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Based on observations, staff and patient interviews and record reviews, the hospital's governing body failed to meet the condition of participation because of the lack of oversight of the functions of the hospital as demonstrated by the failure to meet the following conditions of participation cited:

1. An organized nursing service that will ensure the provision of adequate supervision and education of the nursing staff in the delivery of safe patient care. Refer to A0385.

2. That the pharmaceutical service that will ensure the safe preparation, distribution, storage and administration of drugs and updated competencies of all pharmacy staff . Refer to A0490.

3. That the dietary services will ensure safe handling of potentially hazardous foods, responsible daily management of the dietary services, a comprehensive therapeutic diet manual, menus for all physician ordered diets, that all physician ordered diets were followed, development of improvement activities and maintenance of dietetic service equipment. Refer to A0618.

Based on interview and record review the hospital failed to obtain one (Patient 7) of 68 patients the consent for treatment in the emergency room at the soonest possible time. This failure had the potential that Patient 7's right of informed consent was not observed.

Findings:

By observation and interview on 4/4/12 at 3 p.m., Patient 7 was alert and verbally responded to questions appropriately.

On 4/4/12 at 3:30 p.m., review of Patient 7's Emergency Department (ED) showed that there was no consent for treatment in the chart. The Assistant Nurse Manager ED said the registration computer was not working and the consent would be retrieved later. According to the computerized ED record, Patient 7 arrived in the ED on 4/3/12 at 2:20 p.m. Several tests such as lab works, chest x-ray and a CT scan of the abdomen were done on Patient 7 between 4/3/12 at 5:22 p.m. till 4/4/12 at 2:33 a.m.
On a follow-up record review on 4/5/2012, the Consent for Treatment/Conditions of Admission in the ED was dated and signed by Patient 7, on 4/4/12 at 5:02 p.m. 24 hours after Patient 7 was admitted to the emergency room.

On 4/9/12, review of the policy and procedure entitled, "Consent Informed," revised 9/07, showed that the "Registration Clerk" was responsible for obtaining and witnessing the signature of Patient 7 on the consent at the " earliest possible opportunity. "

Based on observation, staff interview and record review, the facility failed to:
1. Provide inservice for the maternal-child staff members about the visitor badge in use. The staff members did not know that the visitor badge would have red stripes appear after 24 hours of issue and considered expired. This failure could have potentially resulted in the the staff members' inability to quickly recognize expired badges worn by visitors in the maternal-child nursing unit.

2. Follow the manufacturer's instructions to test all infant security tags monthly. This failure potentially compromised the identification of any malfunctioned infant security tag.

3. Follow manufacturer's instructions to test the infant security system monthly for approximately six months after purchase. This failure potentially compromised the integrity and effectivity of the infant security system.

4. Ensure that three (Employee 1, 3, & 4) out of 11 personnel were offered Hepatitis B vaccination. This failure did not ensure the protection of direct care employees against the transmission of bloodborne diseases.

5. Ensure that two (Employee 2 and 3)of two employees that had positive PPD (tuberculin skin test) had chest x-rays taken yearly. This failure compromised the early identification and treatment of TB infection to prevent transmission.

6. Follow the Policy of Performance Appraisal to conduct a yearly performance appraisal from the date of hire for one (Employee 5) out of 11 employee files reviewed. This failure could have potentially compromised the identification of areas to be improved on a staff member's performance related to patient care.

Findings:

1. On 4/4/12 at 5:26 p.m., during an observation with VPQA at K-Building, a main entrance to the hospital, the security guard registered and issued badges to visitors. During an interview, Security Staff 1 said, the visitors are instructed to return the badges after each visit to the security desk.

In a staff interview on 4/5/12 at 2:25 p.m., under the presence of VPQA, ACS, NMMCH and CMCH, DSP said visitor badges are used to identify registered and patient approved visitors. Patients could have preferred visitors that would be listed and given to security. Security would use the list and issue visitors badges based on the patient's preferences. DSP said the visitor badges were self-expired badges and would show red stripes after 24 hours.

On 4/5/12 at 3:23 p.m., VPQA presented an expired badge sample with red stripes and handwritten date 4/5/12 on it.

Interviews with four (UC 1, RN 13, RN 14 and RN 15) out of four staff members in the maternal-child health unit (labor and delivery, post-partum, and nursery) from 4/6/12 at 10:10 a.m. to 10:32 a.m. revealed that not one among the four staff members knew that the red stripes on the visitors' badges would mean that the badges are expired and no longer valid. The staff members said they did not know and did not receive any inservice about the visitors' badge.

On 4/9/12 at 10:28 a.m., VPQA said there was no inservice done to the hospital employees about self-expired visitor badge.

2. Review of the infant security sytem's manufacturer instructions with DSP, a staff member on 4/6/12 at 11:22 a.m., showed that, "all infant security tags in inventory should be tested monthly by taking them into the Tag Exciter field of coverage and observing that the door locks... " as procedure." DSP said the new infant security system was started on 10/2011. DSP said that as 4/6/12 the hospital has not done a monthly test on all security tags since the date of purchase on 10/2011. DSP said, the security tags would be checked.

3. Review of the manufacturer's instruction on infant security system on 4/6/12 at 11:22 a.m. showed that the Code Pink System, (a system activated during a threat to infant security such as abduction) must be tested monthly. The hospital started the current infant security system on 10/2011. During a staff interview on 4/6/12 at 11:22 a.m., DSP showed that the system testing was not done till 3/2012.

In a staff interview and review of the facility's Code Pink System Test on 4/6/12 at 1:54 p.m., , DSP confirmed that 10/2011 and 3/2012, the hospital did not perform a monthly test of the infant security system.

According to the manufacturer's instruction, the Code Pink System Test incldufrom DSP, dated 4/2/12, the checked items included "tag detected in field-warning tone initiated; magnetic lock engaged upon warning; warning timed out setting off Code Pink; external sounder activates; door remains locked during alarm..." for three stairwells and elevator lobby on maternal child floor.

4. In a personnel file review, Employee 1 and Employee 3 did not have evidence that Hepatitis B vaccine was offered to or declined by the employee. During an interview on 4/9/12 at 12:57 p.m., EHN said Employee 1 and Employee 3 would be contacted to be offered about Hepatitis B vaccine.

In a staff interview on 4/9/12 at 1:05 p.m. and 2:03 p.m., review of Employee 3's personnel file with EHN showed that there was no missing data regarding Hep B offering or declination. EHN said the related manager would contact Employee 3 for Hepatitis B offering or declination. EHN confirmed that there was no result of chest x-ray after Employee 3 reported positive PPD (Tuberculosis skin test) on 3/19/10.

During a staff interview on 4/9/12 at 2:10 p.m., review of Employee 4's personnel file with EHN showed that there was no information about Hepatitis B offering or declination. EHN said she notified the related manager to follow up with Employee 4 for Hepatitis B offering or declination.

On 4/9/12 at 4:10 p.m., VPQA said it was the facility's practice to offer Hepatitis B vaccination or obtain declination from employees.

According to Healthcare Personnel Vaccination Recommendations (technical content reviewed by the Centers for Disease Control and Prevention, February, 2012) under www.immunize.org/catg.d/p2017.pdf, Health care personnel who performed tasks that might involve exposure to blood or body fluids should receive a 3-dose series of Hepatitis B vaccine at 0-, 1-, and 6-month intervals.

5. In a personnel file review and staff interview on 4/9/12 2:03 p.m., EHN confirmed that Employee 3 had a positive PPD (Tuberculosis skin test) on 3/19/10, and there was chest x-ray done to detect any active tuberculosis disease.

According to the Centers for Disease Control and Prevention's Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, healthcare workers with a baseline positive or newly positive TST (tuberculin skin test) or BAMT (blood assay for Mycobacterium tuberculosis) result should receive one chest radiograph to exclude a diagnosis of TB disease (or interpretable copy within a reasonable time frame, such as 6 months).

6. Review of a personnel file showed that Employee 5 did not have an annual performance evaluation. According to the files, Employee 5 was hired on 12/6/2010. During an interview 4/9/12 at 11:52 a.m., DHR confirmed a missing annual performance evaluation.

According to the Human Resource Policy of Performance Appraisal, reviewed: 8/02, the performance appraisal would take place between the employee and the employee's immediate supervisor. The Department Manager should be responsible for ensuring that performance appraisals on all employees took place at least annually.

Based on administrative and dietary staff interview and dietary department document review, the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services which resulted in failure to identify issues in safe food handling practices, food storage and sanitation all of which could result in food borne illness. Additionally departmental staff failed to recognize inadequacies in services that could lead to unmet patient nutritional needs.

Findings:

1. During an interview on 4/15/12 at 9:30 a.m., Infection Control Staff (ICS) 10 and 11 revealed that the hospital conducts the environment of care rounds (EOC) twice a year with five members and a department manager. The EOC members observe food production tasks, handwashing practices and review if refrigerator temperatures were taken. ICS 10 and 11 stated that EOC relied heavily on the department manager to identify specific issues surrounding food production systems. The surveyor requested ICS 10 and 11 to provide the previous EOC rounds for the dietary department..

ON 4/9/12 at approximately 10 a.m., the hospital staff were unable to locate any completed EOC rounds, but handwritten notes taken by one of the EOC participants.

Review of a hospital document title "Summary of Dietary Rounds" conducted on "11/16/12" (wrong year) showed that the EOC rounds identified that there were no temperature checks of the trayline and that the thermometers used to test hot food temperatures were inaccurate. As of 4/9/12, fthere was no indiucation that the food service department implemented corrective action to comprehensively monitor food temperatires and provide accurate thermometers. The identified problems identified five months ago were not acted upon.

2. Review of the standardized rounds that included safety, EVS, engineering, administration and infection control revealed that while the EOC rounds has some pertinent elements such as ensuring refrigerator logs were completed, food temperatures were checked, evidence of staff in-service, general cleanliness and prevention of contaminiation, there was no comprehensive evaluation of food safety systems of the department within the EOC rounds.

3.. . In an interview on 4/6/12 beginning at 2:10 pm, with the hospitals' quality assurance team they were asked to describe how the hospital ensured tha performance improvement activities reflected the depth and scope of departmental functions. They stated that RN's have access to nutrition assessment completed by the RD. The QA committee also identified that there were gaps within the electronic medical record, in particular variations to the level of access for different staff members and effectiveness of communications between disciplines. The QA committee also stated that they would rely on the outcome of infection control and environment of care rounds and that there was a quarterly evaluation of performance activities by the Food Services Director (FSD).

In an interview with the FSD on 4/9/12 beginning at 10 am, and concurrent review of performance indicators beginning in 2009 revealed that the dietary department was submitting data on 1) nutrition screening and assessment; 2) timeliness of nutrition follow up; 3) development of nutrition care plans; 4) MD response to recommendations; 4) menu auditing and 5) timely response to nutrition referrals. With respect to food service the department was monitoring compliance with 1) sanitation, 2) tray accuracy; 3) portion control; 4) skin lesions and 4) hand washing. The FSD acknowledged that with the majority of these indicators the department was meeting or exceeding the departmental set thresholds. She also stated that within the last several years the department had not identified new issues that may warrant a performance improvement study. It was also noted that while the department was monitoring some food services performance indicators, there was no evaluation of safe food handling systems within the department.

Review of hospital document titled "Performance Improvement Plan 2011" dated 8/10/11 revealed that the purpose of the plan was to "continually measure, assess and improve the processes and outcomes related to those important services that we provide." The policy also noted that the hospitals' Board of Trustees delegated the responsibility of implementing an organization wide performance improvement program to Administration, the Medical Staff and the Quality Council. There was no indication that these departments identified that the information submitted by Food and Nutrition Services did not systematically identify opportunities for improvement, rather reflected monitoring of elements that demonstrated a satisfactory levels of performance

Based on observations, staff and patient interviews and record review, the hospital failed to ensure an organized nursing service that will provide adequate supervision of the nursing staff in the delivery of patient care for 10 ( Patients 1,7,10,20,22,23,40,41,60 and 61) out of 68 patients in the survey sample. The hospital also failed to ensure patient safety when nursing service failed to educate the nursing staff on the use of the visitors' badge utilized as part of the security plan of the hospital.

Findings:

1. The nursing staff failed to provide complete pain assessments, reassessments, follow physician's medication, treatment and cardiac monitoring orders for nine ( Patients 7,10,20,22,23,40,41,60 and 61) of 68 patients in the survey sample. Refer to A 395.

2. The nursing staff failed to develop and keep current the care plan for four (Patients 1/7/10 and 61) of 68 patients in the survey sample. Refer to A 396.

3. The nursing service failed to ensure that the nursing staff specifically in the maternal and child health unit received education that the security service of the hospital used a self-expiring visitors' badge as a safety measure. Refer to A 117.

4. The nursing staff failed to administer one of the three doses of Toradol ( an injectable pain medication) specifically ordered by the physician for one (Patient 61) of 68 patients in the survey sample. Refer to A 144.

The cumulative effects of these systemic problems resulted in the inability of hospital's nursing services to provide and deliver patient care with adequate supervision and evaluation in accordance with the Condition of Participation for Nursing Service.

Based on observation, interview and record review, the hospital failed to ensure that 10 of 68 sampled patients (Patients 10, 7, 20, 22, 23, 40, 41, 60, 61, and 62) were provided nursing services that were supervised and evaluated to ensure appropriate care for each patient.

For Patient 10, there was an incomplete nursing admission assessment, a lack of reassessment and no evidence of intervention attempts when Patient 10 refused to eat and take oral medications and when he steadily lost weight--11 pounds in 10 days. This failure resulted in a delay in identification and treatment of problems for Patient 10.

For Patient 7, there was no initial admission assessment of a skin ulceration and a large protruding pendulous, abdominal hernia. The staff failed to notify the the wound nurse regarding the skin ulceration as specified in the hospital's policy and procedure. This failure had the potential to delay comfort measures and treatment.

For Patient 4, there was an incomplete nursing admission assessment of pain and inconsistent reassessments which resulted in inadequate pain control.

For Patient 40, the nurses failed to follow the physician's orders for continuous telemetry monitoring. The nurses were unaware that the hospital updated telemetry system could provide continuos off the ward telemetry monitoring for Patient 40. These failures could have placed Patient 40 and other patients at risk for undetected and delayed treatment of potential life threatening abnormal heart rhythm.

For Patient 20, the nurses didn't follow the physician's order for monitoring of vital signs when the patient was on intravenous Patient Controlled Analgesia which had the potential for unrecognized side effects of controlled drugs such as respiratory depression.

For Patient 22, physician orders for incentive spirometry and sequential compression stockings were not followed which had the potential for post surgical complications of pneumonia and blood clots in the legs.

For Patient 23 a physician's order to be out of bed walking was not followed because the nurse thought the patient was on bedrest which had the potential for post surgical complications. Also for Patient 23 there was an hour delay in administration of pain medication and a delay in answering the call light, which resulted in a delay in pain control.

For Patient 60 and Patient 61, there was inconsistent pain assessment which had the potential for unrelieved pain.

For Patient 62 there was no documentation or assessment of a skin tear and bruise on the left hand which had the potential for delayed care planning and unrecognized worsening of the conditions.

Findings:

1. On 4/6/12 review of the history and physical dated, 3/27/12 at 4:40 p.m., showed that Patient 10 was Spanish speaking. Prior to admission, Patient 10 was on medication treatment regimens for an immunological disorder and tuberculosis (TB or tuberculosis is an infectious bacterial disease which most commonly affects the lungs.) The plan for admission was to continue the medication for the immunological disorder and TB and to have an assessment of a fever. Also included in the history and physical was that Patient 10, "...complains for the last 2 days he has been unable to eat secondary to pain in his throat and says that he is unable to swallow. He also complains of pain in his tongue...He has severe thrush in the posterior oropharynx and along his tongue." (Thrush is yeast infection of the oral mucosa which causes painful sores of the mouth and throat.) Review of physician notes showed multiple entries that Patient 10 had throat pain causing difficulties eating and swallowing medications: 3/28/12, 3/29/12, 3/30/12, 4/1/12, 4/2/12, and 4/4/12.

On 4/6/12, at 12 p.m., during mutual electronic record review and interview, with RN 5, the nursing admission assessment on 3/27/12 at 6 p.m., showed that Patient 10 had a pain level of "5" on a 1 - 10 severity scale with 10 being the worst. Subsequent assessments of pain level were "0" from 3/27/12 through 4/4/12 except on 3/31/12 when the pain level was assessed at "4." On both occasions when the nursing assessment showed Patient 10 had pain, there was no documentation of pain location, duration, or actions taken to relieve the pain. Review of the Medication Administration Record (MAR) showed multiple episodes of Patient 10 refusing to take oral medications. See Pharmacy tag 508. There was no documentation of a nursing assessment to include Patient 10's problems of pain from thrush and refusal to take oral medications, as identified by the physicians above.

On 3/29/12 a physician wrote an order for a potent, narcotic analgesic, Fentanyl 25 mcg (microgram is one millionth of a gram--a measure of mass) intravenously (IV) once before giving medications by mouth and can repeat once; then Fentanyl 25 mcg IV every two hours as needed for pain. Review of the MAR from 3/29/12 through 4/4/12 showed that the medication was given once on 3/29/12 at 9:15 a.m.

On 4/6/12 at 9:40 a.m., during an observation and interview, Patient 10 was walking to his bed from the bathroom. He placed his hand over his throat when asked in Spanish if he had pain. During an interview via a Spanish interpreter at 12:40 p.m., Patient 10 said he had a swallowing problem when taking solids and medications which get stuck. Patient 10 said that pain medication helped the throat pain and that today he was getting the pain medication every two hours. He said he was hardly eating anything because of the problem to swallow and that the injection (Fentanyl) was better than the liquid (Lidocaine, numbing medication) for pain. Patient 10 also said sometimes he didn't have pain and didn't need pain medication.

The electronic record review also revealed that of 22 meals from 3/27/12 at 6 p.m. through 4/5/12 at 8 a.m., Patient 10 consumed 0% to 50% of nine meals, 60% to 100% of six meals and there were seven meals without documentation of percentage of meal consumed. Patient 10's admission weight on 3/27/12 was 58.8 kg (2.2 pounds = 1 kg.) Subsequent daily weights showed a slight gain initially to 60.1 kg on 3/29/12 when he ate 75% to 100% of two meals then a steady decline until 4/5/12 when the recorded weight was 53.8 kg; representing a 5 kg or 11 pound weight loss in 10 days. There was no nursing or nutritional assessment addressing the weight loss. On the admission date of 3/27/12, the history and physical showed that Patient 10 had a fever of 100.7° F. Review of physician notes on 3/28/12, 3/29/12, 3/30/12, 4/1/12, 4/2/12 and 4/4/12 showed that Patient 10 had daily temperature spikes as high as 104° F. There were no nursing or nutritional assessments addressing Patient 10's need for increased caloric needs relative to ongoing fevers over 11 days.

On 4/6/12 at 11 a.m., during an interview RN 21 said there was no way to predict whether Patient 10 would eat 0% or 100% or take his medications. RN 21 said that Patient 10 chose not to have pain medication when asked and that the physicians didn't communicate to the nurses that Patient 10 had throat pain. RN 21 said she didn't make a point of asking Patient 10 his pain status when he was eating and didn't know that Patient 10 lost weight. RN 22 said that she had cared for Patient 10 for the last three days. She thought that not eating had something to do with pain on swallowing so yesterday, 4/5/12, she ordered Ensure plus at meals but didn't document it. RN's 21 and 22 said that nurses did not routinely make rounds with physicians to discuss patients' treatment plans and they agreed there was no documentation of assessments related to Patient 10 not eating and refusing medications.

On 4/6/12 at 1:40 p.m., during an interview, the registered dietician (RD 7) stated that Patient 10 had an initial nutritional assessment on 3/30/12. The practice was that every patient received an assessment within three days unless specifically ordered sooner. RD 7 said Patient 10 ate 75 % - 100% of his meals at that time. Record review showed that RD 7 classified Patient 10 as having a moderate nutrition risk because of an immunological diagnosis, which meant that she would re-evaluate him in another five to seven days unless his condition changed. RD 7 said she visited the ward daily to visit other patients and no one informed her that Patient 10 was eating less than 75% of his meals and losing weight. RD 7 said a loss of weight was a positive trigger to initiate a nutritional consult. RD 7 said she would have reassessed Patient 10's nutritional risk to "high" and would have changed the care plan to address the weight loss within 24 hours. RD 7 said there was no communication from nursing staff related to Patient 10 eating less than 75 % and losing weight. RD 7 said it was very rare for dieticians to make rounds with physicians.

Review of the policy and procedure entitled "Documentation: Nursing Process," revised in 6/09, showed the following: "The nursing process is an organized, systematic method of providing individualized nursing care that focuses on the patient's response to an actual or potential alteration in health. The nursing process includes four interrelated and overlapping steps: assessment, planning, implementation and evaluation. The process is dynamic and ever-changing as the patient's identified needs change and/or problems are resolved." Assessment included: "...For RN's the analysis of the data may include making a more complex and in-depth assessment based on the findings." Planning included: "Developing a plan of nursing actions to reduce or eliminate actual/potential problems and promote health." Implementation included: "Communicating to all members of the health care team about the patient's status, the goals, and the plans." Evaluation included: "...incorporate all input from the entire health care team, including the patient. Evaluation leads back to assessment and the entire process begins again."

2. On 4/4/12 review of the Emergency Department (ED) electronic records showed that Patient 7 had presented to the ED on 4/3/12 with complaint of pain for a large umbilical hernia "12 inches in diameter and 8 inches deep." There was a "0.4 centimeter ulceration skin breakdown on the hernia." By observation at 3:30 p.m., Patient 7 was lying on a gurney in the ED and said he was comfortable. The umbilical hernia was pendulous and the size of a small melon. At the distal tip of the hernia there was a dime-sized opened area that was covered with a clear dressing.
On 4/5/12 review of the ED Nursing Report to the medical/surgical nurse showed that Patient 7 was admitted to the ward on 4/4/12 at 9:37 p.m. Mutual review of the electronic record with RN 2 showed there was no documentation of the hernia in the nursing admission assessment. RN 2 said that there should be a wound assessment of the skin breakdown in the wound care section in the electronic record. RN 2 confirmed there was no request for a wound care consult. RN 2 said the wound nurse should have been notified.
On 4/6/12, review of the policy and procedure entitled, "Skin Assessment," revised in 10/07, had the following statement: "It is the Registered Nurse's responsibility to examine the skin and if the skin integrity is compromised, a photo is taken of the area. The physician is notified and a referral to a wound care specialist is requested. The Braden Scale [risk assessment tool] occurs upon admission, daily and reassess when a significant change in a patient's condition occurs."




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3. Record review on 4/3/2012 showed that the hospital admitted Patient 41 on 3/30/2012 for a surgical revision of a previous right knee replacement. The physician's post-operative orders dated 3/30/2012 at 10 a.m. showed the following medications for pain control: Morphine 30 mg ER (extended release) every 12 hours by mouth as an around the clock medication. In addition, the physician ordered Dilaudid (powerful narcotic) 2 mg every four hours by mouth as needed for moderate pain defined as a reported pain level of 4-6 ( at a scale of 0 to 10), Dilaudid 4 mg by mouth every four hours as needed for severe pain, defined as a reported pain level of 7 to 10.

During an observation and family and patient interviews at Patient 41's room on 4/3/2012 at approximately 11 a.m., two persons identified themselves as Patient 41's family members. Patient 41 was in bed, awake and alert, but with limited skills to speak English. One of the two family members confirmed that Patient 451 had limited skills to speak English, would consent to an interview with the family member as an interpreter. The family member who spoke English stated she was with Patient 41 on the the first day of admission and the other present non-English speaking family member was with Patient 41 everyday.

During the interview, with the family as an interpreter, Patient 41 stated that after the surgery, she screamed in pain most of the time and the staff did not answer. Patient 41 said that her pain at times was about at level 9, meaning severe pain. Patient 41 said, "I wanted to run away but I could not walk!" The family member stated that Patient 41 experienced chronic pain and would tolerate a pain level of 3 -4 . When the pain level reached 5, Patient 41 wanted to be treated with pain medication. According to Patient 41, nurses entered her room every two or three hours; some nurses asked if she had pain and some did not. According to the family member, Patient 41 blamed herself for not learning English.

As observed in Patient 41's room, there was a white board mounted on the wall near the door. The name of the registered nurse and a list of nursing concerns were written on the board. The list of nursing concerns included "Monitor heart rhythm; monitor vital signs; Neuro checks; Monitor respirations; Monitor for compartment syndrome" There was no written concerns about pain.

At the bottom edge of the white board, approximately 10 feet away from Patient 41's bed, there was a small laminated card attached to the board. As observed, the card contained the Wong-Baker Faces Scale. The Wong-Baker Faces scale is a visual aid used for patients who may not have the ability to describe their pain with numbers. The faces ranged from happy to crying with the corresponding pain level from 0-10. A patient could point to the face that most described the pain. As tested, the card could not easily be detached from the board to be taken closer to Patient 41. Through the interpreter, the surveyor asked Patient 41 if she could see the faces from her bed (approximately 10 feet away). She squinted to look at the card and stated, "They look like cows!" According to the family member, Patient 41 knew numbers in English and could tell staff her pain level if the card was taken close to her and asked point out her the pain level.

During an interview on 4/3/2012, with QD, the QD, the Quality Director and NMG, the step-down Unit Manager, QD said that pain assessment should be done as necessary every four hours. NMG said, said, "Once a patient reports seven to nine pain and is given pain medication, the nurse would come in again within an hour and re-assess. My expectation is the nurse would check more frequently than every four hours."

Review of the electronic record of the nursing pain assessment and pain medication Patient 41 received from 3/30/2012 at 8:32 p.m. to 4/2/2012 at 4 p.m showed no documentation that Patient 41 received Morphine or Dilaudid to ensure good pain control to her comfort level.

The electronic record print out for Patient 41 showed the following:

a. On 3/30/2012 at 8:32 p.m., there was a documented severe pain at level "8", but there was no documentation of Dilaudid 4 mg being offered or given as ordered by the physician. The next pain assessment was done at 3/31/2012 at 12:16 a.m. as "0," no pain. 19 minutes later, at 12:35 a.m., nursing documentation showed d Patient 41 had severe pain at level of "8." Again, there was no pain medication documented as given. The next pain assessment was done at 4:40 a.m. when nursing documented Patient 41's pain as "0."

b. On 3/31/2012 at 7:13 a.m., nursing documented a pain level of "0", meaning no pain. The next documentation of pain assessment did not occur until 2 p.m. and Patient 41's pain level was assessed as 10, severe or worst pain , according to the pain scale. The pain reassessment was delayed for three hours for an unknown reason,

c. On 4/1/2012 at 11:38 p.m., nursing documented a pain level of "7", severe pain. The follow-up pain assessment was done on 4/2/2012 at 7:43 p.m. and on 4/12/2012 at 4 p.m. Inconsistent pain assessment frequency did not ensure timely intervention Patient 41 needed to maintain pain control at the comfortable level. This validated Patient 41's statement during the interview that she screamed in pain and the staff did not answer. The pain was so sever that she wanted to run, but could not walk. Patient 41's experience of severe pain could have been prevented by timely assessment and administration of appropriate pain medication ordered by the physician.

Review of the hospital policy "Pain Management" revised on 10/11 indicated that the staff should "evaluate drug effectiveness within one hour of administration of a prn (as-needed) analgesic dose and at least q(every) two hours for analgesics administered around the clock."

4. Record review on 4/4/12 showed Patient 40 was admitted to the hospital on 3/28/12 for chest pain/rule out acute coronary syndrome, a condition that can cause decreased blood to the coronary arteries, potentially causing a heart attack. His medical history included chronic renal failure, pulmonary hypertension. His physician documented in Physician Orders dated 3/28/12 an order for telemetry monitoring and Telemetry Parameters (listing lethal or potentially unstable abnormal heart rhythms) for which the hospitalist needed to be called.

Review showed a physician's order dated 4/3/12 for Patient 40 to undergo a CT scan to rule out pulmonary embolism (clot in the lung(s)). On 4/4/12 at 10:15 a.m., the SDU manager confirmed Patient 40 was off the unit undergoing a CT.

On 4/4/2012 at 11:50 a.m. the SDU manager (NMG) stated "Once he's (Patient 40) off the unit, he's put on (monitor) standby."

On 4/4/2012 at 11:55 a.m., the telemetry monitor technician confirmed the practice of nursing staff disconnecting a patient's telemetry and notifying her that the patient was going off the unit. She confirmed she would then place the patient in monitor standby in the central monitor and stated with the new telemetry system, the central monitor would automatically resume monitoring once the patient was reconnected to telemetry.

On 4/4/2012 at 1:50 p.m., the hospital's nursing clinical education director (NCE) described the current telemetry system was new and only in place for a few months. She stated because it was wireless, patients should be able to go off the unit for diagnostic testing. NCE stated "In the past, I believe they did exactly what (NMG) told you. They (telemetry patients) were put on standby when off the unit."

On 4/4/2012 at 2:20 p.m., RN 3 stated nurses disconnected telemetry for patients who required going off the unit for procedures "If the rhythm is stable or at his baseline." " We tell the tele nurse." She was asked if the physicians were aware patients were no longer monitored when they left the unit for a procedure. She stated "To be honest, no."

On 4/4/2012 at 2:22 p.m., RN 4, Patient 40's current nurse, confirmed Patient 40 went off the unit to have his CT earlier that morning. RN 4 stated she disconnected the telemetry and told the telemetry technician Patient 40 was going off the unit. RN 4 stated the nurse does not transport or accompany the patient when leaving the unit unless the patient were transferred to the ICU or SDU. She stated "If they go to a procedure, they're stable. If there are changes, we let the doctor know."

On 4/4/2012 at 2:40 p.m. Physician 1 confirmed he currently had patients on telemetry and stated he expected patients to be continuously monitored when he orders telemetry for a patient. Physician 1 stated he had understood the telemetry signal could be picked up when the patient was off the unit. When he was informed of the staff's past and current practice of discontinuing telemetry when transporting patients off the unit for procedures he stated "Then, there's no point to telemetry. They need to put them on a monitor." Physician 1 agreed that without monitoring, staff would not be able to readily recognize a patient developing unstable or potentially lethal heart rhythms.

Review of the hospital policy "Telemetry Monitoring-Transfer and Monitoring of Patients" indicated "Patients requiring telemetry monitoring will have continuous monitoring and an ongoing assessment of their cardiac rhythms. The purpose of the policy was "To ensure that patients requiring continuous cardiac monitoring are appropriately monitored and assessed."

During an interview on 4/6/12 at 11 a.m., the hospital's medical chief of staff (CMO) confirmed physicians were not aware patients were taken off telemetry when going off the unit for procedures and agreed that once the new system was installed with its wireless capability, staff continued to "implement the old ways." The interim director of nursing (DON), also present during the interview, stated the physicians also thought the old system allowed for monitoring off the unit.


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5. Record review on 4/3/12 showed Patient 20 was admitted and had surgery on 3/28/12 for repair of an incisional hernia.

a. Review of the "Patient Controlled Analgesia Physician Orders", dated 3/28/12 at 3:05 p.m., showed a patient control analgesic dose of Dilaudid (potent opiate narcotic) 0.2 mg dose, a lockout/delay interval of six minutes, and a hourly maximum dose of 2.4 mg. The physician's order included nursing monitoring of Patient 20's respiratory rate, sedation score (level of sleepiness), and pain level every 15 minutes for initial hour, then every two hours for eight hours, then every four hours thereafter.

RN 5, charge nurse on the medical/surgical unit, assisted with electronic health record review of the nurses notes on 4/3/12. The record showed Patient 20's PCA had been started on 3/28/12 at 10:43 p.m., and the first monitoring assessment of respiratory rate and pain level was documented on 3/29/12 at 12:27 a.m., one hour and forty five minutes after the start of the PCA. The next respiratory rates and pain assessments were documented on 3/29/12 at 4:06 a.m. and 7:16 a.m. The first "neurological' (sedation assessment) was done at 12:40 a.m. and the next one was at 7:13 a.m.

Review of the medication administration record (MAR), dated 3/28/11, showed Patient 20 had received Benadryl 25 mg IV on 3/29/12 at 2:45 a.m. for itching. One of the adverse reactions of Benadryl was sedation. Patient 20 was already on Dilaudid, an opiate that has the effect of depressing respiratory and sedation level. The addition of Benadryl with its sedating effect, made it that more important that Patient 20 was monitored as ordered.

During an interview, on 4/3/12 at 11:20 a.m., RN 5 stated monitoring a patient with a PCA for respiratory depression was important because narcotic pain medication can have an effect on a patient's breathing status. The nurse manager for this specific medical/surgical unit (NM I) was present at this time also and stated it was important not only to monitor the effect of the PCA on the patient but also the contributing effect other medications could have on the respiratory status.

Review of the hospital policy and procedure, "Patient Controlled Analgesia (PCA)", last revised 12/10, showed patients on patient controlled analgesia were to be monitor for potential problems with sedation and respiratory distressed. "The RN/LVN will access and record respirations, sedation score and level of pain on the PCA flowsheet at the following intervals." On initiation of the PCA patients were to be assessed every 15 minutes times four, every two hours for total eight hours, then every four hours thereafter.

b. In addition to the Dilaudid PCA dose of 0.2 mg with six minutes lockout/delay, the physician's order for Patient 20 also included a nurse activated bolus of Dilaudid 0.2 mg every 30 minutes as needed. Review of the PCA administration record section of the nurses notes in the electronic health record, showed Patient 20 had received a bolus of 0.4 mg on 4/30/12 at 4 a.m., double the ordered dose of 0.2 mg. No further bolus doses were documented.

During an observation, on 4/3/12 at 12 p.m., RN 5 pressed Patient 20's PCA's controls to reveal the history of usage. The bolus total, the amount that had been given since therapy was imitated showed .59 mg, but only 0.4 mg had been documented in the PCA flowsheet in the nurses notes of the electronic health record.

During an interview, on 4/3/12 at 1:55 p.m., RN 5 stated nurses were not required to have a witness/another registered nurse check the PCA programmed bolus dose before it was infused.

6. Record review on 4/4/12 showed Patient 22 had been admitted to the hospital on 4/2/12 with multiple medical diagnoses, which included insulin dependent diabetes and a left big toe ulcer that had progressed to the bone. On 4/3/12 Patient 22 had surgical amputation of the left big toe.

The physician's order, dated 4/3/12 at 11 p.m., showed Patient 22 was to be on bedrest, have sequential compression stockings, and incentive spirometry. Sequential compression stockings help prevent deep vein blood clots in surgical patients or patients on bedrest by massaging the legs in a wavelike, milking motion that promotes blood flow. An incentive spirometry was a hand held medical device that helps improve the function of the lungs, especially patients on bedrest. Patients, via a mouth piece, take in a deep breath and hold it for several seconds, up to 10 breaths every hour were recommended while the patient was awake. An indicator in the air chamber provides a gauge of how well the patients lungs are functioning, how deep the breathe taken was.
Lippincott's Nursing Procedures, (5 th ed., 2009), Pp. 241, 584-585.

During an interview on 4/5/12 at 10:25 a.m., RN 6 stated the respiratory department was responsible for initiating/teaching the patient on how to use an incentive spirometry. RN 6 stated the use of an incentive spirometry was important because it helped expand the patients' lungs.

On 4/5/12 at 10:40 a.m. the respiratory therapist (RT 1) accessed Patient 22's electronic health record. RT 1 checked the respiratory therapy section of the record and did not find documentation of an incentive spirometry. RT 1 stated it was the respiratory department who initiated the incentive spirometry but that in order to do that they needed to receive the order first.

During an interview, on 4/5/12 at 11 a.m., Patient 22 stated she had not received an incentive spirometry and had not had any sequential compression stocking on after surgery. At 11:15 a.m. Patient 22 stated she had come from surgery with only one sequential compression stocking sleeve, which was at the bedside, but no pump.

During an interview and record review, on 4/5/12 at 11:05 a.m., RN 7 stated when equipment or a treatment was ordered the unit clerk would place the order via computer to the different departments involved and then would write the order number next to that specific order on the physician's order sheet. This would indicate that the order has been placed with the departments responsible to follow through on the order. Review of the physician's order form, dated 4/3/12 at 11 p.m., showed the order for incentive spirometry did not have an order number; it was never ordered.

7. Record review, on 4/5/12, showed Patient 23 had been admitted to the hospital on 3/31/12 with a diagnosis of abdominal pain. On 4/1/12 Patient 23 had a large abdominal surgery which showed a burst appendix, which was removed, a grossly dilated small intestine, and a large collection of pus in the pelvic area. The perforated appendix had caused an obstruction/ileus in the small intestine; an interruption in the normal flow of intestinal contents. The obstruction continued after surgery. A nasogastric tube (NGT) was in place during surgery and left in place after surgery. The NGT tube helps to prevent nausea, vomiting, and abdominal distention after gastrointestinal surgery.

The principal symptoms of an ileus are abdominal pain and distention, nausea, and vomiting. Treatment involves insertion of a NGT to decompress the gastrointestinal distention. Patients are put on intravenously (IV) fluids containing electrolytes (such as sodium and potassium) and glucose because of the disruption in absorption of fluids and nutrients from the intestinal tract. Encyclopedia & Dictionary of Medicine, Nursing, & Allied Health, (6 th ed., 1997), p. 804.

Patient 23 was transferred from the critical care step down unit to the medical surgical unit on 4/4/12. The physician transfer orders dated 4/4/12 at 12:10 p.m. showed Patient 23 was to continue with the NGT on low intermittent suction and no oral intake except for ice chips. Morphine, an opiate, 2 milligrams (mg) IV every two hours as needed for pain was ordered for post operative pain control. Opiates inhibit gastrointestinal motility. The physician had ordered for Patient 23 to walk twice a day. Because of the number of apparatus Patient 23 was connected to, generalized weakness, and the use of opiate pain medication, Patient 23 was dependent on the nursing staff to assist her with getting out of bed and walking. Walking promotes downward gastrointestinal motility, helps pass flatus/gas and lessen intestinal distention.

a. During an interview, on 4/5/12 at 2:45 p.m., Patient 23 was asked if she had walked during the day, Patient 23 stated she had not. Patient 23 stated she wanted to walk and that the physician had informed her she needed to walk. RN 1 (registered nurse), who was present at the time, stated Patient 23 was on bedrest. The Interim Director of Nursing Inpatient Services (DON) was also present at this time and stated it was not beneficial to keep Patient 23 at bedrest.

During electronic record review, on 4/6/12 at 11:30 a.m., RN 2 assisted in accessing the nursing notes on one of the unit computers. No documentation was found to show that Patient 23 had been out of bed since arrival to the medical/surgical nursing unit on 4/4/12 and prior to Patient 23's activity status being questioned on 4/5/12..

During the time of electronic record review RN 2 was asked why it was important that Patient 23 ambulate/walk. RN 2 stated the outcome of surgery would be better, Patient 23 would heal better/faster, and it would also increase gastrointestinal motility thus the sooner the NGT could be removed.

b. During an interview on, 4/6/12 at 7:56 a.m., Patient 23 stated her pain level was 6 out 10 (0=no pain up to 10 being severe pain on the pain scale). Patient 23 preceded to put on the nurses' call light at this time. At 8:05 a.m. the certified nursing assistant (CNA 1) in response to the call light came into the room. Patient 23 informed CNA 1 that she was in pain and needed pain medication. At 8:10 a.m. CNA 1 returned and informed Patient 23 she had made Patient 23's nurse aware of her request for pain medication. At 8:15 a.m. RN 1 came in to Patient 23's room and preceded to clamp the NGT. RN 1 asked Patient 23 if she had pain, Patient 23 stated it was 7 out of 10. Surveyor returned to Patient 23's room at 8:26 a.m. and observed RN 1 re-taping the NGT at Patient 23's nose. At 8:40 a.m. RN 1 left Patient 23's room.

During an observation and interview, on 4/6/12 at 8:48 a.m., RN 1 was in the hallway speaking to CNA 1. RN 1 had not administered pain medication to Patient 23 as of this time. RN 1 was asked if he was in pain when would he want to be medicated, RN 1 stated, "as soon as possible".

Review of the medication administration record (MAR), on 4/6/12, showed Patient 23 had been medicated at 8:55 a.m. with morphine 2 mg IV. No other pain medication was documented as given.

Review of the hospital policy and procedure titled, "Pain Management", last revised 10/11, showed staff were to, "Minimize nursing response times for the administration of doses..."

c. During an observation and interview, on 4/6/12 at 10:55 a.m., Patient 23 was in bed with the privacy curtain pulled around her bed. Patient 2

Based on observation, interview and record review the hospital failed to ensure that the nursing staff developed and kept current care plans for four (1,7, 10 and 61) of sixty-eight patients.

For Patient 1, Dilaudid (a powerful narcotic) was listed as the treatment for pain control on the care plan after the physician discontinued the order. This failure had the potential that staff would initiate interventions based on erroneous information.

For Patient 7, there was no care plan for care of a large hernia with a skin ulceration which had the potential for delayed treatment for comfort and care of the wound.

For Patient 10, there was no multidisciplinary plan of care to ensure that nutritional and medical needs were addressed when the patient suffered from thrush causing difficulty eating and taking medications. This failure contributed to Patient 10 losing 11 pounds in 10 days and had the potential for failed medical treatment.

For Patient 61, the hospital did not develop a care plan for chronic pelvic pain. This failure potentially compromised consistent interventions of pain management.

For Patient 62, the care plan did not include that the patient required a wheelchair gait belt for prevention of falls. This failure resulted in inconsistent staff knowledge about the location of applying the gait belt to prevent falls.

Findings:

1. On 4/3/12, review of the admission face sheet showed that Patient 1 was in the intensive care unit after being hit by an automobile. By observation Patient 10 was receiving a constant intravenous infusion of a potent narcotic, Fentanyl. At 2:30 p.m., RN 23 stated that the Fentanyl was for pain management and presented the physician's order dated 3/28/12. Review of the care plan showed that Dilaudid was being used for pain management. Review of a physician's order dated 3/28/12 at 8:30 p.m., showed an order to discontinue the Dilaudid infusion.

2. During an observation in the Emergency Department on 4/4/12 at 3:30 p.m., Patient 7 was lying on a gurney. He had a pendulous, umbilical hernia the size of a small melon. At the distal tip of the hernia there was a dime-sized opened area that was covered with a clear dressing. When Patient 7 turned he supported the hernia with his hands.
On 4/5/12, after Patient 7 was admitted to the ward, review of the Multidisciplinary Patient Care Plan (MPCP) with RN 2 showed there were no entries for care of either the hernia or the skin ulceration.

3. On 4/6/12 review of the history and physical dated, 3/27/12 at 4:40 p.m., showed that Patient 10 "...complains for the last 2 days he has been unable to eat secondary to pain in his throat and says that he is unable to swallow. He also complains of pain in his tongue...He has severe thrush in the posterior oropharynx and along his tongue." (Thrush is yeast infection of the oral mucosa which causes painful sores of the mouth and throat.) Review of physician notes showed multiple entries that Patient 10 had throat pain causing difficulties eating and swallowing medications: 3/28/12, 3/29/12, 3/30/12, 4/1/12, 4/2/12, and 4/4/12.

During an interview via a Spanish interpreter at 12:40 p.m., Patient 10 said he was hardly eating anything because of the problem with swallowing. Review of the electronic health record showed that Patient 10's admission weight on 3/27/12 was 58.8 kg. On 4/5/12, the recorded weight was 53.8 kg which represented a 5 kg or 11 pound weight loss in 10 days. Review of multiple physician notes (see tag 395) showed that Patient 10 had temperature spikes as high as 104° F. There were no care plans developed to include Patient 10's problems of pain from thrush and refusal to eat and take oral medications.

During an interview RD 7 said that on 3/30/12 she started a MPCP and classified Patient 10 as having a moderate nutrition risk due to his diagnosis of an immunological disease and tuberculosis (TB.) RD 7 said that at that time Patient 10 was eating at least 75 % of his meals. RD 8 said the only intervention she checked was to monitor intake, weight and labs per protocol with a goal that Patient 10 would consume 75% of meals. "Weight loss" was a pre-printed item on the care plan and was not checked as a problem when Patient 10 suffered an 11 pound weight loss in 10 days. "Increased needs" (for nutrition) was not checked when ongoing fevers, as noted above, would increase Patient 10's fluid and caloric needs. (Nursing Diagnosis, Lippincott 2006.) There were no additional entries to the nutrition care plan by either nursing or the dietician until 4/5/12.

On 4/6/12 at 11 a.m., during an interview RN 21 said when she asked Patient 10 if he had pain, he denied it. RN 21 said she didn't make a point to ask Patient 10 if he had pain when he was eating meals. RN 21 agreed there was no documentation to address why the patient wasn't eating or taking medications.














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4. During a staff interview on 4/4/12 at 12:09 p.m., and record review with RN 16 and NMMC showed there was no care plan for Patient 61's pain management in a short stay. Patient 61's admitted with chronic pelvic pain and endometriosis on 4/3/12 with discharge order written on 4/4/12 at 8:50 a.m.

5. On 4/5/12 at 9:30 a.m., as observed in rehab therapy room, Patient 62 was sitting on a wheelchair with a gait belt at her thigh areas. Patient 62 could move her wheelchair forward with her left hand and left leg. OT said Patient 62 could not move her right side due to stroke history, and the gait belt was used to prevent her from falling out of her wheelchair.

On 4/5/12 at 9:41 a.m., as observed on hallway near nurses' station, Patient 62 was on her wheelchair with a gait belt at her thigh areas.

In a staff interview on 4/5/12 at 11:05 a.m., RN 17 said she was a primary nurse of Patient 62 for today. She said the gait belt was applied to Patient 62's waist as a routine care for fall risk. Record review of Patient 62's medical record with RN 17 and NMAR showed that the fall care plan dated 3/22/12 and 3/23/12 had no indication of gait belt use and the location of applying gait belt when the patient was on wheelchair.

On 4/5/12 at 11:30 a.m., as observed, Patient 62 was on wheelchair with gait belt applied at thigh areas instead. PT said it was an appropriate location of applying gait belt when Patient 62 was on wheelchair.

Review of the policy and procedure, " Documentation: Nursing Process, " revised 6/09, had the following direction to the registered nurse: " ...Initiates the plan of care within eight (8) hours of admission and reviews at least daily on the day shift to reflect current patient status and assessment. The policy and procedure, " Standards of Patient Care, Treatment and Services, " revised 11/2011, showed the following: " ...1. The patient can expect that his/her nurse develops and documents an individualized plan of care. 2. The implementation of the plan of care is reflected in the Nursing Documentation. 3. The plan is evaluated every shift and updated as necessary ...B. The patient can expect that the nursing plan of care is coordinated by and integrated with the care provided by other members of the multidisciplinary team ... "

Based on interview and record review the hospital failed to ensure that one of sixty-eight patients (Patient 61) received a medication for pain as ordered by the physician. This failure resulted in a medication omission error which had the potential that Patient 61 would not have his pain relieved.

Findings:

On 4/4/12 record review showed that Patient 61 was admitted with chronic pelvic pain and endometriosis on 4/3/12 with discharge order written on 4/4/12 at 8:50 a.m.

During a staff interview on 4/4/12 at 12:09 p.m., and record review with RN 16 showed that a physician order dated 4/3/12 indicated Patient 61 should have received Toradol 30 mg intravenously or intramuscularly every eight hours for three doses. The first dose of Toradol was given in PACU (recovery room after surgery) at 6:45 p.m. on 4/3/12. RN 16 said night shift nurse did not do any documentation or verbal report about whether Patient 61 already received second dose of Toradol around 2:45 a.m. on 4/4/12. RN 16 said she identified that Patient 61 did not receive second dose of Toradol around 2:45 a.m. on 4/4/12 because the record from automatic dispensing machine did not show Toradol use for Patient 61 at 2:45 a.m. or 3 a.m. on 4/4/12. RN 16 gave 30 mg Toradol IV at 8 a.m. on 4/4/12 after five hours and fifteen minutes passed from missing dose time at 2:45 a.m. on 4/4/12.

Based on observation, interview and record and document review, the hospital failed to ensure medical records for all discharged patients were completed within 14 days per Department regulation and hospital policy.

Findings:

During a tour of the medical records department beginning at 11:55 a.m. on 4/6/12, observation showed multiple shelving units filled with patient medical records. According to the health information management director (HIMD) this area was the incomplete medical record area and consisted primarily of records requiring authentication by attending physicians who were required to cosign H&Ps (History and Physical), operative notes, discharge summaries and progress notes. According to HIMD after 14 days after discharge, physicians receive an e-mail warning and after 21 days 'they get a notification of suspension along with a copy (of the notification) to the department chair.

Review of the hospital's Provider ID--Suspended Providers dated 4/6/12 indicated 139 physicians were listed as suspended. Forty-six of the physicians had over 20 incomplete records ascribed to them.

Review of the hospital's Delinquent Medical Record Tracking document dated 4/2/2012 indicated the most recent completed quarter, the first quarter of 2012 had a 16.9% delinquent rate. Out of 24,829 patient discharges, 4206 medical records were delinquent.

During an interview on 4/9/12 at 9:25 a.m. HIMD stated "We're not sure these records are all incomplete. We'll start the audit next week." and added that the department (HIM) had been understaffed for the past six years.

Review of the hospital policy "Medical Record Delinquency and Medical Staff Suspension" indicated "All elements of the medical record will be completed within the fourteen day period following a patient's discharge."

4. On 4/5/12, review of a Consultation Report in the medical record for Patient 5, had no date, no service and no physician signature listed.



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Based on interview and record review the hospital failed to ensure that medical record entries were legible, complete, dated and timed for three (Patients 28, 29 and 31) of 16 closed medical records reviewed and one (Patient 5) of sixty-eight patients.

1. For Patient 28, the post-anesthesia care unit admission orders, dated 1/11/12 at 3 p.m., had a line drawn diagonally through the page with no date, time, or clear signature. This failure resulted in the inability to establish who the nurse was, when the orders were noted by that nurse and confusion as to what a line drawn diagonally meant.
2. For both Patients 28 and 29 the medication reconciliation and discharge order forms were incomplete, which made it unclear whether Patients 28 and 29 were to continue, discontinue or have their prior home medications adjusted.
3. For Patient 31, an entry for the completion time of a blood transfusion had been written over, the entry was illegible, which resulted in an unclear time when the blood transfusion actually ended.
4. For Patient 5, there was an incomplete Consultation Report.

Findings:

1. Review of Patient 28's "Post-Anesthesia Care Unit (PACU) Admission Orders", dated 1/11/12 at 3 p.m., showed the order sheet had a line drawn diagonally from one end of the page to the other. There was illegible writing on top of the diagonal line. The was no readable signature, nor was there a date or time as to who and when the orders had been noted/initiated. Further review showed the illegible writing was also noted on the signature line of the "PACU Nursing Care Plan", with the addition of "RN" after the entry.

During an interview, on 4/9/12 at 11 a.m., the Quality Assurance Officer (QA 1) stated the anesthesiologist orders had not been noted correctly. QA 1 stated the the correct way to note orders was with a signature, date and time .

Review of the hospital's policy and procedure, "Documentation :Transcription and Noting Orders", last revised 8/09, showed "...the RN [registered nurse] noting the orders enters the date, time, and signs with title in red ink." "The RN's signature must be placed on the line below the physician's signature..."

2. Review, on 4/9/12, of the "Medication Reconciliation And Discharge Order Form" for Patients 28 and 29 showed the home and over the counter medications section had no indications selected for prior home medications after Patient 28 and 29 were discharged home. The home medications could either be continued, discontinued, or adjusted. The physician's signature line in this section was blank for Patient 28.

During an interview, on 4/9/12 at 11:15 a.m., the Assistant Director of Nursing Services (ADON), stated it was the physician's responsibility to indicate on a patient's discharge whether the patient was to continue, discontinue, or adjust the patient's prior home medications.

Review of the hospital policy and procedure, "Medication Reconciliation", last revised 4/10, showed the form applied to all units within the medical center. The "Medication Reconciliation & Order Form" was, "...intended to generate the most accurate medication list available especially at transitions of care (home to admission, admission to discharge). The form was to be placed in the patient's medical record and reviewed by the "Provider" overseeing the patient's care. "The Provider will also sign, date, and time the reconciliation form. The Provider takes responsibility for the accuracy of the medication history with their signature on the form." Once the form was signed by the Provider, it was to be filed on top of the physician's order section in the medical record. The form was be used to order discharge medications. "Each medication listed during the admission process in the 'Continued on Discharge' column, the provider should circle 'YES' to continue or 'NO' to discontinue. The provider must note the quantity and number of re-fills on the space provided on the form or the prescription cannot be filled."

3. Record review on 4/9/12 of Patient 31's blood transfusion record showed the an illegible entry for the time the blood transfusion had been completed. A second entry had been made on top of the original entered time.

During an interview, on 4/9/12 at 1:46 p.m., the health information management director (HIMD) stated documentation errors were not to be written over. A line was to be drawn across the entry error along with the initials of the responsible person. A new entry would then be done.

Based on observation, interviews and administrative record reviews, the hospital failed to ensure that the services and care provided by pharmacy met the needs of the patients as evidenced by:

1. The hospital's pharmacy service ensure that four out seven pharmacy staff had updated competencies on sterile intravenous compounding, (a process of mixing different medicinal ingredients to be administered directly into a vein); that the 24 hour beyond use dating was supported by acceptable references or final product testing; that the chemotherapy (tissue cell killing medications) hood was retested after a sample dated 1/19/12 grew microorganisms; that gloved fingertip testing ( a process to test the gloves of pharmacy staff to detect contamination) was done; that there was routine cleaning of the immediate area of the sterile intravenous compounding room; that the sterile intravenous compounding room was ISO (isolation) Class 7 (measurement of particles in the air) certified; that the air pressure difference in the sterile intravenous compounding room was monitored and evaluated; that every medication removed from Pyxis, the automated medication dispensing cabinet had a valid physician order; that the medication warmer at the Magnetic Resonance Imaging was monitored to be at the appropriate temperature at all times; and, that the staff assessed one newly admitted patient for any medication patch. Refer to A491.

2. The emergency department room failed to have a system in place to account for all controlled drugs removed from Pyxis, an automated drug dispensing system. Refer to A494.

3. The pharmacy failed to ensure in one out of 68 patients in the sample survey that two registered nurses verify the initial PCA ( patient pain controlled medication delivery system) pump program. During the first hour, the respiration rate, sedation score (wakefulness), and pain level (0 to 10, 0 = pain free) was not documented, every 15 minutes. Refer to A500.

4. The pharmacy failed to ensure safe handling of trace chemotherapy (residual of cell tissue killing medication) waste in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room when glass vials trace chemotherapy waste are not sealed in plastic bags before removal from the BSC (chemotherapy mixing hood (device to provide a sterile mixing area). The pharmacy service also failed to ensure safe storage instructions of sterile intravenous compounded when the labels did not have clear storage instructions on the pharmacy labels. Refer to A501.

6. The pharmacy failed to ensure a system to ensure that medication errors of omission were reported to the attending physician when in one of 68 patients in the sample survey , six unreported medication errors were identified. Refer to A508.

The cumulative effects of these systemic problems resulted in the hospital's pharmacy services to provide pharmaceutical services and care in a safe and effective manner in accordance with the Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and document review, the hospital failed to administer pharmaceutical services to meet the needs of the patients in accordance with standards of practice, federal and state laws as evidenced by:

1. The pharmacy failed to ensure the development and implementation of a policy and procedure to maintain, and monitor, the competency (skills) of sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing different medicinal ingredients) staff. The pharmacy scheduled seven pharmacists to work in the sterile IV compounding room. Four (Pharmacist 1, Pharmacist 2, Pharmacist 3 and Pharmacist 4) out of seven pharmacists did not have updated intravenous compounding competencies. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

2. The pharmacy failed to ensure the development and implementation of a policy and procedure to assign beyond use (expiration) dating for sterile (germ free) compounded (mixed) intravenous (IV, directly into a vein) medications. The pharmacy assigns 24 hours from the time of compounding as the beyond use date. The 24 hour beyond use dating is not supported by references, or final product testing. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

3. The pharmacy failed to ensure the development and implementation of a policy and procedure to evaluate viable (living) airborne/surface microorganisms (germs) in the sterile (germ free) compounding (mixing) area. The pharmacy tested, on 1/19/12, a sterile intravenous (IV, directly into a vein) chemotherapy compounding (mixing) hood (germ free area) for viable airborne microorganisms. The sample grew 14 cfu (colony forming units)/m3 (cubic meters) of microorganisms. The pharmacy did not retest the chemotherapy compounding hood. This failure resulted in the potential for approximately 1,600 patients encountered, to be exposed to approximately 1,180 contaminated IV chemotherapy medications, over 59 days.

4. The pharmacy failed to ensure the development and implementation of a policy and procedure to test, and evaluate, gloved fingertip sampling of sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) personnel. The hospital did not test, and evaluate, gloved fingertip sampling of sterile IV compounding personnel. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

5. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, the cleaning (floors, walls, hard surfaces) of the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy does not monitor, and evaluate, the cleaning of the sterile IV compounding room. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

6. The pharmacy failed to ensure the development and implementation of a policy and procedure to certify the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room is ISO Class 7 (measurement of particles in the air) certified. The IV room is not ISO Class 7 certified. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

7. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, air pressure differential (difference) in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) area. The pharmacy did not monitor, and evaluate, the air pressure differential. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

8. The pharmacy failed to ensure the development and implementation of a policy and procedure to monitor, and evaluate, the air changes per hour in the sterile (germ free) intravenous (IV, directly into a vein) compounding (mixing) room. The pharmacy did not monitor, and evaluate, the air changes per hour in the sterile IV compounding room. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

9. The pharmacy failed to ensure the implementation of a policy and procedure to match a valid physician order to every medication removed from the Pyxis (automated medication dispensing) cabinet. The pharmacy turned off the Pyxis override report prior to 1/1/12. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 6,000 avoidable medication errors, over 94 days.

10. The pharmacy failed to ensure the implementation of a policy and procedure to monitor medication warmers. The pharmacy did not monitor medication warmers in MRI (Magnetic Resonance Imaging) and pharmacy. This failure resulted in the potential to expose patients to medications at other than labeled quality.

11. The pharmacy failed to ensure the development and implement of a policy and procedure for fentanyl (narcotic pain reliever) patches. In one patient, out of 67 reviewed, the hospital did not document she was wearing her own fentanyl patch upon admission. This failure resulted in the potential for patients to be exposed to respiratory (breathing) depression.

Findings:

1. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous (chemotherapy) medication compounding area and a non-hazardous medication compounding area. One IV hood (device to provide a sterile compounding area) is in each area.

On 4/6/12 at 11:25 a.m., the surveyor requested the Director of Pharmacy (Pharm D) to provide a list of the pharmacy staff assigned to work in the sterile IV compounding room, with the status of their IV competencies.

During a concurrent interview and record review, on 4/9/12 at 9:05, Pharmacist (Pharm 1) stated that four (Pharmacist 2, Pharmacist 3, Pharmacist 4 and Pharmacist 5), of seven IV pharmacists, do not have documentation of up to date competencies for working in the sterile IV compounding area. Pharm 1 further stated that one (Pharmacist 4) out of seven pharmacists do not have documentation of up to date competencies for working in the IV chemotherapy compounding area. Continuing the interview, Pharm D stated that pharmacists will need to have up to date competencies to continue to work in the IV room.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an interview, on 4/9/12 at 11:20 a.m., Pharm 1 stated three pharmacists (Pharmacist 2, Pharmacist 3, and Pharmacist 4) staffed a total of 70 shifts in the IV room since 1/1/12. Pharmacist 5 staffed 44 night shifts since 1/1/12.

During an administrative record review, of the hospital's policy and procedure for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible) showed Procedure 3. "Pharmacy staff will demonstrate competency in using proper techniques to assure accuracy in medication preparation."

2. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous (chemotherapy) medication compounding area and a non-hazardous medication compounding area. One IV hood (device to maintain a sterile compounding area) is in each area. Total parenteral nutrition (a solution of nutrients prepared to be given into a big vein), antibiotics and chemotherapy are prepared in the two areas.

Touring, on 4/3/12 at 11 a.m., on 7E, the surveyor identified IV vancomycin (antibiotic) for Patient 101. Inspection of the label showed "Expires: 24 hrs." The Director of Pharmacy (Pharm D) stated the expiration time is 24 hours from the date and time the medication is mixed.

During an interview, on 4/3/12 at 2:30 p.m., Pharm D and Pharmacist (Pharm 1) were asked to provide the certification documentation for the sterile IV compounding room. Review of the documents did not show the IV room is certified at ISO 7 (measurement of air particles). Further review of the documentation did not show monitoring of air pressure differential.

The surveyor requested, on 4/4/12 at 12:50 p.m., the pharmacy provide documentation supporting the 24 hour beyond use dating for low (antibiotics) and medium risk (TPN) compounded IV's. Pharm D stated the 24 hour beyond dating is based on historical policy and procedures.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounded 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pgs. 42 - 43) Facility Design and Environmental Controls "Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites...For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02- to 0.05-inch water column is required."

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 33) showed Low-Risk Level (antibiotics) CSPs (compounded sterile products) with 12-Hour or Less BUD (beyond use date) "If the PEC...is a laminar (smooth) airflow workbench (LAFW)(IV hood)...that cannot be located within an ISO Class 7 buffer area (clean room)...administration of such CSPs shall commence within 12 hours of preparation or as recommended in the manufacturers' package insert, whichever is less. Low-risk level CSPs with a 12-hour or less BUD shall meet all of the following four criteria: 1. PECs (LAFWs...) shall be certified and maintain ISO Class 5 as described...and shall be in a segregated compounding area restricted to sterile compounding activities that minimize the risk of CSP contamination."

USP<797> defines a segregated compounding area as "A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding."

3. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consisted of a hazardous (chemotherapy) medication compounding area and a non-hazardous medication compounding area. One IV hood (device to maintain a sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas.

During an interview, on 4/3/12 at 2:30 p.m., the Director of Pharmacy (Pharm D) and Pharmacist (Pharm 1) were asked to provide the certification documentation for the sterile IV compounding room. Review of the documents showed the BSC (chemotherapy hood), air sample, failed the 1/19/12 airborne viable sampling test with 14 cfu's/m3.

Continuing the interview, on 4/3/12 at 2:35 p.m., Pharm D and Pharm 1 were asked to describe the corrective actions taken due to the 1/19/12 failed airborne test. Pharm D stated that equipment was rearranged inside the hazardous compounding hood. Pharm D stated that the pharmacy did not repeat an airborne viable sampling test.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1stated the IV room compounds approximately 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedures for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible) and Compounding/Manufacturing (Effective Date: 5/95, Date Revised: 9/05), Preparation of Antineoplastic Chemotherapy (Reviewed/Revised: 07/04) did not show procedures for airborne viable sampling, reporting, analysis, corrective action and resampling.

Review of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 46) showed Environmental Viable Airborne Particle Testing Program "Review of the data generated during a sampling event may detect elevated amounts of airborne microbial bioburden (levels); such changes may be indicative of adverse changes within the environment."

Review of USP<797> Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 47) showed Action Levels, Documentation, and Data Evaluation "Any cfu count that exceeds its respective action level (action level is greater than 1 cfu/m3) should prompt a re-evaluation of the adequacy of personnel work practices, cleaning procedures, operational procedures, and air filtration efficiency within the aseptic compounding location. An investigation into the source of the contamination shall be conducted. Sources could include HVAC systems, damage HEPA filters, and changes in personnel garbing or work practices. The source of the problem shall be eliminated, the affected area cleaned, and resampling performed."

4. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous medication compounding area and a non-hazardous medication compounding area. One IV hood (device to maintain a sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas.

During an interview, on 4/4/12 at 1:30 p.m., the Director of Pharmacy (Pharm D) was asked to describe the quality assurance monitoring for the sterile IV compounding program. Pharm D stated that the quality assurance measures do not include gloved fingertip testing.

During an interview, on 4/9/12 at 9:10 a.m., Pharmacist 1 and Pharm D stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedures for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible), Compounding/Manufacturing (Effective Date: 5/95, Date Revised: 9/05) and Preparation of Antineoplastic Chemotherapy (Reviewed/Revised: 07/04) did not show procedures for gloved fingertip testing.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 51) showed "Aseptic Work Practice Assessment and Evaluation via Personnel Glove Fingertip Sampling-Sampling of compounding personnel glove fingertips shall be performed for all CSP (compounded sterile preparation) risk level compounding because direct touch contamination is the most likely source of introducing microorganisms into CSPs prepared by humans. Glove fingertip sampling shall be used to evaluate the competency of personnel in performing hand hygiene and garbing procedures in addition to educating compounding personnel on proper work practices, which include frequent and repeated glove disinfection using sterile 70% IPA (alcohol) during actual compounding of CSPs. All personnel shall demonstrate competency in proper hand hygiene and garbing procedures and in aseptic (germ free) work practices..."

5. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous medication compounding area and a non-hazardous medication compounding area. The room contains work surfaces and shelving. One IV hood (device to provide a sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas. Continued inspection showed a 3K (a brand name) Critical Care Sterilization log taped on the outside of the room.

In an interview, on 4/3/12 at 10:22 a.m., Administrator (Admin 1) stated the 3K Critical Care Sterilization log documents the terminal cleaning of the sterile IV compounding room. He further stated that terminal cleaning is to occur once per week. Terminal cleaning includes cleaning of the floors, walls, and hard surfaces in the IV sterile compounding room.

During a concurrent tour and interview, on 4/3/12 at 2:15 p.m., in the sterile intravenous compounding room, the surveyor identified the non-hazardous compounding hood. Inspection of the top of the hood showed a moderate amount of grey dust, some of it gathered into small balls. Pharmacist (Pharm 1) acknowledged that top of the hood was covered with a moderate amount of dust. Pharm 1 further acknowledged that the top of the hood is to be free of dust.

In an interview, on 4/4/12 at 1 p.m., the Director of Pharmacy (Pharm D) described the quality assurance monitoring of the sterile IV compounding program. Pharm D stated that environmental services (EVS) cleans the sterile IV compounding room and is responsible for completing the logs. Pharm D stated pharmacy does not monitor the EVS cleaning logs.

During a concurrent interview and record review, on 4/6/12 at 3:05 p.m., the surveyor requested the daily EVS housekeeping logs for the IV sterile compounding room. Admin 1 stated that EVS did not have logs for 1/12 and 2/12. Admin 1 acknowledged that the 3K Critical Care Sterilization log, for March 2012, room IV, documented the sterile IV compounding room was cleaned six out of 31 days. Admin 1 further stated that the same log is used to document weekly terminal cleaning of the IV sterile compounding room.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

6. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous medication compounding area and a non-hazardous medication compounding area. One IV hood (device to provide a sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas

During an interview, on 4/3/12 at 2:30 p.m., the Director of Pharmacy (Pharm D) and Pharmacist (Pharm 1) were asked to provide the certification documentation for the sterile IV compounding room. Review of the documents did not show the sterile IV compounding room is ISO Class 7 certified.

Touring, on 4/3/12 at 11 a.m., on 7E, the surveyor identified IV vancomycin (antibiotic) for Patient 101. Inspection of the label showed "Expires: 24 hrs." Pharm D stated the expiration time is 24 hours from the date and time the medication is mixed.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedures for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible) and Compounding/Manufacturing (Effective Date: 5/95, Date Revised: 9/05), Preparation of Antineoplastic Chemotherapy (Reviewed/Revised: 07/04) did not show procedures for ISO 7 certification of the sterile IV compounding room.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pg. 33) showed Low-Risk Level (antibiotics) CSPs (compounded sterile products) with 12-Hour or Less BUD (expiration date and time) "If the PEC...is a laminar airflow workbench (LAFW)(IV hood)...that cannot be located within an ISO Class 7 buffer area (clean room)...administration of such CSPs shall commence within 12 hours of preparation or as recommended in the manufacturers' package insert (expiration date and time), whichever is less. Low-risk level CSPs with a 12-hour or less BUD shall meet all of the following four criteria: 1. PECs (LAFWs...) shall be certified and maintain ISO Class 5 as described...and shall be in a segregated compounding area restricted to sterile compounding activities that minimize the risk of CSP contamination."

USP<797> defines a segregated compounding area as "A designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding."

7. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room shows it is entered through a door. The IV compounding room consists of a hazardous medication compounding area, and a non-hazardous medication compounding area. One IV hood (device to provide a sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas.

During an interview, on 4/3/12 at 2:30 p.m., the Director of Pharmacy (Pharm D) and Pharmacist (Pharm 1) were asked to provide the certification documentation for the sterile IV compounding room. Review of the documents did not show the air pressure differential was monitored.

In an interview, on 4/3/12 at 4 p.m., Pharm D stated the hospital does not monitor the air pressure differential.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedures for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible) and Compounding/Manufacturing (Effective Date: 5/95, Date Revised: 9/05), Preparation of Antineoplastic Chemotherapy (Reviewed/Revised: 07/04) did not show procedures for monitoring the air pressure differential.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pgs. 42 - 43) Facility Design and Environmental Controls "Compounding facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites...For rooms providing a physical separation through the use of walls, doors, and pass-throughs, a minimum differential positive pressure (pressure in the IV room is greater than outside the IV room) of 0.02- to 0.05-inch water column is required."

8. During a tour, on 4/3/12 at 10:10 a.m., in the main pharmacy, the sterile IV compounding room was identified. Inspection of the IV compounding room showed that it consists of a hazardous medication compounding area and a non-hazardous medication compounding area. One IV hood (device to provide sterile compounding area) is in each area. Total parenteral nutrition (IV nutrition), antibiotics and chemotherapy are prepared in the two areas.

During an interview, on 4/3/12 at 2:30 p.m., the Director of Pharmacy (Pharm D) and Pharmacist (Pharm 1) were asked to provide the certification documentation for the sterile IV compounding room. Review of the documents did not show the number of room ACPH is monitored.

In an interview, on 4/3/12 at 4 p.m., Pharm D stated the pharmacy does not monitor the number of ACPH in the sterile IV compounding room.

During an interview, on 4/9/12 at 9:10 a.m., Pharm D and Pharm 1 stated the IV room compounds approximately 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedures for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible), Compounding/Manufacturing (Effective Date: 5/95, Date Revised: 9/05), and Preparation of Antineoplastic Chemotherapy (Reviewed/Revised: 07/04) did not show procedures for monitoring ACPH.

During an administrative record review, of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparations (2008, pgs. 42-23) showed "Facility Design and Environmental Controls...Room air exchanges are typically expressed as ACPHs. Adequate HEPA-filtered (filter to remove particles) airflow supplied to the buffer area (compounding room) and ante-area is required to maintain cleanliness classification during operational activity through the number of ACPHs. An ISO Class 7 (measurement of air particles)...buffer area and ante-area supplied with HEPA-filtered (filter to remove small particles) air shall receive an ACPH of not less than 30."

9. During an interview, on 4/3/12 at 9:25 a.m., Pharmacy Technician (Pharm Tech 1) stated that the hospital's Pyxis machines are fully profiled (valid physician order entered by a pharmacist before medications can be removed).

During an interview, on 4/4/12 at 11:45 p.m., Pharm Tech 1 stated the hospital's fully profiled Pyxis override (medications removed without a valid physician order entered by pharmacy) report is disabled. The surveyor requested the hospital provide, for the fully profiled machines, the number of medication overrides, from 1/1/12 to current.

In an interview, on 4/4/12 at 2:45 p.m., Pharmacist (Pharm 1) stated the hospital had approx. 6,000 Pyxis overrides, in the fully profiled cabinets, from 1/1/12 to 3/31/12.

The Director of Pharmacy (Pharm D), on 4/6/12 at 11:20 a.m., acknowledged the hospital had approx. 6,000 Pyxis overrides out of 190,000 Pyxis dispenses. Pharm D stated that the hospital has not established a goal for the number of Pyxis overrides allowed per month.

During an administrative record review, of the hospital's policy and procedure for Pyxis and Pyxis Profile Medstation (Date Revised: 9/09) showed 5. "The following units or departments on the automated/Pyxis 3500 system (Profile): a. Critical Care, b. TCU, c. Med Surge (5E, 7E, 7W)...f. Labor and Delivery/Pediatrics (9E, 9C, 9W)"...Procedure N. Medication Override, Purpose 1. Medications removed by Override: "a valid order for every medication removed using the override function will be sent to pharmacy for prospective pharmacist review. Pharmacy will monitor all medications removed using the override function and will match them to an order. If not order is present, then pharmacy will complete a report and send report to the unit manager. The overridden medications MUST be reviewed daily at the end of each shift by the charge nurse."

10. The surveyor, on 4/3/12 at 12:30 p.m., identified a medication warmer in the MRI room. Inspection of the medication warmer shows it contains 15 ml (milliliter) bottles of Multihance (a type of contrast media used to see an image by x-ray) . Radiation Technician (Rad Tech 1) was requested to provide documentation that the hospital monitored the storage conditions of the Multihance. Rad Tech 1 stated the hospital did not maintain documentation of the storage conditions of the Multihance.

During a concurrent tour and interview, on 4/3/12 at 2 p.m., in the sterile intravenous compounding room, the surveyor identified a medication warmer. Inspection of the warmer showed that it contained bags of intravenous mannitol (diuretic or a drug used to increase urine output). Pharmacist (Pharm 1) was requested to provide documentation that the hospital monitored the storage conditions of the mannitol. Pharm 1 stated the pharmacy did not maintain documentation of the warmer temperature.

During an administrative record review, of the hospital's policy and procedure for Medication: Contrast Media (Date Revised: 10/11) showed Procedure 2. "The Pharmacy Department is responsible for monthly inspections of the area to assure proper storage and security and check for expired contrast media."

Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure appropriateness of that date. A product stored for stability at or near 15 C (Celsius) may have quite a different quality profile at its expiration date than a product stored at or near 30 C.
[Reference: http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072919.htm]

11. During a chart review, on 4/4/12 at 2:15 p.m., the surveyor identified Patient 107's fentanyl patch order dated 3/30/12. Continued review of the records did not show that nursing confirmed Patient 107 was wearing a patch upon admission to the hospital. Registered Nurse (RN 8) reviewed the records and acknowledged the documentation did not include nursing verification of a patch upon Patient 107's admission. RN 8 stated that it is the facilities expectation the nurse document the patch upon admission.

During an administrative record review, of CHA (California Hospital Association) Medication Safety Committee High Alert Medication Guideline - FentaNYL Transdermal Patch (April 2011) showed Nursing Administration "Verify patch placement upon admission and transfer."

Based on interview and record review, the pharmacy failed to implement physician orders and written policies and procedures to ensure the safe use morphine (narcotic pain reliever) administered by a PCA (patient controlled analgesia (pain relief)) pump. In one patient (Patient 108), out of 68 reviewed, two registered nurses did not verify the initial PCA pump program. During the first hour, the respiration rate, sedation score (wakefulness), and pain level (0 to 10, 0 = pain free) was not documented, every 15 minutes. This failure resulted in the potential for patients to be exposed to avoidable adverse effects of morphine (respiratory depression).

The pharmacy also failed to develop and implement a policy and procedure to ensure control of scheduled medications in the emergency department. The pharmacy did not verify that scheduled medications removed from the emergency department Pyxis cabinet had valid physician orders. This failure resulted in the potential for scheduled medication diversion and avoidable medication errors.

Findings:

1. During a concurrent interview and record review, on 4/4/12 at 4 p.m., the surveyor identified Patient 108's Patient Controlled Analgesia Physician Orders, for morphine, dated 4/3/12. Review of the orders showed Nursing Management: "Monitor respiratory rate, sedation score and pain level every 15 minutes for initial hour, then every 2 hours for 8 hours, then every 4 hours thereafter." Further review of the records showed the morphine PCA was started on 4/4/12 at 00:30 a.m.

Registered Nurse 9 reviewed the records and acknowledged that the pump program was not independently verified by a second nurse. Registered Nurse 10 stated it was the facilities expectation the morphine PCA pump program is verified by a second nurse. Continued review of the records did not show respiration rate, sedation score, and pain level was monitored every 15 minutes for the first hour.

During an administrative record review, of the hospital's policy and procedure for Patient Controlled analgesia (PCA) (Effective Date: 1/27/03, Date Revised 12/2010) showed Procedure: 4. "Program the Pump - All programming must be witnessed by 2 RNs."

2. In an interview, on 4/9/12 at 11:25 a.m., Pharmacy Technician 1 stated the Pyxis cabinet in the emergency department is not profiled (valid physician order is not entered by a pharmacist before medications can be removed). The surveyor asked the Director of Pharmacy (Pharm D) to describe the process to account for all scheduled medications in the emergency department. Pharm D stated the pharmacy did not verify emergency room Pyxis controlled medication usage against physician orders.

During an administrative record review, of the hospital's policy and procedure for Pyxis and Pyxis Profile Medstation (Date Revised: 9/09) showed Policy 4. The following units are on automated/Pyxis 3500 system (Non-profile): f. "Emergency Department..." Further review of the policy and procedure did not show pharmacy will monitor scheduled drugs removed in the non-profiled (emergency department) and will match them to an order.

Based on observation, interview, and document review, the hospital failed to ensure that intravenous compounding and intravenous medication labeling is performed consistent with standards of practice, federal and state laws as evidenced by:

1. The pharmacy failed to develop and implement a policy and procedure to ensure the safe handling of trace chemotherapy waste in the sterile (germ free) intravenous compounding room, a designated area in the pharmacy for mixing drugs used to be given directly into a vein. Glass vials with trace chemotherapy waste are not sealed in plastic bags before removal from the BSC (chemotherapy mixing hood (device to provide a sterile mixing area). This failure resulted in the potential for pharmacy staff to be exposed to the avoidable effects of trace chemotherapy.

2. The pharmacy failed to develop and implement a policy and procedure to ensure that sterile (germ free) intravenous (IV, directly into a vein) compounded (mixed) labels included clear storage directions. Two patient's IV's did not have clear storage directions printed on the pharmacy labels. This failure resulted in the potential for approximately 4,472 patients encountered, to be exposed to approximately 9,330 contaminated IV medications, over 94 days.

Findings:

1. During a concurrent tour and interview, on 4/3/12 at 2 p.m., in the sterile intravenous compounding room, the surveyor identified a white and yellow plastic container. Pharmacy Technician 2 stated the container is used to hold trace chemotherapy (hazardous) waste. Inspection of the container showed it contained small vials with trace chemotherapy. Further inspection showed the vials were not sealed inside plastic bags. Pharmacist 1 acknowledged that the vials were sealed in plastic bags.

In an interview, on 4/6/12 at 3:30 p.m., Administrator 3 stated that best practices is to seal trace chemotherapy vials in plastic bags before removing them from the mixing hood. The sealed and bagged waste is then placed in a trace chemotherapy waste container.

2. During a tour of 7E, on 4/3/12 at 11:46, the surveyor identified four doses of intravenous (IV, directly into a vein) piperacillin/tazobactam (antibiotic) for Patient 102. Inspection of the labels showed "do not refrigerate". Continued inspection of the labels showed "keep refrig (keep refrigerated)." Further inspection of 7E showed four IV doses of piperacillin/tazobactam for Patient 103. Inspection of Patient 103's labels showed the same conflicting storage directions. Assistant Nurse Manager H acknowledged the storage directions on the labels.

During an interview, on 4/9/12 at 9:10 a.m., the Director of Pharmacy and Pharmacist 1 stated the IV room compounded 85 medications per day and 20 chemotherapies per day (Monday - Friday).

During an administrative record review, of the hospital's policy and procedure for IV Pharmacy (Effective Date: 4/95, Date Revised: illegible) showed Policy "The pharmacy department shall be responsible for the aseptic preparation of all compounded IV and other special admixtures within applicable regulations and guidelines."

Based on interview and record review, the pharmacy failed to implement a policy and procedure to immediately report drug administration errors to the attending physician. In one, (Patient 10) out of 68 patient charts, six unreported medication errors were identified. This failure resulted in the potential for patients to be exposed to avoidable medication errors.

Findings:

During a concurrent interview and record review, on 4/9/12 at 10 a.m., Patient 10's medication orders are identified. Review of the medication orders, dated 3/27/12 at 5 p.m., showed for heparin (blood thinner) 5000 units subcutaneously (under a layer of the skin) q (every) 12h (hour), Prezista (medication) 800 mg (milligram) po (by mouth) q (every) hs (bedtime), and fluconazole (a drug to treat fungal infection) 100 mg IV q day. Further review showed orders, on 3/28/12, for Magic mouth (a solution to treat mouth infection) wash 10 cc (cubic centimeter) po q 6 hours, swish and swallow, 1st dose now and to change INH (isoniazid, to treat tubeculosis) to 600 mg IV qday. Registered Nurse (RN 12) reviewed the records and acknowledged, on 3/27/12, there was no documentation heparin and Prezista were administered. RN 12 acknowledged, on 3/28/12, there was no documentation Magic mouth wash was administered q 6 hours. RN 12 acknowledged, on 3/29/12, there was no documentation Prezista 800 mg qhs was administered. RN 12 further stated the 3/29/12 INH 600 mg IV and fluconazole 100 mg IV were not administered. RN 12 reviewed the records and acknowledged there was no documentation the physician was notified the patient missed receiving the ordered medications. Pharmacist 1 acknowledged the information above and stated these missed medications were medication errors.

During an administrative record review, of the hospital's policy and procedure for Medication Administration (Date Revised: 2/09) confirmed that the policy did not show a procedure if a scheduled medication was not given, due to reasons other than patient refusal or hospital withholding. The policy and procedure did not define what constitutes a medication error.

During an administrative record review, of the hospital's policy and procedure for Medication Errors-Pharmacy Department (Date Revised: 10/11) showed Procedure, 1. "The pharmacist must notify the patient and the prescriber that a medication error has occurred and the steps required to avoid injury or mitigate the error."

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

1. Ensure safe handling of potentially hazardous foods. This failure resulted in
an Immediate Jeopardy situation called on 4/12/12 at 5:10 p.m. and abated on 4/9/12 at 2:10 p.m. during the survey. Refer to A 619

2. Ensure a responsible daily management of the dietary services to assure the training of staff, participation in the Quality Assurance and Performance Improvement activities and implementation of written policies and procedures related to Food and Dietetic Services. Refer to A 620.

3. Provide a comprehensive therapeutic diet manual that reflected the diets offered in the hospital. Refer to A 631.

3. Ensure the nutritional needs of patients were met as evidenced by the lack of a comprehensive nutritional analysis of regular and therapeutic menus Refer to A 630.

4. Lack of menus for all physician ordered diets. Refer to A 628.

5. Lack of an effective system to ensure that physician ordered diets were followed. Refer to A 629.

6. Develop performance improvement activities that reflected the scope and nature of the services. Refer to A 265.

7. Ensure the maintenance of dietetic services equipment per manufacturers' guidance. Refer to A 701.

The cumulative effect of these systemic problems resulted in the inability of the hospital's food and dietetic to meet the Condition of Participation for Food and Dietetic Services.

Based on food services observations, dietary staff interview and dietary document reviews, the hospital failed to ensure that its food and dietetic services were organized to ensure safe food handling procedures through monitoring the temperatures of potentially hazardous hot and cold foods during production and storage. This failure may result in unsafe food handling practices that could potentially put the acutely ill patients at risk for food borne illnesses and medical complications. This failure resulted in an immediate jeopardy situation to the health and safety of the patients.

Findings:

1. During an observation tour of the kitchen at the main hospital on 4/3/12 at approximately 9:20 a.m., there was a stainless steel pan of cooked pieces of turkey on a cart in the kitchen. Cook G, who was in the area , upon interview, stated that he had recently pulled the pan of turkey from the oven for lunch the next day. As observed and tested , the temperature of one of the turkey pieces 174 degrees Fahrenheit.

During lunch trayline observation on 4/13/12 at approximately 11:20 a.m., the food service staff checked the temperatures of hot food items, but did not check the temperatures of the cold food items. In an interview at 11:50 a.m.The Food Svr Manager 3 said that they staff have taken or recorded cold food temperatures.

At 11:40 a.m, there were there were two pans of whole roasted turkey breasts with an approximate weight of five to seven pounds each in the walk-in refrigerator. The turkey breasts were in a pan with a minimum of ½" of juices and covered with a metal sheet pan. The temperatures of the four turkeys ranged from 116-135°F.

At approximately 2:00 p.m. on 4/3/12, the turkey roasts were again tested.in the refrigerator in the presence of the Food Srv Mgr 4. The temperatures of the four roast ranged from 80 to 90 degrees Fahrenheit. After approximately four and a half hours from the initial time the roasts were placed in the refrigerator and greater than two hours since the last temperatures were checked, none of the roasts tested met the recommended temperature levels necessary to prevent the growth of microorganisms. According to food safety standards, Potentially Hazardous Foods (PHFs) should be cooled from 140 to 70 degrees Fahrenheit within the first two hours of monitoring.

During an interview on 4/3/12 at approximately 2:12 p.m., when asked how the temperatures of the turkey roasts were monitored, FSM3 stated that the hospital does not utilize any cooling logs because turkeys were not usually cooked the day before. FSM3 verbally acknowledged that the turkeys should have been cooled well with the blast chiller to aid in cooling, but the blast chiller was broken.

Cook G could not be interviewed on the monitoring of roasts and other previously cooked foods and leftovers because he had left for the end of the day. The roasts were discarded.

2. At approximately 2:50pm on 4/3/12 the contents of a small freezer stored in the trayline area were reviewed. FSM 3 indicated that the freezer held food for post-partum patients that nursing staff could access containers after hours. These labeled food containers had been labeled with the content and dates. The food containers were prepared from dinner entrees from various days. The dates were from 3/28/12 and 4/2/12. There were a total of 23 containers. Some of the frozen items were pork loin gravy with rice and asparagus, baked chicken, pasta and vegetables, tri-tip with potatoes and carrots, meatloaf, mashed potatoes and zucchini and fish, carrots and rice.

When FSM 3 was asked how the facility ensured that the food was appropriately cooled, she acknowledged that no monitoring logs existed to demonstrate that the facility monitored the food temperatures. Review of the hospital policy and procedure titled " Food Safety " revised 2/2011 indicated " cold food temperatures are monitored at the beginning and end of trayline. Temperatures are recorded on designated logs. "

3. During general food production observations on 4/3/12 beginning at 9:20 am, DS 2 was introduced by FSD as the person responsible for cold food production activities.

In an observation on 4/3/12 beginning at 9:30 am, DS 2 was observed making a deep stainless steel pan of tuna salad. He stated that the tuna salad would have multiple purposes but would primarily be used for the cafeteria salad bar. It was noted that the temperature of the item was 58°F. DS 2 stated that once the item was finished it would be placed in the refrigerator after which it would be part of the salad bar beginning at approximately 10:30 am. He also stated that this production method was his normal routine and that all of the cafeteria items would be produced between the hours of 8 and 9:30 am. The surveyor asked if there were any additional steps that would be taken prior to placing the item in the refrigerator and/or placing the item on the salad bar. He stated there was not.

Canned tuna would be considered a potentially hazardous food (PHF). PHF's are capable of supporting bacterial growth associated with foodborne illness. The standard of practice would be to ensure that PHF's are time/temperature monitored for food safety. Other PHF's that a require time/temperature monitoring for food safety include raw or cooked animal food, cooked plant foods, cut melons, leafy greens or tomatoes. It would also be the standard of practice to ensure that foods PHF's that were prepared for cold production would reach a temperature of 41°F or below within 4 hours of production to ensure for food safety (Food Code, 2009). Hospital policy titled "Proper Cooling of Foods" dated 2/11 guided staff to utilize these parameters.

In an interview on 4/3/12 at 10:30 am, FSD described the system for ensuring safe food handling practices. She stated that she appointed food service supervisors who were responsible for the day to day operations of the department. She also stated that on occasion she did spot checks. The surveyor asked her to describe what the spot checks would entail. She described a general walk through procedure. She also stated that if she happened to notice something that did not meet safe food handling standards she would instruct staff at that time. She also stated there was no formalized system for her spot checks; rather were general, unspecified observations. Undated hospital position description titled "Director of Food and Nutrition Services" revealed that it was the responsibility of this position to ensure safe food handling practices within the department. Similarly the hospital policy titled "Accountability and Responsibility" dated 3/09 noted that the Director of Food and Nutrition Services is directly responsible ...to enforce all federal, state and local laws in Food and Nutrition Services."

4. During a follow up observation on 4/3/12 at 2 p.m., the following deli meats and temperatures were noted: turkey-53°F, roast beef-51°F, pastrami-50°F, tomatoes-50°F. It was also noted that these items were in the salad bar closest to the cash register (Salad Bar #1). In a concurrent interview with DS 5 she was asked if there was any temperature monitoring of these PHF's during service. She stated there was not and replied that the only temperatures taken were of the hot foods at the beginning of service. Concurrent review of hospital document titled "Cafeteria Food Temperature Log" dated 4/3/12 confirmed that during food holding the only items that were monitored were hot items. There was no monitoring of cold PHF's. Additionally the items were only monitored once, at the beginning of service. Hospital policy titled "Food Safety" dated 2/11 guided staff to "Hold potentially hazardous foods at temperature > 140 and < 41F, discard food that spends more than 4 hours total in the temperature zone, this includes the time spent during receiving, storage, preparation and cooking and again during holding, cooling and reheating."

5. In an additional observation on 4/3/12 at 3:15 pm, in the presence of FSD it was noted the roast beef had a temperature of 52°F and the deli turkey was 53°F. It was also noted that the items were moved from salad bar #1 to the second salad bar. In a concurrent interview with DS 6 he acknowledged that he moved the items from the 1st to the 2nd salad bar in an effort to consolidate them prior to setting up the remainder of the bar for the evening meal service. There was no indication that the items were to be removed prior to beginning the evening meal. As the FSD and the surveyor left the cafeteria area on 4/3/12 at 3:30 pm, RDA asked DS 6 to toss the remaining salad bar items. There was no indication that removal of the items prior to the 4 pm, evening meal service was the standard of practice for DS 6.

In an interview on 4/3/12 at 5:10 p.m., FSM 5 stated he felt that holding of PHFs for extended periods of time, up to 6 hours, at temperatures above 41°F was an acceptable method to ensure food safety. The standard of practice for all PHFs which are prepared and held for later use, rather than for immediate consumption, would be to monitor for time/temperature control for food safety (Food Code, 2009).

The lack of the effective systems to ensure that the handling, production and storage processes were safely implemented and that potentially hazardous foods were monitored in accordance with acceptable standards of practice resulted in an immediate jeopardy situation to the health and safety of the patients. The Immediate Jeopardy was related to the lack of effective monitoring of food temperatures during hot and cold production and during cold storage. The immediate jeopardy was called on 4/3/12 at 5:10 p.m. in the presence of the Chief Operating Officer, Director of Quality and the Director of Food Services.

On 4/5/12 at 9 a.m., the hospital submitted an approved plan of correction in response to the Immediate Jeopardy. The plan included the development and implemation of systems and implementation and staff training of the following: 1). to monitor the temperature of cold production of PHFs to ensure that the foods were prepared and served within the proper and adequate time/temperature controls; 2). ensure hot foods were properly cooled within specified time/temperature parameters.

Monitoring of the proposed systems and staff competency from 4/6 -4/9/12 showed that the hospital was able to: 1). develop a system to ensure time/temperature control of potentially hazardous foods; 2). demonstate that the developed system was sustainable; and, 3) demonstrate staff competency in these tasks.

The Immediate Jeopardy was abated on 4/9/12 at 2:10 p.m. at which time, the team notified the hospital's Director of Quality.

Based on food storage and food production observations, dietary staff interview and dietary document review the hospital failed to ensure the Food and Dietetic Service manager effectively developed written procedures, according to standards of practice for operational processes. Failure to develop standardized procedures may result in patients being exposed to foodborne illness and cross contamination which may further compromise medical status.

Findings:

1. During cold food production observation on 4/2/12 from 9:30 a.m. to 10:30 a.m., the cut up romaine lettuce were in a two-compartment sink in the cold food production area at thel left hand of the sink. At 10:30 a.m., there were remants of the romaine lettuce. At 10:45 a.m, during an interview about the process for using lettuce, DS 2 said that he generally washed the lettuce once during his shift. He would fill the first sink, (identified as the left hand side of the sink) with water and salt and soack the lettuce for a hole. He drained the water and would move the lettuce to the second sink (right hand side) for several hours. The described procedure allowed the lettuce to remain in contact with potential contaminants such as soil. The standard paractice (Food Code, 2009) is to thoroughly wash the lettuce in a manner to remove the soil and contaminants.

2. During an observation at the main hospital's kitchen on 4/2/12 from 9:45 a.m.- 10:05 a.m., DS 1 washed pots and pans in the small dishroom with gloves while running the pots and pans through the dishwasher. As observed, he moved consistently berween the soiled and cleaned dishes without handwashing. There was no handwashing sink in the pan dishroom. DS 1 said that he rinsed and scrubbed the food scraps from the dishes and placed the dishes in the dishwasher for final cleaning.

3. On 4/4/12 at the Fairmont Campus kitchen, at approximately 10:05 am a pan of sliced turkey was observed on the kitchen counter being prepared for service in the cafeteria. A check of the temperature revealed the turkey slices to be 55 degrees Fahrenheit. Cook 7 stated that there were no logs available to demonstrate monitoring. Cook 7 stated that the food warmed up while being cut for service.

During food storage observations on 4/5/12 at 12:55 pm, there were three rows of whole, roasted turkey breasts, each weighting approximately 5-7 pounds in the blast chiller. The temperature of two of the roasts on the first row was 73°F and 78°F; the turkey on the 2nd row was 78°F; and the 3rd row was 83°F.


On 4/4/12 at approximately 10:15 am, he provided documentation from the United States Department of Agriculture, 2009 Food Code. Concurrent review of the provided document revealed that while it may be acceptable to utilize time without temperature as a control for food safety all of the following parameters must be met: 1) the food shall have an internal temperature of 41°F or less when removed from temperature control and may not exceed a temperature of 70°F. The hospital did not have a system to monitor the temperature of cold foods before they were placed on the cold food line; 2) The food shall be monitored to ensure the internal temperature does not exceed 70°F during the 6-hour time frame. The hospital did not have a system to monitor cold food temperatures during meal service; 3) the food shall be marked when it was removed from temperature control of 41°F or less and shall be marked with the time that the 6 hours have passed. There was no indication of time when food items were placed on the cold food line. The hospital had not developed a comprehensive system to utilize time without temperature control for the assurance of food safety.


4. During several interviews with the Food Service Director (FSD) from April 3-5, 2012 and April 9, 2012, there were several observations made that reflected lack of oversight of food service or clinical nutrition staff. Some of these deficient practices were exaggerated by the organizational structure and size of the department. Review of the organizational chart showed the FSD to be responsible for staff in two campuses. During the many interviews conducted with the FSD, she indicated that she managed the department through the use of managers. This was evident in the food service portion of the department but there was a vacant position for the position of clinical nutrition manager. There were several nutrition care areas that had not been properly managed.

As a result of this style of management, she was not aware from some of the issues that affected the campus or areas of the department. For example, although she had developed polices and procedures she not been aware that staff were not following the proper cooling methods to ensure food was prepared in a safe manner. The food supplies, food temperatures had not been monitored prior to the survey. The chemical concentration of sanitizing buckets were not been monitored. Food storage and production activities revealed deficient practices that had not been identified prior to the survey. For example, oily residue on green peppers, inadequate production of the different kinds of diet on trayline.

Although, her background is a registered dietitian, and stated that she supervised the clinical dietitians, the quality improvement indicators selected for review did not seem to be those that reflected issues of the department (cross refer A701) Interviews with some of the registered dietitians on 4/4/12 and 4/9/12 showed that they did not participate in the development or activities in the food service operation. Interview with one of the dietitians was not completed because of time limitations; she indicated that she had to leave before a clinical record review was completed. There did not appear to have been direction from the director to ensure that the nutrition care provided to the patients was clearly presented and or demonstrated in the care of this patient (Patient 10).

Menus had not been written for the all diets that were being ordered by the physicians. The nutrient analysis of the diets had not been completed. There did not appear to have effective system to communicate and document the recommendations of the registered dietitians ' (RD) in clinical records. RDs inform the physician ' s of their recommendations by writing them on " post it notes " . These recommendations are available in the electronic version of the record in the nutrition notes that the physicians do not have access to. The concern is that if these notes were displaced, a physician would not be informed of the recommendations. In addition, the hand written versions do not become permanent part of the paper record.

Personnel record review of the food service director was reviewed. There was no documented evidence that her performance as a director was evaluated since 2005.

5. During random review of selected departmental policies and procedures related to identified deficient practices in dietetic services it was noted that policies did not consistently provide sufficient procedural guidance that reflected current standards of practice. In an interview with FSD on 4/9/12 beginning at 9 am, she acknowledged that the scope of the department would include a wide array of processes and that not all of the food handling functions were written as a procedures.
a) The policy titled "Dishwashing Temperature Control Log" dated 1/06 guided staff that when large pots and/or large utensils require "Alternate Means to Wash Pots" in the pot room double sink the first sink was filled with hot water and detergent and the second with sanitizer. This procedure does not support the standard of practice of ensuring a 3-step process for manual ware washing (Food Code, 2009).
b) The hospital document titled "Food Safety: dated 2/11 guided staff that product is washed before cutting; however the policy did not give adequate procedural guidance to prevent additional cross contamination during the food preparation process (Cross Reference A749).
c) The hospital document titled Cleaners and Sanitizers Used in FNS" dated 4/11 noted that the purpose of the document was to ensure that "All equipment and food surface contacts are cleaned and sanitized with the appropriate chemical." While the policy provided a list of the chemicals and which pieces of equipment the list may be used for, there was no procedural guidance on how to correctly use the chemicals.
d) On 4/4/12 beginning at 9:35 am, the cleaning of the large steam kettles was reviewed with DS 7. It was determined there was no sanitation of the large steam kettles. Review of the departmental policy and procedure manual dated 2011 revealed that there was no procedure for cleaning large pieces of equipment.

6. In an interview with FSD on 4/9/12 beginning at 10 am, and concurrent review of performance indicators beginning in 2009 revealed that the dietary department was submitting data on multiple processes within the department (Cross Reference A265). FSD acknowledged that with the majority of these indicators the department was meeting or exceeding the departmental set thresholds. She also stated that within the last several years the department had not identified new issues that may warrant a performance improvement study. It was also noted that while the department was monitoring some food services performance indicators, there was no evaluation of safe food handling systems within the department. Review of dietary department policy titled "FNS Performance Improvement" dated 2/11 revealed that the purpose of performance improvement in the department was to "measure performance indicators and identify areas needed improvement." While the department did measure performance indicators, there was lack of identification of areas that may benefit from improvement.

In a follow up observation on 4/5/12 at 10:50 am, it was noted there was a pan of tuna in the 3-door refrigerator adjacent to the cafeteria line. The temperature of the tuna was 46°F. Additionally a 4-ounce container of yogurt was 44°F. Concurrent observation of the thermometer in the refrigerator read 32°F. In a concurrent interview with FSD she stated the thermometer may be broken. An additional observation on 4/5/12 at 1 pm, noted the temperature of the following items on the salad bar-roast beef-50°F; pastrami-51°; tomatoes-50°. The surveyor asked whether or not staff monitored the ambient air temperature of the refrigerated buffet unit, she replied they did not. It was noted that the 1st unit did not have a thermometer under the pans; however the 2nd unit did.


7. The quality indicators that had been selected by the Nutrition services Department had consistently met threshold required. Nutrition care areas that needed improvement were not measured. The Director of the Foodservice (FSD) was interviewed on why other problems such as failure to screen in a timely manner reviewed and considered for improvement. The FSD had indicated in an interview on 4/9/12 at approximately 9:45 am that she had been aware that nursing staff had not been consistently referring patients who had been identified to be at nutritional risk by the nursing staff and that she had discussed this with the nursing director.

An interview was conducted on 4/9/12 at approximately 11 am, with the Director of Nursing on the lack of referral of nursing staff to the registered dietitian when a nutrition risk factor based on the admission screen. She stated that there has not been a meeting between her and the Director of the Foodservice (FSD) to discuss these concerns.

Based on foodservice observations, clinical record reviews, dietary staff interview and dietary document review the hospital failed to ensure the development of a vegetarian and low purine diets. The hospital ' s failure to develop menus resulted in the inaccuracy of diet provided to three patients (Patients 125 and 126 and one non-sampled patient 130) In addition, the failure to develop menus in conjunction with a nutritional analysis of the menu may result in nutritional deficits within the diet, compromising the nutritional and medical status of patients.

Findings:

1. Clinical record review on 4/4/12 at the Fairmont Campus revealed that Patient 126 was admitted to the facility on 04/03/12 with diagnoses including gout flare up, history of obesity, hypertension and bell ' s palsy. His physician ordered diet was low sodium, low fat, low purine diet.

Gout is a form of arthritis has been associated with high intakes of meats, seafood and alcohol. It occurs when there are high levels of uric acid in the blood. When thee uric acid crystallizes and settles into joints it causes gout. The body produces uric acid when it breaks down purines in the diet. Therefore to limit uric acid production in the body, a low purine diet is usually recommended.

According to the copy of " Low purine/ Purine Restricted Nutrition therapy " by the American Dietetic Association, a documentation provided by the hospital, " No foods must be completely avoided ... ...should limit foods high in purines " Under the list of foods high in purines were fish including cod fish.

Review of the lunch menu on 4/4/12 revealed the entrée was Lemon Pepper fish. In an interview with the foodservice manager (Food srv mngr3) at approximately 3:30 pm, she indicated that the kind of fish used in the preparation of the entrée was cod fish. Therefore the patient received and item that should have been limited in the diet. Due to a lack of a menu, it is difficult to determine that adequate amount of high purine foods were limited in the patient ' s diet to prevent flare ups since the hospital failed to plan the menu and did not have a nutrient analysis.

2. During general meal observations on 4/4/12 beginning at 12:30 pm, at the Fairmont campus it was noted that Patient 43 had a physician ordered vegetarian diet. Non-sampled patient 130 also had a vegetarian diet ordered. However, Patient 125 was not ordered a vegetarian diet.

Meal observation for patient 125 revealed his meal tray slip to have the word " Vegetarian " hand written as a heading on a pink Puree diet meal tray slip, implying that he was on a vegetarian puree diet. In addition, puree fish with lemon sauce was crossed out and no other entrée of protein source written on the meal tray slip. The meal tray slip for unsampled Patient 130 was also reviewed. His meal tray slip was puree diet and not identified as vegetarian.

It was also unclear why one patient on the vegetarian diet had a fish entrée planned and the other did not have fish or other protein source planned since the staff had not interviewed Patient 126 when the meal tray cards were prepared to determine whether the patient would eat fish on his vegetarian diet. The hospital system showed lack of consistency in the planning of the vegetarian diets.

In an interview on 4/4/12 beginning at 3 pm, with DS 8 she was asked to describe how she would provide for this diet. She stated that would take a regular patient menu and remove all the animal based items, depending on whether the patient restricted only meats or all animal based products. She also stated that she would use the undated hospital document titled "Daily Main Entrée Alternates Substitution" to make the meal selections. When asked if there was a spreadsheet for a vegetarian diet she stated there was not. A spreadsheet is the standard foodservice document used in foodservice institutions to direct foodservice staff on specific items to provide to patients based on their food choices and items allowed on the diet for that particular meal.

In an interview at approximately 3:45 pm on 4/4/12, RD 4 indicated that patient 130 was on a vegetarian diet. According to RD 4, it appeared that the diet order for Patients 126 and 130 was accidentally switched because she sure Patient 126 was not a vegetarian but a puree diet and Patient 130 was on a Pureed vegetarian diet. She further stated during the same interview that the diet office may have erroneously entered the wrong diet in the system, thereby causing the patients to receive the incorrect diets.

A review of the spreadsheet at the Highland Campus revealed the food service staff are provided with specific food items for eleven diets (regular, NAS (no added salt) soft, 2gm (gram) Na (sodium), LF (low fat), Low Chol (cholesterol), cardiac, renal, diabetic, pureed and mechanical soft). There was no spreadsheet for patients on the vegetarian or low purine diets. Furthermore, the copy of the one day nutrient analysis provided for review did not include analysis for either the low purine or vegetarian diets.

3. Review of the menu for the Highland campus revealed a menu that had limited variety in its vegetables. The campus which has a one week menu served some vegetables three consecutive days. For example, Broccoli was served Saturday, Sunday and Monday at lunch. Peas and carrots were served Wednesday and Thursday and plain carrots on Friday. According to the spreadsheet, Spaghetti was served Saturday and Sunday for Lunch. When these observations were brought to the attention of the FSD, she stated she had not noticed these repetitions and that the spaghetti was a typographical error. She stated also that she had not observed the error because the hospital staff do not use the spreadsheet.

Review of the Week 1 menu for the Fairmont campus revealed that rice was served in one form or the other for six out of seven days. Patients on Puree diets were also served the same kind of meat each time they are served. The facility uses a preformed product for their meats and vegetables. Each time beef is served, patients on pureed diet will receive the same tasting beef on consecutive days. Mashed potato is another menu item served with high frequency. These observations are significant for patients on the rehabilitation units who may stay between 14 and 21 days at the hospital. Repetition and lack of variety could lead to decreased meal intake and eventually weight loss

The hospital lacked an effective system to ensure that menus provided variety. It failed to ensure that menus for not frequently ordered diets were developed. The hospital failed to ensure that the nutritional needs of patients on low purine and vegetarian diets were met. The failure to develop menus in conjunction with a nutritional analysis of the menu may have resulted in nutritional deficits within the diet, compromising the nutritional and medical status of patients.

Based on medical record review and dietary staff interview the hospital failed to ensure two of 11(Patients 44 and 121) patients reviewed for nutrition care received diets as prescribed by the physician. Failure to ensure diets were prepared per the physicians' diet order may result in compromising patient nutritional and medical status.

Findings:

1. According to the lunch menu and spreadsheet, the following items were to be served for patients on the regular diet: Beef Barley Soup, BBQ Pork Chops, Mustard greens, corn, jello and fruit cup corn bread, margarine and Iced tea.
During tray line observation on 4/3/12 at approximately 11:00 am, the trays of
several unsampled patients were observed on the tray line being prepared for delivery to their rooms. Close observation of the meal trays revealed hand written word " mech " mechanical on preprinted soft diet meal slips. This implied that the diet slips were mechanical soft diets.

The items in served to all patients on Mechanical Soft diets did not appear to be in line with current nutrition care practices. It is generally a regular diet with items chopped to small easy to chew pieces. The expectation was for these patients to receive BBQ Pork chopped, in addition to the other menu items and individualized modification if other menu items were not tolerated. Instead, they were served chopped gingered pork chops, noodles, chopped green beans, jello.

A mechanical soft diet is a diet " designed to minimize the amount of chewing necessary to ingest food " ordered for patients chewing problems to ensure ease with chewing. It is a transition between a soft diet and a regular diet.
The use of a soft diet for Mechanical Soft diets placed patients on more restrictive diets than were ordered by their physicians. This observation was acknowledged in an interview with Foodservice Director (FSD) in interview on 4/3/12 at approximately 12:00 PM in which she stated that mechanical soft diets were served the same items as soft diets but chopped. She also stated it was easier for food production reasons

During the same observation on 4/3/12, the staff was observed to serve patients on other diets more restrictive diets while other diets were not as restrictive as was ordered by the physicians. For example, patients on diabetic diets should have received LF BBQ Pork Chop instead they received the LS Gingered Pork Chop. These patients were restricted in sodium in addition to fat. Patients on Cardiac diets should have received LSLF BBQ Pork Chops, instead they received the Gingered pork Chop which was prepared without salt according to the cook. These groups of patients received a low salt diet but not sure whether it was also low fat. The cook had used a different recipe than was provided by the facility. The hospital did not prepare the LS, LSLF and LF versions of the BBQ Pork Chop.

The same pattern of restricting patients more than diet ordered by the physician was also observed on the Fairmont Campus. On 4/4/12, review of the diet spread sheet indicated that the same food items were served to patients on diabetic, LF, LS and renal. There were no other versions of the entrée except for LS and pureed. A taste test of the lunch meal revealed a low salt, low fat meal. There was a slight difference in terms of sodium between the regular and low salt versions of the Lemon Pepper Fish., the steamed rice was dry, salt-less and oil or sauce free. The mixed vegetable was also salt-less and oil free. Only one pat of margarine was provided which when put on the bread limit its use for other food items served.

2. Patient 44 was admitted to the behavioral health unit with mental health diagnosis. It was also noted that Patient 44 had a medical diagnosis of diabetes. Admission diet orders dated 3/9/12 was for an 1800 calorie ADA diet. Additional physician ordered diets were as follows: 3/11/12-low fat, mechanical soft ADA diet; 3/12/12-low fat, low cholesterol with the addition of Glucerna® 1 can if intake is less than 50%, 3/19/12-2000 calorie ADA low fat, low cholesterol, with no hard fruits of vegetables.

Medical record review was conducted on 4/4/12 beginning at 1 pm. Review of dietary intake from on 3/18-3/26/12 revealed that Patient 44 was offered 3 meals as well as 3 snacks/day, in addition to a nutritional supplement if consumption was less than 50%. In an interview on 4/4/12 with DS 8 beginning at 3 pm, she was asked to describe how Patient 44's diet order would be implemented. She stated that since the physician ordered a 2000 calorie diet she would utilize the 2000 calorie meal pattern that was developed. She also stated that the meal pattern did not include snacks; rather the calories were distributed for three meals/day.

In an interview on 4/4/12 beginning at 3:15 pm, with RD B she acknowledged that Patient 44's physician ordered diet was likely not followed since with the exception of 1 meal on 3/23 there was consistent meal consumption of 100 percent of offered meals in addition to 3 snacks.

3. Patient 121 was admitted on 3/12/12 to the behavioral health unit with mental health related diagnosis. Patient 121 also had a medical diagnosis of diabetes. On 3/21/12 the physician ordered a low fat, no added salt, carbohydrate controlled diet. In an interview and concurrent document review on 4/4/12 beginning at 3 pm, Patient 121's evening meal ticket was reviewed. The following guidance was noted on the meal ticket CHO (carbohydrate) controlled, low fat and no added salt. DS 8 stated that for the CHO controlled diet she would use the 1800 calorie meal pattern and would add cardiac restrictions for the low fat and no added salt portion of the diet.

In an interview on 4/4/12 beginning at 3:15 pm, with RD B she acknowledged that the use of the described meal pattern would not accurately reflect the physician ordered diet and would provide for greater restrictions than the physicians' order. Calorie controlled diets, such as an 1800 calorie diet, limits the amount of calories consumed within a 24 hour period. In contrast, a consistent carbohydrate diet (CCHO), generally indicated as part of the treatment for a diagnosis of diabetes generally would not limit the number of calories consumed rather limits the amount of carbohydrate per meal. In addition the number of carbohydrates would be comparable each day between breakfast, lunch and dinner (American Diabetes Association 2006).

In an interview on 4/4/12 beginning at 4 pm, with FSD she stated that the hospital had switched from calorie controlled diabetic diets to a carbohydrate controlled diet (CHO controlled). She also stated that the physicians ordered the diet as a CHO controlled diet at the time of admission. She further stated that this diet had 4-6 carbohydrate choices per meal which equated to 1800-2000 calories/day. She also stated that after admission the RD did a nutrition assessment and would recommend a change in carbohydrates and/or calories as the need arose.

Review on 4/9/12 of hospital document dated 2011 titled "Nutrition Analysis New Menus" revealed that a cardiac diet (which was a combination of a low fat and sodium diet restricted) limited sodium intake to 2,167 milligrams/day. In contrast a no added salt diet would have had 4,471 milligrams of sodium. The document also guided staff that for a Diabetic/Carbohydrate Controlled diet the "MD should specify calorie level. The hospital document was in direct contrast to the interview with the FSD . Additionally, the hospital document titled "Nutrition Care Process", dated 1/20/11 revealed that the presence of a carbohydrate controlled diet, in the absence of other nutritional risk factors, would not trigger a nutrition assessment prior to the 7th day of admission.

Based on dietary staff interviews and review of dietary departmental documents the hospital failed to ensure the patient regular and therapeutic menus were analyzed for the nutritional components to meet the current national standards including the RDA (Recommended Dietary Allowances) and the DRI (Dietary Reference Intake) of the Food and Nutrition Board of the National Research Council. This has the potential for the patients in the hospital to not receive adequate nutrition and to meet the estimated recommended dietary allowances for all nutrients. In addition, the nutritional needs of one sampled patient (Patient 10) who had been identified as high nutritional risk was not met due to lack of referral nursing staff to the dietitians and failure to follow physician ' s order.

Findings:

Patient 10 was admitted to the hospital on 03/27/12 with diagnoses including severe thrush, fever, TB (tuberculosis). According to hospital policy titled " Nutrition Care Process (Screening Process Assessment) for Acute Care Patients " a nutrition screen is completed within 8 hours of admission on the Admit Data Base and Nursing Assessment . Positive responses to the nutrition triggers will result in a referral to Food and Nutrition Services (FNS). The dietitian (RD) will respond to nursing referral within 48 hours. "

Patient 10 had two positive responses to two out of the ten nutrition triggers. He answered yes to unplanned weight loss and problems swallowing or chewing. These responses were not passed on to the RD and therefore Patient 10 was not assessed by an RD 7 until 72 hours after his admission.

There was documentation in the clinical record that Patient 10 had pain in his throat and was refusing medication and food. His initial diet order was clear liquids and on the recommendation of the RD 7 his diet was changed to mechanical soft. He was assessed at moderate risk due to his other diagnoses and not due to his nutrition triggers.

His recorded food intake was initially up to 75 % when he was on the clear liquid diet but with increasing throat pain due to thrush his intake dropped to 30% and by 4/3/12 he had started to refuse medication and meals and also because he also had nausea. On 4/5/12, Patient 10 was seen for follow up by another RD (RD 8) 5 days after the initial Nutrition assessment by RD 7 per hospital policy due to his classification as a moderate nutritional risk. There was no evidence that Patient 10 was referred to the RDs due to his declining food intake and meal refusals. RD 8 in follow up assessment then recommended that he receive Ensure plus three times a day with meals. She further recommended a " swallow eval (evaluation) due to the patient ' s variable intake " . RD 8 had to leave in the middle of the clinical record review, therefore, she was unable to explain the rationale behind her recommendations.


Patient 10 ' s throat had been examined on 3/27/12 and it was determined that he to have severe thrush affecting his posterior oropharynx and tongue. A swallow evaluation did not appear to be the appropriate recommendation for this patient has the cause of his swallowing difficulty had already been determined. His refusal to eat was due to pain and recommending more nutritional supplements that he would have had to consume by mouth would not have provided any nourishment.

Patient 10 was to have received intravenous pain medication to alleviate pain in his throat to enable him take medications for his thrush and other necessary medications. But this medication was not given by the nursing staff for over seven days. The physician order on 3/29/12 was for Fentanyl IV prior to giving po (oral) meds (medication). The other included receiving Fentanyl every 2 hours for pain as needed. The patient received the medication once and none thereafter until 4/5/12 when it was pointed out to nursing staff by the surveyor that he had not been given medication that would have alleviated this pain and allowed him to take medication to treat the thrush.

In an interview with Nurse10 on 4/5/12 at approximately 4:05 pm, she stated that she was not aware that he was to receive the intravenous medication for pain. She stated that he had been refusing all medications and food and did not indicate that he was in pain. The patient who was only Spanish speaking was interviewed by the surveyor in Spanish. He indicated that he had pain in this throat, pain at the IV site and was feeling very nauseous and was not interested in eating or taking any more medications. The surveyor was able to speak to him and with use of hospital interpreter, he agreed to the intravenous pain medication. Nurse 10 gave him the medication and within five minutes had requested and was drinking " Coke " .

Review of his pain assessment evaluation in the clinical record indicated " 0 " most days and shifts. Documented source of determination was " face " or Wong-Baker, pain scale method developed for infants that uses facial expression to determine level of pain. A " 0 " indicates no pain. There was very little documented evidence that pain was evaluated by asking patient in Spanish, a language he understood. Further review of the clinical record showed inconsistent documentation of the amount of meals consumed by Patient 10. There were several days that the information was not documented,

On 4/9/12 at approximately 11:20 am an interview was conducted with RD 7. In response to a question on how she determined Patient 10 ' s nutritional risk and follow up time, she stated that it was based on his diagnoses. She denied receiving a nursing referral for poor swallowing and unintended weight loss. The diet order document she provided validated this. On the issue of her determination of Patient 10 eating 75 % of his meal, she stated in the same interview that when she spoke with the patient he did not indicate that he was refusing meals and that he was " eating OK " when it was pointed out to her that there were several missing documentation of % of meal consumed, she stated that when the patient stated " he was eating OK " , it meant to her that he was eating fine and intake was " meeting his estimated needs.

She acknowledged that the lack of referral by nursing staff or missing meal intake consumption documentation was not unusual and that her manager and nursing manager were also aware or the inconsistencies. Interviews with FSD at approximately 10:45 am and 11:30 am on 4/9/12 revealed she was aware that patients screened to be at high nutrition al risk were not consistently referred to the FNS and had met with nursing manager to resolve this. She had provided no explanation when asked why this was not included as part of quality improvement for her department (cross refer)

An interview was conducted on 4/9/12 with the director of nurses on the nursing staff inadequately managing the pain of Patient 10, inconsistent documentation of meals consumed and failure to refer patient with nutrition triggers. She stated that she had not been aware of the issues described and had not met with the FSD on any of these issues.

The hospital failed to ensure that the nutritional needs of Patient 10 was met due to failures in referral, assessment and following physician ' s orders.

On 4/2/12 at 3 p.m., the hospital's nutrient analysis for the regular and therapeutic diet menus was requested. On 4/5/12 4:30 pm, the analysis was submitted. In a concurrent interview with FSD she stated that she only had an analysis of 1 day for each of the menus. She stated that the day that was analyzed was Thursday, for the one week menu cycle, using a software program. There was no analysis of the remaining days of the regular or therapeutic menus. It was also noted the analysis was not comprehensive, rather evaluated 8 of 14 vitamins and 7 of 15 elements for which there are recommended intakes. It was also noted that not all of the diets met the recommended adequate intake for fiber.

Review of the DRI for Macronutrients, dated 2002/2005, indicated total fiber for males nine through 13 years of age is 31 g; 14 through 50 years of age is 38 g; and 50 years through greater than 70 years of age is 30 g; females nine through 18 years of age is 26 g; 19 through 50 years of age is 25 g; 50 through greater than 70 years of age is 21 g. The hospital menus were inadequate in Fiber depending on the age and gender. Analysis for the soft diet revealed it contained 19 grams of fiber and the renal diet contained 16 grams of fiber;

On 4/9/12 beginning at 8:30 am, with FSD she acknowledged that she had signed the menu spreadsheets. She also acknowledged that, as the Registered Dietitian, by signing the menus she approved them and that they would meet the nutritional needs of patients as well as follow parameters specified in the hospitals' diet manual and that a single day analysis may not be reflective of the full menu. The menus used were not evaluated for the complete array of macro and micro nutrients specified by the Food and Nutrition Board of the National Research Council. Hospital policy titled "Menu Analysis" noted that the "A computerized analysis of basic menus is kept on file." There was no indication that the hospital policy was followed.

Based on trayline observations, dietary staff interview and dietary document review the hospital failed to have a therapeutic diet manual that accurately reflected physician ordered diets within the hospital and current standards of practice. Lack of a current and comprehensive diet manual that reflected hospitals' routinely ordered diets may result in inaccurate guidance to dietary and hospital staff when meeting the nutritional needs of patients, further compromising medical status.

Findings:

During meal distribution observation beginning at 1 pm, it was noted that Patient 121 had a tray ticket with a physician ordered carbohydrate controlled diet. A carbohydrate controlled diet, indicated as part of the treatment for a diagnosis of diabetes, generally limits the amount of carbohydrate per meal. In addition the number of carbohydrates would be consistent between breakfast, lunch and dinner each day (American Diabetes Association, 2006).

In an interview on 4/4/12 beginning at 4 pm, with FSD she stated that the hospital had switched from calorie controlled diabetic diets to a carbohydrate controlled diet (CHO controlled). She also stated that the physicians ordered the diet as a CHO controlled diet at the time of admission. She further stated that this diet had 4-6 carbohydrate choices per meal which equated to 1800-2000 calories/day.

Comparison of the nutrition care manual on 4/9/12 at 9 am, with the hospitals' undated document titled "About the ACMC Nutrition Care Manual" revealed that it was a conceptual description of diets. This document did not functionally describe the hospitals' most commonly ordered diets nor did it accurately reflect the relationship between the hospitals developed document, the menus served and the Nutrition Care Manual developed by the American Academy of Nutrition and Dietetics. Similarly there was no defined meal pattern for the diets listed; rather noted food selections that may be offered and/or avoided on specific diets.

A diet manual would ensure that the diets offered met the current standards of practice, included a comprehensive description of the therapeutic diets offered by including the purpose of the diet, indications of the diet, nutritional adequacy, sample meal plans consistent with the hospitals' menu and the standard of practice references for the diets. While the hospitals' system for using the Nutrition Care Manual in conjunction with the hospital developed document titled "About the ACMC Nutrition Care Manual" had some of the elements, not all elements were present for each routinely ordered hospital diets that would allow for hospital and/or dietary staff to use the document as a comprehensive resource to order and/or prepare patient diets. Review of hospital policy titled "Menu Analysis" dated 2/11 revealed that the "Nutrition Care Manual indicates the nutritional adequacy of the diets served as compared to the RDI's" there was no indication that the hospital developed a manual that supported the policy nor the standard of practice.

Based on food dietetic services observations, dietary staff interview and dietary document review the hospital failed to ensure that dietetic services equipment was maintained per manufacturers' guidance as 1) evidenced by a blast chiller that no longer printed the temperature monitoring log; 2) cracked areas on two ice machines at the Highland and Fairmont campus; 3) lack of effective sanitation of dishes at both the Highland and Fairmont campus and 4) absence of air gaps in two food production sinks at the Highland campus. Failure to maintain equipment per manufacturers' guidance may result in patients being exposed to cross contamination and/or exposure to the growth of bacteria associated with foodborne illness. Food borne illness may result in compromising medical status of inpatients and in severe instances may result in death.

Findings:

1. Based on food productions observations, dietary staff interview and dietary document review the hospital failed to ensure that the blast chiller was fully operational.

During interview with Food Manager 3 on 4/3/12 at approximately 2:00 pm, he indicated that the kitchen originally had 2 blast chillers but only one was in service. But there was a work order in place to fix the one that was in service. He stated that the blast chiller could have been used to cool the meats.

Review of hospital document titled "Engineering Services Department Service Request" dated 11/15/11 revealed that a request was submitted to have the right side of the blast chiller fixed as soon as possible. There was no indication that this piece of equipment was fixed to its full operational capacity, in a timely manner

2. During interview on 4/3/12 at 9:45 am, with ES 1 regarding the preventive maintenance of the ice machine in the kitchen at the Highland campus it was noted that there were several cracks on the plastic surround of the ice machine door. ES 1 stated he was unaware of the cracks and acknowledged that currently there were no replacement parts on order. Similarly during the food production observations in the presence of ES 3, at the Fairmont Campus on 4/4/12 at 10:45 am, it was noted that a dietary staff member was removing ice from the machine and was holding the door open using a piece of cardboard. He concurrently stated "the door won't stay open." It was also noted that the plastic surrounding the door also had cracks. In a concurrent interview with ES 3 he acknowledged the presence of the cracks and also stated that to his knowledge there were no replacement parts ordered.

It would be the standard of practice to ensure that non-food contact surfaces remained free of unnecessary crevices and allow for easy cleaning (Food Code, 2009).

3a.On 4/3/13 beginning at 2:30 pm at the Highland Campus, the dishwashing process was observed. It was noted that the temperature gauge for the rinse cycle was 150°F. In a concurrent interview with Food Service Manager 4 (FSM)he stated it was the responsibility of the supervisors to monitor the dishwasher temperature daily. He also stated the hospital used a temperature sensitive strip to ensure the rinse cycle reached adequate temperatures for sanitation. The strip would react by turning from grey to black if the temperature of the sanitation cycle reached 160°F or greater. At the request of the surveyor a temperature strip was run through the machine. It was noted that the temperature strip did not change color. The purpose of the strip is to indicate when dishes were properly sanitized (ThermoLabel, 2012). Concurrent review with FSM 2 of hospital dishwasher temperature monitoring log beginning March 2012 revealed that on 3/10, 3/13, 3/14, 3/15 and 3/21/12 the temperature strips did not turn black indicating that the water temperature, required for the effective sanitation of dishes, did not reach 160°F. It was also noted that while there was documentation that the machine was not effectively sanitizing dishes, there was no indication that supervisory staff recognized that the machine was not functioning properly, took steps to ensure that dishes were properly sanitized or requested service for the improperly functioning machine .FSM 5 was unable to offer an explanation why the lack of effective sanitation of the dishes was not recognized.

b. During dishwashing observations on 4/4/12 beginning at 9:50 am, it was noted that temperature recording for the sanitation cycle of the machine was not consistent. It was noted that 1 of 5 cycles observed the temperature gauge read 180°F. The remaining 4 cycles the gauge was150°F. At the request of the surveyor a temperature strip was run through the machine. It was noted that the temperature strip did not change color. In a concurrent interview with DS 3 he was asked how he ensured the machine was functioning properly. He stated that the correct temperature during the sanitation cycle for the machine was 180-190°F. He further stated that the supervisor was responsible for checking the temperatures. Concurrent review of the temperature logs with FSM 3revealed that temperatures were checked on a daily basis, in the morning. It was also noted that on 4/2/12 there was an inadequate reaction of the strip; however there was no indication that supervisory staff recognized that the machine was not functioning properly, took steps to ensure that dishes were properly sanitized or requested service for the improperly functioning machine. FSM 3 was unable to explain why he did not recognize the malfunction of the machine, based on the test strips.

In an interview on 4/9/12 beginning at 8:30 am, with FSD she acknowledged that while the bulk of the dishes were washed after meals, testing of the machine once/day may not offer adequate opportunities to ensure that the hospital equipment was functioning properly.

4. During general kitchen observations on 4/3/12 beginning at 10:45 am, a random dietary staff member was observed using the food preparation sink adjacent to the dish room for food production activities. It was noted that the sink did not have an air gap. Similarly during general kitchen observations on 4/3/12 at 2 pm, DS 4 was observed draining vegetables in the sink across from the steamers. There was no observed air gap for this sink.

In an interview on 4/9/12 at 10 am, with ES 2, he acknowledged there was likely no air gap on these two sinks. It would be the standard of practice to ensure that all food production equipment, non-food equipment or plumbing fixture have an air gap between the water supply inlet and the flood level rim of the equipment or fixture. It would also be the standard of practice to ensure that the air gap is twice the diameter of the water supply and may not be less than one inch (Food Code, 2009).

Based on observation, record review and staff interviews, the hospital failed to ensure a system to control infection did not follow the written policies and procedure in cleaning the bicarbonate containers in the dialysis unit and when the staff did observe handwashing during Patient 23's care/ These failures could potentially cause the transmisson and spread of infections.

Findings:

1. During a tour of the dialysis unit on 4/3/12 at 9:55 a.m., the dialysis technician stated "We mix our own bicarb (bicarbonate, a component combined with acid concentrate by the dialysis machine to create the dialysate used to cleanse a patient's blood). The dialysis technician stated he cleaned the bicarbonate containers after use by immersing them into a bleach solution, rinsing them with purified water, checking for chlorine residual, briefly holding the containers to drain and then placing them on a clean cart for storage. Observation showed a cart with four empty approximately two gallon size containers on their sides with their spouts pointing downward and contacting the cart. The dialysis technician confirmed that was his usual way of storing the containers and did not hang them upside down to completely dry. The dialysis technician agreed that storing the containers with the spouts touching the cart could cause cross-contamination.

During a telephone interview with the dialysis provider's biomed tech on 4/6/12 at 9:45 a.m. he confirmed the rinsing process for the bicarbonate containers included hanging them briefly upside down by the sink. According to the biomed tech, "it only takes a minute (to dry) and the room (space) is limited."

Review of the dialysis provider's Technical Policy and Standards Manual Disinfection Standards for Equipment "Individual Patient Machines Bicarbonate Concentrate Container and Cap and Suction Tube Assembly Disinfection Requirements" indicated "Store disinfected containers in an inverted position on a clean storage rack to allow all water to be drained from the container."

The Association for the Advancement of Medical Instrumentation (AAMI) defines the standards and requirements for equipment, treated water and dialysate quality used for all dialysis centers. According to AAMI standard RD52:2004 Requirement, "Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. When reusable concentrate jugs are used to distribute bicarbonate concentrate, they should be disinfected at least weekly. Following disinfection, jugs should be drained, rinsed, and inverted to dry."

On 4/4/12 at 12:05 p.m. observation showed room 5201 had a tan rectangular sign on the door entitled "Contact Precautions" and listing instructions for staff that included wearing personal protection equipment (PPE) when contacting either the patient or the patient's environment and performing hand hygiene after removal of gloves. A transport staff member (TS) wearing no PPE (gloves or protective gown) appeared in the hallway pushing a patient in a wheelchair. TS opened the door to room 5201 and wheeled the patient just inside the doorway. The patient got out of the wheelchair and walked to his bed. TS then backed the wheelchair out, put on gloves and wiped the wheelchair with a sanitary cleaning cloth. She stated she was the transporter and was returning the patient back to his room after a procedure. TS then pushed the wheelchair down the hallway. She used her elbow to push open a door, then went inside without removing her gloves and performing hand hygiene.

On 4/4/12 at 12:10 p.m., observation showed CNA 2 exiting room 5201, wearing a protective gown and gloves and pushing a small portable trolley that held an automatic blood pressure machine. He removed his gown and gloves and placed a bare hand on the blood pressure machine. He then put on gloves and wiped the front of the blood pressure machine as well as attached wires and tubing with a sanitary cleaning cloth. He then wheeled the trolley down the hallway. Pausing, he removed his gloves and without performing hand hygiene, placed his bare hand on the blood pressure machine to propel the trolley further down the hallway. During an interview immediately afterward, he stated he was employed by the registry and it was his third time working at the hospital. He was asked if he received orientation to the hospital's infection control policies and he stated "I read the sign and follow the instructions." Review of the contact precautions sign showed CNA 2 was to perform hand hygiene after glove removal, but no information for the cleaning and handling of equipment shared among patient rooms.

Review of the hospital's Hand Hygiene policy indicated an "alcohol based waterless antiseptic hand-rub is recommended for routinely decontaminating hands in clinical situations when hands are not visibly soiled or contaminated" and was to performed "After removing gloves and/or personal protective equipment" and "Upon exiting the room of a patient placed in Contact, Droplet, or Aerosol Disease Precautions."





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2. During an observation, on 4/6/12 at 8:15 a.m., RN 1 put on gloves and disconnected Patient 23's nasogastric tube (NGT) from the suction tubing. RN 1 then took off his right hand glove, took a marker and preceded to write on the white eraser board adjacent to Patient 23's bedside. The left hand still had a glove on. Next RN 1 took the left hand glove off and regloved without performing hand hygiene; washing hands with soap and water or using an alcohol base hand sanitizer. RN 1 with gloved hands touch Patient 23's over the bed table and bedding. RN 1 removed gloves and then washed hands at the sink with soap and water.

During an observation, on 4/6/12 at 8:26 a.m., RN 1 put on gloves, removed the adhesive device that loosely secured the NGT tube to Patient 23's external nose and secured the tube with new tape. RN 1 then secured the end of the NGT to Patient 23's gown. Patient 23 spit phlegm into an emesis basin and RN1 emptied the contents into the toilet bowl. RN 1 removed the right hand glove, applied a new one, but no hand hygiene was done. RN 1 next uncovered Patient 23's abdomen, exposed a mid abdominal incision with staples and a wound drain and dressing on the right lower abdomen. RN 1 went from a dirty patient body area to an exposed clean surgical wound without performing hand hygiene. RN 1 put the stethoscope ear pieces on and pressed the stethoscope onto Patient 23's abdomen, moved the stethoscope to the upper abdomen, and using a large syringe pushed air through the NGT. When RN 1 was done with the stethoscope he hung it on the intravenous pole. With the same gloves on RN 1 used the bed controls to lower the bed. RN 1 reach for and gave Patient 23 the bedside incentive spirometry breathing device. Finally RN 1 took the gloves off and washed hands with soap and water.

During an interview, on 4/9/12 at 8 a.m., certified nursing assistant (CNA 1) stated it was important to wash hands after removing dirty/used gloves because of the possibility of a break in the glove integrity.

Review of the hospital's policy and procedure, "Hand Hygiene", last revised 12/09, showed the "purpose" of the policy was to prevent the spread of hospital acquired infections through handwashing. Hand hygiene would decrease the risk of cross contamination. The policy referred to studies that showed, "...(1) handwashing results in reduction in carriage of pathogens on the hands, (2) microorganisms proliferate on skin within the moist environment of gloved hands and (3) handwashing results in reduction of nosocomial infections [hospital acquired infection]."

Based on record review and interview, the facility failed to ensure that all patients will have a medical history and physical exam (H & P) completed no more than 30 days prior to surgery. Three patients (Patient 21, 80, 81) had an H & P completed greater than 30 days prior to surgery and 1 patient (21) had no H & P prior to surgery, resulting in potential adverse outcome to patient safety and quality.

Findings:

1. On 4/3/12 during an inspection of the post anesthesia care unit, three patient records were reviewed, two (80, 81) were found to contain the medical history and physical exam completed months prior to the date of surgery. Nurse Manager J was interviewed on the same date at 1:30 p.m. and responded that those H & P's were older than 30 days, "because they (Ophthalmology) schedule their patients (for surgery) far ahead of time".




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2. Record review, on 4/3/12, showed Patient 21 had been admitted and had left total knee replacement surgery on 3/28/12. There was no history and physical documentation found in the record.

The medical/surgical dayshift charge nurse (RN 5) also checked Patient 21's paper record and accessed the electronic portion of the health record, both of which had no completed history and physical documentation.

The "History and Physical Examination" paper form in the record was not dated, had a signature on the signature line and had the following entries:
1. A list of "Current Medications", with medications listed.
2. "Clinical Impression: L [the L was circled] knee OA [osteo arthritis] failed conservative management,"
3. "Treatment Plan: Pre-op for L [L was circled] TKA [total knee replacement] on 3/23/12"
In a different ink color a note on the left lower side of the second and last page of the form was an entry dated 3/28/12 at 7:10 a.m. which showed it was a "24 hour update" with "no [and a symbol to indicate change]. The entry had a physician's signature. The rest of the form was blank.

Further record review on 4/4/12 showed a dictated "Clinic Note - Orthopedics" which consisted of two pages. At the top of page one was a hand written entry
"H & P". A dictation date of 3/8/12 was at the end of the second page. The dictation did not include a review of body systems; i.e. cardiovascular, respiratory, etc.

Review of the hospital medical staff rules and regulations showed, "A comprehensive and complete general history and physical examination is required on all Medical Center patients." "The History must include at least the following elements: Chief Complaint, History of Present Illness, Relevant Past Medical History, Social, Family and Allergy Histories and a review of body systems."

Based on interview and record review the hospital failed to ensure that an immediate postoperative note after surgery was in the record for one (Patient 22) of 68 patient records reviewed. For Patient 22, who had the left big toe amputated in surgery, there was no documentation of an immediate postoperative note, which resulted in no immediate operative information being available to any physician or other health care providers who would be providing care for Patient 22.

Findings:

Record review on 4/4/12 showed Patient 22 had been admitted to the hospital on 4/2/12 with a left big toe ulcer that had progressed to the bone. On 4/3/12 Patient 22 had the left big toe amputated in surgery.

During record review on 4/4/12 no immediate hand written postoperative note was found. Registered nurse (RN 6) assisted in accessing Patient 22's electronic health record in order to check if a immediate postoperative note had been entered, none was found.

During an interview on 4/4/12 at 3:20 p.m. the Interim Director of Nursing Inpatient Services (DON) stated there needed to be documentation of what was done to Patient 22 in the operating room until the dictated operative report was transcribed and entered into the record.

Review, on 4/5/12, of the hospital's medical staff rules and regulations showed,
"A postoperative note must be entered into the medical record immediately after surgery and include pertinent information that is necessary for care by any provider who will be attending the patient. Immediately after surgery is defined as 'upon completion of surgery, before the patient is transferred to the next level of care', i.e. the Post Anesthesia Unit (PAR)."

Based on interview and record review the hospital failed to have integrated services for the provision of care for one of sixty-eight patients, Patient 7, when there was a delay in decision making between medical and surgical services to determine which service would admit Patient 7. This failure caused Patient 7 to wait in the Emergency Department for 31 hours before admission orders were written which had the potential for delayed care.

Findings:

On 4/4/12 review of the Emergency Department (ED) electronic records showed that Patient 7 had presented to the ED on 4/3/12 with a complaint of pain for a large umbilical hernia "12 inches in diameter and 8 inches deep," and a right inguinal hernia. Patient 7 arrived in the ED on 4/3/12 at 2:20 p.m., was evaluated by the ED physician who requested for a surgical consult. Surgeon P wrote a consultation report on 4/3/12 at 6:30 p.m., recommending that Patient 5 have medical management of ascites (abnormal collection of abdominal fluid) prior to surgical intervention of the hernias. The electronic record showed that Patient 7 was in the ED for 25 hours and 38 minutes and awaiting admit orders. During an interview, the Assistant Nurse Manager (ANM,) said nurses would follow admitting orders once written.

On 4/4/12 at 1:38 p.m., during an interview, Physician T (with the Medical Team) said that the reason that Patient 7 was in the ED was that the surgeons felt the patient required medical management for ascites but Physician T said the patient didn't have ascites. Physician T said that Surgeon P was on call last night and was unavailable today; the surgeon who was on call today was in surgery and also unavailable. Physician T said he would talk with the ED attending physician about Patient 7 to determine suitability for admission.

During an observation in the Emergency Department (ED) on 4/4/12 at 3:30 p.m., Patient 7 was lying on a gurney. He had a pendulous, umbilical hernia the size of a small melon and a right inguinal hernia approximately 2.5 inches long by 1.5 inches wide. At the distal tip of the hernia there was a dime-sized opened area that was covered with a clear dressing. When Patient 7 turned he supported the hernia with his hands. Patient 7 was eating crackers and said he didn't eat since arriving in the ED. The ANM told Patient 7 she would get him something to eat.

On 4/5/12, review of the Ed records showed an ED MD Note, dated 4/4/12 at 8:24 p.m.: "Long discussion with on call medicine [Physician T] who feels that cirrhosis is adequately managed. Rediscussed case with on call surgery [Surgeon P] who reexamined patient. He discussed case with attending [Physician B]. They appreciate the medicine consultants recommendations and will admit the patient." Surgeon P wrote admission orders on 4/4/12 at 9:10 p.m., to include a regular diet. A bed was assigned at 9:30 p.m., and Patient 5 was sent to the ward at 9: 37 p.m., 31 hours and 10 minutes after arrival in the ED.