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Based on observation, staff interviews, reviews of professional standards, manufacturer's directions of use and administrative document review, the hospital failed to have a governing body legally responsible for the conduct of the hospital when:

1. The credentialing process of the Medical Staff did not include a method to assess the competence of Medical Staff members at the time of biennial reappointment. The Governing Body failed to apply the process for assessing practitioners's qualifications and competence when Medical Staff members who had been previously appointed and granted clinical privileges were not reappraised for competence during the reappointment process. Examination of Medical Staff credential files revealed there was no evidence of biennial reappraisal for three (MD 3, MD 8 and MD 9) out of a total nine Medical Staff members. (refer to A 340).

2. The governing body failed to ensure a quality assessment and performance improvement (QAPI) program that reflected the complexity of the hospital services that focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. (refer to A 309, A283, A340, A749, A500)

3. The governing body failed to ensure that pharmaceutical services met the needs of patients and policies and procedures were developed and implemented to provide safe and effective use of drugs. (Refer to A494, A500 findings 1-7)

4. The governing body did not ensure an effective hospital-wide Infection Control program was in place. (Refer to A749 findings 1-14)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observations, staff interviews, clinical record, and administrative document review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program. The hospital's governing body failed ensure the QAPI program reflected the complexity of the hospital and involved all services of the hospital when:

1. The credentialing process of the Medical Staff did not include a method to assess the competence of Medical Staff members at the time of biennial reappointment. The Governing Body failed to apply the process for assessing practitioners's qualifications and competence when Medical Staff members who had been previously appointed and granted clinical privileges were not reappraised for competence during the reappointment process. Examination of Medical Staff credential files revealed there was no evidence of biennial reappraisal for three (MD 3, MD 8 and MD 9) out of a total nine Medical Staff members. (refer to A 340).

2. The governing body failed to ensure a quality assessment and performance improvement (QAPI) program that reflected the complexity of the hospital services that focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. (refer to A309, A283, A500, A749)

3. Pharmaceutical services did not meet the needs of patients and policies and were not developed and implemented to provide safe and effective use of drugs. (Refer to A494, A500 findings 1-7)

4. The QAPI program did not collect and analyze infection control data and did not implement projects to ensure an effective hospital-wide Infection Control program was in place. (Refer to A749 findings 1-14)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on staff interview and administrative document review, the hospital failed to have a Medical Staff that upheld and applied the bylaws approved by the hospital's Governing Body when:

1. The credentialing of the Medical Staff did not include a process to assess the competence of Medical Staff members at the time of biennial reappointment. The Governing Body failed to apply the process for assessing practitioners's qualifications and competence when Medical Staff members who had been previously appointed and granted clinical privileges were not reappraised for competence during the reappointment process. Examination of Medical Staff credential files revealed there was no evidence of biennial reappraisal for three practitioners (MD 3, MD 8 and MD 9) out of a total nine Medical Staff members. (refer to A 340).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

Based on observation, staff interviews and review of administrative documents, the hospital failed to ensure a well organized nursing service and that the nursing service was integrated into the overall hospital-wide Quality Assessment and Performance Improvement Program (QAPI) when:

1. The nursing service did not collect and analyze infection control data and promote accepted professional standards of infection control. (refer to A749 findings 1-14)

2. Nursing did not report, track and analyze medication errors, did not follow nursing standards of practice for medication administration and did not participate in quality improvement projects to reduce medication errors. (refer to A309, A405, A494 and A500 findings 1-7)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of nursing services in a safe environment.

Based on observation, interview and document review the hospital failed to ensure that dietary services met the needs of all patients as evidenced by the failure to:
1. Provide organized dietetic services as evidenced by findings of failure to employee a qualified fulltime Dietary Service supervisor (Refer to A620)
2. Ensure a qualified dietitian supervised the nutritional aspects of patient care including the planning and implementing of medical nutrition therapy necessary to meet the nutritional needs of one patient (Refer to A621).

3. Ensure the regular and therapeutic menus met the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and DRI (dietary Recommended intakes) of the Food and Nutrition Board of the National Research Council (Refer to A630).
4. Ensue a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice (Cross Refer to A631).
5. Monitor performance improvement activities that reflected the scope and nature of the services and that identified opportunities for improvement (Cross Reference A276).
The cumulative effect of these systemic problems resulted in the inability of the hospitals' food and nutrition services to direct and staff the hospital in such a manner to ensure that the nutritional needs of the patients' were met in accordance with the statutory requirements of the Condition for Food and Dietetic Service.

Based on observation, staff interviews and reviews of administrative documents, hospital policy and procedures, manufacturer's directions for use and accepted professional standards, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases when:

1. A comprehensive and effective Infection Control Program that incorporated a system for identifying, reporting, investigating, and controlling infections and communicable diseases was not maintained. No infection control data was collected and submitted to the hospital-wide Quality Assessment and Performance Improvement Program (QAPI). (reference A 749, finding 1)

2. Staff did not follow manufacturer's instructions for the preparation of an effective concentration of enzymatic detergent for cleaning endoscopes and surgical instruments. (refer to A 749, finding 2)

3. Endoscopes were not decontaminated in an area physically separated from locations where clean items were handled and patient care activities were performed. (refer to A 749, finding 3)

4. Staff did not follow manufacturer's instructions when testing a prepared Cidex solution prior to decontaminating an endoscope with the solution. (refer to A 749, finding 4)

5. Endoscopes were not cleaned and disinfected according to hospital policy, manufacturer's directions for use and/or accepted professional standards. (refer to A 749, findings 5a, 5b, 5c, 5d)

6. Instruments opened and prepared in the OR for surgical use were not all cleaned after removal from the OR and prior to wrapping and sterilization. (refer to A 749 finding 6)

7. Cleaning products were not used according to manufacturer's instructions. (refer to A 749, finding 7a, 7b)

8. Air exchanges in the perioperative area were not performed, reported and tracked according to accepted professional standards (Association of periOperative Registered Nurses - AORN).

9. Physical environment of the perioperative area was not maintained in a sanitary manner. (refer to A 749, finding 9a, 9b)

10. The Operating Room suites (OR 1 and OR 2) were not sanitary and free from visible dust and dirt. No system was in place to ensure terminal cleaning was done in an effective manner. (refer to A 749, finding 10)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 1:25 p.m. At the time of the exit 3/19/13 at 9 a.m., the hospital had not submitted an acceptable Plan of Action addressing the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m. (refer to A 749, findings 1 through 10)

Based on observations, staff interviews, and reviews of administrative documents, professional standards of practice and manufacturer's directions for use, the hospital's QAPI program failed to focus on high-risk and problem prone areas and did not take actions aimed at performance improvement when:

1. No Quality Improvement project was in place to ensure staff were trained and ready to address emergency care for pediatric patients. RNs were unable to calculate, draw up and administer emergency medications for pediatric patients (children less than 13 years old). (cross reference A 500, finding 1)

2. No Quality Improvement project was in place to ensure accurate medication administration and prevent delays in medication administrations. This situation was related to equipment failures that the hospital was aware of for at least 9 months. (cross reference A 404)

3. No Quality Improvement project was in place to ensure tracking and accountabilities for controlled substances. (cross reference A494)

4. No Quality Improvement project was in place for surveillance and tracking of rescue agents and to identify medication errors and adverse drug reaction. (Refer to A 500).

5. No Infection Control program was in place to identify and protect patients from cross contamination. The sanitation of the Operating Room area did not follow professional standards of practice. No data was collected to identify areas of concern. No surveillance was in place to identify whether or not procedures in the disinfecting of cystoscopes was being followed. (cross reference A749 finding 1-10)

6. No QAPI project was in place to ensure Medical Staff credentialing followed Medical Staff Bylaws. (cross reference A340)

Findings:

1. The facility failed to ensure staff competency and readiness for handling pediatric emergencies. Five of six licensed nursing staff were not able to timely locate or identify correct type of equipment, or calculate or determine the dose of medications for pediatric patients in an emergency situation. Two of two nurses indicated and prepared 10 times the dose of epinephrine for a hypothetical pediatric emergency.

The same concern was identified during a recertification survey in 2009. At that time, a system was put into place to train staff and to ensure their competency. The hospital QAPI program failed to maintain that system and ensure that new staff was trained and competent to readily participate and assist in a pediatric codes.

On 3/12/13 at 2:15 p.m., during an interview in the Chief Executive Officer's (CEO) office, acknowledged the similar problems related to RNs drawing up and administering pediatric emergency medications in the ED. The CEO stated monitoring was in place "for awhile" and was no longer in place. The CEO did not offer a time frame as to how long the ED nurses were not monitored.

2. On 3/15/13 at 11 a.m., during an interview, LP 10 (Director of Pharmacy) stated the facility staff were aware of the computer problems causing medication error. He stated the pharmacy and therapeutic committee discussed the problem and discovered that it was related to the software of the system. Patients were dropped from the system and as a result medications were missed or delayed. LP 10 stated that the hospital plan was to go back to cart fill, meaning manually dispensing medications to inpatient with a medication cart. He stated that they have not started the process.

According to the Medication Error Summary, provided by the facility, this problem was presented on 7/12/12; however, there was no evidence that any measures were taken to protect patients from receiving medications in error, omitting orders completely, or delaying receipt of ordered medications.

LP 10 stated that the work around for this issue was to have nurses verify orders in the CPSI, which is an order entry computer system, and that when they detected medication inconsistencies or that medications were dropped from the automated dispensing cabinet, (MDG system), the nurses would need to reenter the missing orders.

An example of the steps put into place were not effective included: Patient 1 received the wrong medication lisinopril (for blood pressure) for 4 days, and did not receive what was ordered for him, Lipitor (a cholesterol lowering medication). LP 10 acknowledged that this problem was challenging to new nurses as they were not made aware of the problem and were "caught off guard."

3. The "C-II Perpetual Inventory Form" (the hospital form/log that documented use and tracking for controlled substances such as narcotics) was reviewed on 3/15/13. This form was in use since May 2011. The use of Tylenol with codeine 5ml (milliliter) unit containers was reviewed. Between 3/6/12 and 3/30/12 (24 days) the record showed 40 units (of the 5ml) were dispensed to the Emergency Department (ED). In comparison for the time period 5/27/11 through 8/1/11 20 units were dispensed; for the time period 8/1/11 through 10/5/11 20 units were dispensed. No evidence was provided that the comparative use was evaluated for accuracy and accountability.

No documented evidence was provided to verify trends were evaluated and investigated. No project was in place to validate what was dispensed to different aeas was actually used for patients.

On 3/15/13 at 11 a.m., LP10 (Director of Pharmacy) acknowledged that there were no random audits to evaluate accuracy and accountability of controlled substances and to detect any potential misuse or diversion.

LP 10 stated there was no closed loop accountability of controlled substance that would account for medications from acquisition to disposition or evidence that controlled substance discrepancies were evaluated, tracked, or trended.

4. On 3/12/13 at 9 a.m., a request for a list of rescue agents such as naloxone (narcan) and flumazenil (romazacon) use was made. Rescues agents (also referred to as tracers) are specifically used to reverse the effects of other medications. Naloxone is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiate, like morphine. Flumazenil is a rescue agent that is used to reverse sedation and respiratory depression associated with excessive use for benzodiazepine such as valium.

LN 1 ran reports for use of these agents for three years, but the report showed no evidence of use even though these agents were ordered and distributed to patient care area. The facility was not tracking use for these rescue agents, and did not investigate their use for potential medication error or adverse drug reactions.

There was no documented evidence of a system to identify adverse drug reaction or medication errors timely or adverse drug reactions.

On 3/13/13 at 10 a.m., during an interview, LN 8 stated that she did not recall using any Narcan recently. She said that "anesthesia uses it" and added that they will not bring patients to PACU (Post Anesthesia Care Unit) if patients were not awake.

Review of the facility policy titled "Adverse Drug Reaction Monitoring" approved, 1/15/13, revealed inclusion of "a concurrent surveillance system" which included the following: "Monitoring the use of 'tracer' drugs that are used to treat common adverse drug reactions ... "

Based on observations, staff interviews and administrative document review, the hospital failed to have an effective and on-going program for quality improvement and patient safety when no Quality Assessment and Performance Improvement projects were evaluated by the Governing Body. This failure resulted in the potential of all patients not to receive quality health care in a safe setting.

Findings:

On 3/14/13 at 1:30 p.m., during an interview in the hospital conference room, the Utilization Review (UR) Manager stated, "...we don't have a Quality Assessment and Performance Improvement (QAPI) committee/program...not since 2005 when I began working here.."

On 3/14/13 at 2:10 p.m., during a concurrent observation and interview in the Chief Executive Officer (CEO's) office, the CEO stated,"...Quality Assessment and Process Improvement...what is it?...I don't present it, the CNO presents the information at the board meetings" The CEO was unable to locate any information or documentation of QAPI measures in the Board of Directors or Governing Body's committee meeting minutes.

On 3/5/13 at 2 p.m., during an interview in the conference room, the Chief Nursing Officer (CNO) stated the hospital had no current QAPI projects.

Based on staff interview and administrative document review, the medical staff failed to have a process by which the competence of medical staff members would be assessed on a periodic basis. The medical staff failed to have a process for reappraising its members when three out of a total of nine credential files examined (MD 3, MD 8, MD 9) revealed medical staff members had been reappointed with no evidence of periodic appraisals which considered practitioners competencies.

These failures placed patients at risk of receiving care from an individual not qualified to provide those services.

Findings:

On 3/4/13 at 4:00 p.m. the Hospital Medical staff Bylaws and Rules were reviewed. It states on page 13 "... 4.02 DURATION OF APPOINTMENT The Medical Executive committee shall develop Rules to implement the following: (b) Reappointment to any Staff category shall be for a period of two years, and shall be staggered throughout the year so as to enable a thorough review of each member. Change in staff category may be requested at any time during the reappointment period after requirements of Provisional status are met. 4.03 REAPPOINTMENT PROCESS AND STANDARDS 4.03-1 Procedures for Reappointment The reappointment process shall be as described in the Rules. 4.03-2 Continuing Compliance with Requirements (2) Satisfactory results in Medical Staff quality improvement reviews, or satisfactory correction of any significant problems identified through such reviews."

Medical Staff credential files were reviewed on 3/5/13 at 10:15 a.m. with the Medical Staff coordinator (CC 10). Review of the credential files revealed three (MD 3, MD 8, MD 9) out of a total of 9 (nine) practitioner's credential files which showed no evidence of biennial reappraisals at the time of reappointment which demonstrated the practitioner's competence. CC 10 stated there were Medical Staff quality improvement reviews conducted for the Medical Staff members at the time of reappointment. She stated the information which was collected from the quality improvement reviews was used to appraise the practitioner's competence. She stated she did not know where the appraisal information was kept. She stated she could not substantiate practitioners were routinely reappraised of their competence prior to being reappointed on a biennial basis.

The Chief of the Medical Staff (MD 3) was interviewed over the phone on 3/5/13 at 10:30 a.m. MD 3 stated he was familiar with of the process by which practitioners of the Hospital Medical Staff were reappointed. He stated the Hospital Medical Staff Bylaws quality improvement reviews conducted for the Medical Staff members at the time of reappointment. He stated the information which was collected from the quality improvement reviews was used to appraise the practitioner's competence. He stated he did not know where the appraisal information was kept within the hospital. He stated he could not substantiate practitioners were routinely reappraised of their competence prior to being reappointed on a biennial basis.

The Hospital Chief Executive Officer (CEO) was interviewed on 3/5/13 at 10:45 a.m. The CEO stated he understood he represented the Governing Body of Corcoran District Hospital . The CEO stated he was familiar with the process by which practitioners of the Hospital Medical Staff were reappointed. He stated there was language in the Medical Staff bylaws which allowed for the collection of data used to appraise individual practitioner's competence. He stated on-going appraisals of competence were to be used as a means of assessing individual practitioner's hospital specific record prior to reappointment. He stated he did not know whether the data was being collected or where it was to be found. He stated practitioners were routinely reappointed without appraisals/reappraisals of their competence as called for in the Hospital bylaws.

Based on staff interview and administrative document review, the hospital failed to ensure medications were given as ordered when:

1. Patient 1 was given a blood pressure medication, lisinopril, for 4 days without a physician order;

2. Patient 1 was not administered a medication prescribed by the physician (Lipitor, a cholesterol lowering medication) for 4 days;

3. Patient 1 was not administered Solu-Medrol (an anti-inflammatory medication for breathing problems) every six hours as ordered;

4. Patient 1 was not administered Duoneb (a medication used to relieve shortness of breath and wheezing) as ordered every 4 hours and every hour as needed.

These failures placed patients at risk of the adverse effects of receiving medications not ordered and medication treatment failure by not receiving the care ordered by physicians.
Findings:

1. On 3/12/13 at approximately 5 p.m., a concurrent review of the record for Patient 1 with LN 6, indicated Patient 1 was prescribed Lipitor (medication used to lower cholesterol) on admission to the hospital (3/9/13). The order, written on 3/9/13 at 1:00 p.m., was for Lipitor 20 milligrams (mgs) to be given daily.

Review of the medication administration record (MAR) revealed no Lipitor was administered. The medication administration record showed that Patient 1 was administered lisinopril 20 mg, a medication used to lower blood pressure. Lisinopril 20mg was administered to Patient 1 daily for 4 days even though there was no physician order for it.

Licensed nurses, LN6 and LN2 were interviewed regarding the error. LN6 and LN2 explained the error in this manner: The facility had two computer systems. Orders were usually entered in one computer system (CSPI) which was supposed to communicate with the automated dispensing cabinet, (MDG). Sometimes, staff would have to enter patients into the MDG system in order to access the medications ordered. LN6 and LN2 stated it was possible that the person entering the order into the computer system picked the wrong medication since both have similar starting letters (Lipitor/Lisinopril).

On 3/13/13 at approximately 9 a.m., LN7 was interviewed about the computer issues. He confirmed that he handled computer related issues and he was aware of the computer concerns where patients would be dropped completed from the system after being entered. LN7 stated that it was not his role to handle it. He said that medication related issues would be handled by other staff, LN1, LN 10 or the pharmacist.

LN 6 stated that the problem was identified the day of the survey (3/12/13)and that LN 4 corrected the error and filed an incident report. The MAR printed on 3/12/13 at 5:48 p.m. showed the order for Lipitor 20 milligrams was entered on at 3/12/13 at 3:50 p.m.

2. Lipitor 20 milligrams dose was ordered on 3/9/13 at 1:00 p.m.; however, review of the MAR with LN2 and LN6 revealed no documented evidence that it was administered for 4 days. LN2 and LN6 confirmed Lipitor was not administered as ordered.

3. On 3/12/13 at approximately 5 p.m., a concurrent review of the record for Patient 1 with LN 6, revealed that Patient 1, a 60 year old, was admitted on 3/9/13 for exacerbation of respiratory problems. On admission, Patient 1 was prescribed Solu-Medrol 125 milligrams (mgs) every 6 hours. Solu-Medrol is a steroid type medication with an anti- inflammatory effect and is used for the management of acute flares (exacerbation) of respiratory disease. According to Pharmacopeia Solumedrol reduces the inflammation of the airways and improves symptoms such as wheezing and shortness of breath.

Review of the MAR revealed that the medication was scheduled to be given every 6 hours at 6 a.m. and 12 a.m. 6 p.m. and 12 p.m. Documentation revealed that the medication was not given every six hours as ordered. On 3/10/13, only 2 doses were administered, and on 3/11/13, 3 doses were administered instead of 4 doses per day.
On 3/10/13, Soul-Medrol was given only 2 times instead of 4 times. It was given at 00:36 and again at 13:41 (1:41 p.m.). There was no documented evidence that the Solu-Medrol was given any other times. Review of the history of medication removal from the automated drug dispensing device (MDG) revealed that the medications was not removed or given on 3/10/13 at 6 a.m. or 6 p.m.

On 3/11/13, Solu-Medrol was not administered every 6 hours either. The MAR showed that the medication was given 3 times instead of 4 doses as ordered. Solumedrol was administered on 3/11/13 at 12:29 a.m., 12:10 p.m. and 6 p.m.

LN 2 stated on interview that they had "computer issues" and that delayed medication administration. LN acknowledged there was no clinical justification or documented rationale for not administering the medication correctly as ordered.

4. On 3/12/13 at 12:45 p.m., LN 6 was observed administering inhalation medication (Duoneb) for Patient 1. Review of the record with LN6 revealed that Patient 1 had a physician order, dated 3/9/13, to receive Duoneb every four hours around the clock. In addition, there was an order to give Duoneb every hour as needed. Duoneb is a combination medication, ipratropium and albuterol (open the airways of the lungs), which are used for respiratory problems.

Review of the MAR revealed that Patient 1 was not administered this medication as ordered. Instead of receiving the medication at least 6 times every day, on 3/12/13, he was given 4 doses only. Similarly, on 3/11/13, Patient 1 was given 4 doses instead of at least 6 doses.
According to the MAR, on 3/10/13, two doses were missed. Patient 1 was given one dose at 1:06 a.m. and the subsequent dose was given at 1:38 p.m. - a gap of more than 12 hours after. The missed doses should have been given at 5 a.m. and 9 a.m.

On 3/11/13, Patient 1, did not receive two doses of the Duoneb. The first dose was administered at 1:08 a.m., and the subsequent dose was given at 12 p.m.- a gap of 12 hours where two doses of the medication should have been given according to the order.

Concurrent review of the record for Patient 1, with LN 6, on 3/12/13 in the afternoon, revealed no documentation of the reason for not administering the medication. When asked about the every hour dosing and how it was determined if the patient needed the medication, LN 6 stated on interview that the patient can ask for the medication or if nurses are doing assessment, they can determine if a treatment is needed. On 3/13/13, at 6 p.m., LN 6 stated that after further review of the record that she did not find any documented rationale for not administering the Duoneb.
There was no documented evidence that Patient 1 was assessed for his respiratory status to see if he needed the medication which was ordered every hour. There was no evidence that the as needed medication was administered.

Review of the facility's policy titled, "Uniform Drug Administration Policy" approved,11/2012, revealed the following:

Based on staff interview and medical record review, the hospital failed to maintain accurately written and properly filed medical records when the medical record for Patient 1 did not contain record of the levels of Vancomycin (an antibiotic given intravenously - through the vein) which were obtained during hospitalization. This failure resulted in the potential to negatively affect the medication management for Patient 1 and could have led to potential harm from the toxic effects of the drug.

Finding:

On 3/14/13 at 11:00 a.m., review of the record for Patient 4 revealed that the 37 year old patient was admitted on 3/6/13 for treatment of cellulitis (inflammation of the skin). Vancomycin, a medication to treat infections, was ordered and administered for this patient. Review of the record revealed an order to obtain the trough level (a blood test to assess the lowest concentration of the medication in the blood) of vancomycin (vanco) before the third dose. At 1:45 p.m., LN 2 reviewed the record and confirmed that there was no vanco level in the record, paper or electronic. LN2 confirmed that a sample of blood was collected on 3/7/13 at 4:30 p.m. and sent to the laboratory for analysis.

LN 2 confirmed that the results were not in the record. There was no justification for not including the results in the record. The nurse thought that possibly because the patient was discharged the following morning, so that no one followed up on the level.

Based on observation, staff interview and administrative document review the hospital failed to ensure its pharmaceutical services met the needs of the patients when:

1. Five out of six Emergency Department (ED) nurses (LN 1, LN 4, LN 5, LN 7 and LN 10, LN 11) did not know how to handle a pediatric emergency code when staff were not able to timely locate or identify correct types of equipment, or calculate correct doses of medications for pediatric patients in a mock code situation. Two out of the five nurses had prepared 10 times the dose of epinephrine for a hypothetical pediatric code. (Refer A 500, finding 1)
2. Access and security of medications was not limited to the designated staff (keys to the drug room where medications were stored) were given to unsupervised nursing personnel. (Refer to A 500, finding 2 )

3. Expired medications were available for use. (Refer to A 500, finding 3)
4. The facility failed to follow its policy and procedure on recalled products. (Refer to A 500, finding 4)

5. Medications were not administered in accordance with the physician orders. (Refer to A 500, finding 5)

6. The facility failed to follow the facility policy and procedure for pain assessment. (Refer to A 500, finding 6)

7. The facility failed to implement their policies for adverse drug reaction surveillance. (refer to A 500, finding 7)

8. No system was in place to track, account for and evaluate the use of controlled substances. (refer to A 494)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of pharmacy services in a safe environment. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 4:55 p.m. At the time of the exit on 3/19/13 at 9:00 a.m., the hospital had not completed all Plans of Action to address the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m. (refer to A 500, findings 1 through 6)

Based on staff interview and review of administrative documents, the hospital failed to ensure accurate accountability and tracking of controlled substances from acquisition to disposition. Records were not accurate and not complete. Expired or returned medications were not tracked accurately. There was no surveillance to timely detect and identify potential misuse, abuse, theft or diversion. No system was in place for the evaluation of discrepancies. These failure resulted in the potential of misuse and/or diversion of controlled substances.

Findings:

1. On 3/12/13 at 1:30 p.m., during a concurrent inspection of the Emergency Department (ED) controlled substance log, the record for control substances was reviewed. On 1/4/13 Versed (medication used for sedation prior to procedures) was signed out 5 times for the same patient. The sign out times for Versed 2 milligrams (mgs), a (unit of metric measurement) was documented at 11:07 p.m. five times, for the five vials of Versed. Entry number 5, had documented that 1mg of the 2 milligram vial had been wasted. A total of 9 mgs of Versed was removed at the same time for Patient 3.

On 3/14/13 at 10:40 a.m., during a concurrent interview with LN 2, and a clinical record review of Patient 3, LN 2 stated a procedure was done for Patient 3. The clinical record had a total of 7 mgs of Versed documented as administered during the procedure. The "Emergency Department Physician Record" had an order for Versed at 11:07 p.m., the written amount to be administered was modified. The entire dose of the Versed entry was crossed out, above the crossed out entry was, "Versed 5mg + 2 mg +2 mg."

The medication administration record (MAR) from the ED showed the medication and the time the medication was administered. The time documented did not follow the sequence (chronologically) in which the medications were administered. The record showed, in the same hand writing, entries that medications administered at 11:07 p.m., 11:12 p.m., and 11:15 p.m., then another medication that was administered at 11:05 p.m. LN 2 confirmed the documentation for the Versed was not accurate.

On 3/14/13 at 3:00 p.m., MD 3 stated on interview after quick review of the record, that this patient was given four milligrams of Versed for the procedure. When the written dose, 5 mg in addition to +2mg +2 mg was pointed out, and the 7 milligrams documented in the dictation, MD 3 said that he must have made a mistake.

The ED Controlled Substance Log for 1/4/13 indicated an entry for Dilaudid at 11:05 p.m. for 2 mgs, then again on 1/5/13 at 12:50 a.m. Two additional entries were written for 1 mg at 2:10 a.m. and 2:12 a.m. on 1/5/13. The MAR did not document the administration for the 2:10 a.m. entry.

2. On 3/12/13 at 9 a.m., during an inspection of the drug room, four controlled substance records were evaluated for accuracy. The control count sheet for Fentanyl 100 microgram ampules showed 90 ampules. The actual count was 100 ampules.

The same sheet showed that 10 ampules of Fentanyl were subtracted from the count on 2/22/13. The record did not document to what area of the hospital the ampules were dispensed. No documented evidence was provided to reconcile the counts of Fentanyl.

3. On 3/12/13 review of the "Perpetual Inventory Form" for Tylenol with Codeine revealed that 10 (15 milliliter) units were subtracted from the count on 6/12/12. The record did not show to which area of the hospital these units were dispensed. Documented evidence was not provided to verify reconciliation of the medication.

4. On 3/12/13 review of the "Perpetual Inventory Form" for Tylenol with Codeine, (5 milliliter cups) revealed documentation that on 2/25/13, there was an activity related to expired (units) of Tylenol with Codeine. The document did not include the number of units that were expired. The form did not document from which area of the hospital these units were brought back from or whether the expired drugs were part the stock in the drug room.

Review of the facility's policy entitled, "Controlled medication accountabilities" approved on 3/2011, revealed the following: "When medications are returned to the medication room, they are placed in secure storage and their total added back to the perpetual inventory."

5. On 3/12/13 at 9 a.m. LN 1 was asked about tracking a controlled substance that is expired or unusable. LN1 stated the hospital used EXP a pharmaceutical Reverse Distribution system that collected expired or unusable medications. When the nurse was asked to provide records of an example of a controlled substance that was sent through to EXP, she stated that the "previous nurse did not keep good tracking system."

On 3/15/13, a review of the EXP report system from February 2012 until March 2013, revealed that expired controlled substances were picked up by the EXP. No documented evidence was provided to verify a system was in place to account for which controlled substance and in what amounts were given to EXP. No documented evidence was provided to verify a system was in place to document all expired and unusable controlled substances were tracked.

A list of controlled substances was provided as the record the facility kept. The list did not have a date; the list did not have the area the controlled substance was collected from. No documented evidence was provided for reconciliation of controlled substances.

Review of the facility's policy entitled, "Controlled medication accountabilities" approved on 3/2011, revealed that the procedures were put in place to accurately track movement of controlled substance as follow: "To accurately document the purchase, receipt, delivery to patient care areas, use, destruction of waste, return of excess or outdated supplies to the medication room, return to wholesaler, manufacturer, or reverse distributor, and all other movement of controlled substance ..."

6. On 3/12/13 at 9 a.m., during an interview, LN 1 explained the process the hospital used for accountability of controlled substances and cases of discrepancies. LN 1 stated weekly reports were generated for discrepancies of controlled substances. LN 1 was asked to generate and provide a report for discrepancies for a three to six month period. LN 1 stated she was not able to run the report. When asked to see the weekly reports that were run before, she said that there were no hard copies of these reports and the reports were not printed out.

No documented evidence was provided that discrepancies for controlled substances were evaluated, tracked or trended, to identify potential misuse or diversion.

Review of the facility's policy entitled, "Controlled Medication Accountabilities" approved on 3/2011, revealed that "...the pharmacist will audit the inventory of controlled substances in each patient care area, either completely or on a sampling base ..."

Based on observation, staff interview and administrative document review the hospital failed to ensure safe and effective use of medications and failed to ensure drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law when:

1. Five out of six Emergency Department (ED) nurses (LN 4, LN 5, LN 7 and LN 10, LN 11) did not know how to handle a pediatric emergency code when staff were not able to timely locate or identify correct types of equipment, or calculate correct doses of medications for pediatric patients in a mock code situation. (A pediatric code is an emergent life-threatening situation requiring immediate medical and nursing intervention.) Two out of the five nurses (LN 4, LN 5) had prepared 10 times the dose of epinephrine (medication used to stimulate the heart and increase the heart rate) for a hypothetical pediatric code.

2. Access and security of medications was not limited to the designated staff (keys to the drug room where medications were stored) were given to unsupervised nursing personnel.

3. Expired medications were available for use.

4. The facility failed to follow its policy and procedure on recalled products.

5. Medications were not administered in accordance with physician orders.

6. The facility failed to follow the their policy and procedure for pain assessment

The accumulated findings documented in items 1 through 6 placed patients at high risk for medication errors and potential death. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 4:55 p.m. At the time of the exit 3/19/13 at 9 a.m., the hospital had not submitted an acceptable Plan of Action addressing the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m. The unacceptable Plans of Action prior to the exit was missing components related to successful return demonstration of drawing up and administering pediatric emergency medications by hospital staff. The unacceptable Plan of Action did not address and include a qualified 3rd party (not associated with the hospital) who would monitor and validate the emergency medication training of hospital staff.

The Plan of Action addressed verification of pediatric emergency medication training by a qualified 3rd party and successful return demonstration by hospital staff was verified. the Plan of Action and the IJ was abated with the hospital Administration on 3/26/13 at 1:30 p.m.

7. The facility failed to implement their policy for adverse drug reaction surveillance.

Findings:

1.a On 3/5/13 at 2:10 p.m., during a concurrent observation and interview in the Emergency Department (ED), two of two licensed nurses (LN) on duty LN 7 and LN 11 were given a pediatric code scenario. LN 7 was unable to locate emergency medications and equipment needed for a pediatric code. LN 7 was unable to locate the Broselow tape and Broselow cart supplies (commercial products designed for management of pediatric codes). The Broselow tape facilitates determination of medication dosages and equipment sizes for children, by measuring the length of the child against the length of the tape. The cart and tape have the same color codes. The tape serves as a quick guide to clinicians for location and retrieval of appropriate dosages of medications. LN 7 and LN 11 were unable to find pediatric artificial airways (a short/small tube for infants/small child), to keep the air passages open for mechanical breathing. LN 7 stated,"...he would call the Manager to find them..." LN 7 continued to open and close various drawers on the cart. LN 7 removed a size 2.5 endotracheal tube (ETT) (a smaller diameter tube used as an artificial airway). The length/depth of the tube was recorded in millimeters [units of measurement] and LN 7 stated, "...it is a 8 mm, size 8." LN 7 was requested to find a size 8 ETT. LN 7 failed to know the difference of sizes of ETT's between a 2.5 versus a size 8 which would have been appropriate size for an adult. During this observation LN 11 joined the mock code. LN 11 was unable to locate pediatric supplies which included: intravenous tube (tube placed in a vein, used for fluids and medication administration), Ambu bag, pulse oximetry (measures oxygen levels in blood), and blood pressure cuff.

b. On 3/12/13 at 1:30 p.m., LN 5 was asked to demonstrate what would be done during a pediatric code where a hypothetical emergency situation with a pediatric patient, weight unknown, was brought to the emergency room. LN 5 correctly used the Broselow tape to estimate the weight of the patient. Referring to the Broselow tape indicating the estimated weight, she was asked to prepare a dose of intravenous epinephrine (medication used in code situations to increase blood flow). LN 5 checked the Broselow tape and said that she would prepare 1 milligram of Epinephrine. That dose was in the correct color zone, but it had ET (Endotracheal tube) next to it instead of IV (Intravenous). The intravenous dose for a patient in that (weight range) color zone was 0.1 milligram, not 1 milligram. When intravenous (vein) access cannot be established, an endotracheal tube is placed for patients in code situations (patients not breathing and have no pulse). Medications can be administered through the ET route using a higher dose of medication. The dose of epinephrine that LN 5 would have prepared for the patient was 10 times the correct IV dose. LN 5 was asked if she knew what the terms (ET) or (IV) next to the medication indicated and she did not know.

c. On 3/12/13 at 3:00 p.m., LN 4 was asked to perform a similar demonstration for a simulated pediatric emergency. The nurse successfully used the Broselow tape to estimate the weight of the hypothetical patient which was in the pink zone and that corresponded to 6-7 kilogram (kg). The nurse was asked to draw up the dose of epinephrine for the patient. The nurse checked the ET dose and drew up 0.65 milliliters, which was 10 times the correct IV dose. LN 4 indicated she knew the difference between the IV and ET dose for epinephrine and did not comment when asked to explain the reason she drew up the incorrect dose.

d. On 3/14/13 at 4:05 p.m., LN 10 demonstrated the drawing up of medications in a hypothetical pediatric emergency code. After the nurse estimated the weight of the hypothetical pediatric patient by correctly using the Broselow tape, she was asked to draw up atropine, a medication used to increase heart rate in specific emergency situations. The nurse used the hospital guidelines and identified the dose, located the atropine syringe in the crash cart and stated that she would not use the (prepackaged) syringe, and that she needed to find another syringe to withdraw the specified dose. LN 10 explained that she would not be able to use the remainder of the medication for other patients. The nurse looked in the cupboard in the ED and asked another staff nurse for help. LN 10 spent about a full minute trying to locate an appropriate syringe. LN 10 did not readily recognize the airway kit that was in the crash cart. She shuffled thought the kits, picked two different kits, read the labels on both of them, then pointed out the airway kit. LN 10 did not address the ABC of basic life support (ABC refers to the actions taken to address the Airway, Breathing and Circulation during an emergent situation) even though LN 10 was prompted multiple times that in the scenario presented the patient was not breathing. The entire code process for LN 10 lasted 20 minutes.

On 3/14/13, at 4:00 p.m., during an interview, LN 10 stated her role was to train ED nurses in responding to emergent situations. LN 10 stated he presented cases for the practice (simulated) codes and then asked her staff "what should be done, what medications do we need to give, at what dose" and that they "discuss the case."

On 3/5/13 at 10:00 a.m., during a concurrent interview and review of the job description, the ED Director (MD 1) acknowledged his job description indicated he was responsible for staff education including codes. MD 1 stated he was not involved in the education of the staff.

Nurses that were asked for the demonstration confirmed on interview that they were certified in Pediatric Advanced Life Support (PALS). These nurses also indicated that they participated on practice codes (mock codes) during their monthly staff meetings.

2. On 3/5/13 at 4:35 p.m. during a concurrent observation and interview in the Drug room, the LP 10 (Director of Pharmacy) stated that at night there were no nurses that worked in the pharmacy. When medications were needed the nurses got the key and went to the Drug room and got whatever was needed from the open shelves. The nurses were supposed to sign for the medications they were taking. The nurses would return to their unit and prepare and administer the medications. LP 10 stated that he reviewed medication orders within 24 hours. LP 10 was asked how he knew the nurses all signed out the medications they were taking from the Drug room. LP 10 responded, "it is supposed to be an honor system". LP 10 stated, "The nurses are supposed to be logging the medications correctly." LP 10 stated the keys to the Drug room were to be maintained and kept with the Emergency Department nurse. LP 10 stated his role was to "...come in and sign the required papers..." and stated he did not provide oversight to the nursing staff.

The medication log in the Drug room was reviewed. The information kept on the log was: the date, the name of the medication removed from the Drug room and the nurses' signature. It was noted there were 20 lines per page and on 4 pages reviewed, there were 2 to 3 entries per page that lacked the nurses signatures. It was noted that more than one nurse signature was entered per shift on the daily log so that more than the designated nurse had access to the Drug room.

The hospital policy and procedure, titled,"Medication Distribution" dated 12/18/12 was reviewed and indicated, "...hospital maintains a patient medication dose system that utilizes unit-of-use packaging to minimize the need for further manipulations that can introduce opportunities for error. Medications are distributed exclusively through the MDG (automated drug cabinet) on the Med Surg unit and locked cabinets in the Emergency Department and Operating room...Procedure...A. Med/Surg department 1. c. ...the Director of the medication room reviews all orders...within 24 hours of entry...B. 2. b. ...medications not found in the medication cabinet can be obtained by the nursing supervisor from the medication room. All medications removed...must be documented on the medication distribution log located in the medication room."

3.a On 3/5/13 at 4:45 p.m., during an observation of the open shelf medication storage system, the following expired medications were available for patient use:
(1) 9 Bristoject (Syringe of prepared prepackaged medications) expiration 7/1/12;
(2) 1% Lidocaine 50 mg/5 ml (injectable medication used during treatment of unhealthy heart rhythms)(mg/ml are units of liquid measurement) with an expiration date of 7/1/12.
(3) Propranolol (medication used for heart) 1mg/ml 10 vials with an expiration date of l/13.
(4) Twenty Flovent 44% inhalers, (used for breathing treatments) with an expiration date 1/13.
(5) Nix 5%/2.2 mg. in a cream used for lice with an expiration date of 10/12.
(6) Nupercaine ointment used for topical pain with an expiration date of 1/12.

b. On 3/12/13 from 1:30 - 2:00 p.m., during the tour of the Emergency Department and inspection of the pediatric crash cart, the following expired items were available for use:
(1) D 25% syringes (solution with sugar) were prepared for immediate use, but were stored 30 days past expiration (2/12/13) and were available for use .
(2) 3-10 cup trays of Nystatin suspension had an expiration date of 10/31/12.
(3) Three tubes of Triamcinolone cream 0.5% (topical use for skin rash) had an expiration date of 10/2012.
(4.) There was one open bottle of Betadine with sticky, jelly substance oozing out from it with no expiration date and another Betadine bottle had an expiration date of 12/2012.
(5) One - 100 milliliter (method of measurement) bag(gies) of salt solutions (normal saline, NaCl) was in the cart removed from its protective package.
These baggies come as four in one package. Once removed from the outer wrap, they are considered under modified storage conditions and are usable for a shorter period of time; no date of opening was marked on the packages.
(6) One Portex Endotracheal tube (a catheter inserted into the throat for the primary purpose of establishing and maintaining a patent airway) which expired on 8/10.
(7) One Duodenal tube (tube passed through the esophagus and stomach into the duodenum for performing procedures or for feeding) with an expiration date of 12/12.
(8) One Broselow Hinkle pediatric emergency system intubation kit with an expiration date of 9/12. This "purple" kit had several pieces such as blades and tubes that are used to intubate pediatric patients.
(9) A bottle of glucose strips (used for testing blood glucose) was observed with no open date or use by date indicated on the container. These strips according to the manufacturer's indications may be used for 90 days from opening.

c.) During a concurrent interview and observation in the Operation Room (OR) with LN 9 on 3/13/13 at 11:30 a.m., 3 -100 milliliter baggies of NaCl (salt solution) were found in the medication cart. These baggies were removed from the outer wrap and did not have a date of when they were removed, or a use by date. According to the manufacturer's directions for use, the outer wrap of the solution container should not be removed until the product is needed for use, as the outer wrap protects the container from damage and prevents evaporation of the contents.

A one liter bag of NaCl, was found in the warmer with an expiration date of 3/12/13.

LN 9 confirmed the facility did not have a system in place to ensure that these baggies were not used beyond that time frame recommended by the manufacturer. LN 9 confirmed there was no system in place to track when these baggies were removed from the protective outer wrap or for how long they were usable.

On 3/13/13 at 11:30 a.m., during a concurrent interview, LN 1 and LN 5, stated that they did not know about such restriction for storage or use for the saline solution containers observed in the OR.

4. On 3/12/13, at 9:00 a.m., during an interview, LN 1 explained the hospital's system for handling recalled items. LN 1 stated that either she or LP 10 (Director of Pharmacy) reviewed the notices, checked the stock in both the drug room and on the floor for the recalled items. LN 1 stated on interview that staff usually documented the stock in the pharmacy or on the floor were checked and if the hospital had the affected lot or not.

LN 1 presented a binder with notices and actions taken written on these notices or the print-out of items recalled indicating what was done, and if the hospital carried the product.

Concurrent review of the binder revealed some recall notices did not have any written comments on them. LN 1 was not able to verify whether or not the stock was checked for the presence of the recalled product.

For example, a recall notice for Carvedilol 12.5 mg tablets (medication used to control heart rate and blood pressure) was reviewed. The recall notice did not have a date when the recall was announced. The notice did not have any documentation the notice was reviewed or the notes documenting the hospital supply was checked.

5.a. On 3/12/13 at 5 p.m., during a concurrent interview and clinical record review, LN 6 confirmed Patient 1 had a physician order for Lipitor 20 milligrams (mgs) (medication used to lower cholesterol in the blood) to be given daily. Patient 1 was admitted on 3/9/13.

Review of the Medication Administration Record (MAR) revealed no Lipitor was administered to Patient 1. The MAR documented Patient 1 was administered lisinopril 20 mg, a medication used to lower blood pressure, daily for four days (3/9/13, 3/10/13, 3/11/13, 3/12/13) even though there was no physician order to do so.

LN 6 and LN 2 explained the findings of the medications for Patient 1 in this manner. LN 6 and LN 2 stated the facility had two computer systems. Orders were usually entered in one computer system (CSPI) which was supposed to communicate with the automated dispensing cabinet, (MDG). Sometimes, staff would have to enter patients into the MDG system in order to access the medications ordered. LN 6 and LN 2 could not explain the reason Patient 1 was administered a medication not ordered (lisinopril) and did not receive an ordered medication (Lipitor). LN 6 and LN 2 stated that it was possible the person entering the order into the computer system entered the wrong medication into the MDG. LN 6 and LN 2 stated the problem with the computer system and the automated dispensing cabinet had been going on "for months".

b. On 3/12/13 at 5 p.m., during a concurrent interview and clinical record review, LN 6 confirmed Patient 1 was admitted on 3/9/13 for exacerbation of respiratory illness. On admission Patient 1 was prescribed Solu-medrol 125 milligrams (mgs) every 6 hours. Solu-medrol is a steroid type medication that has anti- inflammatory effect and used for management of respiratory diseases to reduce the inflammation in the airways, and improve symptoms such as wheezing and shortness of breath.

Review of the Medication Administration Record (MAR) revealed that the medication was scheduled to be given every 6 hours at 6 a.m., 12 p.m., 6 p.m., and 12 a.m. each day. On 3/10/13 the MAR documented Patient 1 was administered Solu-medrol at 6 a.m. and 6 p.m. (two doses were missed). Review of the history of medication removal from the automated drug dispensing device (MDG) revealed that the medications was not removed or given on 3/10/13 at 6:00 a.m. or 6:00 p.m.

On 3/11/13 the MAR documented Solu-medrol administration at 12:29 a.m., 12:10 p.m. and 6 p.m. (missing one dose). The MDG did not record medication removal for the 6 a.m. dose.

LN 2 stated on interview that they have "computer issues" and that delays medication administration. LN 2 acknowledged there was no clinical justification or documented rationale for not administering the medication.

c. On 3/12/13 at 12:45 p.m., LN 6 was observed administering inhalation medication (Duoneb) for Patient 1. Review of the record with LN 6 revealed that Patient 1 had a physician order, dated 3/9/13, to receive Duoneb every four hours around the clock in addition to every hour as needed. Duoneb is a combination medication, ipratropium and albuterol (bronchodilators - opens up the airways in the lungs), which is used for respiratory problems. Review of the medication administration record (MAR) revealed that Patient 1 was not administered Duoneb as ordered. Instead of receiving the medication at least 6 times every day, on 3/12/13, he was given 4 doses only. Similarly, on 3/11/13, Patient 1 was given 4 doses instead of the ordered 6 doses.

On 3/10/13 according to the MAR Patient 1 was administered one dose of Duoneb at 1:06 a.m., the subsequent dose was given at 1:38 p.m., more than 12 hours afterwards. In addition on 3/11/13, Patient 1 was not administered 2 doses as the first dose was administered at 1:08 a.m., and the subsequent dose was given at 12 p.m.

Concurrent review of the record for Patient 1, with LN 6, on 3/12/13 in the afternoon, revealed no documentation of the reason for not administering Duoneb. When asked about the physician order to administer Duoneb every hour as needed and how it was determined if the patient needed the medication, LN 6 stated the patient could ask for the medication; or if nurses are doing assessments, they can determine if a treatment is needed.

On 3/13/13, at 6:00 p.m., LN 6 stated that after further review of the record she did not find any documented rationale for not administering the Duoneb. There was no documented evidence Patient 1 was assessed for his respiratory status to see if he needed the medication every hour as ordered by the physician. There was no evidence that the as needed Duoneb was administered.

Review of the facility's policy titled, "Uniform Drug Administration Policy" approved 11, 2012, revealed the following:
"Medication is checked with the Medication Administration Record (MAR) before administration to a patient. The physician's order is recorded on the MAR and the nurse verifies it for accuracy. The pharmacist independently verified the physician's order as soon as possible." In addition, the policy included "The nurse ...verifies the physician's (order) prior to administering the dose."

6. On 3/14/13 at 10 a.m. concurrent review of the record for Patient 2 with LN 2 revealed, Patient 2 was admitted on 1/6/13 for heart related concerns. Among other medications the patient was prescribed morphine sulfate 4 mg every 6 hours as needed for pain. Morphine is a strong opioid narcotic medication used to treat pain. Review of the medication administration record (MAR) revealed Patient 2 was administered 2 doses of morphine on 1/6/13 at 9:53 a.m. and 7:23 p.m.

Morphine is the type of medication required to be evaluated to ensure efficacy (is it working and achieving the intended effect) and prevent toxicity (was there any unwanted effects or adverse reactions related to its use). The clinical record for Patient 1 was reviewed for pain assessment before the morphine was administered (to establish the need for it) and assessment of the pain after the medication was administered (to see if the pain was controlled and the medication had its intended effect). LN 2 checked the printed, closed record, and said that she did not see any documentation of pain assessment. LN 2 reviewed the electronic record and indicated that there was no assessment of the patient before the 9:53 a.m. dose on 1/6/13 or assessment after that dose. LN 2 stated the expectation was to assess pain within an hour after morphine is administered.

LN 2 identified documentation of assessment for the evening morphine dose. The nurse's note, at 7:36 p.m. on 1/6/13 indicated the patient was "discovered alone in room wearing sweat soaked shirt, breathing 30/min (breaths per minute) and writhing in pain... "

Patient 2 was ordered morphine sulfate every 4 hours. The first dose of morphine was administered at 10:00 a.m., and 9 hours later he was found "writhing in pain." There was no evidence that Patient 2 was assessed prior to that time to determine the need for pain medications.

Review of the facility's policy titled, "Pain: Care of the Adult Patient (And use of pain scales), originated June 2012, revealed the following:
Under the procedure for pain assessment the policy directed to:
Assess and document for presence of pain for all painter
a. On initial assessment; b. At regular intervals, with a minimum of every 4 hours and as needed... Re-assess pain intensity after each pain management intervention ( pharmacological and non-pharmacological) ....30 minutes for IV and 60 minutes for PO/IM ..."

Because of the accumulated findings documented in items 1 through 6, the health and safety of patients was placed in imminent danger. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 4:55 p.m. At the time of the exit 3/19/13 at 9 a.m., the hospital had not submitted an acceptable Plan of Action addressing the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m. The unacceptable Plans of Action prior to the exit was missing components related to successful return demonstration of drawing up and administering pediatric emergency medications by hospital staff. The unacceptable Plan of Action did not address and include a qualified 3rd party (not associated with the hospital) who would monitor and validate the emergency medication training of hospital staff.

The Plan of Action addressed verification of pediatric emergency medication training by a qualified 3rd party and successful return demonstration by hospital staff was verified. the Plan of Action and the IJ was abated with the hospital Administration on 3/26/13 at 1:30 p.m.



The Plan of Action addressing the IJ findings was accepted and amongst the plan was the closure of the hospital's Emergency Department on 3/22/13 at 10 a.m. The Plan of Action included successful return demonstration and verification all Registered Nurses could respond to pediatric emergency situations. The IJ was abated on 3/26/13 at 1:30 p.m.

7. There was no documented evidence that the Adverse Drug Reaction Monitoring policy was implemented to identify medication errors or adverse drug reactions. Review of the facility policy titled "Adverse Drug Reaction Monitoring" approved, 1/15/13, revealed inclusion of "a concurrent surveillance system" which included the following: "Monitoring the use of "tracer" drugs that are used to treat common adverse drug reactions ... "

Rescues agents (also referred to as tracers) are specifically used to reverse the effects of other medications. Naloxone is a rescue agent for opiate/opioid type medication that reverses sedation and respiratory depression associated with excessive use of opiate, like morphine. Flumazenil is a rescue agent that is used to reverse sedation and respiratory depression associated with excessive use for benzodiazepine such as valium.

On 3/12/13, at approximately 9 a.m., a request for a list of naloxone and flumazenil use was made. LN 1 ran reports for use of these agents, but the report showed no evidence of use. The range of the report was extended to three years for each of these agents, and for different strengths, still the report showed no evidence of use.

LN 1 was asked if the facility ordered these agents; LN1 stated that these agents were ordered and they were distributed to patient care areas. Review of the order history with LN1 revealed that in August, 2012, six boxes, each containing ten syringes, of naloxone 0.4 mg/ml, were ordered and received. In October and December of 2012, two boxes of 25 syringes, naloxone 1 mg/ml, were ordered and received. Additionally, from September 2010 until October 2011, nine boxes, each containing ten vials of naloxone 0.4 mg, were ordered and received.

Similarly, from March 2011 until January 2013, four boxes of flumazenil 0.1 mg/ml were ordered and received. Each box contained ten- 10 milliliter units.

On 3/13/13, at approximately 10 a.m., LN 8 was interviewed about use of rescue agents; she stated that she did not recall using any Narcan recently. She said that "anesthesia uses it".

There was no documented evidence the use of these tracers, or rescue agents was evaluated for identification of potential medication errors or adverse drug reaction.






27709

Based on observation, staff interview and administrative document review the hospital failed to ensure drugs and biologicals were controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law when:

1. Five out of six Emergency Department (ED) nurses (LN 1, LN 4, LN 5, LN 7 and LN 10, LN 11) did not know how to handle a pediatric emergency code when staff were not able to timely locate or identify correct types of equipment, or calculate correct doses of medications for pediatric patients in a mock code situation. Two out of the five nurses had prepared 10 times the dose of epinephrine for a hypothetical pediatric code.
2. Access and security of medications was not limited to the designated staff (keys to the drug room where medications were stored) were given to unsupervised nursing personnel.

3. Expired medications were available for use.
4. The facility failed to follow its policy and procedure on recalled products.

5. Medications were not administered in accordance with the physician orders.

6. The facility failed to follow the facility policy and procedure for pain assessment

The accumulated findings documented in items 1 through 6 placed patients at high risk for medication errors and potential death. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 4:55 p.m. At the time of the exit on 3/19/13 at 9:00 a.m., the hospital had not completed all Plans of Action to address the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m.

Findings:

1.a On 3/5/13 at 2:10 p.m., during a concurrent observation and interview in the Emergency Department (ED), two of two licensed nurses (LN) on duty LN 7 and LN 11 were given a pediatric code scenario. LN 7 was unable to locate emergency medications and equipment needed for a pediatric code. LN 7 was unable to locate the Broselow tape and Broselow cart supplies (commercial products designed for management of pediatric codes. The Broselow tape facilitates determination of medication dosages and equipment sizes for children, by measuring the length of the child against the length of the tape. The cart and tape have the same color codes. The tape serves as a quick guide to clinicians for location and retrieval of appropriate dosages of medications based on weight and supplies based on length). LN 7 and LN 11, were unable to find pediatric artificial airways (a short/small tube for infants/small child), to keep the air passages open for mechanical breathing. LN 7 stated,"...he would call the Manager to find them..." LN 7 continued to open and close various drawers on the cart. LN 7 removed a size 2.5 endotracheal tube (ETT) (a smaller diameter tube than an artificial airway). The length/depth of the tube was recorded by millimeters [units of measurement] and LN 7 stated, "...it is a 8 mm, size 8." LN 7 was requested to find a size 8 ETT. LN 7 failed to know the differences of sizes of ETT's between a 2.5 versus a size 8 that would be used on an adult. During this observation LN 11 joined the mock code. LN 11 was unable to locate pediatric supplies which included: intravenous tube (tube placed in a vein, used for fluids and medication administration), Ambu bag, pulse oximetry (measures oxygen levels in blood), and blood pressure cuff.
b. On 3/12/13 at 1:30 p.m., LN 5 was asked to demonstrate what would be done during a pediatric code. Presented by a hypothetical situation that a pediatric patient, weight unknown was brought to the emergency room, LN 5 correctly used the tape to estimate of the weight of the patient. Referring to tape where the estimated weight was, she was asked to prepare a dose of epinephrine (medication used in code situations to increase blood flow). LN 5 checked the Broselow tape and said that she would prepare 1 milligram of Epinephrine. That dose was in the correct color zone, but it had ET (Endotracheal tube) next to it instead of IV (Intravenous). The intravenous dose for a patient in that (weight range) color zone was 0.1 milligram, not 1 milligram. When intravenous (vein) access cannot be established, an endotracheal tube is placed for patients in code situations (patients not breathing and have no pulse). Medications can be administered through the ET route but at higher doses. The ET dose of medications is 10 times that of an intravenous dose. The dose of epinephrine that LN 5 would have prepared for the patient was 10 times the correct IV dose. LN 5 was asked if she knew what the terms (ET) or (IV) next to the medication indicated, she did not know.
c. On 3/12/13 at 3:00 p.m., LN 4 was asked to perform a similar demonstration for a simulated pediatric emergency. The nurse successfully used the Broselow tape to estimate the weight of the hypothetical patient which was in the pink zone and that corresponded to 6-7 kilogram (kg). The nurse was asked to draw the dose of epinephrine for the patient. The nurse checked the ET dose and drew 0.65 milliliters, which depending on the concentration may be the correct ET dose but for the IV dose it was 10 times the dose. The nurse on interview knew the indication for ET and IV next to Epinephrine, but she did not use the information when she drew the medication.
d. On 3/14/13 at 4:05 p.m., LN 10 was interviewed about pediatric

Based on observations of food storage, food production and food service, dietary staff interview and dietary document review, the hospital failed to ensure the Director of Food and Dietetic Services was a fulltime qualified staff. Failure to employ a fulltime qualified Director of Food and Dietetic Services could result in patients not receiving physician ordered nutritional support and quality health care.
Findings:
On 3/12/13 starting at 8:30 a.m. the organization of the food and dietetic department was reviewed. Interview with food Service Worker 1 (FSW1) stated that the full time dietary manager who was a DSS (qualified Dietary Service Supervisor ) was no longer an employee of the hospital since February 2013. The DSS prepared meals and served them with other food service workers. She stated there was a Registered Dietitian (RD) part-time but no full time food service manager.

Review of the kitchen area starting on 3/12/13 at 8:30 a.m., revealed the Food Service Worker 2 was serving dinner and was asked to calibrate the dial thermometer. She was not able to demonstrate how to calibrate the thermometer.

Review of the hospital document "Sanitary Conditions in Food Preparation Area" dated 2/27/13 and prepared by the RD did not evaluate the calibrated thermometer "are used to take food temperatures."

Not having a calibrated thermometer to monitor food temperature puts patient at risk of food borne illness when food is not maintained or cooked to the appropriate temperature and temperature are not measured accurately.

Review of the quality appraisal and performance improvement plan showed there were three indicators for food service consisting of :1) diets being followed and proper condiments on tray, 2) med surg and emergency refrigerator temperatures documented, and 3) out dated foods thrown out. The results for the last two quarters -October 30, 2012 and December 2012 were reviewed. They showed that for indicators 1 and 3 the benchmark was 100 percent and they documented 95 to 100 percent compliance for the two quarters reviewed. For the 2 indicator the temperatures in the med surg and ER refrigerators were at 88 to 100 percent.

The three clinical indicators were: 1) RD recommendation followed, 2) RD consult needed, 3) RD consult completed. The benchmark was 100 percent and for indicators 1 and 3 the data showed 100 percent for all months except there was no percentages documented for December.

The number two quality indicator was at 56 to 67 percent for July, August and September and 36 percent to 71 percent for October and November (there was no documentation for December). There was no analysis or discussion documented regarding why the indicator was so poorly implemented.

Most of the quality plan was meeting the estimated benchmark for 2 quarters and yet there was not discussion on changing the indicator. There was no indication that other indicators had been identified. The one quality clinical indicator that did not meet the bench mark and was falling well below the 50 percent was continued and no plan developed to improve the need for RD consults.

Based on staff interview and closed clinical record review, the hospital failed to have a qualified dietitian supervise the nutritional aspects of patient care when Patient 12 was admitted to the hospital and did not receive a nutritional consult. Patient 12 was a known diabetic with multiple admissions and no nutritional assessment. This failure resulted in not providing for the nutritional needs for Patient 12.

Findings:

The clinical record review for Patient 12 indicated an admission date of 12/10/12 and discharged 12/11/12 with diagnoses of diabetes out of control (high blood sugar), rule out diabetic ketoacidosis (potentially life threatening condition resulting from diabetes out of control), altered level of consciousness, and hypronatremia (low sodium in the blood). The physician ordered on admission 1800 calorie ADA (American Diabetic Association) diet.

Clinical review of Patient 12's laboratory results indicated the blood glucose level was 530 mg/dl (milligrams per deciliter - the reference range for blood glucose is 70 to 110 mg/dl; milligrams is a unit of weight and deciliter refers to the volume of blood). The admission nursing screen for Patient 12 indicated a request for a dietitian consult was not documented.

A review of Patient 12's past medical history indicated admission dates for similar symptoms of out of control diabetes: 11/7/12, and 10/23/12. The clinical record also documented visits in the emergency room for elevated blood glucose on 1/13/13 (glucose 535 mg/dl), 1/6/13 (glucose 430 mg/dl), 1/3/13 (glucose greater than 1000), 1/2/13 (complaint high sugars, and 12/8/12 (glucose 398 mg/dl).

Review of the clinical record for Patient 12's past hospitalizations documented no nursing or social services communication for the patient to the hospital's Registered Dietitian (RD) for nutrition assessment including the 1800 ADA diet, and plan for education in the hospital and following discharge.

Interview with the RD on 3/13/13 at 3:00 p.m., acknowledged that there was no nutrition assessment for any of the admissions for Patient 12. The RD stated the nursing admission screen prompts and lists newly diagnosed diabetics to consult the dietitian. The RD acknowledged that they did not monitor admissions to ensure that patients would be evaluated even if they did not get a consult. She acknowledged the nursing and other disciplines did not have a way to communicate to ensure multidisciplinary review of the patients.

Based on staff interview and document review, the hospital failed to ensure the regular and therapeutic menus met the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and DRI ( Dietary Required Intake) of the Food and Nutrition Board of the National Research Council. This failure resulted in the potential all patients not to receive adequate nutrition or meet the established recommended dietary allowances of all nutrients.

Findings:

On 3/12/13 starting at 1:00 p.m., the hospital nutrient analysis for the regular and therapeutic menus was requested. The Registered Dietitian (RD) stated that the hospital did not have a full nutrient analysis of the hospital menus. The RD stated the hospital looked only at the basic four food groups and did not have a full analysis of all of the nutrients.

The provision of the DRI which include the RDA's Adequate Intake and Acceptable macronutrient Distribution Range developed by the Food And Nutrition Board under the aegis of the Institute of Medicine, are used to evaluate nutritional adequacy of patient menus.

The RD stated the hospital menus were not evaluated to ensure they met the required nutrients for patients. The RD stated because there was no nutrient analysis of the hospital menu, nutritional deficiencies for hospitalized patients could not be determined.

Based on observation, staff interview and reviews of administrative documents, the hospital failed to have a therapeutic diet manual that accurately reflected physician ordered diets and current standards of practice. The lack of a current and comprehensive diet manual that reflects hospital-developed diets could result in inaccurate guidance to dietary and hospital staff when following physician ordered diets to meet the nutritional needs of patients.

Findings:

Review of the 14th Edition Clinical Diet manual 2004 Edition (last reviewed date 2009) indicated the following designated hospital diets: "Heart Healthy", "Bland", "Consistent Carbohydrate", "Low Sodium (2 gram sodium)" and large and small portions. The Diet Manual had diet terminology for "fat controlled", "Chronic Peptic Ulcer", "Carbohydrate Controlled diet", "1000 gram sodium". The diet manual did not include definitions or explanations for the terms including "small" or "large" portions.

The Registered Dietitian (RD) stated on 3/12/13 at 1:00 p.m. that the different terminology for the diets would be confusing for the nursing staff. She further acknowledged that the current Diet Manual was out of date and had not been reviewed or revised in a timely manner.

The diet manual should ensure the diets offered met the current standard of practice and included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, the indication for the diet, nutritional adequacy of the diet, and sample menu plans consistent with the hospital's menu and current standard of practice references. The diet manual did have some elements of the standard of practice but was out of date and did not reflect the sample menus and nutrient adequacy based on menu analysis of hospital diets.

Based on observation, staff interview and review of professional standards, the hospital failed to ensure proper storage and prompt disposal of trash when the hospital waste disposal bins were overflowing and evidence of trash and debris were on the ground surrounding the trash bin. This failure resulted in the potential to host rodents and possibly lead to the transmission of communicable disease.

Findings:

On 3/12/2013 starting at 08:30 a.m., 6 trash dumpsters were observed with trash lids open and overflowing with waste and trash. The ground around and under the dumpsters had accumulation of gloves, trash and leaves.

Food Service Worker 1 (FSW1) stated concurrently, the trash area was the responsibility of the Engineering or Housekeeping Departments. She stated the Dietary Department brought out their garbage but she did not know the requirement for keeping the lids closed.

The policy titled "Waste Control and Disposal" dated 06/2009, did not address maintaining the garbage and refuse storage areas clean or the lids closed.

According to the FDA (Food and Drug Administration) Food Code 2009
waste should be stored, located, disposed in a manner that will not permit the transmission of communicable disease or odor, create a nuisance or provide a breeding place for or food source for insects, rodents and vermin (various small animals or insects, such as rats or cockroaches, that are destructive, and injurious to health). Outside receptacles must be constructed with tight fitting lids to prevent the scattering of the garbage and refuse by birds, the breeding of flies, or the entry of rodents. Thorough and proper cleaning of garbage storage areas and receptacles should be done so that unsanitary conditions are eliminated. FDA (Food and Drug Administration) Food Code 2009

Based on observation, staff interview, reviews of administrative documents, manufacturer's instructions and accepted professional standards the facility failed to:

1. Have a comprehensive and effective Infection Control Program that incorporated a system for identifying, reporting, investigating, and controlling infections and communicable diseases. No infection control data was collected and submitted to the hospital-wide Quality Assessment and Performance Improvement Program (QAPI).

2. Ensure staff followed manufacturer's instructions for the preparation of an effective concentration of enzymatic (chemical) detergent for cleaning endoscopes (a surgical instrument used to visualize the interior of body structures such as for the gastrointestinal tract) and surgical instruments.

3. Ensure endoscopes were decontaminated in an area physically separated from locations where clean items were handled and patient care activities were performed.

4. Ensure staff followed manufacturer's instructions when testing a prepared Cidex (a type of chemical disinfectant) solution prior to decontaminating an endoscope with the solution.

5. Ensure endoscopes were cleaned and disinfected properly as evidenced by:
a. A leak test was not conducted prior to cleaning and disinfection of the endoscope as per hospital policy.

b. The entire endoscope, including the control body, was not immersed in Cidex solution for high level disinfection per manufacturer's directions for use.

c. Alcohol was not used to flush channels and ports after disinfection to aid drying of the scope prior to re-use as per hospital policy.

d. Expired Cidex solution was used to disinfect cystoscopes.

6. Ensure that all instruments opened and prepared in the Operating Room (OR) for surgical use were cleaned after removal from the OR and prior to wrapping and sterilization.

7. Ensure that cleaning products were used according to manufacturer's instructions.

8. Ensure air exchanges (the number of ventilations per hour within the operating room area to clear the air of microbes - small microorganisms or germs) in the perioperative area were performed, reported and tracked as per accepted professional standards (Association of periOperative Registered Nurses - AORN).

9. Ensure the physical environment of the perioperative area was maintained in a sanitary manner as evidenced by:
a. A rectangular hole with dimensions of approximately 24 inches by 10 inches was observed underneath the sterilizer in the flash sterilization room.

b. The wall near the scrub sink located near OR 1 and OR 2 was missing tiles with exposed wiring. The linoleum flooring along the length of this area was cracked and damaged.

10. Ensure the Operating Room suites (OR 1 and OR 2) were sanitary and free from visible dust and dirt. No system was in place to ensure terminal cleaning was done in an effective manner.

11. To maintain the kitchen in a clean and sanitary manner when there was unknown substance on the wall and ceiling area.

12. Patient trays were located in the biohazard room.

13. The walk-in refrigerator drain located in the kitchen area was not maintained in a clean manner.

The accumulated findings documented in items 1 through 10 placed patients at high risk for infection and harm. An Immediate Jeopardy (IJ) was called with the hospital Administration on 3/12/13 at 1:25 p.m. At the time of the exit 3/19/13 at 9 a.m., the hospital had not submitted an acceptable Plan of Action addressing the findings that lead to the IJ. The hospital Administration was notified the IJ had not been lifted at the time of the exit on 3/19/13 at 9 a.m.

Findings:

1. During an interview with the Chief Nursing Officer (CNO) and the Emergency Department (ED) Manager on March 12, 2013, at 10:00 a.m., the CNO explained she was currently overseeing the Infection Control Program because they did not have an Infection Control Nurse since January 2013. She explained that they currently did not have an Infection Control Program and that the infection control policies and procedures were being revised. The CNO stated no infection control data had been collected; no surveillance or analysis for infection prevention and control had been done in the hospital. The CNO stated infection control data had been forwarded to the QAPI program. The CNO stated because there was no collected data, no trending patterns had been established.

2. a. On 3/15/13 at 8:30 a.m., during an observation, Operating Room Technician (OR Tech) 1 was cleaning an endoscope (surgical instrument used to visualize internal organs such as the inside of the gastrointestinal tract). OR Tech 1 put an unmeasured and unknown amount of water in a sink and added 4 pumps of Enzol, an enzymatic (chemical) detergent for instrument cleaning. When questioned, OR Tech 1 did not know how much water was in the sink or the manufacturer's recommended concentration of Enzol and water.

The manufacturer's directions on the container of Enzol indicated the concentration should be 1 ounce (1 pump) per gallon of water.

b. During observations of Operating Room 1 on 3/12/13 at 9:35 a.m., OR Tech 3 cleaned and washed surgical instruments in a room between OR 1 and OR 2. OR Tech 3 washed the instruments in a sink that contained water and enzymatic detergent. OR Tech 3 then placed the instruments on a towel to pat dry. OR Tech 3 was asked how the enzymatic detergent concentration was prepared. She stated she put water in the sink and 5 pumps of Enzol. She stated she did not know how much water was in the sink.

The manufacturer's directions on the container of Enzol indicated the concentration should be 1 ounce (1 pump) per gallon of water.

3. During observations on 3/12/13 at 8:30 a.m., OR Tech 1 cleaned an endoscope in the sink of the room between OR 1 and OR 2. During the cleaning process, droplets sprayed out of the sink and onto supplies, books, and clipboards in the room. This area also contained supplies stored in cupboards and a locked box for medication. While OR Tech 1 cleaned the endoscope, an OR staff member came from OR 1, where surgery was being performed. This OR staff member came into the room, picked up a clipboard and papers, and went back into the surgical area. By entering the area where the endoscopes were being cleaned, the OR staff from OR 1 and items picked up provided a vehicle for potential contamination of the OR during surgery.

OR Tech 1 finished cleaning the scope, transported the scope to a Janitor's Closet, and placed it in a container of Cidex for high level disinfection. The Janitor's closet was observed to contain the following items: blue container filled with Cidex; a mop and bucket with cleaning solution; a Neptune suction system cleaning device (used to collect and dispose of surgical fluid waste in operating rooms); a hopper used for emptying the Neptune suction system cleaning device; dirty mop water; a trash bag with dirty mop heads; a sink for filling mop buckets; and other environmental supplies.

National guidelines from the Society of Gastroenterology Nurses and Associates, (2009) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes indicated that reprocessing of contaminated patient equipment should be done in an area designated and dedicated for this function. This should be a room separate from where endoscopic procedures are performed and considerations include adequate space for reprocessing activities, proper airflow and ventilation requirements, work flow patterns, work surfaces, lighting, adequate utilities such as electrical support and water, hand washing and eye washing facilities, air drying capability, and storage.

National Guidelines from the Association of Operating Room Nurses, Perioperative Standards and Recommended Practices indicated flexible endoscopes should be decontaminated in an area physically separated from locations where clean items are handled and patient care activities are performed.

4. On 3/12/13 from 8:30 a.m. until 9:15 a.m., during an observation, OR Tech 1 cleaned and decontaminated an endoscope. After cleaning and before placing the scope in the Cidex solution, OR Tech 1 dipped a test strip in the solution and held it to the strength scale on the bottle of strips. OR Tech 1 held it there 15 seconds, said it was fine, and then placed the scope in the Cidex solution. When asked how long one must wait before reading the strength scale results, OR Tech 1 said 30 seconds to 1 minute.

The label on the test strips indicated that the results were to be read 90 seconds after removal from the solution.

5. On 3/12/13 from 8:30 a.m. until 9:15 a.m., OR Tech 1 was observed cleaning an endoscope.

a. OR Tech 1 cleaned the endoscope without conducting a leak test prior to cleaning. When questioned, OR Tech 1 stated a leak test was done at the beginning of the day, not with every use.

The facility policy and procedure titled "Receiving and Cleaning of Instrumentation. Endoscopes/Bronchoscopes", indicated that a leak test was required after each use and prior to high level disinfection.

b. During this observation, OR Tech 1 immersed the endoscope in the Cidex and put the lid on the container. Part of the control body (the part of the endoscope with the handle and control buttons) was not immersed in the Cidex. OR Tech 1 stated the scope would now soak in the Cidex for 14 minutes and at the end of that time the scope would be disinfected. OR Tech 1 removed the lid of the container upon request and the control body was not completely immersed in the Cidex. When asked about the exposed control body, she said it should be immersed in order to be disinfected.

The directions for use of the Cidex stated "... Ensure all instruments are completely submerged ..."

c. During this observation, OR Tech 1 did not use alcohol to flush the endoscope channels to aid drying prior to re-use. When questioned, OR Tech 1 stated alcohol was not used in the scopes. She stated the scopes were rinsed with sterile water and either hung to dry or immediately used for the next endoscopy procedure. She indicated that sometimes the scopes were wet when taken for use in the next procedure because there were only 2 scopes for use.

Review of a sample of entries from the OR Log on the from 3/1/13 showed through 3/8/13 indicated following dates: showed as many as four endoscopies were done on the same day with only 2 scopes available for use.

The facility policy and procedure titled "Receiving and Cleaning of Instrumentation - Endoscopes/Bronchoscopes" indicated the endoscope channels were to be flushed with alcohol then air to dry the scope.

National guidelines from the Society of Gastroenterology Nurses and Associates, (2009) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes and from National Guidelines from the Association of Operating Room Nurses, Perioperative Standards and Recommended Practices indicated that alcohol was to be flushed through the channels to aid in drying the scopes and to help kill bacteria in the water used for flushing the scopes after disinfection.

d. On 3/8/13 at 8:10 a.m., during a concurrent observation and interview, OR Tech 1 examined the Cidex test strips used for cleaning the cystoscopes that day. The container for the test strips indicated the expiration date was 2/13 (the last day of February 2013 making the test strips 8 days after expiration). OR Tech 1 confirmed she had tested the disinfectant (Cidex) using the expired test strips. The cystoscopes were to be used that same day for procedures. OR Tech 1 confirmed that by using the expired test strips to test the Cidex solution she could not be sure the cystoscopes were disinfected effectively.

On 3/8/13 at 8:15 a.m., during an interview, MD 2 was notified the cystoscope to be used on Patient 5 that morning was disinfected with expired test strips. MD stated "...I don't care about that ..." and proceeded to use the cystoscope to perform a procedure on Patient 5.

Review of the surgery schedule for the period 3/1/13 through 3/8/13 (the period of time with expired test strips) indicated 3 other patients (Patients 6, 7 and 8) had procedures with cystoscopes using expired test strips to test the Cidex solution.

6. During observations on 3/12/13 at 9:35 a.m., Operating Room Technician (OR Tech) 3 cleaned instruments in the room between OR 1 and OR 2. During a concurrent interview OR Tech 3 stated only the instruments actually used in the surgical procedure were washed and cleaned prior to sterilization. OR Tech 3 stated unused and opened instruments were not cleaned. OR Tech 3 stated the unused instruments were placed in the same tray the used instruments were placed after they were cleaned. The tray containing the used and unused instruments was then sent for wrapping and sterilization. She indicated that she could not be sure if the unused instruments were contaminated by splashing or stray bits of organic matter. She then took the tray to the autoclave processing area to be wrapped for sterilization.

7. a. During observation of cleaning of OR 1 on 3/12/13 at 10 a.m., after a surgical case, OR Tech 2 used PDI Super Sani-Cloths (a type of disinfectant wipe) to wipe all surfaces in the room. The surfaces were dry less than one minute after she applied the product to the surface. During a concurrent interview she indicated that surfaces should remain wet for 30 seconds for them to be clean and disinfected.

The label on the PDI Super Sani-Cloths indicated a surface must remain wet with the product for two minutes in order to be disinfected.

b. During an interview on 3/12/13 at 9:20 a.m., OR Tech 1 stated the cabinet for endoscope storage was cleaned daily. OR Tech 1 stated the cabinet was cleaned with PDI Sani-Cloths but she did not know how long the product needed to remain wet on the surface to be clean and disinfected.

The label on the PDI Super Sani-Cloths indicated a surface must remain wet with the product for two minutes in order to be disinfected.

c. During an interview on 3/12/13 at 10:35 a.m., Housekeeper 1 explained the steps and product needed to clean patient rooms. When asked what product was used, she said 18H (a type of chemical disinfectant). When asked how long surfaces needed to stay wet with the product, she stated 10 to 15 seconds.

The label of the 18H product directed that surfaces needed to remain wet for 10 minutes.

d. During an observation of the physical therapy room on 3/12/13 at 10:40 a.m., Physical Therapist 1 (PT 1) explained the steps to clean the patient tables. PT 1 stated the first step was to pull new paper off the roll and change the pillow cases. He indicated they only use cleaner if the table was visibly soiled. The paper only covered the middle of the patient table, leaving 3 inches on either side exposed. When asked what cleaner was used, PT 1 retrieved a spray bottle from a cabinet. The label on the spray bottle indicated the product was a deodorizer. Neither the bottle nor the label contained cleaning instructions or indications that the product was a disinfectant and could be used to clean and disinfect surfaces. PT 1 stated no other product was used to clean and disinfect surfaces between patient use. PT 1 indicated there was no policy and procedure guiding staff on the disinfecting of surfaces between patient use.

8. On 3/7/13 at 4:30 p.m., during an interview, the OR Manager was asked to produce reports and tracking for air exchanges for the perioperative area (OR 1 and OR 2 and the surrounding restricted operative area). The OR Manager stated, "the air exchange rate has never been done since the hospital was built, that is why there are no reports." The OR Manager stated the hospital used AORN as the professional standard for the operating room area.

AORN Standards and Recommended Practices, published in 2010, was reviewed and indicated: "... V.d. The air-exchange rate in the perioperative area should be carefully controlled...The number of air changes per hour is based upon the need to remove microbiological or chemical contaminants from the environment...V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges..."

9. a. On 3/14/13 at 11:30 a.m., during an observation and concurrent interview, a rectangular shaped open hole was located underneath the sterilizer in the flash sterilization room. The hole had dimensions of 24 inches by 10 inches and exposed plumbing pipe could be seen. The area was visibly dirty with a layer of debris. The OR Manager confirmed the presence of the hole and she could not say how long it had been there.

b. On 3/14/13 at 11:45 a.m., during an observation and concurrent interview, the wall near the scrub sink located near OR 1 and OR 2 had missing tiles. There was exposed wiring in this area. The linoleum floor surrounding the scrub sink was visibly cracked and separated from the sub-floor. There were holes in the ceiling in this area.

10. On 3/8/13 at 2:45 p.m., during an observation and concurrent interview with OR Manager, OR 1 and OR 2 were visibly dirty. OR 1 was equipped with wood wall cabinets. The top of the cabinets had a layer of dust and grime. By rubbing a gloved hand over the surface of the cabinets, the dirt and grime were removed onto the gloved hand. The inside of the cabinets were protected by wood framed glass front doors. The cabinets had several shelves storing various surgical instruments and equipment. The shelves had visible dust and grime. On one of the shelves a blue container with suture equipment had a dead and dried insect. The OR Tech stated, "looks like a dead gnat". The top of the lamp over the operating room patient bed was visibly dusty and dirty. The top of both wood doors to OR 1 was touched with a gloved hand and visible dirt was removed. OR 2 was similarly configured to OR 1 and also was visibly dirty. The OR Manager confirmed the presence of the dirt and grime in both OR 1 and OR 2.

The OR Manager was asked the date of the last time OR 1 and OR 2 were cleaned and she stated "Yesterday (3/7/13)". The OR Manager stated terminal cleaning was done every Monday and Friday at night. The OR Manager stated she had not personally observed the terminal cleaning or determined the competency of the staff to terminally clean OR 1 and OR 2. The OR Manager stated the OR staff were responsible to terminally clean OR 1 and OR 2. When the OR staff (OR Techs 1, 2 and 3; and the RN Circulator) were shown the dirty condition of OR 1 and OR 2, there was no comment. The OR Manager confirmed that the hospital used the guidelines from Association of periOperative Registered Nurses (AORN) for the cleaning of the OR's.

AORN recommendation effective January 2008 under Recommended Practices for Environmental Cleaning in the Perioperative Setting indicated the following: "...I.a. The perioperative registered nurse should assess the perioperative environment frequently for cleanliness and take action to implement cleaning and disinfection procedures if needed. Cleanliness means the absence of visible dust, debris, soil, or body substances.
Environmental cleaning and disinfection is a team effort involving surgical personnel and environmental services personnel. The responsibility for verifying a clean surgical environment rests with perioperative nurses ...
I.a.1. Preparation of the OR should include visual inspection for cleanliness before case carts, supplies, equipment, and instrument sets are brought into the room. I.b. All horizontal surfaces in the OR (e.g., furniture, surgical lights, booms, equipment) should be damp dusted before the first scheduled surgical procedure of the day. Plasma and monitor screens should be cleaned according to manufacturers ' instructions.
Dust is known to contain human skin and hair, fabric fibers, pollens, mold, fungi, insect parts, glove powder, and paper fibers among other things. Airborne particles range in size from 0.001 microns to several hundred microns. Contamination from particles can come from an external source (e.g., ventilation, doors) or I.c.2. Single-use disposable mop heads and cloths may be used I.c.3. Mops that dispense cleaning disinfectant may be used...Cleaned and dried mop heads and cleaning cloths decrease the level of contamination. Microfiber mops are an option for mopping floors because they can withstand up to 300 launderings ...I.d. Measures should be taken to prevent vermin infestation of the perioperative environment...Insects and rodents can carry pathogens that cause disease (e.g., flies carrying Shigella which can cause diarrhea by contaminating food)...II.a. Operating rooms should be cleaned after each surgical or invasive procedure with a lint-free or microfiber cloth moistened with a detergent/disinfectant and water...Terminal cleaning and disinfection of the perioperative environment decreases the number of pathogens, dust, and debris that is created during the day...IV.a. 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..."

The survey team met with the hospital Administration (CEO, CNO and OR Manager) on 3/12/13 at 1:25 p.m. to inform the hospital of an Immediate Jeopardy situation related to Infection Control. The hospital Administration was informed the findings represented an immediate threat of harm and/or injury to patients. The hospital Administration was informed immediate action to correct the identified concerns was required. The following findings were detailed to the hospital Administration for immediate action:

A. The hospital failed to have a comprehensive and effective Infection Control Program that incorporated a system for identifying, reporting, investigating, and controlling infections and communicable diseases (cross reference A 749 finding 1);

B. The hospital failed to ensure staff followed manufacturer's instructions for the preparation of an effective concentration of enzymatic detergent for cleaning endoscopes and surgical instruments (cross reference A749, finding 2a, 2b);

C. The hospital failed to ensure endoscopes were decontaminated in an area physically separated from locations where clean items were handled and patient care activities were performed (cross reference A 749, finding 3);

D. The hospital failed to ensure staff followed manufacturer's instructions when testing a prepared Cidex solution prior to decontaminating an endoscope with the solution (cross reference A 749, finding 4);

E. The hospital failed to ensure endoscopes were cleaned and disinfected properly and effectively per hospital policy and/or accepted professional standards of practice. Patients 5, 6, 7 and 8 had procedures done with cystoscopes where the disinfectant solution was tested with expired test strips. (cross reference A 749 findings 5a, 5b, 5c, 5d);

F. The hospital failed to ensure that all instruments opened and prepared in the OR for surgical use were cleaned after removal from the OR and prior to wrapping and sterilization (cross reference A 749, finding 6);

G. The hospital failed to ensure that cleaning products were used according to manufacturer's instructions (cross reference A 749 finding 7a, 7b);

H. The hospital to ensure air exchanges in the perioperative area were performed, reported and tracked as per accepted professional standards (Association of periOperative Registered Nurses - AORN) (cross reference A 749, finding 8);

I. Holes were identified in the ceiling and wall located near the scrub sink for the ORs. The floor in this area was separated from the sub-floor and visibly damaged. A hole was observed underneath the sterilizer in the flash sterilization room (cross reference A 749, finding 9a, 9b);

J. The Operating Room suites (OR 1 and OR 2) were visibly dusty and dirty. No system was in place to ensure terminal cleaning was done in an effective manner (cross reference A 749 finding 10)

On 3/18/13 at 7:21 p.m. the following is a summary of the hospital Plan of Action submitted in response to the IJ findings:

A1. All surgical cases have been canceled starting 3/14/13 and the operating room will remain closed until the plan of correction has been accepted and the construction has been completed.

B2. The hospital-wide Infection Control plan has been revised and will be submitted to the Medical Executive Committee (MEC) and the Infection Control Officer (MD 13) on 3/19/13.

C3. On 3/15/13 an outside vendor submitted a bid to replace the flooring in the operating room area. A permit with the state agency (Office of Statewide Health, Planning and Development) with authority over building was issued

D4. All wood in the surgery department was removed by hospital maintenance on 3/15/13. Wall patching and painting was completed by 3/17/13.

E5. On 3/15/13 OSHPD inspector directed hospital to obtain an architect plan to address planned construction and to submit permit for construction.

F6. An outside vendor placed a bid to replace the OR wood doors on 3/14/13 with metal doors.

G7. On 3/13/13 all staff were in-serviced by the OR Manager on the proper use of Cidex cleaning products and test strips. The in-service topics and information was provided by the manufacturer. Each OR staff were required to perform at a minimum level for competency. Each OR staff member will complete the training offered by the Cidex company each month for a period of 6 months. The competencies are included in all new hired employees.

Daily monitoring of the Cidex log will be performed by the Manager or designee every day that surgery is in operation. The Cidex log data includes: test strip expiration date, solution activation and expiration dates, test date, test start and end times, test results and initial of person who performed the test. A sample of the log was provided to the team for review.

Cidex log results will be tracked monthly and reported to the Quality Assurance Performance Improvement Committee on a quarterly basis.

H8. The hole under the sterilizer was patched on 3/13/13.

I9. An endoscope processor was selected on 3/13/13 and specifications have been submitted to OSHPD and facility management to determine if equipment is a good fit for the surgery department. Once OSHPD approves the plan a request for permit will be issued and a purchase order will be generated. The plan is to place the endoscope processor on the counter next to the sink in the sterilization area. Staff will be educated with return demonstration required for the proper use of the equipment and prior to re-opening the OR.

J10. A draft policy has been created to establish exact guidelines for terminal and between case cleaning routines according to AORN professional standards and CDC guidelines. this policy will be submitted to the Medical Executive Committee (MEC) and the Infection Control Officer on 3/19/13. A checklist has been created to validate surgical staff competencies with respect to daily, between case and terminal cleanings. A 3rd party vendor will be utilized to provide initial training and competency validation of cleaning procedures in the OR prior to re-opening the department. In addition to the initial training, each staff member will be required to successfully complete the competency once a month for the next 6 months. After the initial 6 month monitoring, the surgery cleaning competency will be completed on an annual basis. These competencies will be included in all new hire training.

Checklists have been generated to document staff completion of proper cleaning of the OR including terminal cleaning. The 'daily checklist' will be completed each day prior to the first surgical case. The 'terminal cleaning checklist' will be completed every Friday when the OR is terminally cleaned.

K11. The hospital will amend the current contract with the cleaning service to include 'Cleanroom Services' to replace all surgery room string mops with "Greener" microfiber reusable mops by 3/22/13. Greener mops are a sterile reusable microfiber mop system. The new products will arrive on 3/22/13. An independent 3rd party qualified person will in-service all hospital staff that are responsible for cleaning the surgery department on the appropriate use of the new products. This will take place before the surgery department reopens. Staff competencies on proper use of the new mops will be signed off by the qualified trainer prior to using in the surgery department. Thereafter, monitoring on the proper use of the products will be done by the surgery department manager. Any newly hired surgical staff will be in-serviced on the proper use of the mop and the OR cleaning policy.

The team exited with the hospital Administration on 3/19/13 at 9 a.m. and informed the hospital the Plan of Action was not acceptable. The Plan of Action did not address the following issues:
a. The use of all disinfectants used in the OR and other parts of the hospital. Return demonstration on the proper use of disinfectant (not only Cidex) was required to be addressed.
b. The Plan of Action did not address where the processing of cystoscopes was to occur relative to the Operating Room suites. The hospital did not address the processing area requirement to be separate from the procedure room. The hospital did not address the transport of clean cystoscopes to the OR and the transport of dirty cystoscopes to the processing area. The hospital did not address the proper storage of clean cystoscopes. .
c. The specific use for OR 1 and OR 2 was not addressed in the Plan of Action. Does the hospital intend to keep both OR's as surgical suites?
d. The use of the room between OR 1 and OR 2 was not addressed. The potential for cross contamination was not addressed. The proper processing of surgical instruments (used and unused) from the OR was not addressed.

11. On 3/12/13 starting at 5:00 p.m., there was a rust colored area on the north wall at the ceiling joint that ran the full length of the exterior wall in the kitchen area.

The Registered Dietitian (RD) in concurrent interview, stated she had not seen this area and did not know what the rust colored substance was. The RD agreed the identified area needed to be cleaned.

12. On 3/12/13 starting at 10 a.m. Food Service Worker 1 (FSW1) opened the biohazard room and stated that late trays were placed on the white cart and the food service staff entered the biohazard room to pick up patient trays that were placed on this cart.

On 2/13/13 at 10:00 a.m., the designated Infection Control Practitioner (ICP) stated this room was Biohazard/dirt utility and was used by all staff for both. The ICP was not concerned that the patient tray and food service staff were accessing the biohazard storage area.

13. On 3/12/13 starting at 8:30 a.m., the walk-in refrigerator 8 inch round floor drain located just in front of the door was visibly dirty with a black substance covering the drain. The FSW1, during a concurrent interview, stated that she did not clean this drain and did not know when it had been last cleaned. FSW1 agreed the drain was visibly dirty.

Review of the Sanitary Conditions in Storage of Food check list dated 2/27/13 completed by the registered Dietitian, did not evaluate the floor drain.

RD acknowledged on 2/12/13 at 5:00 p.m., that it was important to maintain the drain clean and had not evaluated this.