HospitalInspections.org

Based on observation, interview, and record review, the facility's Governing Body (GB) failed to ensure the hospital's operation was conducted in an effective, safe, and organized manner by failing:

1. To develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured that the program reflected the different department/services; and that the program focused on indicators in improving health outcomes and the prevention of medical errors (Refer to A263, A273, A283, and A286);

2. To ensure nursing services and operations were provided in a safe and effective manner that would meet the patients' needs (A385, A395, A396, A405, A409, and A144); and

3. To ensure food and dietetic services and operations were provided in a safe and effective manner that would meet the patients' needs (A618, A620, A628, A630, and A631).

The cumulative effect of these systemic problems resulted in failure of the governing body to ensure patients were receiving quality care in a safe and effective manner.

Findings:

On September 27, 2012, at 10:05 a.m., a meeting was conducted with the members of the facility's board managers (GBM) who make up the governing body.

The GBM stated they received reports on the operations of the dietary department, through the Performance Improvement Committee (PIC) and Medical Executive Committee (MEC). The GBM stated the facility utilized outside sources or "external eyes" to evaluate and identify any areas of concern. They stated there had not been any concerning issues brought forth to the board.

The GBM stated they were aware of the event (neonatal death) that had occurred in the facility. They were aware that there had been interaction between the medical and administrative staff, which included specifically the Obstetrical (OB) department and the neonatologist. The GBM were aware that a Root Cause Analysis had been conducted and follow-up actions had been made. The GBM were not aware of any potential areas of concern that may not have been identified and corrected as a result of the RCA.

The GBM stated they unaware of any concerns related to staffing in any areas of the facility, specifically in the newborn nursery. They stated administration would keep them informed if there were any concerns. The GBM were provided information identified during the full survey related to staffing in the newborn nursery (Refer to A144). They were also made aware of the identified concerns identified brought forth during the Quality Assessment and Performance Improvement (QAPI) meeting with the PIC members (Refer to A283, #2). The GBM were informed that the PIC members did not find any concern with the current staffing practices in the newborn nursery. The GB was unaware of the identified staffing concerns.

Based on observation, interview, and record review, the facility failed to:

1. Provide safe care for the newborn infants. This resulted in one nurse being alone and isolated in the Newborn Nursery with one infant who was receiving intravenous (IV - fluid/medications given directly into a vein) antibiotics. This same nurse was also responsible for the care of an infant on the post-partum unit who was on continuous monitoring. In addition, according to facility policy, the newborn nursery had the potential to have one RN (alone) providing care for up to four babies; and

2. Ensure that one employee's background check was thoroughly completed prior to hire to ensure the employee had no history of abuse and neglect, and the patients received care in a safe setting.

Findings:

1. On September 26, 2012, at 10:40 a.m., a tour of the Newborn Nursery was conducted.

The Newborn Nursery was located approximately 100 feet from the post-partum unit nurses' station. In order to reach the Newborn Nursery from the post-partum unit nurses' station, an individual would have to go around a corner, through a set of double doors, transverse a main corridor and around another corner, open the key card access door to go through the Newborn Nursery support area, and then open the door to the Newborn Nursery.

Located in the Newborn Nursery was one infant who was receiving antibiotics with one nurse (RN 14) and an orientee nurse (Orientee RN; first day of unit orientation). RN 14 was also responsible for an infant in the post-partum unit who had been delivered by cesarean section (abdominal delivery of an infant) that shift and was on continuous monitoring.

Orientee RN left the Newborn Nursery at 10:50 a.m., to evaluate the infant in the post-partum unit at the direction of RN 14.

Orientee RN returned to the Newborn Nursery at 11:08 a.m.

During a concurrent interview with RN 14, she stated she was usually alone in the Newborn Nursery with infants.

On September 26, 2012, at 11:40 a.m., an interview was conducted with RN 15. She stated she was assigned to the Newborn Nursery with RN 14 on September 26, 2012, for the 7 a.m. to 7 p.m. shift. RN 15 stated this was "her first day in the nursery," and she had been caring for "an infant under a bili light (phototherapy - a tool used to treat newborn jaundice [yellowish discoloration of the skin] or hyperbilirubinemia [increased bilirubin levels])" in the Newborn Nursery when RN 14 left the Newborn Nursery to attend a cesarean section. RN 15 stated she was alone in the Newborn Nursery with the infant for approximately 20 minutes before she left the Newborn Nursery and transported the infant to the mother's post-partum room. RN 15 stated she was currently responsible for the infant who had been under the "bili light" and was now with its mother, and was drawing a serum bilirubin on another infant who was in the examination room.

On September 27, 2012, at 8:40 a.m., the facility's document titled, "Perinatal Services Scope of Service (no date)," was reviewed with the Director of Perinatal Services (DPS). The DPS stated the Newborn Nursery was staffed with one RN for one baby, and may have up to four babies by him/herself. If the RN in the Newborn Nursery needed immediate assistance (caring for one and may be up to four babies), there was a portable phone and/or emergency call button available for the RN to call for assistance.

On September 27, 2012, starting at 9:25 a.m., a meeting was conducted with the Performance Improvement Committee (PIC) members. According to the members of the committee, the facility had not identified concerns having one RN (alone) in the Newborn Nursery when caring for one baby. The one RN (alone) may have up to four babies assigned to him/her in the Newborn Nursery.

If an emergency arose with one or more of the babies, the RN would have to call for help either via the portable phone or emergency call button. This may delay the RN in assisting the baby/babies and also the response of additional staff to assist her may be delayed due to caring for other patients and not being readily available.

(If that one baby had a change of condition, that one RN would contact another staff member for assistance and respond to the Newborn Nursery, approximately 100 feet from the post-partum unit nurses' station. In order to reach the Newborn Nursery from the post-partum unit nurses' station, an individual would have to go around a corner, through a set of double doors, transverse a main corridor and around another corner, open the key card access door to go through the Newborn Nursery support area, and then open the door to the Newborn Nursery.)



16613

2. On September 25, 2012, starting at noon, personnel file review was conducted. The personnel file for the Director of Food and Nutrition Services (DFNS), showed that she was hired on February 21, 2011. Review of the background check, dated February 17, 2011, located in the personnel file showed the employee's name and address and a notation of "Clear". There was a "Hold" documented under jurisdiction with a note: "Please advise which package you would like run." No other information was documented on the background check.

The DFNS background check was compared to the completed background checks for the Chef and Clinical Nutrition Manager. The comparison background checks showed that inquiries were made in several data bases such as Office of Inspector General (OIG), motor vehicles, social security administration, etc. No such inquiries were run for the DFNS.

On September 25, 2012, at 2:50 p.m., in an interview with the Director of Human Resources, he was not aware that the background check for the DFNS was incomplete. He stated that it was not facility policy to print out the complete background check for each employee. Instead, a summary screen is accessed to determine whether the background check was clear or whether there was a "hit", and only in the event of a "hit" was the background check printed. He stated that the contract company providing the background check investigations already had a list of packages that should be run for each employee, and did not understand why the packages were not automatically run for the DFNS. He also indicated that the comments noted on the printed background check did not appear on the summary page. He could not speculate as to whether this was an issue for background checks completed for other employees.

Review of the facility policy titled, "New Employee Hiring Process", showed: "No applicant will be given a start date until they have completed all their pre-employment requirements including but not limited to; required paperwork determined by Human Resources, background check and physical."

Based on observation, interview, and record review, the facility failed to develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program, in which the governing body (GB) ensured that the program reflected the different department/services; and that the program focused on indicators in improving health outcomes and the prevention of medical errors, by failing:

1. To fully analyze the cause of a neonate's death. The facility failed to implement preventive actions that would reduce and/or mitigate the reoccurrence of the adverse event. This failure had the potential to result in missed opportunities for improvement, which subsequently could cause the increase in risk of the patients' safety (Refer to A286);

2. To have an effective ongoing quality appraisal, which identified and addressed the provision of nursing services (Refer to A385);

3. To have an ongoing quality appraisal and performance improvement program that addressed and monitored the complexity and scope of Food and Nutrition Services. This resulted in failure to identify issues related to safe food handling practices which could result in food borne illness, clinical nutrition indicators impacting patients' nutritional needs such as communicating Registered Dietitian (RD) recommendations to the physician and nutritional management of the wound care patient, and referral of high nutrition risk patients to the dietitian for follow-up (Refer to A283 and A618); and

4. To ensure the gathering of data or monitoring of the blood transfusion/blood product process. This resulted in not knowing if informed consent was obtained, if transfusions were hung within 30 minutes from the time received from the laboratory, if blood products were infused within four hours as required, if two person verification process was occurring, if vital signs were monitored per facility policy and procedure, and if the facility was accurately tracking transfusion reactions (Refer to A273 and A409);

5. To report a medication error involving a death of a pre-term infant, which was omitted from the facility's quality data as a result (Refer to A286); and

6. To identify a potentially unsafe environment for the newborn infants. One nurse was left alone and isolated in the Newborn Nursery with one infant who was receiving intravenous (IV - fluid/medications given directly into a vein) antibiotics and the same nurse was responsible for an infant on the post-partum unit who was on continuous monitoring. In addition, the newborn nursery had the potential to have one RN (alone) providing care for up to four babies (Refer to A144 and A283).

The cumulative effect of these systemic problems resulted in the failure for the facility quality assurance, performance improvement program to ensure high quality healthcare and a safe environment for all patients.

Based on interview and record review, the facility failed to ensure their QAPI program gathered data and monitored the blood transfusion/blood product process. This resulted in the facility not knowing if informed consent was obtained, if transfusions were hung within 30 minutes from the time received from the laboratory, if blood products were infused within four hours as required, if two person verification process was occurring, if vital signs were monitored per facility policy and procedure, and if the facility was accurately tracking transfusion reactions.

Findings:

On September 24, 2012, at 2:10 p.m., an interview was conducted with the Director Laboratory Services (DLS). The DLS stated nursing did the quality review on blood transfusions/blood product process/administration. He stated the laboratory was notified if there was a blood transfusion reaction, but did not receive any documentation from the nursing unit. In addition, the DLS stated he was on the Transfusion Committee, and he had not seen any statistics on the blood transfusion/blood product process.

On September 24, 2012, at 4 p.m., an interview was conducted with the Director of Quality and Patient Safety (DQP). The DQP stated the facility had just started the Transfusion Committee and the first meeting was last week. She stated that no one was reviewing transfusion records. The DQP stated the facility had no data from the review of blood transfusion/blood product process.

Based on staff interview and document review, the hospital failed:

1. To have an ongoing quality appraisal and performance improvement program that addressed and monitored the complexity and scope of Food and Nutrition Services. This resulted in failure to identify issues related to safe food handling practices which could result in food borne illness, clinical nutrition indicators impacting patients' nutritional needs such as communicating Registered Dietitian (RD) recommendations to the physician and nutritional management of the wound care patient, and referral of high nutrition risk patients to the dietitian for follow-up; and

2. To identify a potentially unsafe environment of care for the newborn infants. This resulted in one nurse being alone and isolated in the Newborn Nursery with one infant who was receiving intravenous (IV - fluid/medications given directly into a vein) antibiotics and the same nurse was responsible for an infant on the post-partum unit who was on continuous monitoring. In addition, the newborn nursery had the potential to have one RN (alone) providing care for up to four babies (Refer to A144).

Findings:

1. During the survey from September 24, 2012 through September 26, 2012, deficient practices related to safe and sanitary food services operations (Cross Reference A749) and ensuring patient nutritional needs were met (Cross Reference A628) were identified. In addition, nutritional consults were not consistently triggered via the nursing admission screening process and subsequent assessments when patients were identified with high nutrition risk factors (Cross Reference A395). All of these areas would be considered high risk areas.

In an interview with the Director of Food and Nutrition Services (DFNS) and Clinical Nutrition Manager (CNM) on September 26, 2012, at 9:05 a.m., and concurrent review of quality performance indicators for 2012, revealed that the food and nutrition department was submitting data on multiple processes within the department. The facility was not monitoring processes such as safe cool down of potentially hazardous foods prepared at room temperature according to established standards of practice and regulatory requirements. An indicator titled, "One Hour Time Stamp", was being monitored in lieu of the proper cool down process.

It was also noted that while the department was monitoring food service performance indicators, there was no evaluation of clinical nutrition indicators within the department. The DFNS and CNM stated that there were clinical nutrition indicators monitored in 2011, but they were discontinued when the department met the established thresholds for 2 continuous quarters. No other clinical indicators had been identified for monitoring in 2012.

Review of the facility policy titled, "Scope of Service, Food and Nutrition", showed the following, "The goals of Performance Improvement activities are to improve existing processes and outcomes and then sustain the improved performance ... Improving quality of care is accomplished by identifying those issues that are high risk, high volume, problem prone and high cost related to the care and services provided."

On September 26, 2012 at 1:10 p.m., in an interview with the Director of Quality and Patient Safety, she stated that the facility depended on each department to submit data on quality indicator monitoring that the department heads deemed pertinent to patient care. She acknowledged that additional areas in clinical nutrition services could be identified. She also stated that there was an existing quality indicator related to completion of nutritional screens during the nursing admission process that was monitored by the Director of ICU/Telemetry/Medical Surgical units.

On September 26, 2012, at 3:20 p.m., in an interview with the Director of ICU/Telemetry/Medical Surgical units, she stated that the facility was currently collecting data on whether the nutrition screening component was completed as part of the nursing admission assessment. When asked if the data being collected also reflected whether the nutritional screens being completed accurately reflected the patients' status, she stated that the facility did not back track or look retrospectively at the level of completeness or accuracy of the nutrition screens, only that they were completed.

While the facility may determine compliance when nutrition screens are found to have been completed, the facility would miss the opportunity to identify areas of improvement related to appropriate referral to nutritional services of high nutritional risk patients, if the nutritional screens were not accurately completed.



25338

2. On September 26, 2012, at 10:40 a.m., a tour of the Newborn Nursery was conducted.

The Newborn Nursery was located approximately 100 feet from the post-partum unit nurses' station. In order to reach the Newborn Nursery from the post-partum unit nurses' station, an individual would have to go around a corner, through a set of double doors, transverse a main corridor and around another corner, open the key card access door to go through the Newborn Nursery support area, and then open the door to the Newborn Nursery (Refer to A144).

On September 27, 2012, starting at 9:25 a.m., a meeting was conducted with the Performance Improvement Committee (PIC) members. According to the members of the committee, the facility had not identified concerns having one RN (alone) in the Newborn Nursery when caring for one baby. The one RN (alone) may have up to four babies assigned to him/her in the Newborn Nursery (Refer to A144).

Based on interview and record review, the facility failed identify and reduce medical errors by failing:

1. To fully analyze the causes of the neonate's death (Patient 10). The facility failed to implement preventive actions that would reduce and/or mitigate the reoccurrence of the adverse event. This failure had the potential to result in missed opportunities for improvement, which subsequently could cause the increase in risk of the patients' safety; and

2. To identify and track a medication error involving a death of a pre-term infant (Patient 10).

Findings:

1. Background:

The facility was licensed to provide Perinatal Services, which included Newborn Nursery care. The facility did not have Neonatal Intensive Care (NIC) Services. The Newborn Nursery had a neonatal crash cart (a cart which contained emergency equipment and medications) available for an emergency.

According to facility policy titled, "Emergency/Urgent Use of Drug Supplies Kits (dated April 15, 2011)," the "Neonatal Crash Cart (nursery) medications:" included Sodium Bicarbonate 0.5 meq/ml (milliequivalent/milliliter) - 10 ml (quantity of six).

On September 25 and 26, 2012, Patient 10's record was reviewed. Patient 10 was born on March 23, 2012, at 10:09 p.m., in the facility's Perinatal Unit. The patient's gestational age was 30 weeks and was delivered by emergency cesarean section (C/S) due to pregnancy-induced hypertension (PIH).

The record with headings of "Transport Summary of events..." indicated:

- The Transport Team (a team of licensed practitioners competent to provide NIC) from the receiving hospital (Acute Hospital - AH 2) was called on March 23, 2012, at 9:47 p.m., by the patient's pediatrician. The record indicated the Transport Team left AH 2 approximately 40-50 minutes after the initial call;

- The Transport Team spoke with the pediatrician at approximately 11:30 p.m., and was informed Patient 10 was delivered by C/S, apneic (not breathing) and had bradycardia (heart rate slow and/or irregular); and

- The patient's heart rate improved and infant was stabilized by the time Transport Team arrived.

The AH 2's "Medication Administration Record" was reviewed and indicated the following:

- Na (Sodium) Acetate (sodium replacement; to correct acidosis [acidity in the blood]) bolus 10 ml/kg [milliliter/kilogram] (10 ml) was administered at 1:30 a.m., 2:16 a.m., and 2:29 a.m.; and

- Na Bicarb(onate) 2 meq/kg (milliequivalent/kilogram) 2 ml was administered at 1:50 a.m.

The "Neonatal Transport Record" dated March 23 through March 24, 2012, indicated Sodium Acetate and Sodium Bicarbonate were administered intravenously. The record indicated Patient 10 was pronounced deceased on March 24, 2012, at 2:35 a.m.

According to Lexicomp (a nationally recognized drug reference):
- Sodium Acetate is used as sodium replacement to correct acidosis [acidity in the blood] and must be diluted prior to intravenous (IV) administration.
-Sodium Bicarbonate is used for management of metabolic acidosis; stabilization of acid base status in cardiac arrest and treatment of life-threatening hyperkalemia. Sodium Bicarbonate may be directly administered intravenously in neonates and infants, by using the 0.5 meq/mL solution or dilute the 1 meq/mL solution 1:1 with sterile water injection.

On September 26, 2012, at 8:40 a.m., the Director of Quality and Patient Safety (DQP) was interviewed. The DQP stated the facility had conducted a Root Cause Analysis (RCA; a process/method of problem solving that identifies the root causes of faults or problems) on this event. The DQP stated the facility conducted two RCAs, which involved multiple disciplines and members of the organization. The DQP stated the Transport Team member(s) participated in the second RCA.

On September 27, 2012, at 9:25 a.m., a meeting was conducted with the Performance Improvement Committee (PIC) members. The DQP stated during the two RCA meetings, the facility identified several areas of failure and implemented the following actions addressing these identified areas:

The Transport Team (TT) did not bring their own equipment and medications, which were necessary to provide care when transporting a neonate. Because the TT did not have the medications, the TT had to use the medications available in the facility. The TT asked for Sodium Bicarbonate, but the TT was informed the facility did not have Sodium Bicarbonate available and so the TT asked for Sodium Acetate instead. Facility staff asked the pharmacy department to provide the Sodium Acetate to the newborn nursery. The pharmacy department provided concentrated Sodium Acetate (adult dose) to the unit. The TT then asked for "10 cc (cubic centimeter) or ml" of Sodium Acetate, which the facility staff nurse withdrew 10 cc of concentrated adult dose Sodium Acetate and provided the medication to the TT to administer to Patient 10. The patient received three adult doses of 10 cc undiluted Sodium Acetate.

The DQP stated the RCA also identified that in AH 2, the facility had a standardized protocol where the TT requested from pharmacy "10 cc" instead of an actual dose of Sodium Acetate. The Director of Pharmacy (DOP) stated the AH 2's pharmacy department's practice was to dilute the medication, which had already been pre-determined as the amount and dose needed for a neonatal administration.

The DQP stated the RCA identified that the event was "so chaotic," there had been miscommunication between staff members and the TT. It was also identified that the Newborn Nursery had a neonatal crash cart available, which was where the event occurred. The DQP stated the crash cart was opened, but the sodium bicarbonate was not used.

The DQP stated the facility had taken the following actions:
- The facility will no longer send concentrated electrolyte medications to the nursing units; and
- In the event, a similar scenario reoccurred, the facility would send a pharmacist with the medication, who would ensure the adequate amount and dosing would be prepared for the specific situation. If the scenario occurred, where there was only one pharmacist available, the facility would send a diluted electrolyte medication to the nursing unit.

The Director of Perinatal Services (DPS) stated:
- Two informal mock codes (emergency) involving a neonate had been conducted (which the facility did not have documented evidence of);
- The facility provided education to the perinatal nurses through informal meetings (which the facility did not have documented evidence of the education and the type of information that was provided); and
- The perinatal nurses were NRP (neonatal resuscitation program) certified (prior to the incident) and received a NRP class on August 2012 (approximately six months after the event).

The Director of Pharmacy (DOP) stated the facility had a policy which included "high alert" "high concentration" medications. The policy did not include Sodium Acetate.

The PIC members were asked if the following were identified in the two RCA meetings:
- Sodium Acetate was used when Sodium Bicarbonate was available in the neonatal crash cart. In addition, nursery staff nurses were NRP certified and were not able to demonstrate knowledge of the availability of Sodium Bicarbonate during the event;
- The facility staff nurse withdrew the 10 cc of Sodium Acetate at the instruction of the TT, which the TT administered (prepared and administered by different individuals); and
- A two-person verification before the administration of Sodium Acetate did not occur during the event.

The DPS stated during the event, it was "All hands on deck." The DPS stated because of the "chaos" there was miscommunication. The DPS stated the facility did not require two-person verification prior to the administration of Sodium Acetate and any other intravenous medications for neonates.

The DQP and DPS both stated the facility did not have a policy addressing safe practices for medication administration to neonates.

According to the Agency for Healthcare Research and Quality (AHRQ), "Patient Safety and Quality, An Evidence-Based Handbook for Nurses, Chapter 37, Medication Administration Safety,"

"...One commonly used definition for a medication error is:

Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice... procedures, and systems, including prescribing; order communication; product labeling, packaging... dispensing; distribution; administration; education; monitoring; and use..."

"...Medication administration...The "rights" of medication administration include right patient, right drug, right time, right route, and right dose. These rights are critical for nurses..."

According to the National Association of Neonatal Nurses (NANN), "Medication Safety in the Neonatal Intensive Care Unit (NICU) (dated August 2009),"

"...For every nurse in the NICU...All medications and their calculations are checked by another licensed professional prior to administration..."



25281

2. The facility's medication error report was reviewed and it was noted that the report for March 2012 did not indicate the medication error attributed to the event involving the death of an infant (Patient 10) was reported and addressed in the Pharmacy and Therapeutics (P&T) Committee meetings.

During an interview on September 27, 2012, at 9:40 a.m., the DQP acknowledged that the medication error was discussed, but was not reported to and addressed in the P&T Committee meeting.

During an interview on September 27, 2012, at 10:10 a.m., the DOP acknowledged that the medication error was not presented at the P&T Committee meeting.

Based on observation, interview, and record review, the facility failed to ensure it provided an organized nursing service to all patients by failing:

1. To ensure point of care (POC) blood glucose levels and serum (blood) glucose levels were done/drawn per facility policy and procedure. This had the potential to result in low glucose levels not being recognized, and treated (Refer to A395);

2. To ensure the obstetrical assessment for outpatient obstetrical patients contained the last menstrual period (LMP - first day of last menstrual period before conception) and/or expected date of confinement (EDC - expected date on which a pregnant woman is expected to give birth). This resulted in not knowing how many weeks/days pregnant the patients were (Refer to A395);

3. To ensure that a nutrition consult was triggered for patients admitted with high nutritional risk factors, and when a patient developed an in-house Stage II pressure sore. In addition, nursing staff failed to complete the nutrition screen portion of the admission assessment in a timely manner and failed to investigate a large discrepancy in weight for a patient. Failure to refer high nutritional risk patients to dietary for a consult could result in delayed nutritional intervention and compromised nutritional status of the patients (Refer to A395);

4. To conduct an accurate pain assessment and provide necessary follow-up in accordance with facility policy. This failure had the potential to result in unresolved pain and discomfort for the patient (Refer to A395);

5. To accurately identify the risk factors (bilateral lower extremities' cellulitis wounds) during the initial nutrition screening. This failure resulted in the delay of a Registered Dietitian (RD) assessment, which could subsequently delay the provision of additional nutritional and/or supplemental interventions (Refer to A395);

6. To ensure an individualized plan of care was developed when a patient was identified as being large for gestational age (used to describe infants who were born weighing more than the usual amount for the number of weeks of pregnancy) and point of care (POC) glucose monitoring was initiated. This had the potential to result in blood glucose monitoring not being done, and a low blood glucose not being recognized (Refer to A396);

7. To ensure a care plan was implemented for a patient, which addressed the patient's open wound secondary to a surgical intervention. This failure could potentially result in inconsistencies with the physician's plan for the care and treatment of the open wound and the nursing plan of care for care and treatment of the open wound (Refer to A396);

8. To ensure accurate dose administration of medication and proper documentation of drug wastage in accordance with the physician orders (Refer to A405); and

9. To document stop time for blood transfusions for patients. In addition, the blood transfusion documentation did not include volume hung, volume infused, whether a transfusion reaction was noted, and the patient response. As a result, the facility could not ensure that these blood products were infused within four hours as required, and was unable to accurately track potential transfusion reactions (Refer to A409).

The cumulative effects of these systemic problems resulted in the failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed:

1. To ensure point of care (POC) blood glucose levels and serum (blood) glucose levels were done/drawn per facility policy and procedure for one patient (Patient 29). This had the potential to result in low glucose levels not being recognized, and treated which subsequently may cause brain damage.

2. To ensure the obstetrical assessment of two of two outpatient obstetrical patients sampled (Patient 31 and 32) contained the last menstrual period (LMP - first day of last menstrual period before conception) and/or expected date of confinement (EDC - expected date on which a pregnant woman is expected to give birth). This resulted in not knowing how many weeks/days pregnant the patients were.

3. To ensure that a nutrition consult was triggered when one patient (Patient 2) was admitted with high nutritional risk factors, and when one patient (Patient 1) developed an in-house Stage II pressure sore. In addition, nursing staff failed to complete the nutrition screen portion of the admission assessment in a timely manner and failed to investigate a large discrepancy in weight for one patient (Patient 4). Failure to refer high nutritional risk patients to dietary for a consult could result in delayed nutritional intervention and compromised nutritional status of the patients.

4. For Patient 8, to conduct an accurate pain assessment and provide necessary follow-up in accordance with facility policy. This failure had the potential to result in unresolved pain and discomfort for the patient.

5. For Patient 8, to accurately identify the risk factors (bilateral lower extremities' cellulitis wounds) during the initial nutrition screening. This failure resulted in the delay of a Registered Dietitian (RD) assessment, which could subsequently delay the provision of additional nutritional and/or supplemental interventions.

Findings:

1. The facility policy and procedure titled "Care of the Infant at Risk for Hypoglycemia" dated June 7, 2011, was obtained and reviewed on September 25, 2012. The policy revealed, "... Signs and symptoms of potential hypoglycemia: Jitteriness ... Blood glucose screen as soon as possible in any symptomatic infant. ...

Asymptomatic infants with glucose ... < 35 mg/dL (4-24 hours of life) should be refed and rechecked within one hour after feeding. ...

Goal is to achieve a glucose concentration of 40 to 50 mg/dL. ...

Notify physician for one hours repeat glucose ... < 35 mg/dL (4-24 hours of life) after refeeding per above and send stat lab (laboratory) glucose test. ..."

On September 24, 2012, the record for Patient 29 was reviewed. Patient 29 was admitted to the facility on September 22, 2012, at 2:41 p.m., with the diagnosis of newborn infant.

The "POC - Glucose" on September 22, 2012, at 5:26 p.m., was < 40 mg/dL (less than 40 milligrams per deciliter). The "POC - Glucose" monitor was unable to determine the patient's glucose level, if the patient's glucose was less than 40 mg/dL or greater than 500 mg/dL.

The "Clinician Notification" dated September 22, 2012, at 5:45 p.m., revealed the infant was breastfed for one hour per the mother and the postpartum nurse. In addition, the infant displayed "some jitteriness," was fed 15 milliliters of formula and a serum blood glucose was drawn.

On September 22, 2012, at 5:45 p.m., Patient 29's serum blood glucose was 30 mg/dL.

The "Newborn Breastfeeding Information" dated September 22 and 23, 2012, revealed Patient 29 was breastfed at 8 p.m., 9 p.m., 11 p.m., 12 a.m., and 3 a.m.

The "Activities of Daily Living Nutrition" dated September 23, 2012, revealed Patient 29 was given formula at 12 a.m.

The "POC - Glucose" on September 22, 2012, at 10:16 p.m., 10:20 p.m.; 10:32 p.m.; and September 23, 2012, at 1:24 a.m., were all < 40 mg/dL (unable to determine how much less than 40 mg/dL or the actual glucose level). No "stat (immediately) laboratory glucose test" was obtained in accordance with the facility policy and procedure.

There was no documentation between September 22, 2012, at 10:16 p.m., and September 23, 2012, at 5:11 p.m., that the physician was notified that the "POC - Glucose" was < 40 mg/dL.

During an interview with RN 14, on September 26, 2012, at 10:40 a.m., she reviewed the record and was unable to find documentation of a laboratory glucose being drawn when the "POC - Glucose" was < 40 mg/dL on September 22, 2012, at 10:32 p.m. RN 14 stated if the "POC - Glucose" was < 40 mg/dL, the nurse did not know how much less than 40 mg/dL the actual blood glucose would be. RN 14 stated she would obtain two "POC - Glucose" heel sticks, 30 minutes apart, and if the result was < 40 mg/dL, a laboratory glucose value should be obtained to determine an accurate glucose level. RN 14 stated a laboratory glucose should have been drawn when the "POC - Glucose" for Patient 29 was < 40 mg/dL on September 22, 2012, at 10:32 p.m., and September 23, 2012, at 1:24 a.m.

2a. On September 25, 2012, the record for Patient 32 was reviewed. Patient 32 was admitted to the facility on July 18, 2012, at 12:09 a.m., for obstetrical triage/evaluation of uterine contractions.

There was no indication in the obstetrical outpatient record of Patient 32's LMP, EDC, and/or how many weeks pregnant she was at the time of the obstetrical triage/evaluation.

Patient 32 was discharged to home on July 18, 2012, at 4:01 a.m.

b. On September 25, 2012, the record for Patient 31 was reviewed. Patient 31 was admitted to the facility on July 11, 2012, at 10:52 a.m., for obstetrical triage/evaluation of pregnancy induced hypertension (PIH).

There was no indication in the obstetrical outpatient record of Patient 31's LMP and/or EDC.

During an interview with the Director Perinatal Services (DPS), on September 26, 2012, at 1:47 p.m., she reviewed the records and was unable to find documentation of either an LMP or an EDC in either record. The DPS stated an LMP or an EDC would be needed to evaluate an obstetrical patient. In addition, the DPS stated the obstetrical outpatient record should contain the LMP and/or the EDC for the patient.



16613

3a. On September 25, 2012, at 9:30 a.m., review of the medical record for Patient 2, showed he was admitted on September 20, 2012. Review of the "Nutritional Screen" component of the Admission Nursing assessment showed that the patient was on a regular diet, with no unintentional weight loss and had no nutritional risk factors.

Review of the History and Physical (H&P) completed on September 21, 2012, showed that the patient had end stage renal disease and had been on hemodialysis (a treatment for kidney failure using an advanced dialysis machine to remove waste products from the blood, and then returning the blood back to the body) since 2010. The H&P also documented that the patient had a 10 pound weight loss and hemoglobin (the iron-containing oxygen-transport protein in the red blood cells) of 7.0 g/dl (normal range 13.8 to 18.0 g/dl). On September 20, 2012, the patient was prescribed a Renal diet. In a concurrent interview with the Registered Dietitian (RD 1), she confirmed that she had not received a nutritional consult in regards to Patient 2.

b. On September 25, 2012, at 8:53 a.m., review of the medical record for Patient 1, showed she was admitted on September 17, 2012. On September 24, 2012, nursing documentation showed that the patient had a Stage II pressure ulcer to the right coccyx. There was no documentation showing that a nutritional consult was triggered based on this new development. In a concurrent interview with RD 1, she confirmed that she had not received a nutritional consult alerting her of the patient's wound.

On September 26, 2012, at 8 a.m., review of the "Nutritional Risk Criteria" showed, under High Risk Criteria, "Any pressure ulcer, infected wound, or poorly healing wound." On September 26, 2012, at 3:20 p.m., in an interview with Director of ICU/Telemetry and Medical Surgical unit, she stated that nurses can "put in" a nutritional consult at any time during the patient's stay and that identification of a Stage II pressure sore should have triggered a nutritional consult.

c. On September 25, 2012, at 10:22 a.m., review of the medical record for Patient 4, showed she was admitted on September 11, 2012, with a wound infection. Review of the "Nutritional Screen" component of the Admission Nursing assessment showed that it was not completed until September 14, 2012.

Review of the facility policy titled, "Standard of Care for the ICU/Telemetry/Medical/Surgical Inpatient #722", showed the following: "The admission physical assessment will be completed and documented in the EMR (Electronic Medical Record) within 4 hours of admission."

Further review of the medical record showed the patient's measured weights as:

September 20, 2012 ...... 41.5 Kg
September 21, 2012 ...... 89.9 Kg

There was a documented weight discrepancy of 48.4 Kg (106.5 pounds) in one day. On September 26, 2012, at 3:20 p.m., in an interview with the Director of ICU/Telemetry and Medical Surgical unit, she stated that the nurse obtaining the patient weight should have corroborated the weight in comparison to the initial weight and any discrepancies should have been explained.



25338

4. On September 25, 2012, Patient 8's record was reviewed. Patient 8 was admitted September 17, 2012, through the Emergency Department (ED), with complaints of multiple skin abscesses in both lower extremities and diagnosis of cellulitis (skin infection caused by bacteria).

The record indicated Patient 8 complained of pain on multiple occasions. The following were noted:

a. On September 18, 2012, at 7:58 a.m., the patient had a pain rating of 8, on a 0 to 10 scale, (zero = no pain; 10 = worst pain), but did not indicate the pain location. The patient was given pain medication as ordered.

On September 18, 2012, at 9:26 a.m. (approximately one and a half hours later), the patient had a pain rating of 6; but did not indicate the pain location and no further intervention was provided.

b. On September 18, 2012, at 7:04 p.m., the patient had leg pain rating of 8/10. The patient was given pain medication as ordered. At 7:30 p.m., the patient indicated an acceptable pain level of "5".

On September 18, 2012, at 8:04 p.m. and 8:11 p.m., the record indicated the patient reported the pain medication was ineffective. There was no documented evidence that further interventions were provided to relieve the patient's pain. The patient received pain medication at 10:51 p.m. (approximately three and a half hours after reporting being in pain).

On September 25, 2012, at 11:45 a.m., the Registered Nurse (RN 6) was interviewed. She stated the RNs assessed patients for pain. When a patient complains of pain, pain rating, location, type of pain, and acceptable level of pain were assessed. Then, the patients were to be provided available interventions as necessary, which may include pain medications, if ordered. When interventions were provided for pain, the patient would then be reassessed about 40 minutes to an hour later. If pain was still present and was not within the patient's acceptable level, the patient would be provided further interventions. RN 6 stated, if necessary, the physician would be notified to obtain an order for additional pain medication. RN 6 stated the goal was to reach the patient's acceptable comfort level or for the patient to be relieved of pain.

On September 25, 2012, at 2:30 p.m., Patient 8's record was reviewed with the Director of Medical-Surgical, Telemetry, and Intensive Care Units (DMTI). The DMTI was unable to find documented evidence that Patient 8's pain assessments were completed on September 18, 2012, at 7:58 a.m. and 7:04 p.m.

On September 25, 2012, the facility's policy titled, "Pain Management Standards (dated March 9, 2011)" was reviewed and indicated:

"Purpose/Background: To provide individualized pain management for all patients...to aid in the selection of medical and/or non-medical treatments for pain, and to give guidance regarding evaluating the efficacy of the selected treatment plan in clinical practice."

"Assessment of Pain for Inpatients:
A. The initial pain assessment of pain includes: intensity, location, and quality and shall be documented in the medical record.
B. Assessment of pain shall occur utilizing the patient's self-report of pain as appropriate.
C. The patient's acceptable level of pain is documented a minimum of each shift.
D. Pain intensity will be assessed more frequently as the patient's condition requires...Nursing reassessments will be recorded in the clinical documentation as it pertains to each patient's condition..."

5.On September 25, 2012, Patient 8's record was reviewed. Patient 8 was admitted September 17, 2012, through the Emergency Department (ED), with complaints of multiple skin abscesses in both lower extremities and diagnosis of cellulitis (skin infection caused by bacteria).

The "History and Physical" dated September 18, 2012, indicated, "Physical Examination: Integumentary...Bilateral lower extremities with patches of erythema (skin redness or rash), some necrotic (dead tissue) boils (pus collection under the skin) present, also some sores and ulcerations."

The patient's record included photographs dated September 18, 2012, of the following:
- Left inner knee (erythema);
- Right inner leg (multiple erythema);
- Right inner foot (erythema);
- Right medial (inner) foot (erythema with pus);
- Left lateral (outer) lower thigh (erythema);
- Left palm (erythema);
- Left inner thigh (black-bluish discoloration); and
- Right outer thigh (ulceration with skin discoloration).

The "Adult Patient History (Initial Assessment)" dated September 18, 2012, at 5:14 p.m., included a section entitled, "Nutritional Screen...Risk Factors." The section indicated, "No Risk Factors."

The "Adult Nutrition Initial Assessment/Plan (conducted by the RD)" dated September 20, 2012, at 2:07 p.m. (approximately 45 hours after the initial admission assessment) indicated, "Plan/Goals...Additional Information: High nutritional risk..."

On September 25, 2012, at 2:30 p.m., Patient 8's record was reviewed with the DMTI. The DMTI stated the patient's cellulitis wounds should have been included as a nutrition risk factor.

The facility document titled, "Nutritional Risk Criteria Adult Patients (no date)" was reviewed and indicated, "High Risk Criteria...Any pressure ulcer, infected wound, or poorly healing wound..."

The facility policy titled, "Nutrition Care Process (dated September 25, 2012)" was reviewed and indicated, "...Patients referred at high nutrition risk based on the initial nursing admission screen must be evaluated within 24 hours of completion of the nutrition risk screen..."

Based on observation, interview, and record review, the facility failed:

1. To ensure an individualized plan of care was developed when one patient (Patient 30) was identified as being large for gestational age (used to describe infants who were born weighing more
than the usual amount for the number of weeks of pregnancy) and point of care (POC) glucose monitoring was initiated. This had the potential to result in blood glucose monitoring not being done, and a low blood glucose not being recognized.

2. To ensure a care plan was implemented for Patient 17 which addressed the patient's open wound secondary to a surgical intervention. This failure could potentially result in inconsistencies with the physician's plan for the care and treatment of the open wound and the nursing plan of care for care and treatment of the open wound.

Findings:

1. On September 24, 2012, the record for Patient 30 was reviewed. Patient 30 was admitted to the facility on September 22, 2012, at 4:16 p.m., with the diagnosis of newborn infant.

The "Newborn Birth History" dated September 22, 2012, at 4:16 p.m., revealed "Neonate Complications Size, large for gestational age."

The Physician's "Progress Notes" dated September 23, 2012, at 10:59 a.m., indicated "Diagnosis - Large for gestational age."

The record revealed POC glucoses were obtained on September 22, 2012, at 5:54 p.m. (one hour and 38 minutes after birth); 9:54 p.m. (five hours and 38 minutes after birth); September 23, 2012, at 1:51 a.m. (nine hours and 35 minutes after birth); and 3:42 a.m. (11 hours and 26 minutes after birth).

There was no documented "Plan of Care" initiated for newborn blood glucose monitoring for the large for gestational age infant.

During an interview with RN 10, on September 24, 2012, at 11:40 a.m., she reviewed the record and was unable to find documentation of a plan of care being developed for Patient 30's blood glucose monitoring. RN 10 stated a plan of care should have been developed because the infant was identified as being large for gestational age and blood glucose monitoring was initiated.



22384

2. An observation of Patient 17 was conducted on September 25, 2012, at 11 a.m. Patient 17 was participating in a physical therapy initial evaluation. Observed wrapped around the patient's left knee was a Kerlix dressing (a brown elastic bandage). A Hemovac drain which contained reddish brown fluid was observed coming from the patient's bandaged left knee (Hemovac - a tube placed beneath the skin which removes blood and other fluids from wounds and/or surgical sites into an attached canister).

A review of Patient 17's record was conducted. Patient 17 was admitted to the facility on September 24, 2012, at 10:55 a.m., having sustained a laceration to the left knee when she fell and landed on a broken glass.

Further record review indicated Patient 17, was taken to the operating room on September 24, 2012, at 9 p.m., and had a surgical incision and drainage of the left knee in which the left knee was packed with gauze dressings. The laceration which entered the knee joint was left open, and a Hemovac drain was inserted.

An interview was conducted with the Registered Nurse (RN 4) who was caring for Patient 17 on September 25, 2012, at 11:30 a.m. RN 40 stated a care plan which addressed Patient 17's wound had not been initiated and she did not know what the surgeon wanted nursing to do for treatment, but thought he did not want nursing to touch the surgical area. RN 4 further stated a care plan should have indicated to observe the surgical site for bleeding, to watch for signs of internal rotation of the knee and to watch for signs and symptoms of infection.

A request was made to the Director of Quality and Patient Safety (DQP) for the facility policy and procedure regarding care planning.

The policy and procedure titled "Standard of Care for the Intensive Care Unit/Telemetry/Medical/Surgical Inpatient" undated, unapproved was provided to the survey team on September 25, 2012, and indicated "The RN (registered nurse) develops a plan of care that prescribes interventions to attain expected outcomes and documents in the Care Plan section... The Plan is individualized to reflect the patient's characteristics and needs...priorities for care are established...Initiated within eight hours of admission, Re-evaluated each shift and revised based on the patient's needs."

Based on interview and document review, the facility failed to ensure accurate dose administration of medication and proper documentation of drug wastage in accordance with the physician orders.

Findings:

During an interview on September 26, 2012, at 11 a.m., the DOP stated that a pharmacist was assigned to review an auto-generated daily report called, "Activity by Item," an override report of medications accessed by users, the facility staff, before the pharmacist review. The DOP further explained that the pharmacist would audit the report for override of medications without valid order input in the Computerized Physician Order Entry (CPOE).

During a concurrent interview, Pharmacist 510 stated that any identified override, without a valid physician order in the CPOE would be communicated to the director of the nursing unit where the override took place, and to the DOP via e-mail.

Review of the Activity by Item report dated August 20, 2012, indicated that on August 19, 2012, at 1:11 a.m., RN 520 took out three doses of hydromorphone (controlled substance used for pain) 1 mg/ml injectable syringes and at 1:39 a.m., 4 doses at one time.

On September 26, 2012, at 11 a.m., the Director of Emergency Department (DED) acknowledged that he had received the request for resolution to override medications with the missing physician order, and that it was given to the nurse manager for follow-up. The DED also stated that the nurse should not have taken out multiple doses of medication at one time, unless the dose to be administered called for multiple vials/syringes.

Review of activities from Cerner MedStation (Automated Dispensing Cabinet; a medication distribution system) revealed that RN 520 had taken a total of nine doses of hydromorphone 1 mg/ml between August 18, 2012 and August 19, 2012 (during his 12 hour shift) for Patient 21.

Review of Patient 21's Medication Activity Record (MAR) revealed that RN 520 documented administering a total of ten doses, nine 1 mg/ml doses and one 0.5 mg/ml dose of hydromorphone.

Review of the MAR also revealed that the physician order for hydromorphone 1 mg every 10 minutes for a pain rating of 7 to 10 (on a 0 to 10 scale) was dated August 25, 2012.

It was also revealed that the documentation on the MAR indicated administration of 1 mg dose of hydromorphone on August 18, 2012, at 7:50 p.m., and August 19, 2012, at 1:15 a.m., even though the order on the MAR indicated the dose ordered was 0.5 mg hydromorphone.

The MAR also revealed that the 1 mg hydromorphone doses were administered every 5 minutes and not every 10 minutes.

Furthermore, there was no documented wastage for 0.5 mg/ml dose administered from the 1 mg/ml syringe.

During an interview on September 26, 2012, at 3 p.m., RN 520 stated that multiple doses were taken out at once because the patient had a lot of pain due to leaking abdominal aortic aneurysm (AAA) and he was instructed by the anesthesiologist with the ordering physician to "load her up" with hydromorphone.

RN 520 stated that the documentation on the MAR was done at a later date after being reminded that there were no orders entered in the CPOE. RN 520 stated that he had documented as much as he could and admitted that there would be some "glitches" and wrong entries on the MAR.

RN 520 also acknowledged that documentation on the administration time might not be accurate as indicated by time of administration for several doses 5 minutes apart, instead of at least 10 minutes.

RN 520 also acknowledged the missing documentation of the waste of 0.5 mg hydromorphone.

Review of the facility's policy and procedure titled, "Cerner MedStation RX Policy" indicated the following:

"Partial doses of controlled medications not administered to a patient must be wasted ...This will require a witness."

Review of the facility's policy and procedure titled, "Controlled Substances Procedures" indicated the following:

"All wastage must be witnessed by a second licensed caregiver ...No portion of a controlled substance (CS) may be saved for a later dose - it must be wasted and the waste documented and witnessed."

During an interview on September 27, 2012, at 10:10 a.m., the DOP did not indicate that his investigation included accuracy of documentation on the MAR with the doses accessed from the ADC, and wastage documentation.

Based on interview and record review, facility staff failed to document stop time for blood transfusions for two sampled patients (Patients 24 and 25). In addition, for Patient 24, the blood transfusion documentation did not include volume hung, volume infused, whether a transfusion reaction was noted, and the patient response. As a result, the facility could not ensure that these blood products were infused within four hours as required, and was unable to accurately track potential transfusion reactions.

Findings:

1. On September 24, 2012, the record for Patient 24 was reviewed. The facility document titled, "Transfusion Form," and the "Blood Product Transfusion," section of the record was not complete as indicated:

a. On September 17, 2012, at 4:25 a.m., one unit of red blood cells was infused. Stop time and transfusion completion was not documented;

b. On September 18, 2012, at 10:57 a.m., one unit of thawed plasma was infused. Stop time, volume hung, volume infused, transfusion completion, transfusion reaction, and patient response were not documented;

2. On September 24, 2012, the record for Patient 25 was reviewed. The facility document titled, "Transfusion Form," and the "Blood Product Transfusion," section of the record was not complete as indicated: On September 11, 2012, at 8:15 a.m., one unit of thawed plasma was infused. Stop time was not documented.

On September 24, 2012, at 9:45 a.m., RN 5 was interviewed. RN 5 stated the process of documenting blood administration included start/stop time, amount or volume of blood product that was hung, amount or volume of blood product that was actually infused, if the entire transfusion was completed, if a transfusion reaction was noted or not, and what was the patient response to the transfusion. RN 5 stated all of this must be documented either on the "Transfusion Form" or in the "Blood Product Transfusion," section of the record. RN 5 was unable to locate the missing documentation. RN 5 further stated that blood transfusions must be completed within four hours after it was started.

The facility policy titled, "Administration of Blood and Blood Products," was reviewed. The policy indicated, "Each unit of blood product must be transfused within four hours... Each transfusion must have the care provider complete the 'Transfusion Section' of the 'Transfusion Record' form. Documentation on the 'Transfusion Record' form shall include signature of two transfusionists, start and stop time, volume infused, and whether a transfusion reaction is noted."

Based on interview and document review, the facility failed to ensure a verbal order by a physician was authenticated in a timely manner in accordance with the facility's policy and procedure.

Findings:

During an interview on September 26, 2012, at 11 a.m., the DOP stated that a pharmacist was assigned to review an auto-generated daily report called, "Activity by Item," an override report of medications accessed by users, the facility staff, before the pharmacist review. The DOP further explained that the pharmacist would audit the report for override of medications without valid order input in the Computerized Physician Order Entry (CPOE).

During a concurrent interview, Pharmacist 510 stated that any identified override, without a valid physician order in the CPOE would be communicated to the director of the nursing unit where the override took place, and to the DOP via e-mail.

Review of the Activity by Item report dated August 20, 2012, indicated that on August 19, 2012, at 12:48 p.m., one dose of acetaminophen/Hydrocodone 325/5 mg (generic for Norco, a controlled substance used for pain) for Patient 22 was accessed via override by RN 521 and that Pharmacist 510 had performed the audit identifying the event as missing the physician order in CPOE.

Review of Patient 22's electronic medical record indicated that the physician order for Norco 5/325 mg dose was entered in CPOE on August 25, 2012, six day after the dose was administered, and that the ordering physician did not authenticate the order until August 31, 2012 (12 days after the dose was administered).

Review of the facility's "Rules and Regulations" indicated the following:

"The attending physician shall co-sign such orders within 48 hours. If orders are not signed in a timely fashion as required by the regulatory agencies, the practitioner shall be given notice that further infractions may result in corrective action."

Review of the facility's policy and procedure titled, "Guidelines for Ordering, Dispensing & Administration" indicated the following:

"All verbal and telephone medication orders must be authenticated within 48 hours by the ordering physician or covering physician/designee."

Based on observation, interview, and document review, the facility failed to control medications by failing to:

1. Accurately account for use of controlled substances in the Emergency Department (ED) and resolve inaccurate documentation of administration that did not match the number of doses accessed from the ADC.

2. Ensure the storage and security of emergency crash carts were away from the door leading to the outside of the hospital.

3. Ensure two of two Neonatal Crash Carts were checked every twelve hours by facility personnel according to the facility's policy and procedure. This had the potential to result in specialized emergency supplies, equipment, and medications not being available when needed.

Findings:

1. During an interview on September 26, 2012, at 11 a.m., the DOP stated that a pharmacist was assigned to review an auto-generated daily report called, "Activity by Item," an override report of medications accessed by users, the facility staff, before the pharmacist review. The DOP further explained that the pharmacist would audit the report for override of medications without valid order input in the Computerized Physician Order Entry (CPOE).

During a concurrent interview, Pharmacist 510 stated that any identified override, without a valid physician order in the CPOE would be communicated to the director of the nursing unit where the override took place, and to the DOP via e-mail.

a. Review of the Activity by Item report dated August 20, 2012, indicated that on August 19, 2012, at 12:48 p.m., one dose of acetaminophen/Hydrocodone 325/5 mg (generic for Norco, a controlled substance used for pain) for Patient 22 was accessed via override by RN 521 and that Pharmacist 510 had performed the audit identifying the event as missing the physician order in CPOE.

Review of Patient 22's electronic medical record indicated that the physician order for Norco 5/325 mg dose was entered in CPOE on August 25, 2012, six day after the dose was administered, and that the ordering physician did not authenticate the order until August 31, 2012 (12 days after the dose was administered).

b. Review of the Activity by Item report dated August 20, 2012, indicated that on August 19, 2012, at 1:11 a.m., RN 520 took out three doses of hydromorphone (controlled substance used for pain) 1 mg/ml injectable syringes and at 1:39 a.m., 4 doses at one time.

On September 26, 2012, at 11 a.m., the Director of Emergency Department (DED) acknowledged that he had received the request for resolution to override medications with the missing physician order, and that it was given to the nurse manager for follow-up. The DED also stated that the nurse should not have taken out multiple doses of medication at one time, unless the dose to be administered called for multiple vials/syringes.

Review of activities from Cerner MedStation (Automated Dispensing Cabinet; a medication distribution system) revealed that RN 520 had taken a total of nine doses of hydromorphone 1 mg/ml between August 18, 2012 and August 19, 2012 (during his 12 hour shift) for Patient 21.

Review of Patient 21's Medication Activity Record (MAR) revealed that RN 520 documented administering a total of ten doses, nine 1 mg/ml doses and one 0.5 mg/ml dose of hydromorphone.

Review of the MAR also revealed that the physician order for hydromorphone 1 mg every 10 minutes for a pain rating of 7 to 10 (on a 0 to 10 scale) was dated August 25, 2012.

The MAR also revealed that the 1 mg hydromorphone doses were administered every 5 minutes and not every 10 minutes.

Furthermore, there was no documented wastage for 0.5 mg/ml dose administered from the 1 mg/ml syringe.

During an interview on September 26, 2012, at 3 p.m., RN 520 stated that multiple doses were taken out at once because the patient had a lot of pain due to leaking abdominal aortic aneurysm (AAA) and he was instructed by the anesthesiologist with the ordering physician to "load her up" with hydromorphone.

RN 520 stated that the documentation on the MAR was done at a later date after being reminded that there were no orders entered in the CPOE. RN 520 stated that he had documented as much as he could and admitted that there would be some "glitches" and wrong entries on the MAR.

RN 520 also acknowledged that documentation on the administration time might not be accurate as indicated by time of administration for several doses 5 minutes apart, instead of at least 10 minutes.

RN 520 also acknowledged the missing documentation of the waste of 0.5 mg hydromorphone.

Review of the facility's policy and procedure titled, "Cerner MedStation RX Policy" indicated the following:

"Pharmacy will review override report daily to check for overrides of Attachment 1 medications without corresponding orders. Such issues will be referred to the Nurse manager/Director of the area for resolution/investigation."

During an interview on September 27, 2012, at 10:10 a.m., the DOP stated that the resolution of missing orders for override medications was validated by the pharmacist review, but indicated that he did not review to ensure no multiple doses were taken out of the ADC at once and ensure MAR documentation accurately reflected the amount of controlled substance taken out of the ADC.

Furthermore, the DOP indicated that his review did not address the late charting on the MAR in both cases and late authentication by the ordering physician in one of the cases above.

2. During a tour of the facility's ED on September 24, 2012, at 3 p.m., it was observed that there was a neonatal crash cart located in between the outer sliding door (#1) that opened to the outside and another sliding door (#2) located approximately six feet inside from sliding door facing the outside (#1). It was also observed that the pediatric crash cart was located inside, right next to sliding door #2.

It was observed the carts were movable with wheels.

It was observed that the ED Nursing Station was located on the opposite end and did not have a direct line of sight of both crash carts.

During an interview on September 25, 2012, at 3 p.m., the DOP acknowledged that both crash carts were too close to the outside, where non-staff members can walk out with the crash carts undetected.

It was observed, although there was code access to the entrance of sliding door #1, anyone from inside the ED could physically remove the crash carts without immediately being detected.



28294

3. On September 24, 2012, at 8:50 a.m., a tour was conducted of the Maternal/Child Units with the Director Infection Control (DIC) and RN 11.

A "Neonatal Crash Cart" was observed in the hallway near the Post-Partum Nurses' Station.

The "Neonatal Crash Cart Checklist" for September 2012, revealed the crash cart had been checked daily for the "AM" shift, and the checklist for the "Noc" (night shift) was blank.

The "Adult Crash Cart" located in this same area had been checked daily by both the "AM" shift and the "Noc" shift for September 2012 (not consistent with how often the neonatal crash carts were being checked).

On September 24, 2012, at 11:50 a.m., a "Neonatal Crash Cart" was observed in the Newborn Nursery.

The "Neonatal Crash Cart Checklist" for September 2012, revealed the crash cart had been checked daily for the "AM" shift, and the checklist for the "Noc" (night shift) was not in the "Neonatal Crash Cart" log book.

During an interview with RN 11, on September 24, 2012, at 9 a.m., she reviewed the "Neonatal Crash Cart" log book and was unable to find documentation that the "Neonatal Crash Cart" had been checked by the "Noc" shift during the month of September 2012. RN 11 stated the facility policy and procedure indicated the crash carts should be checked every shift.

The facility policy and procedure titled "Maintenance and Quality Control of Crash Cart" dated April 15, 2011, revealed "... Units will check the crash cart(s), neonatal carts, C-sections carts and Broselow carts every twelve hours. ..."

Based on observation, interview, and document review, the facility failed to ensure an unusable medication was not available for patient use.

Findings:

During a tour of the facility's Physical Therapy/Cardiac Rehab(ilitation) (PT/CR) Unit on September 24, 2012, at 10:30 a.m., it was noted that in one of the cabinets, there was a locked container that contained a vial of nitroglycerin tablets.

During a concurrent interview, RN 500 stated that she was the only person with the key and that no other staff had access to the locked container. When asked if the vial was previously opened or not, she stated that it was not opened since there was no open date written on the vial and that she was the only person that had the key to the locked container. RN 500 stated that CR was open by appointment only, and without her, no staff would be able to unlock the container. RN 500 stated that once it was opened the vial would be thrown away after 30 days.

During a concurrent interview, the DOP stated that the nitroglycerin vials were dispensed with a tamper evident tape around the cap of the vial and acknowledged that the vial did not have the tape around it, indicating that the vial had already been opened.

During an interview on September 24, 2012, at 12:15 p.m., Pharmacist 511 stated that during the monthly inspection of the PT/CR unit in September 2012, she was assisted by the staff (by Pharmacist 511's description not to be RN 500) in unlocking the container containing nitroglycerin for her to inspect. RN 500 stated Pharmacist 511 had brought the key with her and had asked one of the staff, working at the time of the monthly pharmacy unit inspection to unlock the container.

During an interview on September 25, 2012, at 1:30 p.m., the DOP stated the vial of nitroglycerin contained 24 tablets, which indicated one tablet was taken out of the vial. He acknowledged that the vial had been opened, and no open date was indicated on the vial.

Review of the facility's policy and procedure titled, "Medications, Control, Storage of," indicated the following:

"Inspection of Medication supplies outside of Pharmacy: Medication storage areas and emergency drug supplies will be inspected for defined storage criteria every 30 days...

Criteria inspected include...
Absence of expired drugs, drugs with worn or illegible labels, recalled/discontinued drugs, samples or otherwise unusable, unauthorized drugs."

Based on observation, interview and document review, the facility failed to ensure that the food and nutrition services met the needs of all patients as evidenced by failure to:

1. Provide organized food and nutrition services as evidenced by findings of unsafe food handling practices, policies and procedures that were not in line with regulatory requirements, and lack of a comprehensive menu analysis to ensure the menu met the nutritional needs of the populations serviced by the facility (Cross Reference A620, A630, and A749).

2. Ensure that job descriptions were comprehensive and that staff possessed necessary qualifications as outlined in the job descriptions (Cross Reference A620).

3. Ensure the adequacy of disaster food supplies in accordance with the planned disaster menu (Cross Reference A620).

4. Ensure that dietary recommendations were communicated to the physicians and that comprehensive, interdisciplinary nutritional care plans were in place (Cross Reference A628).

5. Develop performance improvement activities that reflected the scope and nature of the food and nutrition services and that identified opportunities for improvement (Cross Reference A267).

6. Ensure safe and effective food storage/production practices were integrated into the facility's Infection Control surveillance system (Cross Reference A749).

7. Ensure that the current Diet Manual was accessible on the units (Cross Reference A631).

The cumulative effect of these systemic problems resulted in the inability of the facility's food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients were met in accordance with acceptable standards of practice. The system problems resulted in the facility's inability to meet the Condition of Participation for Food and Dietetic Services.

Based on observations, interviews and document review, the facility failed to ensure that the Director of Food and Nutrition Services (DFNS) was qualified by experience appropriate to the scope and complexity of the food service operations, in accordance with the hospital job description and identified survey findings. The DFNS failed to:

1. Develop and monitor written procedures, according to standards of practice, for foodservice operational processes and nutritional management of wound care patients.

2. Ensure the adequacy of disaster food supplies.

3. Ensure that job descriptions accurately reflected required personnel qualifications and responsibilities.

4. Ensure clinical indicators were monitored as part of the Quality Assessment Performance Improvement (QAPI) program.

These failures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status, inadequate food supplies in the case of a disaster, and lack of monitoring of quality assurance measures.

Findings:

On September 25, 2012, starting at noon, personnel file review was conducted. The personnel file for the DFNS showed that she was hired on February 21, 2011. The job description located in the personnel file, titled, "Director of Nutritional Services", was signed by the DFNS on March 14, 2011, and showed a "Job Summary" as follows, "Development of the Nutritional Services (NS) program schedule; daily operations of the program; assessing potential patients for the NS program and determination of the level of care - In-Patient versus Partial-Hospitalization ..." The, "Education and Experience" section had a requirement of, "Minimum five (5) years experience in clinical nutrition management." The job description summary did not match the role of the DFNS.

On September 25, 2012, at 2:50 p.m., in an interview with the Director of Human Resources, he stated that the DFNS was originally hired to be the Clinical Nutrition Manager (CNM), but then was appointed as the DFNS. The Director of HR produced another job description, titled, "Director, Food and Nutrition Services", that was signed by the DFNS on March 16, 2011. He stated that he obtained the copy from the DFNS and acknowledged that it had not been placed in the official personnel file of the DFNS.

Review of the job description signed by the DFNS on March 16, 2011, showed under, "Job Summary", that the DFNS was, "Responsible for all foodservice functions related to patients, cafeteria, POB cafe, Dr's Lounge and catering services. Responsible for staffing and supervision of employees in food production and service areas. Responsible for assisting with implementing and monitoring sanitation and safety procedures....Ensures efficient operation of all foodservice areas in accordance with established policies and procedures."

The DFNS was identified as the lead person in charge of administrative foodservice functions, working collaboratively with the CNM on patient menus and clinical systems. The DFNS was also tasked with, "Updating job descriptions and job schedules as changes are made, reviewing at least yearly....Participates in yearly review and update of departmental policies....Develops a quality control plan that demonstrates how the foodservice department will ensure safe and wholesome products."

The "Education and Experience" section of the job description showed, "Minimum of 3-5 years experience in administrative foodservice (preferably healthcare-related)."

Review of the past professional job experience of the DFNS provided on the job application showed:

11/2008 to 6/2009 - Clinical Dietitian (Per Diem)
1/2008 to 6/2009 - Clinical Nutrition Manager I (Lead and directed the efforts of the clinical nutrition and patient satisfaction programs)
8/2010 to 12/2010 - Adjunct Instructor
7/2009 to 2/2011 - Clinical Nutrition Manager II (Lead and directed the efforts of the clinical nutrition and patient satisfaction programs.)

While the DFNS demonstrated managerial experience in clinical nutrition management, administrative foodservice experience, consistent with the job summary outlined above as part of the DFNS job description signed on March 16, 2011, was not noted. This contributed to the following survey findings:

1. During observations and review of selected departmental policies and procedures related to identified deficient practices in the food and nutrition services, it was noted that policies did not consistently reflect current standards of practice:

a. On September 24, 2012 at 9:30 a.m., in an interview with Foodservice Worker 1 (FSW 1), he stated that his job responsibilities occasionally included preparing vegetables and fruit for service. FSW 1 stated that all fruit and vegetables were soaked for 90 seconds in an antimicrobial fruit and vegetable wash before they were peeled or prepared for service. FSW 1 stated all fruits including cantaloupe were just soaked in the wash, not cleaned under running liquid. He indicated there was no brushing to remove dirt or debris in the netting of the exterior of the cantaloupe.

On September 26, 2012, at 8 a.m., review of the facility policy titled, "Washing Fresh Produce", dated August 23, 2012, established by the DFNS, showed the following: "Use Victory (Ecolab Inc.), antimicrobial wash for proper cleaning of fresh fruits and vegetables.....Soak the produce for a minimum of 90 seconds for appropriate pathogen reduction. If there is no Victory wash or if the concentration is not correct: Wash all non-porous produce under cold running (water) for approximately 90 seconds. All porous produce such as cantaloupe, potatoes or kiwi need to be rinsed, scrubbed with a scrub brush and then run under cold water for one minute."

On September 26, 2012, at 2 p.m., review of the Ecolab recommendations for use of their antimicrobial product (Victory), which was being utilized by the facility, showed the following: "Agitation and/or scrubbing is recommended for ground and vine-grown crops such as melons, lettuce and root vegetables to thoroughly remove caked on dirt."

Food and Drug Administration (FDA) guidelines are as follows: "Thoroughly rinse raw fruits and vegetables under running water before eating or preparing them especially fruits that require peeling or cutting - like cantaloupe and other melons. As an added precaution, use a small produce brush to remove surface dirt." Products such as cantaloupe have been known to harbor salmonella on the rind. By not properly washing the fruit and removing imbedded dirt and debris, cutting, slicing and dicing may also transfer harmful bacteria from the fruit's surface to the fruit's flesh.

b. On September 24, 2012, at 9:35 a.m., during an inspection of the "Prep" refrigerator, a container of chicken salad and a container of egg salad, each with approximately four inches worth of product were noted stored on a shelf in the refrigerator. The containers were dated as having been prepared on September 23, 2012 and September 22, 2012, respectively. In a concurrent interview with the DFNS regarding monitoring of the cooling process of these items after preparation, she stated that a temperature monitoring system was not in place for items that are not cooked and then cooled, such as egg salad, chicken salad and tuna salad. She stated that instead, the facility utilizes a "one hour stamp" to monitor those products. The DFNS stated that as long as the items such as egg salad, and chicken salad were prepared and returned to the refrigerator within one hour, then temperature monitoring was not completed and was not required.

Review of the facility policy titled, "Cooling Food" showed the following, "Cold Food Cooling - Food beginning cooling process at 70F or below. Use cold food cooling procedure and log when cooling PHF (Potentially Hazardous Foods) to 41(degrees) F or below after preparation.....Within four hours after the start time, record the time and temperature on the Cold Food Cooling Log."

An additional policy was provided titled, "Food Production Standards," dated August 8, 2012, and developed by the DFNS. The policy delineated the following definition: "Working supply is a small portion of a potentially hazardous food that is removed from a refrigerated supply to undergo further food preparation."

The procedure included the following: "Foods pulled from refrigeration (41 degrees F or below) for working supply will be monitored using the One Hour Timestamp. Any foods not returned to refrigeration within that hour will be discarded....For PHF foods that are not monitored for temperatures during service, a "Time Only" method shall be the Public Health control used. For cold food to be returned to refrigeration, the One Hour Timestamp shall be used."

Per the policy definition, a working supply would be described as the ingredients used to make the final product, and not the final product itself. Therefore, applying a "One Hour Timestamp" to the working supply of ingredients does not relieve the facility from monitoring the cool down of the final product to ensure that, if prepared at 70 degrees F or below, the product reaches a temperature of 41 degrees F or below in four hours or less.

Review of the 2009 Food and Drug Administration (FDA) Food Code, showed the following: "Section 3-501.14 Cooling: 2. (B) Potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 5?C (41?F) or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna." There was no provision listed for a one hour time stamp.

c. On September 25, 2012, starting at 8:53 a.m., medical record review was conducted. Patient 1 was identified with a Stage II pressure sore on the right coccyx and Patient 4 was identified with an infected scalp wound. In a concurrent interview with RD 1 (Registered Dietitian), she stated the facility did not have standardized policies or procedures that addressed nutritional interventions related to staged or surgical wounds.

On September 26, 2012, at 8 a.m., review of the facility policy titled "Pressure Ulcer Identification and Management," showed: "Purpose...The main risk factors of nutrition, activity, mobility, moisture and friction/sheer will be addressed." Under "Interventions," there was no nutritional component indicated.

On September 26, 2012, at 9:15 a.m., in an interview with the CNM, she confirmed that there was no existing policy that addressed nutrition interventions and wounds.

Per the National Pressure Ulcer Advisory Panel, 2009, "Nutrition is an important aspect of a comprehensive care plan for prevention and treatment of pressure ulcers, and it is essential to address nutrition in every individual with pressure ulcers. Adequate calories, protein, fluids, vitamins and minerals are required by the body for maintaining tissue integrity and preventing tissue breakdown."

2. On September 24, 2012, at 10:35 a.m., the "Disaster Preparedness" policy was reviewed with the DFNS. The policy indicated that, in the event of a disaster, "basic dietetic needs" would be provided to patients, staff, physicians and volunteers. This number was determined to be 326 individuals (106 patients plus additional staff, physicians and volunteers.)

Review of the attached disaster menu showed that menus would provide 4 slices of bread per day (two at lunch and two at dinner), for three days, for all individuals except those prescribed clear liquid, full liquid or dysphagia diets. Per the DFNS, she estimated that approximately 15% of the patient population (15 patients) would not be receiving bread. Therefore, the total number of individuals who would receive bread based on the disaster menu would be 311. The total number of slices of bread required to be maintained on hand to meet the needs of the disaster menu would be as follows:

311 individuals x 4 slices of bread x 3 days = 3732 slices of bread.

Review of the emergency food supply inventory attached to the disaster policy showed that the facility maintained 1040 slices of Whole Wheat Bread (40 loaves, 26 slices each) and 192 slices of White Bread (8 loaves, 24 slices each) on hand for a total of 1232 slices of bread. That meant that the facility was 2500 slices of bread short.

3. On September 25, 2012, starting at noon, personnel file review was conducted. The personnel file for the Clinical Nutrition Manager (CNM) was reviewed and showed a job description, signed by the CNM on March 14, 2011, with a job title of, "Dietitian Manager." The CNM was described by the DFNS as the individual responsible for day to day oversight of the diet office including diet clerks, diet technicians and Registered Dietitians.

Further review of the job description for the CNM showed under, "Job Summary", that the Dietitian Manager was "Responsible for assisting with staffing and supervision of employees in food production and service areas. Responsible for assisting with implementing and monitoring sanitation and safety procedures....Assists with monitoring, receiving and storage of food supplies, ensuring maintenance of adequate inventory of food supplies."

Under, "Education and Experience", individuals applying for this position were to possess a, "Minimum of 3-5 years experience in administrative foodservice (preferably healthcare-related)".

Under, "Licensure, Certification, or Registration", the job description indicated, "Registered Dietitian with Commission on Dietetic Registration or Certified Dietary Manager preferred."

Under, "Continuous Quality Improvement", the job duties entailed, "Assists with developing a quality control plan that demonstrates how the foodservice department will ensure safe and wholesome products."

The CNM job description did not reflect any expectations, under the job summary or the essential duties, for that individual to provide oversight of the clinical nutrition systems within the facility or clinical nutrition staff including diet clerks, technicians and RDs. There was no requirement for the CNM to be an RD. there was no requirement for the CNM to develop quality control plans that involved clinical indicators.

4. An interview with the DFNS and CNM on September 26, 2012, at 9:05 a.m., and concurrent review of quality performance indicators for 2012, revealed that the food and nutrition department was submitting data on multiple processes within the department. It was noted that while the department was monitoring food service performance indicators, there was no evaluation of clinical nutrition indicators within the department. The DFNS and CNM stated that there were clinical nutrition indicators monitored in 2011, but they were discontinued when the department met the established thresholds for 2 continuous quarters. No other clinical indicators had been identified for monitoring in 2012.

Based on clinical record review and staff interview, the facility failed to ensure that dietary recommendations were communicated to the physician responsible for the care of the pateints for two patients (Patients 2 and 3), that interdisciplinary care plans were developed for three Patients (Patients 2, 3 and 4), that the Registered Dietitian (RD) addressed the discrepancy in documented height and weight in a timely manner for one patient (Patient 4) and that wound care protocols were in place to ensure the nutritional needs of patients with wounds were met.

Findings:

1. On September 25, 2012, at 9:30 a.m., review of the medical record for Patient 2, showed he was admitted on September 20, 2012. Review of the History and Physical (H&P) completed on September 21, 2012, showed that the patient had end stage renal disease and had been on hemodialysis (a treatment for kidney failure using an advanced dialysis machine to remove waste products from the blood, and then returning the blood back to the body) since 2010. The H&P also documented that the patient had a 10 pound weight loss and hemoglobin (the iron-containing oxygen-transport protein in the red blood cells) of 7.0 g/dl (normal range 13.8 to 18.0 g/dl). On September 20, 2012, the patient was prescribed a Renal diet, and on September 21, 2012, the prescribed diet was Renal, Diabetic, Cardiac.

On September 23, 2012, the RD completed a nutritional assessment and estimated the patient's needs as: 1750-2100 calories and 70-91 grams of protein. The RD documented, "Suggest change diet to 2 gm Na (sodium) 2 gm K+ (potassium) 1800 kcal (calorie) diet to allow increased protein and food choices with limited CHO (carbohydrates)."

In a concurrent interview with RD 1, she confirmed that when a patient was prescribed a "Renal" diet, then a 60 gram protein diet would be served. Patient 2's assessed needs were 70-91 grams of protein, and the patient was on hemodialysis. RD 1 was asked how she would communicate her recommendations to the physician, and she stated that she either spoke to the physician directly or sent her recommendations through nursing staff. RD 1 confirmed that she had not communicated with the physician responsible for Patient 2 regarding liberalizing the patient's diet to promote intake by allowing more food choices and increased protein.

RD 1 was also asked about the process of care planning at the facility. RD 1 stated that there was no "interdisciplinary" approach to care planning. She stated that the dietary "plan of care" appeared as part of the nutritional assessment under the heading, "Plan/Goals". For Patient 2, the "Plan of Care" was: "Dietitian follow up/monitor, Encourage PO (oral) feedings." The RD recommendation to liberalize the patient's diet was under that section as well as a goal for oral intake of "At least 75%." The lack of an interdisciplinary care plan related to nutritional risk may result in lack of implementation of identified nutrition interventions.

2. On September 25, 2012, at 9:55 a.m., review of the medical record for Patient 3, showed he was admitted on September 23, 2012. RD 1 completed a nutritional assessment on September 24, 2012, documenting that the patient stated a 50 pound weight loss over 2 months. The patient was admitted with nausea and vomiting related to chemotherapy treatment. Intake was documented as 20-60%.

On September 23, 2012, the patient was prescribed a Cardiac diet. On September 24, 2012, RD 1 documented, "Consider liberalize diet to regular to max (maximize) po (oral intake)." RD 1 stated that she had not documented communicating her recommendation to the physician responsible for the care of the patient. She also confirmed that there was no interdisciplinary care plan in place, and that the nutritional plan was solely documented in the nutrition Plan/Goals section of the nutrition assessment.

On September 26, 2012, at 9:15 a.m., in an interview with the Clinical Nutrition Manager (CNM), she stated that the RD should be communicating nutritional recommendations to the physician and documenting that action.

3. On September 25, 2012, at 10:22 a.m., review of the medical record for Patient 4, showed she was admitted on September 11, 2012, with a scalp wound infection. On admission, the patient's height was documented as 64 inches and weight at 41.5 Kg (91 pounds). The patient was identified as being less than 80% of ideal body weight (IBW) with an albumin level (a measure of protein stores) of 2.4 g/dl (normal range 3.4 - 5.4 g/dl.)

RD 1 completed a nutrition assessment on September 12, 2012, noting the patient's infected wound, low body weight and inadequate oral intake. RD 1 confirmed that there was no interdisciplinary care plan in place, and that the nutritional plan was solely documented in the nutrition Plan/Goals section of the nutrition assessment. The Plan of Care documented was to, "Encourage PO (oral) feedings." There was no goal documented with regards to wound healing. RD 1 stated that the facility did not have standardized policies or procedures that addressed nutritional interventions related to staged or surgical wounds.

Further review of the medical record showed the patient's measured height/weights as:

September 20, 2012 .... 41.5 Kg (weight), 64 inches (height)
September 21, 2012 .... 89.9 Kg (weight), 60 inches (height)

There was a documented weight discrepancy of 48.4 Kg (106.5 pounds) weight gain and a loss of four inches in one day.

Review of the follow-up nutrition assessment note completed by RD 1 on September 21, 2012, documented the patient as "Obese grade II."

There was no follow-up by the RD on the discrepancy in height and weight documented in the medical record to evaluate the accuracy of the documentation until the next follow-up note dated September 24, 2012, as follows, "Previous high BMI (body mass index) noted in error. Current wt (weight) noted and 92% IBW." There was no evaluation of the discrepancy in height.

Based on staff interviews and document review, the facility failed to ensure standard menus were comprehensively 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 had the potential for the patients in the facility to not receive adequate nutrition and to not meet the estimated recommended dietary allowances for all nutrients.

Findings:

The DRI/RDA consists of nutrient based references whose purpose is to plan diets for individuals, focusing on optimizing health status, disease prevention and ensuring consumption of nutrients in adequate amounts. The provisions of the Dietary Reference Intakes, which include the Recommended Dietary Allowances (RDA's), Adequate Intake, and Acceptable Macro and Micronutrient distribution ranges, developed by the Food and Nutrition Board under the auspice of the Institute of Medicine are used to evaluate nutritional adequacy of patient/resident menus.

On September 24, 2012, at 10:05 a.m., the facility's nutrient analysis for the facility diets was reviewed. The analysis did not include a review for micronutrients that were specified in the RDA or DRI.

In a concurrent interview the Director of Food and Nutrition Services (DFNS), she stated that she was not sure what standard the nutrient analysis was compared to. Upon further review, the DFNS stated the menus were compared to a "healthy adult" and standards as specified to the "Nutritional Labels" on food products.

Review of the hospital census for September 24, 2012, showed that, excluding obstetrics and newborns, approximately 79% of the patients serviced by the facility were over the age of 50. Approximately 12% of the population was obstetric.

The DFNS and Clinical Nutrition Manager (CNM) acknowledged that without comparing the menus to the appropriate reference age group guidelines, and without analyzing for micronutrients, it would be difficult to ensure that the facility' developed menus met the nutritional needs of the patients according to the national standards.

On September 26, 2012, at 9:15 a.m., in an interview with the CNM, she confirmed that the menus were not adjusted for pregnant or post-partum patients, and have not been analyzed to ensure that they met the needs of that population, specifically the increased need for folate, iron and niacin, during the stages of pregnancy and/or lactation. She stated that patients were offered regular diets and the non-select regular menu mirrored the menu that would be sent to any patient prescribed a regular diet at the facility.

Review of an updated nutritional analysis of a "regular" diet showed that it was deficient in the nutrients indicated above, that require an elevated intake by obstetric patients, as follows:

Iron - Needs during pregnancy - 22mg/day, Average amount provided on regular diet - 11 mg/day.

Folate - Needs during pregnancy - 600 ug/day, Average amount provided on regular diet - 61 ug/day.

Niacin - Needs during pregnancy - 18 mg/day, Average amount provided on regular diet - 10 mg/day.

Based on observation and staff interview, the facility failed to ensure that two of three staff interviewed on the facility units were aware of the purpose and location of the facility diet manual.

Findings:

1. On September 26, 2012, at 8:35 a.m., in an interview with RN 1, a floor nurse on the 3rd floor, she stated that she had been employed at the facility "since it opened" approximately eighteen months ago. When asked how she would access the diet manual on the unit, the employee stated she was not familiar with what a diet manual was and was not sure where it was located. RN 1 attempted to locate the manual in the "policy section" online but was unsuccessful. RN 1 was also not sure if a hard copy was available for reference. RN 1 stated she would call the Charge Nurse or dietary in order to get more information.

2. On September 26, 2012, at 8:52 a.m., in an interview with RN 2, a Charge Nurse on the 5th floor, she stated that she had been working at the facility "since before it opened." When asked how she would access the diet manual on the unit, she stated she was not sure but believed it was available on the computer. She consulted a co-worker who told her that it was available online. Neither employee could access the diet manual online until the Director of Food and Nutrition Services (DFNS) provided them with the access information. Both employees also attempted to locate a hard copy that they believed was stored on the unit, but a hard copy of the diet manual could not be located. RN 2 was not sure exactly what the purpose of the diet manual was without looking at the description of the document online. She stated that if she needed nutritional information for a patient, she would request a dietary consult.

Based on observation, interview and record review, the facility failed to ensure that the infection control officer provided effective infection control oversight into food services when the dietary staff failed to:

1. Ensure proper washing of fruits and vegetables.

2. Ensure that food items were not kept past documented discard dates.

3. Ensure that all refrigerators used for the storage of food products were equipped with a functioning thermometer.

4. Ensure refrigerated items held on trayline were maintained at a temperature of 41 degrees F or below.

5. Monitor the food cool down system to ensure cool down monitoring of potentially hazardous foods (PHF) prepared at room temperature.

These processes have the potential of promoting food-borne illness if not appropriately implemented/monitored.

Findings:

1. On September 24, 2012 at 9:30 a.m., in an interview with Foodservice Worker 1 (FSW 1), he stated that his job responsibilities occasionally included preparing vegetables and fruit for service. FSW 1 stated that all fruit and vegetables were soaked for 90 seconds in an antimicrobial fruit and vegetable wash before they were peeled or prepared for service. FSW 1 stated all fruits including cantaloupe were just soaked in the wash, not cleaned under running liquid. He indicated there was no brushing to remove dirt or debris in the netting of the exterior of the cantaloupe.

On September 26, 2012, at 8 a.m., review of the facility policy titled, "Washing Fresh Produce", dated August 23, 2012, established by the DFNS, showed the following: "Use Victory (Ecolab Inc.), antimicrobial wash for proper cleaning of fresh fruits and vegetables.....Soak the produce for a minimum of 90 seconds for appropriate pathogen reduction. If there is no Victory wash or if the concentration is not correct: Wash all non-porous produce under cold running (water) for approximately 90 seconds. All porous produce such as cantaloupe, potatoes or kiwi need to be rinsed, scrubbed with a scrub brush and then run under cold water for one minute."

On September 26, 2012, at 2 p.m., review of the Ecolab recommendations for use of their antimicrobial product (Victory), which was being utilized by the facility, showed the following: "Agitation and/or scrubbing is recommended for ground and vine-grown crops such as melons, lettuce and root vegetables to thoroughly remove caked on dirt."

Food and Drug Administration (FDA) guidelines are as follows: "Thoroughly rinse raw fruits and vegetables under running water before eating or preparing them especially fruits that require peeling or cutting - like cantaloupe and other melons. As an added precaution, use a small produce brush to remove surface dirt." Products such as cantaloupe have been known to harbor salmonella on the rind. By not properly washing the fruit and removing imbedded dirt and debris, cutting, slicing and dicing may also transfer harmful bacteria from the fruit's surface to the fruit's flesh.

2. On September 26, 2012, at 8 a.m., review of the facility policy titled, "Dating of Perishable Foods", showed the following guideline: "All perishable foods stored in the refrigerators will be dated with a use by or discard date, initialed by the person storing the item and identified. Foods not consumed on or before this date will be discarded."

On September 24, 2012, beginning at 9:05 a.m., during a tour of the facility kitchen, and accompanied by the DFNS, the following observations were made:

a. In a reach-in refrigerator in the cooks' area, a container of garlic butter was labeled as prepared on "9/21/12" to be discarded on "10/21/12". Review of the facility policy titled, "Dating of Perishable Foods", showed the "Recommended Maximum Refrigerator Time" for "Opened Butter" was "3 days". The DFNS confirmed that the product should have been labeled to be discarded within 3 days of preparation.

b. In the dry storage room, an opened pack of tortilla shells was labeled with a discard date of "9/21/12". In addition, 24 eight ounce cartons of Wildberry Boost breeze nutritional supplements, stored on a shelf in the dry storage area, were imprinted with a manufacturer "use by" date of September 19, 2012. The DFNS acknowledged that these products should have been discarded.

c. On the spice shelf in the kitchen, a jar of capers was dated as being opened on "9/20/12". Imprinted instructions on the jar of capers read, "Refrigerate after opening." Review of the facility policy titled, "Dating of Perishable Foods", showed that opened jars of capers, "MUST be stored in the Fridge."

d. A container of mixed nuts stored on a shelf in the food preparation area was labeled with a discard date of "9/16/12."

e. In the "Prep" refrigerator, a container of apricots was labeled with a discard date of "9/22/12", a container of salsa, discard date, "9/23/12", a container of pineapple mango salsa, discard date, "9/23/12", and a container of Southwest mix, discard date, "9/23/12."

3. On September 24, 2012, starting at 9:05 a.m., during an inspection of the facility kitchen, the produce refrigerator was noted with an internal thermometer with no thermometer gauge. The DFNS, present at the time of the observation, acknowledged that the thermometer was not functional.

On September 25, 2012, at 10:50 a.m., during an inspection of the nourishment room on the Labor and Delivery unit, the thermometer in the refrigerator located in the nourishment room was noted to have gaps in the red gauge between the 40 degree F and 50 degree F mark. The thermometer could not be used to discern the temperature of the refrigerator. The refrigerator was used to store potentially hazardous food items such as deli sandwiches, milk and pudding.

On September 25, 2012, at 10:52 a.m., during an inspection of the nourishment room on the Post-Partum unit, the thermometer in the refrigerator located in the nourishment room was noted to have gaps in the red gauge between the 36 degree F and 60 degree F mark. The thermometer could not be used to discern the temperature of the refrigerator. The refrigerator was used to store potentially hazardous food items such as deli sandwiches, milk and pudding. The DFNS, present at the time of the observations, acknowledged that the thermometers needed to be replaced.

4. On September 26, 2012, at 12:05 p.m., during an observation of the lunch trayline process, cold food products such as milk and sodas were noted to be stored in a reach-in refrigerator, while other prepared, ready-to-eat cold food items such as turkey sandwiches, salads, yogurt parfaits, etc. were stored in an open cart with no temperature controls. Facility staff was noted to take the temperature of the milk, but no other cold food temperatures were recorded.

In a concurrent interview with the DFNS, she stated that the facility did not have enough trayline refrigerated space, and was utilizing the open cart system for refrigerated food items with the "one hour time stamp" process.

Review of the 2009 FDA Food Code, showed the following: "Section 3-501.19 Time as a Public Health Control." This section referenced Ready to Eat food items held for service. "1. Time - maximum up to 4 hours: If time temperature control is used as the public health control up to a maximum of 4 hours: (1) The food shall have an initial temperature of 5?C (41?F) or less when removed from cold holding temperature control, or 57?C (135?F) or greater when removed from hot holding temperature control; (2) The food shall be marked or otherwise identified to indicate the time that is 4 hours past the point in time when the food is removed from temperature control; (3) The food shall be cooked and served, served at any temperature if ready-to-eat, or discarded, within 4 hours from the point in time when the food is removed from temperature control."

There was no provision in the Food Code for returning Ready to Eat food items, that were not considered a working supply, that have not been monitored for appropriate temperatures (i.e. 41 degrees F or below if a refrigerated item), back to the refrigerator within a "one hour timestamp" for re-service at a later time.

5. On September 24, 2012, at 9:35 a.m., during an inspection of the "Prep" refrigerator, a container of chicken salad and a container of egg salad, each with approximately four inches worth of product were noted stored on a shelf in the refrigerator. The containers were dated as having been prepared on September 23, 2012 and September 22, 2012, respectively. In a concurrent interview with the DFNS regarding monitoring of the cooling process of these items after preparation, she stated that a temperature monitoring system was not in place for items that are not cooked and then cooled, such as egg salad, chicken salad and tuna salad. She stated that instead, the facility utilizes a "one hour stamp" to monitor those products. The DFNS stated that as long as the items such as egg salad, and chicken salad were prepared and returned to the refrigerator within one hour, then temperature monitoring was not completed and was not required.

Review of the facility policy titled, "Cooling Food" showed the following, "Cold Food Cooling - Food beginning cooling process at 70F or below. Use cold food cooling procedure and log when cooling PHF (Potentially Hazardous Foods) to 41(degrees) F or below after preparation.....Within four hours after the start time, record the time and temperature on the Cold Food Cooling Log."

An additional policy was provided titled, "Food Production Standards," dated August 8, 2012, and developed by the DFNS. The policy delineated the following definition: "Working supply is a small portion of a potentially hazardous food that is removed from a refrigerated supply to undergo further food preparation."

The procedure included the following: "Foods pulled from refrigeration (41 degrees F or below) for working supply will be monitored using the One Hour Timestamp. Any foods not returned to refrigeration within that hour will be discarded....For PHF foods that are not monitored for temperatures during service, a "Time Only" method shall be the Public Health control used. For cold food to be returned to refrigeration, the One Hour Timestamp shall be used."

Per the policy definition, a working supply would be described as the ingredients used to make the final product, and not the final product itself. Therefore, applying a "One Hour Timestamp" to the working supply of ingredients does not relieve the facility from monitoring the cool down of the final product to ensure that, if prepared at 70 degrees F or below, the product reaches a temperature of 41 degrees F or below in four hours or less.

Review of the 2009 Food and Drug Administration (FDA) Food Code, showed the following: "Section 3-501.14 Cooling: 2. (B) Potentially hazardous food (time/temperature control for safety food) shall be cooled within 4 hours to 5?C (41?F) or less if prepared from ingredients at ambient temperature, such as reconstituted foods and canned tuna." There was no provision listed for a one hour time stamp.

On September 26, 2012, at 12:07 p.m., in an interview with the Director of Infection Control, she stated that she participated in sanitation rounds with an Environmental Health employee contracted to perform quarterly inspections of the food and nutrition systems. She stated she relied on the DFNS to correct any identified deficient practice. She confirmed that she was not familiar with the FDA Food Code 2009 or HACCP (Hazard Analysis Critical Control Point -
a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material
production, procurement and handling, to manufacturing, distribution and
consumption of the finished product) procedures specific to the food service operations, and was not aware of the deficient practices as cited above.

On September 26, 2012, at 1:45 p.m., in an interview with the Environmental Health representative contracted to perform quarterly sanitation inspections within the facility's foodservice department, he stated that his inspections were consistent with State, Federal, and County guidelines; and that he reviewed policies, temperatures, staff certification and food safety processes during his rounds.

Review of the last sanitation inspection report showed that it was completed on December 28, 2011. Facility staff could not provide an explanation for why the report was not completed quarterly as previously indicated. The Environmental Health representative was asked if he reviewed food cooling procedures for items prepared at room temperature such as tuna salad and egg salad. His response was, "These items are not cooked." When it was explained to him that there were cooling guidelines established for such items, and asked how long it should take for these items to cool properly (to 41 degrees F or below), he stated, "Six hours." It should be noted that the Environmental Health representative's response was not consistent with facility policy or with regulatory guidance as stipulated in the 2009 Food Code, Section 3-501.14.

Based on interview and record review, the facility failed to administer respiratory medication as ordered by the physician for two patients (Patients 24 and 25) in the Intensive Care Unit (ICU).

1. For Patient 24, there was a 32 hour delay in receiving the first dose of Atrovent (an inhaled medication used to treat respiratory difficulties). In addition, there were several missed doses of the same medication.

2. For Patient 25, seven doses of Xopenex (an inhaled medication used to treat respiratory difficulties) was not given. On one occasion there was a lapse of 15 hours between treatments.

These failures placed the patients at an increased risk for respiratory distress and further decline in health status.

Findings:

1. The record for Patient 24 was reviewed. There was a physician order, dated September 17, 2012, at 12:41 p.m., for Atrovent inhaler, two puffs four times a day, with the first dose to be given at 1 p.m.

A review of the Medication Administration Record (MAR), revealed the first dose/treatment of the Atrovent inhaler was not given until September 18, 2012, at 8:55 p.m. (32 hours after it was ordered). In addition, on September 19, 21, 22, and 24, 2012, the 9 p.m. dose/treatment of the Atrovent inhaler was not given.

2. The record for Patient 25 was reviewed. There was a physician order, dated September 21, 2012, for Xopenex inhalation every four hours.

A review of the MAR revealed the Xopenex was not administered on the following occasions:
a. September 22, 2012, at 12:30 p.m. (patient asleep);
b. September 23, 2012, at 3:10 a.m. and 4:15 p.m. (patient asleep);
c. September 24, 2012, at 3 a.m., (patient asleep);
d. September 24, 2012, at 7 and 11 p.m. (no reason indicated); and
e. September 25, 2012, at 3 a.m., (three treatments in a row were missed, with no reason indicated).

The next dose/treatment was administered on September 25, 2012, at 8:40 a.m., which was 15 hours after the previous dose/treatment.

On September 25, 2012, at 1:30 p.m., RN 5 was interviewed. RN 5 stated the Respiratory Therapist (RT) administers all respiratory medication/treatments. RN 5 stated if it was noted that a medication/treatment had been missed or was late, then the nurse would call the RT to notify them.

On September 25, 2012, at 1:45 p.m., RT 1 was interviewed. RT 1 stated when a new respiratory medication was ordered, it should be available for administration within two hours. RT 1 stated, when a medication/treatment was ordered every four hours, she would administer it even if the patient was asleep. She stated, if any medication/treatment was not given as ordered, and a comment to indicate the reason not given should be documented in the record.

The facility policy titled, "Guidelines for Ordering, Dispensing & Administration," was reviewed. The policy indicated, "All routine medications are to be administered within 30 minutes before or after routine administration time. If the medication is given more than one hour after the prescribed time, the responsible caregiver must document the reason for late dose...Upon withholding or patient refusal of a scheduled medication, the attending physician will be notified...The reason for withholding the medication and the physician response must be documented in the medical record."