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Based on observation interview and record review, the hospital failed to protect patients' rights when the following occurred:

1. When the facility failed to promote the rights of two of 31 patients (Patient 44) to receive considerate and respectful care. For Patient 44, the facility use of implied force, through presence of law enforcement, to obtain compliance with an outdated visitation policy resulted in loss of family support on the first night after delivery of a baby (Patient 45). For Patient 44 this failure resulted in sadness and feelings of disrespect. For Patient 45, this failure resulted in loss of access to care and emotional support of the father (FOB) and sibling (SIB), potentially interfering with family bonding.

2. When the staff failed to hang a sufficient number of privacy curtains in three patient rooms 12, 16 and 18 (See A0143)

3. When the facility failed to ensure all employees enforced the facility visitation policy uniformly in the hospital for two of 31 patients (Patient 44 and Patient 45). Three nursing staff on the post-partum unit (Nursing Supervisor 1 [NS 1], Registered Nurse 9 [RN 9], and RN 11) insisted the 10 year old sibling of newborn Patient 45 leave the hospital during the night shift (11 p.m. to 7:30 a.m.) in contradiction to the hospital 24 hour/day visitation policy. The failure to allow visitation resulted in the father of Patient 45 (FOB) taking the sibling of Patient 45 (SIB) home for the night. (See A0217)

Theses cumulative failures resulted in the hospital's inability to protect and promote patients' rights as required by the Condition of Participation.

Findings:

A review of the Delivery Note dated October 2017 reflected Patient 44 gave birth to Patient 45 at 3:12 a.m. by spontaneous vaginal delivery. The Delivery Summary indicated Patients 14 and 15 transferred to the post-partum unit at 7:15 a.m. later the same morning.

During a concurrent observation and interview 10/23/17 at 1:10 p.m., Patient 44 held Patient 45 while FOB packed the patients' belongings. Patient 44 began crying while saying she was still upset because last night a nurse said SIB had to go home, followed by a different nurse bringing deputies to the room and insisting SIB had to leave. Patient 44 said she felt so disrespected when the police came into the room. After FOB and SIB left, she felt so alone and sad; she cried, when she should have been joyful. She felt robbed of experiencing their family's first night all together. In a concurrent interview, FOB said he had been told he and SIB could visit anytime during Patient 44's admission, and he and SIB had both been visiting Patient 44 through all of the previous night. FOB said the first time a post-partum nurse told him SIB had to leave, he did not pay attention because he understood the hospital had 24 hour/day visitation. FOB said a little later, another post-partum nurse came to the room and insisted SIB leave. FOB said he asked the nurse to show him a written copy of the restricted visitation policy, and then was shocked to see police had also entered the room. FOB said no one ever showed him a policy that limited visitation of minor children, but he found information on the facility website stating minors could visit anytime. FOB said he complied with the request to take SIB home in order to avoid confrontation with the police. FOB said SIB was very upset and crying after the incident; he said she was worried she had done something wrong because of the police. FOB said because SIB was so upset, he felt compelled to stay at home with SIB the rest of the night. FOB said he returned to the hospital during day shift.

During an interview 10/25/17 at 7:35 a.m., Registered Nurse 9 (RN 9) said she cared for Patient 44 on the night shift from 11 p.m. on 10/22/17 to the next morning at 7:30 a.m. on 1/23/17. RN 9 said at the beginning of the shift, she had adjusted a blanket covering the Patient 45's face, and the FOB had readjusted the blanket. At the same time, RN 9 said she noticed SIB in the room. RN 9 was concerned about SIB staying overnight as it was against unit policy, but did not feel comfortable talking to FOB about it after the blanket incident. RN 9 asked the charge nurse (RN 11) to speak to the family about SIB needing to go home.

During a telephone interview 10/25/17 at 2:25 p.m., night shift charge nurse, RN 11, said she told Patient 44 and FOB that SIB could not stay overnight in the unit. RN 11 said when she told the family SIB would have to leave for the night, FOB loudly said, "Hell no," and closed the curtain. RN 11 said she could not continue the discussion with FOB after that, so she left the room, and notified the nursing supervisor, NS 1. RN 11 said she asked NS 1 to speak to FOB about the minor child needing to leave, and suggested NS 1 bring deputies to assist. RN 11 said she knew the hospital had a 24 hour/day open visitation policy, but she thought the post-partum unit did not allow visitation of minors overnight. RN 11 said FOB argued with the nursing supervisor about SIB leaving, but he eventually left after the deputies entered the room and spoke with him. RN 11 said Patient 44 was so upset after FOB and SIB left, she asked to leave the hospital.

During a telephone interview 10/25/17 at 2 p.m., NS 1 said just before midnight she went to the room of Patients 14 and 15 at the request of RN 11. NS 1 said RN 11 complained she had "problems" when she asked the family to take SIB home, and suggested NS 1 be accompanied by county sheriff deputies. NS 1 said two deputies, and a ranger, accompanied her to the room. NS 1 said she knew police presence could stimulate aggressive behavior, so she initially entered Patient 44's room alone, while the officers stood in the doorway. NS 1 said Patient 44 and FOB asked to see the written policy for no overnight minor visitation, and then the sheriffs entered the room. NS 1 said FOB began discussing the situation with the sheriffs, and eventually agreed to take SIB home. NS 1 said neither FOB nor SIB were disruptive or threatening during the discussion. NS 1 said calling for sheriff assistance was not the only option: a behavioral nurse, the administrator on call, and the unit manager were also available to assist with patient complaints.

During a telephone interview 10/24/17 at 10:10 a.m., Contra Costa County Sheriff Deputy (DPT 1) said he had gone to the room of Patients 44 and 45 with NS 1 and another Deputy. DPT 1 said NS 1 told him a minor child could not be on the unit after 11 p.m., and FOB had refused to take the child home. DPT 1 said FOB and SIB behaved well, and though the FOB was upset when NS 1 said SIB had to go home, he was not ever threatening. DPT said the deputies did not escort FOB and SIB from the hospital; FOB took SIB home on his own volition. DPT said he informed FOB he could return to the hospital that night, if SIB did not accompany him.

During an interview 10/25/17 at 7:55 a.m., Manager of Perinatal Services (MPS) said the facility removed the "Guidelines for Overnight Support Person," from the computer, as the post-partum policy was not in agreement with the hospital Welcoming Policy adopted by the post-partum unit in April 2017. MPS confirmed FOB and SIB should have been allowed to stay with Patients 44 and 45 overnight.

During an interview 10/26/17 at 8:35 a.m., Manager of Professional Development (MDP) said visitation should not be denied unless there are patient safety or patient care concerns.

Review of the facility policy, "Guidelines for Overnight Support Person," undated, nursing perinatal policy #1.53, reflected, "Only one person to stay at night. That person needs to be 18 years or older unless father of the baby."

Review of the facility website information on visitation on 11/2/17 reflected, "We have a new Welcoming Policy to make the hospital accessible 24 hours a day to family and loved-ones of those receiving care in the medical center. Everyone-including accompanied minors can be with loved ones any time of the day or night at our hospital ..."

Review of the facility posted Patient Bill of Rights on 10/23/17 at 8:15 a.m. in the post-partum unit hallway reflected patients had a right to "Considerate and respectful care, and to be made comfortable. You have the right to respect for your personal values and beliefs."

Based on observation and interview, the staff failed to hang a sufficient number of privacy curtains in three patient rooms (12, 16 and 18). This failure resulted in Patient 35 not having physical privacy while receiving perineal care (cleaning the private areas of a patient.)

Findings:

On 10/13/17 at 10:15 a.m., in an observation of the MICU (Medical Intensive Care Unit), where the patient rooms had sliding glass doors and windows which made the rooms visible from the hallway, privacy curtains were hung to provide privacy for the patients. At 10:17 a.m., Patient 35 was visible from the hallway as the nurse was doing perineal care. The existing privacy curtains covered the center portion of the doors. Portions of the windows were uncovered making the room visible from either side of the curtains. Further observation showed the privacy curtains in rooms 12, 16 and 18 consisted of two curtain panels which did not cover the width of the glass doors and windows. This did not allow complete privacy for the patients in these rooms.

A review of the Patient 35's medical record on 10/24/17, showed multiple diagnoses which included altered mental status (general changes in brain function, such as confusion, memory loss, loss of alertness, disorientation, defects in judgment or thought.)

During an interview on 10/25/17 at 3:15 p.m., the EVS (Environmental Services Supervisor) stated there should be three curtain panels on the windows. The EVS stated there were plenty of curtains available if staff needed more curtain panels.

In an interview on 10/27/17 at 10:05 a.m., HSK (Housekeeper) 1 stated the housekeeping staff had received training on how to hang privacy curtains which included making sure the snaps (used to connect the curtain panels) matched and the door and window was covered.

Based on observation, interview, and record review the facility failed to ensure all employees enforced the facility visitation policy uniformly in the hospital for two of 31 patients (Patient 44 and Patient 45). Three nursing staff on the post-partum unit (Nursing Supervisor 1 [NS 1], Registered Nurse 9 [RN 9], and RN 11) insisted the 10 year old sibling of newborn Patient 45 leave the hospital during the night shift (11 p.m. to 7:30 a.m.) in contradiction to the hospital 24 hour/day visitation policy. The failure to allow visitation resulted in the father of Patient 45 (FOB) taking the sibling of Patient 45 (SIB) home for the night under the threat of force.

For Patient 45, this failure resulted in lack of support from absent family members, and feelings of sadness, anger, and isolation. For Patient 45, this failure resulted in lack of care and support from absent family members, and delayed family bonding.

Findings:

A review of the Delivery Note dated October 2017 reflected Patient 44 gave birth to Patient 45 at 3:12 a.m. by spontaneous vaginal delivery. The Delivery Summary indicated Patients 44 and 45 transferred to the post-partum unit at 7:15 a.m. later the same morning.

During a concurrent observation and interview 10/23/17 at 1:10 p.m., Patient 44 held Patient 45 while FOB packed the patients' belongings. Patient 44 began crying while saying she was still upset because last night a nurse said FOB had to take SIB home. Patient 44 said she cried all night; she felt so alone during a time that should have been joyful. Patient 44 said she was angry the family was robbed of experiencing their first night all together. In a concurrent interview, FOB said during Patient 44's admission he was told he and SIB could visit anytime. FOB said he and SIB had both been visiting Patient 44 through all of the previous night with no problem. FOB said the first time a post-partum nurse told him SIB had to leave, he did not pay attention because he understood the hospital had 24 hour/day visitation. FOB said a little later, another post-partum nurse came to the room with deputies, and insisted SIB leave. FOB said he asked the nurse and the deputies to show him a written copy of the restricted visitation policy, but no one ever did. FOB said he found information on the facility website stating minors could visit anytime, but he complied with the request to take SIB home in order to avoid confrontation with the police. FOB said SIB was very upset and crying after the incident, and so he felt compelled to stay at home with SIB the rest of the night. FOB said he returned to the hospital during day shift.

Review of Nursing Progress Note by Registered Nurse 9 (RN 9) dated 10/23/17 at 6:52 a.m. reflected, "FOB walked in the room around midnight with a ten years old daughter, advised by charge nurse of the policy of hospital about visitors staying overnight (not person under 18 years old), FOB refused to leave. Supervisor and security guard called, FOB left after that. Mom wanted to discharged, but pediatrician came and talked to her, she agreed to stay overnight."

During an interview 10/25/17 at 7:35 a.m., RN 9 said she cared for Patient 44 on the night shift from 11 p.m. on 10/22/17 to the next morning at 7:30 a.m. on 1/23/17. RN 9 said she was concerned about SIB staying overnight, as the post-partum unit had a policy of only one support person to assist the mother, and no minors on the unit overnight. RN 9 said she printed a copy of the unit policy, "Guidelines for Overnight Support Person," and gave it to the nursing supervisor, NS 1.

During a telephone interview 10/25/17 at 2:25 p.m., night shift charge nurse, RN 11, said she told Patient 44 and FOB that the daughter could not stay overnight in the unit. RN 11 said she knew the hospital had a 24 hour/day open visitation policy, but thought the post-partum unit followed the "Guidelines for Overnight Support Person." RN 11 said FOB and the daughter left after speaking with NS 1 and deputies. RN 11 said Patient 44 was upset after FOB left; she came to the nursing station saying she wanted to leave. RN 11 said she called the pediatrician, who convinced Patient 44 to stay.

During a telephone interview 10/25/17 at 2 p.m., NS 1 said she received a call from RN 11 just before midnight. RN 11 wanted NS 1 to speak to a family about taking a minor child home, as the unit policy did not allow a minor child to stay overnight. NS 1 said she received a copy of the "Guidelines for Overnight Support Person," and showed it to Patient 44 after FOB had left. NS 1 said she believed the Guidelines were special visitation rules specifically for the post-partum unit.

During a concurrent record review and interview 10/24/17 at 10:35 a.m., RN 10 said she had been assigned to care for Patient 44 on day shift (7 a.m. to 3:30 p.m.) on 10/23/17. RN 10 said when she went into Patient 44's room at the beginning of the shift she found Patient 44 with teary eyes. RN 10 said Patient 44 said she was unhappy because the nurses and deputies forced her family to leave during the night, and she had expected the birth to be a happy time together with the family. RN 10 said the labor and delivery unit allowed 24 hour/day visitation, but because the post-partum unit had less physical space, the visitation during night shift was limited to one, non-minor support person, as per the "Guidelines for Overnight Support Person." RN 10 said nurses could access the Guidelines under the Policy and Procedures section in the computer. In a concurrent interview and record review of a copy of the Guidelines policy, Manager of Perinatal Services (MPS) confirmed the "Guidelines for Overnight Support Person," undated nursing perinatal policy #1.53, was the post-partum unit visitation policy.

During an interview 10/25/17 at 7:55 a.m., MPS said the facility removed the "Guidelines for Overnight Support Person," from the computer on 10/24/17, as the post-partum policy was not in agreement with the hospital Welcoming Policy adopted by the post-partum unit in April 2017. MPS confirmed FOB and SIB should have been allowed to stay overnight in the post-partum unit. In a concurrent interview, Perinatal Health Services Education and Training Specialist 1 said the unit policy should have been retired when the post-partum unit adopted the hospital Welcoming Policy.

During an interview 10/26/17 at 8:35 a.m., Manager of Professional Development (MDP) said visitation should not be denied unless there are patient safety or patient care concerns. In a concurrent interview, Chief Quality Officer (CQO) said the hospital Welcoming Policy allowing 24 hour/day, seven days per week visitation, and the policy applied to all units. CQO said she had not been aware the post-partum unit still adhered to the old policy of one visitor at the bedside during night shift.

Review of the facility website information on visitation on 11/2/17 reflected, "We have a new Welcoming Policy to make the hospital accessible 24 hours a day to family and loved-ones of those receiving care in the medical center. Everyone-including accompanied minors can be with loved ones any time of the day or night at our hospital ..."

Review of the facility policy, "Guidelines for Overnight Support Person," undated nursing perinatal policy #1.53, reflected, "Only one person to stay at night. That person needs to be 18 years or older unless father of the baby."

Review of the facility policy, "Partners in Care Welcome Policy," Hospital Policy 603, new 4/2013, reviewed 4/2017, reflected, "Family members and/or care partners, according to patient preferences, are respected as essential members of the patient's health care team in sharing information and providing support and comfort during their health center visit, emergency room visit and/or hospital stay ....Share the 'Partners in Care Welcoming Guide,' with all patients and their partners in care."
Review of the Attachment, "Partners in Care Welcoming Guide," dated April 2013, indicated, "Our patient and family-centered approach welcomes families as vital participants in a patient's care. Family and other Partners in Care, as defined by the patient, are welcome at the patient's bedside 24 hours a day, 7 days a week. Our staff will work with you to ensure comfort, health, safety, quality care, privacy and confidentiality for all patients. We are here to work with you and your loved one to support care choices ...Please ensure that all minors are accompanied at all times by an adult to ensure safety."

Based on Registered Dietitian and dietary staff interview and departmental document review he hospital failed to ensure timely action when performance improvement opportunities were identified. The hospitals' food service program identified opportunities for improvement in relationship to food temperatures; however there was no active interventions.

Findings:

On 10/24/17 beginning at 1:20 p.m., the dietary departments' performance improvement activities were reviewed with Registered Dietitian 1. The program elements included patient tray audits that incorporated evaluation of temperatures, portion size, and accuracy of the diet as well as meal appearance. Additional activities included nourishment room audit that evaluated the cleanliness of the area.

The department also completed a patient satisfaction audit. This audit is completed by asking 5 random patients per day to evaluate the meal. The satisfactory rating was listed as 1-5 with 5 being extremely satisfice and 1 not at all satisfied. Concurrent review of the results of the audit revealed an average rating of 3-5, indicating there were opportunities for improvement.

In an interview on 10/24/17 at 1:40 p.m., Dietary Staff (DS) 12 was identified as the person who completed the data analysis of performance improvement activities. DS 12 stated that areas for improvement were identified, in particular there were temperature complaints. DS 12 stated that data was collected monthly and put into a spreadsheet. The current data was collected and tabulated since November 2016.

Review of hospital document titled "Patient Safety and Performance Improvement Routine Report V6" dated 2/4/17 revealed with respect to patient satisfaction of meal service 10 of 10 elements such as overall satisfaction, taste of food, temperatures of hot and cold food and quality of food did not meet the hospital developed goal. While the department identified areas of improvement there were no current activities to demonstrate attempted interventions for quality improvement. Similarly the summary of the data with a report date of 10/18/17 listed a "goal statement" as support for new equipment and restructuring of meal service; however the report did not list specific pieces of equipment, nor did the report demonstrate how equipment would improve the patient meal experience.

Based on interview, and record review, the facility failed to initiate comprehensive care plans for three of 31 patients (Patient 44, Patient 45, and Patient 56):

1. For Patient 44, no care plan generated for psychosocial issues, after Patient 44 experienced an emotionally isolating event.
2. For Patient 45, no care plan generated after identified exposure to intoxicating substance.
3. For Patient 56, no care plan generated for anxiety, after condition identified on unit.

This failure resulted in the inability to identify and design necessary therapeutic interventions, and monitor their effects with the potential outcome of unmet needs, and decreased patient satisfaction.

Findings:

1. A review of Patient 44's Social Work Consult Note dated 10/23/17 at 12:04 p.m. indicated Patient 44 had given birth the previous day. The Note further indicated Patient 44 was concerned she would be a single mother, as the father of Patient 44's baby (FOB) would soon be unavailable for the next two years.

During an interview 10/23/17 at 1:10 p.m., Patient 44 said she was very upset because her husband and ten year old sibling of her newborn (SIB) had been forced to leave the hospital last night. Patient 44 said a nurse told her (SIB) could not stay overnight, and so FOB had to take (SIB) home. Patient 44 said she felt alone and disrespected, and was angry her family had that first night experience taken away.

During an interview 10/25/17 at 7:35 a.m., Registered Nurse 9 (RN 9) said she cared for Patient 44 on the night shift from 11 p.m. on 10/22/17 to the next morning at 7:30 a.m. on 1/23/17. RN 9 said Patient 44 was upset after FOB and the daughter left, so RN 9 tried to comfort her. RN 9 said she told the next shift about the incident, but forgot to start a care plan about the psychosocial issues.

During a telephone interview 10/25/17 at 2:25 p.m., night shift charge nurse, RN 11, said she told Patient 44 and FOB that the daughter could not stay overnight in the unit. RN 11 said FOB and the daughter left after speaking further with the nursing supervisor and deputies. RN 11 said she knew Patient 44 was upset after FOB left because Patient 44 came to the nursing station saying she wanted to leave. RN 11 said she called the pediatrician, who convinced Patient 44 to stay. RN 11 said she never considered writing a care plan for Patient 44, and never considered whether Patient 44 needed emotional support after the incident.

During a concurrent record review and interview 10/24/17 at 10:35 a.m., RN 10 said she had been assigned to care for Patient 44 on day shift (7 a.m. to 3:30 p.m.) on 10/23/17. RN 10 said RN 9 told her during shift change that FOB had to take the daughter home on night shift. RN 10 said when she went into Patient 44's room at the beginning of the shift she found Patient 44 with teary eyes. RN 10 said Patient 44 said she was unhappy because the nurses and deputies forced her family to leave during the night, and she had expected the birth to be a happy time together with the family. Patient 44 said she just wanted to leave the hospital to be with her family, but RN 10 convinced her to stay. RN 10 said FOB returned to the hospital later in the morning. Patient 44, FOB, and baby completed the discharge process together later that day, and left the facility. RN 10 confirmed Patient 44 had been very upset, but said she had not initiated a care plan for any psychosocial concerns except mother/baby bonding.

2. A review of the Discharge Summary dated 10/23/17, reflected Patient 45 was born the previous day by spontaneous vaginal delivery. The Summary also indicated Patient 45's urine toxicology test completed 10/23/17 at 7:16 a.m. had positive results for cannaboids. (Cannaboids are chemical compounds found in marijuana responsible for producing medicinal and/or intoxicating effects.) The positive result indicated Patient 45 had exposure to cannaboids just before birth.

Review of Social Work Consult Note dated 10/23/17 for the mother of Patient 44 showed a maternal history of marijuana ingestion, with the most recent positive marijuana test on 10/21/17.

During a concurrent interview and record review of Patient 45's care plans, RN 10 was unable to find documentation of a care plan for exposure to cannaboids or any other substance. RN 10 confirmed she had cared for Patient 45, and knew of the positive urine toxicology test, but had not initiated a care plan because there were no templates available in the electronic medical record for the issue.

During an interview 10/26/17 at 9:02 a.m., Health Services Perinatal Education and Training Specialist 1 (HETS 1) said the facility had begun discussing the idea of making a care plan template for cannabis (marijuana) exposed babies. HETS 1 confirmed nursing could initiate a care plan for the potential of withdrawal from cannabis without observing actual withdrawal.

3. Review of the History and Physical dated 10/19/17 indicated the physician admitted Patient 56 for respiratory distress, with a history that included medication therapy for the treatment of bipolar disorder. (Bipolar disorder, also called manic-depressive disorder, is a condition causing episodes of depression and/or episodes of hyper-excitability, euphoria, delusions, and other abnormal moods.)

Review of the Medication Administration Record (MAR) reflected a physician order for Patient 56 to receive the oral medication, Quetiapine, "as needed," up to three times per day, for anxiety. The MAR further indicated nurses administered "as needed" Quetiapine on five occasions: 10/20/17 at 6:52 p.m., 10/22/17 at 6:49 p.m., 10/23/17 at 7:03 p.m., 10/24/17 at 9:06 p.m., and 10/26/17 at 6:57 p.m.

During a telephone interview 10/27/17 at 10:30 a.m., Registered Nurse 8 (RN 8) said he had given Quetiapine to Patient 56 on 10/23/17, and 10/26/17 because Patient 56 said she was feeling a little anxious, and wanted it to help her go to sleep. RN 8 said he could have initiated a care plan after administering Quetiapine, but he had not. In a concurrent interview, Nurse Manager 1 (NM 1) said she had reviewed Patient 56's chart, and had been unable to locate a psychosocial care plan for Patient 56. NM 1 said there was a care plan template available for patients with anxiety that nursing staff could have initiated.

During an interview 10/26/17 at 8:43 a.m., Manager of Professional Development (MPD) said the electronic record care plans were still a work-in-progress; they were not yet perfect.

Review of the facility Tip Sheet, "Care Plan Individualization Training," dated 7/17/17, reflected, "Care Plans should be based on assessment of the patient, reflect only current and active problems, and contain realistic goals and interventions ....During your shift, document on goals and interventions applicable to your patient based on your assessment. If the patient status or condition changes, you must update the Care Plan to reflect the change-this is part of individualizing the plan."

Based on interview and record review, staff did not follow established policies and procedures when the hospital staff failed to administer an every 15 minute medication to Patient 53 timely and an "as needed" medication was given to Patient 56 without documenting the reason for, and response to, the medication. These failures resulted in Patient 53's pain level increasing to 10 out of 10 in the post anesthesia care unit (PACU) and resulted in an inability to evaluate effectiveness of the medication regimen over time, in order to meet Patient 56's care needs.

Pain scale definition: For English speaking adults, use a zero to ten scale to describe the level of pain by explaining that zero (0) represents No Pain, and ten (10) represents the Worst Pain Imaginable. [Reference: hospital's policy and procedure titled, "Pain Management" with an approved date of 4/18/16].

Quetiapine: a medication used in the treatment of depression or bipolar disorder. Bipolar disorder, also called manic-depressive disorder, is a condition causing episodes of depression and/or episodes of hyper-excitability, euphoria, delusions, and other abnormal moods.

Findings:

1. Review of Patient 53's electronic health record on 10/27/17 showed that Patient 53 was scheduled for a repair of the left knee patellar tendon (knee cap) on 10/24/17.

In an interview and concurrent record review on 10/27/17 at, Review of Patient 53's "Medication Administration Report (MAR)" in his electronic health record (EHR) on 10/27/17 showed that Patient 53 had an order for Hydromorphone (Dilaudid, a narcotic medication used to treat pain) 1 mg (milligram)/1 ml (milliliter) as needed for a pain score of 7-8 every 15 minutes dated on 10/24/17. Patient 53 reported a pain level of seven out of 10 on 10/24/17 at 1:30 p.m. The Nurse Program Manager of Perioperative Services (NPS) verified that there was no medication administered for Patient 53's seven out of 10 pain level at 1:30 p.m. as ordered. Patient 53's EHR further showed that Patient 53's pain level increased to a 10 out of 10 level at 1:45 p.m. on 10/24/17 and no medication was administered for Patient 53 as ordered. The NPS confirmed there was no evidence in Patient 53's EHR that Patient 53 refused any pain medication at these times. Patient 53 was administered Fentanyl (pain medication) on 10/24/17 at 1:50 p.m. for a pain level of 10 out of 10. The NPS stated that the nurse should have given a pain medication when Patient 53 reported a pain level of seven out of 10 as ordered. The NPS indicated that Patient 53's pain increased without a pain medication as ordered when Patient 53's pain was seven out of 10.


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2. A review of Patient 56's History and Physical dated 10/19/17 reflected a history of bipolar disorder, with a current admission diagnosis of pneumonia. A review of Patient 56's medication orders showed the physician ordered Quetiapine on 10/20/17 at 4:56 p.m., for administration on an "as needed" basis, up to three times per day, for agitation.

Review of Patient 56's Medication Administration Record (MAR) indicated nurses administered "as needed" Quetiapine on five occasions: 10/20/17 at 6:52 p.m., 10/22/17 at 6:49 p.m., 10/23/17 at 7:03 p.m., 10/24/17 at 9:06 p.m., and 10/26/17 at 6:57 p.m.

During a telephone interview 10/27/17 at 10:30 a.m., Registered Nurse 8 (RN 8) said he had given Quetiapine to Patient 56 on 10/23/17, and 10/26/17 because Patient 56 said she was feeling a little anxious, and wanted it to help her go to sleep. RN 8 said he usually wrote a comment in either the nurses' notes or the MAR when he gave "as needed" medications.

During a concurrent interview and record review 10/27/17 at 9:22 a.m., Nurse Manager 1 (NM 1), was unable to find documentation for any of the five times Quetiapine was administered, as to why nurses gave Quetiapine, or nursing evaluation of the effect of administration. NM 1 said nurses should document both the reason for administration, and assessment of the effects of administration on patients after giving "as needed" medications.

Review of the facility policy, "Medication Administration and Documentation," reviewed 1/2017, indicated, "...I.4. Monitor the patient carefully for medication effects ...5. Ask the patient how the medication is affecting them. 6. Document in the EMR [electronic medical record] and in any hand-off of patient care, any effects the medication has on the patient ...L.3.d. Document the reason and outcome of any PRN ['as needed"] medications given in the EMR ..."

Based on interview and record review, the facility failed to ensure that one of 31 patients (Patient 61) had laboratory results were available in the medical record. For Patient 61, the lack of a record of the results of a genetic screening test had the potential to delay provision of patient care needs.

Findings:

A review of the Discharge Summary dated 1/28/17 indicated Patient 61 was discharged after a routine vaginal birth. The Summary indicated results were pending for a genetic abnormalities screening test, a test routinely drawn for newborns to determine if the infant had special needs due to specific genetic abnormalities.

During a concurrent record review and interview on 10/27/17 at 11:10 a.m., Health Services Education and Training Specialist 1 (HETS 1) confirmed collection of Patient 61's genetic screening test on 1/28/17, but was unable to locate test results in the medical record. HETS 1 confirmed the last physician note regarding the genetic screening test indicated the results were still pending on 2/27/17. HETS further confirmed the record indicated Patient 61 left the country for three months between March and July 2017.

During a concurrent record review and interview on 10/27/17 at 11:35 a.m., Physician 6 (MD 6) said both she and medical records department received copies of all newborn genetic screening results. MD 6 said the medical records department was responsible for scanning the results into the record; MD 6 did not keep any paper copies of the results after reviewing them. MD 6 said she reviewed all the test results. MD 6 stated time-sensitive, critical positive results (positive indicating the baby potentially had an abnormal condition) would be available within one to two weeks, and would require her to log a response. MD 6 said the remainder of the test results would normally be available four to five weeks after collection. MD 6 referred the less critical, less time-sensitive positive results to the primary care physician. MD 6 said all the results should be available in the medical record by two months of age; if results were not in the record, the primary care physician should call the processing laboratory. MD 6 called the processing laboratory, and arranged for the processing laboratory to resend Patient 61's results to the facility.

A review of Patient 61's newborn genetic screening test results, provided by the facility as received by facsimile on 10/27/17, reflected 2/14/17 as the original date the processing laboratory mailed test results to the hospital and MD 6.

Review of the California Department of Public Health Newborn Screening Branch website pamphlet, "Important Information for Parents," updated 10/10/17, reflected babies should have the newborn genetic screening test at 12-48 hours of age in order to identify certain disorders and begin early treatment to avoid disabling health problems.

Based on observation, interview and document review, the hospital failed to provide patient safety in one of six sampled areas (Outpatient Pharmacy 1) when medications were not controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law, and as stipulated in the hospital's policies and procedures. The hospital's failure to ensure drugs intended for internal use were not segregated from drugs intended for external use had the potential to cause adverse outcomes (e.g. death, treatment failure) to all patients receiving services in the Infusion Clinic as the result of administration errors (e.g. wrong drug or drug device selected from stock).

Findings:

On 10/25/17 at 2:00 p.m., during an inspection the Outpatient Pharmacy 1 the following medications were observed stocked (in distribution) in a yellow plastic bin on a shelf (Shelf 1):

* Two tubes of Nystatin Cream, 15 grams (g), an antifungal medication intended for external use only, NDC # 51672-1289-1. [Reference: dailymed.nlm.nih.gov] Note: The National Drug Code (NDC) is a unique 10-digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act (FDA).

* Six bottles of Nystatin Topical Powder, 15g, an antifungal intended for external use only, NDC #68308-152-15. [Reference: dailymed.nlm.nih.gov]

* One bottle of Nystatin Oral Suspension, 60 milliliters (2 ounces), an antifungal intended for internal use only. NDC 60432-537-60. [Reference: dailymed.nlm.nih.gov]

On 10/25/17 at 2:05 p.m., during an inspection of the Outpatient Pharmacy 1 the following medical device/medications were observed stocked on a shelf (Shelf 2):

* One package of Liquefied Phenol USP (United Sates Pharmacopeia) 89% swabs, quantity 30 ampoules.

* One box of enteric coated aspirin tablets, quantity 100. NDC #63739-522-10

Liquefied Phenol swabs are a medical device reserved for professional use only and has no FDA labeled indication. According to the manufacturer's label, in bold capitalized letters in the "warnings" section, "DANGER! HIGHLY TOXIC - MAY BE FATAL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN - SEVERELY IRRITATES EYES, SKIN AND MUCUS MEMBRANES - MAY AFFECT LIVER KIDNEYS, RESPIRATORY TRACT AND CENTRAL NERVOUS SYSTEM - COMBUSTABLE. [Reference: Valent Pharmaceuticals overwrap, patent 6,503,013829512201]

Aspirin is a medication used to reduce fever and treat mild pain. The label indicated it was for "internal use." [Reference: dailymed.nlm.nih.gov]

On 10/25/ 17 at 2:10 p.m., during an interview, a pharmacist in Outpatient Pharmacy 1 (PharmD 1) indicated oral nystatin, and all medications intended for internal use only should be stored separately from topical nystatin and all medications intended for external use only. PharmD 1 said, "I expect medications for internal use to be stored on a separate shelf from those intended for external use. She said, "A box of aspirin is on the same shelf as the Phenol EZ swabs." She said, "I definitely expect the phenol swabs to be segregated because it kills the toenail." In the same interview, the Director of Pharmacy (DPH) indicated the hospital had policies to ensure medications were separated according to state laws and the manufacturer's requirements.

The California Code of Regulations (CCR) Title 22 70263(q)(4)) specifies, "Test agents, germicides, disinfectants and other household substances shall be stored separately from drugs."

The California Code of Regulations (CCR) Title 22 70263(q)(5)) specifies, "External use drugs in liquid, tablet, capsule, or powder form will be segregated from drugs for internal use."

A review of the hospital's policy titled, "Drug Procurement, Storage & Inventory Control, revised March 2017, showed, "External use drugs in liquid, tablet, capsule or powder form shall be segregated from drugs for internal use." The policy was not developed to include procedures for separate storage of test agents, germicides, disinfectants and other household substances.

Based on observation, interview, and document review, the hospital failed to follow its policy and procedure to dispose of six expired medication vials of Methylergonovine Maleate. This failure made expired drugs available for use for practitioners in the clink.

Definition: Methylergonovine Maleate is a medication used to contract the uterus at the end of child birth. It is also used to prevent or treat excessive bleeding after child birth.

Findings:

During an observation of gynecological department in the hospital's Clinic A., on 10/25/17 at 11:40 a.m., 6 vials of methylergonovine maleate with expiration dates of 9/2017 were stored in the gynecology clinic's medication refrigerator. Two vials were in a sealed urine specimen collection container and another four vials were inside a second urine specimen collection container.

During an interview on 10/25/17 at 11:41 a.m., RN 13 stated that these expired medications were normally removed by the pharmacist. RN 13 stated that any expired medications identified would be reported and removed by the pharmacist.

During an interview on 10/25/17 at 11:45 a.m., the Outpatient Pharmacist (OP), stated that he/she was sure of not seeing these medications before. When asked, how could he/she be sure, the OP stated the practice of the pharmacist was to remove medications two to three months from their expiration dates so no expired medications would be available for use.

During an interview on 10/25/17 at 12:00 p.m., the Director of Pharmacy (DOP), stated that the storage of six vials of expired methylergonovine maleate was "very unusual". The DOP stated that expired medications were normally pulled out two to three months ahead of time before expiration dates. The DOP further stated that nurses and pharmacy staff were the only ones who had access to medication storages. The DOP later stated that medications are never put in a urine specimen cup.

Review of the hospital's policy and procedure titled, "Drug Procurement, Storage and Inventory Control," with a reviewed/revised date of 3/17, it indicated, "III. POLICY: Responsibility for control of medications within the hospital rests with the Pharmacy Department. Policies and procedures are designed to ensure the safe and accurate dispensing of medications throughout the hospital. C. Inspection: Expired, damaged and/or contaminated medications will be removed from drug storage areas within the hospital during the Pharmacy inspection and will be returned to the Pharmacy Department for proper disposal. Expired, damaged and/or contaminated medications will be stored in an isolated area in the Pharmacy Department that has been designated for the storage of such unusable drugs."

Based on dietetic services observations, dietary and administrative staff interview and document review the hospital failed to ensure comprehensive oversight by the Director and Assistant Director of Food services when 1) the hospital was unable to demonstrate that 1 of 2 hand antiseptics available in the department met United States Department of Agriculture Food Code Requirements and 2) the department did not enforce the use of hair restraints in accordance with the standard of practice. Failure to ensure safe food handling practices are implemented may result in cross contamination of patient food.

Findings:

1. A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall consist of substances that are generally recognized as safe (GRAS). Partial listings of substances with food uses that are GRAS may be found in 21 CFR 182 -Substances Generally Recognized as Safe, 21 CFR 184 -Direct food Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 - Indirect food Substances Affirmed as Generally Recognized as Safe for use in contact with food, and in FDA's Inventory of GRAS Notices (2013 Food Code 2-301.16).

During general dietetic services operations on 10/23/17 beginning at 10:45 a.m., there were multiple hand sanitizer dispensers distributed throughout the kitchen. It was also noted there were two different types of hand sanitizer. The first was a clear product in a dispenser and the second was a milky appearing product was labeled as an "advanced hand gel sanitizer" in a pump dispenser on a utility cart adjacent to the tray line. The clean hand sanitizer was labeled as "Meets Food Code Hand Sanitizer criteria (Section 2-301.16) published by the FDA [Food and Drug Administration]." In a concurrent interview Quality Staff 2 stated the hospital was in the process of switching products as staff found the "advanced" gel was too sticky.

In an interview on 10/23/17 at 1:45 p.m., Infection Control Practitioner (ICP) 3 stated that the hospital had a committee that evaluated new products. They also stated all new products would be evaluated by this committee prior to use. The hospital was unable to demonstrate the "advanced hand gel sanitizer" met Food Code Hand Sanitizer criteria as published by the Food and Drug Administration. While the hospital was currently not in active food production staff did handle ready to eat items such as fresh fruit.

The facility provided a publication that indicated the Food and Drug Administration (FDA) recommended a concentration of 60-90% of ethanol concentration for germicidal efficacy. While the hand sanitizer product did contain 62% ethyl alcohol the facility did not provide information that this specific product was vetted by the manufacturer as being compliant with the 2013 Food and Drug Administration Food Code. Products that are Food Code compliant generally carry manufacturing labeling that is consistent with approved use in food establishments as demonstrated by the clear hand sanitizer.

Review of position descriptions titled "GM 4 Food" dated 8/2003 and Assistant Director of Nutritional Services dated 4/1/17 revealed that each of these positions had responsibilities on overseeing the day to day operations food services including ensuring food service operations conformed to standards of practice.

2. The standard of practice for food employees is to ensure staff wear hair restraints such as hats, hair coverings or nets, beard restraints, and clothing that covers body hair, which are designed and worn to effectively keep their hair from contacting exposed food; clean equipment, utensils, and linens; and unwrapped single service and single use articles (2013 Food Code, Section 2-402.11).

During review of dietetic services operations on 10/23/17 between the hours of 9 a.m., and 2 p.m., there were greater than 2 dietetic staff members with facial hair. It was noted that none of the staff wore restraints to cover their facial hair. In an interview at 10/24/17 at 9:50 a.m., Registered Dietitian 1 stated the departmental policy did not require a hair restraint if facial hair was closely cropped.

Hospital-wide policy titled "Dress Code" dated 7/2010 guided staff that "Hair covering may be required in the operation of certain services."

Based on review of clinical nutrition care the hospital failed to ensure the Assistant Director of Nutritional Services, a Registered Dietitian, provided diabetes meal planning information to all physicians when current physicians continued to order diabetic diets that were not in line with the current standard or practice. Updating medical nutrition therapy to current standards may result in increased patient meal satisfaction and promote compliance with therapeutic diets.

Findings:

Standardized calorie-level meal patterns based on exchange lists have traditionally been used in hospital settings to plan meals for patients. The American Diabetes Association no longer endorses any single meal plan or specified percentages of macronutrients. In the position statement "Translation of the Diabetes Nutrition Recommendations for Health Care Institutions, describes a "consistent-carbohydrate" diabetes meal plan as a suggested alternative.

Diet orders such as "no concentrated sweets," "no sugar added," and "low sugar" are also inappropriate because they do not reflect the diabetes nutrition recommendations and unnecessarily restrict sucrose. However, despite these recommendations based on research evidence, the actual implementation of carbohydrate-based menu planning approaches has been a slow transition that has met much resistance (Diabetes Spectrum, 2000).

The principle of consistent carbohydrate meal planning offers consistent levels of carbohydrate between meals as well as consistent levels from day to day in an effort to normalize blood glucose levels. The current standard of practice limits the level of carbohydrate rather than the caloric content of the diet.

During meal plating observation on 10/23/14 beginning at 11:30 a.m., it was noted there were greater than 10 patient diabetes meal trays that consisted of physician ordered calorie restriction as well as the principle of a consistent carbohydrate diet. In an interview on 10/24/14 at 11 a.m., Dietary Office Staff (DOS) 4 stated when diet orders were received from physicians it included both of these restrictions. DOS 4 also stated the diet translated the order to a specific carbohydrate meal pattern. As an example the 2000 calorie carbohydrate consistent diet, which was the most common pattern ordered by physicians was translated to 5 carbohydrate in each meal; however the calorie content of this diet ranged from 1847 calories to 2136 calories, resulting in a diet that had varying caloric ranges. There was only one day of the menu that had a calorie level of 2,000 calories.

In an interview on 10/24/17 at 1:20 p.m., Registered Dietitian (RD) 1 described education of physicians was limited to sessions with new hospital medical students as part of their Residency program. RD 1 acknowledged there were no standard of practice updates to all hospital physicians.

Review of hospital diet list printed on 10/24/17, pages 21 and 32 revealed that 3 of 3 physician ordered diabetic diets were ordered using a calorie restriction which was then translated by diet office staff to a carbohydrate consistent diet. Similarly 2 of 3 diets utilized "no concentrated sweets" as part of the diet order.

Hospital diet manual dated 6/24/17 described the consistent carbohydrate diet as a meal patter that provides "consistent meal patterns and portion sizes in order to promote euglycemic (normal blood sugar) and manage weight ..." The diet manual description for the diabetic diets did not limit the caloric intake.

Based on departmental document review and Registered Dietitian interview the hospital failed to ensure the nutritional needs of patients were met when the nutrient analysis of the menus failed to include an analysis micronutrients such as zinc and copper. Failure to ensure the hospitals' diet included all nutritionally relevant information may result in nutrient deficiencies further compromising patient medical status.

Findings:

On 10/14/17 beginning at 9:30 a.m., the nutritional adequacy of the hospitals' non-select patient menu was reviewed with Registered Dietitian 1. It was noted that the hospital utilized the Dietary Reference Intakes (DRI) as the measure of nutritional adequacy of the menu. The Dietary Reference Intakes (DRIs) are developed and published by the Institute of Medicine (IOM). The DRIs represent the most current scientific knowledge on nutrient needs of healthy populations.

The hospitals' foodservice was currently provided by an outside food service. The meals arrived pre-packaged on a daily basis. Review of the hospital document titled "Weekly Average Daily Nutrient/Cost Analysis Summary" dated 10/30/13 did not provide the full complement of nutrients in the DRI. The analysis did not include folate, pantothenic acid, copper, magnesium, selenium and zinc. RD 1 stated that the contracted food service provider was in place prior to her assuming the position as Assistant Director of Food and Nutrition Services; however had not noticed that the analysis did not include the full complement of DRI's.

Folic acid is a B vitamin that is needed make genetic material. Folate is also needed for the body's cells to divide. Pantothenic acid is also a B vitamin that is necessary for energy production and produces useful substances for the body such as fatty acids. Copper and Magnesium are important components of making red blood cells as well as nerve and muscle functions. Selenium is important in thyroid regulation and Zinc is important in the body's immune function and cell growth and wound healing.

Based on physical plant observations and engineering staff interview the hospital failed to ensure maintenance of the physical environment when shelving underneath the sink in the post-partum unit was cracked and disintegrating. Failure to maintain a smooth cleanable surface in food storage areas may promote insect and rodent infestation.

Findings:

On 10/14/17 beginning at 11:30 a.m., it was noted that the physical environment in the post-partum nourishment room was compromised. It was noted that the under counter sink was locked. When ES 11 unlocked the cabinet it was noted that the integrity of the cabinet was compromised. The fiberglass coating of the shelving was cracked and soiled exposing porous wood particle board. There was also a soiled white terry towel underneath. The interior surface of the cabinet was no longer a readily cleanable surface.

In an interview Quality Staff 2 stated that she recently participated in an Environment of Care Round of the hospital. These rounds were conducted twice each year; however locked cabinets were not reviewed.

It would be the standard of practice to ensure materials for under conditions of normal use shall be smooth, durable, and easily cleanable for areas where food establishment operations are conducted (Food Code, 2013).

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

1. One oxygen gas cylinder located in the Magnetic Resonance Imaging (MRI, a detailed image of soft tissue and bones through magnetic fields and radio waves) trailer was not secured.

2. One of two storage rooms located in Clinic A did not have oxygen signage.

These failures had the potential to endanger patient, visitor and staff safety.

Findings:

1. In an observation and concurrent interview on 10/24/17 at 1:30 p.m., with the presence of the Diagnostic Imaging Manager (DIM), the Director of Ambulatory Care Services (DACS), and the Quality Manager of the Prenatal Unit, there was one unsecured oxygen gas cylinder located at the corner wall to the left of the entrance in the MRI trailer. Radiologic Technologist (RT) 1 stated that the oxygen gas cylinder was probably from the last patient that came from the Emergency Room (ER). RT 1 stated it was his responsibility to ensure the oxygen gas cylinder was to be brought back with the patient to the ER. RT 1 stated the oxygen gas cylinder should have been secured properly and that "it would not be good" if the oxygen gas cylinder would fall down.

In an interview on 10/24/17 at 2:25 p.m., the DIM stated that RT 1 should have returned the oxygen gas cylinder to where it came from. The DIM stated that the oxygen gas cylinder could cause and injury if not properly secured.

Review of the hospital's policy and procedure titled, "STORAGE AND USE OF MEDICAL GAS CYLINDERS with an approved date of 10/17 indicated as followed, "I. PURPOSE: To provide guidelines for the safe storage of medical gas cylinders in patient care areas. V. PROCEDURE: A. General Requirement: All free-standing cylinders shall be stored in a rack, on a Cart, in a portable cylinder holder, or in a gas cylinder storage cabinet to protect cylinders from damage.


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During a clinic tour and concurrent interview, on 10/25/17, at 11:35 a.m., several partially filled oxygen tanks were found in a storage room on the third floor, no signage was evident outside the door. RN 8 confirmed the lack of signage and agreed that there should be a sign for oxygen on the door. The Director of Ambulatory Care Services (DACS) stated that there was a sticker on the door which the oxygen sign hung and was being laminated. The DACS did not know exactly when the sign was removed.

Review of the policy, entitled, "Storage and Use of Medical Gas Cylinders," with a review date 8/2017, it indicated, "Gas Storage Rooms: The room must have an identifying sign indicating gas storage as well as caution signage."

Based on observation, interview and record review the hospital failed to ensure when:

1. Staff did not perform hand hygiene in between glove changes in the Operating Room(OR).

2. Staff did not change or use an alcohol pad to disinfect Patient 54's intravenous (IV) tubing when it fell and touched the floor in the OR.

3. Staff did not disinfect Patient 54's IV port prior to administrating medication in the OR.

4. Staff did not remove and dispose three blue, biohazard bins that were filled beyond capacity.

5. Staff did not follow the hospital's policy and procedure to perform daily smoke test of the 11 negative pressure rooms.

6. Three IV pumps had tape and/or tape residue remaining after cleaning prior to use.

7. The sanitizer used in the infant formula preparation work area was wiped after sanitizing (See A0749)

8. the hospitals' ice machines were installed in a manner to mitigate the potential of bacterial cross contamination when they were connected directly to the waste water system. (see A0749)

These failures had the potential for infectious and communicable diseases to be spread among the patients, staff, and the public.

1. during an observation of a procedure in Operation Room(OR)#3 suite on 10/25/17 at 8:15 a.m. to 11:15 a.m., Surgeon(SUG)1 and Anesthesiologist (ANS)1 with surgical gloves on, assisted the OR staff to transfer Patient 54 from the gurney to the OR table. After the transfer, SUG 1 removed and disposed the gloves. Without performing hand hygiene, SUG 1 put on shoe covers. After completing Patient 54's surgery, SUG 1 removed and disposed the used surgical gloves donned a new pair of sterile gloves without performing hand hygiene. SUG 1 proceeded to place a sling on Patient 54's left shoulder, the surgical site.

ANS 1 who helped transfer Patient 54 from the gurney to the OR table, removed and disposed the used surgical gloves and donned a new pair without performing hand hygiene. ANS 1 did not perform hand hygiene multiple times in between glove changes throughout Patient 54's surgery after touching different objects such as the garbage bin, next to the anesthesia bin, Patient 54's endotracheal tube (a tube that is placed in the windpipe to allow for mechanical ventilation of oxygen to reach the lungs) after it was inserted, his phone, and medication vials prior to preparation and administration into Patient 54's IV.

In concurrent interviews on 10/27/17 at 12:05 p.m., the Director of Infection Control(DIC)and Infection Control Preventionist(ICP)both stated that all staff members of the surgical team are expected to use the hand gel in between glove changes. The DIC and ICP both stated that the staff did not protect the patient or themselves from infection if they did not perform hand hygiene in between glove changes.

Review of the hospital's policy and procedure titled, "HAND HYGIENE" with an approved date of 9/17 indicated the following: "II. POLICY: All hospital and Health Centers personnel will perform hand hygiene in accordance with World Health Organization guidelines. V. PROCEDURE: D. Alcohol based hand rubs may be used when hands are not visibly soiled. 2. Before donning and after removing gloves."

The WTO, in its "HAND HYGIENE: WHY, HOW & WHEN?" pamphlet notes the following instances when hand hygiene should be performed: "Before touching a patient ... Before clean / aseptic procedure ... After body fluid exposure risk ... After touching a patient ... After touching patient surroundings."

2. In a patient tracer observation in Operation Room(OR)#3 suite on 10/25/17 at 8:15 a.m. to 11:15 a.m., part of Patient 54's IV tubing fell and touched the floor. ANS 1 picked up Patient 54's IV tubing and positioned it off the floor. ANS 1 did not sanitize Patient 54's IV tubing that fell on the floor and continued to use the same IV set.

In concurrent interviews on 10/27/17 at 12:05 p.m., the DIC and ICP both stated if an IV tubing touched the floor then staff are expected to either to change the IV tubing or to wipe the IV tubing down with an alcohol pad. The DIC and ICP both indicated that the IV tubing was dirty and contaminated if it touched the floor.

3. In a patient tracer observation in Operation Room(OR)#3 suite on 10/25/17 at 8:15 a.m. to 11:15 a.m., ANS 1 assisted the OR staff when Patient 54 was transferred from the gurney onto the OR table. ANS 1's OR scrubs brushed against Patient 54's IV port. ANS 1 prepared IV medications for Patient 54 at the anesthesia medication cart. As observed, ANS 1 administered an IV medication through Patient 54's IV without sanitizing its port with alcohol pad. ANS 1 repeated the same procedure one more time during Patient 54's surgery.

In concurrent interviews on 10/27/17 at 12:05 p.m., the DIC and ICP both said, the staff must wipe the IV port with an alcohol pad with friction for 15 seconds before medication administration because the IV port was considered dirty and contaminated.

Review of the hospital's policy and procedure titled, "PERIPHERAL INTRAVENOUS LINE/SALINE LOCK: INSERTION AND MAINTENANCE" with an approved date of 2/17 indicated as followed, "V. PROCEDURE: Medication Administration Via Saline Lock: 4. Cleanse access port with alcohol swab using friction for at least 15 seconds. ALLOW TO AIR DRY."

4. In an observation and concurrent interview on 10/24/17 at 1:30 p.m., in the presence of the Diagnostic Imaging Manager(DIM), the Director of Ambulatory Care Services(DACS), the Quality Manager of Perinatal Unit(QMP)and Radiology Technician (RT) 2, there were three blue, biohazard bins that were filled beyond capacity located inside the CT Room. RT 2 stated that he had called the environmental services to have the three bins changed yesterday (10/23/17), but did not follow up today. RT 2 indicated that he would continue to dispose of any CT contrast (a dye that is injected into a patient for CT imaging) into the bins even if they were filled beyond capacity.

In an interview on 10/24/17 at 2:25 p.m., the DIM stated that the process the Radiology Technicians should have followed was to page the environmental services and if they did not get a response then the RT should escalate his concern to her(DIM)so that she could speak to the Environmental Service Supervisor(EVS). The DIM stated she did not receive a call from RT 2 about this matter.

In an interview on 10/27/17 at 12:20 p.m., the EVS stated that the blue biohazard bins were not to be filled beyond the line that was clearly marked in the front of the bin. The EVS stated that if the bins were filled beyond the indicated line a staff member could get injured, items could be taken out and used, there could be spillage which could lead to an injury, or there could be cross contamination and it was a serious health violation. The EVS stated his department was not informed on 10/23/17 by anyone from CT when the bins were filled beyond capacity.

Review of the hospital's policy and procedure titled, "HAZARDOUS SUBSTANCE AND MEDICAL WASTE PROGRAM", with a reviewed/revision date of 3/16 indicated as followed: "V. PROCEDURE: A. HAZARDOUS WASTE MANAGEMENT PROCEDURES. 1. Definition of Hazardous Substance (hazardous material or hazardous waste): Any substance or mixture of substances having properties capable of producing adverse effects on the health or safety of human health or the environment. Included are substances that are carcinogens, toxic, irritants, corrosives, sensitizers, and agents which damage lungs, skin, mucous membranes, etc. 4. Procedures for Medical Waste Segregation and Disposal. c. Medical waste is separated at the point of generation via staff placing all medical waste in appropriate containers in their work area or in soiled utility rooms. As containers become filled, Environmental Services is called for removal of the waste.


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5. Review of the hospital's P&P(policy and procedure)titled "Guideline: Verification of Proper Operation of Airborne Infection (spread when droplets of pathogens are expelled into the air due to coughing, sneezing or talking)Isolation Rooms(AAIR), dated 8/2017, showed the following:
Purpose: To provide an overview of the Facilities Management process for ensuring appropriate operation of the negative pressure rooms(a ventilation system designed to contain airborne contaminants within the room.)
Procedure: Performed Daily - All rooms designated as Airborne Infection Isolation Rooms:
Air pressure is verified as negative with a visual indicator, for example a smoke tube, flutter strip or calibrated differential pressure device.

During interviews and concurrent record review, on 10/24/17 at 9:50 a.m., the hospital's Airborne Infection Isolation Room Daily Logs showed eleven rooms designated as negative pressure rooms. The LE(Lead Engineer), SE(Stationary Engineer)1 and SE2 confirmed the logs indicated the rooms had been checked for proper functioning by testing the sensor alarm(sounds when pressurization in the room is compromised)and with the smoke test(procedure to determine whether a room is under negative pressure. If the room is under negative pressure, the smoke will travel under the door and into the room.)

During a record review and concurrent interview, on 10/26/17 at 9:30 a.m., the Airborne Infection Isolation Room Daily Log showed SE3 had not documented the time testing had been performed for 10 of 11 rooms on 10/12/17 and 9 of 11 rooms on 10/13/17. SE3 was asked to explain the process for the daily checks and stated sensor test and a temperature check was done in all negative pressure rooms. When asked if the smoke test was done SE3 stated, "No". The LE stated we do the smoke test every time. SE3 responded, "We do?"


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6. During an observation and concurrent interview in a vacant, clean patient room on 10/23/17 at 10 a.m., RN 7, the unit nurse in charge, confirmed the epidural pump at the bedside was ready for patient use. (An epidural pump delivers pain control medication through a catheter(tube) inserted into a blood vessel.) RN 7 confirmed the pump's outer case had one piece of plastic tape, and six areas of sticky residue, each measuring approximately one inch by one-quarter inch.

During an observation and concurrent interview in the clean utility room on 10/23/17 at 10:24 a.m., RN 7 confirmed two epidural pumps on a shelf were ready for patient use. RN 7 confirmed one of the pumps had a piece of tape one inch long and one-half inch wide, and the other pump had two areas of sticky residue, each measuring approximately one inch long by one-half inch wide.

During an interview 10/25/17 at 2:58 p.m., Director of Infection Control (DIC) said both tape, and any sticky residue had to be removed from surfaces in order for the surfaces to be clean. DIC said tape/sticky residue attracts dust and bacteria, and prevents adequate decontamination of surfaces.

Based on observations, nursing and engineering staff interview and document review the hospital failed to ensure 1)The sanitizer used in the infant formula preparation work area was wiped after sanitizing and 2)the hospitals' ice machines were installed in a manner to mitigate the potential of bacterial cross contamination when they were connected directly to the waste water system. Failure to ensure operational processes that protect from contamination may result in foodborne illness, further compromising medical status.

Findings:

1. On 10/24/17 beginning at 11:45 a.m., the procedure for infant formula preparation was reviewed with Registered Nurse (RN) 10. In a concurrent interview the procedure included the sanitation of the work surface where the breastmilk/formula modifier was added. RN 10 demonstrated that a food-safe sanitizing process was applied to the counter. The process included a wet time (the amount of time that the surface needed to remain wet with the sanitizer for maximum effectiveness) of 5 minutes. RN 10 stated that after the 5 minutes and once the surface was dry the infant feeding was prepared.

The standard of practice when preparing an infant feeding would include the wiping of the sanitizer with a clean, dry paper towel prior to feeding preparation (Infant Feeding: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities, American Dietetic Association, 2011).

Facility policy titled "Breastmilk Collection, Fortification, Use and Storage" dated 9/17 did not provide comprehensive guidance on the sanitation of the infant feeding preparation area, rather was limited to " ...wipe down breast milk fortification tray prior to use ..."

2. On 10/24/17 beginning at 11:15 a.m., the preventive maintenance of the hospitals' ice machine was reviewed with Engineering Staff (ES) 11. ES 11 described a process that included descaling and sanitizing the machine in accordance with manufacturers' guidance. Review of the installation of the ice machine revealed the plumbing was directly connected the hospitals' sewer system. ES 11 stated that all of the hospitals' on-campus and off-campus ice machine would be plumbed in the same fashion. MS stated there were approximately 15-16 ice machines.

The Food Code (2013) requires that all food service equipment drains, such as (sinks, ice bins, refrigerators, walk-ins, ice machines, etc.) shall be hard piped with an indirect drain a floor sink, with a proper air gap provided. An air gap is the unobstructed vertical space between the water outlet and the flood level of a fixture, with a minimum clearance of 1 inch. In this case the water outlet from the ice machine producing mechanism rested less than 1 inch above the drip tray of the ice machine.