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22940

Based on interview and document review, the hospital failed to have an effective Governing Body. The Governing Body failed to ensure:

1. Medical staff operated under their current Bylaws, Rules and Regulations
when the Governing Body failed to ensure that the Medical Staff was held accountable for not meeting the requirements of the Condition of Participation for Medical Staff 482.22 (see A 0353).

2. The Governing Body failed to ensure the criteria for selection were individual character, competence, training, experience, and judgment, when the credential files for three staff physicians and three Certified Registered Nurse Anesthetists (CRNA) who had engaged in patient care activities showed no evidence they had been proctored or assessed for competence as set forth in the hospital's Medical staff Bylaws. (Physician 1, Physician 2, Physician 3, CRNA 1, CRNA 2, CRNA 3), with the potential of patients receiving care from unscreened and unqualified persons [see A 0357].)

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment (A 43).

Based on interview and record review, the Governing Body failed to ensure that the Medical Staff was held accountable for not meeting the requirements of the Condition of Participation for Medical Staff 482.22.

Findings:

During a review of the hospital's medical staff appointment roster, on April 19, 2010, the following Physicians were listed as having current appointments/membership to the medical staff: Physician 1, Physician 2, and Physician 3. The roster also indicated that the Certified Registered Nurse Anesthetists (CRNA) 1, 2, and 3 had been granted Clinical Privileges to practice anesthesia under the supervision of a medical staff physician.

Review of the above mentioned Practitioners' Credential files, the following was noted:

1. Physician 1 was appointed to the medical staff on November 19, 2009. The credential file for Physician 1 contained no documented assessment of his competence to practice as a nephrologist.
2. Physician 2 was appointed to the medical staff on May 26, 2004. The credential file for Physician 2 contained no documented assessment of his competence to practice as a psychiatrist.
3. Physician 3 was appointed to the medical staff on April 24, 1998. The credential file for Physician 3 did not contain a documented assessment of his competence to practice as an internal medicine specialist.
4. CRNA 1 was granted anesthesiology clinical privileges on June 28, 2001. The credential file for CRNA 1 contained no documented assessment of his competence to practice as a nurse anesthetist.
5. CRNA 2 was granted anesthesiology clinical privileges on December 16, 2008. The credential file for CRNA 2 contained no documented assessment of his competence to practice as a nurse anesthetist.
6. CRNA 3 was granted anesthesiology clinical privileges on September 24, 2009. The credential file for CRNA 3 contained no documented assessment of his competence to practice as a nurse anesthetist.

On April 19, 2010 at 10:19 AM, during an interview with the Medical Staff coordinator (MSC), she acknowledged that the above mentioned physicians and CRNA files did not contain any documented individual competence assessment forms (proctoring forms) in the credential files. When asked if the practitioners competencies had been assessed according to the process established by the hospital's Medical Staff By-laws and/or Assessment Policy, she stated that she could not be certain because there was no documentation in their file.

During review of the hospital's "Medical Staff By-Laws," on April 19, 2010, section 5.4; subsection 5.4-1 read: "Except as otherwise determined by the Medical Executive Committee, all Initial appointees to the Medical Staff and all members granted new clinical privileges shall be subject to a period of at least six months of proctoring (observation) or shall be proctored for at least the first (6) cases ....The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted; (2) overall eligibility for continued staff membership; and (3) advancement within staff categories, if applicable ....Appropriate records shall be maintained ....During the proctoring, the practitioners must demonstrate that they are qualified to exercise the privileges that were granted and are carrying out the duties of their Medical Staff category."

During concurrent interviews with the hospital's Director of Quality, Chief Nursing Officer, and Chief of Medicine (member of medical executive committee and governing body member), on April 19, 2010 at 2 PM, they all confirmed that the proctoring assessments for the above mentioned physicians and CRNAs were not conducted according to the process established by the faculty's Medical Staff By-laws. They also acknowledged that without the documented proctoring assessment of the individual practitioner there would be no way of verifying each practitioner's Individual clinical skill, competence, or judgment.

22940

The Governing Body failed to ensure the criteria for selection were individual character, competence, training, experience, and judgment, when the credential files for three staff physicians and three Certified Registered Nurse Anesthetists (CRNA) who had engaged in patient care activities showed no evidence they had been proctored or assessed for competence as set forth in the hospital's Medical staff Bylaws. (Physician 1, Physician 2, Physician 3, CRNA 1, CRNA 2, CRNA 3), with the potential of patients receiving care from improperly screened and unqualified persons.

Findings:

Based on interview and record review, the Medical Staff Executive Committee (MEC) made inappropriate recommendations for appointments to the medical staff and granting of clinical privileges to allied health professionals to the Governing Body. The Medical Staff Executive Committee failed to ensure that evaluation of individual practitioners' proctoring was conducted according to the hospital's Medical Staff By-laws.

During a review of the hospital's medical staff appointment roster on April 19, 2010, the following physicians were listed as having current appointments/membership to the medical staff: Physician 1, Physician 2, and Physician 3. The roster also indicated that the certified registered nurse anesthetists (CRNA) 1, 2, and 3 had been granted clinical privileges to practice anesthesia under the supervision of a medical staff physician.

Upon review of the above mentioned practitioners' credential files, the following were noted:

1. Physician 1 was appointed to the medical staff on November 19, 2009. The credential file for Physician 1 contained no documented assessment of his competence to practice as a nephrologist.
2. Physician 2 was appointed to the medical staff on May 26, 2004. The credential file for Physician 2 contained no documented assessment of his competence to practice as a psychiatrist.
3. Physician 3 was appointed to the medical staff on April 24, 1998. The credential file for Physician 3 did not contain a documented assessment of his competence to practice as an internal medicine specialist.
4. CRNA 1 was granted anesthesiology clinical privileges on June 28, 2001. The credential file for CRNA 1 contained no documented assessment of his competence to practice as a nurse anesthetist.
5. CRNA 2 was granted anesthesiology clinical privileges on December 16, 2008. The credential file for CRNA 2 contained no documented assessment of his competence to practice as a nurse anesthetist.
6. CRNA 3 was granted anesthesiology clinical privileges on September 24, 2009. The credential file for CRNA 3 contained no documented assessment of his competence to practice as a nurse anesthetist.

During an interview with the Medical Staff Coordinator, on April, 21, 2010 at 2:16 PM, she stated that according to the Medical Staff By-law, all practitioners that are appointed to staff or granted clinical privileges must first go thru the credentialing process for verification of their education, qualifications, experience, and competencies. After that, the Medical Executive committee meets and reviews the credentialing file and makes the final recommendation for appointment to medical staff or granting of clinical privilege to the Governing Body. When asked how the above mentioned practitioners were granted clinical privileges without documented competence evaluations, she stated, "I don't know."

During an interview with the Chief of Medicine (member of the medical executive committee and governing body member), April 21, 2010 at 10:05 AM, he stated that he was unaware the above mentioned practitioners were not proctored according to the process established in the hospital's Medical Staff By-laws. He admitted that the above mentioned practitioners were currently privileged and treating patients in the hospital. When asked how the hospital ensures the competence of each individual practitioner, he acknowledged that without following the process established by the Medical Staff by-law the hospital could not ensure their competencies.

22940

Based on interview and record review, the hospital failed to meet the requirements of the Condition of Participation: Medical Staff. The hospital failed to:

1. Make appropriate recommendations for appointments to the Medical Staff and granting of clinical privileges to Allied Health Professional to the Governing Body. The Medical Staff Executive Committee failed to ensure that evaluation of individual Practitioners Proctoring was conducted according to the hospital's Medical Staff By-laws (see A 0341), which had the potential for inadequate patient care to be given by persons whose proctoring was inadequate.

2. Ensure that the hospital's Medical Staff By-laws delineating the proctoring assessment of medical practitioners was being enforced. This resulted in the hospital's inability to ensure that practice privileges granted to its physicians and allied heath practitioners were based on assessment that considered the individual practitioners' medical competence, training, and judgment (see A 0353), which had the potential for inadequate patient care to be given by persons whose privileges were granted after inadequate assessment of these criteria.

3. Evaluate physicians' and certified registered nurse anesthetists' (CRNA) individual competencies based on written criteria in the Medical Staff By-laws in order to grant clinical privileges, which had the potential for inadequate patient care to be given by incompetent persons (see A 0357).

The cumulative effect of these failures resulted in the hospital's inability to meet the requirements of the Condition of Participation: Medical Staff, and ensure the provision of quality health care in a safe environment.

Based on interview and record review, the Medical Staff Executive Committee (MEC) made inappropriate recommendations for appointments to the medical staff and granting of clinical privileges to allied health professional to the Governing Body. The Medical Staff Executive Committee failed to ensure that evaluation of individual practitioners' proctoring was conducted according to the hospital's Medical Staff By-laws.

Findings:

During a review of the hospital's medical staff appointment roster, on April 19, 2010, the following physicians were listed as having current appointments/membership to medical staff: Physician 1, Physician 2, and Physician 3. The roster also indicated that the certified registered nurse anesthetists (CRNA) 1, 2, and 3 had been granted clinical privileges to practice anesthesia under the supervision of a medical staff physician.

Upon review of the above mentioned practitioners' credential files, the following was noted:

1. Physician 1 was appointed to the medical staff on November 19, 2009. The credential file for Physician 1 contained no documented assessment of his competence to practice as a nephrologist.
2. Physician 2 was appointed to the medical staff on May 26, 2004. The credential file for Physician 2 contained no documented assessment of his competence to practice as a psychiatrist.
3. Physician 3 was appointed to the medical staff on April 24, 1998. The credential file for Physician 3 did not contain a documented assessment of his competence to practice as an internal medicine specialist.
4. CRNA 1 was granted anesthesiology clinical privileges on June 28, 2001. The credential file for CRNA 1 contained no documented assessment of his competence to practice as a nurse anesthetist.
5. CRNA 2 was granted anesthesiology clinical privileges on December 16, 2008. The credential file for CRNA 2 contained no documented assessment of his competence to practice as a nurse anesthetist.
6. CRNA 3 was granted anesthesiology clinical privileges on September 24, 2009. The credential file for CRNA 3 contained no documented assessment of his competence to practice as a nurse anesthetist.

During an interview with the Medical Staff Coordinator on April 21, 2010 at 2:16 PM, she stated that according to the Medical Staff By-law, all practitioners that are appointed to staff or granted clinical privileges must first go through the credentialing process for verification of their education, qualifications, experience, and competencies. After that, the Medical Executive Committee would meet and review the credentialing file and make the final recommendation for appointment to the medical staff or granting of clinical privilege to the Governing Body. When asked how the above mentioned practitioners were granted clinical privileges without documented competence evaluations, she stated, "I don't know."

During an interview with the Chief of Medicine (member of medical executive committee and governing body member), April 21, 2010 at 10:05 AM, he stated that he was unaware that the above mentioned practitioners were not proctored according to the process established in the hospital's Medical Staff By-laws. He stated that the above mentioned practitioners were currently privileged and treating patients in the hospital. When asked how the hospital ensured the competence of each individual practitioner, he acknowledged that without following the process established by the Medical Staff by-law, the hospital could not ensure their competencies.

22940

Based on interview and record review, the hospital failed to ensure that the hospital's Medical Staff By-laws delineating the proctoring assessment of medical practitioners was being enforced. This resulted in the hospital's inability to ensure that practice privileges granted to its physician and allied heath practitioners were based on assessment that considered the individual practitioners' individual competence, training, judgment (see Q 0357).

Findings:

During a review of the hospital's medical staff appointment roster on April 19, 2010, the following physician's were listed as having current appointments/membership to medical staff: Physician 1, Physician 2, and Physician 3. The roster also indicated that the certified registered nurse anesthetist (CRNA) 1, 2, and 3 had been granted clinical privileges to practice anesthesia under the supervision of a medical staff physician.

Upon review of the above mentioned practitioners' credential files, the following was noted:

1. Physician 1 was appointed to the medical staff on November 19, 2009. The credential file for Physician 1 contained no documented assessment of his competence to practice as a nephrologist.
2. Physician 2 was appointed to the medical staff on May 26, 2004. The credential file for Physician 2 contained no documented assessment of his competence to practice as a psychiatrist.
3. Physician 3 was appointed to the medical staff on April 24, 1998. The credential file for Physician 3 did not contain a documented assessment of his competence to practice as a internal medicine specialist.
4. CRNA 1 was granted anesthesiology clinical privileges on June 28, 2001. The credential file for CRNA 1 contained no documented assessment of his competence to practice as a nurse anesthetist.
5. CRNA 2 was granted anesthesiology clinical privileges on December 16, 2008. The credential file for CRNA 2 contained no documented assessment of his competence to practice as a nurse anesthetist.
6. CRNA 3 was granted anesthesiology clinical privileges on September 24, 2009. The credential file for CRNA 3 contained no documented assessment of his competence to practice as a nurse anesthetist.

During concurrent interviews with the hospital's Director of Quality, Chief Nursing Officer, and Chief of Medicine (member of medical executive committee and governing body member), on April 19, 2010 at 2 PM, they all confirmed that the proctoring assessments for the above mentioned physicians and CRNAs were not conducted according to the process established by the faculty's Medical Staff By-laws. They also acknowledged that without the documented proctoring assessment of the individual practitioner, there would be no way of verifying each practitioner's individual clinical skill, competence, or judgment.

During an interview with the Chief of Medicine (member of medical executive committee and governing body member), April 21, 2010 at 10:05 AM, he stated that he was unaware that the above mentioned practitioners were not proctored according to the process established in the hospital's Medical Staff By-laws. He stated that the above mentioned practitioners were currently privileged and treating patients in the hospital. When asked how the hospital ensured the competence of each individual practitioner, he acknowledged that without following the process established by the Medical Staff by-law the hospital could not ensure their competencies.



27157

Based on interview and record review, the hospital failed to evaluate physicians' and allied health professionals' (AHP) individual competencies based on written criteria in the Medical Staff By-laws in order to grant clinical privileges.

Findings:

During a review of the hospital's medical staff appointment roster on April 19, 2010, the following physician's were listed as having current appointments/membership to medical staff: Physician 1, Physician 2, and Physician 3. The roster also indicated that the certified registered nurse anesthetists (CRNA) 1, 2, and 3 had been granted clinical privileges to practice anesthesia under the supervision of a medical staff physician.

Upon review of the above mentioned practitioners' credential files, the following was noted:

1. Physician 1 was appointed to the medical staff on November 19, 2009. The credential file for Physician 1 contained no documented assessment of his competence to practice as a nephrologist.
2. Physician 2 was appointed to the medical staff on May 26, 2004. The credential file for Physician 2 contained no documented assessment of his competence to practice as a psychiatrist.
3. Physician 3 was appointed to the medical staff on April 24, 1998. The credential file for Physician 3 did not contain a documented assessment of his competence to practice as an internal medicine specialist.
4. CRNA 1 was granted anesthesiology clinical privileges on June 28, 2001. The credential file for CRNA 1 contained no documented assessment of his competence to practice as a nurse anesthetist.
5. CRNA 2 was granted anesthesiology clinical privileges on December 16, 2008. The credential file for CRNA 2 contained no documented assessment of his competence to practice as a nurse anesthetist.
6. CRNA 3 was granted anesthesiology clinical privileges on September 24, 2009. The credential file for CRNA 3 contained no documented assessment of his competence to practice as a nurse anesthetist.

On April 19, 2010 at 10:19 AM, during an interview with the Medical Staff Coordinator (MSC), she acknowledged that the above mentioned physicians' and CRNA files did not contain documented individual competence assessment forms (proctoring forms) in the credential files. When asked if the practitioners' competencies had been assessed according to the process established by the hospital's Medical Staff By-laws and/or Assessment Policy, she stated that she could not be certain because there was no documentation in their file.

During review of the hospital's "Medical Staff By-Laws," on April 19, 2010, section 5.4; subsection 5.4-1 read: "Except as otherwise determined by the Medical Executive Committee, all Initial appointees to the Medical Staff and all members granted new clinical privileges shall be subject to a period of at least six months of proctoring (observation) or shall be proctored for at least the first (6) cases ....The purpose of observation shall be to evaluate the member's (1) proficiency in the exercise of clinical privileges initially granted; (2) overall eligibility for continued staff membership; and (3) advancement within staff categories, if applicable ....Appropriate records shall be maintained ....During the proctoring, the practitioners must demonstrate that they are qualified to exercise the privileges that were granted and are carrying out the duties of their Medical Staff category."

During concurrent interviews with the hospital's Director of Quality, Chief Nursing Officer, and Chief of Medicine (member of medical executive committee and governing body member), on April 19, 2010 at 2 PM, they all confirmed that the proctoring assessments for the above mentioned physicians and CRNA were not conducted according to the process established by the faculty's Medical Staff By-laws. They also acknowledged that without the documented proctoring assessment of the individual practitioner there would be no way of verifying each practitioner's individual clinical skill, competence, or judgment.

Based on observation, interview, and document review, the hospital failed to ensure that nursing services were furnished or supervised by a registered nurse as evidenced by:

1. Failure to ensure a registered nurse furnished or supervised the nursing care provided at the wound center, potentially resulting in unmonitored, inadequate care being rendered (Refer to A 395, item 1).

2. Failure to ensure that a second registered nurse was available to circulate during procedures when conscious sedation (sedation provided that allows a patient to have pain control in a near-sleep state which can potentially effect their respiratory status) was administered by a registered nurse, potentially causing the administering nurse to leave the patient unmonitored and unnecessarily jeopardizing the patient's safety (Refer to A 395, item 2).

3. Failure to ensure that a registered nurse was physically present in nursing units, when patients were present and the entrance doors were closed, secluding patients from the registered nurse, and potentially allowing patients to have serious complications go unnoticed by nursing staff (Refer to A 395, item 3).

4. Failure to ensure four of 28 sampled patients had an appropriate plan of care developed to ensure the needs of each patient were met, potentially causing inadequate or inappropriate care to be delivered. (11, 12, 13, and 14) (Refer to A 396).

5. Failure to use telephone orders infrequently for six of 28 sampled patients (15, 16, 17, 18, 19, and 20). This had the potential to result in miscommunication and therefore errors in physician's orders (Refer to A 407).

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment (A 385).

Based on observation, interview, and document review, the hospital failed to ensure that a registered nurse was available to supervise and evaluate the nursing care for each patient. This failure placed patients at risk of receiving nursing care from someone not qualified to provide nursing services, and to potentially expose staff (who did not know isolation procedures), to infectious agents if they entered the rooms of isolation patients while the registered nurse was away from the unit.

Findings:

1. On April 20, 2010 at 8 AM, a tour was conducted of the hospital's wound center. During the tour it was noted that a patient was receiving hyperbaric therapy.

During a concurrent interview, the Director of the wound center was asked how many patients were seen on a daily basis at the wound center. The Director of the wound center stated that the wound center provided care for six to 12 patients daily, Monday through Friday. The Director of the wound center was asked to explain the various types of staff who work there. The Director stated that he was licensed as a respiratory therapist and was certified in hyperbaric therapy. He stated the medical assistant, also certified in hyperbaric therapy, worked full time. The Director of the wound center stated that the wound center also had a full time housekeeper. The Director of the wound center stated that a registered nurse was recently hired to work per diem, (when needed), to assist with special projects.

On April 20, 2010 at 10:30 AM, the Director of Human Resources was asked for a report showing the actual number of hours Registered Nurse (RN) 1 had worked since January 1, 2010. The employee ledger report was printed, reviewed, and showed that the Registered Nurse had worked 2 hours on February 27, 2010, and 11 hours on March 10, 2010.

On April 20, 2010, at 4 PM, the Chief Nursing Officer (CNO) was interviewed. The CNO was asked to describe the process used at the wound center to ensure that a registered nurse supervised and evaluated the nursing care provided there. The CNO stated that the Wound Center Director was responsible for supervising the delivery of care at the wound center. The CNO stated that the per diem registered nurse worked full time in a physician's office, and was only helping out. The CNO verified that the nursing care provided at the wound center was not supervised or evaluated by a registered nurse.

2. On April 20, 2010 at 10:47 AM, a tour was conducted of the surgical services area. During the surgical services tour, the surgical suite where endoscopic procedures were performed was inspected.

During a concurrent interview, the Surgery Manager was asked to explain the process for performing endoscopic procedures. The Surgery Manager stated that the endoscopic procedures were performed under conscious sedation. The Surgery Manager stated the registered nurse, a gastrointestinal (GI) technician, and the physician were in the surgical suite while the endoscopic procedures were performed. The Surgery Manager stated the registered nurse administered conscious sedation as ordered by the physician performing the endoscopic procedure. The Surgery Manager also stated the GI technician assisted the physician during the procedure by providing instruments or other equipment needed during the procedure, (leaving the registered nurse with no assistant). The Surgery Manager replied, "No, there isn't," when asked if a second registered nurse was present in the surgical suite when patients received conscious sedation for endoscopic procedures.

On April 20, 2010, at 3 PM, the hospital's policy and procedure titled, "IV conscious sedation" was reviewed. The policy and procedure dated May 2008, directed that the registered nurse managing the care of the of the patient receiving conscious sedation shall have no other responsibilities that would leave the patient unattended or compromise continuous monitoring..."

On April 20, 2010, at 5:30 PM, the 2010, AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 317, AORN recommended that the "perioperative registered nurse monitoring the patient receiving moderate sedation/analgesia should have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure." On page 318, item IV.b., AORN recommended that, "An additional perioperative registered nurse should be assigned to the circulating role during the administration of moderate sedation." Under item IV.c. AORN recommended that, "When moderate sedation is administered, the supervising licensed independent practitioner should remain immediately available during the procedure and recovery period."

On April 21, 2010, at 9 AM, the Director of Quality and CNO were interviewed. The Director of Quality and the CNO confirmed that a second registered nurse was not present in the surgical suite when patients received conscious sedation during their endoscopic procedures.

3. On April 19, 2010, at 10 AM, an initial tour was conducted of the intensive care unit. Upon entering the intensive care care unit, it was noted that the entrance doors to the unit were closed. It was noted that two patients (1 and 2), were admitted to Rooms 301 and 302. A sign posted outside of Room 301 indicated Patient 2 was in "Droplet" transmission-based precautions, (precautions that protect staff or bystanders from contaminated droplets in the air caused by coughing, sneezing, or spraying). A staff member was was also observed sitting at the nurses' station watching the cardiac (heart) monitors.

During a concurrent interview, the staff member watching the cardiac monitors was asked if she knew why Patient 2 was in droplet transmission-based precautions. The Charge Nurse responded, and said that the staff member was a telemetry technician, and would not know why the patient was in droplet transmission-based precautions. When asked where the registered nurse who was assigned to care for the patients in Room 310 and 302 was, the Charge Nurse stated the registered nurse also had patient assignments on the medical surgical unit. When asked how would the telemetry technician summon the registered nurse if there was an emergency, the Charge Nurse replied, "She would use the telephone and call the medical surgical unit." The Charge Nurse stated that the patients in Rooms 301 and 302, were "Boarder," (medical surgical overflow), patients and by hospital practice they did not need a registered nurse physically present all of the time.

During an observation on April 19, 2010, at 10:05 AM, it was noted that when the intensive care unit doors were closed, the patients in the area were secluded from the registered nurse assigned to provide their nursing care. It was also noted that when the entrance doors were opened they automatically closed in a minute or two. When asked if the entrance doors were always closed, the Charge Nurse stated that unless the button to open the doors was pushed, the intensive care entrance doors were always closed.

On April 19, 2010 at 11 AM, a request was made to review the intensive care unit nursing assignment records for February, March, and April, 2010. The 24 hour staffing/shift assignment records were provided, reviewed, and they disclosed that approximately 90 percent of the patients admitted to the intensive care unit were "Boarder" patients. Documentation on the 24 hour staffing/shift assignments showed that the registered nurse(s) assigned to provide nursing care for boarder patients admitted to the intensive care unit, were also assigned to care for patients admitted to the medical surgical unit.

On April 20, 2010, at 11 AM, an interview was conducted with the Director of Quality. During the interview, the Director of Quality verified that the intensive care unit entrance doors were always closed unless they were activated to open. The Director of Quality confirmed that the registered nurse assigned to provide nursing care was not always present to supervise and evaluate the nursing care of boarder patients admitted to the intensive care unit.

Based on interview and record review, the hospital failed to ensure four of 28 sampled patients had an appropriate plan of care developed to ensure the needs of each patient were met (11, 12, 13, and 14).

Findings:

1. The clinical record for Patient 12, was reviewed on April 20, 2010 at 10:07 AM. A physician's order was noted to obtain laboratory tests which included a Complete Blood Count (CBC). The laboratory test was obtained with the results received on April 19, 2010. The blood glucose result was 391 milligrams per deciliter (mg/dl). The result was considered critically high. The physician was notified and the patient was placed on regular insulin with a sliding scale coverage. The blood sugars for April 19 and April 20, 2010 ranged from 330 mg/dl to 391 mg/dl and required regular insulin coverage (to bring the level of sugar in the blood down to a safe level). A review of the plan of care was conducted. There was no plan of care developed which addressed the elevated blood sugar levels, which would direct staff of approaches they would implement or an appropriate goal they would strive to attain.

During an interview with the Nurse Manager (NM) 2 on April 20, 2010 at 10:15 AM, after reviewing the clinical record for Patient 12, she acknowledged there was no care plan developed for the elevated blood glucose levels although there should have been.

2. The clinical record for Patient 13 was reviewed on April 20, 2010 at 10:20 AM. The history and physical (H&P) dated April 18, 2010 indicated the patient had a yeast infection and was being treated for the medical condition prior to entering the hospital. A review of the plan of care was conducted. There was no plan of care developed which addressed the yeast infection which would include the approaches staff would implement and an appropriate goal for the medical condition.

During an interview with NM 2 on April 2010, 2010 at 10:35 AM, she acknowledged there was no care plan developed for Patient 13's yeast infection. She indicated there should have been a care plan developed for the yeast infection.

3. The clinical record for Patient 11 was reviewed on April 20, 2010 at 2:30 PM. The H&P was completed on April 7, 2010 which indicated the patient had medical diagnoses which included: symptoms of dyspepsia (indigestion), Chronic Obstructive Pulmonary Disease (COPD) with acute symptoms (respiratory difficulty), Degenerative Joint Disease (DJD, breakdown and soreness to joints), Chronic Pain Syndrome, hypertension (high blood pressure), and a history of Coronary Artery Disease (CAD) (clogging heart arteries). A review of the plan of care was conducted and there were no plan of cares developed which addressed these medical conditions which would include the approaches staff would implement and appropriate goals for the medical conditions.

During an interview with NM 2 on April 20, 2010 at 3:15 PM, she acknowledged the lack of care plans for medical conditions of patients.

4. The clinical record for Patient 14 was reviewed on April 20, 2010 at 2:55 PM. The medical evaluation dated April 18, 2010 indicated the patient suffered from migraine headaches. A review of the the plan of care was conducted and there was no plan of care developed which addressed the medical condition which would include appropriate staff interventions and appropriate goals for the condition.

During an interview with NM 2 on April 20, 2010 at 3:15 PM, she indicated there should be care plans developed for medical conditions and stated it has been a problem.

Based on closed record review, the hospital failed to use telephone orders infrequently with six of 28 sampled patients (15, 16, 17, 18, 19, and 20). This had the potential to result in miscommunication and errors in physician's orders.

Findings:

1. The clinical record for Patient 15 was reviewed on April 21, 2010 at 10:35 AM. From February 15, 2010 to February 28, 2010 there were 13 telephone orders and two physician written orders.

2. The clinical record for Patient 16 was reviewed on April 21, 2010 at 1:30 PM. From March 10, 2010 to March 11, 2010 there were five telephone orders and two physician written orders.

3. The clinical record for Patient 17 was reviewed on April 21, 2010 at 2:30 PM. From November 4, 2009 to November 9, 2009 there were 17 telephone orders and five physician written orders.

4. The clinical record for Patient 18 was reviewed on April 21, 2010 at 2:50 PM. From February 10, 2010 to March 4, 2010 there were 15 telephone orders and three physician written orders.

5. The clinical record for Patient 19 was reviewed on April 22, 2010 at 9 AM. From February 23, 2010 to March 1, 2010 there were seven telephone orders and two physician written orders.

6. The clinical record for Patient 20 was reviewed on April 22, 2010 at 9:15 AM. From March 15, 2010 to March 17, 2010 there were six telephone orders and one physician written order.



18791

Based on record review, the hospital failed to ensure complete medical records for four of 28 sampled patients (21, 22, 23, and 24), resulting in incomplete information with which to base patient treatment and care, and potentially causing inadequate or inappropriate care to be given.

Findings:

The clinical record for Patient 21 was reviewed on April 20, 2010 at 11:10 AM. During the review there were no physician's progress notes for each visit, no written physician's orders and no care plan developed for the treating medical condition.

The clinical record for Patient 22 was reviewed on April 20, 2010 at 11:25 AM. During the review there were no physician's progress notes for each visit, no written physician's orders and no care plan developed for the treating medical condition.

The clinical record for Patient 23 was reviewed on April 20, 2010 at 11:35 AM. During the review there were no physician's progress notes for each visit, no face sheet with demographic information, no written physician's written orders and no care plan developed for the treating medical condition.

The clinical record for Patient 24 was reviewed on April 20, 2010 at 11:40 AM. During the review there were no physician's progress notes for each visit, no face sheet, no physician's written orders and no care plan developed for the treating medical condition.

Based on record review, the hospital failed to ensure all physicians' orders were signed, dated and timed for 10 of 28 sampled patients.

Findings:

1. The clinical record for Patient 15 was reviewed on April 21, 2010 at 10:35 AM. From February 15, 2010 to February 28, 2010 there were two physician written orders with no time when written.

2. The clinical record for Patient 16 was reviewed on April 21, 2010 at 1:30 PM. From March 10, 2010 to March 11, 2010 there were two physician written orders with no time when written.

3. The clinical record for Patient 17 was reviewed on April 21, 2010 at 2:30 PM. From November 4, 2009 to November 9, 2009 there were five physician written orders and four of the five had no time when written.

4. The clinical record for Patient 18 was reviewed on April 21, 2010 at 2:50 PM. From February 10, 2010 to March 4, 2010 there were three physician written orders and three of the four had no time when written.

5. The clinical record for Patient 19 was reviewed on April 22, 2010 at 9 AM. From February 23, 2010 to March 1, 2010 there were two physician written orders with no time when written.



16501

6. On April 19, 2010, at 1: 45 PM, Patient 4's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the hospital on April 14, 2010 at 1 PM.

A review of the physician orders section of the medical record disclosed there were 15 telephone orders written from the time of admission to April 17, 2010 at 11:45 AM, that were not signed or dated/timed by the prescribing physician.

7. On April 19, 2010 at 12:25 PM, Patient 1's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on April 14, 2010 at 5:11 PM.

A review of the physician order section of the medical record disclosed there were six telephone orders written from the time of admission to April 15, 2010, at midnight, that were not signed or dated/timed by the prescribing physician.

8. On April 21, 2010, at 10 AM, Patient 5's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on April 12, 2010 at 9 PM.

A review of the physician orders section of the medical record disclosed that from the time of admission to April 14, 2010 at 10:15 PM, there were eight telephone orders that were not signed or dated/timed by the prescribing physician.

9. On April 20, 2010 at 8:30 AM, Patient 6's medical record was reviewed. Documentation in the medical record showed that on December 24, 2008, the patient began receiving medical treatment at the wound clinic.

A review of the physician orders section of the medical record disclosed from the time the patient was admitted to the wound center to April 14, 2010, there was no evidence of written physician orders directing wound center staff of the type of service to be provided, or the length of time the treatment was to be provided.

10. On April 21, 2010 at 10 AM, Patient 7's medical record was reviewed. Documentation in the medical record showed the patient was admitted to the hospital on April 13, 2010 at approximately 10 PM.

A review of the physician order section of the medical record disclosed that from the time of admission to April 16, 2010 at 5:45 PM, there were four telephone orders that were not signed or dated and timed by the prescribing physician.

On April 21, 2010 at 1 PM, the September 19, 2007 medical staff bylaws were reviewed. Under section 26, direction was given that, "All orders for treatment shall be in writing, dated, and timed appropriately..... Within 48 hours of the order, the attending physician, dentist, podiatrist, or psychiatrists/psychologist shall sign, date, and state the time when such order was signed."

Based on interview and record review, the hospital failed to ensure History and Physicals (H&P) for two of 28 sampled patients were completed timely and/or dated to verify timeliness of the H&P, resulting in potential delays in treatment while this information was sought, and in treatment being rendered based on inadequate information, causing patient harm, (25 and 27).

Findings:

The clinical record for Patient 25 was reviewed on April 22, 2010 at 9:35 AM. The patient was scheduled for an operative procedure. The H&P by the physician was undated and untimed.

The clinical record for Patient 27 was reviewed on April 22, 2010 at 10 AM. The patient was scheduled for an operative procedure on March 4, 2010. The H&P by the physician was undated and untimed.



22940

Based on interview and record review, the hospital failed to ensure two of 28 sampled patients clinical records included laboratory results which had the potential to affect the appropriate monitoring of the patients' medical conditions.

Findings:

1. The clinical record for Patient 28 was reviewed on April 19, 2010 at 1 PM. A physician's order dated April 13, 2010 was noted for a urinanalysis (UA). A laboratory report dated April 13, 2010 indicated the test was performed at another hospital. The results of the UA could not be found in the patient's clinical record.

During an interview with the Nurse Manager (NM) 1 on April 19, 2010 at 3:30 PM, he was unable to find evidence in Patient 28 clinical record of the UA laboratory results. He indicated the laboratory reports were given to him daily and acknowledged he had in his possession the UA results for Patient 28.

2. The clinical record for Patient 11 was reviewed on April 20, 2010 at 2:30 PM. A physician's order was noted for a urine culture. A laboratory report for April 13, 2010 indicated the test was performed at another hospital. No urine culture results could be found in the patient's clinical record.

During an interview with NM 2 on April 20, 2010 at 3:10 PM, after reviewing the clinical record for Patient 11, she was unable to find any urine culture results.

Based on interview and medical record review, the hospital failed to ensure that the medical record of one patient was completed within 30 days of the patient discharge (3).

Findings:

On April 21, 2010 at 8:30 AM, Patient 3's medical record was reviewed. Documentation in the medical record showed that the patient was admitted to the hospital on February 19, 2010 and was discharged from the hospital on February 23, 2010 at 9:15 PM.

A review of the physician orders disclosed six telephone orders were written during the patient's admission to the hospital. Documentation showed the physician did not date or time the orders when they were signed.

During an interview on April 21, 2010 at 9:45 AM, medical records staff confirmed that the physician orders were to be dated and timed when signed by the physician.

On April 21, 2010 at 1 PM, the September 19, 2007 medical staff bylaws were reviewed. Under section 26, direction was given that, "All orders for treatment shall be in writing, dated, and timed appropriately..... Within 48 hours of the order, the attending physician, dentist, podiatrist, or psychiatrists/psychologist shall sign, date, and state the time when such order was signed."

Based on observation, interview and record review, the hospital's dietary services failed to ensure safe food storage as evidenced by:

1. There was failure to maintain acceptable temperature parameters in the cold storage units.
2. There was failure to ensure accuracy of cold storage temperatures when there were multiple thermometers in the cold storage units.
3. There was spilled milk in one refrigerator.
4. There were undated items in one refrigerator.
5. There was a failure to follow the policy and procedure when a cold storage unit's temperature was found out of the acceptable range.
6. There was a failure to ensure refrigerated produce was covered in two refrigerators.
7. There was a failure to ensure expired foods were not made available for consumption.

These failures had the potential to result in food borne illnesses.

Findings:

1. During a general kitchen observation in the hospital's Campus 1 with Cook 1, on April 19, 2010 at 9:45 AM, the following was observed: Refrigerator No. 1 had four thermometers inside and the temperatures ranged from 28 degrees Fahrenheit (F) to 38 degrees F. Refrigerator No. 1 had a crate filled with 1/2 pint cartons of milk and below the crate there was a white liquid substance. Freezer No. 6 had six thermometers inside and the temperature readings on them ranged from -8 degrees F to +8 degrees F. Five of the six thermometers read above acceptable parameters. Freezer No. 6 contained items such as prepared meals, frozen produce, vegetables and cooked meats. Refrigerator No. 5 contained 10 small single serving containers of ranch dressing which had no date when filled. Freezer No. 4 had two thermometers which ranged from -2 degrees F to -10 degrees F. Freezer No. 3 had four thermometers which ranged from -20 degrees F to +4 degrees F. During an interview with Cook 1, he indicated he was not responsible to monitor refrigerator and freezer temperatures. Cook 2 indicated that when she was assigned to monitor temperatures of the refrigerators and freezers, she documented the thermometer which had the highest reading for each unit. Also observed on the counter top was an open container of instant protein powder which was approximately half full with no open date.

During an interview with the acting Dietary Services Supervisor (DSS), on April 19, 2010 at 10:10 AM, she was informed of the above findings. The temperature logs were also reviewed. The temperature log for Freezer No. 6 had noted documented temperatures on April 1, 2010; April 2, 2010; April 3, 2010 which contained temperatures out of acceptable parameters for a freezer temperature. The temperatures read, respectively, +10, +9, +10 degrees Fahrenheit, which were above the acceptable temperature for a freezer. When the DSS, was asked the process they used when temperatures read out of acceptable parameters, she indicated a maintenance request was completed. After reviewing the maintenance requests for April 2010, no request for those dates could be found. DSS also acknowledged there were too many thermometers in the cold storage units, making it difficult to determine the accuracy of the readings for each unit. She indicated the filled containers of ranch dressing should have been dated when filled. During subsequent interviews the DSS acknowledged the 1/2 pint containers of milk have come in the past like that, not completely sealed causing the leakage.

The hospital policy and procedure titled, "FREEZER STORAGE PROCEDURES" with a revision date of May 2008 read in part under the procedure subheading, "1. Each freezer must have a thermometer that is easily visible. 2. Upon receipt, frozen foods should be immediately stored in the freezer. The freezer should be maintained at a temperature of 0 (degrees) F to -10 (degrees) F..."

The hospital policy and procedure titled, "REFRIGERATED STORAGE PROCEDURES", with a revision date of May 2008 read in part under the procedure subheading, "...8. Leftover food or unused portions of packaged foods should be covered, labeled and dated to assure they will be used first..."

2. During a general kitchen observation at the hospital's Campus 2 with Cook 3, on April 20, 2010 at 9:10 AM, the following was noted: Nine cans of 27 ounce cans of green Chiles with an expiration date of February 28, 2010. In Refrigerator No. 3, boxes of uncovered lemons, bell pepper, onions and tomatoes were noted. In the walk in refrigerator there was one box of uncovered oranges.

During an interview with the acting DSS, on April 20, 2010 at 1:35 PM, she indicated all refrigerated foods should be covered.

The hospital policy and procedure titled, "REFRIGERATED STORAGE PROCEDURES", with a revision date of May 2008 read in part under the procedure subheading, "...6. All refrigerated foods will be covered properly..."



27157

Based on observation, interview, and document review, the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases, potentially allowing the transmission of infection to patients, staff and bystanders, as evidenced by:

1. Failure to implement polices and procedures for transmission based precautions to reduce the risk of infectious disease transmission in all areas of the hospital, which placed all hospital patients, staff and bystanders at risk of developing infections and communicable diseases (Refer to A 749, items 1 and 2 b).

2. Failure to ensure the inside of the hyperbaric chambers were disinfected between patients to reduce the risk of resistant organism transmission, which placed all hyperbaric chamber treated patients at risk of developing infections and communicable diseases (Refer to A 749, item 2 a).

3. Failure to develop and implement a glucometer and other patient care equipment cleaning policy and procedure to reduce the risk of transmission of bloodborne pathogens, and other communicable diseases, potentially causing infection in patients and staff (Refer to A 749, items 3 and 4).

4. Failure to notify patients that they had an acute infection or were colonized with a resistant organism, effecting the patients' knowledge of their health and infectiousness, and causing the preventable spread of their infections to others (Refer to A 749, item 5).

5. Failure to ensure that single patient use items were not used for multiple patients, potentially spreading infection among those who used contaminated single-use items (Refer to A 749, item 6).

6. Failure to ensure that brushes used to clean the channels of flexible endoscopes were only used to clean one flexible endoscope, potentially spreading infection among the patients who used the same, brush-contaminated endoscope (Refer to A 749, item 7).

7. Failure to ensure that all healthcare workers were annually screened for tuberculosis, with the potential of spreading tuberculosis among susceptible patients, staff and family members (Refer to A 749, item 8).

8. Failure to develop and implement a policy and procedure for the storage of flexible endoscopes to ensure storage was in accordance with recommended standards of practice, increasing the risk of contamination of the scopes (Refer to A 749, item 9).

9. Failure to review, update, and approve their infection control manual every three years, with the potential of updates being missed, old outdated procedures continuing to be used, resulting in obsolete care measures being utilized and the patients receiving inadequate care. (Refer to A 749, item 10).

10. Failure to notify the Quality Committee, Medical Executive Committee, and the Governing Board of instances when employees were at risk of contacting communicable diseases (Refer to A 749, item 11).

11. Failure to implement the hospital approved policy and procedure for the insertion and management of central venous catheters, increasing the risk of contamination of central venous catheters during insertion and management (Refer to A 749, item 12)

The cumulative effect of these systemic practices resulted in the hospital's inability to ensure the provision of quality health care in a safe environment (A 385).



22940

Based on observation, interview, and document review, the hospital failed to ensure a system was developed to identify, report, investigate, control infections and communicable diseases of patients and personnel. This failure had the potential to place all patients, staff and bystanders at risk of developing infections and communicable diseases when proper isolation precautions were not followed.

Findings:

1. During observation of the medical surgical unit on April 19, 2010, at 1:10 PM, a sign was noted outside Room 140, indicating that transmission based "Contact" precautions were in effect.

On April 19, 2010, at 1:15 PM, Registered Nurse (RN) 3 and Physician 1, were observed in Room 140. It was noted that neither the registered nurse or physician were wearing gloves or isolation gowns.

On April 19, 2010, at 1:18 PM, Physician 1 was observed exiting Room 140. It was noted that the physician did not perform hand hygiene (scrubbing hands with soap and water) after exiting the room. At the same time RN 1 was also observed exiting the room, and without performing hand hygiene, putting on a yellow isolation gown, and gloves, and reentering room 140.

On April 19, 2010, at 1:30 PM, the medical record of Patient 4 was reviewed. Documentation in the medical record indicated that on April 15, 2010, the patient had right groin surgery.

Documentation in the medical record showed that the patient had a surgical site infection and was being treated with two strong antibiotics, both administered intravenously (in the vein).

During a concurrent interview, the Charge Nurse stated the patient had developed a MRSA, (a highly drug resistant bacteria causing an infection that is difficult to treat) surgical site infection.

On April 19, 2010, at 5 PM, the hospital's policy and procedure titled, "Hand hygiene" was reviewed. The policy and procedure dated March 2004, directed that handwashing and hand antisepsis (preventing germ contamination) was required when hands are visibly dirty, before having direct patient contact, after contact with medical equipment, and after removing gloves.

On April 15, 2010, at 5:15 PM, the hospital's policy and procedure titled, "Guideline for isolation precautions in hospitals" was reviewed. On Page 2 of the March 2004 policy and procedure, direction was given that transmission based precautions are for patients documented or suspected to be infected or colonized with highly transmissible or epidemiologically important pathogens for which additional precautions beyond standard precautions are needed to interrupt transmission (spread). On Page 3, direction was given that washing/disinfecting hands promptly and thoroughly as possible between patient contact....equipment...is an important component of infection control and isolation precautions. On Page 5, direction was given that various types of gowns and protective apparel were to be worn to provide barrier protection and reduce opportunities for transmission of microorganisms (germs) in hospitals. Gowns were to be worn to prevent contamination of clothing and to protect skin of personnel from blood and body fluid exposures.

2. On April 20, 2010 at 8 AM, a tour was conducted of the hospital's wound and hyperbaric therapy center.

a. During a concurrent interview, the Center's Director was asked about the process used to clean the hyperbaric chambers between patients. The Center's Director stated that the inside of the acrylic hyperbaric chambers were cleaned with fresh water every Friday.

On April 20, 2010 at 8:30 AM, a request was made to review the manufacturer's manual. The manufacturer's recommendations were provided and reviewed. On Page 34 the manufacturer recommended that the "Chamber interior, including the stretcher and mattress, should be disinfected after patient use as directed by the medical staff. In the next paragraph the manufacturer recommended, "The following disinfecting agents may be used inside the chamber and on the acrylic window inside surfaces: (mixed per manufacturer's instructions). Sanitizers 1, 2, 3, and 4."

During a concurrent interview, the Center's Director was asked if the policy and procedure manual had been approved by the medical staff and the governing body. The Wound Center's Director stated that to his knowledge, the medical staff and governing body had not approved the wound care center's policy and procedure manual.

b. On April 20, 2010, at 8:30 AM, a request was made to review the medical record of a wound center patient. Patient 6's medical record was provided and reviewed. Documentation in the medical record showed that the patient began treatment at the wound center on December 24, 2008.

A review of the medication list showed a prescription dated March 23, 2010, for (antibiotic) 1 Gram intravenously every 24 hours. The prescription did not specify how long the patient was to receive the (antibiotic). Documentation on the physician's prescription disclosed that the patient had methicillin resistant staphylococcus aureus (MRSA), and needed a PICC (peripherally inserted central catheter).

During a concurrent interview the Wound Center's Director was asked about the process the center used to place patients with active infections in transmission based precautions (isolation). The Wound Center's Director stated that the majority of the patients receiving wound care at the Wound Center had infected wounds. The Wound Center's Director also stated that no additional procedures, such as isolation were implemented when patients with infected wounds received wound care or hyperbaric therapy.

On April 20, 2010, at 10:30 AM, the hospital's policy and procedure titled, "Recommendations for the prevention of the transmission of methicillin resistant staphylococcus aureus (MRSA)" dated October 2006, was reviewed. Item 4 of the policy and procedure directed, "If a patient is identified as having MRSA (infection of colonization), he/she shall be placed in CONTACT ISOLATION and cultures repeated on the original sites AND the patient's nares. Item 5 of the policy and procedure directed that, "CONTACT ISOLATION will be discontinued when 3 consecutive negative cultures, taken 48 hours after therapy for MRSA has ended and at least 24 hours apart."

3. a. On April 20, 2010, at 8:30 AM, a tour was conducted of the hospital's wound and hyperbaric therapy center.

During the tour the center's glucometer was inspected. During a concurrent interview, the Center's Director was asked about the process and type of cleaning product used to clean the glucometer. The Center's Director stated that, "Typically we do not clean it." The center's Director was asked if the glucometer was cleaned what cleaning product they used. The Center's Director stated that they would use alcohol swabs or (X Wipes, a germicidal).

The container of (X Wipes) was inspected and disclosed that X Wipes used to clean the glucometer did not contain bleach, nor would destroy hepatitis B, hepatitis C, or the virus that causes human immunodeficiency (AIDS).

b. On April 19, 2010, at 9:30 AM, a tour was conducted of the medical surgical unit. During a tour of the medication room, the glucometer was inspected. The Charge Nurse was asked how frequently the glucometer was cleaned and what cleaning product was used. The Charge Nurse stated that the glucometer was cleaned once a day using alcohol swabs.

c. On April 19, 2010, at 10:30 AM, a tour was conducted of the intensive care unit. During the tour the glucometer was observed sitting on a counter in the nurses' station. Inspection of the case where the glucometer and supplies (test strips, alcohol swabs, lancet devices) were stored, disclosed a brown substance in the edges and corners of the top and bottom of the case, including the space were the glucometer was stored.

During a concurrent interview, the Charge Nurse was asked how frequently the glucometer was cleaned and what disinfectant was used. The Charge Nurse stated that the glucometer was cleaned once a day, and that alcohol swabs or (X Wipes) were used to clean the glucometer.

On April 20, 2010, at 10 AM, a request was made to review the hospital's policy and procedure for cleaning patient care equipment, including the glucometer.

On April 20, 2010, at 11 AM, the Director of Quality stated that the hospital did not have a policy and procedure directing when to clean the glucometer, or the disinfectant to use.

In April 2009, APIC (Association of Professionals in Infection Control), reported in their position paper that failure to clean glucometers between patients, with a disinfectant that destroyed bloodborne pathogens, or the use of a 1-10 bleach solution, resulted in the increased transmission of bloodborne pathogens (spread of germs and viruses) such as acquired immune deficiency syndrome (AIDS), Hepatitis B and C.

4. Beginning on April 19, 2010, at 9:30 AM, tours were conducted of in-patient care areas of the two campuses and the out patient care services (Wound Care Center).

During the tours it was noted that the manufacturer labeled their blood pressure cuffs as reusable. During concurrent interviews, hospital staff were asked about the frequency of cleaning and what cleaning product was used to clean the blood pressure cuffs.

Staff stated that if the blood pressure cuff needed cleaning they would wipe if off with either a (X Wipe) or an alcohol swab.

Staff stated that, "Typically we do not clean the blood pressure cuffs." Wound Care Center Staff also stated that if a blood pressure cuff was visibly soiled they would wipe it of with an alcohol swab.

Staff stated that they cleaned the blood pressure cuff with an alcohol wipe at the end of each shift.

5. On April 19, 2010 at 9:30 AM, a request was made to review a list of patients who had the diagnosis of MRSA. A list of eight patients who were diagnosed with MRSA was provided, and the medical records of two patients were selected for review.

a. Patient 8's medical record was reviewed on April 21, 2010 at 3 PM. Documentation showed the patient was admitted to the hospital on March 19, 2010. Documentation in the medical record also showed the patient was discharged home on April 3, 2010.

A review of the physician orders disclosed an order dated March 23, 2010, that directed nursing staff to culture the patient's right thigh wound.

A review of the laboratory reports disclosed a final culture report dated March 25, 2010. Documentation in the laboratory report disclosed that the wound culture was positive for MRSA. Printed below the MRSA diagnosis was, "If a patient tests positive for MRSA, the attending physician shall inform the patient or the patient's representative immediately or as soon as practically possible. This must be documented in the patient's medical record."

A review of the physician's daily progress notes and the discharge summary contained no evidence that the physician had notified the patient or the patient's representative of the MRSA infection.

b. Patient 7's medical record was reviewed on April 21, 2010 at 3:30 PM. Documentation in the medical record showed that the patient was admitted to the hospital on April 13, 2010.

A review of the physician orders disclosed an untimed order dated April 14, 2010, to culture the patient's buttock wound for MRSA.

A review of the laboratory reports disclosed a final wound culture report dated April 16, 2010. Documentation in that laboratory report showed that the wound culture was positive for MRSA. Printed below the MRSA diagnosis was, "If a patient tests positive for MRSA, the attending physician shall inform the patient or the patient's representative immediately or as soon as practically possible. This must be documented in the patient's medical record."

A review of the physician daily progress notes contained no documentation showing that the physician had notified the patient or the patient's representative of the MRSA infection.

On April 21, 2010 at 9 AM, the Director of Quality was interviewed. The Director of Quality was asked if the hospital had a process in place where the attending physician notified the patient or patient's representative of a MRSA infection as directed in the laboratory culture report. The Director of Quality stated that the hospital did not have a process or had implemented a policy and procedure ensuring that the attending physician notified the patient or their representative of the MRSA infection or that the information was recorded in the patients' medical record.

6. On April 19, 2010, at 10 AM, a tour was conducted of the intensive care unit (ICU). During the ICU tour, a procedure cart located in the storage room was inspected. Inside the procedure cart, four plastic pressure infusers (bags that tighten around IV fluid bags, to speed the rate the fluid is given to the patient) were observed. Inspection of the pressure infusers disclosed that the pressure infusers had yellowed with age. It was also noted that the manufacturer had printed on the pressure infusers, "Recommended for single patient use."

During a concurrent interview the Charge Nurse stated that she was not aware that the pressure infusor were intended for single patient use.

On April 20, 2010, at 2:30 PM, the Federal Government' June 2000 report titled, "Medical Device Reporting" was reviewed. Information in the report directed that single use devices should not be used on multiple patients due to patient safety issues. In 2005, the Food Drug Administration (FDA) mandated that single use devices could be reprocessed if the device was reprocessed at a FDA approved reprocessor.

7. On April 20, 2010 at 10:47 AM, a tour was conducted of the area where flexible endoscopes (flexible devices that are inserted into the upper or lower gastrointestinal (GI), tract) are cleaned and reprocessed. It was noted that a brush used to clean the channels of flexible endoscopes was coiled and laying on the counter.

During a concurrent interview, the gastrointestinal technician (GI Tech), was asked to explain the process for cleaning the flexible endoscopes after the GI procedures were completed. While explaining the flexible endoscope cleaning process, the GI Technician was asked to explain how the channel brushes were used. The GI Technician explained that she used the same brush, to clean the channels of all flexible endoscopes reprocessed in a day, then discarded the channel brush.

During the concurrent interview, a request was made to inspect a channel brush in the manufacturer's package. Inspection of the manufacturer's package showed that the channel brush was labeled for use on a single endoscope. When asked if she was aware of the manufacturers' recommendations, the GI Technician stated she was not aware that the channel brushes were intended to be used to clean the channels of only one flexible endoscope.

On April 20, 2010 at 2:30 PM, the Federal Government's June 2000 report titled, "Medical Device Reporting" was reviewed. Information in the report directed that single use devices should not be used on multiple patients due to patient safety issues. In 2005, the Food Drug Administration (FDA) mandated that single use devices could be reprocessed if the device was reprocessed at a FDA approved reprocessor.

On April 20, 2010 at 3 PM, the 2010 AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 413, item X.b.3., AORN recommended that "Reusable brushes may be a cause for cross contamination.... Disposable cleaning brushes are available and may be safer, more efficient, and more economical to use."

8. On April 19, 2010, the credential files of eight members of the medical staff were reviewed. During the credential file review it was noted that none of the credential files contained documentation showing that the medical staff members were annually screened for tuberculosis.

On April 20, 2010 at 3 PM, an interview was conducted with the Medical Staff Coordinator. The Medical Staff Coordinator was asked about screening medical staff members for tuberculosis. The Medical Staff Coordinator stated that the hospital did not require members of the medical staff be screened for tuberculosis.

On April 20, 2010 at 4 PM, the medical staff bylaws dated September 19, 2007, were reviewed. The September 19, 2007 medical staff bylaws contained no direction about screening medical staff members for tuberculosis.

On April 21, 2010, at 8 AM, the Centers for Disease Control and Prevention (CDC), "Guidelines for the Preventing the Transmission of Mycobacterium tuberculosis in health-care settings 2005" was reviewed. In the report, the CDC described "HCW (healthcare workers) refer to all paid and unpaid persons working in health-care settings who have the potential for exposure to M. tuberculosis through air space shared with persons with infectious TB disease. Part time, temporary, contract, and full time HCW should be included in the TB screening program." A review of the sample list of HCW showed that physicians, medical students, interns and mid level practitioners should be screened for tuberculosis annually.

9. On April 20, 2010, at 11:20 AM, a tour was conducted of the area where flexible endoscopes are reprocessed. During the tour, a towel was observed laying on an equipment table across from the endoscope reprocessor.

a. During a concurrent interview, the Surgery Manager was asked to identify what was lying under the towel. The Surgery Manager stated that a flexible endoscope that had been through the reprocessor was under the towel. The Surgery Manager was asked to identify the time the flexible endoscope had finished the reprocessing cycle. The Surgery Manager reviewed the reprocessor tape and stated the reprocessing cycle was completed April 19, 2010, at 9:40 AM (over 24 hours).

b. On April 19, 2010, at 10 AM, a tour was conducted of the intensive care unit (ICU). During the ICU tour the supply room was inspected. A power supply box was observed sitting on top of a procedure cart. A covered metal instrument tray was also observed sitting on top of the procedure cart.

During a concurrent interview the Charge Nurse was asked if she knew what was inside the metal instrument tray. The Charge Nurse stated she did not know what was inside the covered metal instrument tray. The Charge Nurse attempted to open the metal instrument tray but was unable to do so.

On April 20, 2010, at 1 PM, the Surgery Manager was asked if the hospital performed bronchoscopies (procedure where a flexible endoscope is inserted into a patients' lungs). The Director of Surgery stated that the hospital did not perform bronchoscopies. The Surgery Manager was asked if she would open the covered metal instrument tray and identify the contents.

On April 20, 2010 at 1:15 PM, the Surgery Manager opened the covered metal instrument tray. A flexible bronchoscope was observed laying, coiled inside the metal instrument tray. The Surgery Manager stated she was not aware that a bronchoscope had been stored in the metal instrument tray. When asked about a time limit for reprocessing flexible endoscopes if they were not used, the Surgery Manager stated that after processing, if the flexible endoscope was not used within thirty days of processing, the flexible endoscope would be reprocessed prior to use. The Surgery Manager also stated that the hospital did not have a policy and procedure that directed hospital staff on the process of cleaning and storage of flexible endoscopes.

On April 21, 2010 at 10 AM, the Director of Quality was interviewed. The Director of Quality was asked for information about the flexible bronchoscope. The Director of Quality stated that he thought the flexible endoscope was purchased in October of 2008. The Director of Quality stated that he was not aware that the flexible endoscope had been stored in the metal instrument tray, or how long it had been there.

On April 20, 2010, at 11 AM, the hospital's policy and procedure titled, "Processing of gastroscope, camera, scopes, light cords" was reviewed. The October 2008 policy and procedure contained no guidance about storage of the flexible endoscopes after disinfection and reprocessing.

On April 20, 2010 at 3 PM, the 2010, the AORN (Association of periOperative Registered Nurses), Perioperative Standards and Recommended Practices was reviewed. On page 411, item IX.a. recommended that, "Flexible endoscopes should be stored in a closed cabinet with venting that allows air circulation around the flexible endoscopes...adequate height to allow flexible endoscopes to hang without touching the bottom of the cabinet, ...hanging in a secure vertical position....when flexible endoscopes are hung in the vertical position, coiling or kinking is prevented, allowing any remaining moisture to drain out of the endoscope and decreasing the potential of an environment conducive to microbial growth in the endoscope. Proper storage facilitates drying and decreases potential for contamination. The scope protector may create an environment favorable for microbial growth if the flexible endoscope is not dry and cannot hang straight." Additional AORN recommendations on page 411, item IX.b. provide guidance that "Flexible endoscopes should be reprocessed before use if unused for more than five days."

10. On April 19, 2010 at 9:30 AM, a request was made to review the hospital's infection control policy and procedure manual.

On April 19, 2010 at 3 PM, the infection control policy and procedure manual was reviewed. Documentation on the signature page showed that the infection control manual was the, "2004 annual review." Documentation on the signature page disclosed that the Governing Board approved the infection control manual on October 7, 2004.

The document titled, "Infection control scope of services" was reviewed. Item A, under the section titled Purpose directed, "The infection control program manual will be reviewed every three years."

On April 21, 2010 at 10 AM, an interview was conducted with the Chief Nursing Officer and the Director of Quality Improvement. During the interview, they confirmed that the infection control policy and procedure manual had not been reviewed since 2004.

11. On April 20, 2010 at 2 PM, a request was made to review a log of employee injury reports.

During a concurrent interview, the Chief Nursing Officer (CNO) stated that employee injury reports were tracked by human resources because of the workers' compensation component. The CNO stated that most employee injuries were a result of their patients physically assaulting staff.

On April 20, 2010 at 2:30 PM the Director of Human Resources was asked for an employee injury report. The employee injury report was printed and reviewed. Documentation in the report showed that since January 1, 2010, seven employee injuries were reported. It was noted that the second injury listed was an employee was cut by a razor while inspecting a patient's personal effects during in an intake search.

On April 21, 2010 at 9 AM, the CNO was interviewed about the employee's hand injury. The CNO stated that an employee had been cut by a patient's double edge razor while searching the belongings of a newly admitted patient.

On April 21, 2010 at 9:30 AM, the CNO provided a document titled, "Report of accident/illness/injury." Documentation in the report showed that on January 25, 2010, while searching for contraband, a patient's razor cut the left hand of a licensed vocational nurse, resulting in a 1 cm by 2 cm laceration. Documentation in the report also showed that after the incident, the licensed vocational nurse was provided first aid.

On April 21, 2010 at 8 AM, the February 25, 2010, Quality Review Committee meeting minutes were reviewed. There was no documentation in the meeting minutes that the infection control employee injury was reported to the Quality Committee, and forwarded on to the Medical Executive Committee and Governing Board.

During an interview on April 21, 2010 at 9 AM, the Director of Quality was asked to explain the hospital's system used to ensure that employee infection control issues were communicated to the Medical Executive Committee and Governing Board. The Director of Quality stated that infection control employee injuries were not reported at the Quality Committee. The Director of Quality stated that issues not reported at the Quality Committee, subsequently were not forwarded to the Medical Executive, or the Governing Board.

12. On April 22, 2010 beginning at 8 AM the following medical records were reviewed:

a. Documentation in Patient 8's medical record showed that on March 23, 2010, the patient had a CVC (central venous catheter, an intravenous catheter placed in the neck, chest, groin or arm, and used for the administration of intravenous fluids and medications), inserted into the right femoral vein. Documentation in the medical record showed that the CVC was inserted prior to discharge on April 3, 2010.

Additional documentation on the central line insertion practices form showed that the physician did not wear a surgical mask, face shield, or a hair covering when the CVC was inserted.

b. Documentation in Patient 9's medical record showed the patient had a CVC (central venous catheter) inserted in her right subclavian vein on March 15, 2010. Documentation in the medical record also showed the CVC was removed on March 18, 2010.

Additional documentation on the central line insertion practices form showed that the physician did not wear a surgical mask, hair covering or a sterile gown when the CVC was inserted.

c. Documentation in Patient 3's medical record showed the patient had a CVC catheter inserted in the right femoral vein on February 22, 2010. Documentation in the medical record showed that the right femoral CVC was in place at the time of discharge on February 23, 2010 at 9:15 PM.

On April 22, 2010 at 10 AM, the hospital's February 3, 2010, policy and procedure titled, Central line insertion practice (CLIP)" was reviewed. The purpose of the policy and procedure was that central line-associated blood stream infections can be prevented through proper management of the central line. On page two, under item 6 direction was given, "For adult patients do not use the femoral vein, unless other sites are unavailable. Under item 7, direction was given that, "Maximal sterile barrier will be maintained at all times." Under item 11, direction was given that "The physician will do a daily assessment of the central line necessity for all patients with central lines under their care."

There was no documentation in the three medical records or evidence provided that showed that the physician responsible for the patient had performed a daily assessment of the central line necessity. In addition, there was no documentation showing that with Patients 8 and Patient 3 there was no documentation in the medical records showing that no other CVC sites were available to justify use of the femoral vein for CVC insertion.



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