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Based on document review the hospital failed to ensure the staff met applicable standards required by State law at California Business and Professions Code 2586 (d) (1) when the Diet Technician and the Diet Technician Registered were developing patient care plans a form of nutritional or dietary therapy.

Findings:

On 3/7/12 at 9:00 a.m., the job description of the Diet Technician II was reviewed. The Performance expectations 1.1 stated "Designs and implements a nutrition care plan based on established nutrition screening."

The job duties assigned were in conflict with the California Professions and Business Code.

Based on observation, interview, and record review, the hospital failed to provide visual privacy for patients laying on gurneys (a wheeled patient stretcher) in the hallways of the emergency department. As a result, patients laying on gurneys in the hallways of the emergency department did not have visual privacy while in the emergency department.

Findings:

During an observation on 3/5/12 at 10:32 a.m., accompanied by the chief nursing officer (CNO) and manager 8, a patient was laying on a gurney in the hallways outside of an examination room while in the emergency room (ER). A licensed nurse was obtaining vital signs of the patient. The patient was not given any privacy during the obtaining of the vital signs.

During an interview on 3/6/12 at 10:18 a.m., a licensed nurse (LN 11) indicated the hospital does not have any type of portable privacy curtains for patients laying on gurneys in the ER hallways. LN 11 explained the ER has a total of seven patient gurneys.

Review on 3/9/12 of the policy policy and procedure titled " Patient's Rights and Responsibilities" dated 6/11, indicated "examinations and treatments are confidential" and "privacy curtains" will be used.

Based on record review, observation, and interview, the hospital failed to protect the confidentiality of patient medical records. Computer screens were not protected in a manner to prevent viewing by unauthorized individuals. Information on computer screens was visible to unauthorized individuals. The failure had the potential of patient protected information being seen by unauthorized individuals.

Findings:

1. Review on 3/5/12 of the hospital policy and procedure titled "Patient's Rights and Responsibilities" dated 6/11, indicated "You (the patient) have the right to confidential treatment of all communications and records pertaining to your care and stay in the hospital."

Review of the hospital policy and procedure titled "Safeguarding PHI (protected health information) and Sensitive Information" dated 8/22/08, indicated "In non-restricted areas where sensitive information is maintained and access is not controlled, or otherwise restricted, business unit or department managers shall implement the following safeguards: keep information that is electronically displayed from view of unauthorized individuals. For example, this may require the use of privacy screens, physical re-orientation of the monitor, password protected screen savers, or other appropriate methods."

Review of the hospital policy and procedure titled "Confidential Information" dated 11/11, indicated "Confidential patient information can include computerized patient data."

a. Observation and concurrent interview on 3/5/12 at 11:10 a.m., on "2 South" of the hospital, accompanied by director 1, director 2, and manager 3, a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen. A licensed nurse (LN 5) was inside the patient room. As LN 5 exited the patient room, LN 5 explained that she was not the nurse assigned to the patient and did not know why the computer screen had not been turned off and indicated hospital staff are to "sign off and never leave (the computer screen) unoccupied" when not sitting in front of the computer screen. LN 4 explained that she was assigned to take care of the patient. LN 4 explained the computer "should have been turned off."

b. Observation on 3/5/12 at 11:55 a.m., on "2 North" of the hospital, accompanied by director 1, director 2, and manager 3, a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

c. Observation on 3/5/12 at 12:37 p.m., on the "4 North" of the hospital, accompanied by the chief nursing officer (CNO) and manager 6, outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

d. Observation on 3/5/12 at 1:45 p.m. on "3 South" of the hospital, accompanied by director 1 and manager 5 a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

Interview on 3/5/12 at 2:15 p.m. with the compliance and privacy officer (CPO), the CPO explained privacy screens "are needed."

Based on review of the facility's medication error report and interview with facility staff the facility failed to ensure that corrective action had been taken for all of the hospital's staff which were involved in this medication error and that the limited corrective action had been put into place, which would prevent this type of medication error from reoccurring at the facility in the future.

Findings:

Review of the facility's "official" medication error report on 3/8/12 at 2:30 p.m. revealed that a neonatal patient had been admitted to the facility's Neonatal Intensive Care Unit (NICU) at the end of 10/11. During this patient's stay, the patient's Physician had written an order for the incorrect dose of medication. The facility's Pharmacist filled this medication order and Nursing administered the medication to the patient. Further review of the report revealed that an extensive plan of corrective action had been outlined for the Nurse involved in the medication error. Pharmacy's portion of corrective action in this report was very minimal and a more detailed list of corrective actions could have been developed in the medication error report to ensure that this type of medication error would not reoccur with Pharmacy staff in the future. At least 1 out of the 3 corrective actions proposed for the facility's Pharmacist had not been implemented; almost five months after the corrective action plan had been developed by the facility's Quality Assurance Committee according to the report. Interview with the facility's Director of Pharmacy on 3/8/12 at 3:45 p.m. revealed that more elements for correction could have been taken to ensure that this type of event would not reoccur with the facility's Pharmacists in the future. The facility's corrective action report for this medication error was silent on any corrective actions which could have been implemented by the facility to ensure that this type of medication error did not reoccur with the patient's Physician, who had written the medication order incorrectly. This medication error originated, with the Physician, however no corrective action had been documented in the facility's plan of action. The facility's failure to address in detail each of the elements above, prevented the hospital from developing a mechanism which included feedback and learning for the Physician and to a lesser degree the facility's Pharmacist, who had both been involved in this medication error.

Based on record review and interview, the facility failed to ensure the medical staff enforced its bylaws.

1. The medical staff bylaws indicated a physician will have its medical privileges suspended for delinquent medical records. Four physicians (P2, P3, P4, and P5) on the suspension list were still able to admit and take care of patients on the floor, schedule and and perform surgery.

2. The medical staff bylaws define what type of history and physical needs to be completed prior to patients undergoing surgery. A physician (P1) completed an abbreviated history and physical instead of a history and physical.

Findings :

Review on 3/5/12 of the hospital Medical Record Suspension Policy dated 3/7/2011, indicated that "physicians who are suspended for delinquent medical records, expired licensure, and expired malpractice insurance" have restrictions" which include "may not admit patients, schedule surgeries or other invasive procedures, perform surgery unless case was scheduled prior to suspension, give anesthesia, consult, or provide any professional services in the hospital other than continue to care for their patients in the hospital at the time of suspension, admit a patient only in a life-threatening situation, schedule outpatient tests / procedures which are not performed by the suspended physician, admit patients while on ER call, perform surgery if case was scheduled prior to the suspension."

Review on 3/5/12 of the hospital's Medical staff by laws dated January 2012 indicated that the medical executive committee shall be accountable to the medical staff. The duties of the Medical Executive committee include reviewing "issues regarding medical records related to medical record suspension, delinquent rates, new forms and policies."

1. During record review and concurrent interview with director 7 on 3/8/12 at 1:30 p.m. of the facility census, medical staff bylaws, medical record suspension policy, list of suspended physicians, director 7 explained that as of 03/05/12, there were 594 delinquent medical records. Director 7 explained that medical records are considered delinquent if not completed within 14 days after a patient is discharged. A medical record shall not be considered close until it is completed by the responsible practitioner or is ordered closed by the Medical Executive Committee.

The physician suspension list dated 3/5/2012 had a total of 29 suspended physicians. 25 physicians placed on suspension list were due to incomplete medical records and four physicians for lack of documentation of malpractice insurance and delinquent medical licensure. The incomplete medical records were from 10/05/11 to 2/29/12.

Review of the current census dated 3/5/12 revealed that physicians were admitting, consulting, and providing professional services even though they were on the suspension list. P2, P3, P4, and P5 were providing services to patients although their privileges had been suspended.

P2' s privileges were suspended 2/22/12. P2 was providing consultative and professional services to five patients currently admitted in the facility, N17, N20, N28, N33, and N34. All patients except N17 were admitted after 2/22/12, the date P2's privileges were suspended.

P3 was suspended 2/15/12. P3 was providing services to four patients currently admitted in the facility: N13, N21, N23, and N35, all admitted after 2/15/12. P3 scheduled a surgical procedure for 3/7/12 on 2/21/12 even though P3 was still on the suspension list.

P4's privileges were suspended 2/29/12 . As of 3/5/12, P4 was providing services to three patients currently admitted in the facility. Two of the three patients N22 and N36 were admitted after P4's clinical privileges were suspended.

P5 admitted and provided professional services to N19 since 2/15/12 even though his privileges had been suspended 1/18/12.

Director 7 explained that the list of physicians on the suspension list with delinquent records is sent to the medical executive staff every week. The list of suspended physicians is made available to all facility staff on the Quadrimed (hospital computer software accessible to all staff) including the admitting personnel at the Emergency room department. Director 7 was not able to explain why the physicians on the list were able to admit and provide consultative and professional services even though their privileges had been suspended. Director 7 indicated that the Medical executive committee should have enforced the policy.

Interview with director 3 on 3/8/12 at 8:20 a.m., director 3 explained the suspension list is constantly updated. Facility staff can view the most current version of the list on the hospital computer system at any time. Physician names are removed from the suspension list once medical records are completed, proof of insurance, or proof of license is completed.

Interview with surgery scheduler (SS) on 3/8/12 at 8:30 a.m., she explained that she is responsible for the scheduling of surgery cases. The SS indicated she is aware of the suspension list. She could not explain how a suspended physician was allowed to schedule a surgical procedure.





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2. Review on 3/7/12 of "Medical Staff Bylaws" dated 1/12, indicated, "Short form: the abbreviated hospital short form H&P report, or equivalent, may be utilized in any case of illness, injury or operation of a minor nature requiring hospitalization for less than 48 hours."

On 3/7/12 review of Patient N31's record revealed Patient N31 was scheduled for a carotid endarterectomy (a surgical procedure where a vascular surgeon removes the inner lining of the carotid artery [the main artery in the neck supplying blood to the brain] if it has become thickened or damaged. The procedure eliminates a substance called plaque from the artery and can restore blood flow to the brain.) A short form history and physical was completed by the surgeon.
Interview on 3/7/12 10:30 a.m. with director 10 and manager 8, they explained a carotid endarterectomy is "not a minor operation." They both indicated the surgeon should have completed a history and physical, not the short form history and physical.

Based on interview with facility staff and review of documents the hospital failed to ensure that the medical staff bylaws included a requirement that a medical history and physical examination be completed and documented for each patient prior to surgery or a procedure requiring anesthesia services.

Findings:

Review of the medical staff bylaws revealed the statement that a medical history and physical examination (H & P) could be dictated as a preamble to the procedure note for outpatient procedures performed in the gastrointestinal, pulmonary, cardiac, and other special procedure laboratories. This was confirmed in an interview with the director of medical staff services on 3/6/12 at 8:45 a.m. However an H & P dictated as part of the procedure note would not be available prior to surgery or the procedure as required.

Based on observation, staff interview and document review, the hospital failed to evaluate the nursing care for one Patient (D1) when significant weight changes were not evaluated and the physician notified and intake and output was not consistently documented and evaluated. This is a potential of compromising patient medical care.

Findings:

Patient D1 was admitted 2/21/12 with diagnoses of severe gallstone-induced necrotizing pancreatitis, peritonitis, anemia, borderline hypokalemia, and hyperglycemia. Medical record was reviewed 3/6/12.

1. Review of the weights trend report showed weights:

2/21/12 99.8 kilograms
2/21/12 99.8 kilograms
2/25/12 117.9 kilograms
2/26/12 119.16 kilograms
2/27/12 119.88 kilograms
2/29/12 110.50 kilograms
3/1/12 109.81 kilograms
3/3/12 107.5 kilograms
3/4/12 108.0 kilograms
3/5/12 108.0 kilograms
3/6/12 100.56 kilograms

Review of the paper and electronic medical record on 3/6/11 starting at 9:00 a.m. with the Nurse Manager 2 North and LN 1 could not show documentation of notification of the physician of the patient ' s significant weight changes for the period of 2/21/12 to 3/6/12. Patient D1 had significant weight gain while in ICU and continued weight loss on the med surg floor. The Nurse Manager 2 North was unable to show documentation by the RNs identifying the weight changes and evaluating their significance to patient care. Nurse Manager 2 North acknowledged the weight changes were critical and should have been noted by the RN overseeing the patient care and the physician notified.

In addition, in review of the weight changes the electronic medical record did not record how the weight was obtained as bed scale, standing, or stated weight. The Nurse Manager 2 North finally found a review event screen that recorded the method of weight. Nurse Manager 2 North stated this was a problem with the electronic chart and made the evaluation of weight changes difficult when there was one screen per day.

2. Review of the in and out documentation for Patient D1 2/23/12 to 3/5/12 showed the recording of 12 hour intake and output for 13 shifts where no output totals were recorded. There could be no accurate assessment of the patient fluid balance when the documentation was incomplete. Nurse manager 2 North acknowledged there intake and output documentation was incomplete.

Review of the policy titled " Assessment and Reassessment on 3/7/12 showed general policy and procedure. The care plan section stated " upon completion of the collaborative, interdisciplinary assessment a plan of care will be developed by all health care team members ... " There were no procedures for the completion and assessment of the intake and output forms. There were no procedures for the assessment of patient weight variations. There were no directions for staff to notify the patient ' s physician when there was concern.

3. During an observation and concurrent interview on 3/6/12 at 9:10 a.m., Patient N 8 was in the room with Patient N5. A licensed nurse ( LN 15) revealed that Patient N 8 gave birth on 2/29/12 to Patient N5 and both were on discharged on 3/4/12. Patient N5 was readmitted on 3/5/12 due to jaundice( yellowish pigmentation of the skin). LN 15 indicated that Patient N8 does not speak and understand English and staff use the Cyraphone (a dual handset phone which provides telephonic interpretation services services using three way conversation -with staff, interpreter and patient or family member) during provision of services. LN 15 revealed that staff explained to Patient N8 how to use the Cyraphone, the benefits of using it and encouraged her to use it to communicate with staff. The evaluator conducted an interview with Patient N8 using the Cyraphone. Patient N8 indicated that she was not sure about receiving enough information about her rights as a patient, discharge planning and the use of interpreter services during her stay at the facility.

Review of Patient N8's medical record on 3/6/12 revealed Patient N8 was admitted on 2/29/12 for a repeat caesarian section and gave birth to Patient N5. Both Patients N5 and N8 were discharged on 3/4/2012.

Patient N8's admission record identified Patient N8 as having a communication barrier. Patient N8's primary language is Spanish, does not understand and speak English and needed interpreter services.

The daily perinatal assessment /review from 2/29/12 to 3/4/12 revealed that staff identified Patient N8 to have problems with pain, risk for infection, risk for impaired skin integrity, risk for knowledge deficit related to feeding and infant care, risk for fluid volume deficit and altered tissue integrity. Subsequent plans of care that included goals, interventions and expected outcomes were developed for the identified problems. Although , a communication problem related to language barrier was identified on admission, there was no documented evidence that a care plan that included goals, interventions, strategies, access to and use of interpreter services and education related to language barrier was developed and included in the daily perinatal assessment and review.

During a concurrent review and interview with manager 1 and director 11 on 3/7/12 at 10 a.m., both confirmed that Patient N8 was identified to have a communication problem due to language barrier during admission and that Patient N8 used the device (Cyraphone) to communicate during her stay. Director 1 explained that nursing plans of care are in the facility's software Quadrimed. However, the labor and delivery department uses a different software (Centricity) which is not incorporated in Quadrimed. Director 1 agreed on 3/7/12 at 10 a.m. that a nursing plan of care related to language barrier should have been developed on admission as it was identified during assessment process. Staff should not rely on the computer generated care plans in the software.

Review on 3/7/12 of the facility's policy and procedure titled "Communication with Persons with Communication Barriers or Interpretative / Translation Needs" dated 1/2012, indicated "The facility will make every reasonable effort to meet the needs of patients and their families, as well as staff, when a language or communication barrier exists." The facility will "provide communication aids and /or interpreter services (at no cost to the person being served) to limited English proficiency (LEP) persons and any other persons experiencing barriers to communication in connection" with the services.

Review on 3/7/12 of the facility's policy and procedure titled "Assessment and Reassessment" dated 8/11, indicated "Patients who are admitted will receive a complete head to toe assessment by a qualified individual to allow the development and implementation of the care plan that will best meet the individualized health care needs of the patient. The interdisciplinary care plan is based on data gathered during patient assessment . The plan, initiated at the time of admission , identifies the patient care needs , documents patient driven treatment goals and objectives and list strategies for achieving the desired outcomes. Patients are involved in the care planning process when the care plan is developed. The interdisciplinary care plan is revised as patient needs changes and updated by the all disciplines involved in the care of the patient."




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Based on observation, interview, and record review, the hospital failed to develop care plans for three patients (Patient N1, Patient N3, and Patient N8.

1. Patient N1 was admitted to the hospital with a latex allergy (an acquired sensitized response to latex). The hospital did not develop a care plan relating to the latex allergy.

2. Patient N3 was admitted to the hospital due to fever and placed on isolation to rule out an infection. The hospital did not develop a care plan relating to the infection.

3. Patient N8 was identified on admission to have a communication problem due to a language barrier. The hospital did not develop a care plan relating to the language barrier.

The failure had the potential of patients not receiving the necessary care based on their diagnosis.

Findings:

1. Review on 3/5/12 of the hospital policy and procedure "Latex Sensitivity Policy-Patients" dated 7/11, indicated "When a patient has been identified as having a suspected or actual latex sensitivity / allergy, the following will be done: Order a latex safe cart in the hospital's clinical information system to be placed outside a patient room immediately upon arrival to the unit. Signage will be placed above the patient's bed and a lime green arm band will be placed on patient identifying the patient as latex sensitive. These arm bands are located inside the latex safe supply cart and on the nursing units."

During an observation and concurrent interview on 3/5/12 at 11:42 a.m., accompanied by director 1 and director 2, Patient N1 had a sign posted on the door to Patient N1's room indicating Patient N1 had a "latex" allergy. Licensed nurse (LN 13) explained Patient N1 should have "a cart outside the door with the latex allergy products." No cart was observed outside the door of Patient N1's room. Director 1 explained that when Patient N1 came to the floor "a latex free cart should have came with Patient N1 or been ordered immediately." No lime green armband was observed on Patient N1. Patient N1 explained a "sensitivity" and "has problems when there are lots of latex products."

Review of Patient N1's medical record on 3/6/12 revealed that although Patient N1 was identified to have a latex allergy , a plan of care that included information on risk factors, goals, interventions, strategies, and patient family education was not developed.

2. During an observation and concurrent interview on 3/5/12 at 10 a.m. accompanied by director 1, managers 1 and 2, Patient N3 was on observational status and placed on isolation due to fever and uterine contractions. Manager 3 explained that patients who come in with fever are usually placed on isolation precautions to rule out the presence of methicillin resistant staphylococcus aureus (MRSA), vancomycin resistant enterococci (VRE) infection, and influenza. MRSA and VRE are forms of bacteria infections resistant to antibiotics. Signage is placed on the patients' doors to indicate the type of isolation precautions. Director 1 indicated that patients, family and visitors are educated for proper isolation precautions, specific to the type of isolation, by the nurse assigned to the patient. Director 1 emphasized that proper handwashing is important to prevent cross contamination in patients placed on isolation precautions.

Review of Patient N3's medical record on 3/6/12 revealed Patient N3 was admitted on 3/2/12 due to uterine contractions and fever. Patient N3 was placed on isolation to rule out infection.

Patient N3's perinatal care plan dated 3/5/12 identified pain, anxiety and fluid volume as actual and ongoing problems. Nursing care plans related to the identified problems of pain, anxiety and fluids volume were developed. There was no documented evidence that a care plan for infection and isolation precaution was developed even though Patient N3 was admitted for this reason.

Based on record review and interview, the facility failed to ensure the physician ordered medication orders contained parameters for the medication or indications for the medications for five patients (Patient N2, Patient N3, Patient N4, Patient N6, and Patient N8.

Finding:

1. On 3/6/12 record review of Patient N2's record revealed a telephone order dated 3/1/12 for Tylenol (medication for fever) 650 milligrams (mg) every four hours PRN (as needed) for "temperature." The physician order did not include the specific temperature when the Tylenol is to be administered nor the form of the medication.

2. On 3/6/12 record review of Patient N3's record revealed a physician order indicating, "Pt (patient) request for nicotine gum. Nicotine gum, 2 milligrams (mg) per piece. 1 piece every two hours PRN (as needed), per pharmacy recommendation." The physician order did not contain an indication for the use of the nicotine gum.

3. On 3/6/12 record review of Patient N4's record revealed a physician order dated 3/1/12 at 10:10 p.m. for Balmex (an ointment used in the treatment diaper rash, minor burns, severely chapped skin, or other minor skin
irritations) peri-area rash PRN (as needed). The physician order did not indicated how often and how many times the Balmex could be used.

4. On 3/6/12 record review of Patient N6's record revealed a telephone order dated 2/26/12 at 10:30 a.m. for Cepacol (used to alleviate painful mouth or sore throat supplied either as a lozenge or spray form ) every hour PRN (as needed). The order did not indicate the indication for use nor the form of the product to be use. A telephone order dated 2/29/12 for Ambien at bedtime PRN. The order did not have indication for use nor the dosage or form .

5. On 3/8/12 record review of Patient N8's record revealed a verbal order dated 2/24/12 at 6:30 p.m. for Nicorette Gum PRN (as needed) and a telephone order dated 2/25/12 at 2:30 p.m. for Cepacol lozenge one tab every two hours PRN. Neither orders did not include the indications for use.

Review on 3/6/12 of the facility policy and procedure titled "Medication Orders, PRN Medications" dated 1/11, indicated "PRN (as needed ) medications are to be qualified and as such must obtain the indication or symptom for administration."

During an interview with director 7 on 3/7/12 at 1:30 p.m., director 7 explained that PRN physician orders should contain an indication for their use.

Based on review of documents the hospital failed to ensure that medical records were accurately written and promptly completed. One of one medical record was not accurately written or promptly completed.

Findings:

Review of the medical record of Patient 7 revealed she underwent a transesophageal echocardiogram and cardioversion on 12/16/11. The medical record contained a medical history and physical examination (H & P) form which was completed with the phrase " See data base. " Review of the electronic data base and the paper chart did not show any further information regarding the patient ' s H & P. Additionally the form was dated 1/3/12 which was over three weeks after the procedure had been performed.

Based on record review, observation, and interview, the hospital failed to protect the confidentiality of patient medical records. Computer screens were not protected in a manner to prevent viewing by unauthorized individuals. Information on computer screens was visible to unauthorized individuals. The failure had the potential of patient protected information being seen by unauthorized individuals.

Findings:

Review on 3/5/12 of the hospital policy and procedure titled "Patient's Rights and Responsibilities" dated 6/11, indicated "You (the patient) have the right to confidential treatment of all communications and records pertaining to your care and stay in the hospital."

Review of the hospital policy and procedure titled "Safeguarding PHI and Sensitive Information" dated 8/22/08, indicated "In non-restricted areas where sensitive information is maintained and access is not controlled, or otherwise restricted, business unit or department managers shall implement the following safeguards: keep information that is electronically displayed from view of unauthorized individuals. For example, this may require the use of privacy screens, physical re-orientation of the monitor, password protected screen savers, or other appropriate methods."

Review of the hospital policy and procedure titled "Confidential Information" dated 11/11, indicated "Confidential patient information can include computerized patient data."

1. Observation and concurrent interview on 3/5/12 at 11:10 a.m., on "2 South" of the hospital, accompanied by director 1, director 2, and manager 3, a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen. A licensed nurse (LN 5) was inside the patient room. As LN 5 exited the patient room, LN 5 explained that she was not the nurse assigned to the patient and did not know why the computer screen had not been turned off and indicated hospital staff are to "sign off and never leave (the computer screen) unoccupied when not sitting in front of the computer screen." LN 4 explained that she was assigned to take care of the patient. LN 4 explained the computer "should have been turned off."

2. Observation on 3/5/12 at 11:55 a.m., on "2 North" of the hospital, accompanied by director 1, director 2, and manager 3, a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

3. Observation on 3/5/12 at 12:37 p.m., on the "4 North" of the hospital, accompanied by the chief nursing officer (CNO) and manager 6, outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

4. Observation on 3/5/12 at 1:45 p.m. on "3 South" of the hospital, accompanied by director 1 and manager 5 a computer located in the hallway outside of a patient room, the computer screen had private patient information visible on the screen with no hospital staff in the immediate area of the computer screen.

Interview on 3/5/12 at 2:15 p.m. with the compliance and privacy officer (CPO), the CPO explained privacy screens "are needed."

Based on interview and record review, the hospital failed to ensure medical records are accurately written and promptly completed.

1. Medical records for four patients (Patient N15, Patient N16, Patient N17, and Patient N33) contained abbreviations that were not on the current approved abbreviation list.
2. The medical records of two patients (Patient N5 and Patient N9) were incomplete. The Maturational Assessment of Gestation age was not completed by the hospital staff.

Findings :

1. Review on 3/5/12 of the Medical Staff By Laws dated 1/12, indicated "Symbols and abbreviations may be used only when they have been approved by the Medical Staff. An official list of approved and prohibited abbreviations shall be kept on file in the Medical Records Department and in other areas as designated."

Review of the hospital policy "Abbreviations in Medical Records" dated 12/11, indicated the policy is "to utilize a standard set of abbreviations and symbols. Each approved abbreviation and symbol shall have only one meaning." The policy also indicated abbreviations that are never to be used including "MS."

During a concurrent review and interview with director 7 on 3/7/12 at 1:30 p.m. revealed the use of abbreviations not in the current list of approved abbreviations:

a. Patient N15's record contained abbreviations including SBP and DBP.
b. Patient N16;'s record contained abbreviations including SBP, DBP, SCD, IMC, MS, and K Phos.
c. Patient N17's record contained abbreviations including PNH, PICC, TIBC,and FNA.
d. Patient N33's record contained abbreviations including HH and IHSS.

Director 7 explained the hospital utilizes a standard set of abbreviations and symbols. Each approved abbreviation shall have only one meaning.

2. Review of the hospital's policy and procedure titled "Gestational Age (the period of time between conception and birth) Assessment" dated 12/11, indicated "All infants will have a gestational age assessment (GAA) completed as a component of the newborn admission assessment."

a. Review of Patient N5's medical record on 3/6/12 revealed Patient N5 was born on 2/29/12 and discharged on 3/5/12. A Maturational Assessment of Gestational Age form was in Patient N5's medical record but did not contain any entries.

b. Review of Patient N9's medical record on 3/6/12 revealed Patient N9 was born on 2/22/12 and discharged on 2/26/12. A Maturational Assessment of Gestational Age form was in Patient N9's medical record but did not contain any entries.

During an interview with manager 1 on 3/6/12 at 1:15 p.m., she explained that the GAA is a very important tool used to assess infant maturity and should be done immediately after birth. Manager 1 confirmed that a GAA was not completed for Patient N5 and N9.

Based on record review and interview the hospital failed to ensure medical records were legible for one of 59 patients (Patient D2) and failed to ensure one of one (Patient 3)procedure reports had been authenticated.

Patient D2 diet order was incorrectly transcribed and Patient 3's procedure report was not signed, dated, and timed by the physician.

Findings:

1. On 3/6/12 at 11:15 a.m., the medical record of patient D2 was reviewed. The order dated 3/3/12 was a hand written order by the physician. There were seven orders included in the one third page order section. The order numbered five was "less than 2 gram NA (sodium) day diet K."

On 3/6/12 at 11:15 a.m a licensed nurse (LN 2) stated the " K " at the end of the diet order was not clear and the Registered Nurse entering the orders should have confirmed with the ordering physician.

On 3/6/12 at 11:15 a.m. Nurse Manager 2 South reviewed the form and confirmed the "K" was part of the physician signature and not part of the diet order. Nurse Manager 2 South confirmed there was too much written on the small space and the diet order was not clear.


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2. Review of the medical record of Patient 3 revealed she had undergone placement of an inferior vena cava filter (to block clots) on 12/18/11. As of 3/6/12 the report of the procedure had not yet been authenticated with the signature of the physician and the date and time. Review of the medical staff bylaws showed the requirement that all clinical entries in the patient ' s medical record shall be legible, accurately dated and timed, and authenticated.

Based on record review and interview, the hospital failed to enure that telephone and verbal orders were signed or initialed by the prescribing physician within 48 hours in the medical records for three patients (Patient N1, Patient N2 and Patient N17).

Findings :

Review on 3/6/12 of the Medical Staff By laws dated 01/12, indicated "The responsible practitioner shall authenticate such orders by signing and dating them within 48 hours."

1. Review of Patient N1's medical record on 3/6/12 revealed verbal orders dated 3/2/12 at 4:20 p.m. and 3/2/12 at 5:10 p.m. not signed as of 3/6/12.

2. Review of Patient N2's medical record on 3/6/12 revealed telephone orders dated 3/1/12 at 4:54 p.m. and 3/1/12 at 11 p.m. not signed as of 3/6/12.

3. Review of Patient N17's medical record on 3/8/12 revealed verbal orders dated 2/17/12 at 9:15 a.m. 2/18/12 at 4:20 p.m., and 2/19/12 at 11:45 a.m. not signed as of 3/6/12.

During an interview with director 7 on 3/8/12 at 2:30 p.m., director 7 explained all verbal and telephone orders must be signed by the practitioner within 48 hours as outlined in the medical staff bylaws.

Based on review of documents the hospital failed to ensure that verbal orders were authenticated within 48 hours. Two of two verbal orders were not signed by a physician until 14 days after they had been written.

Findings:

Review of the medical record of Patient 2 revealed it contained a verbal order for morphine which was recorded on 12/14/11 at 4:30 p.m. but not signed by a physician until 12/28/11. Review of the medical record of Patient 8 revealed it contained a verbal order for Vicodin (for pain) which was recorded on 12/15/11 but not signed by a physician until 12/29/11. Review of the medical staff bylaws showed the requirement that the responsible practitioner shall authenticate all verbal orders by signing and dating them within 48 hours.

Based on medical record review and staff interview, the hospital failed to ensure the physician acknowledged the recommendations of the Registered Dietitian for one patient (D1) which put the patient at risk of compromised care when the information necessary to monitor the patient ' s condition was not available.

Findings:

Patient D1 was admitted 2/21/12 with diagnoses of severe gallstone-induced necrotizing pancreatitis, peritonitis, anemia, borderline hypokalemia, and hyperglycemia. Medical record was reviewed 3/6/12.

On 3/6/12 at 9:00 a.m., the medical record of Patient D1 was reviewed.

The nutrition note dated 3/2/12 stated Patient D1 ' s nutritional needs were 1450 to 1740 calories, 87 to 110 grams protein per day. The present TPN at D25 (dextrose), 4.25 percent AA (amino acids) at 80 ml hour with 20 percent lipids 250 milliliters on Monday and Thursday, provided 2029 calories and 82 grams protein and current TPN exceeding calorie needs and not meeting protein needs. The RD recommended a change to D20 and a goal rate of 85 ml/hour to provide 1805 calories and 87 grams protein to meet needs.

Review of the physician progress notes from 3/2/12 to 3/6/12 showed no acknowledgement of the RD ' s recommendation.

Review of the facility's policies and procedures, the facility's Omnicell controlled drug discrepancy data reports, interview with the facility's Pharmacy Director and the facility's Pharmacy Manager the facility failed to ensure that all unresolved controlled drug discrepancies had been resolved in accordance with the facility's established policies and procedures.

Findings:

Met with the facility's Director of Pharmacy and the facility's Pharmacy Manager on 3/5/12 at 11:00 a.m. The Pharmacy Manager ran an "unresolved controlled drug discrepancy report" and he found that there were more than 7 unresolved discrepancies involving Scheduled II-IV narcotics (drugs with very high abuse potential according to Federal law). These Scheduled narcotics included drugs like: Morphine Sulfate, Fentanyl, and Versed. An unresolved controlled drug discrepancy report, tells the facility about controlled drug discrepancies (e.g. a miss count by nursing staff of a controlled drug, the possible diversion of a controlled drug, etc.). The facility's policy and procedure entitled: "Automated Medication Dispensing System (Omnicell)", states: "In accordance with established policies and procedures for medication use, all record keeping requirements and dispensing practices will conform to federal and state laws and regulations ...a. Discrepancies occur whenever the actual count of medication in a ADC does not reconcile with the count expected ...c. Pharmacy staff will print and review all Discrepancy Reports for all locations, verifying that all discrepancies have been resolved with adequate explanations. D. Discrepancies must be resolved each time they occur. It is the responsibility of each user to resolve these discrepancies as soon as they are discovered and prior to the end of shift. Pharmacy department will monitor all discrepancies and resolutions. If a discrepancy is not resolved in a timely manner, the Department Director will be contacted by the Pharmacy Director or designee to seek a resolution. F. The Department Director and/or designee must print a 24-hour Discrepancy Report for all transactions that occur in their department. Every attempt should be made to resolve these discrepancies at the ADC."
Review of the facility's unresolved controlled drug discrepancy report for the previous 30 days revealed that the facility had more than 6 unresolved discrepancies (discrepancies which were still open with no investigation), during the last 30 days. During the interview with the facility's Pharmacy Manager on 3/5/12 at 11:00 a.m., the Pharmacy Manager indicated that he was unaware that the facility had any current unresolved controlled drug discrepancies. The Pharmacy Manager also indicated that the Nursing Managers on each unit were responsible for ensuring that any unresolved controlled drug discrepancies were resolved. During the interview, the Pharmacy Manager he also indicated that the Pharmacy Department did not keep any records or logs of the facility's unresolved controlled drug discrepancies for follow up. Three (3) of the 6 unresolved controlled drug discrepancies remained open without an investigation for almost 25 days after discovery. The Pharmacy Manager also indicated during the interview that the current Omnicell console (these are the Automated Drug Storage Cabinets which nursing retrieve their drugs from on the floor) display, only allow for these discrepancy alerts to be displayed to nursing staff on the floor for a maximum of 7 days. After the 7th day, the discrepancy alert falls off the console, so that nursing staff can no longer see that a controlled drug discrepancy, still remained uninvestigated. None of the 6 unresolved controlled drug discrepancies had been resolved by the end of the nurses' shifts as outlined in the facility's policy and procedure above. No evidence could be provided by the facility's Pharmacy to show that these unresolved controlled discrepancies had been printed, reviewed, and investigated by the facility's Pharmacy, as outlined in the facility's policy and procedure above.

Based on observation of the facility's Medication Nurse, who was about to administer medications to a patient, medication pass observation, and review of the facility's policy and procedures the facility failed to:
1. Ensure that a safe system had been put in place for the administration of all of the facility's "high risk" medications.
2. Ensure that unclear physician orders were clarified by nursing and pharmacy staff in accordance with the facility's policy and procedures for one of 5 patients reviewed.
3. Ensure that Pediatric Nursing staff were capable of administering lifesaving medications during a mock code (a made up emergency exercise).
4. Ensure that all of the necessary medications on the facility's drug reference guide for Pediatric patients (the Braselow Tape) were available for administration during a Pediatric Code.
5. Ensure that the facility's Malignant Hyperthermia cart refrigerator had been maintained in accordance with the facility's established drug refrigerator temperature range.
6. Ensure that the facility's Pharmacists were inspecting the facility's Malignant Hyperthermia cart on a monthly basis as referenced in the facility ' s policy and procedure.
7. Ensure that an adequate supply of Sterile Water for injection for mixing all 36 vials of Dantrolene which were inside the facility's Malignant Hyperthermia cart.

Findings:

1. Review of the facility's "High Risk Medication" policy and procedure states the following: "Purpose: To ensure safe processes for procuring, storing, ordering, transcribing, preparing, dispensing, administering and/or monitoring high risk medications. Policy: High-risk medications are those drugs involved in a high percentage of medication errors and carry a higher risk for abuse, errors, or other adverse outcomes. (Hospital's names) shall maintain a list of high risk medications, which is reviewed and approved by medical staff, and have identified safety mechanisms in place to reduce risk of errors ....2. The current list of the hospital high risk medications includes the following: a. Concentrated electrolytes ...c.Therapeutic Heparin, d. Insulin, e. Opiates by PCA (Patient Controlled Analgesic), NCA (Nursing Controlled Analgesic), or Intravenous (I.V.) drip ....All pediatric medications. Prior to administering the high-risk medication, the RN/LVN will validate the dose and medication with another licensed nurse qualified to give the medication ....".

During a morning medication pass with Medication Nurse 1 on 3/6/12 at 10:15 a.m. this Nurse administered Heparin 5000 units (a high risk medication) to one of her patients. The medication nurse documented the medications which she was about to administer in the patient's Medication Administration Record (MAR) in the facility's computer. During the process the Nurse demonstrated that in order for her to have any Nurse in the computer's system verify (complete the necessary double check process prior to giving any medication), this Medication Nurse only needed to start typing into the computer any nurses' last name and pick this nurse as a witness from drop down screen. No other verification system was in place at the facility at the time and the nurse who could be put in as a witness was not even required to be physically present, on the floor or in the hospital for the verification of the medication which the medication nurse was administering. The system which had been put into place did not represent a "true" double check for the dangerous and even possibly, deadly "high risk" medications which the Nursing staff had been administering to the facility's patients.

Further discussion about this observation with facility Pharmacy staff revealed that the facility had a very similar incident (which resulted in a medication error for a patient) back on 10/23/11, almost five months earlier. A neonatal/pediatric nurse had administered a medication to one of her patients and the nurse completed the high risk medication verification without a second Nurse, by using the same drop down name verification system feature independently. This medication error resulted in the pediatric patient receiving 10 times the intended dose of medication. The facility stated that they have implemented a system in the neonatal patient area which no longer allows nursing staff to administer a medication without a second nurse to actually witnessing and verifying any medication prior to it being administered to a patient. Unfortunately the neonatal unit is not the only area of the hospital where "high risk" medications are administered to patients. The facility had taken over four (4) months from the time that this medication error had been identified to try and develop a system, but the system has still not been implemented, creating an unsafe system for patients receiving high risk medication in other locations of the hospital.

2. Review of the clinical record for patient P-1 on 3/6/12 at 11:20 a.m. revealed that this patient's physician had written an order on 3/5/11 at 3:45 a.m. for this patient to receive Xoleda 500mg by mouth twice daily; this was the only information in the physician's order. Xoleda is a drug used to treat various types of Cancer. This medication is usually given for 2 weeks straight then followed by a 1-week (drug free) rest period, as this medication is given in 3-week cycles. The Physician's order above, did not reflect or include the information about a 3-week cycle. The patient's Medication Nurse, during an interview on 3/6/12 at 11:50 a.m. revealed that she had spoken with the patient and the patient had indicated to the Medication Nurse that this week was the patient's third week of her cycle (this would be the drug free or rest week for this medication). This same Medication Nurse also indicated during the interview that she had relayed this same information to the hospital's Satellite Pharmacist. The facility's Satellite Pharmacist documented this information in his notes on the computer (which could only be seen by Pharmacy). Neither the Medication Nurse nor the Satellite Pharmacist ever contacted the patient's physician in order to obtain clarification about the patient's order for this medication. Neither the Medication Nurse nor the Satellite Pharmacist followed up with a new or clarification order in the patient's clinical record for the Xoleda.

3. Inspection of the facility's 3 South (Pediatric Unit) revealed that the facility stored one of its nine Pediatric Crash carts (emergency drug supply) on this unit. A review of the facility's Braselow Tape (which facility staff verified during the inspection, that this tape was the nurse's drug reference guide for administering Pediatric medications to patients during a Pediatric Code), revealed that on 3/7/12 at 8:40 a.m. Magnesium Sulfate for injection was not present on any of the facility's nine Pediatric Crash carts. The facility's Pharmacy staff also indicated during the inspection of the cart, that none of the other eight Pediatric Crash carts in the facility contained the Magnesium Sulfate for injection.

According to the current literature for Pediatric emergencies (American Heart Association and Pediatric Advanced Life Support [PALS]), Magnesium Sulfate is used as an antiarrhythmic agent, magnesium sulfate is the drug of choice for treatment of torsades de pointes (which literally means a "twisting of the point"). Torsades is characterized by QRS complexes (which is a normal part of the heart's beating cycle) that changes in amplitude and polarity with each beat so that they appear to rotate around a non-changing straight line. Magnesium sulfate is also recommended for pulseless Ventricular Tachycardia/Ventricular Fibrillation (irregular heartbeats), associated with low magnesium levels.

Further discussions with the facility staff revealed that Magnesium Sulfate had not been added to the facility's list of contents for any of the nine Pediatric Crash carts within the facility. Facility staff also indicated during the interview that the Magnesium Sulfate had been left off of the Pediatric Crash cart's list of contents by mistake and that this medication should have been included on the facility's list of medication contents for these Crash carts. The facility also indicated that Magnesium Sulfate injectable products had been in short supply or completely unavailable at times from the various manufacturers of the drug. The facility's Director of Pharmacy did indicate during the survey that the facility did have a small supply of Magnesium Sulfate for injection, in their possession.

4. After inspection of the facility's Pediatric Crash cart on the 3 South Unit, one of the unit's two Pediatric (PALS) trained nurses was interviewed and asked to participate in a mock (pretend) emergency code. This Nurse was given an emergency scenario and she was asked to draw up a dose of medication for a very specifically described (imaginary) Pediatric patient. Pediatric Nurse 1was asked to draw up an Atropine dose for the imaginary Pediatric patient. Pediatric Nurse 1 set up the Atropine syringe and began to push out the drug which she was going to administer to the Pediatric patient. After pushing out more than 2mls of the drug from the syringe, Pediatric Nurse 1 turned to me and stated that she could not administer the correct dose of 1.7 milliliters (mls) as indicated on the facility's reference guide (the Braselow Tape). This Nurse indicated before the exercise that she had been a Pediatric Nurse for 3 years. The Nurse also indicated that during her three years as a Pediatric Nurse, she has never been involved in administering medications in a Code and that the facility had never had any mock drills. The Pediatric Nurse also stated that: "PALS recertification only occurs every two years and there is a lot of time in between the next recertification class, to forget the information that we have been taught." Pediatric Nurse 1 indicated that she would like to see the facility establish routine Code Drills, as this would give the nursing staff to see, touch, and get to know the contents of drugs and other supplies, which are locked inside the facility's various Crash carts. The Nurse indicated that this would give Nursing staff more confidence and familiarity during a real Code with the drugs that needed to be administered. The Nurse also indicated that routine Code Drills would allow Nursing staff to calculate, draw up, and fictiously administer doses of these medications accurately during the Drill.

5. Inspection of the facility's Malignant Hyperthermia (MH) cart refrigerator on 3/7/12 at 2:00 p.m. revealed that the refrigerator's current temperature was 30 degrees Fahrenheit. Further visual inspection of the facility's MH cart revealed a solid block of ice (at least 4 inches by 6 inches had formed in the refrigerator's freezer compartment), indicating that this refrigerator had not been defrosted in quite some time. The facility's Pharmacist monthly inspection sheets for the Operating Room (where the MH cart had been stored) were reviewed. These sheets indicated that for the last 6 months, the facility's pharmacist had not mentioned that the MH Cart's medication refrigerator had been having problems maintaining a temperature above 36 degrees Fahrenheit. The facility was also unable to provide evidence that the facility's Pharmacist had even opened this refrigerator to inspect it and the drugs which had been kept inside the refrigerator. The facility's medication storage policy indicates that medications which require refrigeration shall be stored at 36 to 46 degrees Fahrenheit. Review of the facility's Malignant Hyperthermia temperature logs revealed the following: a. For the entire month of 11/11the MH refrigerator only had two days during the month where the medication refrigerator's temperatures were above 35 degrees Fahrenheit. b. For the entire month of 12/11the MH medication refrigerator only had five days during this month where the refrigerator's temperatures were above 36 degrees Fahrenheit. c. For the entire month of 1/12 the MH refrigerator only had two days during this month where the medication refrigerator's temperatures were above 35 degrees Fahrenheit. d. For the entire month of 2/12 the MH refrigerator only had 10 days during this month where the medication refrigerator's temperatures were above 36 degrees Fahrenheit. e. For the 7 days during the month of 3/12 the MH medication refrigerator only had 1 day where the temperature of the medication refrigerator exceeded 36 degrees Fahrenheit. Temperatures were recorded by staff, during these periods, and the temperatures on the record dipped down as low as 29 degrees Fahrenheit (32 degrees Fahrenheit is freezing).

6. Inspection of the facility's MH cart on 3/7/12 at 2:00 p.m. revealed that the facility had made the decision to follow the MHAUS (Malignant Hyperthermia Association of the United States) guidelines. In the MHAUS guidelines and on the Dantrolene vials, the literature states that each of the facility's 36 vials must be diluted with 60 milliliters (mls) of Sterile Water for Injection. This meant that the facility needed 60 ml of Sterile Water for dilution for each of the 36 vials totaling (36x60ml= 2160 ml). During the inspection of the MH cart, the facility only had 1000 ml of Sterile Water for injection available on the cart. This meant that the facility was short of Sterile Water for injection by 1,160 ml. Further inspection of the MH cart revealed one packet of Chloraprep Swab-sticks with an expiration of 7/09. The Chloraprep Swab-sticks and the other equipment for the cart had been placed into the cart originally by the facility's Central Supply Department. A phone call was placed to the facility's Central Supply department during the survey to inquire when the last time was, that Central Supply had inspected the equipment portion of this cart. The chief of Central Supply indicated that he could not ever remember having anyone go up and restock or check the supplies on this MH cart.

Based on inspection of the facility's Operating Room Satellite Pharmacy and interview with the Director of Pharmacy and the Satellite Pharmacist the facility failed to store medication security locks (red locks) in an area which would not have been accessible to other non-Pharmacy staff. The facility also failed to develop a written policy and procedure for securing these medication locks.

Findings:

Inspection of the facility's Operating Room Satellite Pharmacy on 3/7/12 at 3:30 p.m. revealed an unsecure drawer with three unused red medication locks. These red medication locks are used by the facility's Pharmacists to secure and seal all of the facility's emergency drug storage supplies. These supplies include Emergency Crash carts, Emergency incubation trays, and other emergency drug supplies which are kept in various locations throughout the hospital. These red locks are used to determine if these various drug supplies have been used or even to determine if these drug supplies have been tampered with by authorized or unauthorized facility staff. Interview with the facility's Operating Room Satellite Pharmacist on 3/7/12 at 3:40 p.m. revealed that she was unaware that these red locks had been placed into this unsecured drawer. The Operating Room Satellite Pharmacist indicated that Nursing staff and Anesthesiologists had unrestricted access to this room without a Pharmacist being present. Interview with the facility's Director of Pharmacy on 3/7/12 at 3:41 p.m. revealed that it was the facility's policy not to keep these red locks in areas where non-Pharmacy staff would have access. The facility's Director of Pharmacy was asked if facility Nursing staff or any other non-Pharmacy staff, were allowed to lock the facility's Emergency Drug supplies. The Director of Pharmacy indicated that only a Pharmacist is allowed to lock or secure any Emergency Drug supply. The Director of Pharmacy also indicated during the interview that even though it was the facility's policy and procedure for a Pharmacist to secure any Emergency Drug supply, the facility had not developed a written policy and procedure to for the handling of the facility's red locks.

Based on medication pass observation, interview with facility's Medication Nurse, inspection of the facility's Malignant Hyperthermia cart, and interview with the Director of Pharmacy the facility failed to ensure that expired or unusable medications were not available for use.

Findings:

During a medication pass observation on 3/6/12 at 10:30 a.m. the surveyor observed a one liter (1000 milliliter) bottle of Sodium Chloride solution for irrigation. This bottle had been opened previously by staff and sat back on the patient's bedside sink. The Medication Nurse was asked how long these bottles could be kept for use after they had been opened. The Nurse indicated that these bottles can only be kept for 24 hours after opening. The Medication Nurse also indicated that she did not see a date on the bottle to indicate when the bottle had been opened. Interview with the facility's Director of Pharmacy on 3/6/12 at 10:45 a.m. confirmed that this bottle of Sodium Chloride for irrigation should have been discarded within 24 hours according to the facility's policy and procedure.

Inspection of the facility's Malignant Hyperthermia cart on 3/7/12 at 2:00 p.m. revealed one swab-stick of Chloraprep (a disinfectant product) was found on the cart with an expiration date of 7/09.

Based on interview with facility staff and review of documents the hospital failed to ensure that the blood bank policies required records of the source and disposition of all units of blood and blood components be retained for at least 10 years from the date of disposition and that a fully funded plan to transfer these records to another hospital or other entity if the hospital ceased operation for any reason was created.

Findings:

Review of the blood bank policy titled " Blood Bank Record Retention " revealed it required retention of blood bank records for 5 years rather than ten years. No policy for the funding of record retention could be located. In an interview on 3/7/12 at 11:15 a.m. the director of the blood bank stated he was not aware of these requirements. Review of the contract for off-site record storage revealed it did not contain a plan for funding the storage of blood bank records in the case of the closure of the hospital. In an interview on 3/7/12 at 10:30 a.m. the chief financial officer stated he was not aware of any fund for the storage of blood bank records.

Based on observation, staff interviews and review of hospital documents the Chief Clinical Dietitian failed to:

1) ensure the emergency menu was adequate for the planned patient and staff and included the puree diet,

2) maintain can openers in clean and safe repair,

3) ensure safe temperature monitoring of potentially hazardous food.

These failures have the potential to result in: 1) inadequate food during an emergency and choking for patients receiving a puree diet during the event of an emergency or disaster; 2) contamination of foods with metal shavings or microorganism from unclean can openers, 3) food borne illness from potentially hazardous food held in the danger zone (135 degrees Fahrenheit (F) to 41 degrees F.

Findings:

1. On 3/5/12 starting at 1:30 p.m. the hospital disaster and emergency food plan was reviewed. The plan was for 285 patients and 700 staff and visitors. There were plans for a four day menu with day 2 to 4 to use nonperishable food and nutrition cars and nutrition supplement for the staff if needed. Review of the nonperishable food list showed the number of cases for tuna, baked beans and chili beans (items for protein content) were not adequate to serve the planned 985 servings when the menu included these items for both lunch and dinner for three days. The Chief Clinical Dietitian acknowledged the plan for nonperishable food needed to be recalculated to ensure there was adequate food on hand to provide for the number of days and meal planned.

In addition, the plan did not specify the location and quantity of food that would be used for puree diets when needed.

2. On 3/5/12 at 11:15 a.m., the two table mounted can openers were observed. There was a thick accumulation of black debris on both of the table bases and the can openers had black debris on the ledge behind the blade. There were visible metal shavings in the black residue and food debris.

The Food Service Manager stated on 3/5/12 at 11:15 a.m., that he did not know when the blades had been changed and they did not have a system to ensure they blades were inspected to ensure they were safe and not dull with the production of metal shavings. He acknowledged the can openers were to be washed each day but they did not appear to be clean and sanitary.

3. On 3/5/12 at 11:00 a.m., there was cottage cheese in one salad bar area. The Salad Bar- Deli Bar temperature log dated 3/5, was reviewed and there was no temperature of the cottage cheese recorded. The Food Service Manager took the temperatures of the cottage cheese which read 46 degrees F. The cottage cheese was stirred and the second temperature was 48 degrees F.

The Food Service Manager stated the cottage cheese was in the danger done (potential for growth of pathogenic microorganisms at temperatures between 41 degrees F and 135 degrees F) and the temperatures should have been monitored.

Based on staff interviews and review of hospital documents, the hospital failed to ensure standard menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. This has the potential for the patients in the hospital to not receive adequate nutrition and to meet the estimated recommended dietary allowances for all nutrients including fiber, calcium, and zinc.

Findings:

On 3/7/12 at 8:00 a.m., the hospital's nutrient analysis for the regular menu was reviewed. The analysis showed the no analysis for calcium or zinc and daily nutrient provided for fiber or macro or micro nutrients as specified in the RDA or DRI.

Review of the Dietary Reference Intakes (DRIs): Recommended Dietary Allowances and Adequate Intakes for Elements indicated for Calcium that males and females between nine through 18 years of age to receive 1,300 mg; females between the age of 51 through 70 to receive 1,200 mg; and females and males greater than 70 years of age is 1,200 mg. The DRIs for Calcium are dated 1997. The hospital menus were not evaluated for calcium so there was no way to ensure the menus served patient met the RDAs or RDIs. It indicated for Zinc that males between 14 through greater than 70 years of age are to receive 11 mg. The DRIs for Zinc are dated 2001. The hospital menu was not evaluated for zinc and there was no way to ensure the menus met the requirements. Zinc is an essential nutrient in healing and metabolic functions.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males nine through 13 years of age is 31 grams; 14 through 50 years of age is 38 grams; and 50 years through greater than 70 years of age is 30 grams; females nine through 18 years of age is 26 grams; 19 through 50 years of age is 25 grams; 50 through greater than 70 years of age is 21 grams. The hospital menus were inadequate in Fiber depending on the age and gender.

On 3/7/12 at 8:00 a.m. an interview was conducted with the Chief Clinical Dietitian regarding the nutrition analysis of the regular and therapeutic menus. The Chief Clinical Dietitian states that she had evaluated a limited number of nutrients on excel program as she did not have a nutrition analysis program that would include all of the nutrients including the macro and micro nutrients in the RDA or DRIs. She stated she had not evaluated the menus and determined how to bring the menus in line with the current nutrient requirements.

Based on record review, observation, and interview, the facility failed to maintain glucose testing solutions that were not expired. Two of two glucose meter test kits in the emergency room (ER) contained expired testing solutions. The failure had the potential of inaccurate blood glucose testing results for patients having blood glucose tests performed in the ER.

Findings:

Review on 3/5/12 of the manufacturer direction for use for the glucose control solution dated 1/03, indicated "The control solution can be used for 3 months after using the vial. Discard any remaining control solution 3 months after the vial was first opened."

Review of the hospital policy and procedure titled "(name of product) Whole Blood Glucose Testing, Point of Care Testing" dated 8/11, indicated "The control solution can be used for 3 months after opening the vial. One must record the date opened on the vial. In addition, one should calculate the date the vial expires and record the shortened expiration date on the vial; clearly indicate this is an expiration date, record initials. A sticker may be used to capture this information and placed on the vial at opening. Discard any remaining control solution 3 months after the vial was first opened."

Observation on 3/5/12 at 10:32 a.m., accompanied by the chief nursing officer (CNO) and manager 8, while in the emergency room, two vials of blood glucose testing solution were outdated. One vial was opened 12/02/11 and should have been replaced with new testing solution on 3/2/12. An additional vial was opened 11/4/11 and should have been replaced with new testing solution on 2/4/12.

Interview with licensed nurse (LN 11) on 3/5/12 at 11:00 a.m., she explained the hospital standard is to discard and replace the solutions every three months.

Based on observation and staff interview, it was determined that the hospital failed to be maintained to ensure the safety of the patients. The cumulative effect of the systemic problems identified during the Life Safety Code (LSC) portion of the validation survey resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

The facility failed to ensure the facility is protected from fire, and that all building construction, fire protection systems and hazardous areas are maintained and tested as required. This was evidenced by combustible storage in patient care areas, and by soiled linen and trash receptacles exceeding 32 gallons in a 64 square foot area. This affected three of five floors in the hospital and two of three suite areas on the mall level. The failure to protect hazardous areas could result in the spread of fire, in the event of a fire.

The results of the survey are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. (Refer to A710 in the Health Survey, and K29 and K75, of the LSC survey document).

Findings:

1. The facility failed to maintain hazardous areas with 1 hour rated construction and failed to ensure hazardous areas are separated from other spaces by smoke resisting partitions and self closing doors. This was evidenced by storage areas, greater than 50 square feet in size, with penetrations, without walls and without doors that self close and latch. Combustible storage areas greater than 50 square feet shall be protected as hazardous areas. Combustible storage was located in two areas of the lab, in three areas of the OR suite and in the endoscopy suite. Storage areas were not protected with walls and self-closing doors. In the lab one door was obstructed from closing.

During an interview on 3/6/12, at 9:30 a.m., Pre Op staff reported that the corner cubical is used for storage. During interviews on 3/7/12, at 11:12 a.m., the Compliance and Privacy Officer and LN 10 reported that the area outside of OR 8 was used for "overflow storage." Engineering Staff 2 confirmed there were no walls or doors protecting the storage area.
(Refer to K29 of the LSC survey document.)

2. The facility failed to ensure the storage of soiled linen and trash was in accordance with NFPA 101. This was evidenced by soiled linen and trash containers, greater than 32 gallons, stored in areas that were not protected as hazardous storage areas. Soiled linen and trash receptacles without hazardous area protection were located in the OR suite, the emergency room, on the 4th level and in the lab area.
(Refer to K75 of the LSC survey document.)

Based on interview with facility staff and observation the hospital failed to ensure that the overall hospital environment was maintained in such a manner that the safety and well-being of patients are assured.

1. Car washing was observed in the hospital parking lot.

2. An elevator in the operating room suite did not have an even surface when opening
/ landing onto the operating room suite floor.

Findings:

1. On 3/7/12 at 12:15 p.m. a vendor was observed in the hospital ' s parking lot for visitors replacing a windshield in a car. On 3/9/12 at 10:30 a.m. a vendor was observed washing a car in the visitor ' s parking lot. However no policy governing the activities of non-contracted vendors operating on the hospital grounds could be located by the patient safety and regulatory compliance officer. There was no assurance that the safety of patients and visitors to the hospital was maintained during vendor activities such as automobile repair or car washing on the hospital campus.



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2. During an observation on 3/7/12 at 7:59 a.m., accompanied by chief nursing officer (CNO), director 10, and manager 8, an elevator used to transport patients to and from the operating room suite from the critical care unit (CCU) and intensive care units (ICU), was observed. When the door of the elevator opened, the floor of the elevator and the floor of the operating room suite were not even, having a distance of one inch between the floor heights.

Interview and review of elevator repair records with director 9 on 3/8/12 at 3:30 p.m., director 9 indicated the facility was aware of the problems with the elevator. Director 9 indicated the contracted elevator repair service can not level the floor of the transport elevator.

Based on observation and facility staff interviews, the hospital did not meet the provisions of the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The facility failed to maintain the integrity of the building structure with smoke resistant walls, to ensure doors close and latch, and to protect hazardous areas with self closing doors. These failures affected three of five levels of the hospital and one offsite building. This could result in the spread of smoke and fire and increased the risk of injury to patients without the ability to protect themselves.

Findings:

During the facility tour, facility staff interviews, and building and hazardous area inspection, from 3/5/12 through 3/8/12, the hospital was found out of compliance with the 2000 edition of the Life Safety Code 101 of the National Fire Protection Association. The results of the survey are cross referenced to the CMS 2567 representing the K tags for the Life Safety (LSC) Code. The condition level deficiencies were as follows: K29 and K75.

During the facility tour on 3/6/12, 3/7/12 and 3/8/12, there were multiple areas with combustible storage that were not protected with smoke resistant walls and self-closing doors. Unprotected storage was located in the lab, in the endoscopy store room, and in three areas of OR suite.

The storage of soiled linen and trash containers, in quantities greater than 32 gallons, was documented on three levels of the hospital. (refer to K75 of the LSC survey.) The facility failed to ensure hazardous areas were protected as required by NFPA 101.

During interviews on 3/6/12 and 3/7/12, facility staff confirmed that combustible storage was located in areas that were not protected as hazardous areas.
(Refer to K29 and K75 of the LSC survey.)

Based on observation and staff interview, the hospital failed do ensure the trash was transported in a closed container from the kitchen to the compactor.

Findings:

On 3/5/11 at 11:45 a.m., the trash transport was observed. The plastic bagged trash was transported in an open cart.

Solid waste was not transported in a manner to preclude transmission of communicable diseases in leak-proof bins with tight-fitting cover.

5. Inspection of the facility's Isolation Cart/Cupboard outside of Room 2111 (Unit 2 North) on 3/8/12 at 9:10 a.m. revealed that this cart contained one 25 gauge 5/8 inch needle. Interview with Nurse P-1 on 3/8/12 at 9:10 a.m. revealed that the facility usually maintains items such as lotions, soaps and gauze inside these cupboards/carts. Inspection of the facility's Isolation Cart/ Cupboard outside of Room 2217 (Unit 2 South), revealed two 25 gauge 5/8 inch needles. I.V. Tubing sets were also found in these isolation Carts/Cupboards. Nursing staff on both Units (2 North and 2 South), both indicated that Central Supply stocks these Isolation Carts/Cupboards. Interview with the facility's Central Supply Supervisor on 3/8/12 revealed that Central Supply was responsible for routinely stocking the supplies contained inside these /Cupboards/Carts. Central Supply also provided a copy of the facility's Isolation Cart Inventory Check List, which listed the items which should have been maintained inside of these Carts. The Checklist contained items such as Isolation Masks, Gloves, Temp-Dots, Isolation gowns, etc. However the list did not contain the lotions, soaps, gauze, I.V. Tubing sets, or needles which were described by Nursing staff or found inside these Isolation Carts/ Cupboards. Nursing staff verified that family members of patients utilize these carts when visiting family members. The reaching in and out of these Carts/Cupboards by patient family members could lead to contamination of such items as sterile gauze, which had been stored inside these Isolation Carts/Cupboards. These family members also had access to dangerous devices such as needles, which the hospital indicated that they routinely keep secure.




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4 a. On 3/5/12 starting at 11:00 a.m., the bin ice machine in the kitchen was observed. There was visible yellow discoloring on the top of the ice harvester section where the ice is formed.

At 2:40 p.m. on 3/5/12 Maintenance staff 1 stated the approximately 60 ice machines, including the kitchen and cafeteria ice machines were cleaned by an outside service.

Review on 3/5/12 at 2:45 p.m., of the work order checklist procedure reports dated for the October, November, and December 2011, for the dietary and cafeteria ice machines shoed the comment "PM (preventative maintenance) and sanitized, cleaned bin and greased bearings. Replaced tubes."

On 3/6/12 at 1:15 p.m., Maintenance 2 staff confirmed all of the hospital ice machines were cleaned by the outside company and provided product information from the cleaning company. The ice machines were cleaned with a nickel safe ice machine cleaner and IMSII ice machine sanitizer. Maintenance staff 2 acknowledged that they were not aware if the hospital ice machines were cleaned in accordance with the manufacturer's requirements.

b. On 3/5/12 starting at 10:00 a.m., there were three kitchen handwashing sinks observed, one next to a bread rack, one next to food production counter and one by clean dishware. There was no barrier to prevent overspray from handwashing to cross contaminate the clean food areas. Chief Clinical Dietitian stated on 3/5/12 at 10:00 a.m. that they acknowledged the potential for cross contamination from the handwashing overspray. They planned a barrier to be installed on the side of the handwashing sink to prevent overspray.

c. On 3/5/12 at 11:45 a.m., the trash compactor area at the back dock was observed. There was trash consisting of plastic straw, yogurt container, leaves, dirt, blue disposable gloves, and debris on the ground around the compactor. The EVS Supervisor was interviewed on 3/5/12 at 12:00 p.m. She stated the are was pressure washed one time a month and swept daily Monday through Friday.

Review of the policy titled "Trash compactor equipment (B-4) effective 1/12 stated "The
entire area around the compactors will be cleaned and swept daily."

d. On 3/6/12 at 2:30 p.m. the NICU breast mild refrigerator was observed. The temperature log dated March 2012 showed the temperature range of 46 degrees Fahrenheit to 36 degrees Fahrenheit. NICU nursing staff had been using this form to record and monitor the breast milk refrigerator temperatures. The refrigerator was designated for breast milk.

Review of the policy titled "Breast milk collection, storage, and handling" reviewed 2/09 stated maintain the refrigerators and freezers used to store breast milk at acceptable temperatures equal to or less than 41 degrees Fahrenheit or less than O degrees respectively."

NICU Nurse Manager acknowledged the refrigerator log was not correct and was replaced by a log with ranges of 41 degrees F and below.

e. On 3/712 at 11:00 a.m., the Infection preventionist and the Infection Preventionist Officer were interviewed regarding the infection control oversight of the Food Service Department. They stated that they were involved in environment of care rounds and sanitation rounds of the kitchen. They stated this was monthly and used a form to complete the observations.

The Preventions and Officer were asked if they were aware of how the hospital ice machines were sanitized and if here was infection control oversight and they acknowledged they were not aware of the sanitizing requirements or was there oversight by the committee. In addition, they were asked about the kitchen handwashing sinks and they stated they had not observed the potential for the overspray when they had been in the kitchen.

They stated they were not aware of the FDA Food Code or the HACCP (Hazard Analysis Critical Control Point Program). This program is a systematic preventive approach to food safety that addresses physical, chemical, and biological hazards as a means of prevention rather than finished product inspection. HACCP is used in the food industry to identify potential food safety hazards, so that key actions can be taken to reduce or eliminate the risk of the hazards being realized. (FDA Food Code 2009).

Review of the Infection Prevention and Control Plan for 2011 showed the plan was to encompass all facility departments. There were no specific goals directed for the Food Service Department to ensure compliance with food safety requirements and prevent potential for food borne illness to the hospital patients, staff and visitors.



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Based on record review, observation, and interview, the infection control officer failed to successfully develop, implement and evaluate measures of a hospital wide infection prevention and control program. Observations made during tours of the facility revealed infection control policies and procedures were not consistently implemented by all staff and departments including:

1. Staff failed to implement the hospital's infection control policies and procedures, including effective handwashing / hand hygiene. Hospital staff were observed caring for multiple patients without performing handwashing / hand hygiene and when handwashing was performed the process was less than the required 15 seconds.

2. Failed to ensure housekeeping staff were trained and verified as competent to mix different concentrations of cleaning solutions. The hospital staff did not follow manufacturer's directions for use relating to cleaning solutions. Hospital staff did not mix the proper chemical concentration for three of three cleaning solutions. Hospital staff did not use the appropriate testing strips to ascertain the appropriate chemical concentration of the cleaning solutions.

3. Failed to ensure equipment and surfaces within the operating room were made of wipeable surfaces.

4. Failed to develope a system for identifying potential for food borne illness in the dietary department.

5. Failed to maintain an infection free and safe method of storage (dangerous needles and gauze) on both of the facility's Isolation Carts/Cabinets located on nursing units, 2 South and 2 North.

As a result, patients were at greater risk for the spread of microorganisms and infection.

Findings:

1. The Center for Disease Control (CDC) "Guideline for Hand Hygiene in the Health-Care Setting" dated 10/25/02, indicated "When washing hands with soap and water, wet hands first with water, apply an amount of product recommended by the manufacturer to hands, and rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers."

Review on 3/5/12 of the hospital policy and procedure titled "Hand Hygiene" dated 12/11, indicated the hospital "will follow the Center for Disease Control (CDC) recommendations. Hand hygiene refers to either hand washing, antiseptic hand wash, antiseptic hand rub, or surgical hand antisepsis. All personnel shall cleanse hands before any patient contact, between care of individual patients, upon leaving an isolation / patient care area, after removal of gloves."

a. During an observation on 3/5/12 at 10:30 a.m. accompanied by the chief nursing officer (CNO) in the triage area, a licensed nurse (LN 12) finished the task of triaging a patient. LN 12 escorted the patient to another area of the emergency room (ER). LN 12 returned to the triage area and started the triage process on another patient. At no time did LN 12 perform hand hygiene.

b. During an observation on 3/5/12 at 2:50 p.m., accompanied by the CNO, while on the fourth floor of the hospital, an environmental services staff (ES 1)
removed a pair of disposable gloves. ES 1 did not wash her hands or perform hand hygiene after removing the gloves. When ES 1 was asked if she needed to something after removing her gloves, she washed her hands with soap and water for a total of seven seconds.

c. During an observation on 3/6/12 at 2:00 p.m., accompanied by the CNO, while on the second floor the hospital, an environmental service staff (ES 4) removed a pair of disposable gloves. ES 4 did not wash her hands or perform hand hygiene after removing the gloves.

2. Review on 3/6/12 of the manufacturers directions for use undated of the cleaning and disinfecting solutions utilized by the environmental services department of the hospital indicated solution "2" needs to achieve a level of of sodium hypochlorite (bleach) of "50 parts per million" (PPM), solution "3" a level of sodium hypochlorite of 218 PPM, and solution "4" a level of sodium hypochlorite of 1100 PPM.

Review of the test strips used to test the PPM of sodium hypochlorite revealed the strips of could test only the highest level of 200 PPM.

During an observation of 3/6/12 at 2:00 p.m., accompanied by the chief nursing officer (CNO), an environmental service staff (ES 1) was asked about the cleaning solutions in the environmental services closet on the fourth floor, 4 South. ES 1 explained the hospital uses four different solutions to clean the hospital. ES 1 explained all four of the solutions are bleach based and are mixed by the environmental services staff. The solutions are mixed utilizing a wall mounted system which dispenses a pre-determined amount of chemical solution based on the type of solution and the amount of water dispensed from the faucet. The system has the capability of mixing four different solutions, one at a time. After mixing each different solution, the environmental staff needs to test the strength of each solution. The test strips innidiate four distinct levels: 10 PPM, 50 PPM, 100 PPM, and 200 PPM. ES 1 was asked to demonstrate the testing of solution "2". ES 1 obtained a plastic tub, configured the dispensing system to dispenses solution "2", turned on the faucet, allowing solution "2" to gather in the plastic tub. ES 1 was asked to test the solution. ES 1 was asked what type of results should be expected from the solution. ES 1 indicated the solution should test at 50 PPM. ES 1 obtained testing strips from the environmental services cleaning cart. ES 1 dipped a testing strip into the solution. After removing the test strip from the solution, ES 1 was asked the results. ES 1 indicated the test strip did not indicate any presence of the necessary chemicals. ES 1 retested the solution, obtaining the same negative results. ES 1 obtained a different container of test strips, again testing the solution, obtaining the same results. ES 1 changed out the container of solution concentrate, again mixing and testing the solution, obtaining the same negative results.

The surveyor, CNO, and ES 1 moved to the environmental services closet on the fourth floor, 4 North. ES 1 asked to demonstrate the mixing and testing of solution "4". ES 1 obtained a plastic tub, configured the dispensing system to dispenses solution "4", turned on the faucet, allowing solution "4" to gather in the plastic tub. ES 1 was asked to test the solution. ES 1 was asked what type of results should be expected from the solution. ES 1 indicated the solution should test at 200 PPM. ES 1 obtained testing strips from the environmental services cleaning cart. ES 1 dipped a testing strip into the solution. After removing the test strip from the solution, ES 1 was asked the results. ES 1 indicated the test strip did not indicate the strength of the solution to be at 200 PPM. ES 1 retested the solution, obtaining the same results of less than 200 PPM.

The surveyor, CNO, and ES 1 moved to the environmental services closet on the second floor, 4 North. ES 4 asked to demonstrate the mixing and testing of solution "2". ES 4 obtained a plastic tub, configured the dispensing system to dispenses solution "2", turned on the faucet, allowing solution "2" to gather in the plastic tub. ES 4 was asked to test the solution. ES 4 was asked what type of results should be expected from the solution. ES 4 indicated the solution should test at 50 PPM. ES 4 obtained testing strips from the environmental services cleaning cart. ES 4 dipped a testing strip into the solution. After removing the test strip from the solution, ES 4 was asked the results. ES 4 indicated the test strip did not indicate the strength of the solution to be at 50 PPM. ES 4 retested the solution, obtaining the same results of less than 50 PPM.

Observation on 3/7/12 at 10:15 a.m. in the operating room, accompanied by the CNO, director 10, manager 8, and IC 1, ES 5 was asked about the cleaning solutions and methods used in the operating rooms. ES 5 explained the solutions are the same ones used throughout the hospital. A metal bucket filled with solution and a submerged mop sponge was located in the environmental closet. ES 5 was asked what solution was in the bucket. ES 5 explained solution "2" was in bucket. ES 5 was asked to test the solution. ES 5 was asked what type of results should be expected from the solution. ES 5 indicated the solution should test at 50 PPM. ES 5 obtained testing strips from the environmental services cleaning cart. ES 5 dipped a testing strip into the solution. After removing the test strip from the solution, ES 5 was asked the results. ES 5 indicated the test strip did not indicate the strength of the solution to be at 50 PPM. IC 1 explained storing the mop head in the solution is not "recommended" by the manufacturer since it "causes dilution" of the chemical.

During an interview on 3/6/12 at 3:15 p.m. with IC 1, IC 2, ES 4, and senior director of environmental services (SDES), all indicated the solutions used for disinfection and cleaning throughout the hospital are standardized. The system is a pre-measured delivery system, sodium hypochlorite (bleach) based solution. Solution "1" contains no bleach and requires no testing. Solution "2" is for the mopping of floors, contains bleach, requires testing to 50 PPM. Solution "3" is for general cleaning including the walls, contains bleach, requires testing to 100 PPM. Solution "4" is for high touch areas, contains bleach, requires testing to 200 PPM.

The SDES could not provide any documented evidence relating to the calibration and maintenance of the delivery system. There was was no documented evidence indicating testing of the strength of the cleaning solutions.

During an record review and concurrent interview on 3/8/12 at 9:02 a.m. with director 8, there was no documented evidence in the environmental services employee files indicating employee competencies for the use and mixing of the cleaning solutions.

3 a. Observation on 3/5/12 at 10:32 a.m., accompanied by the chief nursing officer (CNO) and manager 8 while in the emergency room, at the triage area, the triage area is a cubicle lined with fabric. The purpose of the triage area is for a hospital staff to access the immediate needs of potential patients. The needs could include bleeding, coughing, sneezing, vomiting, diarrhea. The CNO and manager 8 were asked how the hospital clean the fabric cubicle if a potential patient bled, coughed, sneezed, or vomited onto the fabric. The CNO and manager 8 explained there would be no way to clean / disinfect the fabric after exposure to body fluids from a patient.

b. Observation on 3/7/12 at 7:59 a.m., accompanied by the CNO, director 10, and manager 8 while in the operating room (OR), a clip board made of compressed paper was located in the the pre-operative holding area (an area where patients are prepared for the OR) of the OR. A cloth fabric chair was located in OR #1. The chair is used by the anesthesiologist during a surgical procedure. The CNO, director 10, and manager 8 explained there was no way the items could be cleaned / disinfected between uses.

Based on interview with facility staff, observation, and review of documents the hospital failed to ensure that policies governing surgical care were designed to assure the achievement and maintenance of high standards of medical practice and patient care.

Findings:

During a tour of the gastrointestinal procedure area on 3/8/12 at 2:15 p.m. staff personnel was interviewed regarding the transportation of the dirty endoscopes from the procedure room to the processing area. The staff stated the current practice was to wrap the endoscope in a white cotton towel after wiping it down and then to carry it in the towel to the processing area. This was confirmed at the time in an interview with the director of perioperative services. The towel provided little protection against the leakage of fluid from the scope. Review of the hospital policy titled " Disinfection of Endoscopy Equipment and Sterilization " showed it did not contain recommendations for the secure transportation of endoscopes from the procedure room to the area where they were to be cleaned.

Based on review of documents the hospital failed to ensure that policies governing anesthesia services were enforced in the area of conscious sedation. Two of two patients were not monitored during conscious sedation according to the hospital ' s policy.

Findings:

Review of the hospital policy on conscious sedation revealed it required at least one individual to monitor the vital signs of any patient receiving conscious sedation. Review of the medical records of Patients 3 and 8 showed both had received medications consistent with conscious sedation. In both records the individual who was monitoring the patient was also listed as circulator. The nurse in these cases was performing the tasks of two roles despite the policy ' s requirements.

Based on record review, observation, and interview, the hospital failed to ensure licensed nurses who administered conscious sedation (a combination of medicines to help you relax (a sedative) and to block pain (an anesthetic) during a medical procedure) to patients in the cath lab followed the hospital policy and procedure relating to conscious sedation. The failure placed patients at risk for the development of complications while receiving conscious sedation.

Findings:

Review on 3/8/12 of the hospital policy and procedure titled "Conscious Sedation and Analgesia for Diagnostic and Therapeutic Procedures" dated 1/11, indicated "Moderate Sedation / Analgesia (Conscious Sedation): A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patient airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Procedural sedation privileges required to perform. Staffing: The individual whose responsibility is directed only to the patient (administering medication, monitoring the patient, and observing the patient's response to both the sedation and the procedure.) Competency: Registered Nurses: The registered nurse is required to have knowledge and skills in administering mediation to induce sedation as well as the ongoing monitoring of a patient during and after the procedure. Evidence of competency in these areas will include: successful completion of medication exam to include effects of medication, potential side effects of the medication, contraindications for the administration of the medications, and proper dosage and medicine administration. Blood pressure, respirations and heart rate are documented every five minutes. The licensed personnel responsible for monitoring the patient should have no other duties that would cause the patient to be unattended or compromise continuous monitoring. Credentialing requirements for professionals administering : Registered Nurses: Recertification every two years, satisfactory completion (80%) of the procedural sedation examination, competency validation in the procedure for assessing, monitoring and discharge/transfer of patients from the unit."

1. Record review on 3/5/12 of Patient N3 revealed Patient N3 had a procedure in the cath lab involving conscious sedation on 3/2/12. Review of the Special Procedures Report dated 3/2/12 indicated the procedure started at 5:40 p.m. and lasted until 7:30 p.m. The report indicated Patient N3 received medications for conscious sedation including versed (a drug that causes relaxation, sleepiness and can cause a partial or complete loss of memory) and fentanyl (narcotic pain reliever). The report indicated Patient N3 was not monitored every five minutes for blood pressure and heart rate with times ranging between nine and 11 minutes between monilating. No documented evidence indicating respirations were checked every five minute could be located on the report. Review of the Invasive Cardiovascular Lab Record dated 3/2/12 indicated Patient N3 was not monitored every five minutes for blood pressure, heart rate and respirations with times ranging from ten to 20 minutes between monitorings.

2. Record review on 3/5/12 of Patient M3 revealed Patient M3 had a procedure in the cath lab involving conscious sedation on 12/9/11. Review of the Special Procedures Report dated 12/9/11 indicated the procedure started at 8:40 a.m. and lasted until 10:45 a.m. The report indicated Patient M3 received medications for conscious sedation including versed and fentanyl. The report indicated Patient M3 was not monitored every five minutes for blood pressure and heart rate with times ranging from ten to 18 minutes between monitorings. No documented evidence indicating respirations were checked every five minute could be located on the report. Review of the Invasive Cardiovascular Lab Record dated 12/9/11 indicated Patient M3 was not monitored every five minutes for blood pressure, heart rate and respirations. Patient M3 was monitored every 15 minutes.

3. Record review on 3/5/12 of Patient M8 revealed Patient M8 had a procedure in the cath lab involving conscious sedation on 12/15/11. Review of the Special Procedures Report dated 12/15/11 indicated the procedure started at 10:09 a.m. and lasted until 11:10 a.m. The report indicated Patient M8 received medications for conscious sedation including versed. The report indicated Patient M8 was not monitored every five minutes for blood pressure and heart rate with times ranging from nine to 12 minutes between monitorings. No documented evidence indicating respirations were checked every five minute could be located on the report. Review of the Invasive Cardiovascular Lab Record dated 12/15/11 indicated Patient M8 was not monitored every five minutes for blood pressure, heart rate and respirations. Patient M8 was monitored every 15 minutes.

Observation and concurrent interview on 3/8/12 starting at 10:15 a.m. while in cath lab 1, cath lab 2, and cath lab 3 accompanied by the chief nursing officer (CNO) and radiology technician (Rad 1), Rad 1 explained how a patient would be placed on a special table while in the cath lab. Rad 1 explained where the registered nurse, responsible for the administration of the conscious sedation medications and the monitoring of the patient, would be located in the room. The CNO estimated the distance between the location of the patients' head and the location of the registered nurse in cath lab 1 would be approximately five meters (16 feet). The CNO estimated the distance between the location of the patients' head and the location of the registered nurse in cath lab 2 would be approximately four to five meters (13-16 feet). The CNO estimated the distance between the location of the patients' head and the location of the registered nurse in cath lab 3 would be approximately five meters (16 feet).

Interview on 3/8/12 at 1:28 p.m. with P6, he indicated the anesthesiology department had "developed" the policy and procedure relating to conscious sedation. The expectation of the anesthesiology department is that the policy and procedure is "followed" as written.

During an record review and concurrent interview on 3/8/12 at 9:02 a.m. with director 8, she indicated the hospital has a total of eight registered nurses in the cath lab area who administer conscious sedation. Director 8 explained that no documentation could be located in the employee files of the eight registered nurses indicating the recertification every two years, satisfactory completion (80%) of the procedural sedation examination, competency validation in the procedure for assessing, monitoring and discharge/transfer of patients from the unit relating to the administration of conscious sedation.