a plasma substitute in the treatment of hemorrhage), three 500 milliliter bags with the expiration date of 4/12/12. The CNO stated the bags should have been removed from the medication room by the pharmacist.

Regular Insulin (medication used to treat high blood sugar), one vial which was labeled as opened on 4/1/12. The CNO stated the vial should have been discarded 28 days after it was opened.

Octreotide (a hormone), one vial which was opened on 2/28/12. The CNO stated he was not sure how long this open vial should be kept before discarding it.

The hospital policy and procedure titled "Single and Multiple Dose Vials" dated 12/07/11, read "Multiple dose vials (MDV): 1. Once opened, MDV may be used for up to 28 days from the date they were opened. 2. Once opened, the staff that opens the vial is responsible for labeling the vial correctly....b. Staff will put the expiration date on the label."



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2. During a tour on 5/21/12, of the surgical department and observation of warming cabinet 010392 with a temperature of 86 degrees Farenheit (F). There were two 1000 milliliter (ml) intervenous bags of lactated ringers (irrigating fluid used with instruments to look at interior of body) in the lower cabinet. The bags were not dated or identified as being warmed.

During an interview with the Director of Surgery (Dir Surg), on 5/21/12, at 10:33 AM, she was asked how long the bags could stay in the warmer. The Dir Surg stated, "They can stay for 72 hours." When questioned about how long the bags had been in the warmer, the Dir Surg stated, "I don't know...they probably should have a date."

The manufactures recommendation, dated 8/23/06, indicated "...product should be stored at a constant of 25 degrees celsius (77 degrees F). Prolonged storage at higher temperatures may accelerate changes in final product. Solutions of volumes 150 ml or greater can be warmed in their plastic overpouches to temperature not exceeding 104 degrees F, and for no longer than 14 days or 150 degrees F, no longer than 72 hours. The product should be identified as being warmed."

Association of periOperative Registered Nurses: Standards and Recommended Practices (2010). Blanket and solution warming cabinet... Recommendation VIII, VIII.b.1 states "Fluids kept in warmers should be labeled with the date they should be removed or the date when they were placed in the warmer."

Based on observation, interview, and record review, the hospital failed to:

1. Minimize the risk of cross contamination by having food in the surgical restricted area; and,
2. Ensure staff were monitoring the temperature and humidity of surgical suites.

These failures had the potential to cause the spread of infections.

Findings:

1. During a concurrent observation and interview with the Director of Surgical Services (Dir Surg) on 5/21/12, at 10:45 AM, in the Gastrointestinal laboratory (GI lab), the medication/syringe storage cart top drawer was opened. Inside the drawer was a denture cup with crystal light hard candy (6 pieces), Jolly rancher hard candy (1 piece), cough drop (1 piece), and gum (1/2 of stick). There was also a white tin container with white, round, hard candies (approximately 30 pieces). The Dir Surg stated, "Looks like somebody's stash."

Association of periOperative Nurses: Standards and Recommended practices (2010). Prevention of Transmissible Infections. Recommendation IX, indicated at 1. "... Activities involving hand-to-mouth action can contribute to direct or indirect transmission via inanimate surfaces and should be prohibited in the work area. These prohibited activities include, but not limited to: eating, drinking..." 3. "Food and drink should not be present in the restricted and semirestricted areas of the surgical suite."

2. During an interview with the Licensed Vocational Nurse (LVN) 1 , on 5/23/12, at 11:15 AM, the surgery temperature and humidity logs were requested. LVN 1 stated, "We don't have one. We don't do that." The policy for checking temperature and humidity was requested, and Dir Surg stated, "There isn't one, but I will work on it now."

The hospital policy and procedure titled "Infection Prevention and Control Measures" dated KVHD #6351-R 8/09, indicated B. 1. "Keep the relative humidity at 20-60 percent...", and B.2. "Temperature of the operating rooms will be maintained at 68-73 degrees F."

Association of periOperative Nurses: Standard and Recommended practices (2010). Safe Environment of Care. Recommendation V., indicated at V.b. "Relative humidity should be maintained between 30% and 60 %." , V.b.2. "Humidity should be monitored and recorded daily using a log format or documentation...", V.c. "Temperature should be monitored and recorded daily using a log format or documentation...", and V.c.1. "Temperature should be maintained between 68 to 73 degrees Farenheit."

Based on interview and record review, the hospital failed to maintain a clinical record system that ensured the completion of clinical records within fourteen days after a patient's discharge and failed to ensure the medical staff suspension process for delinquent records was followed. These failures resulted in a 31 percent medical record delinquency rate.

Findings:

During an interview with the Registered Health Information Administrator (RHIA), on 5/23/12, at 3:30 PM, she stated there were no current physician suspensions for medical record delinquency. She stated delinquent record data was forwarded to the Chief Executive Officer (CEO) and the Chief of Medical Staff weekly. The RHIA stated the hospital had a hybrid medical record system, with a portion of the record electronic (EMR) and a portion paper. The hospital had converted to an EMR on 4/1/12, and the physician's EMR went online 5/21/12. As of 3/28/12, 24 of 78 discharged patient records were incomplete over 14 days, which calculated to a 31 percent delinquency rate. The RHIA explained the physician suspension process as a five letter procedure that encompassed up to 6 weeks before a physician's privileges would be suspended.

During a concurrent interview with the RHIA and the Medical Records Supervisor (MRS), on 5/24/12, at 11:05 AM, the MRS stated the new medical record system with the EMR had not yet been used to produce delinquency reports as it was "still in process."

During an observation on 5/24/12, at 11:50 AM, in the Medical Record Department, with the RHIA, the shelves containing incomplete discharged medical records was viewed. Fifty-two medical records were counted as incomplete/delinquent.

The hospital policy and procedure titled "Delinquent Medical Records", dated 6/2003, indicated, in part, "A medical record is considered delinquent if not completed within fourteen days after a patient's discharge." "As stated in the medical staff bylaws, suspension of all clinical privileges will be effective until delinquent medical records are completed following written notice to the physician. This suspension shall be imposed automatically for failure to complete delinquent medical records within the above described time frames."

Based on interview and record review, the hospital failed to ensure verbal or telephone physician's orders were authenticated within the required hours of when the orders were given to the hospital staff for three of 21 sampled patients (4, 7, and 18), which had the potential for transcription errors to adversely affect patient safety.

Findings:

1. During a clinical record review on 5/23/12, for Patient 4, the physicians for the patient had not authenticated one telephone order dated 5/17/12.

During an interview with the Director of Social Services/Discharge Planner/Utilization Review Nurse (Soc Serv), on 5/23/12, at 11 AM, she confirmed the telephone order for Patient 4 should have been authenticated by 5/18/12, and had not yet been authenticated by the physician. The Soc Serv stated verbal/telephone orders are to be signed by the physician within 24 hours for any medications and 48 hours for other orders.

2. During a concurrent interview and clinical record review with Soc Serv, on 5/23/12, at 11 AM, for Patient 7, the physicians for the patient had not authenticated one telephone order dated 5/17/12. She stated the order should have been authenticated by the physician by 5/18/12.

3. During a clinical record review on 5/23/12, for Patient 18, the physicians for the patient had not authenticated one telephone order dated 5/14/12.

Based on interview and record review, the hospital failed to have a current physician privilege list available in Surgical Services. This had the potential to have unqualified or suspended surgeons schedule cases.

Findings:

During an interview with the Licensed Vocation Nurse (LVN) 1, on 5/23/12, at 3:45 PM, she was asked for the Physician privilege list. The LVN 1 stated, "Oh, let me look for it." After several minutes it was located in a binder on a shelf. When asked if this was current, LVN 1 stated, "I believe so." The list presented was dated 2010. LVN 1 stated, "I will call to get updated list."

Based on observation, interview, and record review, the hospital failed to ensure an effective program to evaluate the quality and appropriateness of remedial action addressed deficiencies identified as medical record quality concerns. Health Information Management quality data had not been reviewed for 2011 or to-date for 2012.

Findings:

During an interview with the Registered Health Information Administrator (RHIA), on 5/23/12, at 3:30 PM, she stated there were no current physician suspensions for medical record delinquency. She stated delinquent record data was forwarded to the Chief Executive Officer (CEO) and the Chief of Medical Staff weekly. As of 3/28/12, 24 of 78 discharged patient records were incomplete over 14 days, which calculated to a 31 percent delinquency rate. The RHIA explained the physician suspension process was a five letter procedure that encompassed up to 6 weeks before a physician's privileges would be suspended.

During a concurrent interview and record review with the RHIA and the Medical Records Supervisor (MRS), on 5/24/12, at 11:05 AM, the MRS stated the new medical record system used with EMR had not yet been used to produce delinquency reports, it was "still in process." The RHIA stated Quality reports were collected from last year (2011) and were sent to the medical staff committees, however she did not attend the Medical Records Committee. She stated she had not submitted the 2011 Quality Improvement reports for the Medical Record Department to "Committee."

The Health Information Management (HIM - Medical Records Department) (Quality Improvement) quarterly reports for 2011 were reviewed with the RHIA on 5/24/12. The record delinquency rates by month were as follows: January-29 %; February-60%; March-36%; April-50%; May-67%; June-61 %; July-39%; August-67%; September-93%; October-72%; November-56%; and December-29%. Various indicators over the 2011 year indicated less than 75% compliance on a monthly basis, such as verbal orders authorized within 24 hours, entries for nursing timed and dated, nursing response to pain medication/therapy documented and nutritional screen within 24 hours. Review of the Medical Record Committee or Medical Staff Committee meeting minutes did not indicate these deficiencies/delinquencies were reviewed or acted upon.

The hospital "Medical Staff Rules", dated 2008, indicated the Medical Quality Council Committee will "3) Review and act upon, as needed, factors affecting the quality, appropriateness and efficiency of patient care provided in the hospital."

During an observation on 5/24/12, at 11:50 AM, in the Medical Record Department, with the RHIA, the shelves containing incomplete discharged medical records was viewed. 52 medical records were counted as incomplete/delinquent.

The hospital policy and procedure titled "Delinquent Medical Records", dated 6/2003, indicated, in part, "A medical record is considered delinquent if not completed within fourteen days after a patient's discharge." "As stated in the medical staff bylaws, suspension of all clinical privileges will be effective until delinquent medical records are completed following written notice to the physician. This suspension shall be imposed automatically for failure to complete delinquent medical records within the above described time frames."

Based on interview and record review, the hospital failed to:

1. Have physicians sign restraint order sheets; and,

2. Indicate the reason and type of restraint for two of 21 sampled patients (2 and 17), which had the potential to violate patient rights to be free of restraints.

Findings:

1. The clinical record for Patient 2 was reviewed on 5/23/12. The restraint order sheet, dated 5/18-20/12, indicated, Medical indication: high fall risk..., confusion..., and Type of restraint: 4 side rails. There was no signature, date, or time from the physician.

During an interview with the Director of Social Service/Discharge Planner/UR (Soc Serv), on 5/23/12, at 11:37 AM, she reviewed the restraint order sheet and stated, "I thought these were not going to be in the chart since the doctors went live (electronic charting)." When asked the date the doctors went live, she stated, "The 21 st of this month."

During an interview with Certified Nursing Assistant (CNA) 1, on 5/23/12, at 11:40 AM, she was asked how often the restraint order sheet should be signed, and stated, "They should be signed every 24 hours."

2. The clinical record for Patient 17 was reviewed on 5/24/12. The restraint order sheet had no date, time, medical indication for restraints, or type of restraint.

During a concurrent interview and record review with Registered Nurse (RN) 1, on 5/24/12 , at 10:14 AM, he verified Patient 17 had soft wrist restraints from 4/9/12 to 4/11/12. When asked about the restraint order sheet not being completed, RN 1 stated, "I don't know, but that is Medical Doctor 1's signature.

The hospital policy and procedure titled "Restraint use, Acute Medical and Surgical Care", 8/26/02, indicated, at 9.3 B. "The physician must countersign...within twenty-four (24) hours." and 13.2 A."The medical necessity for the restraint; B. The type of restraint to be used; C. The body part to be restrained."