HospitalInspections.org

Based on observation, interview and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients by the following:


1. The governing body did not ensure that surgical services were provided in a safe setting when operating room (OR) staff did not implement the hospital's policy and procedure regarding the sterilization and storage of surgical instruments, and the cleaning and disinfection of endoscopes. (A Tag 940)

2. The governing body did not ensure that the quality assurance system was in place to ensure oversight of the hospital wide infection control program to include high risk, problem prone areas such as sterile processing and storage of surgical instruments, and the cleaning and disinfection of endoscopes. (A Tag 283)

An interview was conducted with the representatives of the governing body on 1/16/14 at 2:15 P.M. The members of the board stated that they were not informed that the OR staff were not implementing the hospital's policies and procedures regarding the sterilization and storage of surgical instruments, and the cleaning and disinfection of endoscopes. They stated that they had not received any information or data regarding any direct observations or evaluations of the sterilization and storage of instruments, or the cleaning and disinfection of endoscopes. They stated that they had been provided data that showed the hospital had low post-surgical infection rates and felt reassured that there were no other issues regarding the surgical services sterile processing department. They acknowledged that they had not provided any direction for the hospital to perform prospective studies to look for problems with the processing and storage of instruments, or the cleaning and disinfection of endoscopes.

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.

Based on observation, interview, and document review, the hospital failed to protect and promote each patient's rights when patient care was not provided in a safe environment for patients by the following:

1. Operating room (OR) staff did not implement the hospital's policy and procedure regarding sterilization and storage of surgical instruments, and cleaning and disinfection of endoscopes. (A Tag 144 #1 and #2)

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Patient's Rights and failure to provide patient care in a safe and secure environment.

Based on observation, interview and document review, the hospital failed to ensure that surgical services were provided in a safe setting when operating room (OR) staff did not implement the hospital's policy and procedure regarding sterilization and storage of surgical instruments, and the cleaning and disinfection of endoscopes. Failure to ensure that surgical instruments were sterilized and stored appropriately, and the cleaning and disinfection of endoscopes was in accordance with its policies and procedures led to a potential risk of infection for all patients undergoing procedures.

Findings:

1. During a tour of the surgical department OR area on 1/13/14 at 8:30 A.M., the emergency crash cart was opened and observed to contain 4 peel packs (sterilization packaging) containing sterilized surgical instruments. Peel pack's 1-3, each contained scissors in the closed position with tape on the handles. Peel pack 4 had (1) forceps in the closed position. The peel packs had backing paper that appeared discolored and stained. Peel pack 1 had a sterilization date of 3/25/1998 and peel pack 3 had a sterilization date of 6/1/1998. Peel pack 4 had a sterilization date of 3/15/2004. The sterilization date for peel pack 2 was not observed.

A review of the hospital's policy entitled "Shelf Life of Processed Instruments and Outdated Supplies" was conducted on 1/13/14 at 2:00 P.M. The policy indicated that steamed items will be wrapped in double layer paper that has been approved by infection control. Per the same policy, it stipulated that "These items have event related sterility. This means they do not expire unless package yellow, torn or question of package integrity."

An interview with the OR Director was conducted on 1/13/14 at 8:35 A.M. She stated that the hospital used event related sterilization practices. She stated that if the packaging that contained a sterilized instrument that was observed to be compromised, such as torn or damaged, that the instrument should be re-sterilized. She did not provide an explanation as to why the instruments in the crash carts that had discolored packaging, had not been re-sterilized.

On 1/13/14 at 2:30 P.M. the sterile storage area was toured. In the sterile storage area, the temperature in the room was very warm. An interview with sterile processing technician (SPD) 1 was conducted on 1/13/14 at 2:35 P.M. She stated that that there was no thermometer in the room to monitor temperature or humidity. She stated that the room overheating had been an ongoing issue.

The sterile processing area was toured on 1/13/14 at 2:45 P.M. and observed to have a temperature of 78 degrees F (Fahrenheit). SPD technicians 1, 2 and 3, all acknowledged that the temperature was too warm in the processing room. They stated that in the past when they called plant services with this high temperature issue in the processing room, it took time to correct the issue. Surgeries were cancelled that day as a result of the high temperatures in the sterile storage areas.

A review of the hospital's policy entitled "Sterile Storage SPD" was conducted on 1/13/14 at 3:00 P.M. The policy indicated that "the sterile storage area shall have a well controlled temperature range with relative humidity regulated."

A tour of a small adjacent room in the sterile processing area was conducted on 1/13/14 at 3:10 P.M. A plastic tub 2 ? by 2 feet in size was observed with sterilized instruments in peel packs all stacked horizontally and some with apparent crushed packaging. The tips of instruments were noted to be in the closed position and some instruments had tape on them. The backing of the peel packs was noted to have discoloration with what appeared to be water spots. The SPD technicians 1, 2 and 3, all stated that this was how they stored their instruments that had been sterilized.

A sterilized plastic surgery tray was observed to be opened on 1/13/14 at approximately 3:15 P.M. A stringer (metal stand for instrument storage within the sterilization tray) was observed with multiple surgical instruments on it that had the tips closed. SPD Technicians 1,2 and 3, all stated that the stringer used was the only size that they had and that was what the hospital provided. The SPD staff were not aware that the closed tip was not ensuring adequate sterilization. A peel pack was observed with 16 surgical instruments all stacked on top of each other within the pack. The SPD staff were not aware that this was not an acceptable practice per the hospital's policy. Two loose scissors were observed in the tray underneath the peel packs on the bottom of the tray. The staff stated this was the only sized tray they had available and that was why it was packed that way.

A review of the hospital's policy entitled "Sterilization and Disinfection, SPD" was conducted on 1/13/14 at 4:00 P.M. The policy indicated that all items to be sterilized shall be arranged so all surfaces shall be directly exposed to the sterilizing agent for the prescribed time and temperature. All jointed instruments are opened and/or unlocked. When utensils are nested in one package they shall be separated by an absorbent towel or other most absorbent material.

An interview with the OR Director was conducted on 1/16/14 at 9:15 A.M. She stated that she was responsible for Hospital A's OR department and a "sister hospital's" (another hospital under the same corporate ownership) OR department. She stated that she visited Hospital A's OR department approximately 2 to 3 times a week. She stated she did not use a formal checklist or a formal observation tool, to validate staff knowledge or how they processed instruments. She stated that she had observed the sterilization process but not the whole process from beginning to end. She stated that all staff had observed the stacking of instruments in trays and acknowledged that some may have needed to be pulled for re-sterilization but it had not been a "bone of contention" so no action was taken.

An interview with the infection control practitioner (ICP) was conducted on 1/15/14 at 11:25 A.M. She stated the hospital does not use tape on the surgical instruments. She acknowledged that the hospital did not have a policy that specified that tape would not be used on surgical instruments or that it must be removed prior to the sterilization process. She further stated that she did not have direct oversight of the sterile processing technicians' duties, as that role was performed by the OR Director.


2. An observation was conducted on 1/13/14 at 10:45 A.M. with operating room technician (ORT) 1 responsible for the Endoscope reprocessing. ORT 1 demonstrated the process he used to reprocess an Endoscope after and before the next patient. ORT 1 was observed to forget or skip three important steps in cleaning and disinfection of the endoscope. ORT 1 failed to: 1) process the scope with sterile water per the manufacturers instructions 2) use forced air in drying the scope to prepare for storage 3) process with 70% alcohol to aid in the drying of the scope.

During an concurrent interview on 1/13/14 at 10:50 A.M., the surveyor asked ORT 1 if he had missed any steps. ORT 1 responded, "No." In response to the question, "Do you have written policy and procedures you follow?", ORT 1 responded, "No." That was the way he did it every day.

During a subsequent observation on 1/14/14 at 7:30 A.M., ORT 1 failed to use enough force when forcing air and/or detergent cleaning to create a flow of detergent through the tube and out the distal end.

During an observation on 1/14/14 at 7:40 A.M., ORT 1 failed to use 70% alcohol to aid in the drying of the scope to prevent bacteria growth.

During an interview on 1/14/14 at 7:45 A.M., the surveyor inquired if the air/detergent pushed in should be visualized flowing out the distal end? ORT 1 responded, "oh yes! I need a 'buddy' (A motorized device that forces the detergent and air through the channels)." He gave a bigger push on the plunger and looked down and said, " See! Now you can see it."

During a interview on 1/14/14 at 7:50 A.M., in response to the question asked by the surveyor, "Do you use alcohol in your processing of the scope, ORT 1 responded, "Yes, at the end of the cases." Surveyor clarified, "At the end of cases? Not, between patients when cleaning for next patient?" ORT 1 responded, "Yes, at the end of the day when all cases are done." In response to the surveyors' question when was your last training regarding your duties with the endoscope? ORT 1 responded, "Since this company took over we do not get training."

A record review on 1/16/14 at 10:00 A.M. was conducted. The review of ORT 1's employment file did not reveal any continuing education documentation.

A review of the written manual endoscope processing instructions from Olympus, the manufacturer of the hospital's endoscopes was conducted on 1/16/14 at 10:00 P.M. Under the instructions on page 4 of the fax under the heading "Rinse the endoscopes and accessories", the following information was provided. "Flushing the interior and recessed parts of the endoscope and accessories with alcohol facilitates drying. Olympus recommends the use of alcohol." The manual also indicated that the endoscopes should be dried with compressed air after flushing them with alcohol.

Based on observation, interview and document review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement (QAPI) program as evidenced by:

1. The hospital did not ensure that its performance improvement activities included the evaluation of their sterile processing and storage of surgical instruments, and the cleaning and disinfection of endoscopes, which were high risk, problem prone areas. (A Tag 283 #1)

An interview with the members of the hospital's Performance Improvement (PI) department was conducted on 1/16/14 at 1:30 P.M. The Performance Improvement Director (PID) stated that he had not been provided any data of direct observation or evaluation of the sterile processing department, staff's performance of the sterilization and storage of instruments, or the cleaning and disinfection of endoscopes. He stated that he did collect data regarding the post-surgical infection rates and because the rates were low he felt reassured that the processing of instruments, and the cleaning of endoscopes were not an issue. He acknowledged that the PI department had not conducted any prospective studies to look for problems regarding the sterilization and storage of instruments, or the cleaning and disinfection of endoscopes to look for opportunities for improvement.

2. The hospital failed to ensure that the Performance Improvement data collected related to falls was accurate. (A-Tag 273)

3. The hospital failed to evaluate the hospitals pharmacy contracted services to ensure the safety of pharmaceutical products. Lastly the hospital did not insure that the QAPI program provided effective oversight over the hospital-wide infection control program. (A Tag 283 #2)

The cumulative effect of the hospital's failure to have a quality assurance system in place to ensure oversight of the hospital-wide infection control program to include high risk, problem prone areas such as sterile processing and storage of surgical instruments, and the cleaning and disinfection of endoscopes resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment, in an effort to prevent the transmission of infections.

Based on interview and document review, the hospital failed to ensure that the Performance Improvement data collected related to falls was accurate. Inaccuracy in the hospital's fall data was due to staff's failure to report a fall incident as defined by the hospital's fall management policy. The hospital's failure to collect accurate data related to falls may cause a delay in the identification of problem areas, which could also impede the hospital's performance improvement opportunities related to fall prevention.


Findings:

Prior to the survey start date, and during a review of the hospital's incident/complaint history on 1/9/14 at 2:00 P.M., an incident at the hospital involving a patient who was assisted to the floor in July 2013 was identified and reviewed.

A review of the hospital's policy and procedure titled "Fall Prevention and Management", dated March 2012, was conducted on 1/13/14 at 11:40 A.M. The policy indicated that, "a fall is considered as any unintentional and unanticipated descent to the floor or any other lower surface and is not intended by the patient for any secondary gain."

An interview with the Director of Performance Improvement (DPI) and Chief Nursing Officer (CNO) was conducted on 1/21/14 at 11:14 A.M. The DPI stated that the data collected for performance improvement were based on national safety goals and the Collaborative Alliance For Nursing Outcome (CALNOC - leading provider of actionable information and research on nursing sensitive quality indicators). The DPI stated that the PI data were collected monthly and were discussed with clinical leaders on a monthly basis. Falls was one of the categories listed on their PI dashboard. According to the DPI, the falls that were tracked and collected for performance improvement purposes were witnessed falls, when a patient was assisted to the floor, and when a patient was found on the floor.

An interview and joint document review of the hospital's 2013 "Fall" data was conducted with the DPI and the CNO on 1/21/14 at 11:18 A.M. The "Fall" data indicated that for the month of July in the 3 East unit of Hospital A, there were no reported falls and no reported incidents of patient being assisted to the floor. Per the same report, there was 1 incident of a patient found on the floor. When asked about the incident regarding a patient who was assisted down to the floor in July 2013, the DPI and the CNO requested an opportunity to validate their fall data.

An interview with the CNO was conducted on 1/21/14 at 1:03 P.M. The CNO stated that she had an opportunity to review the hospital's fall data and the patient's medical record. The CNO stated that the incident regarding the patient that was assisted down to the floor, in the 3 East Unit of Hospital A in July 2013, was not reported to leadership as a "fall". The CNO stated that the nurse who witnessed the incident did not complete an occurrence report. The CNO stated that occurrence report, if completed, would have been forwarded to leadership to ensure that correct reporting of a fall incident was done and that necessary actions were put into place. The CNO acknowledged that the hospital's 2013 fall data was incorrect.

An interview with the DPI was conducted on 1/21/14 at 3:15 P.M. The DPI stated that it was important for the Performance Improvement committee to receive accurate data so they could "identify problem areas and to come up with solutions for identified problems." The DPI acknowledged that the hospital's 2013 fall data was inaccurate.

Based on observation, interview and document review, the hospital failed to ensure that its performance improvement activities included the evaluation of their sterile processing and storage of surgical instruments, the cleaning and disinfection of endoscopes, and the quality of the pharmaceutical products obtained from the hospital's pharmacy vendor, which were all high risk, problem prone areas.

There was no documented evidence to demonstrate that the hospital's Quality Assurance and Performance Improvement (QAPI) program had complete oversight over the sterile processing and storage of surgical instruments, and the cleaning and disinfection of endoscopes. The failure to have a quality assurance system in place to ensure oversight of the hospital-wide infection control program to include high risk, problem prone areas such as sterile processing and storage of surgical instruments, and the cleaning and disinfection of endoscopes, led to an increased risk for the transmission of infections amongst patients undergoing procedures.

In addition, there was no documented evidence to demonstrate that the quality of pharmaceutical products obtained from the hospital's pharmacy vendor was evaluated for sterility (free of microbial contamination) or compliance with the hospital's pharmacy vendor's guidelines. The hospital's failure to ensure the quality of their pharmaceutical products from their pharmacy vendor, had the potential to negatively impact patients when contaminated or ineffective medications may have been used which could lead to the development of infections, or could cause medical treatment failures.

Findings:

1. An interview with the members of the hospital's Performance Improvement (PI) department was conducted on 1/16/14 at 1:30 P.M. The Performance Improvement Director (PID) stated that he had not been provided any data of direct observation or evaluation of the sterile processing department, staff's performance of the sterilization and storage of instruments, or the cleaning and disinfection of endoscopes. He stated that he did collect data regarding the post-surgical infection rates and because the rates were low he felt reassured that the processing of instruments, and the cleaning of endoscopes were not an issue. He acknowledged that the PI department had not conducted any prospective studies to look for problems regarding the sterilization and storage of instruments, or the cleaning and disinfection of endoscopes to look for opportunities for improvement.




16276

2. On 1/15/14 at approximately 11:00 A.M., the Director of Pharmacy (DOP) was asked about, the hospital's pharmacy vendor who provided certain injectable medications to the hospital. When asked about the quality assurance for products from the hospital's pharmacy vendor, the DOP stated that the pharmacy vendor had quality reports posted quarterly on their website (a location connected to the internet). Review of these documents revealed a situation where the pharmacy vendor took corrective action, from 7/1/13 to 9/30/13. When the DOP was asked about the specifics of these corrective actions, he said that he would need to investigate the issue further.

Further evaluation of these documents revealed a graph for "Compliant Rate Per 1 Million Unit Produced" with months on the "x" access, and numbers up to 35 on the "y" access. The graph was not clear and it was difficult to interpret the information. Was the pharmacy vendor compliant only 12 times in September 2012 and 32 times in March 2013 per Million of units produced? It was not clear. The DOP could not provide an explanation or an answer to the questions asked.

Similarly, there were graphs representing "Numbers of Media Positives," which showed two media positive in March 2013. There was no data showing what was the organism that grew or in which products. There was no documented evidence to demonstrate how the information was evaluated by the hospital and how the information relates to their patients.

Another graph showed the "Number of Sterility Positives." The graph from September 2012 until September 2013 showed a very small bar, right above the zero mark. The DOP was not sure what the Sterility Positive meant.

On 1/16/14, the DOP shared an email communication with the hospital's pharmacy vendor that explained some of the terms in question. Sterility positive was explained as positive microbial growth such as contaminations.

There was no documented evidence that the hospital evaluated the quality of the products they had received from their pharmacy vendor to ensure that patients received sterile and effective products.

Based on observation, interview, and record review, the hospital failed to ensure that the registered nurses (RNs) had adequate oversight of the nursing care for 6 of 32 sampled patients (11, 13, 45, 48, 51, 84, 66). There was no evidence in Patient 11's medical record that an intervention was provided when the patient complained of pain. The lack of documented evidence of an intervention made it difficult to ascertain whether the patient's pain was addressed, and that the patient was relieved of pain.

There was also no documented evidence that pain reassessments were performed on patients after the administration of pain medications. The lack of documented evidence of pain reassessments made it difficult to ascertain the effectiveness of the patients' pain status and management.

The nurses failed to clarify, with the ordering physician, tube feeding and water flush orders when the routes for administration were not indicated on the written orders. By assuming the prescribing physician's intended feeding route, the nursing staff were implementing a physician's tube feeding order without a specified route for the tube feeding and water flush administration. Failure to clarify the physician's tube feeding and water flush orders had the potential for wrong-site administration which could negatively impact patients medically fragile health status.

There was also a lack of documented evidence that the ordered water flushes were consistently provided to Patient 13. The lack of documented evidence made it difficult to determine whether or not the ordered water flushes were being administered to the patient to ensure adequate hydration.

In addition, three of nine RNs (RN 12, RN 13, RN 1) were not able to correctly identify and verbalize the type of incidents that the hospital defined as a fall. The nurses' lack of knowledge may cause a delay or even totally miss the opportunity in identifying patients who had fallen, and may cause a delayed response in the initiation of appropriate fall interventions.

Lastly, the hospital failed to ensure that the management of an intravenous (IV) infiltration was performed and documented by the nursing staff, for 1 of 38 sampled patients (65). During a medication pass observation, Patient 65's IV infiltrated during the administration of an intravenous medication. There was no documented evidence to demonstrate that the Patient 65's IV infiltration was assessed and treated by the nursing staff. The lack of documentation related to the management of an IV infiltration by the nursing staff made it difficult to determine if the patient was assessed and treated accordingly when the IV infiltration was identified.

Findings:

1. A tour of the 2nd floor North Unit at Hospital B was conducted with the Nurse Director of Behavioral Health (NDBH).

Patient 11's medical record was reviewed on 1/13/14 at 2:00 P.M. Patient 11 was admitted to Hospital B on 1/7/14 with diagnoses that included osteoarthritis (the most common joint disorder, which is due to aging and wear and tear on a joint) per the History and Physical, dated 1/8/14. Due to a change in condition, Patient 11 was unavailable for an interview.

A review of the physician's order, dated 1/7/14 at 11:15 P.M., indicated an order for Patient 11 to receive Tylenol (pain medication) 650 mg (milligrams) every 4 hours as need (PRN) for pain and headache.

A review of Patient 11's assessment, completed by RN 11 on 1/8/14 at 5:21 A.M., indicated that the patient complained of lower back pain at a rate of "9" (severe pain). The assessment also indicated that the patient's acceptable pain level was "5". However, there were no documented evidence that RN 11 provided any type of intervention to address the patient's pain.

A review of Patient 11's care plan related to pain, dated 1/8/14, indicated the following interventions:
? Educate patient in alternative pain relief measures re: relaxation, music, deep breathing every shift
? Medicate patient as ordered
? Educate patient on use of pain scale
? Document patient's response to pain and/or alternative pain relief measures
The patient's care plan was not followed when there was no documented evidence that RN 11 provided relief measures to address Patient 11's pain.

A review of the hospital's policy and procedure titled "Pain Management" indicated that, "Based on the patient's pain tolerance and goal, pain intervention will be performed." This policy was not followed when there was no documented evidence that RN 11 provided an intervention when Patient 11 complained of severe pain to his lower back.

RN 11 was not available for an interview during the survey.

A joint record review and interview with the NDBH was conducted on 1/13/14 at 2:50 P.M. The NDBH acknowledged that there was no evidence in Patient 11's medical record that RN 11 addressed the patient's pain. The NDBH acknowledged that the patient's care plan and the hospital's policy was not followed by RN 11.

2a. A tour of 5 North Telemetry Unit at Hospital A was conducted on 1/15/14 at 11:05 A.M. At 11:20 A.M., that same day, Patient 13 was observed in his room, sitting on a wheelchair. The patient was observed with a nasogastric tube (NGT - a medical process involving the insertion of a plastic tube through the nose, past the throat, and down into the stomach). The tube feeding was set to run at a rate of 60 ml (milliliter)/ hr (hour) and water flushes to run at 160 ml every 6 hours. An interview with Patient 13 was attempted however, the patient did not respond to any of the questions.

Patient 13's medical record was reviewed on 1/15/14 at 11:35 A.M. The patient was admitted to Hospital A with diagnoses that included cerebrovascular accident (CVA - a loss of brain function due to disturbance in the blood supply to the brain) per the History and Physical, dated 1/15/14.

A review of the physician's order, dated 1/14/14 at 5:15 P.M., indicated to, "increase feeding by 10 ml every 8 hrs with the goal rate of being 60 mls/hr for 24 hrs, and if tolerated, call (physician's name) to see if appropriate to increase to 75 mls/hr." The order did not include the route for the tube feeding administration. There was no documented evidence in Patient 13's medical record that the nurses clarified the order with the physician.

A review of registered dietician (RD) 11's notes, dated 1/11/14 at 3:43 P.M., indicated that water flushes of 160 ml was recommended for Patient 13, four times a day.

A review of the physician's order, dated 1/11/14 at 6:28 P.M., indicated an order for water flushes 160 ml every 6 hours. However, the order did not include the route for the administration of the water flushes. There was no documented evidence in Patient 13's medical record that the nurses clarified the water flush order with the physician.

A joint record review and interview with the Nursing Director of Telemetry (NDOT) was conducted on 1/16/14 at 11:45 A.M. NDOT acknowledged that the written orders for the tube feeding and water flush were incomplete because the orders did not specify the route. NDOT stated that the nurses should have clarified the orders to determine the correct route with the physician, to avoid confusion and provide clear orders for all healthcare providers.

According to the hospital's policy and procedure entitled Enteral Feeding Management (87200-119; last reviewed March 2012), "1. Process order for enteral feeding into the order communication (OC) system. Order should include name or type of formula; total volume, or ml per hour if using a pump or ml per shift, and ml of water per shift ...."
On 1/21/14 at 2:35 P.M., the Chief Nursing Officer (CNO) acknowledged that the above policy and procedure needed to be updated and revised as it was not in accordance with standards of practice, as it lacked the requirement for the enteral access and delivery site to be specified.
According to standards of practice in the industry an element of the tube feeding order should include the enteral access delivery site (route). (American Society for Parenteral and Enteral Nutrition, Enteral Nutrition Practice Recommendations, Journal of Parenteral and Enteral Nutrition, published on January 27, 2009)

2b. A review of the physician's order, dated 1/11/14 at 6:28 P.M., indicated an order for water flushes 160 ml every 6 hours.

A review of Patient 13's intake and output record, dated 1/11/14 thru 1/13/14, showed no documentation that the ordered water flushes were administered as ordered.

A joint record review and interview with the Nursing Director of Telemetry (NDOT) was conducted on 1/16/14 at 11:45 A.M. NDOT stated that the ordered water flushes were necessary to ensure that the feeding tube remained patent and to ensure that Patient 13 was receiving adequate hydration. NDOT acknowledged that there was no documented evidence in the patient's medical record that the water flushes were administered, on 1/11/14 thru 1/13/14, as ordered by the physician. NDOT acknowledged that it was difficult to determine whether or not the nurses provided the water flushes due to the lack of documentation.

3. An interview with RN 12 was conducted on 1/13/14 at 11:30 A.M. at Hospital B. A scenario was provided to RN 12 to determine her understanding of the hospital's fall management policy. During the interview, RN 12 stated that a patient that was assisted down to the floor, in a effort to stop the patient from hitting the ground, would not be considered a fall.

A joint document review of the hospital's policy and procedure titled "Fall Prevention and Management" was conducted with RN 12 and the Nurse Director of Behavioral Health (NDBH) on 1/13/14 at 11:40 A.M. The policy indicated that, "a fall is considered as any unintentional and unanticipated descent to the floor or any other lower surface and is not intended by the patient for any secondary gain." RN 12's understanding of a fall was contrary to the hospital's definition of a fall as defined in the hospital's own policy and procedure.

An interview with the NDBH was conducted on 1/13/14 at 11:45 A.M. The NDBH acknowledged that RN 12 was not able to correctly identify and verbalize the incidents that the hospital defined as a fall. The NDBH acknowledged that the nurse's lack of knowledge may cause a delay in identifying patients who had fallen, and therefore may also cause a delayed response in the initiation of interventions that would prevent the patients from future falls.

An interview with RN 13, a charge nurse, was conducted on 1/13/14 at 11:58 A.M. at Hospital B. A scenario was provided to RN 13 to determine her understanding of the hospital's fall management policy. During the interview, RN 13 stated that a patient that was eased down to the floor would not be considered a fall because the patient did not actually fall to the ground.

A joint document review of the hospital's policy and procedure titled "Fall Prevention and Management" was conducted with RN 13 and the NDBH on 1/13/14 at 12:00 P.M. The policy indicated that, "a fall is considered as any unintentional and unanticipated descent to the floor or any other lower surface and is not intended by the patient for any secondary gain." RN 13's understanding of a fall was contrary to the hospital's definition of a fall as defined in the hospital's own policy and procedure.

An interview with the NDBH was conducted on 1/13/14 at 12:00 P.M. The NDBH acknowledged that RN 13 was not able to correctly identify and verbalize the incidents that the hospital defined as a fall. The NDBH acknowledged that the nurse's lack of knowledge may cause a delay in identifying patients who had fallen, and therefore may also cause a delayed response in the initiation of interventions that would prevent the patients from future falls.

















22930

4. An interview with RN 1 was conducted on 1/16/14 at 11:15 A.M. at Hospital A. A scenario was provided to RN 1 to determine his understanding of the hospital's fall management policy. During the interview, RN 1 stated that when a patient was assisted to the floor during a transfer from bed to wheelchair, he would not consider that a fall. He stated that he would not have performed a post-fall assessment of the patient unless otherwise directed by the charge nurse because he definitely would have informed the charge nurse of the incident.

A review of the hospital's policy and procedure titled "Fall Prevention and Management" was conducted on 1/16/14. The policy indicated that, "a fall is considered as any unintentional and unanticipated descent to the floor or any other lower surface and is not intended by the patient for any secondary gain." RN 1's understanding of a fall was contrary to the hospital's definition of a fall as defined in the hospital's own policy and procedure.

An interview with the Intensive Care Unit Director (ICUD) was conducted on 1/16/14 at 11:22 A.M. The ICUD acknowledged that RN 1 was not able to verbalize the hospital's definition of a fall in accordance to the hospital's fall management policy. He agreed that a post-fall assessment was important after a patient fall because of the assessment for injury and prompt interventions that may be required to ensure that patient was injury-free and and that a safe environment was provided. He acknowledged that RN 1 would not have performed a post-fall assessment because he did not consider assisting a patient to the floor, as a fall. He acknowledged that when staff did not know the hospital's definition of a fall, the following potential problems could occur: staff's inability to identify a fall, post-fall assessments not performed, a delay in the implementation of interventions related to the fall, possible injuries, and ensuring that preventive measures were put into place, in effort to prevent future falls.


25321


5. A review of Patient 45's medical record was conducted on 1/15/14 at 10:50 A.M. Patient 45 was admitted to Hospital A on 1/13/14 per the Facesheet. The history and physical, dated 1/13/14, indicated a past medical history that included metastatic (spread of cancer to other organs) breast cancer that had spread to the lungs and liver.

An interview and joint review of Patient 45's pain assessment and Medication Administration Record (MAR) with the Medical-Surgical Manager and Registered Nurse (RN) 45 were conducted on 1/15/14 at 11:00 A.M. The pain assessment dated 1/14/14 at 8:00 P.M. indicated that Patient 45 described pain level as a 10 out of 10 (Numeric/Simple Descriptive Pain Intensity Scale 10 equal worst possible pain). The MAR, dated 1/14/14 at 8:36 P.M., indicated the administration of morphine sulfate (pain medication) 1 milligram (mg) intravenously (IV). After review of the Nursing Clinical documentation, RN 45 stated, there was no pain reassessment found after the 8:36 P.M. morphine administration. RN 45 further stated a pain reassessment should have been within fifteen minutes after the IV morphine administration.

A joint observation and interview with Patient 45 and the Nursing Director of Telemetry (NDOT), the Medical Surgical Manager (MSM), and RN 45 was conducted on 1/15/14 at 11:45 A.M. Patient 45 rested in the bed and stated the "pain was controlled and would go home later today or tomorrow."

A review of the hospital's policy titled Pain Management was conducted on 1/15/14 at 12:30 P.M. The policy indicated, "H. Based on the patient's stated pain tolerance and goal, pain intervention will be performed. A reassessment for the presence and intensity of pain shall be performed as a component of the shift assessment for inpatients and following any intervention intended to lessen the patient's pain (e.g., administration of pain medication, application of cold packs, repositioning). 1. Such reassessment shall take place within a clinically appropriate time frame, depending on the type of intervention and the route of medication administration, (For example 15 minute [min] for IV medications, 30 minutes for intramuscular [IM], 60 minutes for oral)."

Both RN 45 and the MSM stated it was the expectation that pain level was reassessed per the hospital's policy after the administration of pain medication on 1/15/14 at 5:00 P.M. The MSM and the NDOT acknowledged that Patient 45's pain had not been reassessed after the administration of IV morphine.

An interview with the Chief Nursing Officer (CNO) was conducted on 1/21/14 at 2:20 P.M. The CNO stated it was expected that reassessment of pain occurred after the administration of pain medication per the hospital's policy.

6. A review of Patient 48's medical record was conducted on 1/16/14 at 9:40 A.M. Patient 48 was admitted to Hospital A on 1/14/14 with a previous visit print diagnoses that included attention to gastrostomy (G-tube creation of an artificial external opening into the stomach for nutritional support) per the Facesheet.

A joint observation of Patient 48 with Registered Nurse (RN) 46 and the Respiratory Care Manager (RCM) was conducted on 1/16/14 at 9:45 A.M. Patient 48 rested in the bed with both eyes closed and had a tube feeding of Fibersource infusing at 50 milliliters (ml) per hour (hr).

An interview and joint review of the physician orders with RN 46 was conducted on 1/16/14 at 10:15 A.M. The physician order, dated 1/14/14, indicated "Start tube feeding with Fibersource HN at 50 ml/hr. Water flush 50 ml every two [2] hours." RN 46 stated when tube feeding orders were written, the order should include the route based on the type of tube. RN 46 further stated the tube feeding order should have been clarified to ensure the completion of the order. RN 46 acknowledged that Patient 48's physician order for tube feeding was incomplete since it did not include the route for administration of the feeding.

On 1/16/14 at 11:45 A.M., a review of the hospital's policy titled, "Physician Orders Giving, Receiving, Authenticating" was conducted. The policy under, "A. Written orders: A.1. All written orders, including those on pre-printed forms or electronically transmitted orders, must be clear, legible, and complete. A.2. Orders that are illegible or improperly written will not be carried out until rewritten or clarified and understood by the licensed or certified professional."

On 1/21/14 at 2:20 P.M., an interview with the Chief Nursing Officer (CNO) was conducted. The CNO stated the physician order should be complete to indicate the route for all tube feedings.
According to the hospital's policy and procedure entitled Enteral Feeding Management (87200-119; last reviewed March 2012), "1. Process order for enteral feeding into the order communication (OC) system. Order should include name or type of formula; total volume, or ml per hour if using a pump or ml per shift, and ml of water per shift ...."

On 1/21/14 at 2:35 P.M., the CNO acknowledged that the above policy and procedure needed to be updated and revised as it was not in accordance with standards of practice, as it lacked the requirement for the enteral access and delivery site to be specified.
According to standards of practice in the industry an element of the tube feeding order should include the enteral access delivery site (route). (American Society for Parenteral and Enteral Nutrition, Enteral Nutrition Practice Recommendations, Journal of Parenteral and Enteral Nutrition, published on January 27, 2009)





27157

7. On 1/14/14 at 11:25 A.M., Patient 51's medical record was reviewed. Patient 51 was admitted to Hospital A on 12/26/13 per the Admission/Registration form.
On 1/14/14 at 11:25 A.M., RD (Registered Dietician) 85 said that a nutrition assessment was completed for Patient 51 on 12/27/13, as a result of a nutrition consult referral by nursing due to patient's intubation (an insertion of a tube into the mouth to provide an airway).
On 1/1/14 a physician ordered "tube feeding (TF) glytrol 30 ml (milliliters)/hr (hour)." On 1/1/14 under "Nursing Communication" for the same tube feeding order specified above was further documentation, "Directions: When Glucerna at 30 ml/hr is tolerated, increase TF rate 10 ml every 8 hrs to goal rate 50 ml/hr."
On 1/15/14 at 11:55 A.M., the Intensive Care Unit Director (ICUD) reviewed the above physician's order for tube feeding and acknowledged that the route for tube placement was not specified, nor clarified with the physician. The ICUD verified that lack of specifying the route for a tube feeding order could impact the tube feeding plan of care, as there could be different monitoring processes in place depending on the desired route and location for the tube feeding (such as nasogastric [NGT - a tube inserted through the nose and into the stomach], nasoduodenal [a tube inserted through the nose and into the intestine], and nasojenunal [a tube inserted through the nose and into the small intestine]).
On 1/15/14 at 11:58 A.M., RN 86 reviewed Patient 51's physician's order for tube feeding ordered on 1/1/14, and verified that the route for the tube feeding placement had not been specified, nor clarified with the physician.
At that time, RN 86 was asked how she implemented the physician's order for the tube feeding ordered on 1/1/14, and she said, "The patient already had an NGT secondary to she was intubated, so it's the only route we have."
According to the nursing clinical record, dated 1/1/14, "Diet Type - Tube Feeding, Gastrointenstinal Tube Location - Right Nare, Tube Feeding/Supplement Type - Glucerna 1.2, Tube Feeding Rate - 30 ml/hr ..."
Nursing implemented the tube feeding order as nasogastric via right nare, without clarifying the order with the practitioner responsible for the care of the patient.
On 1/21/14 at 2:35 P.M., the Chief Nursing Officer (CNO) verified that a physician's order for tube feeding, that lacked the route was an incomplete order, and should be clarified with the physician.
8. On 1/16/14 at 11:15 A.M., Patient 84's medical record was reviewed.
On 12/19/13 the physician ordered "Tube Feeding Fibersource 20 ml (milliliters)/hr (hour)." Hospital staff 83 (HS 83) verified that there were no further details to the above order in Nursing Communication. According to the ICU flow sheet, dated 12/20/13 the tube feeding was implemented as an NGT (nasogastric tube - a tube inserted through the nose and into the stomach) feeding, without clarifying the physician's order.
On 1/16/14 at 11:29 A.M., RN 88 was assigned to taking care of Patient 84 at the time of the interview. RN 88 was asked to review 84's tube feeding order from 12/19/13, and acknowledged that the tube feeding order was not a complete order, as the route for the tube feeding, was not specified.
RN 88 reviewed Patient 84's physician's orders around the time period of 12/19/13 and said that if the order was clarified it would appear as a physician's order, "I do not see that the order was clarified."
On 1/16/14 at 12:05 P.M., MD (Medical Doctor) 87 acknowledged that the route for tube feeding should be specified in a physician's tube feeding order. MD 87 agreed that if a tube feeding order had not specified the route, then it was an incomplete order.
On 1/21/14 at 2:35 P.M., the Chief Nursing Officer (CNO) verified that a physician's order for tube feeding that lacked the route, it was an incomplete order, and should be clarified with the physician.
The hospital's policy and procedure entitled Physician Orders Giving, Receiving, Authenticating (87100-041; last reviewed November 2009) indicated, "Intent: To outline the process for giving, receiving and authenticating physician orders, i.e., written, verbal and telephone, in order to reduce or prevent medical errors ..., A.1. All written orders, including those pre-printed forms or electronically transmitted orders, must be clear, legible, and complete."
According to the hospital's policy and procedure entitled Enteral Feeding Management (87200-119; last reviewed March 2012), "1. Process order for enteral feeding into the order communication (OC) system. Order should include name or type of formula; total volume, or ml per hour if using a pump or ml per shift, and ml of water per shift ...."
On 1/21/14 at 2:35 P.M., the CNO acknowledged that the above policy and procedure needed to be updated and revised as it was not in accordance with standards of practice, as it lacked the requirement for the enteral access and delivery site to be specified.
According to standards of practice in the industry an element of the tube feeding order should include the enteral access delivery site (route). (American Society for Parenteral and Enteral Nutrition, Enteral Nutrition Practice Recommendations, Journal of Parenteral and Enteral Nutrition, published on January 27, 2009)








16276

9. On 1/21/13 at 9:00 A.M., a review of Patient 66's electronic medical record was conducted with Registered Nurse (RN) 71. Patient 66 was admitted to Hospital A on 1/10/14 for complaints related to pain.
Patient 66 had multiple orders for pain medications, which included the followings:
Morphine sulfate 1 mg (milligram) every 6 hours as needed for severe pain (pain scale 7-10)
Percocet (oxycodone /acetaminophen 5-325) one tablet every 4 hours as needed for moderate pain (pain scale 4-6)

Patient 66's medical record revealed no documented evidence of a pain assessment after interventions and medication administrations. According to nurses notes on 1/11/14 there was no documentation of pain at 4:28 A.M. and 4:38 A.M. But at 4:57 A.M., Patient 66 was medicated with Percocet (pain medication) for a pain score of 10 (severe pain). There was no evidence that the pain was evaluated until 7:00 A.M., which was two hours after the medication administration.
Similarly, on 1/13/14 at 3:37 A.M., and 4:31 A.M. there was documentation of the presence of pain, and at 4:31 A.M., the pain intensity was 10 (severe). One dose of Percocet was administered. There was no documentation of a pain assessment until 7:48 A.M., which was about 3 hours after the medication was administered.
Review of the hospital policy, titled Pain Management, last reviewed on April 2012, revealed the following regarding a pain reassessment:
"Such reassessment shall take place within a clinically appropriate period, depending on the type of interventions and the route of medication administration. For example 15 min (minute) for IV(intravenous - administered in the vein) medication, 30 minutes for IM (intramuscular - administered in the muscle), 60 minute for oral."

10. On 1/14/14 at approximately 9:00 A.M., on the 6 North Nursing Floor, Patient 65 was observed receiving morning medication (med). During the med pass, the Registered Nurse (RN 67) that was administering the medications was administering Protonix, a medication used to suppress secretion of stomach acid, by injections into the veins (IV). As the nurse tried to administer the medication into the line, in the right hand, the Patient was saying something that came out as noises that could not be understood, because of a breathing mask covering the mouth and nose of Patient 65. The spouse was in the room and tried to console and comfort Patient 65, but the nurse noticed bleeding around the line. There was evidence of fresh bleeding under the skin, the area measured about three to four centimeters in diameter. The bleeding site was on the medial side of the wrist and to the left of the IV line.
The nurse then stopped. Later, the nurse administered the medication in the IV line that was in the left upper arm. While administering the medications, the patient was pushing the hands of the nurse with other hand and saying something that could not be understood through the mask.
At that time, another family member of Patient 65 came into the room and held the patient's hand. When the nurse finished administrating Protonix, there were visible infiltrations (leakage of the medications to the tissue around the tip of the IV line). There was evidence of fluid accumulation (ballooning) under the skin about the size of a small egg.

On 1/14/14 at approximately 5:00 P.M., RN 67 was asked about what was done to manage the infiltration; RN 67 stated that the issue was resolved when the IV line was removed that morning around 9:30 A.M. There was no documentation about the infiltrations, nor what was done to manage them.

On 1/16/14 at approximately 1:30 P.M., the electronic medical record for Patient 65 was reviewed with RN 68. There was no documented evidence of Patient 65's bleeding incident or the infiltration. There was no documentation found in the medical record about Patient 65's IV infiltration and bleeding, as to how they were handled, what was done, and any assessments performed on Patient 65.

On 1/16/14, RN 68 and the Director of Pharmacy (DOP) were asked for the hospital's policy addressing management of infiltration. He presented a draft copy, indicating that the policy was formulated in December 2013. The policy was not implemented; it was in a draft form.

Based on observation, interview, and record review, the hospital failed to ensure that several medications were administered, for 3 of 38 sampled patients (63, 66, 65), in accordance with the physician's orders as follows:

1. Patient 63 was not given potassium as ordered.
2. Patient 63 was not given hydralazine, a blood pressure medication, as ordered.
3. Patient 66's medications: heparin (a medication used to thin the blood and prevent formation of blood clots), insulin (medication to treat elevated blood sugar levels) and Protonix (a medication used to suppress stomach acid secretions) were not administered even though there was no physician orders to hold (not administer) them.
4. Patient 66 was administered 15 units of insulin in the absence of an order. In addition, the insulin protocol was not implemented when the physician was not contacted for the elevated blood sugar, to obtain an order.
5. Patient 66 was not administered morphine for severe pain (pain scale of 10) as ordered.
6. Patient 65 was not administered Lasix (a medication used to waste salt and water to reduce blood pressure), when there was no physician order to hold or discontinue it.
7. Heparin protocol for verifying heparin dose was not implemented for Patient 63.

Failure to follow physician's orders related to medication administration, and hospital protocols as prescribed by the physician, could negatively impact the patients medically fragile health status when prescribed medications and protocols were not administered as ordered.

Findings:

1. On 1/14/14 at approximately 9:15 A.M., on the 5 North Nursing Floor, Patient 63 was observed receiving morning medication. At 10:15 A.M., the electronic medical record for Patient 63 was reviewed with the Director of Pharmacy (DOP) and hospital staff (RT 70). Patient 63 had high blood pressure and atrial fibrillation (irregular heartbeat). The record revealed physician's orders for potassium replacement as needed, which was based on the level of potassium in the blood. Potassium was needed for cells to function properly. Potassium replacement was used to prevent hypokalemia (low potassium level). Severe hypokalemia could be life threatening and required immediate medical attention.
The potassium protocol, ordered on 1/11/14 at 12:45 A.M., instructed the nursing staff to administer 10 milliequivalents (unit to measure potassium) of potassium chloride intravenously over 1 hour X (times) 3, for potassium levels of 3.1 to 3.6.

Review of the labs revealed that on 1/13/14 and 1/14/14, the potassium level was 3.5 on both days. According to the electronic medication administration record (eMAR), there was no evidence that potassium replacement was given on 1/13/14 and 1/14/14. The DOP and Respiratory Therapist (RT) 70 confirmed the finding on 1/14/14 at 10:30 A.M.

2. On 1/14/14 at approximately 9:15 A.M., on the 5 North Nursing Floor, Patient 63 was observed receiving morning medication. At 10:15 A.M., the electronic medical record for Patient 63 was reviewed with the Director of Pharmacy (DOP) and Respiratory Therapist (RT 70). Patient 63 had high blood pressure and atrial fibrillation (irregular heartbeat). The record revealed a physician's order for hydralazine as needed. Hydralazine was used for lowering blood pressure. The physician's order, dated 1/11/14 at 12:45 A.M., was for 10 milligrams (mg) of Hydralazine to be given every 6 hours for a systolic blood pressure (when the heart is pushing blood out to the body) higher than 150, or a diastolic blood pressure (when the heart is receiving blood back) higher than 95.
During a concurrent review of the electronic medication administration record (eMAR) with the DOP, Registered Nurse (RN) 66, and RT 70, the record indicated that there were several times when the blood pressure was higher than the parameters indicated in the order, but there was no documented evidence to demonstrate that the medication was administered. The following were some examples:
On 1/10/14 at 8:12 P.M., the blood pressure was recorded as 157/89.
On 1/13/14 at 5:14 A.M., the blood pressure was recorded as 159/96.
On 1/13/14 at 11:37 P.M., the blood pressure was recorded as 153/86.
On 1/13/14 at 7:00 A.M., the blood pressure was recorded as 157/95.
There was no documented evidence in Patient 63's medical record to demonstrate that hydralazine was administered in accordance with the physician's order.

3. On 1/14/14 at 8:30 A.M., on the 6 North Nursing Floor, Patient 66 was observed receiving morning medication. During the medication pass, Registered Nurse (RN) 65 was administering the medications and said the patient was suppose to receive Protonix by mouth, but she was going to hold the medication because the patient was NPO (Latin term for nothing by mouth).
RN 65 stated that Patient 66 was not given insulin that morning either because Patient 66 was NPO due to a scheduled surgery on 1/14/14. Per RN 65, Patient 66 did not receive breakfast.
RN 65 also stated that she was not going to administer heparin, a medication used to thin the blood and prevent formation of blood clots, because the patient was going for surgery later that day (1/14/14).
On 1/14/14 at 3:26 P.M., the electronic medical record for Patient 66 was reviewed with RN 65. There were no physician's order to withhold Protonix because of the patient's NPO status, nor was there an order to withhold the insulin and heparin before patient went to surgery. There was no documentation found in the medical record to demonstrate that the physician was notified about Patient 66's Protonix, insulin and heparin not being administered due to the patient's NPO status and surgery that day. In addition, there was also no documented evidence in the eMAR or Nurses Notes about not administering Patient 66's Protonix, insulin and heparin.

4. On 1/14/14 at 3:26 P.M., the electronic medical record for Patient 66 was reviewed with RN 65. Patient 66 had a history of diabetes; he was receiving insulin (a medication to treat high blood sugar levels) to manage the blood sugar. The insulin order indicated to administer a specific amount of insulin based on the sugar level in the blood (sliding scale - a set of instructions for administering insulin dosages based on specific blood glucose readings). The order also instructed nurses to contact the physician for blood sugar levels that were low (less than 70) or high (more than 400).

On 1/11/14 at 4:52 P.M., the blood sugar level for Patient 66 was recorded as 425 mg/dl (milligrams in each deciliter: unit measurements). According to the insulin protocol, for a blood sugar level "greater than 400," the nurses were directed to "Call MD (Medical Doctor) to consider Insulin Infusion."

There was no documented evidence found in Patient 66's to demonstrate that the physician was informed of the high blood sugar level. The electronic record under Chemistry did show documentation of "Doctor notified." However, there were no details as to who contacted the doctor, what doctor, what time, or if there were any interventions ordered or directions given by the doctor during that time. On 1/16/14 at 10:00 A.M., RN 69 clarified that "Doctor Notified" was a selection from the drop down menu on the glucometer (a medical device for determining the approximate concentration of glucose in the blood) after the blood sugar was read. The drop down menu included different options: Doctor Notified, Repeated, Juice food/D50/Give, Cleaned Meter, Received Meds ... etc. These options were independent and did not communicate with other systems. For example, the "Doctor Notified" when checked did not automatically send notice to the physician of the blood levels.
According to the eMAR (electronic medication administration record), on 1/11/14, for the 425 blood sugar, Patient 66 was administered 15 units of insulin. However, there was no documented evidence to demonstrate that a physician's order to administer 15 units of insulin was obtained.

The insulin protocol was not implemented when the blood sugar was higher than 400; the physician was not notified to consider insulin infusion. In addition, Patient 66 was administered 15 units of insulin without a physician's order.

5. On 1/12/14 at 9:00 A.M., the electronic medical record for Patient 66 was reviewed with Registered Nurse (RN) 71. Patient 66 was admitted to the hospital on 1/10/14 for complaints related to pain. Patient 66 had multiple orders for pain medications, which included the following:
Morphine sulfate 1 mg (milligram) every 6 hours as needed for severe pain (pain scale 7-10)
Percocet (oxycodone /acetaminophen 5-325) one tablet every 4 hours as needed for moderate pain (pain scale 4-6)
On 1/12/14 at 9:00 A.M., a concurrent review of Patient 66's record with RN 71 revealed that pain medications were not administered as ordered. Inconsistent with the physician's order, Percocet was administered to Patient 66 for severe pain (pain scale of 8) on 1/13/14 at 8:07 A.M.
Similarly, on 1/14/14 at 11:11 A.M., Patient 66 was administered a dose of morphine sulfate for pain scale of zero. The nurse notes on 1/14/14 at 11:00 A.M., contained documentation that indicated that Patient 66 had no presence of pain.

6. On 1/14/14 at approximately 9:00 A.M., on the 6 North Nursing Floor, Patient 65 was observed receiving morning medication. During the medication pass, Registered Nurse (RN) 67 was administering medications and said that Patient 65 was suppose to receive Lasix (a medication used to waste salt and water to reduce blood pressure), but she was going to hold the medication because the blood pressure was very low. RN 67 stated that Patient 65's blood pressure was 86/57 (normal blood pressure was anything from 90/60 to 120/80). Low blood pressure could cause dizziness or lightheadedness, fainting, rapid, shallow breathing, and fatigue.

On 1/14/14 at approximately 5:00 P.M., RN 67 was asked about Lasix. She stated that she contacted the doctor to let him know about the low blood pressure and that she was told to hold the Lasix. However, there was no physician's order to hold the Lasix.

On 1/14/14, Respiratory Therapist (RT) 70, the Director of Pharmacy (DOP) and the nurse manager were asked about any hospital policy addressing procedures for holding medication and what actions were expected; it was stated that there were no policies in place addressing such concerns. There were no standardized procedures, which authorized nurses to function independently without the need to obtain physician's orders. Patient 65's Lasix was held without physician's order.

7. On 1/14/14 at approximately 9:15 A.M., on the 5 North Nursing Floor, Patient 63 was observed receiving morning medication. During the medication administration, Registered Nurse (RN) 64 administered 5000 units of heparin (a medication used to thin the blood and prevent formation of blood clots). RN 64 withdrew the medication into a syringe and administered it by injection under the skin, in the abdomen. RN 64 did not ask another nurse to verify the dose of heparin when it was drawn, and consequently, did not ensure that a co-signature was obtained. Review of the eMAR (electronic medication administration record), with the Respiratory Therapist (RT) 70, revealed no documented evidence that a co-signature had been obtained for the verification of the heparin dose.

Review of the hospital's policy, titled Medication Administration Safety, last reviewed in 11/2011, revealed the following: "Doses of insulin and heparin will be verified by a second licensed nurse. Both nurses will initial and sign the eMAR."

Based on staff interview and record review, the hospital failed to ensure that verbal telephone orders were cosigned within 48 hours, in accordance with hospital policy, for 3 of 38 sampled patients (62, 64, 66).
A delay in co-signing telephone orders within the specified time could delay timely identification of problems with inappropriate orders, or the potential for medication errors to continue to be undetected; therefore, putting patients at risk of receiving medications in error and related consequences.

Findings:

1. On 1/16/14 at approximately 4:00 P.M., the record for Patient 62 was reviewed with the Director of Pharmacy (DOP). Patient 62 had a telephone order, dated 1/10/14 at 1:00 P.M. for Fentanyl patch (opioid type medication in a patch form, which is applied to the skin.)

Review of the electronic records showed that the electronic order was co-signed by the prescriber on 1/15/14/ at 9:07 A.M., that was almost 5 days after the order was written. That was not consistent with the hospital's policy.

Review of the hospital's policy, titled Physician Orders Giving, Receiving, Authentication, reviewed 11/209, revealed the followings: "All verbal and telephone orders will be authenticated by the prescribing physician within forty-eight (48) hours per title 22 requirements. ..."

2. On 1/21/14 at approximately 9:00 A.M., the record for Patient 64 was reviewed with the Director of Pharmacy (DOP). Patient 64 had a telephone order, dated 1/09/14 at 6:09 A.M., for flumazenil. Flumazenil was a rescue medication, which was used to treat an overdose of benzodiazepine (tranquilizers) type medications such as Ativan (medication used to relieve anxiety) or Valium (used to treat anxiety). Review of the electronic records showed that the electronic order was co-signed by the prescriber on 1/13/14/ at 9:57 A.M., which was more than 4 days after the order was written.

Review of the hospital's policy, titled Physician Orders Giving, Receiving, Authentication, reviewed 11/209, revealed the following: "All verbal and telephone orders will be authenticated by the prescribing physician within forty-eight (48) hours per title 22 requirements. ..."

3. On 1/14/14 at 4:00 P.M., the record for Patient 66 was reviewed with Registered Nurse (RN) 65. Patient 66 had a telephone order, dated 1/11/14 at 5:00 P.M. for insulin. The order was not co-signed. On 1/15/14 at 10:15 A.M., a follow up review of the electronic records with the RN showed that the electronic order for insulin (a medication to treat high blood sugar levels) was not co-signed by the prescriber, which was about four days after order was written.
Review of the hospital's policy, titled Physician Orders Giving, Receiving, Authentication, reviewed 11/209, revealed the followings: "All verbal and telephone orders will be authenticated by the prescribing physician within forty-eight (48) hours per title 22 requirements. ..."

Based on observation, interview, and record review, the hospital failed to ensure that the medical records included complete and consistent documentation of pain assessment for 1 of 32 sampled patients (47). The Registered Nurse (RN) and the Nursing Care Partner (NCP) 42 had inconsistent documentation for the assessment and evaluation of Patient 47's rating of pain. The inconsistent documentation made it difficult to ascertain whether the patient's pain was addressed and effectively relieved by the prescribed pain medication. Furthermore, the inconsistent documentation amongst the RN and the NCP made it difficult to ascertain whether Patient 47's complaint of pain to the NCP was communicated to the RN for further assessment or intervention.
Findings:
A review of Patient 47's medical record was conducted on 1/14/14 at 10:25 A.M. Patient 47 was admitted to Hospital A on 1/2/14 with diagnoses that included Enteritis (inflammation of the small intestines) and presented with lower abdominal pain per the History and Physical, dated 1/2/14.
A joint observation of Patient 47 and interview with RN 47 was conducted on 1/14/14 at 10:30 A.M. Patient 47 rested in the bed with both eyes closed. RN 47 stated Patient 47 had an IV (intravenous) for hydration, nutrition, and pain management. RN 47 further stated that Patient 47 was monitored for pain at least hourly.
A review of the hospital's policy titled Pain Management was conducted on 1/15/14 at 12:30 P.M. The policy indicated under, "E. Pain assessment is considered the "fifth" vital sign. Assessment and reassessment of pain intensity and pain relief will be performed with routine vital signs and as needed, and findings will be documented in the medical record. G.1. Scale #1- 0-10 Numeric/Simple Descriptive Pain Intensity Scale (Verbal):
? 0 = No
? 1 = Discomfort
? 2 to 3 = Mild pain, annoying
? 4 to 5 = Moderate pain, uncomfortable
? 6 to 7 = Severe Pain, distressing
? 8 to 9 = Very severe pain, dreadful
? 10 = Worst possible pain, stops functions, agonizing, unbearable
Under procedure- Nursing Units: 11. Document on the Nursing Clinical record ... Level of pain. Pain rating scale used. Pain relieving measures. Patient's reaction."
A joint observation and interview with Patient 47, the Medical-Surgical Manager (MSM), RN 45, and the Infection Control Practitioner (ICP) was conducted on 1/15/14 at 4:15 P.M. Patient 47 rested in the bed awake and visited with family members at the bedside. Patient 47 stated, "pain was currently controlled by the parenteral controlled analgesic (Patient Controlled Analgesia (PCA) -device used to administer pain medication directly through the vein), highest level of pain usually at a 4-5." RN 45 stated that the PCA pain medication was Dilaudid 2.0 milligrams (mg) with a 15 minute delay.
A joint review of the medical record with RN 45, the MSM, and the ICP was conducted on 1/15/14 at 4:30 P.M. The PCA Record dated 1/15/14 at 7:30 A.M., indicated, "Medication: Dilaudid; Infusion Mode Setting: Intermitent; Intermittant Dose Setting: 0.50, Delay: 15; Dosage Infused: 2.00; Number of Attempts: 7; Number of Injections: 4; Intensity: 4; Scale Used: Numeric.
The NCP documented that Patient 47 had reported yes for pain and rated it as a 4, whereas, the RN documented at the same time as the NCP, that Patient 47 reported no for presence of pain on 1/15/14 at 7:38 A.M. On the same day at 11:09 A.M., the RN documented no pain whereas the NCP documented yes for pain at a level of 4.
A joint interview with NCP 42, RN 45, the MSM, and the ICP was conducted on 1/15/14 at 4:40 P.M. NCP 42 stated when the vital signs were checked; she asked patients if they were in pain; if the answer was yes, she would ask what the pain level was, 0-10 and document in the computer under vital signs. When asked if she reported Patient 47's complaint of pain to the RN today, the NCP stated "No, the RN should check, it is in my vital signs." The NCP further stated if the reported pain was less than a 5 she would not inform the RN.
A joint review of the pain assessment and interview with RN 48, RN 45, the MSM, and the ICP was conducted on 1/15/14 at 4:45 P.M. RN 48 stated when a patient is on a PCA the pain assessment was conducted every hour. After review of the Care Activity which RN 48 documented that Patient 47 had no presence of pain. RN 48 stated she had not documented presence of pain on the Care Activity because the results would be documented on the PCA flow sheet. RN 48 stated that Patient 47 usually reported being comfortable; however, sometimes the patient would rate the pain at a level 4.
Both the MSM and RN 45 stated it was the expectation that the documentation be consistent throughout the medical record. Both acknowledged that the inconsistent documentation of the pain assessment made it difficult to ascertain whether the patient's pain was addressed and effectively relieved by the prescribed pain medication.

Based on interview and record review, the hospital failed to ensure that a telephone order entered into the electronic medical record for an oral nutrition supplement and the administration of water flush for 2 of 32 sampled patients (34, 13) was authenticated by a practitioner responsible for the care of the patient within 48 hours per hospital policy. According to the hospital's policy and procedure, authenticating physician's orders in a timely manner could reduce and prevent medical errors.
Findings:
1. On 1/14/14 at 10:20 A.M., Patient 34's medical record review was initiated. Patient 34 was admitted to Hospital B on 12/31/13 per the Admission/Registration form.
On 1/8/14, RD (Registered Dietician) 36 completed a nutrition assessment for Patient 34. RD 36 noted that Patient 34 was 86% of his ideal body weight and was underweight; "1/6 2.4 # [pound] loss [weight loss]."
On 1/8/14, RD 36 documented, "Nutrition Note/Recommendations: 1. Continue regular diet, 2. Trial run of Boost [an oral nutrition supplement] one can per day at breakfast x (times) 3 days ..."
On 1/8/14, RD 36 entered a telephone order for Boost every day at breakfast into the electronic medical record.
On 1/14/14 at 2:47 P.M., RN 37 reviewed Patient 34's electronic medical record. Per the audit trail, the telephone order for Boost at breakfast every day, was entered by RD 36 on 1/8/14. RN 37 said that the telephone order had not been authenticated by a physician, or practitioner responsible for the care of the patient. RN 37 reviewed the hospital's policy and said that the telephone order should have been authenticated by the physician within 48 hours.
The hospital's policy and procedure entitled Physician Orders Giving, Receiving, Authenticating (87100-041; last reviewed November 2009) indicated, "Intent: To outline the process for giving, receiving and authenticating physician orders, i.e., written, verbal and telephone, in order to reduce or prevent medical errors ..., All verbal and telephone orders will be authenticated by the prescribing physician within forty-eight (48) hours ..."






21052

2. Patient 13's medical record was reviewed on 1/15/14 at 11:35 A.M. The patient was admitted to Hospital A with diagnoses that included cerebrovascular accident (CVA - a loss of brain function due to disturbance in the blood supply to the brain) per the History and Physical, dated 1/15/14.

A review of registered dietician (RD) 11's notes, dated 1/11/14 at 3:43 P.M., indicated that water flushes of 160 ml (milliliters) was recommended for Patient 13, four times a day.

A review of the physician's telephone order, dated 1/11/14 at 6:28 P.M., indicated an order for water flushes 160 ml every 6 hours. However, the order was not authenticated until 1/15/14 at 11:58 A.M., almost 96 hours later.

A review of the hospital's policy and procedure titled "Physician Orders Giving, Receiving, Authenticating" was conducted on 1/15/14 at 4:30 P.M. The policy indicated that the intent of the policy was, "To outline the process for giving, receiving and authenticating physician orders, i.e., written, verbal and telephone, in order to reduce or prevent medical errors." The policy also indicated that, "All verbal and telephone orders will be authenticated by the prescribing physician within forty-eight (48) hours..." This policy was not followed when the telephone order, dated 1/11/14 at 6:28 P.M., for water flushes was not authenticated by the ordering physician until 1/15/14 at 11:58 A.M., almost 96 hours later.

A interview and joint document review with the Nursing Director of Telemetry (NDOT) was conducted on 1/16/14 at 4:10 P.M. The NDOT acknowledged that Physician 11 did not authenticate the telephone order for water flushes within 48 hours as indicated in the hospital's own policy and procedure.

A telephone interview with Physician 11 was conducted on 1/16/14 at 4:15 P.M. Physician 11 stated, "I would be more mindful next time."

Based on staff interview and record review, the hospital failed to ensure accurate accountability of all controlled substances when they failed to perform surveillance for timely detection and the identification of potential misuse, abuse, or theft. There was no documented evidence to demonstrate that situations were evaluated, such as a review of discrepancies, or the tracking and trending of these occurrences. The lack of accountability could potentially facilitate the misuse or abuse of controlled substances, and subsequently put patients at risk of harm by being cared for by an intoxicated person, or suffer in pain when the medications intended to treat them were diverted.

Findings:

On 1/15/14 at 11:00 A.M., the hospital's system for controlled drugs accountability was evaluated. The Director of Pharmacy (DOP) stated that pharmacy staff in conjunction with nursing managers evaluated discrepancies. Pharmacy Technician 62 (Tech 62) stated on interview that a daily report of discrepancies was generated and evaluated. Concerns were communicated to the charge nurse to see if the discrepancy could be explained or fixed. Tech 62 stated that these unresolved discrepancies fall off the report after seven days.
Tech 62 added that after several (three) notices, if the issue was not resolved, the user was deleted from the system, and can no longer access medications. She added that usually such action necessitated communication with Tech 62, for resolution of the issue if possible and for the user to be re-instated.
It was confirmed by Tech 62 and the DOP that there was no tracking or trending of these occurrences to evaluate patterns or potential misuse or abuse. The hospital did not have a system to track or trend such occurrences. The hospital was not tracking the number of times an individual was involved in discrepancies. There was also no tracking for the number of times an individual was involved in a discrepancy, that fell off the list, before it was addressed. There was no tracking of the number of incidences that an individual was involved in, a resolved or un-resolved discrepancy, or the number of times an individual user was deleted from the system. Consequently, there was no trending.

On /15/14 at 2:00 P.M., the record for Patient 66 was evaluated for controlled substance use. Patient 66 was admitted to the hospital on 1/10/14 for complaints related to pain. Patient 66 had multiple orders for pain medications, which included Meperidine (an opioid type medication used to treat moderate to severe pain.) The record from the automated dispensing cabinet (ADC - a computerized drug storage device) tracked medications removed, the strength of the medication, the amount, by whom, the date, the time, and for whom (patient name) the medication was obtained for. The ADC report showed that on 1/14/15, six- 5 milligrams (mg) syringes of meperidine were removed at the following times: 12:58 P.M., 2:59 P.M., 1:06 P.M., 1:06 P.M., 3:17 P.M., and 3:17 P.M. The same report showed that, on the same day, two- 25 mg syringes of meperidine were removed at 2:54 P.M. and 3:03 P.M.
A review of the electronic MARs (Medication Administration Records), ORM (charting for pre and post operation) and Phase I Record, which were used in the PACU (post-operative care unit) revealed documentation for four doses of the following medications that were removed:
Two, 50 mg doses were administered at 1:13 P.M. and 3:10 P.M., and two 25 mg doses were administered at 3:06 P.M. and 3:15 P.M. Review of the Phase I Record showed documentation, on 1/14/14 at 3:28 P.M., that meperidine was administered three times, but the doses were not specified. The times on the Phase I Record indicated administration of meperidine were at 3:05 P.M., 3:10 P.M., and 3:16 P.M. which duplicated the entries from the eMAR.
DOP and Tech 62 explained that 2 of the 50 syringes were dispensed from the pharmacy and restocked into the vault, that left two doses of meperidine unaccounted for.
On 1/16/14 at 4:00 P.M., the DOP was asked if random audits of controlled substances were performed to identify what was removed from the ADC to what was actually administered, he said that they did not.

Based on observation, interview, record and policy review, the hospital failed to ensure that medications were administered in a safe and effective manner as evidence by the following:
Fentanyl patch, a potent pain medication delivered through patches, applied to the skin, was used in a manner inconsistent with the manufacturer's specifications. The dose was increased too quickly, for 1 of 38 sampled patients (61). The dose was increased from 25 mcg/hour (micrograms every hour) to 37 mcg/hr within 24 hours. Patient 61 was not given enough time, as outlined in the package insert, before the dose was increased.
The hospital also failed to develop policies that were consistent for all settings to include inpatient and clinics. The hospital's policy for recalled products for hospital-based clinics included identifying and contacting patients if they receive recalled products. The same hospital policy regarding recalled products for inpatients, did not contain the same language to inform patients or their physicians when inpatients may have received a recalled product.

In addition, the hospital failed to ensure that 1 of 38 sampled patient's (11) pain medication orders contained clear instructions for when either of the oral pain medications should be administered. Patient 11 was ordered two pain medications with the same indication. The lack of clear instruction for the nurses may create inconsistent practices on which medication to give first and for what type of pain.

Findings:

1. On 1/16/14 at approximately 3:30 P.M., the record for Patient 61 was reviewed with the Pharmacist (Pharm 61). Patient 61 was admitted to Hospital A on 12/26/13, with history of post-surgical abdominal pain. The record for Patient 61 revealed a telephone order, on 12/27/13 at 6:30 P.M., for fentanyl patch (opioid type medication in a patch form, which is applied to the skin). The order was for fentanyl patch 25 micrograms per hour (mcg/hr) to be applied every 72 hours.
The fentanyl patch, also known as fentanyl transdermal system, contained fentanyl, a potent synthetic opioid medication used to treat pain. This medication had a boxed warning which was the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that could lead to serious injury or death. The boxed warning for the fentanyl patch documented that it has the potential to cause fatal respiratory depression.
The boxed warning also included that the fentanyl patch was "Indicated only for the management of persistent, moderate to severe pain that requires continuous, around the clock opiate administration for an extended period of time and that cannot be managed by other means (e.g., NSAIDs [non-steroidal anti-inflammatory drugs - a class of analgesic medication], opiate combination preparations, immediate-release opiates)."
Use only in opiate-tolerant patients who required a total daily opiate dosage equivalent to ? (greater than or equal to) 25 mcg of transdermal fentanyl per hour.
Opiate-tolerant patients were those who have been receiving ? 60 mg of oral morphine sulfate daily, ? 30 mg of oral oxycodone hydrochloride daily, ? 8 mg of oral hydromorphone hydrochloride daily, or equianalgesic dosage of another opiate for ? 1 week ...."
Patient 61's History and Physical revealed that the patient was receiving Percocet 5-325 one tablet every 4 hours. Percocet contained 5 milligrams (mg) oxycodone, an opioid type medication. Based on a concurrent record review with the DOP and Pharm 61, there was no documented evidence that Patient 61 was opiate tolerant and that the patient was receiving opioid for one week or longer, in accordance with the manufacturer's specifications. There was no evidence that she received, 30-67 mg of oxycodone for at least a week, consistent with the hospital's preprinted order form for fentanyl, dated 9/28/12.
Pharm 61 pointed out that Patient 61 was ordered Dilaudid (very potent opioid medication) 1 mg every three hours, and that she received 5 milligrams according to the fentanyl order form. Pharm 61 stated that the Dilaudid use might have been the rational used for "opioid tolerance." Dilaudid was only used for one day. It did not meet the definition of opioid tolerant per the boxed warning.

1a. On 1/16/14, further review of the record for Patient 61 with Pharm 61 revealed that on 12/28/13, at 8:50 P.M., an order to increase the fentanyl patch by 12 mcg/hr (micrograms per hour). The order to increase the patch was written only about 27 hours after the initial order. Such increase in fentanyl did not comply with the manufacturer's specifications.
According to the package insert, "If analgesia is inadequate after initial application of a transdermal system, dosage may be titrated upward after 3 days. Initial transdermal dose may be increased after 3 days based on the daily dose of supplemental opiates during the second and third day after initial application."
The increase of the dose for Patient 61 was inconsistent with the labeling instruction for the use of a fentanyl patch. The dose was increased within about 27 hours from 25 to 37. Patient 61 was not allowed 3 days from when the initial dose was administered.
There was no documented evidence that a pharmacist or pharmacists had processed these orders, had questioned them or had intervened. There was no clinical justification documented or provided during the interviews for the increase in the dose.

1b. On 1/16/14 at approximately 3:00 P.M., the record for Patient 62 was reviewed with the Director of Pharmacy (DOP). Patient 62 had a telephone order, dated 1/10/14 at 1:00 P.M., for a Fentanyl patch. The hospital had a system in place for ordering fentanyl patches. They used a Pre-Printed Physician's Order for "Fentanyl Transdermal Patch." The preprinted order, dated 9/23/12, was to be used for the initial orders for fentanyl patch. Under section 1 for using criteria, the order had instructions that "All boxes must be checked before the fentanyl patch therapy was initiated, if not patient DOES NOT qualify for fentanyl patch."
These boxes included the criteria for using fentanyl patch as outlined in the boxed warning: for persistent, moderate to severe pain, for patients that are opioid tolerant, and used for chronic pain.
The order set for Patient 62 did not have any of the three boxes checked. Pharmacy staff approved the fentanyl order and entered it into the computer system, making the medication available for access by the nursing staff. Nursing staff applied the patch even though the order was not complete.
There was no documented evidence to demonstrate that a clarification or an intervention had been made related to the order. Pharm 61 corroborated this finding, on 1/16/14 at approximately 4:00 P.M.

2. On 1/15/14 at approximately 10:00 A.M., the hospital process for handling recalled medications was evaluated. The Director of Pharmacy (DOP) explained the process and presented the hospital policy titled "Recall of Medications", revision date September 2010.
The policy included a procedure for "Hospital Based Clinics" with the following steps"
" ... patients' having received the recalled medication will be tracked and a reasonable attempt to notify the patient will be made.
The Patient's medical chart will be pulled and given to the physician for decision/plan of action.
Action will be taken as ordered by the physician ..."
The policy did not include similar procedures for inpatients. It included steps to inspect the pharmacy and other medication storage areas to locate any of the recalled medications. The policy included that the outpatient prescription files will be searched for the prior six month for specific lot numbers involved in the recall.
The policy did not include any direction or procedures to identifying inpatients that may have received recalled products. Additionally, there were no directions for contacting the prescriber or the patient in case of exposure (receiving recalled medications). This finding was corroborated by the DOP on 1/16/14 at 4:15 P.M.

On 1/21/14 at 10:00 A.M., a pharmacy technician, (Tech 62) stated on interview that the hospital followed recall notices and the steps that needed to be taken. When asked about recent recalls that the hospital had in their stock, she presented two examples: Dilantin (medication used to control seizure) and folic acid (used in treating anemia). Tech 62 stated that these recalled products were found in the hospital on inspection due to the recall notice. When asked if the number of patients that received the recalled product could be determined, she said that she could not find out. That there was no system in place to help identify patients that had received recalled medications.






21052

3. Patient 11's medical record was reviewed on 1/13/14 at 2:00 P.M. Patient 11 was admitted to Hospital B on 1/7/14 with diagnoses that included osteoarthritis (the most common joint disorder, which is due to aging and wear and tear on a joint) per the History and Physical, dated 1/8/14.

A review of the physician's order, dated 1/7/14 at 11:15 P.M., indicated an order for Patient 11 to receive Tylenol (pain medication) 650 mg (milligrams) by mouth (PO) every 4 hours as needed (PRN) for pain and headache.

A review of the physician's order, dated 1/11/14 at 5:15 P.M., indicated an order for Tramadol HCL/Ultram (pain medication) 50 mg (milligrams) PO every 4 hours PRN for pain. Both the Tylenol and the Tramadol were ordered for pain. The physician's order for both medications did not contain clear instructions for the nurses to know which medication to administer first and for what type of pain.

An interview with Registered Nurse (RN) 15 was conducted on 1/13/14 at 2:50 P.M. When asked which of the two medications to use first, RN 15 stated, depending on the severity of pain, if it was moderate to severe pain Tramadol would be use and for mild pain, Tylenol would be used. However, RN 15, acknowledged that the pain medications ordered were not clear.

An interview with Pharmacist 11 was conducted on 1/16/14 at 4:05 P.M. Pharmacist 11 acknowledged that Patient 11's pain medication orders should have clear instruction for the nurses to ensure consistent practices.

Based on observation, interview, and record review, the Director of Food and Nutrition Services (FSD) failed to ensure safe food handling and sanitary conditions were maintained at Hospital A as evidenced by: 1) Dietary staff had not followed correct cool down procedures for food that needs time and temperature control for safety (TCS food; food capable of supporting microbial growth), 2) The wash water temperature of the 3-compartment sink had not reached 110 degrees F (Fahrenheit) per hospital policy, 3) A stainless steel pan that contained raw chicken was placed directly on the floor during the thawing process, 4) A dietary employee's personal beverage was stored inside a reach-in refrigerator designated for patient food.
At Hospital B, the Dietary Management Staff (DMS), failed to ensure a thaw date monitoring system was in place to ensure that a frozen juice product was used within 10 days of thawing per manufacturer's guidelines.
Failure to ensure safe food handling and sanitation practices had the potential for risk of foodborne illness further compromising the health status of medically fragile patients.
Findings:
1. On 1/13/14 at 9:40 A.M., at Hospital A inside a walk-in refrigerator, in the kitchen, was a pan that contained cooked pork which was covered with plastic wrap and labeled "pork loin; 1/13/14 use by 1/20/14."
Cook 31 said that he cooked the pork loin to an internal temperature of 155 degree F, and then placed it in the walk-in refrigerator to cool down.
Cook 31 was asked if he had a cool down log. Cook 31 said yes, and showed a log entitled HACCP (Hazardous Analysis of Critical Control Points- guidelines to provide safe food to patients, staff, and visitors) Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods. The log contained a column that indicated, "1/13/14; Pork; 9:45 Time in Refrigerator, 60 Temp. after 2 hours." Cook 31 said that the above documentation referred to the pork that was currently in the walk-in refrigerator for cool-down. Cook 31 verified that he had placed the pork loin in the refrigerator at 9:45 A.M. on 1/13/14. When Cook 31 was asked to explain why the log indicated 60 degrees F under the column titled "Temp. after 2 hours," when he just placed the pork in the refrigerator, he had no explanation.
On 1/13/14 at 9:57 A.M., Cook 31 was asked to check the temperature of the pork loin that was in the walk-in refrigerator, and it was, "152.4 degrees F."
On 1/13/14 at 1:15 P.M., Cook 32 was now the cook on duty, and he said the pork loin was moved to the walk-in freezer at noon, 2 hours after the initial cool down period began, because the pork loin was 100 degrees F, and needed to be cooled down faster.
According to the directions located on top of the HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods, "...Take internal temperature after 2 hours and record on log. It must be at 70 degrees F. or lower."
The hospital's policy and procedure entitled Food Preparation (83400-114; last reviewed July 2013) indicated, "Food preparation in Food and Nutrition Services is carried out according to established procedures to maintain food safety and prevent contamination ..., 6. Internal temperature is to be taken of food at the end of 2 hours and recorded on the Cooling Log. The temperature must be at 70 degrees F or less at the end of the 2 hours. If it is not, the food is either discarded or reheated to 165 degrees F and the cooling process begun again."
The FSD, and the Food Service Manager (FSM) was present for the above interviews and observations with Cook 31, and Cook 32, and verified that the hospital's cool down procedures had not been followed to ensure food safety by both cooks.
The FSM verified that Cook 32 should have re-heated the pork loin to 165 degrees F, and begun the cool down process again when the pork had not cooled down to 70 degrees F or less after the initial 2 hour cool down process began.
Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009: Annex 3 - Public Health Reasons/Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling.)
According to the hospital's job description for "Cook; Job Summary: To provide quality food in a safe and sanitary environment for patients, employees, medical staff and visitors."
2. On 1/13/14 at 10:11 A.M., inside the kitchen at Hospital A, dietary employee 33 (DE 33) was using the 3-compartment sink to wash foodservice equipment. The first compartment had wash water in which foodservice equipment was submerged, the second compartment had rinse water, and the third compartment contained sanitizer.
DE 3 said that after he washed the foodservice utensils he would place them on a clean rack to air dry. DE 3 said that he kept a log for the 3-compartment sink, as he was required to check the concentration of the sanitizer.
At that time, the Director of Food and Nutrition (FSD) was asked to check the temperature of the wash water, and the thermometer indicated "103.2 degrees F (Fahrenheit)." The FSD was asked if the wash water temperature was acceptable, and she said, "Yes." The Food Service Manager (FSM) was asked if the water temperature was acceptable, and he said, "Yes, the wash water temperature is okay since there is a sanitizer."
According to the hospital's policy and procedure entitled Cleaning And Sanitation Procedures (83400-108; last reviewed July 2016) indicated, "Intent: To describe cleaning and sanitation procedures for Nutritional Services ..., D.3.1. Wash (Sink #1) - Use 1 oz. Detergent per gallon of water. A dispenser for detergent is available. Keep wash water as hot as possible, at least 110 degrees [F]."
3. On 1/13/14 at 1:14 P.M., was a large container of raw chicken that was located on the kitchen floor in very close proximity to pipes that had white and orange discoloration on them. Approximately two feet above the large container of raw chicken was a water outlet that was running water down and over the container of raw chicken, which had the potential to create splash from the surrounding environment.
The Director of Food and Nutrition (FSD) and the Food Service Manager said they were aware of the above practice and said it was okay. The FSD said, "We don't have the space to thaw the chicken anywhere else."
On 1/13/14 at 3:53 P.M., the above practice was shared with the hospital's designated infection control preventionist (ICP), and she said, "That's an infection control violation."
Per the hospital's policy and procedure entitled Food Preparation (83400-114; last reviewed July 2013) indicated, "Food Preparation in Food and Nutrition Services is carried out according to established procedures to maintain food safety and prevent contamination ..., 1. All food items, while being prepared, shall be protected against contamination from dust, flies, roaches, rodents, and other vermin; unclean utensils and work surfaces; unnecessary handling; droplet contamination; flooding, drainage, and overhead leakage; and any other source of contamination ..., ...it is the responsibility of the director to see that proper production procedures are used in handling and preparation of all products ...Avoiding Cross Contamination ...5. All sinks, utensils and equipment used in food preparation are washed, rinsed and sanitized before use ..."
According to the hospital's policy and procedure entitled Thawing of Frozen Foods (83400-080; last reviewed July 2013), "Frozen foods will be thawed in such a manner to protect their quality and minimize foodborne microorganisms from multiplying ..., Procedure B.1. There are four acceptable methods for thawing potentially hazardous frozen food., B.1.1. In a refrigerator, at 41 degree F or lower, B.1.2. Submerged under running potable water, at a temperature of 70 degrees F or lower. Water flow must be strong enough to wash loose food particles into the overflow drain, B.1.3. In a microwave oven, if the food will be cooked immediately after thawing, B.1.4. As part of the cooking process. The product must meet the required minimum internal cooking temperature ..."
4. On 1/13/14 at 10:40 A.M., inside the kitchen at Hospital A, was a reach-in refrigerator located next to a food preparation area that contained a dietary employee's personal beverage that had been opened, and had the lid on. The Director of Food and Nutrition (FSD) acknowledged the beverage belonged to a dietary employee, and said, "I know that shouldn't be there."
The Food Service Manager (FSM) said that dietary employees had their own designated refrigerator, and acknowledged it was the hospital's expectations that patient food supplies should be stored in a separate area than staffs'.
According to the hospital's policy and procedure Food Preparation (83400-114; last reviewed July 2013) indicated, "9. Chewing gum, smoking and eating are not allowed in the kitchen."
At Hospital B, inside the kitchen was a walk-in refrigerator that contained a case that was half filled with individually packaged juice (4 ounces), and on the shelf above was 4 more of the individually packaged juices.
The Dietary Management Staff (DMS) was asked how long had the juices, that came in individual 4 oz, portioned cartons from the manufacturer, been in the refrigerator? The DMS said that she was not sure because they were not dated as to when they were placed in the refrigerator, but that they were used up quickly, and were ordered weekly. The carton felt thawed when shook. The DMS said the 4 cartons on the upper shelf were probably "leftover" from a previous order.
The DMS said that the hospital received the juice product frozen, and placed the 4 oz. individual carton sized juice product directly in the walk-in refrigerator, and added, "We would keep a week to 2 weeks."
The DMS then proceeded to read the manufacturer's guidelines that were printed on each individual, 4 oz. carton that indicated, "Keep frozen, thaw, refrigerate and use within 10 days."
The DMS acknowledged that the foodservice operation lacked a thaw date monitoring system to ensure that a frozen juice product was used within 10 days of thawing per manufacturer's guidelines.
The hospital's policy and procedure entitled Food Labeling And Dating (83400-113; last reviewed July 2013) indicated, "All stored food will be labeled with the date of shelf life expiration."

Based on observation, interview, and record review, the hospital failed to ensure that 2 of 2 cooks interviewed were competent in regard to hospital procedures to cool down food that needs time and temperature control for safety (TCS food; food capable of supporting microbial growth).
Failure to ensure safe food handling had the potential for risk of foodborne illness further compromising the health status of medically fragile patients.
Findings:
On 1/13/14 at 9:40 A.M., at Hospital A inside a walk-in refrigerator, in the kitchen, was a pan that contained cooked pork which was covered with plastic wrap and labeled "pork loin; 1/13/14 use by 1/20/14."
Cook 31 said that he cooked the pork loin to an internal temperature of 155 degree F (Fahrenheit), and then placed it in the walk-in refrigerator to cool down.
Cook 31 was asked if he had a cool down log. Cook 31 said yes, and showed a log entitled HACCP (Hazardous Analysis of Critical Control Points- guidelines to provide safe food to patients, staff, and visitors) Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods. The log contained a column that indicated, "1/13/14; Pork; 9:45 Time in Refrigerator, 60 Temp. after 2 hours." Cook 31 said that the above documentation referred to the pork that was currently in the walk-in refrigerator for cool-down. Cook 31 verified that he had placed the pork loin in the refrigerator at 9:45 A.M. on 1/13/14. When Cook 31 was asked to explain why the log indicated 60 degrees F under the column titled "Temp. after 2 hours.", when he just placed the pork in the refrigerator, he had no explanation.
On 1/13/14 at 9:57 A.M., Cook 31 was asked to check the temperature of the pork loin that was in the walk-in refrigerator, and it was, "152.4 degrees F."
On 1/13/14 at 1:15 P.M., Cook 32 was now the cook on duty, and he said the pork loin was moved to the walk-in freezer at noon, 2 hours after the initial cool down period began, because the pork loin was 100 degrees F, and needed to be cooled down faster.
According to the directions located on top of the HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods, " ...Take internal temperature after 2 hours and record on log. It must be at 70 degrees F. or lower."
The hospital's policy and procedure entitled Food Preparation (83400-114; last reviewed July 2013) indicated, "Food preparation in Food and Nutrition Services is carried out according to established procedures to maintain food safety and prevent contamination ..., 6. Internal temperature is to be taken of food at the end of 2 hours and recorded on the Cooling Log. The temperature must be at 70 degrees F or less at the end of the 2 hours. If it is not, the food is either discarded or reheated to 165 degrees F and the cooling process begun again."
The FSD, and the Food Service Manager (FSM) was present for the above interviews and observations with Cook 31, and Cook 32, and verified that the hospital's cool down procedures had not been followed to ensure food safety by both cooks.
The FSM verified that Cook 32 should have re-heated the pork loin to 165 degrees F, and begun the cool down process again when the pork had not cooled down to 70 degrees F or less after the initial 2 hour cool down process began.
Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling.)
On 1/13/14 at 1:25 P.M., the FSD stated that it was the FSM responsibility to provide oversight of the cool down procedures and training of the cooks.
At that time, the FSM was asked how he provided oversight over the cool down procedures and the cool down performance of the cooks to ensure food safety, and that hospital procedures are adhered to. The FSM stated that he reviews the cool down logs, and that he had provided training via an in-service to the cooks on cool down on 9/18/12.
The HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods that the cooks used to document the cool down procedures was reviewed with the FSM. The log required the cooks to record the initial time the cool down began, and required the cooks to check the temperature two hours later to ensure the TCS food had reached at least 70 degrees F or less. The cool down log had not required the cooks to document the time that they actually took the temperature of the TCS food, which should have been two hours later.
The FSM was asked how he ensured that the procedures were being followed when he reviewed the cool down logs, to ensure the cooks were actually checking the temperature two hours later, versus waiting until 2 ? hours later, or three hours later, or filled out in advance just to have the form filled out. The FSM acknowledged that reviewing the log would not have enabled the food service department to have identified the unsafe food handling practices of Cook 31 and Cook 32 that was identified during the survey. The FSD was present for the interview and confirmed that they were unaware that Cook 31 or Cook 32 had not followed the cool down policy and procedures, until the observation during the survey. Cook 31 said he worked at the hospital at least 10 years. Review of the HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods indicated that there were 42 logged entries on the cool down log in the past 6 months.
The FSM said the cooks have received training on proper cool down procedures. The FSM provided the attendance signature page and curriculum used, in which Cook 31 and Cook 32 had signed, completed on 9/18/12. One of the questions posed as part of the curriculum was, "How long should it take to cool chili from 135 degrees F to 41 degrees F?", and Cook 31 wrote "6 hours."
The FSM was asked to review the above question, and was asked, if further details were provided in regard to the hospital's procedures for cool-down to capture all the steps. The FSM said that he also used the HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods during that same in-service.
On 1/13/14 at 1:30 P.M., Cook 31's personnel file was reviewed. The personnel file had not contained a specific skills competency checklist relevant to the cook's position and job duties. At that time, the FSM verified that there was not a skills specific competency checklist reflecting that the cook was able to demonstrate in some manner that he was competent on carrying out the hospital's cool down policy and procedures. The FSM said he relied on the performance appraisal process, and in-servicing education that was provided, as well as oversight over the cool down logs. The FSM reviewed Cook 31's performance appraisal and confirmed that an issue of non-compliance in following the hospital's policy and procedure on cool down procedures had not been identified.
According to the job description for the position of "Director Of Food And Nutrition; Job Summary; Oversees the food safety ... of the Food and Nutrition Services Department..., Participates in the development and enforcement of policies and procedures that direct...food preparation...staff education and development."

Based on interview and record review, the hospital failed to ensure that a therapeutic diet order, pre-renal dialysis diet, was prescribed to 1 of 32 sampled patients (81) by the practitioner responsible for the care of the patient.
Failure to clarify physician orders for a therapeutic diet had the potential to provide a therapeutic diet not intended by the physician which may impact a patient's medical status.
Findings:
On 1/16/14 at 10:15 A.M., Patient 81's medical record was reviewed. Patient 81 was admitted to Hospital A on 1/12/14 per the Facesheet.
On 1/12/14, the physician ordered an "American Diabetic Association (ADA- a diet for patients with abnormal blood glucose levels), Renal (kidney) Specific Diet" in the electronic medical record.
On 1/16/14 at 10:20 A.M., the Director of Food and Nutrition (FSD) was asked how the hospital implemented a "renal specific diet." The FSD said that a renal specific diet was not a diet order recognized by the hospital in accordance with the hospital's diet manual. The FSD said that the renal specific diet order was an incomplete order, and that the physician should have specified the parameters of the diet, such as but not limited to, a protein restriction, if any, or how much potassium or sodium the physician wanted the patient to receive. The FSD demonstrated in the electronic medical record the screen that would have required the physician to enter a complete diet order, which was left blank.
The FSD was asked how the food and nutrition department addressed a non-complete diet order for a "renal specific diet." The FSD said that the hospital wide approved diet manual contained a renal pre-dialysis diet, and a renal post-dialysis diet. The FSD said the diet clerk would call the nurse on the unit and ask if the patient was receiving dialysis or not, and then would implement either a renal pre-dialysis diet, or a post-dialysis diet accordingly because "there is not a renal specific diet."
On 1/16/14 at 3:15 P.M., the FSD verified that the food and nutrition department would independently change the diet order from a renal specific diet, to a pre-dialysis or post-dialysis diet after the diet clerk called the nurse to ask if the patient was receiving dialysis, or not. The FSD said, "I didn't realize it was a problem. Well, we have to feed the patient." The FSD said that she had not communicated the practice to leadership staff in order to get the problem resolved because she did not realize it was a problem.
On 1/16/14 at 3:23 P.M., the diet clerk (DC 82) was asked what the food and nutrition department would do if they received a renal specific diet order for a patient. DC 82 said, "I will call the nurse and ask if the patient was pre-dialysis, and then I would put the pre-renal dialysis diet directly into Computrition (a foodservice software system used by the food and nutrition department to provide guidance to dietary staff on what food items to place on the patient's meal tray)."
DC 82 reviewed Computrition and verified that a pre-dialysis, ADA diet was provided to Patient 82 on 1/12/14 and 1/13/14. DC 82 said that she would approximate that she would receive about 15 diet orders as "renal specific", in which she would need to call the nursing staff and ask if the patient was pre-dialysis or not, and then she would immediately enter either a pre-dialysis diet, or post-dialysis diet into computrition to implement the meal process for the patient.
During the same medical record review on 1/16/14 at 10:20 A.M., the FSD and hospital staff 83 (HS 83) verified that the physician's order on 1/12/14 was for an "American Diabetic Association (ADA), Renal Specific Diet", and remained the same diet order for 1/13/14. The FSD verified that the food and nutrition department provided a pre-renal dialysis diet to Patient 81, and had not clarified the physician's order to ensure the hospital provided a therapeutic diet as ordered, and intended, by the physician responsible for the care of the patient, during those two days.
According to the hospital's policy and procedure entitled Diet Orders (83400-012; last reviewed July 2013), "Intent: To serve the patient/resident the proper diet prescription. All patients are required to have a physician written diet order, which follow guidelines of the Clinical Diet Manual ..., Meals are not sent to a patient/resident unless a diet order is given ..., Diets shall be in accordance with the hospital approved Diet Manual."

Based on interview and record review, Hospital B failed to document that nutritional supplements was provided to 2 of 32 sampled patients (34, 12) as ordered by the practitioner responsible for the care of the patient.
In addition, Hospital B failed to ensure that nutrition care plans were detailed to reflect specific nutrition interventions that were planned for patients to address an identified nutritional concern in accordance with hospital policy, for 2 of 32 sampled patients (34, 35). Lack of specific individualized nutrition care plans created a barrier to the multidisciplinary healthcare team responsible for monitoring the dietary and nutritional intake status of patients.
Furthermore, Hospital A and Hospital B failed to ensure that the patient menus for regular and therapeutic diets had a comprehensive nutrient analysis in accordance with the Recommended Dietary Allowances or the Dietary Reference Intake to ensure patients nutritional needs were met.
Failure to give patients ordered diets, nutritional supplements, and nutritionally adequate patient menus could negatively impact the nutritional status of medically fragile patients.

Findings:

1. On 1/14/14 at 10:20 A.M., Patient 34's medical record review was initiated. Patient 34 was admitted to Hospital B on 12/31/13 per the Facesheet.
On 1/8/14, RD (Registered Dietician) 36 completed a nutrition assessment for Patient 34. RD 36 noted that Patient 34 was 86% of his ideal body weight, was underweight; "1/6 2.4 # [pound] loss [weight loss]."
On 1/8/14, RD 36 documented, "Nutrition Note/Recommendations: 1. Continue regular diet, 2. Trial run of Boost [an oral nutrition supplement] one can per day at breakfast x 3 days ..."
On 1/8/14, RD 36 entered the order for Boost every day at breakfast as a telephone order per physician's orders.
On 1/13/14, RD 36 documented, "Nutrition Note F/up [follow-up]: ...Pt [patient] drinks the Boost intermittently. Sometimes pt saves the Boost for later in the day. Will continue to send Boost for now ..."
On 1/14/14 at 10:43 A.M., RN 38 was caring for Patient 34 at that time. RN 38 was asked to show the documentation that the order for Boost at breakfast was implemented. RN 38 said that the Boost was not specifically documented but that it was included in the documentation of overall percentage of the meal consumed. RN 39 verified that he also would document the Boost on the overall Percent Meal Consumed, a section of the electronic medical record.
On 1/14/14 at 2:47 P.M., RN 37 reviewed Patient 34's medical record and verified that there was no documentation in the electronic medical record (EMR) or the paper medical record that Boost, specifically, had been provided to Patient 34 since ordered on 1/8/14.
During the same interview, RD 36 was asked how she obtained information in regards to the quantity consumed of a planned nutrition intervention, and she said, "I ask the patient or the nurse." RD 36 acknowledged that she had followed up on Patient 34, five days later after the Boost was ordered, and asking if the patient took the Boost would not provide meaningful data collection for a comprehensive nutrition assessment, as compared to assessed nutritional needs without knowing how often, and how much of the Boost was consumed.
On 1/14/14 at 3:54 P.M., RN 39 acknowledged that there was not a standardized system for hospital staff to know where to document an ordered nutrition supplement.
Health care team members were not completing documentation of a patient's nutritional intake from all nutritional sources which was a barrier to nutritional assessment, and monitoring effectiveness of the planned nutrition intervention that was to address an identified nutrition concern, to ensure the patient's nutritional needs were met.
On 1/14/14 at 10:20 A.M., Patient 34's medical record was reviewed. RD 36 reviewed Patient 34's EMR and said that she could not find documentation that an interdisciplinary nutrition care plan had been developed for Patient 34.
On 1/14/14 at 2:47 P.M., RN 37 reviewed Patient 34's medical record. RN 37 said that the interdisciplinary care plans on the 3rd floor were developed on paper and should be located in the paper medical record on the nursing unit. At the same time, RD 36 acknowledged that she had not reviewed the interdisciplinary nutrition care plans in the paper medical record before.
On 1/14/14 at 3:47 P.M., the charge nurse (RN 40) was able to locate the interdisciplinary nutrition care plan (INCP) in the paper medical record. The INCP indicated under short term goal "maintain meal intake of 100% q [every] meal and fluid intake 2000 cc daily", and long term goal was "Monitor food and fluid intake, weigh weekly." The specific nutrition intervention ordered to address the "underweight" status per RD 36 was not included on the nutrition care plan (Boost at breakfast).
Lack of specific, individualized nutrition care plans were a barrier to the multidisciplinary healthcare team responsible for monitoring the dietary and nutritional intake status of patients.
On 1/14/14 at 3:54 P.M., in a joint interview with RN 39, FSD, and RD 36. RN 39 said that dietary or nursing was able to develop an interdisciplinary nutrition care plan. At that time, the FSD said, "We haven't been trained on that."
On 1/21/14 at 1:35 P.M., RN 39 confirmed it was the hospital's expectations that the interdisciplinary team member who initiated the nutrition intervention should have updated and revised the nutrition care plan to reflect the specific planned nutrition interventions that the hospital was providing.
The hospital's policy and procedure entitled Plan Of Care, Interdisciplinary (87200-405; last reviewed April 2012) indicated, "Intent: To define the process of assessing, developing, implementing and evaluating the patient's interdisciplinary plan(s) of care (POC, Care Plan, Interdisciplinary Treatment Plan) in order to coordinate care ..., A. Inpatients will have a POC (via electronic medical record [EMR] or hardcopy) developed that includes assessment based on comprehensive patient needs, treatments and goals..., E. The POC will be reviewed and/or updated every shift based on the RN's comprehensive assessment of the patient's condition, as pertinent information is obtain, prn as needs change and per patient encounter by the interdisciplinary team ..., G. Whenever a need is identified/resolved, the health care team member who identified the problem/resolution of the problem will document it on the POC ..., I 1.2 Professionals contributing to the overall POC for a patient include: ...clinical dietitians ..."
2. On 1/14/14 at 10:11 A.M., Patient 35's medical record review was initiated. Patient 35 was admitted to Hospital B on 1/11/14 per the Admission/Registration form.
On 1/11/14 during the initial (admission) nursing assessment, the nurse put "yes" next to a nutrition trigger entitled "Dx [diagnosis] of Malnutrition/Dehydration", and ordered a nutritional consult.
On 1/13/14, RD (Registered Dietician) 36 documented, "Nutrition Note: Consult received for evaluation proper caloric intake. Pt is severely underweight with BMI [body mass index] 16.0 and 70% ideal body weight ...sending double portions and HS [bedtime] snack to aid in wt [weight] gain."
RD 36 reviewed Patient 35's medical record and said that an interdisciplinary nutrition care plan in the electronic medical record was not developed. When RD 36 was asked how she could review the documentation in the medical record to determine how often, and how much the patient was consuming the HS snack, she said she would just have to ask the patient or nursing staff.
On 1/14/14 at 3:20 P.M., RN 37 reviewed Patient 35's electronic medical record and verified that an interdisciplinary nutrition care plan had not been developed electronically. RN 37 said that the interdisciplinary nutrition care plans are located in the paper medical record on the nursing unit.
On 1/14/14 at 3:47 P.M., the charge nurse (RN 40) reviewed Patient 35's paper medical record, and said, "There is not an interdisciplinary nutrition care plan developed."
On 1/14/14 at 3:54 P.M., in a joint interview with RN 39, FSD, and RD 36. RN 39 said that dietary or nursing was able to develop an interdisciplinary nutrition care plan. At that time, the FSD said, "We haven't been trained on that."
On 1/21/14 at 1:35 P.M., RN 39 confirmed it was the hospital's expectations that the interdisciplinary team member that initiated the nutrition intervention should have updated and revised the nutrition care plan to reflect the specific planned nutrition interventions that the hospital was providing.
The hospital's policy and procedure entitled Plan Of Care, Interdisciplinary (87200-405; last reviewed April 2012) indicated, "Intent: To define the process of assessing, developing, implementing and evaluating the patient's interdisciplinary plan(s) of care (POC, Care Plan, Interdisciplinary Treatment Plan) in order to coordinate care ..., A. Inpatients will have a POC (via electronic medical record [EMR] or hardcopy) developed that includes assessment based on comprehensive patient needs, treatments and goals..., E. The POC will be reviewed and/or updated every shift based on the RN's comprehensive assessment of the patient's condition, as pertinent information is obtain, prn as needs change and per patient encounter by the interdisciplinary team ..., G. Whenever a need is identified/resolved, the health care team member who identified the problem/resolution of the problem will document it on the POC ..., I 1.2 Professionals contributing to the overall POC for a patient include: ...clinical dietitians ..."
3. On 1/14/14 at 9:46 A.M., the FSD presented the nutrient analysis that had been conducted for the patient's menus. The Registered Dietician (RD) acknowledged that the nutrient analysis was not a comprehensive nutrient analysis for the patients' planned menu for the regular or therapeutic diets in accordance with the recommended dietary allowances (RDA) or the Dietary Reference Intake (DRI) of the Food and Nutrition Board of the National Research Council.
According to the hospital's policy and procedure entitled Diet Manual (83400-055 Diet Manual; last reviewed July 2013), "The diet manual used is the most current edition of Clinical Diet Manual by FNMS (Food and Nutrition Management Services, Inc.) The manual states the dietary deficiencies of any diet. The current Dietary Reference Intakes are used as a guideline." Section T: Appendix of the hospital's diet manual contained the RDAs, DRIs, and AIs (Adequate Intakes) that is nationally available from the Food and Nutrition Board, Institute of Medicine, National Academies. The above policy also indicated, "5. The diet manual serves as the guide for ordering diets, and menus are consistent with the requirements in the manual."
During the same interview with the FSD, and in the presence of RD 36, the FSD said that "corporate" had completed the limited nutrient analysis of the patient menus, and confirmed, the nutrient analysis was not comprehensive in accordance with recognized dietary practices.
According to the hospital's job description for Director of Food and Nutrition (Formulated: 12/3/09), "Oversees the food safety and nutritional care aspects of the Food and Nutrition Services Department to ensure full compliance with federal, state and other regulatory agencies..."



















21052

4. A closed record review of Patient 12's medical record was conducted on 1/14/14 at 2:50 P.M. Patient 12 was admitted to Hospital B on 1/9/14 with diagnoses that included malnutrition per the History and Physical, dated 1/10/14.

A review of registered dietician (RD) 12's notes, dated 1/10/14 at 3:04 P.M., indicated that Patient 12 stated that she had lost 50 lbs (pounds) but was not able to verbalize the time period of the weight loss. The notes also indicated that the patient had an albumin (the most abundant protein in human blood plasma) of 2.8 (reference range of 3.4 - 5.0 g/dL [grams per deciliters]). Per the same notes, RD 12 encouraged the patient to drink Boost supplement for good nutrition.

A review of the physician's order, dated 1/10/14 at 6:18 P.M., indicated that an order was written for Patient 12 to receive Boost supplement three times a day with meals. However, there was no documented evidence that Patient 12 was provided the Boost supplement from the time the supplement was ordered, on 1/10/14, until the time of the patient's discharge, on 1/13/14.

An interview with registered nurse (RN) 12 was conducted on 1/14/14 at 3:00 P.M. RN 12 stated that there was no assigned area in the electronic medical record where nurses should document nutritional supplements that were administered to the patients. RN 12 stated that the supplement could be documented on the intake and output (I&O) record or in the nurse's narrative notes.

A joint record review and interview with RN 14, a charge nurse, was conducted on 1/14/14 at 3:10 P.M. After reviewing Patient 12's I&O record, nurse's narrative notes, and medication administration record, RN 14 acknowledged that there were no documented evidence that Patient 12 was provided the ordered nutritional supplement from the time it was ordered until the patient's discharge.

An interview with RD 12 was conducted on 1/14/14 at 4:00 P.M. RD 12 acknowledged that due to the lack of documentation regarding the ordered nutritional supplement, it was difficult to determine whether Patient 12 received the supplements or if they were refused by the patient. RD 12 stated that it was important to know whether the patient was receiving the nutritional supplement because the patient was nutritionally challenged.

Based on observation and interview, the hospital failed to ensure that battery operated lighting units were installed in 2 of 2 labor and delivery (L&D) operating rooms (OR's) to ensure uninterrupted lighting during surgical procedures in the event of a power loss and a delay in the initiation of generator power.
Findings:
A tour of the two L&D operating rooms was conducted on 1/15/14 at 10:00 A.M., there were no battery operated lighting units observed in either of the two OR's. Functioning flashlights were observed in each of the L&D OR's.
An interview with an L&D Registered Nurse (RN 21) was conducted on 1/15/14 at 10:15 A.M. She stated that the L&D OR's depended on flashlights in the event of a power loss. She further acknowledged that the L&D OR's did not have battery operated lighting units installed.

Based on observations, staff interviews, policy and procedure (P&P) and document review, the facility failed to maintain an active infection control program for the minimization of infections and communicable diseases in accordance with nationally accepted infection control guidelines as evidenced by failure to ensure:

1. Endoscopes were cleaned and processed according to manufacturer's instructions (A Tag 749 #1)

2. Re-usable surgical instruments were sterilized in accordance with accepted infection control guidelines (A Tag 749 #2)

3. The temperature of the sterile supply room(s) was maintained in accordance with nationally accepted infection control guidelines (A Tag 749 #3)

4.Sterile supplies were maintained in accordance with event-related sterility standards (A Tag 749 #4)

5. A qualified infection control officer developed and implemented policies governing the control of infectious and communicable diseases (A Tag 748)

The cumulative effects of these systemic problems resulted in the facility's inability to comply with the statutorily-mandated Condition for Participation for Infection Control.

Based on observations, staff interviews, policy and procedure (P&P) and document review, the facility failed to maintain an active infection control program for the minimization of infections and communicable diseases in accordance with nationally accepted infection control guideline as evidenced by failure to ensure that a qualified infection control officer developed and implemented policies governing the control of infectious and communicable diseases.

On 1/14/14 at 1:52 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 940 and A Tag 748. The Administrator, the Chief Nursing Officer, the Chief Financial Officer, and the Chief Compliance Officer from corporate were present. The Immediate Jeopardy was abated on 1/16/14 at 4:00 P.M. after an acceptable corrective action plan was implemented.

Findings:

During an interview on 1/13/14 at 1:30 P.M., the infection control practitioner (ICP) revealed her duties were mainly targeted at the reportable diseases. The ICP could not verbalize a substantial facility-wide Infection Control program. The ICP could not verbalize the goals and objectives of the infection control program as written in the hospital's infection control program plan.

During an interview on 1/14/14 at 12:30 P.M., the ICP stated that, she would not answer the surveyor's questions regarding her ability to cover all the areas and duties required by CMS (Centers for Medicare and Medicaid Services). The ICP indicated that she would discuss that with her management at another time.

A review of the CMS conditions of participation requirements for infection control was conducted with the ICP on 1/14/14 at 12:35 P.M. In a concurrent interview the ICP, she was surprised when she read over the expectations from CMS for an Infection Control Program. The ICP indicated she was not aware of the vast number of ICP requirements, and therefore, thought the hospital's program, which focused on reporting mandated reportable diseases, was adequate.

On 1/16/14 at 1:30 P.M, during the Infection Control and Performance Improvement Committee meeting, the ICP stated, that she did not reach the goals set for the year, "I did not make rounds of the Sterile Processing monthly." A concurrent review of record "Infection Control Goals for 2013" was conducted. On this document, Item #9 designated the ICP to conduct Surveillance of cleaning and sterilization of equipment used in radiology, Operating Room and all Sterile Procedures. The document called for monthly unannounced visits. The ICP and the operating room director (ORD) both admitted they did not have written documentation of surveillance of any kind related to Infection Control.

In a review of personnel records conducted on 1/16/14 at 4:00 P.M., the ICP employment record revealed that the ICP came to this position from a staff position. Her professional background and work history did not include Infection Control experience.

Based on observation, interviews, and record reviews, the hospital failed to ensure that infection control practices were maintained regarding single-dose and multi-dose medication vial administration, the storage of bi-level positive airway pressure machine (BiPap-a breathing apparatus that helps its user get more air into the lungs) masks, the application of personal protective equipment (PPE - protective barriers from splashes or sprays of blood, body fluids, secretions and excretions such as gloves, gown, mask and face shield), and the storage of staff liquids with patient edible items. Bipap masks were not stored in a sanitary manner, for 2 of 32 sampled patients (44, 45). On two separate occasions, observations were made and Respiratory Therapists (RTs) were not wearing a gown when they provided direct patient care (such as the connection of an in-line suctioning device, respiratory suctioning of the breathing tube, oral care, listening to breath sounds and the repositioning of the patient), for 1 of 32 sampled patients (1), who had a known infection. In addition, endoscopes were not cleaned and processed according to manufacturer's instructions. Re-usable surgical instruments were not sterilized in accordance with accepted infection control guidelines. The temperature of the sterile supply room(s) were not maintained in accordance with nationally accepted infection control guidelines. Sterile supplies were not maintained in accordance with event-related sterility standards.

Failure to maintain infection control practices could potentially lead to the transmission of infections and the increase incidence of hospital acquired infections throughout the entire hospital.
The hospital also failed to ensure that the multi-dose medication vial policy and procedure provided guidance to staff regarding infection control practices in an effort to avoid contamination and potential spread of infection.
In addition, the hospital's Infection Control Program failed to ensure that the Food and Nutrition Department was sufficiently integrated into the Infection Control Program as evidenced by: (Cross Reference A-0620); time/temperature control of foods capable of supporting bacterial growth were not handled in accordance with food safety, a container of raw chicken was placed directly on the floor in close proximity to pipes with white and orange discoloration while water ran over the chicken from above, during a thawing process. In addition, patient food was co-mingled with staff food in refrigerators at Hospital B, and at Hospital A near the nursing units.

Findings:

1. An observation was conducted on 1/13/14 at 10:45 A.M. with operating room technician (ORT) 1 responsible for the Endoscope reprocessing. ORT 1 demonstrated the process he used to reprocess an Endoscope after and before the next patient. ORT 1 was observed to forget or skip three important steps in cleaning and disinfection of the endoscope. ORT 1 failed to: 1) process the scope with sterile water per the manufacturers instructions 2) use forced air in drying the scope to prepare for storage 3) process with 70% alcohol to aid in the drying of the scope.

During an concurrent interview on 1/13/14 at 10:50 A.M., the surveyor asked ORT 1 if he had missed any steps. ORT 1 responded, "No." In response to the question, "Do you have written policy and procedures you follow?", ORT 1 responded, "No." That was the way he did it every day.

During a subsequent observation on 1/14/14 at 7:30 A.M., ORT 1 failed to use enough force when forcing air and/or detergent cleaning to create a flow of detergent through the tube and out the distal end.

During an observation on 1/14/14 at 7:40 A.M., ORT 1 failed to use 70% alcohol to aid in the drying of the scope to prevent bacteria growth.

During an interview on 1/14/14 at 7:45 A.M., the surveyor inquired if the air/detergent pushed in should be visualized flowing out the distal end? ORT 1 responded, "oh yes! I need a 'buddy' (A motorized device that forces the detergent and air through the channels)." He gave a bigger push on the plunger and looked down and said, " See! Now you can see it."

During a interview on 1/14/14 at 7:50 A.M., in response to the question asked by the surveyor, "Do you use alcohol in your processing of the scope, ORT 1 responded, "Yes, at the end of the cases." Surveyor clarified, "At the end of cases? Not, between patients when cleaning for next patient?" ORT 1 responded, "Yes, at the end of the day when all cases are done." In response to the surveyors' question when was your last training regarding your duties with the endoscope? ORT 1 responded, "Since this company took over we do not get training."

A record review on 1/16/14 at 10:00 A.M. was conducted. The review of ORT 1's employment file did not reveal any continuing education documentation.

A review of the written manual endoscope processing instructions from Olympus, the manufacturer of the hospital's endoscopes was conducted on 1/16/14 at 10:00 P.M. Under the instructions on page 4 of the fax under the heading "Rinse the endoscopes and accessories", the following information was provided. "Flushing the interior and recessed parts of the endoscope and accessories with alcohol facilitates drying. Olympus recommends the use of alcohol." The manual also indicated that the endoscopes should be dried with compressed air after flushing them with alcohol.

2. During an observation on 1/13/14 at 2:35 P.M., a sterile tray with a variety of instruments labeled "plastics" was opened at the Surveyors request. The packet revealed a variety of instruments piled on top of each other with the addition of a peel pack of 16 tightly packed surgical instruments placed on top of 2 loose surgical instruments. Placed in a small tray, a stringer (a long metal type rod made to hold surgical instruments open for sterilization) was loaded with a row of instruments that had ratchets unlocked with tips touching with blades closed.

During an interview on 1/13/14 at 2:40 P.M., Tech 1 verified that was the usual manner in which the instruments were placed to be sterilized. Tech 2 nodded in agreement. In a concurrent interview, both Tech 1 and 2 indicated that they were not aware of the proper placement of the instruments. Both Tech 1 and 2 indicated that they were appropriately placing the instruments when the handles were unlocked but the tips were closed. Neither Tech 1 or 2 could verbalize why they positioned the instruments with the instrument tips and blades closed. "We have been packing this way for years. Never been told it is wrong", said Tech 1.

An interview on 1/13/14 with Tech 1 and 2 indicated that they did not know where to find policy and procedures related to storage of "Event related Sterile Supplies and Surgical Instruments".

An interview on 1/13/14 at 10:30 A.M., both the infection control practitioner (ICP) and the operating room director (ORD) could not determine if the facility adopted National Recognized Standards (NRS) to ensure sterility of Surgical Instruments in Accordance with State Regulations. Neither the ICP or the ORD could find policy and procedures related to Event related Sterility.

3. An observation on 1/13/14 at 10:00 A.M. revealed a Sterile Surgical Instrument storage room to be at 78 degrees. During a concurrent interview with Tech 1 revealed this was an event that happened often. Tech 1 and Tech 2 did not verbalize the effect the event could have on the Sterile Supplies or Surgical Instruments. In addition, when asked, Tech 1 and 2 indicated that they did not know where to find policy and procedures related to storage of Event related Sterile Supplies and Surgical Instruments.

4. An observation, on 1/14/14 at 10:30 A.M., of sterile instruments in the Operating Room (OR) hallway storage area revealed event related sterility of instruments. Peel packs were observed to have dates as far back as March 1998 and were found to be labeled "Sterilized". The packs had signs of wear including curled corners, brown spots on the backside, yellow discoloration and tape wrapped around the Instrument handle. A concurrent interview with the operating room director (ORD) revealed that she was not aware of Policy and Procedures for Event related Sterility.

An observation on 1/13/14 at 2:30 P.M. revealed a clear plastic tub approximately 2 feet by 3 feet packed with Sterile Surgery Instruments marked with sterile unless opened or damaged before use. The instruments were all packed in peel packs. One third (1/3) of instruments visual defects including faded yellow covered backs, spotted backs, curled edges and crushed packs. The sterile dates were dated as far back as 1998. These Sterile Surgery Instruments were located in the sterile supply room just beyond the sterile processing.

A concurrent interview on 1/13/14 at 2:30 P.M. was conducted with Tech 1 and Tech 2. Tech 1 and Tech 2 acknowledged that the packs were compromised. Tech 1 and Tech 2 revealed neither of them could identify the policy and procedures that should apply to the storage of sterile supplies or instruments.

During an interview on 1/15/14 at 1:30 P.M., Tech 1 and Tech 2 could not verbalize a policy and procedure related to taped wrapped sterile instruments nor any additional action to be taken with taped wrapped instruments to ensure sterility.

On 1/15/2014 at 10:30 A.M., both the infection control practitioner (ICP) and the ORD could not verbalize a process for the Governing board to review Event Related Sterility policy and procedures. Both the ICP and the ORD could not determine if the facility adopted National Recognized Standards (NRS) to ensure sterility of Surgical Instruments in accordance with State Regulations. The ORD stated, "I always try to put references on my 'Surgical' Policy and Procedures."




.








26660

5. During a tour of the post anesthesia care unit (PACU) on 1/13/14 at 10:00 A.M., an interview was conducted with the PACU charge registered nurse (RN 22). He stated that if a patient required medication from a multi-dose vial such as insulin (a medication to treat high blood sugar levels), he would bring the multi-dose vial to the patient bedside to be scanned into the computer and then the vial would be returned to the medication storage area to be used for multiple patients.
An interview was conducted with the Chief Nursing Officer (CNO) on 11/15/14 at 1:25 P.M. She stated that there was no other policies regarding multi-dose vial medications that gave direction to staff regarding infection control practices in the administration of multi-dose vial medications.
An interview was conducted with the infection control practitioner (ICP) on 11/15/14 at 2:30 P.M. She stated that the hospital followed CDC's infection control practice guidelines for multi-dose vial administration. She acknowledged that CDC's guidelines state that if multi-dose vials are used for multiple patients that the vial should not be kept or accessed in the immediate patient treatment area to avoid contamination.
6. During a tour of the outpatient clinic on 1/15/14 at 10:45 A.M., five medication vials were observed in the medication storage cabinet to be opened and dated. Three sensorcaine (local anesthetic) vials .5% 10 ml (milliliters) were observed with a written date of 1/10/14 as the opening date with an expiration date of 8/16 (2016).
One lidocaine (local anesthetic) HCL 2% 5 ml vial had a written date of 1/10/14 as the opening date and an expiration date of 6/16 (2016). The 3 sensorcaine and 1 lidocaine vials all had "single dose" printed on their labels. One betamethasone (steroid medication) 30 mg (milligrams)/5 ml had a written opened date of 1/10/14 and an expiration date of 2/2014. The betamethasone vial had a printed label that read "multi-dose".
An interview with the licensed vocational nurse (LVN 21) was conducted on 1/15/14 at 10:45 A.M. She stated that the single dose vials that were observed to be opened and dated were being used for multiple patients. She also stated that the multi-dose vial could be used for 30 days from the dated that it was opened.
A review of the hospital's policy titled "Expiration Dates of Medications", dated March 2012, was conducted on 1/15/14 at 1:00 P.M. The policy indicated that single dose vials expiration date was as labeled; after syringe transfer for immediate patient use, discard remainder. The remaining contents of an unused medication will be disposed of using proper disposal procedures; disposal of controlled substances that are discarded must be observed and so documented by a second licensed person. The policy further indicated that multi-dose medication vials could be used for 28 days from the date and time opened. The policy did not provide guidance to staff regarding infection control practices in the administration of multi-dose vials.
An interview was conducted with the Chief Nursing Officer (CNO) on 11/15/14 at 1:25 P.M. She stated that there was no other policies regarding multi-dose vial medications that gave direction regarding infection control practices in the administration of multi-dose vials medications.
An interview was conducted with the infection control practitioner on 11/15/14 at 2:30 P.M. She stated that single dose vials should not be used for multiple patients. She further stated that a multi-dose vial should be used within 28 days from the date and time of opening as stated in the hospital policy. She stated that the hospital followed CDC's infection control practice guidelines for multi-dose vial administration. She acknowledged that CDC's guidelines state that if multi-dose vials are used for multiple patients that the vial should not be kept or accessed in the immediate patient treatment area to avoid contamination.


25321

7a. A review of Patient 44's medical record was conducted on 1/13/14 at 3:25 P.M. Patient 44 was admitted to Hospital A on 1/4/14 and discharged from the hospital on 1/8/14 per the Facesheet.
A joint tour of the Behavioral Health's opened unit at Hospital A with the Nursing Director of Telemetry (NDOT) and Registered Nurse (RN 41) was conducted on 1/13/14 at 3:30 P.M. During a tour inside of the exam room, a BiPap machine was observed near the entrance door. A clear plastic mask attached to a hose was stored across the top of the machine uncovered.
On 1/13/14 at 3:35 P.M., RN 41 stated there were no patients in the unit who was currently prescribed to use the BiPap machine. RN 41 further stated the mask should be stored in a plastic bag since it was not in use.
A joint review of the physician order and interview with RN 43 was conducted on 1/14/14 at 10:10 A.M. The physician order dated 1/8/14 at 3:35 P.M. for BiPap initiation and management indicated, "order cancelled by patient discharge." RN 43 stated the BiPap machine was maintained by the Respiratory department. RN 43 stated the BiPap machine had been used by Patient 44, who had been discharged on 1/8/14. RN 43 stated the BiPap mask should have been stored in a plastic bag when not in use. RN 43 further stated the BiPap machine should have been returned to the Respiratory department upon Patient 44's discharge.
A joint observation and interview with Respiratory Therapist (RT) 41 was conducted on 1/15/14 at 11:55 A.M. RT 41 stated the normal practice was to place the mask inside the holster (a device on the left side of the machine to hold the mask) when the BiPap machine was not in use. RT 41 further stated when the BiPap machine was discontinued it would be sanitized then sent or taken back to the Respiratory department for cleaning and storage.
An interview with the Infection Control Practitioner (ICP) was conducted on 1/15/14 at 2:40 P.M. The ICP stated it was an expectation that respiratory equipment such as masks would be stored in a plastic bag when not in use. This would prevent the potential spread of infection.
An interview and joint review of the Hospital's BiPap policy with the Respiratory Care Manager (RCM) was conducted on 1/16/14 at 11:15 A.M. The RCM stated when the BiPap machine was not in use the mask could be stored in either the holster or in a plastic bag. After review of the BiPap policy, the RCM stated that the policy did not mention storage of the mask when the machine was not in use. The RCM acknowledged that the uncovered mask was considered an infection control concern.
7b. A review of Patient 45's medical record was conducted on 1/15/14 at 11:40 A.M. Patient 45 was admitted to Hospital A on 1/13/14 "in distress secondary shortness of breath, currently on BiPap" per the History and Physical, dated 1/13/14.
A joint observation and interview with Patient 45, the Nursing Director of Telemetry (NDOT), the Medical Surgical Manager (MSM), and RN 45 was conducted on 1/15/14 at 11:45 A.M. Patient 45 rested in the bed, wore a nasal cannula (plastic tubing with prongs in the nose) with oxygen administered at 2 liters (lt). Patient 45 stated was "doing better and planned on being discharged home either today or tomorrow." Next to the bed, a BiPap machine was stored against the wall. A clear plastic mask attached to the hose was stored across the top of the machine uncovered. RN 45 stated, the mask should have been stored in a plastic bag since it was not currently used.
A joint observation and interview with Respiratory Therapist (RT) 41 was conducted on 1/15/14 at 11:55 A.M. RT 41 stated the normal practice was to place the mask inside the holster (a device on the left side of the machine to hold the mask) when the BiPap machine was not in use. RT 41 further stated Patient 45 was not currently using the BiPap and switched to the nasal cannula on the night shift. RT 41 confirmed that the BiPap mask was stored across the top of the machine uncovered.
An interview with the Infection Control Practitioner (ICP) was conducted on 1/15/14 at 2:40 P.M. The ICP stated it was an expectation that respiratory equipment such as masks would be stored in a plastic bag when not in use. This would prevent the potential spread of infection.
An interview and joint review of the Hospital's BiPap policy with the Respiratory Care Manager (RCM) was conducted on 1/16/14 at 11:15 A.M. The RCM stated when the BiPap machine was not in use the mask could be stored in either the holster or in a plastic bag. After review of the BiPap policy, the RCM stated that the policy did not mention storage of the mask when the machine was not in use. The RCM acknowledged that the uncovered mask was considered an infection control concern.
8. A joint tour of the Behavioral Health Unit locked unit at Hospital A with the Nursing Director of Telemetry (NDOT) and RN 42 was conducted on 1/14/14 at 9:00 A.M. A patient refrigerator was observed inside the medication room. There were numerous sandwiches, milk, juice, applesauce, and a few items labeled with various patient names inside the refrigerator. Stored on the door of the patient's refrigerator was an unlabeled plastic bottle filled with a clear liquid. RN 42 stated that she believed "the water bottle belonged to the medication nurse and it's not supposed to be in the patient's refrigerator."
The medication nurse was unavailable for an interview due to the administration of scheduled medications and behavioral outbursts of numerous patients.
An interview with the Chief Nursing Officer (CNO) was conducted on 1/21/14 at 2:20 P.M. The CNO stated staff have their own designated refrigerators and should not store their personal food items or beverages inside the patient's refrigerator. The CNO confirmed that commingling of patient's edible items and staff edible items was not the proper practice of the hospital.








22930

9a. On 1/14/14 beginning at 9:45 A.M., RT 1 was observed in Patient 1's room with a mask and gloves while he provided direct patient care. Registered Nurse (RN) 2 instructed RT 1 to wear a gown when in Patient 1's room. An orange sign was posted outside of Patient 1's room by the door. It read "Droplet Precautions" and below that in parenthesis it instructed staff to use the droplet precautions in addition to standard universal precautions.

According to the hospital's policy entitled "Isolation, Care of Patient", dated 7/2012, the policy indicated that "When isolation is initiated without a physician's order, the attending physician is notified." Per the same policy, it stipulated that "The reason for the isolation is explained to the patient. Any restrictions are explained to the patient and visitors."

Per the hospital's policy entitled "Isolation Precautions", dated 6/2012, standard precautions combined the features of universal precautions and body substance isolation. Standard precautions applied to all patients regardless of their diagnosis or suspected infection status. Standard precautions also applied to the following: blood; all body fluids; secretions and excretions; nonintact skin; and mucous membranes. Per the same policy, gowns were to be worn when performing procedures that may be likely to generate splashes or sprays of blood, body fluids, secretions or excretions, in an effort to protect the skin and to prevent the soiling of clothing.

An interview with the hospital's Infection Control Preventionist (ICP) was conducted on 1/14/14 at 9:55 A.M. The ICP stated that staff were expected to wear protective personal equipment such as a gown if there was a potential for splashing or possible contact with infectious organisms, in an effort to prevent the transmission of infection in the hospital.

A review of Patient 1's medical record was conducted on 1/14/14 beginning at 10:20 A.M. Patient 1 was admitted to Hospital A on 1/12/14 with diagnoses that included pneumonia (lung inflammation caused by a bacterial or viral infection) and hypoxia (a deficiency in the amount of oxygen that reaches the tissues) per the Facesheet. According to Physician's Progress Note, dated 1/15/14, Patient 1 had Influenza A (a highly contagious viral infection of the respiratory passages) and acute hypoxemic respiratory failure requiring medical treatment to include respiratory support and the administration of an antiviral drug, antibiotics and diuretic medications (used to increase the passing of urine).

An interview with RT 1 was conducted on 1/15/14 at 1:30 P.M. RT 1 recalled caring for Patient 1 on 1/14/14 in the A.M. He stated that he was the back-up RT and was assisting Patient 1's primary RT with checking that the patient's respiratory devices and supplies were in place after Patient 1 was intubated (a tube inserted through the mouth into the trachea, to provide an airway). He stated that he was prompted by RN 2 to wear a gown when in Patient 1's room. He stated that when patients were on "droplet precautions", all staff wear, at a minimum, a mask and gloves after handwashing and before entering the patient's room. He acknowledged that if staff anticipated possible contact with bodily fluids, they were required to wear a gown in an effort to protect themselves and not spread any infectious organisms that they may have come in contact with while providing direct patient care.

A review of the hospital's policy entitled "Isolation Precautions", dated 6/2012, was conducted on 1/16/14. The policy indicated that there were standard precautions which was designed for the care of all patients in hospitals regardless of their diagnosis or presumed infection status. Per the same policy, it stipulated that transmission-based precautions were designed for patients documented or suspected to be infected or colonized with highly transmissible or epidemiologically (the study of patterns, causes, and effects of health and disease conditions) important pathogens (microorganisms) for which additional precautions beyond standard precautions were needed to interrupt transmission in hospitals.

An interview with the Intensive Care Unit Director (ICUD) was conducted on 1/16/14 at 10:45 A.M. The ICUD stated his expectation of all staff, who cared for patients in the ICU, were to follow the instructions listed on the isolation precaution signs and if the staff were to anticipate contact with bodily fluids or secretions to use the appropriate PPE such as a gown when providing direct patient care. He acknowledged that RT 1 should have been wearing a yellow gown when performing direct patient care to Patient 1.

An interview and joint policy review was conducted with the Respiratory Care Manager (RCM) on 1/21/14 at 9:14 A.M. The RCM acknowledged that the hospital's policy was not followed when standard precautions were not implemented in conjunction with transmission-based precautions by RT 1, when he provided direct patient care to Patient 1, who had a known infection.

9b. On 1/16/14 beginning at 10:22 A.M., an observation of Patient 1 was made. RN 3 and Respiratory Therapist 2 were seen providing the following direct patient care to Patient 1: respiratory suctioning, linen change, repositioning and listening to breath sounds. RT 2 was not wearing a gown when he performed these direct patient care tasks. An orange sign was posted outside of Patient 1's room by the door. It read "Droplet Precautions" and below that in parenthesis it instructed staff to use the droplet precautions in addition to standard universal precautions.

Per the hospital's policy entitled "Isolation Precautions", dated 6/2012, standard precautions combined the features of universal precautions and body substance isolation. Standard precautions applied to all patients regardless of their diagnosis or suspected infection status. Standard precautions also applied to the following: blood; all body fluids; secretions and excretions; nonintact skin; and mucous membranes. Per the same policy, gowns were to be worn when performing procedures that may be likely to generate splashes or sprays of blood, body fluids, secretions or excretions, in an effort to protect the skin and to prevent the soiling of clothing.

A review of Patient 1's medical record was conducted on 1/14/14 beginning at 10:20 A.M. Patient 1 was admitted to Hospital A on 1/12/14 with diagnoses that included pneumonia (lung inflammation caused by a bacterial or viral infection) and hypoxia (a deficiency in the amount of oxygen that reaches the tissues) per the Facesheet. According to Physician's Progress Note, dated 1/15/14, Patient 1 had Influenza A (a highly contagious viral infection of the respiratory passages) and acute hypoxemic respiratory failure requiring medical treatment to include respiratory support and the administration of an antiviral drug, antibiotics and diuretic medications (used to increase the passing of urine).

An interview with RT 2 was conducted on 1/16/14 at 10:38 A.M. RT 2 stated that he was in Patient 1's room performing direct patient care such as respiratory suctioning, listening to breath sounds, assisted with repositioning the patient and the handling of soiled linens. He confirmed that he was not wearing a gown while he performed the above tasks. He acknowledged that because there was a potential for coming in contact with infectious organisms while he provided direct patient care to Patient 1, he should have worn a gown to prevent the possible transmission of infection in the hospital.

A review of the hospital's policy entitled "Isolation Precautions", dated 6/2012, was conducted on 1/16/14. The policy indicated that there were standard precautions which was designed for the care of all patients in hospitals regardless of their diagnosis or presumed infection status. Per the same policy, it stipulated that transmission-based precautions were designed for patients documented or suspected to be infected or colonized with highly transmissible or epidemiologically (the study of patterns, causes, and effects of health and disease conditions) important pathogens (microorganisms) for which additional precautions beyond standard precautions were needed to interrupt transmission in hospitals.

An interview with the Intensive Care Unit Director (ICUD) was conducted on 1/16/14 at 10:45 A.M. The ICUD stated his expectation of all staff, who cared for patients in the ICU, were to follow the instructions listed on the isolation precaution signs and if the staff were to anticipate contact with bodily fluids or secretions to use the appropriate PPE such as a gown when providing direct patient care. He acknowledged that RT 2 should have been wearing a yellow gown when performing direct patient care to Patient 1.

An interview and joint policy review was conducted with the Respiratory Care Manager (RCM) on 1/21/14 at 9:14 A.M. The RCM acknowledged that the hospital's policy was not followed when standard precautions were not implemented in conjunction with transmission-based precautions by RT 2, when he provided direct patient care to Patient 1, who had a known infection.





27157

10. On 1/13/14 at 9:40 A.M., at Hospital A inside a walk-in refrigerator, in the kitchen, was a pan that contained cooked pork which was covered with plastic wrap and labeled "pork loin; 1/13/14 use by 1/20/14."
Cook 31 said that he cooked the pork loin to an internal temperature of 155 degree F (Fahrenheit), and then placed it in the walk-in refrigerator to cool down.
Cook 31 was asked if he had a cool down log. Cook 31 said yes, and showed a log entitled HACCP (Hazardous Analysis of Critical Control Points- guidelines to provide safe food to patients, staff, and visitors) Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods. The log contained a column that indicated, "1/13/14; Pork; 9:45 Time in Refrigerator, 60 Temp. after 2 hours." Cook 31 said that the above documentation referred to the pork that was currently in the walk-in refrigerator for cool-down. Cook 31 verified that he had placed the pork loin in the refrigerator at 9:45 A.M. on 1/13/14. When Cook 31 was asked to explain why the log indicated 60 degrees F under the column titled "Temp. after 2 hours.", when he just placed the pork in the refrigerator, he had no explanation.
On 1/13/14 at 9:57 A.M., Cook 31 was asked to check the temperature of the pork loin that was in the walk-in refrigerator, and it was, "152.4 degrees F."
On 1/13/14 at 1:15 P.M., Cook 32 was now the cook on duty, and he said the pork loin was moved to the walk-in freezer at noon, 2 hours after the initial cool down period began, because the pork loin was 100 degrees F, and needed to be cooled down faster.
According to the directions located on top of the HACCP Daily Temperature Log - For Cooling Cooked Potentially Hazardous Foods, "...Take internal temperature after 2 hours and record on log. It must be at 70 degrees F. or lower."
The hospital's policy and procedure entitled Food Preparation (83400-114; last reviewed July 2013) indicated, "Food preparation in Food and Nutrition Services is carried out according to established procedures to maintain food safety and prevent contamination ..., 6. Internal temperature is to be taken of food at the end of 2 hours and recorded on the Cooling Log. The temperature must be at 70 degrees F or less at the end of the 2 hours. If it is not, the food is either discarded or reheated to 165 degrees F and the cooling process begun again."
The FSD, and the Food Service Manager (FSM) was present for the above interviews and observations with Cook 31, and Cook 32, and verified that the hospital's cool down procedures had not been followed to ensure food safety by both cooks.
The FSM verified that Cook 32 should have re-heated the pork loin to 165 degrees F, and begun the cool down process again when the pork had not cooled down to 70 degrees F or less after the initial 2 hour cool down process began.
Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 3, Food 3-501.14 Cooling.)
According to the hospital's job description for "Cook; Job Summary: To provide quality food in a safe and sanitary environment for patients, employees, medical staff and visitors."
In addition, on 1/13/14 at 1:14 P.M., there was a large container of raw chicken that was located on the kitchen floor, in very close proximity to pipes that had white and orange discoloration on them. Approximately two feet above the large container of raw chicken was a water outlet that was running water down and over

Based on observation, interview and document review, the hospital failed to ensure that surgical services were provided in a safe setting when operating room (OR) staff did not implement the hospital's policy and procedure regarding the sterilization and storage of surgical instruments, and the cleaning and disinfection of endoscopes. Failure to ensure that surgical instruments were sterilized and stored appropriately, and the cleaning and disinfection of endoscopes was in accordance with its policies and procedures led to a potential risk of infection for all patients undergoing procedures.

On 1/14/14 at 1:52 P.M., a situation of Immediate Jeopardy was determined to be present due to the findings outlined in A Tag 940 and A Tag 748. The Administrator, the Chief Nursing Officer, the Chief Financial Officer, and the Chief Compliance Officer from corporate were present. The Immediate Jeopardy was abated on 1/16/14 at 4:00 P.M. after an acceptable corrective action plan was implemented.

Findings:

During a tour of the surgical department OR area on 1/13/14 at 8:30 A.M., the emergency crash cart was opened and observed to contain 4 peel packs (sterilization packaging) containing sterilized surgical instruments. Peel pack's 1-3, each contained scissors in the closed position with tape on the handles. Peel pack 4 had (1) forceps in the closed position. The peel packs had backing paper that appeared discolored and stained. Peel pack 1 had a sterilization date of 3/25/1998 and peel pack 3 had a sterilization date of 6/1/1998. Peel pack 4 had a sterilization date of 3/15/2004. The sterilization date for peel pack 2 was not observed.

A review of the hospital's policy entitled "Shelf Life of Processed Instruments and Outdated Supplies" was conducted on 1/13/14 at 2:00 P.M. The policy indicated that steamed items will be wrapped in double layer paper that has been approved by infection control. Per the same policy, it stipulated that "These items have event related sterility. This means they do not expire unless package yellow, torn or question of package integrity."

An interview with the OR Director was conducted on 1/13/14 at 8:35 A.M. She stated that the hospital used event related sterilization practices. She stated that if the packaging that contained a sterilized instrument that was observed to be compromised, such as torn or damaged, that the instrument should be re-sterilized. She did not provide an explanation as to why the instruments in the crash carts that had discolored packaging, had not been re-sterilized.

On 1/13/14 at 2:30 P.M., the sterile storage area was toured. In the sterile storage area, the temperature in the room was very warm. An interview with sterile processing technician (SPD) 1 was conducted on 1/13/14 at 2:35 P.M. She stated that that there was no thermometer in the room to monitor temperature or humidity. She stated that the room overheating had been an ongoing issue.

The sterile processing area was toured on 1/13/14 at 2:45 P.M. and observed to have a temperature of 78 degrees F (Fahrenheit). SPD technicians 1, 2 and 3, all acknowledged that the temperature was too warm in the processing room. They stated that in the past when they called plant services with this high temperature issue in the processing room, it took time to correct the issue. Surgeries were cancelled that day as a result of the high temperatures in the sterile storage areas.

A review of the hospital's policy entitled "Sterile Storage SPD" was conducted on 1/13/14 at 3:00 P.M. The policy indicated that "the sterile storage area shall have a well controlled temperature range with relative humidity regulated."

A tour of a small adjacent room in the sterile processing area was conducted on 1/13/14 at 3:10 P.M. A plastic tub 2 ? by 2 feet in size was observed with sterilized instruments in peel packs all stacked horizontally and some with apparent crushed packaging. The tips of instruments were noted to be in the closed position and some instruments had tape on them. The backing of the peel packs was noted to have discoloration with what appeared to be water spots. The SPD technicians 1, 2 and 3, all stated that this was how they stored their instruments that had been sterilized.

A sterilized plastic surgery tray was observed to be opened on 1/13/14 at approximately 3:15 P.M. A stringer (metal stand for instrument storage within the sterilization tray) was observed with multiple surgical instruments on it that had the tips closed. SPD Technicians 1, 2 and 3, all stated that the stringer used was the only size that they had and that was what the hospital provided. The SPD staff were not aware that the closed tip was not ensuring adequate sterilization. A peel pack was observed with 16 surgical instruments all stacked on top of each other within the pack. The SPD staff were not aware that this was not an acceptable practice per the hospital's policy. Two loose scissors were observed in the tray underneath the peel packs on the bottom of the tray. The staff stated this was the only sized tray they had available and that was why it was packed that way.

A review of the hospital's policy entitled "Sterilization and Disinfection, SPD" was conducted on 1/13/14 at 4:00 P.M. The policy indicated that all items to be sterilized shall be arranged so all surfaces shall be directly exposed to the sterilizing agent for the prescribed time and temperature. All jointed instruments are opened and/or unlocked. When utensils are nested in one package they shall be separated by an absorbent towel or other most absorbent material.

An interview with the OR Director was conducted on 1/16/14 at 9:15 A.M. She stated that she was responsible for Hospital A's OR department and a "sister hospital's" (another hospital under the same corporate ownership) OR department. She stated that she visited Hospital A's OR department approximately 2 to 3 times a week. She stated she did not use a formal checklist or a formal observation tool, to validate staff knowledge or how they processed instruments. She stated that she had observed the sterilization process but not the whole process from beginning to end. She stated that all staff had observed the stacking of instruments in trays and acknowledged that some may have needed to be pulled for re-sterilization but it had not been a "bone of contention" so no action was taken.

An interview with the infection control practitioner (ICP) was conducted on 1/15/14 at 11:25 A.M. She stated the hospital does not use tape on the surgical instruments. She acknowledged that the hospital did not have a policy that specified that tape would not be used on surgical instruments or that it must be removed prior to the sterilization process. She further stated that she did not have direct oversight of the sterile processing technicians' duties, as that role was performed by the OR Director.


The hospital's failure to ensure that surgical instruments were sterilized and stored, and the cleaning and disinfection of endoscopes was in accordance with its policies and procedures led to a potential risk of infection for all patients undergoing procedures.

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Surgical Services and failure to provide care to their patients in a safe environment.