HospitalInspections.org

Based on observation, interview and record review, the Governing Body failed to exercise leadership over the functions and the conduct of the hospital as evidenced by:

1. The hospital failed to maintain a Medical Record Service that was in compliance with 42 CFR 482.24. (Refer to CoP A-0431)

2. The hospital pharmacy services failed to ensure safe medication use to its patients. (Refer to CoP A-0490)

3. The hospital failed to ensure that dietary services was organized, directed, staffed in a manner that met the nutritional needs of all patients. (Refer to CoP A-0618)

4. The hospital failed to ensure the hospital was maintained in a manner that would ensure the safety of all the patients. (Refer to CoP A-0700)

5. The hospital failed to ensure a sanitary environment that reduced the transmission of infections and communicable diseases. (Refer to CoP A-0747)

6. The hospital failed to ensure that surgical services were in accordance with acceptable standards of practice. (A-0940).

The cumulative effect of these systemic problems resulted in the hospital Governing Body's inability to exercise adequate leadership over its daily function and operation of the hospital.

Based on document review, staff interview, and observation, the hospital failed to ensure that for one of two companies (Company B) providing off-site medical record storage a current agreement was not in effect. This failure had the potential to jeopardize the confidentiality, security and availability of medical records.

Findings:

During an interview with Director of Health Information Management (DHIM) on the afternoon of 3/14/11, he stated that medical records were stored at an off-site location. A current agreement with Company A was provided and reviewed on the morning of 3/15/11. During review of the Medical Records Policy & Procedure Manual on 3/15/11, Policy No. IM: 139 (revised 3/11) stated that records from 1996 through 1999 are located at an additional company (Company B), so DHIM was asked if records were still stored there and if so, to provide the agreement for review. Later that afternoon, in the hospital lobby glass case, this surveyor observed a letter from the California Licensing & Certification office, dated 6/7/1995, which gave approval for the off-site storage of medical records with Company B. On 3/17/11 at 2:50 PM, DHIM provided an agreement for Company B which was effective 1/1/11 and signed by both parties on 3/17/11. DHIM stated that the previous agreement had expired in 1999 and a new one had not been implemented until 3/17/11.

Based on observation, review of the hospital's policy and procedure, and patient and staff interviews, the hospital failed to ensure one of 59 sampled patients was given the opportunity to participate in menu selection. Such failure had the potential to cause Patient 57's poor appetite.

Findings:

The clinical record for Patient 57 was reviewed. Patient 57 was admitted on 2/25/11 with diagnoses including perianal squamous cell cancer (Cancer of the anus), neutropenic fever (fever found in cancer patients who have undergone chemotherapy or radiation) and diarrhea. His physician's ordered diet was a regular diet.

A continued review of the clinical record for Patient 57 was conducted. On 3/14/11 the physician ordered a dietary consultation and calorie count for three days as part of an evaluation to determine his nutritional needs due to the reported poor food intake. In addition, there was an order written as follows: "Pt (patient) requests cold cereals and milk for breakfast". The dietary consultation was completed on 3/14/11 by Registered Dietitian (RD) 3. She documented "no sig. (significant) changes expected since pt (patient) is refusing most meals."

During an interview with Patient 57 on 3/16/11, at approximately 10 AM, he stated that he was not eating because he did not like cold foods. In response to the order from the physician for cold cereals and milk for breakfast, he stated he had requested cold cereals because his hot foods were consistently cold. He said the "food is cold not even warm. Food taste great, does not like cold foods." He further stated that he "does not like juices, comes back up."

Review of the hospital's regular diet menu showed that juice is the non-select option offered daily. Therefore, Patient 57 was served juice daily, although he did not like and/or could not tolerate juices. His inability to consume this food item contributed to decreased intake and calories.

Chief RD 1 was present during the interview with Patient 57 on 3/16/11 at approximately 10 AM and she explained that by policy, the patients in that unit are not allowed to self select meals and food likes and dislikes are not conducted.

During an interview with Nurse Manager (NM) 3 on 3/16/11 at 10:36 AM, he stated the restrictions were as a result of a contract the hospital had entered with the agency who had all the patients on the unit. Review of the policy titled, "Food service for the hospital's Medical Guarded unit and Food Service for Off -Unit Guarded Patients revised 03/09" showed that patients "will receive a non-select menu appropriate to their diet".

Chief RD 1 was present during the interview with NM 3 on 3/16/11 at 10:36 AM. Concerns were raised about why RD 3 had not identified the problem of cold foods and its contribution to the patient's poor intake. She stated the registered dietitians are not allowed to go into the patient's rooms on that unit therefore the RD was not able to gather the information.

Chief RD 1 was further interviewed on her knowledge of the patient's complaints or the department's procedures on identifying food temperature complaints. She stated, her department conducts monthly test tray audits which are evaluated by different staff members. She stated that unit was one of the areas audited.

Review of test tray audits from 9/10 through 3/11 was conducted on 3/16/11. The Chief RD 1 explained how the audits were conducted. She stated that audits were conducted in the kitchen and others were conducted on the various units. The test tray evaluation form showed that food temperatures dropped to below acceptable levels in different areas of the hospital at different times. Three of three audits conducted (12/6/10; 1/14/11 and 2/1/11) on that unit showed the food to be cold and rated below expectations. One of the comments written by the evaluator (RD 3) at the bottom of the form in the comments/suggestions/corrections area was "food too cold - difficult to eat because of temperature" and the food taste was rated mostly "2" (below expectation and in one instance a "1" (not acceptable).

During a subsequent interview with Chief RD 1 on 3/16/11, at 4 PM, she stated the reason the foods on the unit are cold is they are served on disposable plates with no temperature maintenance system used to keep the food warm during transport or distribution. She also stated when the audits were completed the results were shared with the former food service director.

During an interview with one the hospital's managers on 3/17/11 at 11 AM, he was asked about the hospital's practices regarding patient care on the unit. He stated that some of the hospital policies were developed as a result of the contract but acknowledged the registered dietitians should have been able to take care care of the problem if the nurses were able to provide care on the unit.

The hospital's failure to ensure the patients on that unit including Patient 57 were able to self select their meals resulted in his inability to eat meals that would have contributed to his nutrition care plan.

Based on interview and record review, the hospital failed to determine the wishes regarding provisions of treatment for one of 59 sampled patients (29) which had the potential to result in unwanted care goals and treatments.

Findings:

The clinical record for Patient 29 was reviewed on 3/14/11 at 11:30 AM. The Conditions of Admission and Treatment dated 2/25/11, indicated Patient 29 had a written advance directive concerning health care decisions and that a copy of the advanced directive had not been provided to the hospital.

During an interview with Nurse D, she reviewed the clinical record and was unable to find documentation of an Interim Health Care Instructions or a level of care form in the clinical record. She could not find documentation of any follow-up done to determine Patient 29's care wishes.

The facility policy and procedure titled "Advance Healthcare Directive" dated 2/09, indicated, "Request that any patient who has an Advanced Health Care Directive that is not available at the time of admission, complete and sign an Interim Health Care Instructions; make a copy for the patient; attach original to chart."

Based on observation, staff interviews, and review of hospital policies and procedures, the hospital failed to ensure two of 59 sampled patients' privacy was preserved (54 and 55). Information posted on care boards in patients' rooms had violated their privacy.

Findings:

1. During an observation of the activities of the nutrition assistant on 3/15/11 at approximately 2:20 PM, Patient 54 was visited for food preference documentation. The wall in the room had a board which according to hospital staff was called a 'care board'. The white care board had the following written information: IV fluids, monitor blood sugar, vital signs and "Renal diet 1800 ADA (American Diabetes Association)".

This information was visible to visitors and other hospital staff who were not part of her health care team and provided information the patient had a renal and diabetic diagnosis.

2. During an observation on 3/15/11 at 4 PM, Patient 55's bed was noted to be the closest to the door. Hanging on the wall across from Patient 55's bed was a white board with information which included the name of the nurse and the care goals for the day. The goal for the day was to "control and monitor loose stools".

These goals were visible from the hallway when the room door was left ajar. Visitors and other hospital staff not part of the patient's care team were able to read the information.

The hospital policy and procedure titled "Patient Bundling" with an effective date of 10/06, indicated, "the admitting nurse identifies key actions from the patient's perspective that will assist in reducing the patient's perspective that will assist in reducing the patient's anxiety..." The nurse documents the actions on the care board (white board) and explains to the patient how this will be used during hospitalizations. According to the policy the writing is "so our entire team will know what is important for you today."

During an interview with Nurse Manager (NM) 1 on 3/15/11 at approximately 4:30 PM, she stated the 'care board' was for the benefit of the patient. She stated she had not considered how that same information could result in breach of privacy.

The hospital failed to ensure that it protected the health information of its patients.

Based on observation, record review, and patient and staff interviews, the hospital failed to ensure that data collected from food test tray audits were used to identify improvement opportunities and correct unacceptable food temperature problems. This failure contributed to the poor intake experienced by one sampled patient. (57)

Findings:

The clinical record for Patient 57 was reviewed. Patient 57 was admitted on 2/25/11 with diagnoses including perianal squamous cell cancer (Cancer of the anus), neutropenic fever (fever found in cancer patients who have undergone chemotherapy or radiation) and diarrhea. His physician ordered diet was a regular diet. On March 14, 2011 the physician ordered "Pt (patient) requests cold cereals and milk for breakfast".

During an interview with Patient 57 on 3/16/11, at approximately 10 AM, he stated he was not eating because he did not like cold foods. In response to the order from the physician for cold cereals and milk for breakfast, he stated he had requested cold cereals because his hot foods were consistently cold and so he had not been able to eat. He said the "food is cold not even warm. Food tastes great does not like cold foods."

Chief Registered Dietician (RD) 1 was present during the interview with Patient 53 on 3/16/11, at approximately 10 AM. Chief RD 1 was further interviewed on her knowledge of the patient's complaints and the department's procedures on identifying food temperature complaints. She stated her department conducts monthly test tray audits, which are evaluated by different staff members.

A review of the test tray audits from 9/10 through 3/11 was conducted on 3/16/11. An interview was conducted with Chief RD 1 on 3/17/11 at 11:22 AM. She stated audits were conducted in the kitchen and others were conducted on the various units. The test tray evaluation form showed that food temperatures dropped to below acceptable levels in different areas of the hospital at different times.

A continued review of the audits showed of 24 audit forms reviewed, 14 had food temperatures below acceptable temperatures. Three of three audits conducted (12/6/10; 1/14/11 and 2/11/11) on the CDCR (California Department of Corrections and Rehabilitation) showed the food to be cold and rated below expectations. One of the comments written by the evaluator (RD 3) at the bottom of the form in the comments/suggestions/corrections area indicated, "food too cold - difficult to eat because of temperature." Food taste was rated mostly "2" (below expectation) and in one instance a "1" (not acceptable). Another comment was "informed supervisor...about drop in soup temperature on unit." The food temperature served should be at a temperature acceptable to the patients.

During an interview with the Chief RD 1 on 3/17/11 at approximately 3:15 PM, she discussed what issues were being evaluated as part of performance improvement. She stated they were conducting QA (Quality Assurance) on Total Parenteral Nutrition (TPN is intravenous feeding that provides a patient fluids and nutrients when the patient is unable to eat by mouth) being justified, TPN timeliness with their policy, Coumadin (medication used to treat blood clots) education and timeliness of the nutrition assessments. She stated she was not aware of any performance improvement program in place as a result of the test tray food temperatures. Chief RD 1 indicated the results of the test trays were shared with the former food service director but she was not sure what the former food service director did with the information.

Based on interview and document review, the medical staff failed to equally apply bylaws to the allied health practitioners [nurse practitioners, physician's assistants, registered nurse first assistants, dental assistants, scrub technicians (techs), surgical techs] and failed to enforce bylaws when the process for assessing and ensuring the competence for 21 of 21 AHPs (Allied Health Practitioners) was not followed prior to their biennial reappointments to the medical staff and the renewal of their privileges.

Findings:

The Hospital's Medical Staff Bylaws state on page 2 "11. ALLIED HEALTH PROFESSIONAL (AHP) means an individual, other than a physician, dentist, or podiatrist, who is a licensed or otherwise legally credentialed health care provider; who has been given permission by the hospital to exercise practice prerogatives or clinical privileges, in the hospital, under the supervision of or at the request of the Member who is responsible for both the patient's care and supervision of the AHP; and who meets the qualifications set forth in Section 11.1 of these Bylaws.

The BYLAWS OF THE (HOSPITAL...COMMUNITY BOARD state on page 3 "ARTICLE 2 MEDICAL STAFF MATTERS 2.2 Medical Staff Executive Committee. On behalf of the Medical Staff, the the Medical Staff Executive Committee ("MSEC") shall make recommendations to the Hospital Community Board, concerning the following: (a) Appointing, re-appointing, restricting, materially reducing, suspending, terminating, and revoking Medical Staff membership; (f) The mechanisms for reviewing credentials, delineating clinical privileges,conducting, evaluating and revising quality assessment and performance improvement activities, appointment, reappointment, corrective action, and fair hearing procedures, and restriction, reduction, suspension, termination, and revocation of Medical Staff membership or clinical privileges. 2.7 Medical staff Bylaws (b) Provisions. The Hospital shall collaborate with Medical Staff leadership to assure that Medical Staff Bylaws shall, at a minimum provide for: (1) A description of the Medical staff's organization, including categories of Medical Staff membership and appropriate officer positions with the stipulation that each officer is a Medical Staff member; (2) Written , defined criteria for Medical Staff appointment and the granting of clinical privileges, including the categories of practitioners eligible for Medical Staff membership and clinical privileges (4) appointing, reappointing, delineating, restricting, reducing, suspending, terminating, and revoking Medical Staff membership and/or clinical privileges. (5) The establishment of controls to facilitate the achievement and maintenance of high standards of ethical practices including a requirement that all members of the Medical Staff be required to demonstrate their ability to perform surgical and other procedures competently at the time of original appointment and at least every two years thereafter.

The Medical staff Bylaws of the hospital state on page 18 "4.15-3 REAPPOINTMENT APPLICATION The reappointment application shall be in writing, on a from prescribed by the Executive committee had approved by the Hospital Community board and shall require detailed information concerning the changes in the applicant's qualifications since his or her last review. Specifically, the form shall request an update of all information and certifications requested in the appointment application form, as described in Section 4.3, except for that information which cannot change over time, such as information regarding the member's pre-medical and medical education, date of birth, etc. The form shall also require information as to whether the applicant requests any change in his or her status and in his or her clinical privileges, including reduction, deletion, or additional privileges. Requests for additional must be supported by the type and nature of evidence which would be necessary for such privileges to be granted in an initial application. If the staff member's level of clinical activity at this Hospital is not sufficient to permit the staff and Hospital Community Board to evaluate his or her competence to exercise the clinical privileges requested, the staff shall have the burden of providing evidence of clinical performance at his or her principle institution in any form as is requested by the Executive Committee or the Hospital Community Board. "

The Medical staff Bylaws of the hospital states on page 22 "ARTICLE V CLINICAL PRIVILEGES 5.2-3 BASES FOR PRIVILEGES DETERMINATION The elements to be considered in making determinations regarding privileges, whether in connection with periodic reappointment or otherwise, shall include education, training, observation of professional performance, judgement and clinical skills, the documented results of patient care audit and other quality review, evaluation, monitoring and information regarding the practitioners physical and mental condition, professional liability claims and adverse actions by other hospital or professional entities. Privileges determination shall also take into account pertinent information concerning clinical performance obtained from other sources, especially other institutions and health care settings where a member exercises clinical privileges."

Medical staff credential files were reviewed on 3/15/11 at 2 PM with Medical Staff Office Supervisor (MSOS), Credentialing Specialist (CS) and Consultant (C) 1. Document review and record review revealed 21 out of a total of 21 non provisional (previously credentialed) AHPs had been reappointed without being reappraised. Reappointments had been done on a biennial basis, however, the reappointments did not include reappraisals as set forth in the Medical Staff bylaws.

MSOS and C 1 were interviewed together at 2:30 PM on 3/15/11. Both stated 21 of 21 nonprovisional AHPs on the medical staff had been reappointed without documentation of reappraisals. Both stated the practitioner specific data needed for reappraisal had not been collected in a manner which would allow for the appraisal of each individual AHP. Both stated the data required for reappraisal of the AHPs was bundled with that of their supervising physicians. Both stated the respective AHPs data could not be separated from their respective supervising physician's data. Both stated the supervising physicians had exercised proper oversight of the AHPs, however, there was no documentation of individual evaluations rendered by supervising physicians which could be used for reappraisals. Both stated the reappraisals for the reappointed AHPs were based largely upon the verbal assessments of supervising physicians.

Chief of the Emergency Medicine section of the Medicine Department was interviewed by phone on 3/15/11 at 3 PM. He stated all the AHPs in question worked under physician's supervision in the emergency room setting. He agreed the AHPs had been reappointed without reappraisals in violation of the medical staff bylaws. He stated he understood the requirement for reappraisal at the time of reappointment. He stated he would work with the emergency room physicians and the medical staff office to ensure appropriate reappraisals were conducted as a part of the reappointment process. He stated he understood the respective emergency room physicians must evaluate the respective AHPs in such a way as to allow for periodic reappraisal prior to reappointment.

Chief Executive Officer (CEO) and C1 were interviewed together at 9 AM on 3/16/11. The CEO stated he had been made aware of the situation with the AHPs. He agreed the lack of documentation of appropriate evaluations did not allow for the required reappraisals of the AHPs at the time of their reappointment. C1 stated a solution to the situation had been discussed. She stated appropriate evaluations rendered by supervising physicians would be performed and the data would be captured to allow for reappraisals at the time the AHPs were being reappointed. She stated the reappraisals would be used in the reappointment process as a means of assessing the competence of the individual AHPs as set forth in the bylaws.

Based on observation, interview and record review, the hospital failed to ensure the registered nurse evaluated the care for two (18 and 34) of 59 sampled patients when critical abnormal laboratory values were not forwarded to the physician timely to be acted upon. This had the potential to result in a lack of timely evaluation of the patient care needs by the physician.

Findings:

1. During an observation on 3/14/11 at 10:30 AM, Patient 18 was observed in bed in no apparent distress.

The clinical record for Patient 18 was reviewed on 3/14/11 at 11:50 AM. A Vancomycin peak (a blood test used to measure the amount of Vancomycin medication in the blood at it's highest concentration) result was greater than 40 micrograms per milliliter. This result was written on a form titled, "CRITICAL DIAGNOSTIC RESULTS READ-BACK DOCUMENTATION" and was received by the registered nurse on 3/12/11 at 4:30 AM. According to the form, the registered nurse should "CALL THE PHYSICIAN WITHIN 30 MINUTES OF RECEIVING RESULTS." There was no documented evidence the nurse called the physician within 30 minutes to one hour of receiving the abnormal laboratory value.

During an interview with Nurse Manager 1 (NM 1 to 2 West and 5 West floor on the main campus), on 3/15/11 at 3:30 PM, after reviewing Patient 18's clinical record, she was unable to find documented evidence the physician was notified of the critical laboratory value within 30 minutes to one hour of receiving the results.

The hospital policy and procedure titled, "CRITICAL TESTS AND CRITICAL VALUES NOTIFICATION", last reviewed/revised on 12/10, read in part under the purpose subheading, "This policy provides guidelines to accurately communicate diagnostic test critical results in a timely manner to the physician..." Under the procedure subheading it read in part, "...The RN/LVN will communicate the critical results to the Physician or Licensed Independent Practitioner (LIP) within 45 minutes." The list of critical test values was reviewed and according to the list and Vancomycin level greater than 40 micrograms per milliliter is considered critical and therefore would require notification to the physician.



27926

2. The clinical record for Patient 34 was reviewed on 3/16/11. The "Critical Diagnostic Results Read-Back Documentation " form dated 2/24/11 indicated nursing staff was notified by laboratory staff of a lactic acid ( a laboratory test) level of 4.5 on 2/24/11 at 5:25 AM. The form included directions to staff to "Call the physician within 30 minutes of receiving results". There was no documentation that the physician was notified on the form.

During an interview with Nurse C, on 3/17/11 at 12 PM, she reviewed the record and was unable to find documentation that the physician was notified of the elevated lactic acid level.

The facility policy and procedure titled " Critical Tests and Critical Values Notification" dated December 2010 indicated "The RN/LVN must communicate the result of the critical diagnostic test result to the physician within 45 minutes of notification. The "Critical Values List", dated 10/10, indicated a lactic acid level greater than 4.0 is considered a critical test value.

Based on observation, interview, and record review, the hospital failed to accurately assess pain for three of 59 sampled patients (26, 27, and 28).

For Patient 26, the hospital failed to accurately determine the acceptable comfort-function goal upon admission and develop this goal into the patient care plan which had the potential to result in inconsistent approach to pain management.

For Patient 27, the hospital failed to accurately assess pain in the non-verbal patient which had the potential to result in inadequate pain control.

For Patient 28, the hospital failed to document the presence of pain with each recorded vital sign (blood pressure, pulse, respirations, and temperature measurements) which had the potential to result in inadequate pain control.

Findings:

1. During an interview with Nurse A, on 3/17/11 at 10:45 AM, she stated the acceptable comfort-function goal is determined by the patient in an interview as part of the admission process. She reviewed Patient 26's admission physical assessment screen and stated Patient 26 stated her acceptable pain goal was 0-4 on a scale of 0-10.

During an interview with Patient 26, on 3/17/11 at 11 AM, she stated her acceptable level of pain is 6-10 on a scale of 0-10. She stated she preferred not to take pain medication and used other measures to help to relieve pain that included sitting up in a chair, padded mattresses, and use of a walker. She stated she was admitted to the hospital for uncontrolled pain.

The clinical record for Patient 26 was reviewed on 3/17/11. The care plan for pain management, dated 3/14/11, did not indicate the acceptable comfort-function goal determined by Patient 26 and did not identify alternate comfort measures used by Patient 26 to control her chronic pain.

The hospital policy and procedure titled "Pain Management" dated 6/08, indicated, "The patient's self-report will be the primary means of determining pain..."

2. The clinical record for Patient 27 was reviewed on 3/14/11. The Medication Administration Record (MAR) dated 3/10/11, indicated Patient 27 had a 4 of 5 pain level using the nonverbal pain scale of 0-5 at 3:15 PM and received pain medication. The MAR dated 3/11/11, indicated Patient 27 had a 6 of 10 pain level using the nonverbal pain scale at 4:30 AM and received pain medication. The "Daily I&O [intake and output measurements]/Vital Signs/Observations form for 3/11, 12, 13, 14/11 indicated "N/V" for non-verbal for the pain level documented with each vital sign.

During an interview with Nurse B, on 3/14/11 at 4:10 PM, she stated the hospital used the FLACC pain scale for non-verbal patients and the scale was based on a 5-point rating. She reviewed the pain scale documentation on the computer and stated she used the wrong scale and the FLACC pain scale was based on a 10-point system. She stated "non-verbal" should not be used because the FLACC pain scale converts the pain level of the non-verbal patient to a numeric value based on the patient's face, legs, activity, crying , and consolability.

The hospital policy and procedure titled "Pain Management" dated 6/08, indicated "Intensity of pain will be assessed and documented with a tool appropriate to the patient's age, cognitive level, or language, using one of following scales...the FLACC scale for the preverbal/nonverbal patients." The FLACC scale consists of 5 categories (face, legs, arms, cry, and consolability) and is scored for 0-2 for each category which results in a total score between 0-10.

3. The clinical record for Patient 28 was reviewed on 3/15/11. The "Daily I&O [intake and output measurements]/Vital Signs/Observations form for 3/15/11, indicated vital signs were taken at 1 AM, 1:15 AM, and 1:45 AM. The pain level section of the form for those vital signs was blank.

During an interview with Nurse C on 3/15/11 at 10:30 AM, she reviewed the clinical record and was unable to find documentation of the pain level documented for those vital signs.

The hospital policy and procedure titled "Pain Management" dated 6/08, indicated "Pain will be considered the 5th vital sign, will be documented with the vital signs, and will be monitored and reported accordingly."

Based on observation, review of the clinical records, policies and procedures, hospital training logs and other hospital documents, the hospital failed to ensure the nursing staff were competent in the use of a feeding tube. Nursing staff failed to ensure that illegible or incorrect tube feeding order were clarified prior to being started. Nursing staff failed to follow proper infection control practices on the hang-times for patients requiring tube feedings. These failures had the potential to impact four of 59 sampled patients (12, 18, 52, and 55).

Findings:
1. The clinical record for Patient 18 was reviewed. Patient 18 was admitted to the hospital on 2/9/11 with diagnoses including septicemia (a disease caused by the spread of bacteria and their toxins through circulating blood); urinary tract infection, dementia (a group of symptoms that are caused by changes in brain function) and PEG (percutaneous endoscopic gastrostomy) placement. A PEG is a surgical opening into the stomach used for feeding usually via a feeding tube called a gastrostomy tube, but does not necessitate doing an operation to open the abdomen.

A continued review of the clinical record for Patient 18 was conducted. On 3/8/11 at approximately 9:10 AM, Patient 18 was transferred to an area of the hospital with the following order, "NGT (nasogastric tube-the insertion of a plastic tube through the nose, past the throat, and into the stomach, used for alternate means of nutrition) and start Glucerna 10 L (liter)/hr and increase to 50 L". A liter is 1000 milliliters, the usual volume infused for tube feeding is a milliliter (ml). The order as written by the physician could be interpreted as start feeding at 10,000 ml per hour and increase to 50,000 ml per hour. There was documentation that this order was noted at 4 PM on 3/8/11.

The documentation and initial written above the order was in a different colored ink which implied the nurse had initiated/attempted to start this order. It stated, "pt refused, very feisty". Further review of the Transport hand-off communication form dated "3/8/11 at 1600 (4 PM)" in the area of the form which addressed any concerns, there was documentation which indicated, "MD ordered NGT insertion but patient is refusing". This showed nursing staff attempted to initiate the erroneous order. The order was later changed at 4:45 PM and another order was given by a different physician for "once NGT started, TF (tube feeding) Glucerna x 10 ML/hr increase to 50 ML/hr.

During an interview with Nurse N (responsible for caring for Patient 18) on 3/16/11 at approximately 4 PM, she was asked how much water the patient receives while on tube feeding. She stated the tube feeding pump automatically provides water at hourly intervals. Nurse N was unable to indicate how much water the patient was receiving. She was unable to demonstrate how the feeding pump functioned in adding water to the patient's stomach.

2. The clinical record for Patient 12 was reviewed on 3/14/11. Patient 12 was admitted on 3/11/11 with diagnoses that included intubation [placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway] for respiratory distress (difficulty breathing) and pneumonia (infection in the lungs) with septic shock (overwhelming infection leads to life-threatening low blood pressure).

Review of the physician's orders dated 3/11/11 at 5:07 AM, showed an illegible order for NGT Feeding to start at 30 milliliters (ml) per hour. However, after an interview on 3/16/11 at 10:45 AM with Nurse G (the charge nurse for the unit) regarding the illegible physician's order and the fact the nurse initiated the tube feeding without clarifying the order, she stated she was told the order stated "Ensure and the substitute was Jevity 1.5". She did not indicate who told her it was Ensure. During another interview with Nurse G on 3/14/11 at approximately 3:30 PM, she stated maybe "they" thought feeding stated "Jevity". Nurse G later acknowledged after close evaluation of the handwriting she thought the order read, "NGT Feeding - ensure at 30 ml."

Review of the nursing flow sheet dated 3/11/11, showed the intake of Tube Feeding (TF) was Jevity at 30 ml at 4 PM. Review of the electronic diet order entered on 3/11/11 at 9:36 PM, showed "Fiber Jevity Plus" at the rate of 30 ml per hour full strength. Jevity Plus or Fiber Jevity Plus provides more calories than Ensure. Ensure provides 1 calorie per ml while Jevity Plus provides 1.5 calories per ml. The substitution made by the nursing staff resulted in the patient receiving more calories than was ordered by the physician.

During an interview with Nurse I on 3/16/11, at approximately 10:40 AM, she stated if the TF order is unclear then they will call and clarify the order with the physician. The clarifying order should be written and stated, "clarified". She stated she thought the original order stated Ensure.

During an interview with the Chief Registered Dietician (Chief RD) 2 on 3/16/11 at 11:20 AM she was asked about TF substitutions. Chief RD 2 stated they would use Ensure and that Jevity was not a substitute for Ensure. Review of the Tube Feeding Formulary dated 6/08 indicated to use Osmolite in the place of regular Ensure.

Review of the General Medical Staff Rules and Regulations, dated 11/10, showed the practitioner's orders must be written legibly and completely. Order which are illegible or improperly written will not be carried out until rewritten or understood by the nurse.

Review of the hospital's policy and procedure titled "physician's orders - transcribing accurately and timely", dated 12/97 and reviewed/revised on 1/08, showed any questions should be clarified immediately with the unit clerk and any discrepancies should be corrected by the Registered Nurse (RN) as soon as they are identified.

3. The clinical record for Patient 55 was reviewed. Patient 55 was admitted to the hospital on 2/27/11 with diagnoses including dehydration (loss of water and minerals necessary for normal body function) and dysphagia (inability to swallow as a result of injury to the parts of the brain that control the muscles for swallowing). Her tube feeding (a feeding tube is a medical device used to provide nutrition to patients who cannot obtain nutrition by swallowing) ordered on 3/11/11 was for a "G-tube feed with lactose free formula".

During an observation at approximately 4:15 PM on 3/15/11, a tube feeding bag was observed hanging on a pole next to the Patient 55. The bag was labeled with the rate of 20 ml/hour and the date was 3/15/11 with no start time. There was approximately 240 ml of feeding left in the bag. The feeding bag was an "open" system. An open system of tube feeding is one in which the formula is opened and poured into a bag by the hospital staff as compared to a "closed" system in which the formula is prefilled and hermetically sealed by the manufacturer.

During an interview on 3/15/11 at approximately 4:20 PM, the patient's nurse was interviewed. She was asked about the hospital's procedure for the management of a patient receiving tube feeding. She explained the night shift nurse hangs the tube feeding daily and the feeding bag may have contained about two cans (500 milliliters) worth of liquid feeding when she came in to work that morning. She stated that she had not added any more formula to the bag.

A review of the hospital's policy and procedure titled "Enteral Feeding" revised 4/10, showed "if using the open system only 12 hours worth of feeding will be added to the delivery set and should be hung no longer than 12 hours." A reference book titled Clinical Procedures which the Nurse M of Quality Management described as the hospital reference stated, "....add a 4-hour volume of formula in bag."

Interview with other nurses indicated the bag is changed everyday at midnight. Based on this practice, Patient 55's tube feeding had been hanging for approximately 16 1/2 hours, 4 1/2 hours longer than the hospital policy and 12-1/2 hours longer than the hospital's reference book. The rationale provided by the reference book for adding only 4 hour volume is it "prevents the leakage from excessive volume and spoilage of formula hanging too long without refrigeration".

The hospital failed to ensure that its nursing staff followed sound infection control practices as it relates to the hang times of tube feeding formula.

A continued review of the clinical record for Patient 55 was conducted. The assessment by Chief RD 1 on 3/11/11, discussed some laboratory values and the need to monitor trends, "might indicate fluid overload". There was further evaluation of the fluids to determine the amount of fluids she may be receiving. During an interview with Chief RD 1 on 3/16/11, at approximately 3:35 PM she was asked, how the hospital ensures patients fed via tube feeding received adequate fluid. She stated, the nurses were responsible for administering water flushes but she was not sure exactly how much.

4. The clinical record for Patient 52 was initiated on 3/14/11. Patient 52 was admitted to the hospital on 3/8/11 with diagnoses that include acute (sudden) respiratory failure (a condition in which not enough oxygen passes from your lungs into your blood) and acute renal failure (loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes).

A review of the physician's orders dated 3/9/11 at 7 AM, showed a tube feeding (TF) order for Nepro at 10 milliliters (ml) per hour and to increase to 50 ml per hour. Another physician's order dated 3/12/11 at 1:30 PM, showed to increase TF to 60 ml per hour.

Patient 52 was observed on 3/14/11 at approximately 4:50 PM, with a TF bag being hung next to the bed. The TF bag was an open system containing a label that showed Nepro with a goal of 60 ml per hour, dated 3/14/11. No time was documented on the label. There was approximately 300 ml of Nepro in the bag at this time.

During an interview with Nurse J on 3/14/11, at approximately 4:55 PM she stated, the TF bag and tubing is changed during night shift at midnight for all types of TF. The night shift will label and date the TF bag when they hang it.

During an interview with Chief RD 2 on 3/15/11, at approximately 2:40 PM, she was asked about the TF system in the hospital. Chief RD 2 stated they use open and closed system at the hospital and Nepro is in cans so the open system will be used.

During an interview with Nurse K on 3/15/11, at approximately 3 PM she stated, they change the bags for both an open and closed system and the tubing every 24 hours. They will then chart in the medication administration record once that it is completed.

A review of the medication administration record, dated 3/14/11, showed at 0000 hours, new tubing and a new bag of Nepro was hung. The nurse's initials were next to this indicating it was completed.

A review of the hospital's Tube Feeding Formulary list, dated 6/08, showed the hang time for canned formula is eight hours.

A review of a nursing policy and procedures, labeled with the name of a different hospital, titled Enteral Feeding, dated 7/93 and revised on 4/10, showed when using the open system, only 12 hours worth of feeding will be added to the delivery set and should be hung no longer than 12 hours. Feeding pumps, delivery sets, and syringes will be labeled with the patient's name and date. Delivery sets and syringes will be changed every 24 hours.

During an interview with Nurse K on 3/15/11 at approximately 4 PM, regarding the tube feeding orders that are not specific as to how the goal rate to be achieved, she stated she checks the residual every six hours. If the residual is less than the rate it is running, the tube feeding is increased by 10 (ml) until the goal is met. Review of the nursing policy labeled with the name of a different hospital titled "Enteral Feeding" revised 4/10" indicated that initiation and advancement rate should be individualized to each patient as determined by RD (registered dietitian and MD (medical director). According to the policy feeding residuals will be checked and documented every four hours.

Interviews were conducted with nursing staff in different areas of the hospital on how much water was given to the patients. Answers varied significantly from one unit to another. According to the "Enteral Feeding" policy the nurse will flush the feeding tube using a syringe 35 ml or larger with tap or sterile water (a) before and after each intermittent feeding, before and after administering medication, every hours during continuous feeding or per physician's order, each time the feeding set is disconnected, each time the feeding is filled/changed, each time the pump is stopped and each time the residual checks are done. The policy further states the nurse may adjust the amount of water to flush the tube for patients with special fluid needs, i.e. fluid restriction, dehydration per MD order.

During an interview with Nurse M on 3/16/11 at approximately 2:45 PM she was asked to provide the manufacturer's operating manual on the use of the feeding pump with dual water flush which was observed being used in Patient 18's room.

Review of personnel record for Nurse N showed she was hired in 2/07. The Supervisor of Risk and Compliance (SRC) was asked to provide proof of in-service/training on the use of the feeding pump with the dual water flush system. SRC was unable to provide proof Nurse N was trained on the use of the pump.

The hospital failed to ensure its nursing staff were provided training on the use of the feeding pumps and on administration of tube feeding to ensure the hang time did not exceed recommended hang time. Nursing staff failed to clarify illegible or erroneous orders written by physicians. The hospital also failed to ensure that nursing staff followed hospital policies on the administration if water flushes in patients receiving tube feeding.

Based on interview and record review, the hospital failed to maintain a consistent practice of identifying drug allergies and adverse drug reactions prior to the administration of medications and failed to administer medications in accordance with the hospital's policy and procedures and accepted standards of practice for two of 59 sampled patients (1 and 2). This had the potential to adversely impact the patients' condition due to unidentified drug reactions.

Findings:

The Clinical Record for Patient 1 was reviewed on 3/15/11 at 3 PM. The Medication Administration Record (MAR) dated 3/14/11, indicated Patient 1 had received one dose of Acetaminophen (pain- reliever) 650 mg at 3 AM. The MAR also indicated Patient 1 had a coded allergy for Acetaminophen. The Medication Reconciliation Order Form, dated 3/8/11 indicated Allergies: Amoxicillin and Vicodin, with the side effect of the Vicodin listed as SOB (shortness of breath). The Allergy Management screen dated 3/6/11, indicated Acetaminophen (from Vicodin) Shortness of Breath, Verified: Yes.

The Clinical Record for Patient 2 was reviewed on 3/15/11 at 4 PM, the Medication Administration Record (MAR) dated 3/13/11, indicated that Patient 2 had received a Clonidine (blood pressure medication) patch 5 mg (milligrams) on 3/12/11 at 10:30 PM, the MAR also indicated that Patient 2 had a coded allergy to Clonidine and no other Allergies. The Medication Reconciliation Order Form indicated Patient 2's allergies as Pain Medications, Omnipaque (a type of medical contrast medium used to improve the visibility of bodily structures in an X-ray based imaging techniques) and Clonidine.

During an interview with Nurse Manager (NM) 2 on 3/17/11 at 3 PM, she reviewed the clinical records and was unable to find nursing documentation of a communication with the patient, pharmacy or the patient's doctors indicating that it was safe to give these medications. There were no allergy stickers on the front of either charts indicating their allergies, per hospital policy and procedure.

The hospital Policy and Procedure titled "Admission, Patient", dated 4/09, indicated, "Upon admission the Registered Nurse Completes an allergy sticker and adheres it to the front of the chart."

The hospital Policy and Procedure titled, "Medication Record Administration", dated 1/09 indicated, "The Registered Nurse Checks Medication Allergies or sensitivity to Medications."

According to "Clinical Nursing Skills and Techniques" by Anne Perry RN, MSN and Patricia Potter RN published by the C.V. Mosby Company, it indicated in part, "Nurse's should assess a patient's need for drug therapy, this assessment should include medication history and drug allergies."

During an interview with the hospital Pharmacist, on 3/16/11 at 09:45 AM, he stated "If an allergy is stated by the patient, perceived or associated with a medication, the pharmacist will review that medication with the patient, Registered Nurse or Doctor to determine if it should be given. After that has been determined, we would then place it in our pharmacy module profile, on the list of coded override medications. The stated allergy will still populate on the Medication Administration Record as a coded allergy. Nursing has no access to this Pharmacy override module. When asked, how nurses would then know if a medication noted as a coded allergy was cleared by pharmacy, he indicated, "I don't know but they can call here. There is clearly an issue with communication here and this is a valid concern."

Based on medical record and document review, observation, and staff interview, the hospital failed to maintain a Medical Record Service that was in compliance with 42 CFR 482.24 as evidenced by:

Findings:

1. Failed to ensure that medical records were promptly completed, properly filed and accessible. (Refer to A 438)
2. Failed to ensure that unauthorized individuals cannot gain access to patient records. (Refer to A 442)
3. Failed to ensure that entries in medical records are complete, dated, timed, and authenticated. (Refer to A 450)
4. Failed to ensure that all medical records documented a discharge summary. (Refer to A 468)
5. Failed to ensure that all medical records were completed with 14 days following discharge. (Refer to A 469)
6. Failed to ensure that outside services were provided in a safe and effective manner under a current agreement. (Refer to A 084)

The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Records Service.

Based on document review, observation, and staff interview, the hospital failed to ensure that medical records were accurately written, promptly completed, properly filed, and accessible. This failure was evidenced by records awaiting assembly and analysis dating back to 2/25/11, 194 inches of loose papers awaiting filing into the records, and 2805 delinquent records awaiting completion by physicians. When there are backlogs of processing recently discharged records, they may already be delinquent (more than 14 days after discharge) when made available to the physicians for their final completion.

Findings:

1. On 3/15/11 beginning at 3:05 PM, a tour of the Health Information Management (HIM) Department was made with Director of Health Information Management (DHIM). Stacks of paper were observed and Staff H explained that the papers were awaiting filing into the appropriate medical records. Examples of the reports were consents signed by patients, electrocardiograms, and pathology reports which dated back to February 2010 (over one year ago). At the end of the tour, DHIM provided a "HIM Performance Improvement Weekly Dashboard" report which was reviewed. The report indicated, in part, that on 3/15/11, the total number of inches of loose papers was 194 (over 16 feet); inpatient records awaiting assembly and analysis (processing after discharge) was 7-18 days backlogged; and the total number of delinquent records was 2805.

The Medical Staff Rules and Regulations (approved 11/10) were reviewed on 3/15/11. Section VII. N. states, in part: "The patient's medical record shall be complete at the time of discharge.... If the record still remains incomplete for fourteen (14) days after discharge and all essential records have been received and filed in the record, on the fifteenth (15th) day .... The practitioner shall continue to be suspended until the records have been completed...."



28773

2. Review of the medical record for Patient 51 was initiated on 3/14/11. Patient 51 was admitted on 3/11/11 with diagnoses that included intubation (placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway) for respiratory distress (difficulty breathing), pneumonia (infection in the lungs) with septic shock (overwhelming infection leads to life-threatening low blood pressure).

Review of the consent to surgery or special procedure form for peripherally inserted central catheter (a form of intravenous access that can be used for a prolonged period of time)
placement, signed by Patient 51's family representative and dated on 3/15/11 and witnessed by the Registered Nurse. Review of the Catheter Associate Blood Stream Infection form, signed by Patient 51's family representative, dated 3/15/11. Review of the Central Line Insertion Procedure Checklist form, it did not have a date or signature. The Central Line Insertion Procedure Checklist form was not dated, did not have a signature, and was labeled with the wrong patient's name. All of these three forms contained a printed label with a different patient's name. This patient had the same last name as Patient 51 but no other identifier on the label was the the same as Patient 51. This could result in a procedure or surgery done on the wrong patient.

An interview was conducted with Nurse L on 3/17/11 at approximately 10:45 AM regarding the forms. Nurse L acknowledged the wrong label was printed on the forms from the computer. Nurse L stated however, that the correct patient family representative (Patient 51's) signed the forms.

Based on observation of the Health Information Management (HIM) department and staff interview, the hospital failed to ensure that unauthorized individuals cannot gain access to patient records.

Findings:

During a tour of the HIM department on 3/15/11 beginning at 3:05 PM, it was observed that the Art and Spirituality Center (A&SC) was connected to the HIM building. The back door of the A&SC was open to the hallway leading to areas of the HIM department where patient records were located and, at times, unattended by staff. There was one person using the A&SC and the restroom for the center is accessed via this HIM hallway. In this hallway there were carts of records alongside the wall and in the incomplete chart file room. The HIM staff work in several separate offices throughout the building and may not always have visual oversight of the patient records. When asked about this arrangement, Director of Health Information Management responded that the security of records was a concern.

Based on medical record and document review and staff interview, the hospital failed to ensure that entries were legible, complete, dated, timed and authenticated in 10 of 59 sampled patients' records (1, 2, 3, 4, 5, 6, 7, 8, 9, and 51).

Findings:

The Medical Staff Rules and Regulations, approved 11/10, were reviewed on 3/15/11. Section VII. H. states: "Symbols and abbreviations may be used only when they have been approved by the medical staff." Section VII. G. states: "All clinical entries in the patient's record shall be accurately dated, timed and authenticated...." Section VII. J. states: "....Oral orders ... shall be signed, dated, and timed by the physician within forty-eight (48) hours."

1. The "approved" abbreviation list was reviewed on 3/15/11 and no evidence of approval by the medical staff was provided, even after several requests by this surveyor. Review of medical records on 3/16-3/17/11 revealed six of nine records contained abbreviations that were not on the "approved" list. (Records 1-6).

2. Eight of 9 records lacked documentation of the time and/or date of the entry on physician orders, obstetrical admission history and physical examination, anesthesia assessment/evaluation and post-operative note, and physician progress notes. (1, 2, 3, 4, 6, 7, 8, and 9)

3. The Daily Intake and Output/Vital Signs forms contained documentation/authentication by more than one nurse, however there was no indication which entries were made by which nurse. (Records 2 and 3)

4. In three of nine records there were forms that were in a continuous, double-sided fold-out format, but not all sections contained patient identification (such as name and medical record number). Since information is photocopied or scanned in 8-1/2 by 11 inch pages, every page must stand alone and be identifiable to the patient. (2, 8, and 9)

5. In four of nine records, there were dictated/transcribed reports that contained blanks, indicating some portions were unable to be understood by the transcriptionist. These reports included a cardiology consultation, history and physicals, and an emergency room report. These reports were signed by the physician who dictated them, however the missing information was not completed. (1, 2, 8, and 9)

6. Record 2 contained two signed Consent to Surgery or Special Procedure forms that lacked the name of the primary surgeon.

7. Record 2 contained five daily restraint orders that did not have all four sections completed as required.

8. Oral orders were not signed by the physician within 48 hours, or were not dated/timed when signed (2, 4, 8, and 9). One oral order from 1/14/11 in Record 8 was not signed and had not been flagged for the physician as a missing signature.

The above findings were reviewed and confirmed by Director of Health Information Management (DHIM) and Peer Review Manager (PRM) on the morning of 3/17/11.



28773

9. Review of the medical record for Patient 51 was initiated on 3/14/11. Patient 51 was admitted on 3/11/11 with diagnoses that included intubation (placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway) for respiratory distress (difficulty breathing), pneumonia (infection in the lungs) with septic shock (overwhelming infection leads to life-threatening low blood pressure).

Review of the physician's orders dated 3/11/11 at 5:07 AM, showed an illegible order for Nasogastric Tube Feeding (insertion of a plastic tube though the nose, past the throat and down to the stomach then using the tube to feed alternate nutrition) to start at 30 milliliters (ml) per hour. However, after an interview on 3/16/11 at 10:45 AM with Nurse G, the charge nurse for the unit regarding the illegible order and the fact that the nurse initiated the tube feeding without clarifying the order. She stated she was told the order stated "Ensure (a brand name of a nutritional supplements) and the substitute was Jevity 1.5 (a brand name of a nutritional supplements)." However, she did not state who told her it was Ensure. During another interview with Nurse G on 3/14/11 at approximately 3:30 PM, she stated maybe "they" thought feeding stated Jevity. The charge nurse later acknowledged after close evaluation of the handwriting she thought the order read, "NGT Feeding - ensure at 30 ml."

Review of the nursing flow sheet dated 3/11/11, showed the intake of Tube Feeding (TF) was Jevity (a brand name of a nutritional supplements) at 30 ml at 4 PM. Review of the electronic diet order entered on 3/11/11 at 9:36 PM, showed "Fiber Jevity Plus (a brand name of a nutritional supplements)" at the rate of 30 ml per hour full strength. Jevity Plus or Fiber Jevity Plus provides more calories than Ensure. Ensure provides 1 calorie per ml while Jevity Plus provides 1.5 calories per ml. The substitution made by the nursing staff resulted in the patient receiving more calories than was ordered by the physician.

An interview was conducted with Nurse I on 3/16/11, at approximately 10:40 AM. Nurse I stated if the TF order is unclear then they will call and clarify the order with the physician. The clarifying order should be written and stated, "clarified". She stated she thought the original order stated ensure.

An interview was conducted with the Chief Registered Dietitian (RD) 2 on 3/16/11 at 11:20 AM regarding TF substitutions. Chief RD 2 stated they would use Ensure and Jevity is not a substitute for Ensure. Review of the Tube Feeding Formulary dated 6/08, showed use Osmolite in the place of regular Ensure.

Review of the General Medical Staff Rules and Regulations, dated 11/10, showed the practitioner's orders must be written legibly and completely. Order which are illegible or improperly written will not be carried out until rewritten or understood by the nurse.

Review of the hospital's policy and procedure titled physician's orders - transcribing accurately and timely, dated 12/97 and reviewed/revised on 1/08, showed any questions should be clarified immediately with the unit clerk and any discrepancies should be corrected by the registered nurse as soon as they are identified.

Based on interview, and review of the hospital's documents, the hospital failed to ensure one of 59 sampled patient's records (48) contained evidence of a medical history and physical examination in the medical record within 24 hours after admission, which had the potential to cause inadequate medical treatments.

Findings:

Review of the clinical record for Patient 48 was initiated on 3/15/11. Patient 48 was admitted on 2/28/11 with diagnoses that include rule out sepsis (severe illness in which the bloodstream is overwhelmed by bacteria) and rule out drug withdrawal. Review of the clinical record showed no history and physical (H & P) examination completed and documented in the chart or electronic record.

An interview was conducted with the Nurse E on 3/15/11 at approximately 3:40 PM regarding the H & P. Nurse E stated the H & P should be in the chart and done especially since the baby is two weeks old. She stated she could not find it in the electronic record but would have someone else look into this at this time.

An interview was conducted with the Unit Clerk/Certified Nursing Assistant A on 3/15/11, at approximately 3:52 PM. She stated she used to be the unit clerk for this unit. She stated she was unable to find the H & P in the electronic record and just got off the telephone with Medical Records and they were unable to locate this document as well.

The failure to complete a history and physical in a timely manner could result in duplication of therapies and/or inappropriate treatment due to lack of pertinent information in the record.

Review of the hospital's general medical staff rules and regulations, dated 11/10, showed the history and physical examination shall be completed on all cases within 24 hours after admission.

Based on document and medical record review and staff interview, the hospital failed to ensure that all records documented a discharge summary. This failure had the potential to result in lack of information needed for continuity of care, as the summary is routinely shared with a patient's primary care physician.

Findings:

1. The Medical Records Policy and Procedure Manual, approved 3/7/11, was reviewed beginning on the afternoon of 3/15/11. Policy No. 303.00 Discharge Analysis, Section 1.3.2 states that a discharge summary is not required for normal deliveries or newborns.

The Medical Staff Rules and Regulations, approved 11/10, were reviewed during the same afternoon. Section VII. L. states: "A discharge clinical resume shall be written or dictated on all medical records. Later that afternoon, the Director of Health Information Management (DHIM) confirmed that during the analysis of discharged records, staff would consider records of normal deliveries and newborns to be complete, even though they did not contain a discharge summary, or final progress note, which documented the outcome of hospitalization, disposition of care and provisions for follow-up care.

2. Records of normal/vaginal deliveries and a normal newborn record were reviewed on the afternoon of 3/16/11 (Patient 3, 4, and 5). The patients' lengths of stay were under 48 hours. None of the records contained documentation of a discharge summary or a final progress note. This finding was confirmed by the DHIM and Peer Review Manager on the morning of 3/17/11.

Based on document review and staff interview, the hospital failed to ensure that medical records were completed within the time period specified in the Medical Staff Bylaws, Rules and Regulations. This failure had the potential to result in records lacking vital information for continuity of care for patients.

Findings:

The Medical Staff Bylaws, Rules and Regulations, approved 11/10, were reviewed on 3/15/11. Section VII. N. states, in part, that the patient's medical record shall be complete at the time of discharge and if it still remains incomplete for fourteen (14) days after discharge and all essential records have been received and filed in the record, on the fifteenth (15th) day after discharge, the practitioner shall be notified that his/her privileges have been suspended.

The "HIM Performance Improvement Weekly Dashboard" report was reviewed with Staff H on 3/15/11. The report indicated on 3/15/11, the total number of delinquent records (not completed within 14 days after discharge) was 2805. On 3/17/11 at approximately 3 PM, the Director of Health Information Management (DHIM) provided a current number of discharge summaries that had not been dictated with 14 days post-discharge as 198.

The "Suspension List 3/8/11" was reviewed with Staff H on 3/14/11. There were 40 physicians who had been suspended due to delinquent records, with the oldest chart being 342 days post-discharge. The list indicated the total delinquent records for these 40 physicians was 561, even though the total number of delinquent records was 2805.

The hospital pharmacy services failed to ensure safe medication use to its patients as evidenced by:

1. Failure to ensure patients' drug allergy was communicated to other health care professionals immediately which had the potential to cause avoidable adverse drug events and possible injuries to patients. (Refer to A 500 Item 2 and 3)

2. Failure to generate an adverse drug reaction (ADR) report timely which had the potential to cause injuries to patients when a suspected drug reaction was not detected. (Refer to A 500 Item 1)

3. Failure to ensure an anesthesia cart in the operating room suites was locked. This had the potential to allow unauthorized personnel the access to the medications stored in the anesthesia carts. (Refer to A 502)
4. Failure to ensure single dose medication was not available for reuse and proper labeling of a syringe that was filled with medication. Such failure had the potential to cause unsafe medication administration to patients. (Refer to A 505)

5. Failure to evaluate the competency of pharmacy personnel annually per hospital's policy which had the potential to provide unsafe and ineffective treatment. (Refer to A 491)

6. Failure to maintain a consistent practice of identifying drug allergies and adverse drug reactions prior to the administration of medications and failure to administer medications in accordance with the hospital's policy and procedures and accepted standards of practice. (Refer to A 404)

The cumulative effect of these systemic problems resulted in the hospital's failure to provide optimal, safe medication therapy to patients.

Based on interview and record review, the hospital failed to obtain annual competencies for two randomly selected pharmacy personnel. Such failure had the potential to cause unsafe medication administration and undesirable medication therapy outcome to patients.
Findings:
On 3/17/11, at 1:30 PM, during an interview, the Director of Pharmacy Services (DPHARM) stated all pharmacists and pharmacy technicians are required to complete an annual competency evaluation. For the year 2010, there were 21 pharmacy department specific competencies for pharmacist and five for pharmacy technicians. He stated that there are currently 7 pharmacists and 12 pharmacy technicians in its Pharmacy Department and that all competencies for the pharmacy staff have been completed and current.
At 2:30 PM, the documents for the pharmacy department specific competencies for one pharmacist (Pharm 2) and one pharmacy technician (PhTech 1) were randomly selected and reviewed. Both pharmacy staff did not have complete records to show that they had completed competencies for the year 2010. DPHARM stated he had to look for these documents in different places and more time would be needed. He was given the opportunity to submit further documents to the office the next day if he could locate them.
On 3/18/11, the faxed competency reports from DPHARM were reviewed. There were only two competencies received from the hospital, one pharmacist (Pharm 2) and one pharmacy technician (PhTech 1). Pharm 2 had two records, one from the year 2008 and the other was 2010. The one from the year 2008 had a check (?) marked under "Completed" section but had no date written when these 21 competencies were done. However, on the bottom of this specific page, there was a hand written note, read, "All complete: BT (a supervising pharmacist's initial) 8/19/10." Pharm 2's second record was from the year 2010. There was a date "12/2010" written under the "Completed" section for four out of 21 required annual specific competencies. According to the requirements for 2010, Pharm 2 did not complete 17 of 21 annual specific competencies. The document was unclear that all competencies listed for 2008 were completed on 8/19/10 or only four competencies were completed for the year 2010. He was unable to provide the information that the number of pharmacy personnel who had completed the annual competency.
PhTech 1's pharmacy specific annual competency record was reviewed on 3/18/11. His record showed that he had completed all his required competencies for the year 2010 but did not have a date to specify when each competency was completed. Further review of his records, PhTech 1 did not have an "Annual Technician Competency Assessment" for the year 2010. The last one he completed was on July 29, 2009.
The DPHARM could not provide evidence he had implemented his responsibilities and hospital policies to routinely evaluate the performance and competency of the pharmacy personnel.

Based on interview and record review, the hospital's pharmacy services failed to review three of patients' allergies (1, 2, and 53) which had the potential for these patients to incur unexpected adverse drug reactions due to pharmacy services failing to evaluate, monitor and review the use of the drug delivery system by the nursing staff.
Findings:

1. On 3/16/11, the hospital's "Dispensing Alert Notification" for Patient 53 was reviewed. "Dispensing Alert Notification" is generated by the Omnicell (an automatic dispensing cabinet) when an adverse reaction towards medication is suspected. The notification indicated that on 1/26/2011, Patient 53 had an adverse drug reaction as a result of antibiotic use. Patient 53 was admitted on 1/17/2011. The admission assessment indicated she did not have any medication allergies and had been on an antibiotic, "Ampicillin," three times a day. After being admitted to the hospital, Patient 53 was placed on Ampicillin two grams intravenously every eight hours. On 1/22/2011, at 4:33 PM, according to the flow sheet (a form used by licensed staff to document patient ' s progress), Patient 53 developed skin rash under her breasts and on her back. A physician's order was received to apply Nystatin (a medicated cream to treat rash) to affected area and Benadryl by mouth (a medication used for itching or rash). Nystatin cream was applied on 1/22/2011 at 5:40 PM and Benadryl was given on 1/23/2011, at 12:15 PM. During further review of the patient's medication administration records (MAR) from 1/22 to 1/26/2011, the suspected allergy to Ampicillin was not listed on as an allergy on the MAR until 1/26/2011, four days after the allergic reaction was identified. During this time, Patient 53 continued to receive Ampicillin, Nystatin cream, and Benadryl.

On 3/17/2011, at 1:30 PM, during a concurrent interview and record review, the Director of Pharmacy (DPHARM) stated the medication computerized distribution system automatically sends the "Dispensing Alert Notification" to pharmacy when certain medication was pulled from the Omnicell at each nurses' station, such as Benadryl. This is how the hospital generates information on adverse reaction to medications. A pharmacist reviews the report immediately and enters into a pharmacy computer system. DPHARM added that this particular computer system was only accessible to the pharmacists, not to the other health care professionals such as nurses or physicians. At this time, DPHARM was informed that Patient 53 had received Benadryl on 1/23/2011 at 12:15 PM but the "Dispensing Alert Notification" was not generated until 1/26/2011, three days later. DPHARM reviewed the patient's clinical record and could not provide further explanation.

On 3/17/2011, the pharmacy's policy and procedure on "ADVERSE DRUG REACTION," reviewed/revised on 7/10, was reviewed. Under Procedure C, it read: Several reversal agents stored in our automatic dispensing cabinets (ADC) such as Benadryl ...etc., will prompt the user to address ADR (adverse drug reaction) documentation at the time of removal. The documentation process will verify if the reversal agent is being used for an ADR, if "yes," further documentation is required ... this triggers a hardcopy to be printed in the pharmacy to be reviewed by a pharmacist. The pharmacist will review the drug & reaction involved with the ADR & using a physician communication form, and provides a suggestion to prevent future occurrences, if applicable ..." This process was not evidenced in Patient 53's clinical record.



28467

2. The Clinical Record for Patient 1 was reviewed on 3/15/11 at 3 PM, the Medication Administration Record (MAR) dated 3/14/11, indicated that Patient 1 had received one dose of Acetaminophen 650 mg at 3 AM, the MAR also indicated Patient 1 had a coded allergy for Acetaminophen. The Medication Reconciliation Order Form dated 3/8/11 indicated "Allergies: Amoxicillin and Vicodin", with the side effect of the Vicodin listed as SOB (shortness of breath). The Allergy Management screen dated 3/6/11, indicated Acetaminophen (from Vicodin) Shortness of Breath, Verified: Yes.

3. The Clinical Record for Patient 2 was reviewed on 3/15/11 at 4 PM, the MAR dated 3/13/11, indicated that Patient 2 had received a Clonidine patch 5 mg on 3/12/11 at 10:30 PM, the MAR also indicated Patient 2 had a coded allergy to Clonidine and no other Allergies. The Medication Reconciliation Order Form indicated Patient 2's allergies as Pain Medications, Omnipaque and Clonidine.

The hospital Policy and Procedure titled, "Medication Record Administration" dated 1/09 was reviewed on 3/16/11. The document indicated, "The Registered Nurse Checks Medication Allergies or sensitivity to Medications."

During an interview with Nurse Manager (NM) 2 on 3/17/11, at 3 PM, she reviewed the clinical records and was unable to find nursing documentation of a call to pharmacy or the patient's doctors indicating that it was safe to give these medications.

During an interview with the hospital Pharmacist. on 3/16/11 at 9:45 AM, he stated, "If an allergy is stated by the patient, perceived or associated with a medication, the pharmacist will review that medication with the patient, Registered Nurse or Doctor to determine if it should be given. After that has been determined, we would then place it in our pharmacy module profile, on the list of coded override medications. The stated allergy will still populate on the Medication Administration Record as a coded allergy. Nursing has no access to this Pharmacy override module. When asked how nurses would know if a medication noted as a coded allergy was cleared by pharmacy he indicated, "I don't know, but they can call here. There is clearly an issue with communication here and this is a valid concern."

Based on observation and interview, the hospital failed to ensure an anesthesia cart in one of 7 operating room suites was locked (OR 3). This had the potential to allow unauthorized personnel to access the medications stored in the anesthesia cart.

Findings:

On 3/16/11, at 11 AM, during a tour of the surgical department at the main campus and accompanied by the Director of Surgical Services (DSS) 1, noticed the anesthesia cart in Operating Room 3 was not locked. Inside the cart, there were four anesthesia trays (a tray full of anesthetic medications that were ready for anesthesiologists to use on patients undergoing surgeries) in the drawers.

On 3/16/11, at 11:30 AM, during an interview, DSS 1 stated the surgery for Operating Room 3 was cancelled about half an hour ago and the surgery was scheduled for 11 AM. He did not offer further information regarding the unlocked anesthesia cart. DSS1 stated the anesthesia cart was supposed to be locked when not in use.

Based on observation, interviews, review of clinical records, and review of hospital documents, the hospital failed to ensure that dietary services was organized, directed, staffed in a manner met the nutritional needs of all patients as evidenced by failure to:

1. Provide a full-time person in the position of director of food and dietetic services. This lack of leadership was evidenced by findings of unsafe food handling practices, and lack of supervision of the dietary department. (Cross Reference A620 and A749)

2. Ensure the availability of adequate qualified personnel. A dietary staff was unable to correctly demonstrate how to calibrate the food thermometer. In addition, a registered dietitian (RD) 3 inaccurately applied the incorrect formula in the calculation of an underweight patient. (Cross Reference A622)

3. Ensure that menus were developed for all patients. Menus were not available for the different diets served in the hospital. Vegetarian diets served to patients with no menus for them to select from. (Cross Reference A628)

4. Ensure that the therapeutic diets for two patients in a sample of six medical records were ordered by their physicians. These failures resulted in a delay of medical nutrition therapy as prescribed by the physician and may further compromise patients' medical status. (Cross Reference A629)

5. Ensure that nursing staff clarified illegible or erroneous tube feeding orders prior to initiating care. Physicians wrote tube feeding orders without set protocols on how to consistently increase tube feeding rates. In addition, hospital dietitians failed to ensure that tube feeding orders was evaluated for adequacy of fluids. (Cross Reference A630)

6. Ensure that an effective infection control system was developed and implemented for the safe storage and distribution of food. These deficient practices had the potential to result in growth of microorganisms that could result in food borne illness. (Cross Reference A749)

7. Ensure that the nutritional needs of one sampled patient was evaluated prior to discharge. This failure would have resulted in the patient being sent home with a tube feeding that exceeded his nutritional need. (Cross Reference A806)

8. Ensure that data collected from food test tray audits were used to identify improvement opportunities and correct unacceptable food temperature problems. (Cross Reference A276)

The cumulative effect of these systemic problems resulted in the hospitals inability to ensure that the nutritional needs of the patients are met in accordance with the Condition of Participation for Food and Dietetic Services.

Based on staff interviews and review of personnel record, the hospital failed to ensure that it had a full-time person in the position of director of food and dietetic services, which had caused daily operation of the dietary services to be managed improperly.

Findings:

During the tour of the Main Campus' kitchen on 3/14/11 at approximately 9:50 AM, the hospital's Chief Operating Officer (COO) stated the hospital's former director had transferred to another hospital in the system the month before. He further indicated the hospital found a replacement but that individual would not be able to start until the end of the month.

There were patterns of deficient practices identified between 3/14/11 and 3/16/11 in the kitchen some of which could be attributed to poor or lack of leadership. For example, there was no system in place to ensure previously cooked food or other potentially hazardous foods were properly cooled. There were no policies or procedures in place for cleaning food equipment.

The cooks prepared food in a manner that did not conserve the nutritive value. Another cook used an uncalibrated thermometer to check food temperatures.

There was a broken external thermometer on one of the refrigerators and no internal thermometer had been placed in it to ensure that it worked properly. The refrigerator log did not include this refrigerator. Not clear on how long the refrigerator had been without monitoring. (Cross refer A749)

There was overproduction of food resulting in a large amount of left overs. These leftovers were stacked improperly in the refrigerators and did not allow for good air circulation and cooling.

The hospital did not have menus for all the diets that were being ordered by the physicians. for example, there are no vegetarian menus.

The hospital failed to ensure that there was a food service director to supervise the daily operations of the dietary department.

Based on staff interviews, review of clinical records, and the hospital policies and procedures, the hospital failed to ensure the dietary staff were able to correctly demonstrate how to calibrate the food thermometer, which had the potential to cause food borne illnesses.

The hospital also failed to ensure one Registered Dietitian (RD) 3 accurately applied the correct formula in the calculation for one underweight patient (56), which had the potential to cause Patient 56 further underweight conditions.

Findings:

1. The clinical record for Patient 56 was reviewed on 3/16/11. Patient 56 was admitted with diagnoses including a replacement of a PEG (Percutaneous Endoscopic Gastrostomy tube which is generally placed into a patient's stomach as a means of feeding them when they are unable to eat). According to the nutrition assessment conducted by RD 3 on 3/14/11, he was 5'8" and 140 pounds or 63.5 kilograms (kg). She calculated his ideal body weight (IBW) to be 69.85 kg and documented he was 90.9% of his IBW. RD 3 documented, "Pt's (patient's) BMI (Body Mass Index-a measure of body fat used to determine whether a person is underweight or overweight/obese) reflects normal weight". Although she documented the patient's BMI reflects normal weight she calculated his nutritional needs using a calculation described as "adjusted body weight".

Adjusted body weight is a calculation developed for patients who are overweight to prevent overfeeding or drug overdose or toxicities (the degree in which a substance can harm a human). In 2007, the American Dietetic Association (ADA) in a review of formula equations used to determine nutritional needs found the "common practice of applying an 'adjusted body weight' to the equation in obesity is not supported...and resulted in underestimation in most (72%) obese patient's." Based on ADA's position, the adjusted body weight equation should not be used for the calculation of the nutritional needs of patients.

RD 3 used the adjusted body weight equation to estimate the caloric and nutrient needs of Patient 56 who was underweight. The position statement of the ADA was shared with the Chief RD 1 in an interview on 3/16/11 at approximately 12 PM. She indicated they had sampled nutrition care practices in other hospitals three years earlier and changed some of their practices and procedures based on the responses received.

During a subsequent interview on 3/17/11 at approximately 1 PM, with the Chief RD 1, she stated she was able to interview RD 3. RD 3 indicated that was "her professional judgement". There was no clear explanation the reason why RD 3 applied the equation meant for an overweight patient to Patient 56, who was underweight. The correct equation would have been to use the patient's IBW of 154 lbs.

The personnel record for RD 3 was reviewed on 3/17/11. The personnel record included a performance evaluation. One of the standards on the performance evaluation included her ability to "assess the nutritional status of the individual patients". She was rated as "outstanding"

2. During an interview with Cook 2 on 3/15/11 at approximately 11:30 PM, Cook 2 was asked to calibrate her thermometer due to discrepancies between the temperature taken by the surveyor and the cook. Using the ice water method (starting with a cup of water and ice to a temperature of 32 degrees Farenheit (F) a thermometer is placed inside-if the thermometer is not at 32 degrees F then an adjustment of the thermometer is done to ensure 32 degrees F), she incorrectly read the thermometer as 32 degrees Fahrenheit, although the thermometer read 28 degrees Fahrenheit. The cook had been using an uncalibrated thermometer to take food temperatures on the cafeteria tray line. It was later determined the cook could not read the thermometer due to the small temperature gauge.

An inaccurate temperature measuring tool could give a false sense of security when the actual food temperature may be in the food temperature danger zone (41 to 135 degrees), a temperature range that supports the growth of microorganisms that could result in a food borne illness. It could also cause food palatability issues when food that is not at the appropriate temperature is passed off as such.

3. During the tour of the Main Campus' kitchen on 3/14/11 a large pot of water with red potatoes cut-up in pieces dated "3/13" and "3/15." The same pot was observed later with cooked red potatoes. Cook 3 who prepared the potatoes was interviewed on 3/15/11, at approximately 3 PM on his knowledge of nutrient loss due to long term soaking of potatoes. He stated that there was no difference in the nutrient loss due to soaking and loss during cooking in the steamer. He further stated during the interview that all the cooks soak the potatoes ahead to save time cutting vegetables into small pieces and exposing them to air before cooking which may result in the loss of vitamins particularly vitamin C. Steaming prevents losses due to leaching.

The personnel record for Cook 3 was reviewed. Cook 3 was hired in 10/09. His (undated) job description for the position of cook identified one of the performance expectations as "...Prepare and/or cook food items for patients, staff and visitors and special functions following standardized recipes and acceptable methods of preparation". He was evaluated in his most recent performance evaluation dated 7/22/10 as "fully competent" in this category.

Soaking cut potatoes in water for about two days prior to cooking results in loss of Vitamin C an important nutrient in wound healing and immunity maintenance, both of which are important in the hospitalized patients.

The hospital failed to ensure that staff was knowledgeable in assessing the nutritional needs of patients, proper food preparation methods and calibrating thermometers.

Chief RD 1 who was present during the interview stated she was not aware the practice was going on. She asked him whether he used the water that the vegetables had been soaked in, in any other part of the meal preparation in which he replied, "No".

Based on observation, review of clinical records, hospital menus, diet manual, policies and procedures and staff interviews, the hospital failed to ensure menus were developed for all patients, which caused patients on vegetarian or cardiac diets to receive inadequate nutrients.

Findings:

The hospital menus on the main campus were reviewed on 3/14/11. The menus revealed the hospital had printed menus for only the following four diets: Regular, Diabetic diet -No sugar, Renal diet - No Salt, Heart healthy diet-No salt. Review of the hospital diet manual revealed other diets listed which included: Pureed, clear liquids, full liquids, bariatric, and formula.

A review of the diet list revealed that there are other patients on diets, such as vegetarian and cardiac diets; however there was no vegetarian menus. During the lunch tray line observation on 3/14/11, the patient on a vegetarian diet received a plate of vegetables. When concerns were raised to Chief Registered Dietician (RD) 1 concerning the lack of a menu, she stated the nutrition assistants take food preferences when they visit the patients therefore fulfill the vegetarian diet without the menu.

During an observation on 3/15/11, at approximately 12:05 PM, a cook was observed preparing stir-fry vegetables on the grill. In a concurrent interview with the cook, he stated the vegetables were for the patient on the vegetarian diet. For patients on vegetarian diets he provides different kinds of vegetables. He further stated in response to the lack of protein in the meal being prepared, sometimes the patients will ask for veggie burgers as a source of protein. He confirmed the meals prepared were not following any specific plan. Due to the presence of more than one cook in the kitchen, there was a possibility the patients could receive the same vegetables from one meal being prepared by different cooks if the patients were not able to preselect their meal choices.

Protein and calories to meet individual needs may be inadequate in some of the vegetarian diets. The lack of an approved menu planned to meet the nutritional needs of a hospitalized patient could result in patients not receiving adequate protein and calories that may be necessary for wound healing and/or weight loss.

According to the hospital policy and procedure titled "Basic Nutrition Care" dated 5/97, "select menu is provided to patients on oral diet. Patients on clear liquids, full liquids and CDC (California Department of Corrections) patients will not receive a select menu." Patients on pureed diets are sent the regular diet menu but do not receive the items on the menu they may have selected. For example, main entree selections on the lunch menu for Monday was penne with sun dried tomato sauce, grilled citrus shrimp salad plate, cafeteria grill special. Although there were three entree options, patients on pureed diets were sent carrots, noodles and chicken. These items were not listed on the menu sent to patient on the purred diets.

During tray line observation on March 14, 2011, at approximately 11:55 am, two plates each containing pureed carrots, noodles and chicken were stored in the food warmer in the kitchen. According to Cook 2, the plates were prepared for patients on pureed diets. These items were made from preformed molds and not the entree prepared in the pureed texture. There was no documented evidence the preformed pureed chicken, carrots and noodles were comparable in nutrients as those in the regular diets. The penne with sun dried tomato sauce entree was described on the menu as "penne pasta with seasoned chicken, sun dried tomato sauce, red peppers and pine nuts and parmesan cheese served with sauteed spinach and breadstick. The pureed diet plate did not include parmesan cheese or bread sticks.

Based on observation, staff and patient interviews, review of medical records and review of hospital documents, the hospital failed to ensure the therapeutic diets for two patients (49 and 50) in a sample of six medical records were ordered by their physicians. These failures resulted in a delay of medical nutrition therapy as prescribed by the physician and may further compromise patients' medical status.

Findings:

Southwest Campus

1. Review of the medical record for Patient 49 was initiated on 3/16/11. Patient 49 was admitted on 3/13/11 with a diagnosis of back pain.

Review of the physician's order dated 3/13/11 at 3:25 PM, showed a 2,000 milligram (mg) sodium diet. Another physician's order dated on 3/13/11 at 6:30 PM, showed to change diet from heart healthy to thickened liquids. According to hospital policy titled "Patient Menu" effective 10/10, a 2000 mg sodium diet order will be served a heart healthy diet. This policy did not indicate that a pureed diet will be served with thickened liquids.

Review of the printed Diet Order List dated 3/16/11 at 1:43 PM, showed Patient 49's diet was puree (foods that have been blended into a puree consistency) with thickened liquids.

There are generally three levels of consistencies for thickened liquids: nectar thick consistency, honey thick consistency and pudding thick consistency. An observation of dinner tray line (where meals are assembled and placed on trays in the kitchen then delivered to the patients on the nursing units) was conducted on 3/16/11, at approximately 2:30 PM, showed Patient 49's tray contained honey thick milk, nectar thick apple juice, mashed potatoes, puree green bean mold (purchased frozen pureed food items formed into a mold to look more like the food item), pureed beef mold, and vanilla pudding. The tray had all various consistencies.

An interview was conducted with the Chief Registered Dietitian (RD) 2 on 3/16/11, at approximately 2:35 PM. Chief RD 2 stated the nutrition assistants should clarify an order that just states thickened liquids without the consistency of the liquid. She stated if they are unable to clarify then the default would be for honey thick liquids. The surveyor showed the Chief RD 2, Patient 49's dinner tray. The Chief RD 2 took off the nectar thick apple juice. The food service workers informed the Chief RD 2 that they ran out of honey thick juice.

Review of the hospital's dinner menu for 3/16/11, showed the following items were to be served: puree beef, puree pasta with sauce, puree squash.

An interview was conducted with the Chief RD 2 on 3/16/11, at approximately 2:40 PM. The Chief RD 2 stated the puree menu follows what the regular menu is getting. She acknowledged they are not following the puree menu. The surveyor asked, how does the staff know what the patient received for lunch and that it was not the same thing if they are not following the menu? The Chief RD 2 stated that was "a good point".

Review of the electronic diet order record entered on 3/14/11 at 7:48 AM, showed Patient 49 was ordered a heart healthy 2,000 milligrams of Sodium, low fat, low cholesterol diet with thickened liquids. Review of another electronic diet order record entered on 3/16/11 at 5:32 AM, showed a puree diet with thickened liquids.

An interview was conducted with Nurse H on 3/16/11, at approximately 3:18 PM. Nurse H stated there is no order in the medical record for a puree diet. Nurse H stated they are just supposed to ask the patient if they are alert and oriented what kind of thickened liquid they can tolerate and that is the consistency that will be provided.

An interview was conducted with Nurse Manager (NM) 4 on 3/16/11, at approximately 3:30 PM. NM 4 stated the diet order should have been clarified with the physician. She was unsure of what kind of texture of solids the patient should be receiving with the thickened liquids.

An interview was conducted with the Chief RD 2 on 3/16/11, at approximately 3:40 PM. The Chief RD 2 stated thickened liquids are not a diet and they would need to enter in the solid diet first then could add the thickened liquids in the computer.

An interview was conducted with Patient 49 on 3/16/11 at approximately 3:47 PM. Patient 49 stated no one from the kitchen has come to ask about food preferences. She stated she can tolerate finely chopped food. She stated the mashed potatoes and gravy are not good so she will not eat that food and would "prefer baby food over that food". It was undetermined what diet texture the physician wanted the patient to receive.

2. Review of the medical record for Patient 50 was initiated on 3/15/11. Patient 50 was admitted to the hospital on 3/1/11 with diagnoses that included acute and chronic Congestive Heart Failure (failure of the heart to pump blood with normal efficiency, Hypertension (high blood pressure), and Diabetes Mellitus.

Review of the physician's orders dated 3/11/11 at 2:30 PM, showed a cardiac, 2000 mg Sodium diet and a fluid restriction of 1.5 Liters. Review of the electronic diet order entered on 3/14/11 at 9:53 AM, showed an 1800 calorie diabetic diet with soft foods and ground meat and a 1.5 Liter fluid restriction. The electronic diet order was what was entered into the computer from the nursing station and printed out for the kitchen to provide the appropriate diet to the patient.

An interview was conducted with Nurse F on 3/16/11 at 11 AM, regarding the diet order for Patient 50. Nurse F stated the order in the computer did not include the low sodium portion of the diet order. She also stated the physician's order did not include the diabetic portion. Nurse F stated that nursing can downgrade the texture of the diet before notifying the physician. The electronic diet order did not match the diet ordered by the physician.

Review of the hospital's policies and procedures titled "Diet Orders", dated 5/94, revised 10/10, showed the attending physician writes diet orders in the medical record. Nursing informs the Diet Office in the kitchen of the patient's diet order by documentation of the diet order through the electronic computer system onto the "Diet List." Once every 24 hours, it is the responsibility of the nursing unit to pull a diet list with inquiries and make any necessary changes. An interview was conducted with the Chief RD 2 on 3/16/11 at 11:20 AM. Chief RD 2 stated diet changes needed to have a physician's order even with texture changes.

Nursing staff failed to review the electronic diet order resulting in Patient 50 receiving diets not ordered by the physician.

Based on review of clinical records and staff interviews, the hospital failed to ensure nursing staff clarified illegible or erroneous tube feeding orders prior to initiating care for three of 59 sampled patients (18, 51 and 55). Physicians wrote tube feeding orders without set protocols on how to consistently increase tube feeding rates. In addition, hospital dietitians failed to ensure that tube feeding orders were evaluated for adequacy of fluids, which had the potential to cause inappropriate fluids status of these patients.

Findings:

1. The clinical record for Patient 18 was reviewed. Patient 18 was admitted to the hospital on 2/9/11 with diagnoses including septicemia (a disease caused by the spread of bacteria and toxins through circulating blood); urinary tract infection, dementia (a group of symptoms that are caused by changes in brain function) and PEG (percutaneous endoscopic gastrostomy) placement. A PEG is a surgical opening into the stomach used for feeding usually via a feeding tube called a gastrostomy tube, but it does not necessitate doing an operation to open the abdomen.

A continued review of Patient 18's clinical record was conducted. On 3/8/11, at approximately 9:10 AM, the patient was transferred to an area of the hospital with the following order, "NGT (nasogastric tube-a tube passed through the nose to the stomach to provide nutrition) placed and start Glucerna (a type of liquid nutrtional supplement) 10 L (liter)/hr and increase to 50 L". A liter is 1000 milliliter, the usual volume infused for tube feeding is a milliliter (ml). The order as written by the physician could be interpreted as start feeding at 10,000 ml per hour and increase to 50,000 ml per hour. There was documentation that this order was noted at 4 PM on 3/8/11.

The documentation and initial written above the order was in a different colored ink implied that the nurse had initiated/attempted to start this order. It stated "pt refused, very feisty". Further review of the Transport hand -off communication form dated "3/8/11 at 1600 (4 PM)" in the area of the form which addressed any concerns, there was documentation which read in part, "MD ordered NGT insertion but patient is refusing". This showed that nursing staff attempted to initiate the erroneous order. The order was later changed, at 4:45 PM and another order was given by a different physician for "once NGT started, TF (tube feeding) Glucerna x 10 ML/hr increase to 50 ML/hr.

The order did not include water flushes, a standard in most tube feeding orders. Review of the nutrition assessments conducted by the registered dietitians (RD) showed calculations for estimated needs for calories and protein but there was no estimated needs for fluids.

During an interview with Nurse N (responsible for caring for Patient 18) on March 16, 2011, at approximately 4 PM, she was asked how much water does the patient receive while on the tube feeding. She stated, the tube feeding pump automatically provides water at hourly intervals. Nurse N could not state how much water the patient received. A review of Daily I &O (Intake and Output)/vital signs/Observation Form from 3/12-3/16/11, showed no addition on the amount of fluids that was provided by tube feeding and IVF's (intravenous fluids). The amounts were written twice (per shift) but the 24 hour total was never compiled. Lack of a 24 hour total indicates lack of assessment of fluid information.

2. The clinical record for Patient 55 was reviewed. Patient 55 was admitted to the hospital on 2/27/11 with diagnoses including dehydration (loss of water and minerals necessary for normal body function) and dysphagia (inability to swallow as a result of injury to the parts of the brain that control the muscles for swallowing). Her tube feeding (a feeding tube is a medical device used to provide nutrition to patients who cannot obtain nutrition by swallowing) order on 3/11/11 was for a "G-tube feed with lactose free formula."

A review of the nutrition assessments conducted by the RD showed calculations for estimated needs for calories and protein but there was no estimated needs for fluids.

The assessment completed by Chief RD 1 on 3/11/11 discussed some laboratory values and the documentation read, "might indicate fluid overload". There was no further evaluation of the fluids to determine amount of fluid Patient 55 may be receiving. Chief RD 1 was interviewed on 3/16/11, at approximately 3:35 PM on how the hospital ensures that tube fed patients received adequate fluid. She stated the nurses were responsible for administering water flushes but she was not sure exactly how much.

Interviews were conducted with nursing staff in different areas of the hospital on how much water was given to the patients. Answers varied significantly from one unit to another.



21905

During an interview with Nurse O, on 3/15/11 at 3:10 PM, she was asked to describe the process for Gastrostomy tube feedings if the physician's order indicates to start at a certain rate per hour to reach a goal rate. She indicated she was not sure but "as far as I know" we check residuals (amount of the formula left in the stomach) every six hours and if the rate is less then the rate of flow then the rate would be increased by 10 milliliter (ml) increments until the desired rate is reached.

During an interview with Nurse Manager Manager 5, on 3/16/11 at 2:55 PM, she was asked to describe the process for Gastrostomy tube feedings if the physician's order indicates to start at a certain rate per hour to reach a goal rate. She indicated, first there is no water flushes provided anymore. She stated, "Nothing is designated for water." In addition she indicated you would check the residual every two hours, if the patient is tolerating, as determined by the amount of residual, then you would titrate it up by 10 ml per hour until the desired goal rate is met. If the patient is not tolerating, then the nurse would hold the feeding and check the residual every one hour and again follow the procedure of titrating up by 10 ml per hour until the desired goal rate is met.

During an interview with Nurse P, on 3/17/11 at 11:20 AM, she was asked to describe the process for Gastrostomy tube feedings if the physician's order indicates to start a certain rate per hour to reach a goal rate. She indicated, she would check the residual every four hours and if the patient is "retaining a lot...greater then 150 ml would put on hold (referring to holding the feeding)".



28773

3. Review of the medical record for Patient 51 was initiated on 3/14/11. Patient 51 was admitted on 3/11/11 with diagnoses that included intubation (placement of a flexible plastic tube into the trachea (windpipe) to maintain an open airway) for respiratory distress (difficulty breathing), pneumonia (infection in the lungs) with septic shock (overwhelming infection which leads to life-threatening low blood pressure).

Review of the physician's orders dated 3/11/11 at 5:07 AM, showed an illegible order for Nasogastric Tube Feeding (NGT-insertion of a plastic tube through the nose, past the throat and down to the stomach then using the tube to feed alternate nutrition) to start at 30 milliliters (ml) per hour and then by nutrition consult, and for a nutrition consult to be done.

An interview was conducted with Nurse G on 3/14/11, at approximately 3:30 PM, she stated maybe they thought feeding stated Jevity (liquid supplement) but she thought the order read, "NGT Feeding - ensure at 30 ml." During another interview on 3/16/11 at 10:45 AM with Nurse G, she stated she was told the order stated "Ensure and the substitute was Jevity 1.5".

Review of the nursing flowsheet dated 3/11/11, showed the intake of Tube Feeding (TF) was Jevity at 30 ml at 4 PM.

Review of the electronic diet order entered on 3/11/11 at 9:36 PM, showed "Fiber Jevity Plus (liquid supplement)" at the rate of 30 ml per hour full strength.

Review of the nutrition assessment dated 3/11/11, at 3:11 PM and ending at 3:28 PM, showed the diet order was Jevity at 30 ml per hour. The nutrition assessment showed that according to the registered nurse, the physician had ordered TF through the NG tube and it will start soon. No assessment was done to determine if estimated needs were being met. No specific recommendations were given on what the RD thought the goal rate of the TF needed to be in order to meet the patient's energy needs.

An interview was conducted with RD 4 on 3/14/11, at approximately 4:05 PM, regarding her nutrition assessment. RD 4 stated she documented the diet order of Jevity at 30 ml per hour because that is what the nurse told her. She stated she did not verify the diet order in the physician's order. RD 4 stated she was unaware that a nutrition consultation was ordered on 3/11/11. RD 4 stated she did not write what percent of the patient's needs were being met by the TF.

An interview was conducted with the Chief RD 2 on 3/14/11, at approximately 4:15 PM. The Chief RD 2 stated they should be checking the diet order when the RD does the assessment and this is something they check to see if the diet order is correct (what is in chart is what is being provided) when they do peer chart audits on each other. She stated the RD's should determine if what is being provided by TF is meeting the patient's needs and then makes recommendations on what to do next. The Chief RD 2 stated this was not done for this patient.

An interview was conducted with Nurse I on 3/16/11, at approximately 10:40 AM. Nurse I stated if the TF order is unclear then they will call and clarify the order with the physician. The clarifying order should be written and stated, "clarified". She stated she thought the original order stated ensure.

An interview was conducted with the Chief RD 2 on 3/16/11 at 11:20 AM regarding TF substitutions. The Chief RD 2 stated they would use Ensure (liquid supplement) and that Jevity was not a substitute for Ensure.

Review of the Tube Feeding Formulary list, dated 6/08, showed use Osmolite (liquid supplement) in the place of regular ensure.

Based on interview, document review, and the testing of the fire alarm system, the hospital failed to:

1. Ensure door devices connected to the fire alarm system are maintained in accordance with NFPA 101, Life Safety Code (2000 Edition), to release upon activation of the fire alarms as evidenced by doors failing to release during fire alarm testing on floors one through five in the Patient Tower Building. This could result in the failure to contain smoke to a compartment, causing potential harm to the occupants. (Refer to K 021 of the Life Safety Code Survey)

2. Ensure the fire alarm system components and devices were maintained in accordance with NFPA 72, National Fire Alarm Code (1999 Edition), as evidenced by:

a. failing to provide documentation for the repairs of devices that failed to pass quarterly test and inspections by,
b. failing to maintain and repair a fire alarm system "trouble" reported on the main fire alarm control panel and sub-panels,
c. failing to provide documented evidence of acknowledging trouble alarms and investigating the problems for repairs; and,
d. failure of audible devices. This failure affected the entire hospital and could result in the fire alarm system not functioning as designed in the event of a fire or emergency. (Refer to K 051 Life Safety Code Survey)

The cumulative effect of these systemic problems resulted in the hospital's failure to provide a safe environment for the protection of the health and safety of all patients, personnel and the public from fire.

Based on observation, interview, and document review, the hospital failed to ensure a sanitary environment that reduced the transmission of infections and communicable diseases as evidenced by:

1. Failure to ensure that health care workers wore gloves when handling items and equipment contaminated with blood. (Refer to A 748, item 1)

2. Failure to ensure that equipment manufactured for single patient use was not used for multiple patients. (Refer to A 748, item 2)

3. Failure to to ensure that emergency department patients with infectious and communicable diseases were provided written instructions about measures to prevent transmission to to family and community. (Refer to A 748, item 3)

4. Failure to ensure that housekeeping staff were trained and competent about the disinfectants used in the hospital, and that resource information was available. (Refer to A 748, item 4)

5. Failure to ensure that cloth sleeves used cover positioning devices in the neonatal intensive unit were laundered in a way that ensured they were sanitary. (Refer to A 748, item 5)

6. Failure to ensure that all health care workers were screened for tuberculosis annually. (Refer to A 748, item 6)

7. Failure to ensure that intensive care patients with central venous catheters were assessed daily by a physician for medical necessity. (Refer to A 748, item 7)

8. Failure to ensure that all patient care units were thoroughly sanitized, and that culture media punctured by a needle was not available for use on another patient. (Refer to A 748, item 8)

9. Failure to ensure an effective infection control system was developed in the dietary department as evidenced by safe storage and distribution of food. Failure to ensure its nursing staff followed sound infection control practices as it relates to the hang times of tube feeding formula for patients. Failure to ensure dialysis machines were safe for patients. (Refer to A 749)

The cumulative effective of the systemic failures resulted in the hospitals inability to ensure a sanitary environment, placing all patients, and staff at risk of being exposed to infectious and communicable diseases.

Based on observation, interview, and document review, the hospital failed to develop and implement policies and procedures to reduce the risk of developing infections and communicable diseases.

Findings:

1. On 3/14/11 at 10:35 AM, an initial tour of the emergency department (ED) at the Southwest campus was conducted. During the tour, a metal cart was observed in the nurses' station. Five glucometers (machines used to test were observed sitting on the top shelf of the metal cart. An inspection of one of the glucometers revealed that the test strip (a sample of the patient's blood is placed on the test strip), was inserted in the glucometer. Nurse Manager 6 (NM 6 of the Emergency Department) was observed picking up the glucometer, without wearing gloves (personal protective equipment), and removed the test strip from the glucometer. It was noted that there was blood on the test strip. NM 6 was then observed discarding the test strip in the trash, and proceeded to clean the glucometer using a bleach wipe, without wearing personal protective equipment.

During a concurrent interview, NM 6 was asked about the hospital's policy for handling a glucometer strip containing blood and the process for cleaning the glucometer. NM 6, stated that gloves should be worn when handling items that have had contact with blood.

On 3/14/11 at 2 PM, the hospital's 12/10 policy and procedure titled, "Cleaning and disinfection" was reviewed. On page 3 of the policy and procedure, direction was given to use a 1 to 10 bleach solution and to wear gloves during the process.

On 3/14/11 at 3 PM, the 4/2010 article published by the Association for Professionals in Infection Control and Epidemiology, Inc, was reviewed. On page 171, direction was given that, "The use of safe injection practices is critical to prevent microbial contamination.... Administrators of medical facilities must be aware of safe injection practices and ensure that employees have the knowledge, training, and equipment to safely implement these procedures. It is critical that injectable medications, IV (intravenous) delivery systems, and glucose monitoring are used safely in all health care settings."

The hospital failed to develop and implement policies/procedures ensuring that nursing staff wore personal protective equipment (gloves), when removing test strips that had been exposed to blood, and when handling non-clean glucometers. Failure to wear personal protective equipment (gloves) placed nursing staff at risk of being exposed to bloodborne pathogens which can cause the development of hepatitis B, hepatitis C, and HIV (human immunodeficency virus).

2. On 3/14/11 at 10:35 AM, an initial tour of the ED at the Southwest campus was conducted. During the tour, the triage (area where ED patients are initially seen and ranked in order to be seen according to severity of illness), area was inspected. It was noted that white plastic blood pressure cuffs in three sizes, were available for use. Inspection of the white blood pressure cuff revealed that they were labeled by the manufacturer as "Single patient use."

During a concurrent interview, NM 6 was asked if the three blood pressure cuffs were used for all patients seen in the triage area. NM 6 stated that the three white blood pressure cuffs were used for all patients seen in the triage area.

3. During the tour of the ED on 3/14/11 at 10:50 AM, a cart labeled, "Epidural" (the outermost part of the spinal canal), was inspected. Inside the epidural cart, five pressure infusors (devices that are inflated to rapidly infuse fluids or hold pressure), labeled by the manufacturer as, "Replaceable." It was also noted that the five pressure bags were various shades of white, indicating the different age of equipment.

During a concurrent interview, NM 6 was asked what replaceable meant? NM 6, stated that she thought replaceable meant the items were disposable.

4. On 3/15/11 at 11 AM, an initial tour of the intensive care unit located at the Southwest campus was conducted. During the tour, the clean equipment storage area was inspected. It was noted that there were 28, white plastic pressure infusors were available for patient use. Inspection of the 28 pressure infusors revealed that they were stamped by the manufacturer as, "Replaceable." It was also noted that the 28 pressure infusors were various shades of white, indicating different age of equipment.

During a concurrent interview, Nurse G (intensive care unit charge nurse), was asked what replaceable meant? Nurse G, stated that she thought it meant the item was disposable.

5. On 3/15/11 at 2:30 PM, a tour was conducted of the intensive care unit located at the main hospital campus. During the tour the clean utility room was inspected. It was noted that 30 pressure infusors were available for patient use. It was noted that the 30 pressure infusors were various shades of white indicating that the equipment was different ages. It also noted that the manufacturer stamped the pressure infusors as replaceable.

During a concurrent interview, NM 5 (of the intensive care unit) confirmed that she was not aware that the pressure infusors were single patient use and were to be discarded.

6. On 3/16/11 at 10 AM, an initial tour was conducted of the surgery clean equipment storage area located at the main hospital campus. During the tour, 14 white plastic pressure infusors was observed available for use. Inspection of the 14 devices revealed that they were labeled as, "Replaceable" by the manufacturer. It was also noted that the 14 pressure bags were various shades of white, indicating different age of equipment.

During a concurrent interview with Director of Surgical Services (DSS) 1 was asked what replaceable meant? DSS 1, stated that he was not sure what replaceable meant. During the concurrent interview, Infection Control Specialist (ICS) confirmed that the white plastic pressure infusors were manufactured for single patient use.

The hospital failed to develop a system ensuring that items manufactured for single patient use, were not used for multiple patients.

7. On 3/16/11 at 11 AM, the following medical records were reviewed and documentation disclosed:

a. On 2/19/11, Patient 58, presented to the emergency department with an abscess (a pocket or collection of pus), on her right buttock. Documentation in the medical record disclosed that the physician drained the abscess and the diagnosed the patient with an infection probably due to methicillin resistant staphylococcus aureus (bacteria that is extremely contagious and resistive to many antibiotics used to treat staphylococcus infections). Documentation in the treatment record disclosed that the abscess was covered by a dressing prior to discharge, and that antibiotics were prescribed to treat the methicillin resistant staphylococcus aureus (MRSA) infection.

Documentation in the initial nursing assessment disclosed the patient had a history of having a MRSA infection.

A review of the patient's discharge instructions revealed that the patient was not provided written instructions on how to prevent transmitting the MRSA infection to other areas of her body or to other individuals.

b. On 2/20/11, Patient 17, presented to the emergency department with complaints of fever and a skin rash. Documentation showed that the patient was diagnosed with scarlet fever (acute contagious disease caused by a hemolytic streptococcus bacteria).

A review of the written discharge instructions revealed that the patient or responsible person was not provided with written instructions on how to prevent the transmission of scarlet fever (avoiding direct contact with saliva or mucus of the infected person), after being discharged from the emergency department.

c. On 2/15/11, Patient 59, presented to the emergency department complaining of an itchy rash. Documentation showed that the patient was diagnosed as having scabies (a contagious skin infection that occurs among humans and other animals by direct physical contact with the person infected with the scabies mite).

A review of the discharge instructions revealed that the patient was not provided written instructions about how to prevent transmitting scabies to other humans or animals.

The hospital failed to ensure that patients diagnosed with infectious or communicable diseases were given written discharge instructions to reduce the incidence of transmitting the diseases to family and community members.

8. On 3/14/11 at 10:30 AM, a tour was conducted of the Southwest Campus intensive care unit. During the tour, an interview was conducted with Housekeeper (HK) 1. HK 1 was asked about the products she prepared and used the products to disinfect the surfaces in the intensive care unit. HK 1, stated that the disinfectant was prepared for use by an automatic mixing dispenser. When asked about the kill time (required kill time listed on the U.S. Environmental Protection Agency registered label indicates the minimum amount of time the disinfectant must be in contact with the surface being disinfected).

HK 1, stated that she was not sure about the kill time. HK 1 stated that the disinfectant was new and was only used in the intensive care unit. When asked if she had printed information about the disinfectant, HK 1, stated that she did not have any printed information about the disinfectant.

On 3/15/11 at 11 AM, HK 1's personnel and competency files were reviewed. The personnel and competency files contained no documentation showing that HK 1 received training about the new disinfectant and was competent to use the disinfectant.

On 3/15/11 at 11:15 AM, an interview was conducted with the Director of Environmental Services (DES). DES stated that she had worked one on one with HK 1, when the disinfectant was brought into the hospital. When asked if she had documentation showing that HK 1 was trained to use the disinfectant, DES stated that she did not have documentation showing that training was provided on how to use the disinfectant. When asked if the hospital had printed information about how to use the disinfectant, DES, stated that currently, she did not have printed information available, but she had contacted the manufacture for the information.

The hospital failed to ensure that housekeeping staff were trained and competent to use the disinfectant, and that printed information was available as a resource for staff. Failure to ensure staff were trained and competent to use the disinfectant increases the risk of patients developing a hospital associated infection.

9. On 3/14/11 at 3 PM, a tour was conducted of the neonatal (pertaining to the first four weeks after birth), intensive care unit (NICU). During the tour the storage area between the two obstretical suites was inspected. It was noted a plastic basin contained long narrow cloth sleeves.

During a concurrent interview, the Director of Neonatal Intensive Care Unit (DNICU) was asked what the cloth sleeves were used for? DNICU stated the cloth sleeves were placed over devices that were used to position NICU patients. When asked how the cloth sleeves were laundered, DNICU, stated the cloth sleeves were laundered on site by housekeeping staff.

On 3/14/11 at 11:30 AM, site where the washing machine was located was inspected. It was noted the washer and dryer were a stackable unit. A sign posted on the outside of the washing machine disclosed that the washing machine was used to launder items for the NICU. No temperature gauges were observed nearby the washing machine indicating the temperature of the water to wash items for the NICU was monitored.

During a concurrent interview, the Director of Environmental Services (DES) was asked what type of detergent was used when the cloth sleeves were laundered, DES stated that the detergent was institutional grade without bleach. When asked, if the laundry wash temperature was monitored, DES, replied the temperature of the water used to launder the cloth sleeves was not monitored.

On 3/14/11 at 5 PM, Centers for Disease Control and Prevention (CDC), published 6/6/03/ 52(RR10);1-42, Guidelines for Environmental Infection Control in Health-Care Facilities was reviewed. Under the section titled, "Laundry process" CDC recommended: "A. If hot-water laundry cycles are used, wash with detergent in water >160?F (>71?C) for >25 minutes (1,270).... D. Choose chemicals suitable for low-temperature washing at proper use concentration if low-temperature (<160?F [<70?C ]) laundry cycles are used (365--370). Category II... "

The hospital failed to ensure that cloth sleeves used to cover positioning devices used to position patients in the NICU were laundered in a way that ensured the sleeves were sanitary reducing the risk of transmitting infectious diseases.

10. On 3/15/11 at 4:30 PM, Medical Staff Office Supervisor (MSOS) was interviewed. During the interview, MSOS was asked how frequent medical staff members (physicians), and allied health professional (nurse practitioners, physician assistant, and registered nurse surgical assistant), were screened for tuberculosis (TB), MSOS stated that medical staff members, and the allied health professionals were screened for TB at the time of initial appointment, and then other year when they were re-appointed. When asked approximately how many medical staff members and allied health professionals were on staff at the hospital, MSOS replied there were about 600 physicians and 30 allied health professionals on staff at the hospital.

On 3/15/11 at 5 PM, CDC's Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, published 12/30/05, was reviewed.

Documentation in the guidelines was that Healthcare workers (HCWs) 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 HCWs should be included in TB screening programs. All HCWs who have duties that involve face-to-face contact with patients with suspected or confirmed TB disease (including transport staff) should be included in a TB screening program. It was noted that the list of HCWs that should be included in a TB screening program included physicians and allied health professionals. Additional recommendations in the 2005, guidelines was that All HCWs should receive baseline TB screening upon hire, using two-step TST (TB skin test) or a single BAMT (blood assay mycobacterium tuberculosis) to test for infection with M. tuberculosis. After baseline testing for infection with M. tuberculosis, HCWs should receive TB screening annually (i.e., symptom screen for all HCWs and testing for infection with M. tuberculosis for HCWs with baseline negative test results). HCWs with a baseline positive or newly positive test result for M. tuberculosis infection or documentation of previous treatment for LTBI (latent TB infection), or TB disease should receive one chest radiograph result to exclude TB disease. Instead of participating in serial testing, HCWs should receive a symptom screen annually. This screen should be accomplished by educating the HCW about symptoms of TB disease and instructing the HCW to report any such symptoms immediately to the occupational health unit. Treatment for LTBI should be considered in accordance with CDC guidelines.

The hospital failed to develop and implement a policy and procedure ensuring that all HCWs were screened annually for TB. Failure to annually screen all HCWs for TB, places patients and other HCWs at risk of exposure to, and developing TB.

11. On 3/15/11 at 2:30 PM, Patient 15's medical record was reviewed. Documentation in the medical record showed Patient 15 was admitted to the intensive care unit on 3/7/11. Documentation showed that a peripherally inserted central line (PICC) was inserted on 3/9/11.

A review of the physician progress notes section, and physician orders disclosed there was no evidence that the physician had determined that continued use of the PICC line was medically necessary on 3/10/11 and 3/12/11 (two out of five days).

During a concurrent interview, Infection Control Specialist (ICS) confirmed that the patient's medical record contained no evidence that the physician had determined that continued use of the PICC line was medically necessary.

On 3/15/11 at 3 PM, the hospital's 2/09 policy and procedure titled, "Central line-associated bloodstream infection (BSI) prevention bundle" was reviewed. On page two, of the policy and procedure, under item 6, direction was that, ".... The risk of a bloodstream infection increases the longer the central catheter remains in place. The patient's physician will complete and sign a Central line Daily Assessment Form..."

The hospital failed to ensure that the policy and procedure to prevent the incidence of blood stream infections was implemented by HCWs. Failure to implement their policy and procedure places patients who have central venous catheters at risk of developing bloodstream infections.

12. On 3/15/11 at 2 PM, a tour was conducted of the locked unit located at the main hospital campus.

a. During the tour it was noted that pieces of trash and other refuse was scattered on the hallway floors. It was also noted that all of the walls in the hallways, and counter tops were sticky with some unknown substance. An inspection of the medication room revealed pieces of trash and obvious dirt scattered on the medication room floor.

b. An inspection of an open phlebotomy (contains supplies used to draw blood) box sitting on a supply shelf, disclosed a container of bottle of culture (blood or body fluid is inserted into fluid to test for presence organisms), media without a protective cap. Inspection of the bottle of culture media revealed evidence of two needle puncture marks in the rubber septum.

During a concurrent interview, Nurse Manager (NM) 3 confirmed that the locked unit needed to be thoroughly cleaned. When asked about the culture media that had been punctured, NM 3 stated that the culture media should have been discarded if the rubber septum was punctured with a needle and the culture media was not used.

The hospital failed to ensure that all patient care areas were routinely cleaned and sanitized, reducing the risk of staff and patients being exposed to infectious and communicable diseases. The hospital also failed to ensure that after a needle was inserted into a culture media, the bottle of culture media was discarded if not used. Reusing the vial of culture media places patients at risk of incorrect diagnosis and subsequent incorrect treatment.

Based on observation, interview, and review of hospital documents and staff interviews, the hospital failed to ensure an effective infection control system was developed and implemented.

1. The hospital failed to ensure an effective infection control system was developed in the dietary department as evidenced by safe storage and distribution of food. These deficient practices had the potential to result in growth of microorganisms that could result in food borne illness.

2. The hospital failed to ensure its nursing staff followed sound infection control practices as it relates to the hang times of tube feeding formula for two of 59 sampled patients (52 and 55).

3. The hospital also failed to ensure dialysis machines were safe for patient use as evidenced by:

a. Failure to ensure a dialysis machine was not available for use when the colony count (bacteria growth) was above acceptable range. This had the potential to cause device-associated infections to patients. Colony count is performed by counting number of individual bacteria growth on a plate contains nutrients.

b. Failure to ensure endotoxin (A toxin produced by certain bacteria and released upon destruction of the bacterial cell and could induce multiple-organ failure) level was performed monthly on dialysis machines which had potential to place patients at risk for shock (a circulatory medical emergency).

Advancement of Medical Instrumentation (AAMI) is a professional organization in which committees composed of representatives of the dialysis industry, providers, and regulatory agencies develop voluntary guidelines for medical products and procedures. AAMI practice guidelines are incorporated by referenced and are reflected in the Code of Federal Regulations. AAMI recommends every water distribution pipeline system including dialysis machines dialysis machine be tested for bacteria growth and endotoxin level every month. The acceptable colony count is 50 or less and the endotoxin level is 2 or less. When the colony count is greater than 50 or the endotoxin level is greater than 2, the dialysis machine must be pulled off the floor, cleaned, and tested again.

Findings:

1. During the tour of the kitchen of the Main Campus on 3/14/11 at 9:50 AM, a blender stored on the counter as cleaned was observed to have a build up of a tan colored substance visible from the glass container on top. Closer observation revealed that the base of the blender where the blade is attached was stuck to the rubber gasket/washer. After several attempts by three different employees to separate the clear container from the base, it was forcefully separated from the glass container. It revealed a build up of a black substance on and around the rubber gasket and the base of the clear container. Food service staff interviewed during the concurrent observation, stated there was no policy and procedure on the correct method to clean the blender.

2. At approximately 10:20 AM, inside refrigerator 8, there was a large stainless steel pan labeled "Brisket" and dated 3/13 and 3/15. According to the food service supervisor (FSS) who was present during the observation, the first number was the date it was placed in the refrigerator and the second date was the last date it could be stored. There were seven pieces of cooked brisket each about 8 inches by 6 inches and about 5 pounds (lbs) each. The cooked brisket pieces were stacked on top of another and on the bottom of the pan was congealed meat juices.

Temperatures of the brisket pieces varied from 42.4 to 43.3 degrees Fahrenheit. The FSS stated that she was unsure when the brisket was placed in the refrigerator. She stated that there was no cooling log completed on the cooling process of the brisket. Review of the hospital menu revealed that the refrigerated brisket was leftover from the Yankee Pot Roast prepared the previous day for lunch.

The cook (1) who stored the brisket in the refrigerator was interviewed on 3/14/11 at approximately 11:22 AM. She explained that the brisket was placed in the refrigerator at approximately 5:30 PM after it had been taken off the cafeteria and patient traylines. In response to whether she had followed proper cooling process of food cooling from 140 degree Fahrenheit to 70 degrees Fahrenheit within 2 hours and further cooling to 40 degrees or below within 6 hours; she stated that she did not have adequate time to complete the cooling because the department was short-staffed because many employees had been out sick.

The brisket had been stored in the refrigerator for approximately 16 1/2 hours and had not cooled down to the recommended temperature of 40 degrees or less within six hours. Improper cooling of potentially hazardous food could result in growth of microorganisms that causes food borne illness.

Further interview revealed she was knowledgeable on the proper procedure but had failed to follow them. Also stored in the same refrigerator on a cart across from the counter where the brisket had been found, was a cart with several containers of food stacked on top of other containers and on the shelves on the cart. There was LS (low sodium) carnitas, chicken cordon bleu, black beans, gravy. These items were leftovers from meals served days before. The food temperatures of these food varied 39.3 to 44 degrees Fahrenheit.

3. During an interview with the Chief Registered Dietitian (RD) 1 on 3/15/11 at approximately 10:10 AM, she indicated that patients on regular diets are given the option to choose menu items from the cafeteria line. On 3/15/11, at approximately 11:27 AM, refrigerator 6 in the cafeteria area was observed to be without an internal or external thermometer. The other refrigerators in the area had thermometers and logs to indicate monitoring. When Chief RD 1 was interviewed about the lack of monitoring for refrigerator 6 she stated that they take the temperature of refrigerator 5 and had no explanation why 6 was never monitored.

At about 11:30 AM on 3/15/11, Cook 2 was asked for temperature log for the cold items in the salad bar area. She stated that she did not have logs for the cold foods because the salad bar was the responsibility of the cold prep employees. Interview on 3/15/11 at 12 PM with food service worker(FSW) 2 in the cold food preparation area; FSW 2 stated that she does not take food temperatures because the food is taken from the refrigerator and directly placed on ice in the salad bar. In addition she stated that she assumed that the server on the cafeteria line was recording food temperatures. FSW 2 stated that she had worked in her position for seven years and had never recorded food temperatures prior to placement in the salad bar.

The lack of monitoring of cold food prior to placement in the cafeteria, could result in the service of food that may have been held in the food danger zone (41 -135 degrees Fahrenheit). Foods held in the food danger zone could support the growth of microorganisms, someone of which could produce toxins that are not killed during heating or cooling and could result in food borne illness.

4. During tour of the kitchen on 3/14/11 and 3/15/11, several green sanitizing buckets (a two compartment bucket containing a squirt bottle filled with a chemical sanitizer in one compartment and another compartment with a cloth soaking in a chemical sanitizer) were stored on top of the kitchen counters next to the sinks. The storage of these sanitizing buckets posed a risk of chemical splashing and contaminating food that may be in the same area.

On 3/15/11, FSS and Chief RD 1 were asked concurrently why the buckets were stored on the counters and the concern about the potential for chemical contamination was raised. Both had no explanation why these buckets were stored on the counters. The buckets were removed and stored in the lower shelves away from food.

The hospital failed to ensure that there was a effective infection control monitoring system in place to ensure safe storage and distribution of food.

5. The clinical record for Patient 55 was reviewed. Patient 55 was admitted to the hospital with diagnoses including dehydration (loss of water and minerals necessary for normal body function) and dysphagia (inability to swallow as a result of injury to the parts of the brain that control the muscles for swallowing). Her tube feeding (a feeding tube is a medical device used to provide nutrition to patients who cannot obtain nutrition by swallowing) order was for a "G-tube feed with lactose free formula".

At approximately 4:15 PM on 3/15/11, a tube feeding bag was observed hanging on a pole next to the patient. The bag was labeled with the rate of 20 ml/hour and date of 3/15/11 no time. There was approximately 240 ml of feeding left in the bag. The feeding bag was an "open" system. An open system of tube feeding is one in which the formula is opened and poured into a bag by hospital staff as compared to a "closed" system in which the formula is prefilled and hermetically sealed by the manufacturer.

The patient's nurse was interviewed at approximately 4:20 PM on the hospital's procedure for the management of a patient receiving tube feedings. She explained that the night shift nurses hung the tube feeding daily and that the feeding bag may have contained about 2 cans (500 milliliters) worth when she came in to work that morning. She stated that she had not added any more formula to the bag.

Review of the hospital's policy and procedure titled "Medication management" revised 4/10, showed "if using the open system only 12 hours worth of feeding will be added to the delivery set and should be hung no longer than 12 hours." A reference book titled Clinical Procedures which the Nurse M of Quality Management described as the hospital reference stated "....add a 4-hour volume of formula in bag."

Interview with other nurses indicated the bag is changed everyday at midnight. The patients's tube feeding had been hanging for approximately 16 1/2 hours, 4 1/2 hours longer than is the hospital policy and 12-1/2 hours longer than the hospital reference book. The rationale provided by the reference book for adding only 4 -hr volume is that it "prevents the leakage from excessive volume and spoilage of formula hanging too long without refrigeration".

The hospital failed to ensure that its nursing staff followed sound infection control practices as it relates to the hang times of tube feeding formula.



28773

6. During the initial kitchen tour of the Southwest Campus on 3/14/11, at approximately 10 AM, multiple stainless steel pans of previously cooked potentially hazardous food items were identified in one of the walk-in refrigerators. These food items were in pans as follows:

a. Mashed potatoes, dated 3/10/11, expiration date of 3/13/11.
b. Low sodium peas, dated 3/10/11, with no expiration date.
c. Low sodium Chinese pepper steak, dated 3/9/11, expiration date 3/12/11.
d. Cooked bowtie pasta, dated 3/11/11, no expiration date.
e. Cooked bowtie pasta, dated 3/10/11, no expiration date.
f. Low sodium gravy, dated 3/9/11, expiration date 3/13/11.
g. Cooked white rice, dated 3/11/11, expiration date 3/13/11.

An interview was conducted with Chief RD 2 on 3/14/11, at approximately 10:05 AM regarding how long foods can stay in the refrigerator. Chief RD 2 stated, the peas or vegetables can stay for five days but all other food items are three days.

An interview was conducted with the Chef on 3/17/11, at approximately 10:15 AM, regarding the expiration date of foods. The Chef stated all food items are good for three days.

Review of the hospital's policy and procedure titled labeling, dating, covering food, undated policy number 600.12, showed the expiration date will be three days from opening or use of the product with the exception of poultry, being two days. Items will be discarded the "day" of expiration, by the end of the day.

7. During the initial kitchen tour on 3/14/11, at approximately 10:15 AM, a stainless steel pan of tuna salad and egg salad were identified in one of the reach-in refrigerators. The reach-in refrigerator temperature was at 40 degrees Fahrenheit (F). The pan of tuna salad, dated 3/13/11 at 4 PM, expiration date of 3/16/11. The temperature of the tuna was 45.9 degrees F. The pan of egg salad, dated 3/13/11, expiration date of 3/16/11. The temperature of the egg salad was 45.7 degrees F.

An interview was conducted with Chief RD 2 on 3/14/11 at approximately 10:20 AM; she stated the food should be below 40 degrees F. Chief RD 2 stated they open and use the refrigerator at lot during food preparation times.

On 3/14/11, at approximately 10:25 AM, lunch tray line was observed to be in process. The hospital uses a cook chill system which food is cooked food a couple days ahead of time, then cools the food and on the day of service the cold food items are taken from the refrigerator and placed on the patient trays. The trays are then placed in a docking station [where the cold food is docked onto a unit that will re-heat by convection when the timer is set to begin cooking food to be hot (approximately 165 degrees Fahrenheit) and will keep the cold food cold (less than 40 degrees Fahrenheit)]. As part of the evaluation of hospital meal service, the surveyor requested to see the food temperatures that staff may have recorded prior to the start of lunch tray line. The temperatures that were shown were not from lunch tray line, they were only of the food items once they are re-heated. There is a possibility the food that was stored may have been in the food danger zone which would encourage the growth of microorganisms and toxins that may not be killed by heating.

An interview was conducted with Chief RD 2 on 3/14/11, at approximately 10:28 AM, regarding food temperatures on tray line. Chief RD 2 stated they do not take cold food temperatures before or during tray line.

An interview was conducted with food service worker (FSW) 1 on 3/14/11, at approximately 11:15 AM. FSW 1 stated she makes the tuna and egg salad. She will get the tuna, eggs, and mayonnaise out of the walk-in refrigerator then will make them. FSW 1 stated she will not take any temperatures of the tuna or egg salads but the cafe worker will take them before they place in the salad bar.

An interview was conducted with the Chef on 3/14/11, at approximately 11:20 AM. The Chef stated the first temperature taken of the egg and tuna salads would be by the cafe worker. The Chef stated since the refrigerator is monitored and the temperatures of the refrigerator are okay then they are not concerned.

An interview was conducted with the Chef on 3/14/11, at approximately 11:45 AM. The Chef stated they cook food three days a week for patient meal service. The Chef stated on Monday they cook food to be served on Tuesday and Wednesday, on Wednesday they cook food to be served on Thursday and Friday; and on Friday they cook food to be served on Saturday, Sunday, and Monday.

An interview was conducted with Chief RD 2 on 3/14/11, at approximately 2:30 PM. Chief RD 2 stated the food comes from the refrigerator and the refrigerator temperatures range from 33 to 40 degrees F so she assumed the food is in that range. Chief RD 2 stated they have no system to verify the temperatures of food on the tray line.

During an interview with the Chef on 3/14/11, at approximately 2:40 PM, he stated the tuna and egg salad can be used for patients as well as for the cafeteria.

Review of the hospital's policies and procedures, titled food preparation and food preparation/production, did not show that any cold food temperatures needed to be taken except when the staff would be thawing foods.

8. Review of the medical record for Patient 52 was initiated on 3/14/11. Patient 52 was admitted to the hospital on 3/8/11 with diagnoses that include acute (sudden) respiratory failure (a condition in which not enough oxygen passes from your lungs into your blood) and acute renal failure (loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes).

Review of the physician's orders dated 3/9/11 at 70 AM, showed a tube feeding (TF) order for Nepro at 10 milliliters (ml) per hour and to increase to 50 ml per hour. Another physician's order dated 3/12/11 at 1:30 PM, showed to increase TF to 60 ml per hour.

Patient 52 was observed on 3/14/11 at approximately 4:50 PM, with a TF bag being hung next to the bed. The TF bag was an open system containing a label that showed Nepro with a goal of 60 ml per hour, dated 3/14/11. No time was documented on the label. There was approximately 300 ml of Nepro in the bag at this time.

An interview was conducted with Nurse J on 3/14/11, at approximately 4:55 PM. Nurse J stated the TF bag and tubing is changed during night shift at midnight for all types of TF. The night shift will label and date the TF bag when they hang it.

An interview was conducted with Chief RD 2 on 3/15/11, at approximately 2:40 PM regarding the TF system at the hospital. Chief RD 2 stated they use both open and closed system at the hospital and Nepro is in cans so the open system will be used.

An interview was conducted with Nurse K on 3/15/11, at approximately 3 PM regarding TF hang times. Nurse K stated they change the bags for both an open and closed system and the tubing every 24 hours. They will then chart in the medication administration record once that it is done and complete.

Review of the medication administration record, dated 3/14/11, showed at 0000 hours, new tubing and new bag of Nepro was hung. The nurse's initials were next to this indicating it was completed.

Review of the hospital's Tube Feeding Formulary list, dated 6/08, showed the hang time for canned formula is eight hours.

Review of the hospital's policies and procedures titled Enteral Feeding, dated 7/93 and revised on 4/10, showed when using the open system, only 12 hours worth of feeding will be added to the delivery set and should be hung no longer than 12 hours. Feeding pumps, delivery sets, and syringes will be labeled with the patient's name and date. Delivery sets and syringes will be changed every 24 hours.



25558

9. On 3/17/11, during a concurrent interview and record review, the Director of Nursing Informatics (DNI) stated that the hospital contracted the dialysis services to three dialysis providers depending on the type of insurance each patient had. Each dialysis provider tested and maintained own dialysis machines. A report from each provider was sent to the Infection Control Specialist (ICS) for review. While reviewing a dialysis provider's (DP) A "Machine & Water Cumulative Trending Report," DNI stated that DP A used only three machines (A25, A 26, and A 29) in the main campus. It was noticed one of the dialysis machines (A25) had a colony count of 1010 on 9/21/10. It was more than 20 times the acceptable range. There was no documentation that machine A 25 was cleaned and re-tested. DNI was also unable to verify that machine A 25 was pulled from the floor.

10. On 3/17/11, during a concurrent interview and review of "Machine & Water Cumulative Trending Report," noticed DP A did not perform monthly endotoxin levels on all of its three dialysis machines (A 25, A 26, and A 29) for the year 2010. DNI stated she was not aware that both colony count and endotoxin levels were required to be completed monthly. After DNI further searched for documents, she returned and stated she was not aware of the change and agreed that both tests should have been done monthly.

Based on review of clinical record and staff interviews, the hospital failed to ensure that the nutritional needs for one of 59 sampled patients (56) was evaluated prior to discharge. This failure could result in the patient being sent home with a tube feeding that exceeded his nutritional need.

Findings:

The clinical record of Patient 56 was reviewed. Patient 56 was admitted to the hospital on 3/10/11 with discharge diagnoses including malposition of PEG (percutaneous endoscopic gastrostomy-surgical procedure which placing a tube for feeding through a small incision in the abdomen) tubes. A PEG is a surgical opening into the stomach used for feeding usually via a feeding tube called a gastrostomy tube, but it does not necessitate doing an operation to open the abdomen. Other diagnoses include s/p (status post) replacement, mild superficial localized infection of PEG and, history of throat cancer.

The registered dietitian conducted an initial nutrition assessment on 3/14/11. The nutritional needs assessed by the dietitian was 1700 to 2100 calories per day.(cross refer A622). She recommended the patient receive 2160 kcal's (kilocalories) via tube feeding. Patient 56 was 90% of his ideal body weight range.

His physician wrote discharge orders for him on 3/16/11 which included "Jevity 1.5, a nutritional supplement, 2 cans per PEG QID (four times a day)". As written, the tube feeding order would have provided approximately 2840 calories per day. The patient would have received between 740 and 1140 more calories than he was assessed.

If the intent of the physician was to ensure weight gain by giving added calories because the patient was underweight, the hospital's registered dietitians did not take it into consideration when the initial assessment was conducted. The registered dietitian was not called for a consultation to provide advice on how much the patient needed for his tube feeding on discharge.

Chief Registered Dietician (RD) 1 who was present asked the unit charge nurse on 3/16/11 at approximately 11:30 AM about the tube feeding order. Nurse Manager (NM) 3 stated that it was for a bolus feeding (feeding via tube a set volume of feeding several times a day). The patient was on continuous feeding while in the hospital, Chief RD 1 stated concurrently that a nutrition consultation is needed when a patient is discharged home on a bolus feeding. NM 3 stated he was not aware Patient 56 needed consultation.

The RD conducted a reassessment and made recommendations to the physician on 3/16/11 after the physician's discharge tube feeding order was brought to her attention by the surveyor who had reviewed the patient's clinical record.

The hospital lacked an effective system to ensure that patients that could benefit from nutrition assessment or medical nutrition therapy received it at discharge.

Based on observation, interview and document review, the hospital failed to ensure that surgical services were in accordance with acceptable standards of practice as evidence by:

1. Failure to ensure that implantable devices (like hip and knee joint replacements that are left inside a patient) were not routinely flash sterilized (a quick method of sterilization). (Refer to A 951, item 1)

2. Failure to ensure that surgical mask were worn in operating rooms when sterile equipment and supples were open. (Refer to A 951, item 2)

3. Failure to ensure that all operating rooms maintained the minimum number of air exchanges to reduce the risk of cross contamination. (Refer to A 951, item 4)

4. Failure to ensure that reusable hair covering were laundered daily by a health care accredited laundry. (Refer to A 951, item 5)

5. Failure to ensure that instruments were open when sterilized, and that an indicator strip was placed inside each package to ensure sterility. (Refer to A 951, item 6)

The cumulative effect of these systemic failures resulted in the hospital's inability to provide surgical services in a manner that reduced the risk of cross contamination and the potential of patients developing surgical site infections.

Based on observation, interview, and document review, the hospital failed to ensure surgical services policies and procedures were designed to assure high standards of medical practice.

Findings:

1. On 3/16/11 at 10 am, a tour was conducted of the surgical services area. During the tour, the Director of Surgical Services (DSS) 1 was asked how often the department flashes (rapid) sterilized instruments and supplies. DSS 1 stated that the surgery department used flash sterilization about 20 percent of the time. When asked if implantable devices (like hip and knee replacements that are left inside a patient), were flashed DSS 1 replied, "yes".

During the tour a white binder was observed sitting on a counter. It was noted that the binder was labeled, flash log. A review of documents inside the "flash log" disclosed that since 1/11 to 3/15/11, surgery flash sterilized 104 loads (all items placed in the sterilizer at one time).

During a concurrent interview, a request was made for the number of implantable devices that were flashed during the same time period.

On 3/16/11 at 11 am, documentation provided by DSS 1 revealed that 21 implantable devices were flash sterilized from 1/1/11 to 3/15/11.

During a concurrent interview, DSS 1 was asked to describe what the hospital was doing to reduce the incidence of flash sterilization. DSS 1 replied, "We are working on it."

On 3/16/11 at 2 PM, the hospital's 2/11 policy and procedure titled, "Sterilization of implants in the operating room" was reviewed. On page 1, under the statement section, direction was given that, "Sterilization of implants in the sterile core will only be done when: There is urgent need for the items, and there is no alternative. Such an emergency situation is to be considered to be an exception and not a routine occurrence."

On 3/16/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of periOperative Registered Nurses (AORN) was reviewed. On page 469, under section IV.g., AORN recommended that, "Flash sterilization should not be used for implantable devices except in cases of emergency when no other option is available. Implants are foreign bodies and they increase the risk of surgical site infection..."

The hospital failed to ensure that implantable devises were not routinely flash sterilized increasing the risk of patients developing surgical site infections.

2. On 3/16/11 at 10 AM, a tour was conducted of the surgical services area. During the tour, DSS 1 was asked if surgical masks were worn during all surgical procedures performed in the operating rooms. DSS 1 stated that the hospital did not require that surgical masks be worn during cystoscopy. (The cystoscope is inserted into your urethra and slowly advanced into the bladder. Surgical instruments can be inserted through the cystoscope that allow your doctor to remove samples of tissue or samples of urine.) When asked for additional information/clarification, DSS 1 replied that urologists (a physician who has specialized knowledge and skill regarding problems of the male and female urinary tract and the male reproductive organs) did not consider cystoscopy a surgical procedure. When asked if sterile equipment and supples were used for cystoscopy procedures, DSS 1 replied, "yes".

On 3/16/11 at 2 PM, the hospital's 7/05, policy and procedure titled, "Traffic patterns in the operating room" was reviewed. On page 1 of the policy and procedure direction was given that restricted (areas within the surgical area that requires strict environmental control and surgical attire (clothing that is only worn within the surgical services area) area included the operating rooms. On page 2, under the action section, direction is given to put on surgical attire and mask when entering the restricted area.

On 3/16/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perOperative Registered Nurses (AORN) was reviewed. On page 95, under Recommendation I, under the restricted area section, direction is given that the restricted area included the operating rooms, procedure rooms, and the clean sterile core. Additional direction provided guidance that, "Masks are required where open sterile supplies or scrubbed persons are located..."

The hospital failed to implement their policy and procedure ensuring that surgical masks were worn in the operating rooms when sterile supplies were open. Failure to ensure that surgical mask were worn when sterile supples were open, placed patients patients at risk of developing surgical site infections.

3. On 3/14/11 at 3 PM, a tour was conducted of the women's service department. During the tour it was noted that the women's service area had two operating rooms (operating rooms where cesarian (surgery where a baby is delivered through a surgical incision) section were performed. During the tour, a request, was made for a copy of the air exchange rate for the two operating rooms in the women's service area.

During an interview on 3/15/11 at 11 am, the Director of Facilities (DF) was asked for the air exchange report for the operating rooms located in the women's service area. DF stated, he had no documentation showing that the air exchange rate had been determined or maintained for the operating rooms located in the women's service area.

On 3/16/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perOperative Registered Nurses (AORN) was reviewed. On page 218, under Recommendation V, AORN directed that, "Air in the perioperative environment contains microbial-laden dust, lint, skin.. and respiratory droplets.....Outbreaks of surgical-site infections have been traced to airborne contamination from colonized health care workers" (health care workers carry evidence of the organism without signs of infection such as a temperature). On page 219, under item V.d.1., AORN recommended that, "The minimum rate of total air exchanges per hour should be maintained as a constant level as follows. Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...."

The hospital failed to develop and implement a process ensuring that operating room maintained the minimum number of air exchanges to reduce the incidence of patients developing surgical site infections.

4. On 3/16/11 at 10 am, a tour was conducted of the surgical services area located at the main hospital campus. During the tour it was noted 1/3 to 1/2 of the staff working in surgery were wearing reusable hair coverings.

During a concurrent interview, DSS 1 was asked if the hospital's laundry, laundered the reusable hair covering. DSS 1 stated that if operating room wore reusable hair coverings, they were responsible for laundering them.

On 3/16/11 at 4 PM, the hospital's 7/05, OR (operating room) attire policy and procedure was reviewed. Direction in the policy and procedure was that OR garments should be laundered daily in a laundry approved and monitored by the hospital. It was noted that the policy directed that OR staff were to cover all head and facial hair while in the semi-restricted and restricted areas.

On 3/16/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perOperative Registered Nurses (AORN) was reviewed. On page 62, under item IV.a.2., AORN recommended that, "Reusable head coverings should be laundered in a health care accredited laundry after each daily use."

The hospital failed to ensure that reusable hair coverings worn in the operating room were laundered daily by a health care accredited laundry reducing the risk of cross contamination and surgical site infections.

5. On 3/16/11 at 10 am, the sterile storage area inside the surgery services area was toured. During the tour, sterilized instruments in individual pouches were inspected. It was noted that all of the scissors were closed or shut when sterilized. It was also noted that there was not an indicator strip (a piece of paper that changes colors when the contents have been sterilized).

During a concurrent interview, DSS 1 was asked if he considered the closed instruments as sterilized. DSS 1 replied that instruments should be opened when sterilized. When asked if an indicator strip should be placed in each instrument pouches, DSS 1 stated that it was hospital practice to place an indicator strip inside each individual instrument pouch.

On 3/16/11 at 5 PM, the hospitals' 7/05 sterilization policy procedure revealed that instruments such as scissors were to be open when sterilized, and that an indicator strip was to be placed inside each instrument pouch.

On 3/16/11 at 5 PM, the 2011, Perioperative Standards and Recommended Practices, published by the Association of perOperative Registered Nurses (AORN) was reviewed. On page 453, AORN recommends that an indicator strip be placed inside each package to be sterilized. In addition, AORN recommends that instruments should be open during sterilization to ensure the surfaces are sterilized.

The hospital failed to ensure that instruments were open when placed in the sterilizer, and that an indicator strip was placed inside each package to ensure sterilization.