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Based on observation, review of hospital policies and procedures, facility documents, menus, staff interviews and clinical record review, the hospital did not have an organized dietary services that was directed and staffed by adequate qualified personnel.

The hospital failed to ensure that the Director of Support Services (DSS) who was responsible for the food services department was qualified. The hospital failed to check his credentials and was therefore unable to provide proof of his training and education. (Refer to A-620)

The DSS was responsible for three departments and was disconnected from the managements of the day to day management of the food service department.
The department did not have an organizational chart that delineated the hierarchy of staff. This lack of organization and direction resulted in the kitchen coordinator with a high school diploma and no training in field of dietetics being assigned to validate the competency of the registered dietitian for at least two consecutive years.

Staff were not knowledgeable in reading thermometers and accurately recording information on logs. The errors/practice were long term and no evidence that the DSS or RD were aware because that had not checked the logs or observed staff completing the tasks.
There were no systems in place to ensure that all foods served met the minimum food safety threshold. Staff did not test or record food temperatures of all food served. The forms were not designed to evaluate the temperatures of all cold foods. This failure to evaluate resulted in lack of knowledge. Hospital staff knew of cold foods being out of range because the surveyor who took food temperatures informed them. (Refer to A-622)

Although the hospital had a full-time registered dietitian (RD), her responsibilities were shared with the skilled nursing facility (SNF). Most of her time was not in the hospital resulting in failure to ensure systems were in place to ensure that the diet met the nutritional needs of the patients.
The hospital did not have a diet manual, the SNF's manual was passed as the hospital manual. The language and basis or rationale for the diets including the use of the terminology " residents ' instead of " patients " , revealed this failure.( Refer to A-631) The hospital menu had not been evaluated for adequacy to ensure that it met the needs of the patients. Although the hospital served all age groups, there were no pediatric menus. (Refer to A-628.)

Nutritional assessments were missed because nursing staff were not aware of a tool that might increase the number of referrals to the RD. (Refer to A-621, A-630)

Policies and procedures were not updated resulting in practice not matching policies. There were inadequate staff in the dish room, one employee was observed loading and unloading. This resulted in frequent glove changing as he moved from one area to another. But he was not observed to wash his hands between glove changes. There is no RD coverage on weekends and when she is out ill. There was no explanation given for why a high nutritional risk patient was not reassessed for a ten-day period.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure organized dietary services, directed and staffed by adequate qualified personnel, were provided.

Based on observation, staff interview and review of facility documentation, the facility failed to maintain a comprehensive and on going infection control program to minimize infections. The facility failed to ensure adequate resources were available to maintain an ongoing, comprehensive infection control program ( Refer A-0748) The facility failed to have an infection control program that provided a consistent, comprehensive plan for preventing, identifying and managing infections. (Refer A-0749). The facility failed to maintain a current infection control log. (Refer A-0750). The facility failed to ensure hospital wide quality assurance programs were identified by the infection control officer and failed to ensure implementation of successful corrective action plans in affected problem areas ( Refer A-0756).

The cumulative effect of these systemic failures resulted in the facility's inability to maintain an ongoing infection control program to minimize infections and communicable disease and provide quality patient care in a safe and sanitary environment.

Based on interview with facility staff and review of documents the hospital failed to maintain a list of all contracted services that included the scope and nature of the services provided.

Findings:

Review of the facility's list of contracted services on 9/2/10 revealed it did not include the hospitals contract for the transcription service, and did not include the scope of the services being provided. In an interview at 11:30 a.m. on 9/2/10 the hospital administrator stated there was no other list available.

Based on interview with facility staff and review of documents the facility failed to ensure that the medical staff examined the credentials of candidates for medical staff membership.

Findings:

Review of the credential file of practitioner 1 on 8/31/10 at 11:00 a.m. revealed there was no documentation of verification of licensure for the practitioner in the state in which he was located. The State Operations Manual Appendix A Revision 37 states: " When telemedicine is used, and the radiologist who interprets radiological tests and the patient are located in different states, the radiologist interpreting the radiological test must be licensed and/or meet the other applicable standards that are required by the State of local laws in both the state where the practitioner is located and the state where the patient is located. "

In an interview on 8/31/10 at 11:30 a.m. the medical staff coordinator stated no documentation of medical licensure in their home state had been obtained for any of the teleradiologists on the medical staff.

Based on medical record review, facility document review, and staff interview, the hosptial failed to ensure adequate numbers of nurses were available in the operating room (OR) to promote patient safety and in accordance with professional standards of care. Two of eight surgical records of patients reviewed (N6, N7) had no circulating nurse in the operating room (OR). The facility did not schedule a circulator RN (registered nurse) when intravenous (IV) sedation/moderate sedation was administered by a RN.

Findings:

The nationally recognized, Association of Perioperative Registered Nurses (AORN), written guidelines for, "Perioperative Standards and Recommended Practices" 2008 edition, page 258, reflected in part, " ... 1 RN per patient per OR in the role of the circulation nurse ..." Under moderate sedation AORN states, "One RN dedicated to monitoring the patient and separate from the dedicated RN circulator ..."

Medical record review beginning on 8/31/10 at 10 a.m. indicated that N6 and N7 were admitted for colonoscopies which were performed under IV sedation. The intra-operative record documentation reflected that the IV sedation was administered by an RN, and that there was no other RN in the operating room.

Concurrent facility policy review and interview with the Director of Nursing (DON) on 9/3/10 at 11 a.m. revealed the facility's policy for, "Care of Surgical Patients Receiving Local Anesthesia and/or Conscious Sedation" did not meet current professional standards of care. The facility policy required two people in the OR, but did not specify that a registered nurse circulator was required at all times.

The DON confirmed that when an RN administers IV sedation that RN is the only RN in the OR. The DON indicated that she was unaware an RN circulator was required in the OR intra-operatively for all procedures.

Based on observation, staff interview, facility document review, and personnel file review, the hospital failed to ensure nursing staff were adequately trained and competent to provide nursing care in accordance with the individual needs of the patient and professional standards of practice. 1. A review of the personnel files of five nurses ( RN's 2, 3, 6, 7, 8) who provided direct patient care, revealed all five nurses provided surgical nursing care to pediatric patients. There was no documentation to verify the five nurses were trained and verified competent in delivery of care to the pediatric patients assigned. 2. The hospital failed to implement professional standards of care for safe patient care; although providing pediatric surgical care the hospital does not require the surgical nursing staff be trained in pediatric advanced life support (PALS). 3. The facility failed to ensure their policy requiring the completion of a pediatric medication administration test was consistently implemented. 4. RN 3 was administering intravenous (IV) conscious sedation with no documented training or competency verification. 4. RN 2 was assigned to work in multiple areas/departments of the hospital, however, training, orientation, and competency verification was completed for only one department. The competency review completed for nurse supervisor (RN 6) was completed by a staff directly under her supervision.

Findings:

The facility policy, "Competence - Nursing" stated as its purpose: "To ensure that all members of the nursing staff are competent to fulfill their assigned responsibilities to the populations they serve." As part of orientation the policy included " ... The pediatric Medication Administration test is also administered when appropriate for patient population assignment."

1. During the facility tour beginning on 8/30/10 at 11:40 a.m. a pediatric patient was observed being cared for in the intensive care (ICU) unit. In talking with various nurses it was learned that pediatric patients were cared for in various areas of the facility, including surgical services.

Personnel file review beginning on 9/1/10 at 3 p.m. included a review of five nurses who provide direct pediatric care ( RN's 2, 3, 6, 7, 8 ). All five nurses worked with pediatric surgical patients. There were no documentation to indicate that the five nurses had received age specific training and competencies verified for the care of the pediatric patient. There was no documentation to indicate that the five nurses had completed the facility's pediatric medication administration test. Interview with the Director of Nursing (DON) on 9/3/10 at 11 a.m. confirmed that none of the five employees had completed the pediatric medication tests as required by facility policy.

2. According to AORN (Association of perioperative Registered Nurses) 2008 edition; Perioperative standards and recommended practices, under Nursing care policies; "Personnel should be trained in the use of emergency equipment and cardiopulmonary resuscitation for both adult and pediatric patients if pediatric care is provided. Advanced cardiac life support and pediatric advanced life support training is, if pediatric care is provided, recommend for all PACU nurses."

Although the hospital provides pediatric surgical care, it had no system in place to ensure professional standards for safe nursing care for the pediatric surgical patient were implemented. The hospital had no requirement that the nurses who work in surgery have pediatric advanced life support (PALS).

3. Personnel file review on 9/2/10 beginning at 10:30 a.m. revealed that RN 3 was administering IV conscious sedation, however, there was no documentation to verify RN 3 was verified as competent to perform this procedure. RN 3's personnel file indicated that a procedural sedation test was taken on 6/5/09, however there was no indication that the test had been corrected/reviewed and the "Competency met: ___ Competency not met ____:" sections were blank. There was no documentation that RN 3 had been evaluated for, or was verified competent, in the administration of IV sedation, which she had been administering for over a year.

4. During the facility tour on 8/30/10 beginning at 11:40 a.m. RN 2 was observed at one end of the intensive care unit (ICU) caring for a post-operative patient. In an interview with RN 2, he listed all the areas of the facility that he worked included, "post anesthesia care (PACU), Emergency Room (ER), Out Patient Surgery (OPS), ICU, and as house supervisor."

Personnel file review beginning on 9/1/10 at 3 p.m. indicated that RN 2's job description, orientation and competencies were for the emergency room only. There was no documentation that RN 2 had been oriented or verified as competent to work in any of other areas of the hospital he had been assigned to.

Personnel file review on 9/2/10 at 10:30 a.m. revealed one evaluation for the OR Coordinator ( RN 6) was completed by the Director of Nursing (DON); it did not involve observation of skills but was a general job performance evaluation. The skills evaluation that included direct observation of required surgical skills was in fact completed by an employee under the direct supervision of the OR Coordinator.

Based on interview and personnel file review, the hospital failed to ensure all nurses were competent to fulfill their assigned responsibilities. Non-employee, contracted traveling nurses were not adequately supervised, oriented, or evaluated for the clinical duties assigned for one of one personnel files reviewed. ( RN 7) The facility failed to implement their policy and procedures for assessing nursing competency.

Findings:

Review of the facility policy and procedure (P&P) titled "Competence - Nursing " on 9/2/10 at 10:30 a.m., reflected in part, "...All nursing personnel who provide direct patient care shall be assessed for clinical competence during the hiring process ... and throughout orientation by the Department Coordinator and preceptor..."

Concurrent personnel file review and interview with the human resource manager on 9/2/10 beginning at 10:30 a.m. indicated that RN 7, a Traveling Nurse, was contracted to work in the emergency room (ER) and as the night house supervisor as of 4/26/10. The night house supervisor position was explained in part as providing oversight and direction to all the departments in the hospital after hours.

RN 7 has been providing patient care in the hospital for over four months, with no evidence of competencies or evaluations of clinical skills. There was no documentation that RN 7 was orientated to the facility or to the job duties and responsibilities of the night house supervisor position.

Based on policy and procedure review, medical record review and interview, the facility failed to ensure written physician orders for medications were received for three of eight records reviewed (N6, N7 and N8). (Refer to A-490)

Findings:

Mosby's 5 th edition, Fundamentals of Nursing by Potter & Perry in the section titled " Medication Administration" beginning on pg 907 indicated, "A medication order is incomplete unless it has the following parts... Dose. The amount or strength of the medication is included... Time and frequency of administration." "If the medication order is incomplete, the nurse should inform the the prescriber and ensure completeness before carrying out any medication order."

Review of the policy and procedure titled, Medication Administration, on 9/1/10 at 10 a.m., reflected in part, " ...A. Requirements 1. All orders for drugs must be written clearly, legibly, and completely by the prescribing physician or by a person authorized to verbally accept such orders. ...2. The order must include: a. name of patient, b. name of drug, c. dosage, (if appropriate in the metric system). d. strength, (if appropriate in the metric system), e. frequency or time of administration, f. route of administration, g. the date, the time, and the signature of the prescriber ... "

Patients N6 and N7 were admitted for colonoscopies (examination of the upper portion of the rectum with an elongated speculum or a colonscope). Both of the patient records had preoperative physician's orders to have "Versed and Fentanyl available" for the procedure. According to the documentation on the intra-operative nursing forms Versed and Fentanyl (drugs used for conscious sedation) were administered to the patient at various times. There was no documentation, in either record, to reflect that a physician's order, verbal or written, was received for the actual administration of these drugs, as given by the registered nurse.
There was no documentation in either record to indicate the dosage measurement, such as milligrams (mg) or milliliters (ml) of the medications (Versed and Fentanyl) or the route of administration, such as by mouth, intramuscular (IM) or intravenously (IV) for the medications given.

Patient N8 was admitted on 7/13/10 for a left cataract extraction with lens implant. Pre-operative physician orders included six different eye drop medications to be administered pre-operatively.

The documentation on intra-operative record reflected that Tetracaine 0.5% (local anesthetic) was given preoperatively, but, there was no documented physician's order for this medication. Nursing documentation did not include the time of administration, the number of drops, or which eye received the drops. Post operatively Brimonidine 0.2% eye drop was administered to the patient (N 8), however there was no documented physician's order for the medication.

Subsequent interview with RN 1 verified that there were no physician's orders in the records for the medications.

Based on review of documents the hospital failed to ensure that all medical records were accurately written.

Findings:

During a tour of the pre-operative holding area on 9/2/10 at 11:00 a.m. (where patients were evaluated prior to having a procedure) the facility form titled " anesthesia record " was reviewed. A portion of the form titled " pre-anesthesia evaluation " is completed when the patient is admitted and prior to surgery. A component of the pre anesthesia evaluation is to ascertain the patients allergic. The allergy box on the form was filled in with a pre-printed notation of "NKA " ( no known allergies).

When the pre printed form including the pre anesthesia evaluation is completed for each patient there was no system in place to ensure this pre-printed notation on the form accurately reflected the patient's status. This system created a potential for harm for a patient who did have allergies that were not captured on the pre printed form.

Based on facility policy and procedure review, medical record review and interview, the hospital failed to ensure documented physician orders were received for all medications administered for three of 13 records reviewed. (N6, N7, N8) The facility failed to have timed, dated and signed pre and post surgical assessments for five of 13 medical records reviewed. ( M1, M2, M3, M4, M5). N2 (one of 13 records) had an order for an antibiotic, however the time of the order was illegible, making it difficult to ensure the administration time of the medication was as prescribed.

Findings:

Review of the policy and procedure titled, Medication Administration, on 9/1/10 at 10 a.m., reflected in part, " ...A. Requirements 1. All orders for drugs must be written clearly, legibly, and completely by the prescribing physician or by a person authorized to verbally accept such orders. ...2. The order must include: a. name of patient, b. name of drug, c. dosage, (if appropriate in the metric system). d. strength, (if appropriate in the metric system), e. frequency or time of administration, f. route of administration, g. the date, the time, and the signature of the prescriber ... "

1. Patients N6 and N7 were admitted for colonoscopies. Both patient records had a preoperative physicians' orders to have "Versed and Fentanyl available" for the procedure. The documentation on the intra-operative nursing forms reflected the medications Versed and Fentanyl (drugs used for conscious sedation) were administered at various times. There was no documentation, in either record, to reflect that a physician's order, verbal or written, was received for the actual administration of these drugs, which were given by the registered nurse. There was no documentation in either record to indicate the medications' (Versed and Fentanyl) dosage measurement, such as milligrams (mg)/ milliliters (ml) or the route of administration, such as by mouth, intramuscular (IM) or intravenously (IV).

2. Patient N8 was admitted on 7/13/10 for a left cataract extraction with lens implant. Pre-operative physician orders included six different eye drop medications to be administered pre-operatively, and according to the documentation on the intra-operative record Tetracaine 0.5% (local anesthetic) was also given to the patient preoperatively. Post-operative documentation indicates that the patient received Brimonidine 0.2% . There were no documented physician orders for either the Tetracaine or the Brimonidine.

Interview with RN 1 verified that there were no physician orders in the patient records for these medications.

3. Concurrent interview and medical record review beginning on 8/31/10 at 9:25 a.m., with the Clinical Manager, revealed that N2 was admitted on 8/26/10 through the emergency room (ER) with an infection that had not responded to antibiotic therapy. A new antibiotic was ordered by the patient's primary care physician to be administered every six hours. The first dose was documented as being given at 6 p.m.

A review of the physician's order for the new antibiotic order revealed the time of the order was illegible, making it difficult to ensure that the every six hours administration time prescribed was met. The Director of Nursing revealed that the patient had not come into the ER until 2 p.m., she confirmed that the physician's order time was illegible but that the patient had received the prescribed antibiotic timely.

4. Review of the surgical record of patient M1 on 8/31/10 at 9:23 a.m. revealed the front of the pre-operative checklist was not dated or timed. The back of the form did not have the time of completion documented.

Review of the surgical records of patient M2 and M5 on 8/31/10 at 9:40 a.m. and 10:15 a.m. respectively revealed both the pre-anesthesia evaluation and the post-anesthesia evaluation of each patient were not dated or timed to ensure the evaluations were done timely.

Review of the surgical record of patient M3 on 8/31/10 at 9:58 a.m. revealed the follow up record did not have the date, time, or the name of the person who completed it.

Review of the surgical record of patient M4 on 8/31/10 at 10:39 a.m. revealed the medical history and physical examination was not dated, timed, or signed..

Based upon a review of the hospital's drug storage areas, pharmacy record reviews, policy and procedure reviews, patient health record reviews and staff interviews the hospital failed to provide pharmaceutical services to meet the needs of each patient.
Findings:

1. See A491 - A minimum of 36 vials was not available in surgery to treat the emergency condition of Malignant Hyperthermia. There was no proper oversight for the safe and appropriate use of medications taken by nurses from the night locker.
2. See A492 - There was inadequate supervision of pharmacy services.
3. See A494 - Control substance inventories were not accurately maintained.
4. See A406 - Intravenous and eye medications were administered to patients without any evidence of a physicians order.
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure that pharmaceutical services provided a safe patient care environment.

Based upon observation, hospital staff interview, and document reviews, the hospital failed to ensure all drug storage areas were maintained and administered in accordance with accepted professional principles, standards, and established hospital policies and procedures.

Findings:

1. During an inspection of Surgery on 9/1/10 at 1:50 p.m., a review of the Malignant Hyperthermia (MH) box revealed that only 24 vials of Dantrolene were in stock. The Malignant Hyperthermia Association of the United States (MHAUS) a nationally recognized authority on Malignant Hyperthermia (MH) recommends that a minimum of 36 vials of Dantrolene must be kept in stock to treat MH. MH is an emergency condition characterized by an uncontrolled increase in skeletal muscle oxidative metabolism, which overwhelms the body's capacity to supply oxygen, remove carbon dioxide, and regulate body temperature, eventually leading to circulatory collapse and death if not treated quickly. MH may be triggered when a patient is subjected to general anesthesia and neuromuscular blocking agents (both of which are used routinely in surgery). During an interview with Rx1 on 9/1/10 at 2:00 p.m., he stated he knew 36 vials of Dantrolene were needed but that there was no room in the surgery box to house 36 vials. He said the 12 additional vials in the pharmacy. Rx1 then confirmed that the pharmacy was only open from 7:00 a.m. to 6:00 p.m. and that the 12 vials would not be immediately or even readily available for the treatment of MH after 6:00 p.m.. Thus after the pharmacy closed, the hospital could not provide 36 vials of Dantrolene in an emergency.

2. As identified by Rx1, the pharmacy is closed between the hours of 6:00 p.m. and 7:00 a.m. the following morning. So, a night locker was developed In order to allow nurses to access required medications after the pharmacy closes.
A review of the hospital's Medication Administration Policy and Procedure, page 2, on August 31, 2010 revealed: "B. A pharmacist shall review all medication orders against the medication profile and other relevant patient information before administration of the first dose. The only exceptions include:"
1. "A licensed independent practitioner, with appropriate clinical privileges controls the prescribing or ordering, preparation, and administration of the medication ..
".2. " Emergency and STAT orders ...."
A review of the Obtaining Medications After Hours Policy and Procedures, page 2, on September 1, 2010 indicated: "The pharmacist reviews the medication order and the patient ' s Medication Administration Record (MAR) the next morning to verify that the correct medication was removed and administered to the patient."
The American Society of Health-Systems Pharmacists (ASHP), an internationally recognized professional group under its guidelines on preventing medication errors in hospitals indicates: "All systems should provide for review and verification of the prescriber's original order (except in emergency situations) before a drug product is dispensed...."
The Institute for Safe Medication Practices (ISMP), a nationally recognized organization which specializes in the cause of medication errors, in its July 26, 2000 newsletter indicates: "PHARMACISTS SHOULD REVIEW ALL NON-URGENT DRUG ORDERS PRIOR TO ADMINISTRATION. For example, whether medications are obtained from floor stock or automated dispensing cabinets, it's risky to remove and administer non-critical first doses and other routine medications that can safely wait until a pharmacist is able to review the order."
A review of the night locker list on September 1, 2010 at 10:00 a.m.. revealed:

a) There were 261 different medications in the locker including such drugs as Bupropion (an anti-depressant), Carbamazepine (an Anti-convulsant), Clopidogrel (an anti-platelet - anticoagulant type), Dobutamine Intravenous (for cardiac decompensation), Dopamine Intravenous (for shock), Warfarin (an anticoagulant) and Heparin (an anticoagulant) which has a special alert because of reduced potency. These drugs have an FDA warning and are considered high alert medications by the ISMP. High alert medications are designated as agents which have a high risk of causing significant patient harm when used in error.
b) A total 56 medications were removed from the night locker by nursing staff between 8/9/10 and 8/30/10. During an interview with Rx1 on 9/1/10 at 10:30 a.m., he could not confirm that the doses were removed because of an emergency; he could not confirm that a licensed independent practitioner, with appropriate clinical privileges, controlled the preparation and administration of the dose; he could not confirm that a pharmacist reviewed the order before the first dose was administered and he could not confirm that a pharmacist reviewed the order the following morning, all in violation of hospitals Medication Administration and Obtaining Medications After Hours policies and procedures.

c) During the same interview, Rx1 stated that all hospital policies and procedures should be reviewed every 3 years and that the Pharmacy and Therapeutics (P & T) committee must review the night locker contents each time the contents changed. Rx1 confirmed that the P & T had not reviewed the use and contents of the night locker since 2006. Thus there had been no review of the contents or sue of the night locker by Medical Staff in 4 years.

Based upon observation, patient health record reviews, staff interviews and hospital policy and procedure reviews, Rx1 failed to ensure that his responsibilities for the supervision and coordination of pharmaceutical services were in place to control the distribution and administration of drugs.

Findings:
A review of the job description summary of the Director of Pharmacy (Rx1) revealed that Rx1 is responsible for the management of personnel and services to deliver pharmaceutical care to hospital patients. Also, the job description requires Rx1 to oversee employee performance and department and hospital compliance with regulations. The job description also requires that Rx1 make certain all duties are performed in a manner consistent with established hospital guidelines (usually referred to as policies and procedures).

1. Rx1 failed to make certain there were 36 vials of Dantrolene available in surgery to treat the emergency condition of Malignant Hyperthermia.
2. Rx1 readily admitted he could not confirm that pharmacists were monitoring drugs taken from the night locker by nurses after the pharmacy closed.
3. Rx1 readily admitted that medical staff has not reviewed the use and contents of the night locker which contained FDA warning drugs and High Alert drugs since 2006, which is a violation of hospital policy.
4. Rx 1 failed to make certain that orders entered by pharmacists into the computer, which automatically print on the medication administration record (MAR), were ordered by a physician. The MAR is a pharmacy generated form placed in the patient's health record which lists the medications which have been ordered for a patient and the time the medications are to be administered to the patient. A nurse follows this form to administer all medications to his/her patient. Thus, if a medication and time is listed, the nurse may administer the dose even though a physician has not ordered the medication.

A review of the health record for P7 on 9/1/10 at 2:40 p.m.. showed that Naloxone (a narcotic antagonist) was listed on the MAR. A review of the physician's orders for P7 revealed there was no evidence of a Naloxone order. A review of the health record for P11 on 9/1/10 at 2:50 p.m. showed that Gentamicin (an antibiotic) was listed on the MAR. A review of the physician's orders for P11 revealed there was no evidence of a Gentamicin order.

During an interview with RN6 on 9/1/10 at 2:55 p.m.. she confirmed that both Naloxone and Gentamicin were listed on the MAR's of P7 and P11 respectively and that there was no evidence of a physician's order for either of the drugs.

5. Rx1 failed to make certain that policies and procedures (P&P's) for high alert medications were followed.
Page 13 of the hospital's medication administration policies and procedures reads as follows: "B. High Alert Medications, 1(b) Insulin; 1 (c) PCA (patient controlled analgesia) medications; these medications require a 2nd Nurse Verification of medications on the MAR with a co-signature."
Page 8 of the same medication administration policies and procedures reads:"B. 1. All medication will be given within one hour (1 hour) of the scheduled time."

A review of the health record for P9 on 9/1/10 at 8:30 a.m.. revealed that Insulin was administered on August 31, 2010. However, there was no time indicating when the Insulin had been administered nor was there any evidence that a 2nd nurse witnessed an initialed the MAR as required by hospital's P&P's.

A review of the health record for P12 on 9/1/10 at 8:40 a.m.. revealed that a Morphine PCA was started on August 31, 2010. However there was no evidence of a 2nd nurse signature on P12's MAR witnessing administration of the medication as required by hospital's P&P's.

During an interview with RN 5 on 9/1/10 at 8:45 a.m.. she confirmed there were no 2nd signatures on the MAR for P9 and P12 as required by hospital's P&P's. RN5 also confirmed there was no administration time documented for the administration of insulin for P9 as required by hospital's P&P's.

Based upon observation and record review, the facility failed to maintain accurate inventory records of controlled substances (CS).

Findings:

During an inspection of the pharmacy starting at 8:15 a.m. on 9/2/10, the CS log book was reviewed. The log showed there should have been 472 vials of Morphine Sulfate 30mg/30ml in stock. An actual physical count revealed there were only 39 vials in stock. The log showed there should have been 5 Fentanyl Transdermal patches in stock. An actual physical count revealed there were only 4 patches in stock.

Based upon record review, interview and policy and procedure reviews, the hospital failed to ensure that drugs dispensed from the night locker were appropriate and correct and failed to ensure compliance with Federal Law and State Law.

Findings:

During an interview with Rx1 on 9/1/10 at 2:00 p.m.. he stated that the pharmacy was open from 7:00 a.m. to 6:00 p.m. Since the pharmacy is CLOSED between the hours of 6:00 p.m. and 7:00 a.m. the following morning, a night locker was made available to access required medications during that time.
A review of the Obtaining Medications After Hours Policy and Procedures, page 2, on 9/1/10 at indicated: "The pharmacist reviews the medication order and the patient's Medication Administration Record (MAR) the next morning to verify that the correct medication was removed and administered to the patient."
A review of the Medication Administration Policy and Procedure, page 2, on 8/31/10 indicated: "B. A pharmacist shall review all medication orders against the medication profile and other relevant patient information before administration of the first dose. The only exceptions include:"
1. "A licensed independent practitioner, with appropriate clinical privileges controls the prescribing or ordering, preparation, and administration of the medication ...."
2. "Emergency and STAT orders ...."

A review of the night locker on 9/1/10 at 10:00 a.m.. revealed a total of 56 medications were removed by nursing staff between 8/9/10 and 8/30/10. During an interview with Rx1 on 9/1/10 at 10:30 a.m.. he could not confirm that the doses were removed because of an emergency nor could he confirm that a licensed independent practitioner, with appropriate clinical privileges controlled the preparation and administration of the dose. Thus Rx1 could not confirm that the dispensing and administration of the medications from the night locker were under the supervision of a pharmacist.


During that same interview, Rx1 stated that all hospital policies and procedures should be reviewed every 3 years and that the Pharmacy and Therapeutics Committee (P&T) must review the night locker contents each time the contents changed. Rx1 confirmed that the P&T had not reviewed the use and contents of the night locker since 2006. Thus there has been no review of the contents or use of the night locker by Medical Staff in 4 years.

Based upon record reviews and interview, the facility failed to ensure that medication errors were properly identified and reported to medical staff and the hospital quality assurance program and failed to ensure compliance with Federal Law and State Law (reference the California Code of Regulations Title 22, Division 5, Chapter 1 70263 (c)(1).
Findings:
On September 1, 2010, a review of the medication errors furnished by the facility (which occurred between June 11, 2010 and July 28, 2010) revealed there were 10 errors on the list.
a. The hospital identified 3 errors as due to Drug Information not available or incorrect. A review of those errors revealed that 2 were due to incorrect pharmacy labeling and 1 was due to pharmacy incorrect order entry.
b. The hospital identified 5 errors as due to omission, incomplete documentation, transcription error, label unclear and incorrect duration. A review of those errors revealed they were all due to pharmacy incorrect order entry.
During an interview with Rx1 starting at 10:30 a.m. on September 1, 2010, he agreed there was no evidence of any review which determined the real cause of these errors and no discussion at any medical staff or quality assurance meeting. Thus, the facility could not modify any system or procedure to prevent these errors from occurring in the future.

Based on interview with facility staff and review of documents the facility failed to ensure that tissue specimens were sent to the correct laboratory, as per their policy and procedure.

Findings:

In an interview on 9/2/10 at 11:00 a.m. the laboratory director it was learned that pathology specimens were being sent to acute facility A. A review of the pathology laboratory policy for the handling of pathology specimens on 9/2/10 reflected the pathology specimens were to be sent for processing to a different facility than was actually being used by the laboratory. The policy did not reflect the current facility practice.

Based on observation, review of hospital documents and staff interviews, the hospital failed to ensure that there was a full-time employee who serves as the director of food and dietetic services. The hospital failed to ensure that the chef/kitchen coordinator, who was responsible for the daily management of the department, was qualified by training and experience.

Finding:

According to the administrator, during the entrance interview on 8/30/10 at approximately 10 am, the director of support services (DSS) was also the director of the food and dietetic services. Review of the personnel record of the DSS revealed that he was hired on 9/27/2000. The position summary of the job description and performance evaluation of the DSS identifies him as being responsible for three departments, engineering and environmental services and nutritional departments.

The DSS ' s food service responsibilities listed in the position summary are limited. The food service responsibilities listed was " investigates and resolves food quality and service complaints. Inspects food and food preparation to maintain quality standards and sanitation regulations " . The job summary did not hold him accountable for the day to day management of the food service department.

Due to his responsibilities in three departments, the DSS was not always available to be interviewed because of his need to participate in other key areas of the survey including life safety. He did not appear to take an active role in the day to day management of the department. He did not have an office in the foodservice area and did not participate in the training.

Observation of the food temperature log revealed that documentation of only a few items. Not all food served had documented food temperatures. There were no cold food temperatures recorded. The form which the food temperatures were documented did not include an area for cold foods. Observation during tray line on 8/30/10 at approximately 11:50 am showed the yogurt to be 63. 3 degrees Fahrenheit, custard was 50 degrees Fahrenheit, Mighty Shake was 47.3 degrees Fahrenheit. The recommended holding temperature of cold potentially hazardous foods is between 35 and 41 degrees Fahrenheit. No corrective action was taken because the hospital staff was not aware of the improper food temperatures because the cold foods were not checked.

Neither the RD nor the kitchen coordinator had any explanation for why temperatures of all foods were not taken and recorded.

According to the job description, the minimum educational qualifications person in the position of director of support services is a " B.A. (Bachelor of Arts degree) from a four year college or university, or one to two years related experience and /or training ...degree in engineering, preferable mechanical or electrical or hospital engineering ..... " There was no educational requirement for the food service portion of his job.
During request for documents, the DSS indicated on 8/31/10 at 11 AM that he possessed a DSS (Dietary Services Supervisor) certificate, a California state requirement. Personnel record review however, did not support this. There was no documented evidence that he possessed the other requirement, a B.A. degree. The Human resources manager and other administrative staff made attempts to obtain the said credentials but after the fourth day, it became apparent that the hospital would not be able to provide the credentials during the survey. The DSS did not have the minimum requirements based on state regulations and the hospital job description. A final attempt was made on 9/2/10 to interview the DSS on his food service responsibilities and clarify other related issues. The Human Resources Manager stated in an interview at approximately 2:00 p.m. that he was unable due to a family emergency.

Based on observations during the survey, review of performance and competency evaluations of dietary staff and staff interviews, his responsibilities in the engineering and environmental services departments, it was determined that the Director of Support Services was not responsible for the day to day operation of the dietary department and therefore could not be considered full-time in the food and dietetic services department.

The hospital failed to hire a full-time food service director who was qualified by education and training and responsible for the day to day management of the food service department.

Based on observation, review of clinical record, personnel record review, review of other facility documents and staff interviews, the hospital failed to ensure that the services provided by registered dietitian was sufficient to meet the needs of all patients admitted to the hospital.
Findings:
A review of the personnel record for the registered dietitian (RD) revealed that she was hired as a full-time clinical dietitian on or about 1/1/06 to the hospital. Her responsibilities however included not only the acute care hospital but also the skilled nursing facility (SNF) attached to the hospital. In an interview on 8/30/10 at approximately 3:15 p.m. with the RD she indicated that she spent ? day Mondays, Wednesdays and Fridays at the acute care hospital providing diet instructions, tube feeding and other nutrition assessments and that the rest of the time is spent in the SNF.

She stated in the concurrent interview that she approves menus; provide in service to food service workers among other things. Review of the diet manual, menus and policy and policy manuals, showed limited input in the hospital. For example, the hospital did not have a diet manual, the SNF diet manual that was presented as the diet manual for the hospital was designed for adults 51 years old and older. It did not provide guidance for diets for all the population served by the hospital. (Refer to A-631)

There was a hospital menu provided. The hospital served pediatric patients but there was no pediatric menu. Review of the menus showed the lack of portion sizes and production sheets to guide the kitchen staff in serving the appropriate amount of food to meet the needs of the patients. It was unclear what the RD approved on the menu. The RD was unable to demonstrate that the menu met the Daily Recommended Intake (DRI) of the population served. There is no nutrient analysis of the menu or the diets provided. In an interview with the RD on 8/31/10 at approximately 3:15 p.m. she said in a response to the question regarding portion sizes, that the kitchen staff will use the same portion sizes as is being used to serve the residents in the SNF.

Record review on 8/31/10 at approximately 11:50 a.m. revealed that Patient N1 is a 8 year old patient admitted to the hospital on 8/30/10. She was 54 inches tall and weighed 83.3 lbs on admission. According to her BMI, 20.2 she was greater than 90th percentile for weight/height and was therefore classified as " overweight " . The patient was not identified as being high risk due to a nursing error (Refer to A-629) and was not referred to the RD for nutritional assessment.

In a discussion with the RD on 8/31/10 at approximately 12:30 p.m. regarding nutritional plan of care for overweight children, and the change in therapy based on the position of the American Dietetic Association and American Academy of Pediatrics, she indicated that she is not able to keep up every area of the field. Review of the RD ' s personnel record showed that she had been evaluated on her age-related competency for the pediatric patients. The evaluation form did not properly evaluate her knowledge of the nutrition care of the pediatric population. Instead, it measured her ability to prepare fruit cups and desserts. The evaluator for this age-related competency was the chef/kitchen coordinator, who did not have any formal education in the areas of nutrition or food service (cross refer A 0618)

Closed record review showed that Patient D-4 was admitted to the hospital on 1/14/10 during his admission, he was on several physician ordered diets from clear liquids to TPN. The RD visited the patient to conduct a nutritional assessment on 1/15/10 a day after the physician ordered TPN. But there was no documented evidence that she followed up on this patient for a period of 10 days.

According to the hospital policy and procedure titled " Nutrition Care and Assessment " , reassessment would " be conducted in a time frame as indicated by the findings of the initial assessment by the dietitian .... " There was no documented evidence that the lack of follow-up or reassessment was planned. The RD in an interview on 9/2/10 at approximately 12:00 p.m. was not able to explain why she had not followed up on the patient for that period of time. The RD had stated in an interview on 8/30/10 at 3:15 p.m. that she was the only RD for both acute hospital and SNF and was on call on weekends, and was covered by another RD only when she was on vacation not when she called out sick.

Closed record review of Patient N-2 showed that he was admitted on 8/26/10 and discharged on 9/1/10.The physician ordered discharge diet was 1500 calorie diet with no more than 15 grams sugar per serving. Discharge instructions only included the 1500 calorie restriction of the diet order. It is unclear why the RN did not refer the patient to the RD for diet instruction and clarify the complicated diet. The patient was sent home without any education. The RD was interviewed on 9/02/10 at approximately 2:15 p.m. on why she had not provided the discharge education for Patient N-2. She stated that she was not notified. The RD was not consistently included in the provision of nutrition counseling for all patients that meet the criteria.

The face sheet of the manual showed that the P/P manual was last approved by the registered dietitian and the medical staff on 10/02/08. The hospital ' s Policy and Procedure (P/P) manual had policies that did not match information and practices observed during the survey. For example, the P/P stated that the hospital ' s diet manual was the 2003 American Dietetic Association ' s Clinical Manual of Dietetics. The hospital presented the SNF ' s diet manual as the hospital manual (cross refer A 0630)

The P/P titled " Nutrition Screening/Monitoring " lists nutritional screening risk factors but does not list risk those appropriate for children. The hospital ' s computerized medical record lists risk factors for children not included in the policy. The tool necessary to determine whether a child met the criteria for nutritional assessment , a growth chart was not used by the staff. This tool according to the hospital staff had been installed in the program to enable the staff make a quick determination. The RD was not aware of this tool and was therefore unable to educate the nursing staff on its use to accurately identify children who were at nutritional risk.

Based on observation and staff interviews, the hospital failed to ensure that food service workers were competent in reading refrigerator thermometers and correctly logging chemical sanitizer levels on hospital designed forms.

Finding:

At approximately 12:10 p.m. on 8/30/10, the kitchen coordinator (KC) was asked to check the temperature of the food in the refrigerator due to identified food temperature problems on the lunch tray line (cross refer A-620). He inaccurately read the freezer thermometer as " - 16 degrees " . The refrigerator temperature was approximately 0 degrees Fahrenheit. It appeared that he may have the Celsius portion of the thermometer. The temperatures logs were designed for Fahrenheit.

The following day, 8/31/10 at approximately at approximately 3:20 p.m. KC was observed to read the freezer temperature in the storage room as Celsius while documenting the temperature as Fahrenheit. This error in reading and resulting documentation made it appear as the freezer was out of range.

The erroneous readings of both days were brought to his attention. He was interviewed concurrently on his knowledge on reading thermometers. He had no explanation on why he consistently read the Celsius temperatures instead of the Fahrenheit range. This error is of significance because the KC, based on his job description was responsible for the day to day management of the kitchen and therefore was responsible for training staff. If he was unable to correctly read the temperatures staff under his direction may learn to read thermometers incorrectly and may not be able to identify food temperature problems readily. Review of the personnel record for KC revealed that he was hired on 02/07/04 as a staff engineer, later became the head chef/kitchen coordinator on or about 7/14/10 based on job description. He did not have the educational requirements required by state law. (cross refer A 023)

At approximately 3:15 p.m. on 8/31/10, dietary staff #3 (DS#3) was observed while testing the chlorine concentration of the sanitizer of the dish washing machine. Although the test strip read approximately 100 ppm (parts per million), DS#3 recorded " 140 " on the log. When he was interviewed on why he documented 140 instead of 100 he had no rationale. The color strip did not have a 140 ppm range. The next range after 100 ppm was 200 ppm.

Review of the log titled Dietary Department Dishwasher temperature log from November 2008 through August 2010, showed dietary staff consistently recording 140 in the column labeled " Chem lev. (chemical level) " . 140 degrees Fahrenheit is the highest optimal water temperature the low temperature dish machine operates. DS#3 was not observed checking the temperature gauge prior to recording on the log.

The fact that the incorrect levels have been consistently documented by different employees, indicated by the different initials for approximately two years indicate lack of oversight of the dish washing duties by management staff.

At approximately 3:30 p.m. another dietary employee was asked to test the " red bucket " . The red bucket is used in most food service establishment to hold sanitizing solution with sanitizing cloth soaking in it ,in between use, to clean counter tops and other food contact surfaces in the kitchen. The most common sanitizer used is the quaternary ammonia sanitizer. A test of this sanitizer revealed a blue color. The color chart which the test strip is compared against did not include the color blue. Staff present did not indicate that this was an usual incident and what corrective action to take. It was unclear whether staff consistently tested the sanitizer and knew how to prepare the sanitizer to ensure that the correct amount was prepared to disinfect food contact surfaces.

The hospital failed to ensure that its dietary staff were competent in their respective duties.

Based on clinical record review, review of policies and procedure and staff interview, the hospital failed to ensure that the physician ordered the diet of one of five clinical records reviewed.

Finding:

Patient N-1 is an 8 year old admitted on 8/30/10 with diagnoses including " amastics " and atypical pneumonia. The physician ordered diet was " diet as tolerated/no peanuts/shellfish. " On 8/31/10, the physician ordered diet for Patient N-1 was again " Diet as tolerated: No Nuts/ No shellfish.

Review of the computerized medical record showed the patient ' s diet entered as a " regular " . There was no documented evidence that the diet was clarified with the physician by the nurse on the exact diet he wanted the patient on.

The hospital did not have a pediatric menu and so child was served the regular diet served to adults. The patient was observed at approximately 12:30 p.m. on 8/31/10 eating a salad. In an interview with the parent, she indicated that she was aware that the child was overweight and had been watching the patient ' s intake of carbohydrate. Also did not have milk because she wanted to decrease mucus production and therefore opted for no milk and instead requested for ginger ale. There were three small cans of ginger ale on the patient ' s tray. (cross refer A-0621)

In an interview with the hospital dietitian on 8/31/10 at approximately 1:00 p.m. she stated that per hospital policy the kitchen does not honor diet as tolerated orders and that nursing staff will with the physician what diet should be served. The nutritional adequacy and appropriateness of the diet had not been determined because the RD had not yet completed a nutrition assessment on the patient.

The hospital failed to ensure that diet served to Patient N-1 was ordered by the physician.

Based on staff interview, review of hospital documents, staff interviews and clinical record reviews, the hospital failed to ensure that the nutritional needs of two of four sampled patients were met.
Finding:

Based on the determination that the hospital did not own diet manual, a nutrient analysis of the diets based on the menu provided was requested. The hospital had menus for regular, carbohydrate controlled, cardiac, high fiber, bland or low residue, no added salt and 2 grams sodium diets. The registered dietitian (RD) stated in an interview on 8/30/10 at approximately 3:20 p.m. that there was no nutrient analysis for the diets being served.

In the same interview, the RD was asked for the spreadsheet and /or production sheet used by the kitchen staff to determine how much food to serve the patients. She indicated that there were none and that kitchen staff had been directed to serve the hospital patients the same amounts served to residents in the skilled nursing facility (SNF).

According to the diet manual for the skilled nursing facility, a regular diet contains approximately 2300 - 2600 calories per day, and averages about 5-6 gram sodium without a salt packet on the tray.

Patient N1 is a 8 year old patient admitted to the hospital on 8/30/10. She was 54 inches tall and weighed 83.3 lbs on admission. She was served a regular diet during her stay. The patient was not identified as being high risk by the nurse who screened her on admission was not referred to the RD for nutritional assessment.

Among the hospital criteria for children at nutritional risk and therefore needing a referral to the RD were children weight/ht greater than the 90th percentile. Patient N-1 was not identified as being high risk due to the failure of the nursing staff to evaluate the criteria. The computerized medical record system had provisions for determining this risk but the nursing staff were not aware and had therefore had not used this tool to evaluate this risk factor this patient or any other pediatric patient that had been admitted to the hospital.


The RD and other hospital staff were not aware that she met this criteria until it was calculated by the dietitian surveyor and brought to the hospital ' s attention. According to her BMI (Body Mass Index) of 20.2, she was on the 92nd percentile. She was also in this same range for weight/height. The patient was determined to be overweight based on this criterion. Interviews at approximately 3:00 p.m. on 9/1/10 with two nursing staff (Nurse A and B) who care for pediatric patients, including one who screened Patient N-1, revealed that the computerized system had been in operation over a year and were trained on its use. Both indicated however, that the training did not include the page/tool that would have helped in the determination of BMI, weight for height or a growth chart.

The RD acknowledged that the training did not include this tool and that she was not aware or informed that such a tool existed in the hospital ' s system. This failure in referral delayed the evaluation of the nutritional needs of this patient.

The Reference Daily Intake (or Recommended Daily Intake) (RDI) is the daily dietary intake level of a nutrient which was considered (at the time they were defined) to be sufficient to meet the requirements of nearly all (97-98%) healthy individuals in each life-stage and sex group. The RDI is used to determine the Daily Value which is printed on food labels in the U.S., Canada, and Australia.

The RD stated that the kitchen add 3 cups of milk to the regular diet to make it a pediatric diet. According to the RDI, an eight year old female would need significantly less calories than is provided on the regular diet provided on the SNF menu. This high calorie diet (2300 -2600 calories) would not be in line with the recommendations of the ADA ' s ( American Dietetic Association) Evidence Based Pediatric Weight Management Nutrition Practice Guidelines.

Patient D-5 was admitted to the hospital 8/30/10 with diagnoses including congestive heart failure. His medications included lasix, aldactone and cardizem. His physician ordered diet was NAS (no added salt diet). The NAS diet is a regular diet with no salt packet added on the tray. Typically, this diet contains approximately 4 grams of sodium. However, if the SNF diet is followed, the patient may have received 5- 6 gram sodium, 1 - 2 grams more than his physician may have wanted him to receive.

The hospital failed to ensure that the nutritional needs of its patients were met.

Based on observation, review of documents and staff interviews, the hospital failed to ensure that its therapeutic diet manual was current and was used for ordering and preparing patients ' therapeutic diets in the hospital.

Findings:

The acute care hospital has a dependent skilled nursing facility (SNF) attached. The copy of the diet manual provided for review appeared to be for the SNF. The diet manual indicated that the diet regular was " planned to meet the nutritional needs of the resident 51 years of age and older " the population served by the SNF. The terminology used in this diet manual indicated that it was for the use of the long term care facilities, including the terminology residents and not patients. the P/P stated that the hospital ' s diet manual was the 2003 American Dietetic Association ' s Clinical Manual of Dietetics. The hospital presented the SNF ' s diet manual as the hospital manual. This manual was not presented for review.

According to review of clinical records and staff interviews, the hospital provides medical and nutrition care to patients all ages and not only those from 51 years old and older. The hospital did not have a diet manual for the population it serves.

In an interview with the registered dietitian on 8/30/10 at approximately 3:15 p.m., the diet manual had been approved by her and the medical staff. She provided no explanation for why the diet manual did not include the diets for pediatric and younger and middle-aged adults. In response to a question on the appropriateness and nutritional adequacy of the diet for pediatric patients, the RD stated that the regular diet for the older adults is modified for pediatric patients by the addition of 3 cups of milk per day.

The copies of the hospital menu provided for review however, was different from that of the SNF that the RD stated was modified to meet the needs of the pediatric patients admitted in the hospital. No nutrient analysis was completed on the hospital menu and so it could not be determined that it met the nutritional needs of the population served. The hospital failed to obtain a current therapeutic diet manual in accordance with national standards.

Based on observation the facility failed to ensure that the condition of the physical plant and the overall hospital environment was maintained to protect the safety and well-being of the patients, visitors and staff.

Findings:

On arrival at the facility on 8/30/10 at 10:00 a.m. the parking lot was observed to have an irregular surface with cracks and holes. On 9/1/10 at 1:15 p.m. a patient was observed attempting to cross a portion of the parking lot with an IV pole (a pole with wheels used to hold intravenous solutions). The wheels of the pole appeared to catch in the cracks of the parking lot making the patient's progress very difficult.

During a tour of the surgery suite on 9/1/10 at 2:10 p.m. the stone flooring of the suite had areas where the flooring was missing and the concrete under the flooring was exposed. The deep, wide cracks in the stone flooring created an even surface and a potential safety hazard.
(Refer A-748)

Based on observations, interview and policy and procedure review, the hospital failed to ensure adequate resources were available to provide active surveillance, over sight and training to maintain an on- going, effective, infection control program. 1. An in-patient's isolation status was incorrectly posted and incorrect precaution instructions implemented by staff and visitors. The patient's isolation/infection status was not identified on the facility's infection control log. 2. The facility's policy and practice for the terminal cleaning of the operating rooms did not meet professional standards. 3. The uneven surface area of the surgical suite flooring was not identified by the staff or the infection control designee as a hazard and a source of potential infections. 4. There was no oversight/monitoring of the complete facility campus, the infection control designee was unaware of the complete services of the hospital.
( Refer A-749, A-750, A-756)

Findings:

1. Interview with staff. prior to the initial facility tour on 8/30/10 beginning at 11:40 a.m., revealed the facility had no current inpatients on isolation precautions. However, after noticing an isolation sign for "Droplet Precautions" outside the door of Patient N2's room, it was learned that patient N2 had been in isolation since admission on 8/26/10, four days earlier.

The Director of Nursing (DON) was questioned about the patient's status at this time (8/30/10 at 11:45 a.m.), since the initial information given to the surveyors indicated there were no isolation patients in house. The DON stated the patient had been on isolation since his admission. However, she indicated that the signage was incorrect, adding that the patient should have been placed on, "Contact isolation."

Concurrent medical record review and interview with the Clinical Manager on 8/31/10 beginning at 9:25 a.m. revealed Patient N2 had been admitted on 8/26/10 and "Droplet Precaution" isolation was initiated by nursing, related to the patient's history of MRSA (methicillin-resistant Staphylococcus aureus). However, a review of the facility's, "Isolation Guidelines from Infection Control" revealed that "Contact Isolation" is what should be instituted for patients with MRSA.

For five days the sign on Patient N2's door incorrectly advised facility staff and visitors to follow, "Droplet Precautions." The sign listed precautions to be instituted when entering the room which included, wearing a mask if within three feet of the patient but, did not mention the need for gloves.

On 8/30/10, the same date as the facility tour, the posted instructions were changed by the DON to, "Contact Precautions" which specified, " ... Wear gloves when entering the room. ..."

Interview with the Infection control consultant on 9/2/10 at 9:20 a.m., revealed that she was unaware that there were any patients in isolation, and she did not have anyone on isolation listed on her infection control log. She had not received the isolation information on Patient N2 and was unaware that the patient had been on isolation precautions since admission to the facility on 8/26/10, eight days earlier. The Infection control consultant was unaware that staff had posted and implemented incorrect precautions until corrected by the DON four days after admission, and she was not aware of the patient's previous history of MRSA.

2. The nationally recognized, Association of Perioperative Registered Nurses (AORN), written guidelines for, "Perioperative Standards and Recommended Practices" , 2008 edition on page 379, reflected in part, " ...Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily..."

Review of the facility's policy and procedure for, "Environmental Sanitation" on 8/31/10 at 1:30 p.m. revealed the following operating room (OR) cleaning instructions, "A terminal cleaning will be done with a hospital approved disinfectant three times a week ..."

Concurrent observations of the OR and interview with the OR coordinator on 8/31/10 at 3 p.m. confirmed that terminal cleaning of the operating rooms was done three times a week; Monday, Wednesday, and Friday, even though surgeries were scheduled Monday through Fridays. The OR coordinator was unaware that the facility policy and procedure did not meet recommended standards for terminal cleaning.

Interview with the Infection control consultant on 9/2/10 revealed she was unaware that the hospital's policy and procedure on terminal cleaning did not reflect current professional standards of care. She was unaware that the terminal cleaning of the OR was not being done on daily basis.

3. Initial tour of the surgical area on 8/31/10 beginning at 2:30 p.m. revealed a red line on the floor just inside the double doors. Per staff the red line indicated the beginning of the restricted or sterile area, and surgical attire was required to proceed. Just beyond the red line however, the floor was gouged out in a striped pattern from wall to wall exposing naked under flooring. The OR Coordinator explained, "We moved the red line to include the sterilization room" and "the gouged area was where the old red line used to be." The exposed area created a potential breeding ground for pathogens as well being a trap for dust and debris. There was no way to ensure proper disinfection of the restricted area's flooring.

4. Review of facility policies and procedures related to infection control beginning on 9/2/10, revealed that the hospital's out patient center for headaches, had policies in place, however, they were not incorporated into the overall infection control plan for the whole campus. The outpatient center advertised that invasive procedures were performed, such as local analgesic injections and acupuncture, which would require some type of surveillance activity.

Interview with the Infection Control Consultant on 9/2/10 at 9:20 a.m. revealed that she was unaware of the condition of the surgical floor, and verified that the outpatient center was not included in the overall infection control plan for the whole campus.

Based on observations, interview and policy and procedure review, the infection control officer failed to develop and implement a site specific comprehensive system for identifying, reporting, and monitoring infections. Active surveillance and monitoring of the facility and the environment was not done in an effort to identify, report, monitor and control infections. The current system of reporting infections was inaccurate and not effective. 1. A patient's isolation status was incorrectly posted resulting in ineffective and inaccurate infection control measures being implemented by staff and visitors. The patient's isolation/infection (N2) status never appeared on the facility's infection control log. 2. The facility's policy for the terminal cleaning of the operating rooms (OR) did not meet professional standards. The OR's were terminally cleaned three times per week however, surgeries were scheduled Monday through Friday. 3. An area of the surgical suite flooring was gouged out from wall to wall, exposing the under flooring and creating an uneven surface that could not be properly disinfected. 4. There was no oversight/monitoring of the complete facility campus. An adjacent building, used for outpatient treatment of headaches, was not included as part of the facility's infection control plan.

Findings:

1. The initial facility tour on 8/30/10 beginning at 11:40 a.m. included the intensive care unit (ICU) with a census of four and the medical surgical (med/surg) area with a census of four. Neither area was reported to have patients in isolation. The medical surgical unit (med/surg) secretary was specifically asked at this time if there were any patients in isolation, she reported there were none. At 2:30 p.m. as the facility tour continued in the med/surg area with the Director of Nursing (DON) a green isolation sign was observed on the door to room 110 (Patient N2). The sign indicated that the patient was on isolation with, "Droplet Precautions." The DON was questioned about the patient since the initial information given to the surveyors indicated there were no isolation patients in house. The DON stated the patient had been on isolation since his admission. However, she indicated that the signage was incorrect. The patient should have been on, "Contact isolation."

Concurrent medical record review and interview with the Clinical Manager on 8/31/10 beginning at 9:25 a.m. revealed that patients could be placed on isolation either by a physician's order or by nursing. Patient N2 had been admitted on 8/26/10 and was put on isolation, "Droplet Precaution" by nursing, due to a history of MRSA (methicillin-resistant Staphylococcus aureus). However the facility's, "Isolation Guidelines from Infection Control" states that "Contact Isolation" should be instituted for patients with MRSA.

For five days (from 8/26/10 to 8/30/10) the sign on Patient N2's door incorrectly advised facility staff and visitors to follow, "Droplet Precautions." The sign listed precautions to be instituted when entering the room and included, wearing a mask if within three feet of the patient but, did not mention the need for gloves.

The instructions were changed by the DON on 8/30/10 to, "Contact Precautions" which specified, " ... Wear gloves when entering the room. ..."

In a discussion with the DON on the process of disseminating isolation/infection information to hospital staff she stated that the information would be put into the computer. Once it was in the computer the DON stated a daily report would be generated for supervisors; the DON, Administrator, House Supervisor, Dietician, and the Infection Control Nurse. The DON stated housekeepers and other staff would be notified by the posted door signs.

Interview with the Infection Control Consultant on 9/2/10 at 9:20 a.m., revealed that she was unaware that any patients were in isolation, and did not have any patients with any infection control concerns listed on her infection control log. She had not received information on Patient N2 and was unaware that the patient had been on isolation precautions for eight days since admission to the facility on 8/26/10.

2. The nationally recognized, Association of Perioperative Registered Nurses (AORN), written guidelines for, "Perioperative Standards and Recommended Practices" , 2008 edition on page 379, reflected in part, " ...Surgical and invasive procedure rooms and scrub/utility areas should be terminally cleaned daily..."

Review of the facility's policy and procedure for, "Environmental Sanitation" on 8/31/10 at 1:30 p.m. revealed the following operating room (OR) cleaning instructions, "A terminal cleaning will be done with a hospital approved disinfectant three times a week ..."

Concurrent OR observations and interview with the OR Coordinator on 8/31/10 at 3 p.m. confirmed that terminal cleaning of the operating rooms was done three times a week; Monday, Wednesday, and Friday, but surgeries were scheduled Monday through Fridays.

3. Initial tour of the surgical area on 8/31/10 beginning at 2:30 p.m. revealed a red line on the floor just inside the double doors. Per staff the red line indicated the beginning of the restricted or sterile area, and surgical attire was required to proceed. Just beyond the red line however, the floor was gouged out in a striped pattern from wall to wall exposing naked under flooring. The OR Coordinator explained, "We moved the red line to include the sterilization room" and "the gouged area was where the old red line used to be." The exposed area created a potential breeding ground for pathogens as well being a trap for dust and debris. There was no way to ensure proper disinfection of the restricted area's flooring.

4. Review of facility policies and procedures related to infection control beginning on 9/2/10, revealed that the hospital's out patient center for headaches, had policies in place, however, they were not incorporated into the overall infection control plan for the whole campus. The outpatient center advertised that invasive procedures were performed, such as local analgesic injections and acupuncture, which would require some type of surveillance activity.

Interview with the Infection Control Consultant on 9/2/10 at 9:20 a.m. revealed that she was unaware of the current terminal cleaning schedule of the OR suites and was also unaware of the condition of the surgical floor. The outpatient center was not included in the overall infection control plan for the whole campus.

Based on observations and interview, the facility failed to ensure infection control logs were current and updated. A patient's isolation/infection status never appeared on the facility's infection control log (Patient N 2).

Findings:

The initial facility tour on 8/30/10 beginning at 11:40 a.m. revealed that no current inpatients were on isolation. However, after discussion with medical surgical staff and noticing an isolation sign for "Droplet Precautions" outside the door of Patient N2's room, it was revealed that the patient had been in isolation since admission on 8/26/10.

The DON was questioned about the patient since the initial information given to the surveyors indicated there were no isolation patients in house. The DON stated the patient had been on isolation since his admission. However, she indicated that the signage was incorrect. The patient should have been on, "Contact isolation."

Concurrent medical record review and interview with the Clinical Manager on 8/31/10 beginning at 9:25 a.m. revealed Patient N2 had been admitted on 8/26/10 and was put on isolation, "Droplet Precaution" by nursing, due to a history of MRSA (methicillin-resistant Staphylococcus aureus). However, the facility's, "Isolation Guidelines from Infection Control" stated that "Contact Isolation" should be instituted for patients with MRSA.
..."

Interview with the Infection Control Consultant (ICC) on 9/2/10 at 9:20 a.m., revealed that she was unaware of any patients in isolation, and did not have any patients with any infection control concerns listed on her infection control log. She had not received information on Patient N2 and was unaware that the patient had been on isolation precautions since admission to the facility, over a week earlier. The ICC was not aware of the patient's previous history of MRSA.

Based on observation, interview, and manufacturer's document review the facility failed to ensure surgical services were provided according to professional standards of care to ensure patient safety. The facility had no system in place to ensure the manufacturer's instructions for the re-sterilization of the Laryngeal Mask Airways (LMA) were implemented, placing the surgical patients at risk for harm.

Findings:

During a tour of the surgical area on 8/31/10 beginning at 2:30 p.m. the sterilization process of equipment was observed. The LMA's were sterilized but when the operating room (OR) coordinator was asked how she tracked the number of times the LMA's were sterilized she stated, "I didn't know we still had to do that." The OR coordinator was then asked to pull manufacturer's instructions to verify if tracking was required for the device type in use.

The manufacturer's instructions reflected the following in part,"LMA 40 USE PROGRAM...LMA airways can be used a maximum of 40 times. The manufacturer can accept no liability for failure beyond 40 uses ...LMA North America provides a tracking card with every reusable product to facilitate the tracking process ...If a fractured airway tube occurs, there is the risk of airway obstruction, hypoxia, and aspiration of tube fragments ...."

Based on document review the facility failed to ensure the anesthesia services policy reflected the required pre-anesthesia evaluation requirement that it is to be performed within 48 hours prior to surgery.

Findings:

Review of the current facility anesthesia service policy for anesthesia assessment on 9/1/10 at 11:00 a.m. revealed that it did not include a requirement that the pre-anesthesia evaluation must be performed within 48 hours prior to surgery. There were no time limits set by the policy for performing the pre-anesthesia evaluation. The facility policy did not reflect the requirements.

Based on review of hospital menus, clinical record review and staff interviews, the hospital failed to ensure that the menus met the needs of the patients.

Findings:

According to hospital staff, the hospital serves all age groups from 0 through 99 years. The registered dietitian provided different menus but there was none for the pediatric patients. The RD stated that they add 3 cups of milk to the regular diet to make it a pediatric diet. The manual she was using to make the determination was based on the menu of the skilled nursing facility, which was not the same menu offered in the hospital.

The hospital ' s menu did not have portion sizes. Review of the menus showed the lack of portion sizes and production sheets to guide the kitchen staff in serving the appropriate amount of food to meet the needs of the patients. The RD was unable to demonstrate that the menu met the Daily Recommended Intake (DRI) of the population served. There is no nutrient analysis of the menu for the diets provided. In an interview with the RD on 8/31/10 at approximately 10:30 a.m. she said in a response to the question regarding portion sizes, that the kitchen staff will use the same portion sizes as is being used to serve the residents in the SNF.

Based on observations, medical record review, interview and policy and procedure review, hospital administration failed to ensure the hospital wide quality assessment and performance improvement (QAPI) program was involved in ensuring a comprehensive, hospital wide infection control program was in place for identifying, reporting and monitoring infections. 1. Potential areas of infection were not identified, reported, monitored or controlled. 2. Active surveillance of the environment and the facility was not done as a component of the infection control program. 3. The current system for identifying, reporting, and monitoring infections at the hospital was inaccurate. 4. The current facility practice of completing terminal cleaning of the operating rooms did not reflect current professional standards of practice. None of these high risk, problem prone practices were identified by staff, the infection control consultant or through the facility's infection control program, and reported to the hospital wide quality assurance program for implementation of corrective actions, placing patients at risk for infection. (Refer to A-748, A-749, A-951)

Findings:

1. Interviews with staff on 8/30/10 on 11:30 a.m. revealed that currently there were no patients in the hospital who were on isolation precautions. However, observations made during a tour of the facility on 8/30/10 beginning at 11:40 a.m. revealed Patient (N2), a patient on medical surgical floor, was in isolation with "Droplet Precautions. " Further investigation revealed Patient N2 had been in isolation since admission to the hospital on 8/26/10, four days earlier yet staff were unaware of the patient's isolation status.

The Director of Nursing (DON) revealed Patient N2 had been on isolation since his admission, and she indicated that the signage posted on the patient's door was incorrect. "Contact isolation" should have been implemented related to the patient's history of MRSA (methicillin-resistant Staphylococcus aureus), which included the instructions to " . Wear gloves when entering the room. ..." The correct precautions were posted by the DON on 8/30/10.

In a discussion with the DON on the process of disseminating isolation/infection information to hospital staff at this time she stated that the information would be put into the computer. Once it was in the computer the DON stated a daily report would be generated for supervisors; the DON, Administrator, House Supervisor, Dietician, and the Infection Control Nurse.

Interview with the Infection control consultant on 9/2/10 at 9:20 a.m., revealed that she was unaware that any patients were in isolation, and did not have any patients on isolation listed on her infection control log. She had not received information on Patient N2 and was unaware that the patient had been on isolation precautions since admission to the facility on 8/26/10, eight days earlier. The current system of communicating and sharing important infection control information was not effective.

The Infection control consultant was unaware that nursing staff had posted and implemented incorrect precautions until corrected by the DON four days after admission. The infection control consultant was unaware of the patient's previous history of MRSA (methicillin-resistant Staphylococcus aureus. (refer to A-748)

2. A tour of the surgical area on 8/31/10 beginning at 2:30 p.m. revealed a red line on the floor just inside the double doors. Per staff the red line indicated the beginning of the restricted or sterile area, and surgical attire was required to proceed. Just beyond the red line the floor was gouged out in a striped pattern from wall to wall exposing naked under flooring, creating a potential breeding ground for pathogens as well being a trap for dust and debris.

Review of the facility's policy and procedure for, "Environmental Sanitation" on 8/31/10 at 1:30 p.m. revealed the following operating room (OR) cleaning instructions, "A terminal cleaning will be done with a hospital approved disinfectant three times a week ..."

Concurrent observations of the OR and interview with the OR coordinator on 8/31/10 at 3 p.m. confirmed that terminal cleaning of the operating rooms was done three times a week; Monday, Wednesday, and Friday, even though surgeries were scheduled Monday through Fridays. (refer to A-748)

3. Observations and review of facility documentation on 9/2/10 revealed the hospital provided outpatient services. However, the facility failed to include the outpatient infection control policies and procedures and active surveillance of the outpatient services into the hospital wide infection control plan. (refer to A-749)

Interview with the Infection control consultant on 9/2/10 at 9:20 a.m., revealed that she was unaware of the above identified infection control problems, or of the need for staff training to identify and address infection control problems.