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Based on observations, review of records, and staff interviews, it was determined that the Governing Body failed to demonstrate effective functioning, to ensure that hospital services are provided in compliance with the Medicare Conditions of Participation, and according to acceptable standards of practice, as evidenced by condition-level, noncompliance identified in five (5) of 23 areas; two (2) of which were identified as Immediate Jeopardy as follows:

42 CFR §482.21- A-0273: Quality Assessment and Performance Improvement Program - Failure to establish an effective program that measures, analyzes, and tracks quality indicators, which assesses processes of care, hospital services, and operations of pharmacy services and environmental services, to ensure safety from widespread nosocomial infections.

42 CFR §482.25- A-0489: Pharmaceutical Services - An Immediate Jeopardy was identified on 04/06/18 at 6:00 PM, under 42CFR 482.25, Pharmacy Services, for failure to ensure a pharmacist competently supervises and coordinates pharmacy activities and services. The pharmacist failed to monitor, evaluate and act on Air Sample test results that were identified as "highly pathogenic" in the ISO [International Organization for Standardization]-7 [Sterile Compounding Room]. This practice revealed a failure to implement infection control precautions as to protect from potential widespread nosocomial infections.

42 CFR §482.41- A-0700: Physical Environment - The hospital staff failed to ensure that the hospital was maintained in a sanitary manner as to ensure safety of the patient to avoid sources and transmission of infections as evidenced by the observation of unsanitary conditions in the pharmacy Sterile Compounding room. Air Sample tests revealed results that required action.

42 CFR §482.42, A-0747: Infection Control - The hospital staff failed to ensure that the program established for infection prevention, included surveillance, monitoring, analysis and evaluation of the pharmacy environment. Air Sample tests conducted of the pharmacy ISO [International Organization for Standardization]-7 [Sterile Compounding Room] revealed results that were repeatedly identified as "highly pathogenic" and were not acted upon. There was no evidence that the Infection Control Program integrated surveillance of pharmacy services as a method to avoid sources and transmission of infections and communicable disease. As a result, an Immediate Jeopardy was identified on April 6, 2018 at 6:00 PM under 42 CFR §482.42, A-0747 - Infection Control.

The cumulative effect of these systemic deficient practices, resulted in the Governing Body's failure to comply with the Federal regulations, regarding the Governing Body and Administration.

Based on observations, reviews of records to include, medical, data, personnel, committee meeting minutes and staff interviews, it was determined the Governing Body failed to develop an effective monitoring mechanism to ensure the Chief Executive Officer managed the hospital in accordance with acceptable standards of practice.

Findings included:

The Chief Executive Officer failed to:

Ensure a mechanism was in place for supervision and coordination of pharmacy activities and services and for monitoring all compounding, packaging, and dispensing of drugs performed, consistent with state and federal laws. The pharmacist failed to monitor, evaluate and act on Air Sample test results that were identified as "highly pathogenic" in the ISO [International Organization for Standardization]-7 [Sterile Compounding Room]. This practice revealed a failure to implement infection control precautions as to protect from potential widespread nosocomial infections. The surveyors identified an Immediate Jeopardy on 04/06/18 at 6:00 PM. (Cross-reference A-0489).

Establish an infection prevention program, to include surveillance, monitoring, analysis and evaluation of the pharmacy environment. Air Sample tests conducted of the pharmacy ISO [International Organization for Standardization]-7 [Sterile Compounding Room] revealed results that were repeatedly identified as "highly pathogenic" and were not acted upon. There was no evidence that the Infection Control Program integrated surveillance of pharmacy services as a method to avoid sources and transmission of infections and communicable disease. As a result, the surveyors identified an Immediate Jeopardy on April 6, 2018, at 6:00 PM. (Cross-reference A-0489 and A-0749).

Ensure that the hospital staff maintained the hospital in a sanitary manner to ensure the safety of patients to avoid sources and transmission of infections as evidenced by the observation of unsanitary conditions in the pharmacy Sterile Compounding room. Air Sample tests revealed results that required action. (Cross-reference A-0700 and A-0489).

Establish an effective Quality Assessment and Performance Improvement Program (QAPI), that measures , analyzes, and tracks quality indicators, which assesses processes of care, hospital services, and operations of pharmacy services and environmental services, to ensure safety from widespread nosocomial infections. (Cross-reference A-0273).

Maintained current and accurate records to reflect the receipt and disposition of all scheduled drugs (Cross-reference A-494).

Develop an effective monitoring mechanism to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use. (Cross-reference A-0505).

Implement a mechanism to ensure the maintenance of facilities, supplies, and equipment, to provide safety and well-being of patients (Cross-reference A-0724).

Develop and implement a current individualized plan of care for each patient in all areas of the hospital. (Cross-reference A0396).

Establish and implement a mechanism to ensure that hospital staff has evidence of training to include competencies, for documentation in the medical record, for all new and current employees. (Cross-reference A-0454).

Establish and implement an effective monitoring mechanism to ensure that the nursing staff administered drugs and biologicals, in accordance with Federal and State laws, and accepted standards of practice (Cross-reference A-0405). This is a repeat deficient practice from 07/17.

The cumulative effect of these systemic deficient practices resulted in the Chief Executive Officer failure to comply with the state licensure regulations, regarding the Governing Body and Administration.

During a face-to-face interview conducted on 04/11/18 at approximately 5:00 PM, with Employee #70, Director of Quality, she reviewed, discussed, and acknowledged the findings.

Based on record review, policy review, and staff interviews, the hospital staff failed to ensure the patients' right to receive care in a safe environment, in eight (8) of 15 observations.

Findings included...

Record review of the hospital's policy titled, "Patient Rights and Responsibilities," revised 04/17, shows that patients have the right to receive care in a safe environment.

Record review of the hospital's policy titled, "Drug Storage and Unit Inspections," dated 09/17, shows that all medications and medical supplies are to be locked and secured.

A. During a tour of the Emergency Department (ED) on 04/04/18 at approximately 12:30 PM, the surveyor observed an unlocked intravenous supply cart, located in the front of Room #5, displaying #20, 22, and 24 angiocatheters and insulin syringes. The cart faced the hallway and the sharps were exposed to patients and passersby.

B. The Central Line cart, located near Room #2 was unlocked. It contained sharps to include a lumbar puncture tray with spinal needles and two pleuravacs with needles and scalpels.

The observations were made in the presence of Employee #3, Nurse Manager.

The practice lacked evidence that staff maintained a safe environment to prevent the risk of sharps injury.

The surveyor queried, Employee #3, regarding the staff practice. He explained that the hospital is expecting new carts "today," and in the meantime staff are aware to ensure the drawers are closed and the cart is facing the wall, away from patient view. He explained that the central line cart should have been locked. Employee #3 acknowledged the findings.

C. During a tour of the Emergency Department (ED) on 04/04/18 at approximately 3:45 PM, the surveyor observed Employee #78, Emergency Department Technician, obtain a flush from the intravenous cart (located in the hallway, across from Room #2), and leave the drawer open, exposing sharps to patients and passersby.

The practice lacked evidence that staff maintained a safe environment to prevent the risk of sharps injury.

The surveyor queried, Employee #3, regarding the staff practice. He explained that the hospital is expecting new carts "today," and in the meantime staff are aware to ensure the drawers are closed and the cart is facing the wall, away from patient view. Employee #3 and 78 acknowledged the findings.





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D. During a tour of the Primary Care clinic (PCC) on 04/06/18, at approximately 9:15 AM, the surveyor observed supply room 302-2 unlocked and open, facing several patient exam rooms. The supply room contained multiple medications, both, oral and injectable, and medical supplies. Furthermore, multiple syringes in various sizes of 1, 3, 5, 10, and 20 milliliter (ml) with needle sizes; 27 gauge (G)18, and 22, were noted to be available in the open and unsecured storage room. In the hallway, an unlocked and unsecure cabinet was found to contain medication sample packets.

The practice lacked evidence that the PCC staff insured the patient's right to receive care and treatment in a safe environment.

A face to face interview at that time, with the Primary Care Director Employee #31 Physician, on 04/06/18, regarding the medication room. Employee #31 reported that the clinic staff keeps the medication and storage room door open and unlocked, throughout the time the clinic is open to patients, but, it is locked and secure when the clinic is closed at night. He further stated that a locking key pad would be put on the storage room door "today", and the interview concluded in the presence of Employee #27 Registered Nurse

E. A tour was conducted of The Infectious Disease (ID) Clinic on 04/11/18 at approximately 11:00 AM, with Employee's # 27 Registered Nurse and 30 Patient Care Technician. The surveyor discovered a box containing 9 tablets of the medication Ribasphere expired 06/17; on top of a filing cabinet in an open and unsecured provider's office. In exam room 9, an exam table drawer contained 17 packets of Povidone-Iodine, expired 06/17.

The practice lacked evidence that the ID clinic staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with ID clinic Employee # 30, the surveyor inquired why medications and biologicals were expired, unsecured, and available to passersby in the clinic. She stated that she was not aware that expired medications or supplies were unsecured in the clinic, and proceeded to discard the items found. Employees # 30 and 27 acknowledged the findings.

F. An observation during a tour of the 5th floor medical surgical area with Employee's #25 Assistant Director of Nursing , #49 Registered Nurse, and #27 Registered Nurse, on 04/04/18 at 10:35 AM, showed a rolling computer station with drawers underneath, found unlocked and unsecured by the nursing station. The unlocked medication drawers contained syringes with needles.

The practice lacked evidence that the 5th floor medical surgical unit staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with Employee's #25, and 49, on 04/04/18 at approximately 10:55 AM, the Employees acknowledged the findings of the unsecured and unlocked syringes with needles available to passersby, and locked the computer station. Furthermore, Employee # 25, stated, "Those items should never be in the computer station", in the presence of Employee #27.

G. A tour of the 8th floor medical surgical area, conducted on 04/05/18 at 03:15 PM with Employee's #27 Registered Nurse (RN), and #36 RN. A rolling computer station with medication drawers was found with unlocked medication drawers, by the nursing station, containing syringes with needles, and patient medications (Patients 49 and 65).

The practice lacked evidence that the 8th floor medical surgical unit staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview completed with Employee #36, at approximately 3:25 PM on 04/05/18. Employee #36 acknowledged the findings of unsecured and unlocked patient medications, and syringes with needles available to passersby, in the presence with Employee #27.

H. During a tour of The Wound Clinic, conducted on 04/11/18 at 9:25 AM, with Employee's # 27 Registered Nurse, and 29 Wound Clinic Director. The tour showed multiple expired items on the code cart, to include defibrillator pads expired 08/12, and electrodes expired 01/13. An Accucheck Glucose Monitor with a full bottle of test strips expired 01/31/18, was found in treatment room # 3. Furthermore, multiple scalpels, biopsy needles, and curettes were found expired, unlocked and unprotected from passersby, in multiple patient treatment rooms.

The practice lacked evidence that the Wound Clinic staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with Wound Clinic Employee #29 was conducted at that time, in the presence of # 27. She stated that there had been a complete staffing change, and that she was in the process of re-organizing the clinic. Both Employees #29 and 27 acknowledged the findings.

Based on observation, policy review, staff interviews, and staff confirmation, the registration staff failed to maintain the privacy and confidentiality of patients' sensitive information, whose health information and/or electronic medical records (EMRs) were left open and unattended, in two of five observations (Patients #3).

Findings included...

Record review of the hospital's policy titled, "Patient Rights and Responsibilities," revised 04/15, shows that patients' have the right to confidentiality of their medical records.

A. During a tour in the Emergency Department (ED) on 04/05/18, at approximately 10:50 AM, the surveyor observed the computer, located in the registration area, unattended and displaying Patient #37's personal identifiers, to include the patient's name, age, diagnosis, date of birth and address. Employee #76, Registration Supervisor, was logged into the computer.

The practice failed to follow the hospital's policy, and to provide evidence that ensured the privacy and confidentiality of patients' medical/health information.

During a face to face interview on 04/05/18, at approximately 10:55 AM, with Employee #76, she acknowledged the findings, stating, "I usually lock my screen."

B. During a tour in the Emergency Department (ED) on 04/05/18, at approximately 11:00 AM, the surveyor observed the computer, located in the registration area, unattended and displaying the registration tracker that included personal identifiers (of patients' name, age, complaint, and status). Employee #87, Registration Clerk, was logged into the computer. The observation was made in the presence of Employee #76, Registration Supervisor.

The practice failed to follow the hospital's policy, and to provide evidence that ensured the privacy and confidentiality of patients' medical/health information.

Employees #87 and 76 acknowledged the findings.

Based on medical record review, policy review, and staff interview, the medical staff failed to write orders for restraints, for one of two patient records reviewed (Patient #41). This is a repeat finding from the survey conducted 07/11/17.

Findings included...

Record review of the hospital Policy titled, "Restraints and Seclusion," revised 05/16, shows that medical staff are to write an individual order for the use of restraints.

Review of Patient #41's medical record on 04/06/18 at approximately 9:50 AM, revealed the patient exhibited non-violent behavior to include pulling lines and tubes; which required bilateral upper extremity soft limb restraints. Review of the nursing documentation from 03/26/18 to 04/06/18 revealed the patient was in bilateral upper extremity soft limb restraints; however, the medical record lacked documented evidence of a physician order for the use of restraints, on 03/27/18, 03/20/18, 04/03/18, 04/05/18 and 04/06/18.

The practice lacked documented evidence that the medical staff wrote an order for the patient maintained in restraints.

During a face to face interview with Employee #92, Physician, on 04/06/18 at approximately 10:00 AM, he acknowledged that the patient's behavior required the restraints. He explained that the staff has to do a better job to ensure written restraint orders.

Based on Quality Assessment Performance Improvement (QAPI) Program review, record review, and staff interview, the hospital staff failed to measure, analyze, and track quality indicators to include aspects of performance that assess processes of care, services, and operations related to pharmacy and environmental services and infection control (A-0273); and failed to set priorities for its performance improvement activities that focus on problem-prone areas related to pharmacy and environmental services/physical plant and infection control that affect health outcomes, patient safety, and quality of care (A-0283).

The cumulative effect of these systemic practices, resulted in the hospital's failure to comply with conditions of participation in Quality Assessment and Performance Improvement Program.

Based on the Quality Assessment Performance Improvement (QAPI) Program review, committee meeting minutes review, and staff interview, the hospital staff failed to measure, analyze, and track quality indicators to assess processes of care, hospital services, and operations related to pharmacy services, the physical environment, in ISO [International Organization for Standardization]-7, Sterile Compounding Room and infection control.

Findings included...

During the complaint investigation survey on 04/06/18, the following concerns were identified:

Failure to ensure a pharmacist supervises and coordinates pharmacy activities and services, cross reference CFR §482.25- A-0492;

Failure to ensure the hospital maintains a current and accurate record for the receipt and distribution of all scheduled drugs, cross reference CFR §482.25(a)(3)-A-0494;

Failure to ensure all compounding, packaging, and dispensing of drugs and biologicals are performed consistent with state and federal laws CFR §482.25 (b)(1)-A-0501;

Failure to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use, cross reference CFR §482.25(b)(3)-A-0505;

Failure to maintain equipment in a manner such that the safety and well-being of patients is assured, cross reference CFR §482.41- A-0700;

Failure to ensure the condition of the physical plant and hospital environment is maintained in a manner that ensures safety and well-being of patients, cross reference CFR §482.41 (a) - A-0701;

Failure to ensure facilities, supplies and equipment is maintained to ensure an acceptable level of safety and quality, cross reference CFR §482.41 (c)(2)- A-0724;

Failure to ensure the hospital staff provides a sanitary environment to avoid sources and transmission of infections, cross reference CFR §482.42, A-0747; and

Failure to ensure the infection control officer develops a system for identifying, reporting, investigating and controlling infection, related to pharmacy and environmental services, cross reference CFR §482.42(a) -A-0749.

During a face to face interview on 04/11/18 at approximately 5:00 PM, with Employee #70, Director of Quality, the quality program and the identified concerns were reviewed and discussed to include the results of the surface and air samples that were deemed highly pathogenic, requiring remedial action; and the unsanitary condition, in the ISO [International Organization for Standardization]-7, Sterile Compounding Room]. Employee #74 explained that she relied on pharmacy and infection control staff to convey findings and concerns; however, neither conveyed any findings or concerns about the aformentioned findings, though they attended the meetings. Employee #70 acknowledged the findings.

Based on quality program review and staff interviews, it was determined the hospital failed to implement an effective mechanism for setting quality priorities to ensure performance improvement activities address problem-prone areas, related to pharmacy and environmental services, and infection control.

Findings included...

During review of the Quality Assessment Performance Improvement (QAPI) Program on 04/11/18 at approximately 4:00 PM, the hospital staff failed to recognize, monitor, measure and track problem-prone areas and issues identified during the complaint investigation survey related to pharmacy services, the physical plant and infection control, to ensure care delivery and process improvement.

The quality and patient safety plan lacked documented evidence of structural, procedural or process changes to achieve sustainable remediation of chronic deficient practices related to unacceptable air samples. The action plan lacked documented evidence of priorities and process improvement activities related to pharmacy activities, environmental services and infection prevention for the following identified problem-prone areas:

Failure to ensure a pharmacist supervises and coordinates pharmacy activities and services, cross reference CFR §482.25- A-0492;

Failure to ensure the hospital maintains a current and accurate record for the receipt and distribution of all scheduled drugs, cross reference CFR §482.25(a)(3)-A-0494;

Failure to ensure all compounding, packaging, and dispensing of drugs and biologicals are performed consistent with state and federal laws CFR §482.25 (b)(1)-A-0501;

Failure to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for patient use, cross reference CFR §482.25(b)(3)-A-0505;

Failure to maintain equipment in a manner such that the safety and well-being of patients is assured, cross reference CFR §482.41- A-0700;

Failure to ensure the condition of the physical plant and hospital environment is maintained in a manner that ensures safety and well-being of patients, cross reference CFR §482.41 (a) - A-0701;

Failure to ensure facilities, supplies and equipment is maintained to ensure an acceptable level of safety and quality, cross reference CFR §482.41 (c)(2)- A-0724;

Failure to ensure the hospital staff provides a sanitary environment to avoid sources and transmission of infections, cross reference CFR §482.42, A-0747; and

Failure to ensure the infection control officer develops a system for identifying, reporting, investigating and controlling infection related to pharmacy and environmental services, cross reference CFR §482.42(a) -A-0749.

During a face to face interview on 04/11/18 at approximately 5:00 PM, with Employee #70, Director of Quality, the quality program and the identified concerns were reviewed and discussed to include the results of the surface and air samples that were deemed highly pathogenic, requiring remedial action; and the unsanitary condition, in the ISO [International Organization for Standardization]-7, Sterile Compounding Room]. Employee #74 explained that she relied on pharmacy and infection control staff to convey findings and concerns; however, neither conveyed any findings or concerns about the aformentioned findings, though they attended the meetings. Employee #70 acknowledged the findings.

1. Based on medical record review, policy review, and staff interview, the staff failed to ensure accurate, complete, and consistent patient assessments, in accordance to the patient's plan of care, in four of 17 records reviewed (Patients #3, 32, 36, and 62).

Findings included ...

A. Record review of the hospital's policy titled, "Restraints and Seclusion," dated 05/16, showed Chemical Restraint observation shall be conducted every 15 minutes and continue two hours after the chemical restraint is administered. The RN is responsible for documentation of individual assessments and reassessments and medications given and their effect.

DCMR Chapter 54: Standards related to registered nurse scope of practice. The registered nurse utilizes the nursing process to assess, diagnose, establish a plan with outcome criteria, intervene, evaluate, and document health problems in nursing practice settings. The registered nurse shall " ... 2. Conduct a comprehensive nursing assessment determined by the knowledge, skills, and abilities of the registered nurse and by the client's immediate condition or needs ..."

Review of Patient #3's medical record showed the patient received Benadryl 50 milligrams (mg), Ativan 2 mg and Thorazine 100mg intramuscular (IM) as a chemical restraint on April 5, 2018, at 1:28 AM and 1:29 AM respectively. The patient received the medication because of aggressive behavior and attempted to assault the nursing staff physically. The physician ordered the medications remotely after notification by the nursing staff.

During a face-to-face interview on April 5, 2018, at approximately 2:50 PM, Employee #16, Nurse Manager stated that the nursing staff should complete an Emergency Medication assessment after medications administrated for chemical restraints. Employee #16 navigated the electronic medical record to the section where the nursing staff document the Emergency Medication assessment. The section remained blank. The nursing staff failed to complete the Emergency Medication assessment for chemical restraints.

Employee #16 questioned regarding the nursing staff updating the care plan. Employee #16 said the nurse documented a progress note to include a plan. However, the patient's multidisciplinary care plan meeting previouslyplanned. Discharge plans for placement in progress.

Employee #16 reviewed and acknowledged the findings on 04/05/18, at approximately 3:00 PM.





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B. Record review of the hospital's policy titled, "Pain Assessment and Management," revised 10/16, shows that nursing staff are to perform a patient pain assessment, upon arrival to the emergency department, and with response to intervention; and document it on the triage form.

Review of Patient #32's medical record on 04/05/18 at approximately 12:00 PM, revealed the nurse triaged the patient on 04/04/18 at 10:53 PM; however, the record lacked evidence the nurse performed and documented a pain assessment, upon admission.

During a face-to-face interview with Employee #84, Registered Nurse, on 04/05/18 at approximately 12:00 PM, she reviewed the record and acknowledged the findings.

C. Review of Patient #36's medical record on 04/05/18 at approximately 10:25AM, revealed the nurse triaged the patient on 04/04/18 at 10:13 PM to have pain measured at eight out of ten on the numeric pain scale (0 is no pain and 10 is the worst pain), for which she was medicated at 04/05/18 at 2:25 AM; however, the record lacked evidence the nurse performed and documented a pain reassessment, until 04/05/18 at 10:20 AM.

During a face-to-face interview with Employee #84, Registered Nurse, on 04/05/18 at approximately 10:40 AM, she reviewed the record and acknowledged the findings.

2. Based on medical record review, policy review and staff interview, the nursing staff failed to follow physician's orders and plan of care for glucose management, in two of four patients (Patient #40 and 41).

Findings included...

A. Review of Patient #40's closed medical record on 04/05/18 at 3:40 PM, revealed a physician order dated, 04/04/18 at 1:06 PM that directed staff to discharge the patient home, when the fingerstick is less than 300mg/dl (milligrams/deciliter).

Review of the nursing documentation revealed the last fingerstick performed read 497 mg/dl, and the patient received correctional insulin; however, the record lacked documented evidence that staff repeated the fingerstick to ensure the level of less than 300mg/dl; prior to patient discharge.

The practice failed to ensure that staff followed physician orders to ensure adequate glucose management.

During a face-to-face interview on 04/06/18 at approximately 10:20AM, with Employee #26, Performance Improvement Coordinator, she reviewed and acknowledged the findings.

During a subsequent face to face interview on 04/09/18 at 11:00 AM with Employee #91, Physician, he acknowledged the findings, stating he will follow up with the patient.

B. Review of the physician order dated, 03/27/18 at 10:37 AM, directed staff to perform fingersticks every four hours, on Patient #41. Review of the nursing documentation from 03/27/18 to 04/06/18 revealed staff failed to perform fingersticks every four hours from 03/29/18 at to 04/05/18; and the record lacked documented evidence that staff performed fingersticks on 04/06/18, up to the time of record review at 10:00 AM.

The practice failed to ensure that staff followed physician orders to perform fingersticks every four hours.

During a face-to-face interview on 04/06/18 at approximately 10:20AM, with Employee #26, Performance Improvement Coordinator, she reviewed and acknowledged the findings.





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3. Based on medical record review, staff interview, nursing staff failed to notify the physician promptly of an acute change in mental status, accordance with the plan of care, in one of one patient records reviewed (Patient #25).

Findings included ...

Review of the medical record showed that Patient #25 presented to the emergency room on 12/23/17 from a nursing home for respiratory distress. The patient had an oxygen saturation of 97% on room air on arrival to the emergency room.

Review of the history and physical on 12/23/17 at 11:40 PM showed that Patient #25 was nonverbal and did not follow commands. Further review of the assessment documented on 12/24/17 at 12:36 AM showed that the patient tracked occasionally with her eyes and moved all extremities. Patient #25 was admitted for Acute Kidney Injury, Delirium and Dehydration with a plan for aggressive intravenous (IV) fluid resuscitation.

The surveyor conducted a face to face interview with Employee #100, Medical Chief of Staff, on 04/10/18 regarding Patient #25 after reviewing the record of her previous admissions, he stated that she had a past medical history of Seizures, and the neurological assessment in the emergency department was her baseline.

Review of the first nursing assessment completed on 12/24/17 at 5:45 AM, when Patient #25 arrived to the medical surgical floor, showed that her level of consciousness (LOC) was confused. Her Glasgow coma scale (GCS - a scoring system used to describe the level of LOC in a person by assessing eye opening, motor response and verbal response. The score can be between 3 indicating coma and 15 indicating best prognosis) score was documented as a 5. Patient #25 opened her eyes only to pain, a score of 2; her motor response was abnormal extension, a score of 2; and she had no verbal response, a score of 1. The patient's extremities were documented as severely weak. In the section titled "Reflexes", it was documented that the patient had an absent cough and absent corneal reflexes.

The record lacked documented evidence of physician notification regarding the acute changes in the neurological status.

Additional review of the medical record showed a neurological nursing assessment dated 12/24/17 at 8:09 AM. Documented in the assessment was a new onset left facial droop not previously documented. In a nursing note dated 12/24/17 at 9:54 AM, the nurse documented " ...At around 0846 AM the writer ....came to see the [patient] and found that [patient] was unresponsive with pulse and breathing. Called rapid response at 8:48 AM ..." A computed tomography (CT ) of the head was ordered and showed a "Large area ... in the right cerebellar hemisphere, concerning for acute/subacute infarction ..." Patient #25 was transferred to the ICU.

During a face to face interview and record review on 04/10/18 at 11:32 AM, Employee #100 acknowledged the findings.





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4. Based on medical record review, hospital policy review, and staff interview, that the nursing staff failed to accurately assess a wound, in accordance with the plan of care and hospital policy, in one of one medical records reviewed (Patient #62).

Findings included ...

Record review of the hospitals policy titled, "Skin and Wound Care", dated 10/17, showed that the patient's nurse will perform a systemic skin inspection on all patients and document in the patient record. All alterations in skin integrity will be assessed to include location, description of the wound, and condition of the wound. Documentation of wounds will be done at least once each shift.

During a review of the medical record conducted on 04/05/18 at approximately 9:50 AM, a wound assessment dated 04/02/18 at 11:03 PM, showed a right below the knee amputation (BKA), and no wounds.

The Wound Nurse Treatment Order dated 4/3/18, showed, "Wound #1, Cleanse affected areas with wound cleanser, pat dry, apply Hydrogel, fluff and cover with dry dressing daily and PRN [as needed] left stump [BKA] DAILY. Wound # 2, Apply skin prep, leave open to air Daily and PRN right lateral foot DAILY."

The practice lacked evidence that the nursing staff followed hospital policy as per plan, to include all relevant characteristics and information to accurately assess Patient #62's wounds. Employee #27 acknowledged the findings.

Based on record review, policy review, and staff interview, the hospital failed to ensure that nursing staff received training related to complete and accurate documentation of care and treatment for patient's undergoing cardiac catheterization and special procedures, in two of two patient records reviewed (Patients #34 and 35).

Findings included...

Record review of the hospital's policy titled, "Medical Record Content," revised 06/17, shows that persons other than the physician are to document on designated forms, to provide a pertinent, chronological report of the patient's course and results of treatment.

A. Record review of Patient #34's medical record on 04/09/18 at 3:00 PM revealed he underwent removal of a right pleural drain on 04/04/18; for which the patient received Lidocaine, subcutaneously at 1:55 PM.

Record review of the 'Department of Radiology Special Procedures Flow Sheet' lacked evidence that nursing staff documented the dose and reason for administration, as indicated on the form. Additionally, the allocated space to document the pre-operative diagnosis and symptoms was left blank; and nursing staff documented the time out was performed at 1:55 PM and at 2:00 PM.

Review of the orientation and training documentation for Employee #95, Registered Nurse, on 04/09/18 at approximately 5:00 PM, lacked documented evidence that he received training related to the documentation of care and treatment, on the special procedures flow sheet.

The practice lacked evidence that the hospital provided the nurse training related to complete and accurate documentation on the special procedures flow sheet.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, he explained the patient was prepped for the procedure at 1:55 PM, and the time out occurred at 2:00 PM. He explained that he did not receive orientation to the necessary paperwork for Catheterization Laboratory and Special Procedures department. Employee #95, stated, "I did the best I could." He acknowledged the findings.

B. Record review of Patient #35's medical record on 04/09/18 at 3:45 PM revealed he underwent cardiac catheterization and bilateral lower extremity angiograms on 03/29/18; for which Versed one milligram (mg), Fentanyl 25 mg, and Heparin 2,000 units were ordered at 11:30 AM, and Fentanyl 25 mg was ordered at 12:15 PM.

Record review of the 'Department of Radiology Special Procedures Flow Sheet lacked evidence that nursing staff documented all medications, dose, route, time, reason for administration, and initials, as indicated on the form. All medications lacked evidence of the reason for administration and initials, and there was no route documented for Versed, and the Fentanyl given at 12:30 PM. Additionally, nursing staff documented the procedure was performed on 03/29/19.

Review of the orientation and training documentation for Employee #95, Registered Nurse, on 04/09/18 at approximately 5:00 PM, lacked documented evidence that he received training related to the documentation of care and treatment, on the special procedures flow sheet.

The practice lacked evidence that the hospital provided the nurse training related to complete and accurate documentation on the special procedures flow sheet.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, he explained that he
did not receive orientation to the necessary paperwork for Catheterization Laboratory and Special Procedures department. He stated, "I did the best I could." He acknowledged the findings.

1. Based on medical record review and staff interview, nursing staff failed to administer Fentanyl, as ordered, in one of two records reviewed, in the cardiac catheterization and special procedures area (Patient #35).

Findings included...

Record review of Patient #35's medical record on 04/09/18 at 3:45 PM, revealed he underwent cardiac catheterization and bilateral lower extremity angiograms on 03/29/18; for which Versed one milligram (mg), Fentanyl 25 mg, and Heparin 2,000 units were ordered at 11:30 AM, and an additional dose of Fentanyl 25 mg was ordered at 12:15 PM.

Review of the 'Department of Radiology Special Procedures Flow Sheet' and nursing documentation, lacked documented evidence that the nurse administered the 11:30 AM Fentanyl, as ordered.

The practice lacked evidence that the nurse followed the 11:30 AM order to administer Fentanyl to Patient #35, during the procedure.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, Registered Nurse, he acknowledged the findings.




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2. Based on record review and staff interview, the nursing staff failed to administer insulin to patients requiring a corrective dose, in accordance with physician orders, in two of five patient records reviewed (Patients #21 and 22).

Findings included ...

A.Review of a physician order dated 03/27/18 showed that Patient #21 was to be administered low dose correctional insulin as follows: for a fingerstick blood glucose (FSBG) level from 150 - 199 milliliters per deciliter (mg/dl), give one unit; for 200 - 249 mg/dl, give two units; 250 - 299 mg/dl, give three units; 300 - 349 mg/dl give four units; for a value of 350 - 400 mg/dl, give five units; and for a value greater than 400, notify the physician.

Review of the point of care (POC) test results showed that on 04/02/18 at 6:31 PM, Patient #21's FSBG was 176 mg/dl; on 04/03/18 at 1:16 AM the FSBG value was 208 mg/dl, and on 04/03/18 at 6:04 AM the FSBG value was 217 mg/dl. Review of the electronic Medication Administration Record (eMAR) showed there was no insulin coverage administered for the above values and no documentation of a reason for the missed administration.

The surveyor conducted a face to face interview on 04/04/18 at approximately 11:30 AM with Employee #12, ICU Manager, regarding the missed correctional dose insulin administration. He acknowledged the findings.

The surveyor conducted a face to face interview on 04/09/18 at 2:12 PM with Employee #161, Diabetic Educator. She stated that nurses have been instructed to document a reason for missed insulin administration. She acknowledged the findings.

B.Review of the medical record for Patient #22 showed a physician order dated 04/03/18 for medium dose correctional insulin to be administered as follows: for a fingerstick blood glucose (FSBG) level from 150 - 199 milliliters per deciliter (mg/dl), give one (1) unit; for 200 - 249 mg/dl, give three units; 250 - 299 mg/dl, give five units; 300 - 349 mg/dl give seven units; for a value of 350 - 400 mg/dl, give eight units; and for a value greater than 400, notify the physician.

Review of the point of care (POC) test results showed that on 04/03/18 at 12:04 PM, Patient #22's FSBG was 200 mg/dl; on 04/04/18 at 03:39 AM the FSBG value was 169 mg/dl. Review of the electronic Medication Administration Record (eMAR) showed that there was no insulin coverage administered for the above values, and no documentation of a reason for the missed administration.

The surveyor conducted a face to face interview on 04/04/18 at approximately 11:30 AM with Employee #12, ICU Manager, regarding the missed correctional dose insulin administration. He acknowledged the findings.

The surveyor conducted a face to face interview on 04/09/18 at 2:12 PM with Employee #161, Diabetic Educator. She stated that nurses have been instructed to document a reason for missed insulin administration. She acknowledged the findings.

Based on medical record review, policy review, and staff interview, nursing staff failed to authenticate verbal medication orders, in one of two records reviewed, in the cardiac catheterization and special procedures area (Patient #35).

Findings included...

Record review of the hospital's policy titled, "Verbal/Telephone Physician Orders", reviewed 10/15, shows that staff are to document the order was read back and sign the order.

Record review of Patient #35's medical record on 04/09/18 at 3:45 PM revealed he underwent cardiac catheterization and bilateral lower extremity angiograms on 03/29/18; for which Versed one milligram (mg), Fentanyl 25 mg, and Heparin 2,000 units were ordered at 11:30 AM, and Fentanyl 25 mg was ordered at 12:15 PM. Review of the order form lacked evidence that the nurse read back the order, and there was no nurse's signature on the verbal orders.

The practice lacked evidence that the nurse followed the policy to ensure properly executed orders.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, Registered Nurse, he explained that he did not sign the orders. He acknowledged the findings.

Based on medical record review and staff interview, the hospital staff failed to ensure the medical record was complete to include a consent for treatment, in two (2) of 10 patient records reviewed (Patients #31 and 32).

Findings included...

Record review of the hospital's policy titled, "Consent For Uses and Disclosures To Carry Out Treatment, Payment or Healthcare Operations," reviewed 06/17, shows that staff are to make every attempt to obtain a consent or document the reason why the consent cannot be obtained.

A. Review of Patient #31's medical record on 04/05/18 at approximately 10:40 AM revealed the patient was triaged in the Emergency Department on 04/04/18 at approximately 10:03 AM. Further review of the record lacked evidence of a consent for treatment or the documented reason why the consent could not be obtained.

The practice lacked evidence that staff obtained a general consent for treatment.

During a face-to-face interview on 04/05/18 at approximately 10:50 AM, with Employee #75, Director of Patient Access, she acknowledged the findings.

B. Review of Patient #32's medical record on 04/05/18 at approximately 10:00 AM revealed the patient was triaged in the Emergency Department on 04/04/18 at approximately 10:53 PM. Further review of the record lacked evidence of a consent for treatment or the documented reason why the consent could not be obtained.

The practice lacked evidence that staff obtained a general consent for treatment.

During a face-to-face interview on 04/05/18 at approximately 10:50 AM, with Employee #75, Director of Patient Access, she acknowledged the findings.

1. Based on the review of records (patients' electronic medical record and instrument print out), and confirmation by staff interview conducted on April 5, 2018 at approximately 12:00 Noon, the hospital failed to ensure that urinalysis test results performed at the hospital's primary medical clinic are recorded in each patient's medical chart. Four (4) of the four (4) patients' records randomly selected for review, failed to include urinalysis results in its entirety ( Patient Numbers 87, 88, 89 and 90).

The findings included:

Review of randomly selected medical records for Patient #s 87, 88, 89 and 90 revealed that the urinalysis results performed by Point Of Care staff, is not documented in the chart as detailed below:

A. According to the review of the Clinitek Status (urinalysis machine) print out, on March 30, 2018 Patient #87 had urinalysis test. Review of the machine printout revealed results for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, PH (Potential Hydrogen), Protein, Urobilinogen, Nitrite, and Leukocyte Esterase. However, review of the patient's electronic medical record failed to document the result in its entirety. The record revealed a physician's note regarding the abnormal parameters.

B. According to the review of the Clinitek Status print out, on March 26, 2018 Patient #88 had urinalysis test. Review of machine printout revealed results for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, PH, Protein, Urobilinogen, Nitrite and Leukocyte Esterase. However, review of the patient's electronic medical record failed to document the result in its entirety. The record revealed a physician's note indicating that the results were within normal limit.

C. According to the review of the Clinitek Status print out, on March 28, 2018 Patient #89 had urinalysis test. Review of machine printout revealed results for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, PH, Protein, Urobilinogen, Nitrite, and Leukocyte Esterase. However, review of the patient's electronic medical record failed to document the result in its entirety. The record revealed a physician's note indicating seven (7) of the ten (10) parameters (Glucose, Bilirubin, Ketone, Blood, Protein, Nitrite, and Leukocyte Esterase).

D. According to the review of the Clinitek Status print out, on March 28, 2018 Patient #90 had urinalysis test. Review of machine printout revealed results for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, PH, Protein, Urobilinogen, Nitrite, and Leukocyte Esterase. However, review of the patient's electronic medical record failed to document the result in its entirety. The record revealed a physician's note indicating five (5) of the ten (10) parameters (Glucose, Ketone, Blood, Nitrite, and Leukocyte Esterase).

Interview with Employee #50 confirmed the lack of mechanism in the Primary medical clinic to upload urinalysis results in the patients' electronic medical records.

2. Based on the review of patients' closed medical records and confirmation by interview with Employee #3, the the hospital failed to to establish a monitoring mechanism for documentation of communicating with patients or patients primary care physicians regarding abnormal laboratory results after patients are discharged from the Emergency Department (ED). There was no documented evidence for patient or primary care physician notification of significant laboratory results for six (6) of the ten (10) patients' whose records were randomly selected for review (Patients #70, #72, #74, #75, #76, and #77).

Findings included...

A. There was no evidence that the hospital established a monitoring mechanism to ensure that patient or primary care physician notification for laboratory test results that require intervention had been documented in the patients' chart for patients discharged from the ED prior to obtaining laboratory test results as detailed below:

a. Review of Patient #70 closed record revealed that a specimen collected at the time of the patient's ED visit on 10/4/17, the laboratory reported a positive result for Chlamydia on 10/6/17. There was no documented evidence that attempts were made to communicate the positive result with the patient or the patient's primary care.

b. Review of Patient #72 closed record revealed that a specimen collected at the time of the patient's ED visit on 10/22/17, the laboratory reported a positive result for Gonorrhea on 10/23/17. There was no documented evidence that attempts were made to communicate the positive result with the patient or the patient's primary care.

c. Review of Patient #74 closed record revealed that a specimen collected at the time of the patient's ED visit on 10/8/17, the laboratory reported a positive result for Gonorrhea on 10/9/17. There was no documented evidence that attempts were made to communicate the positive result with the patient or the patient's primary care.

d. Review of Patient #75 closed record revealed that a specimen collected at the time of the patient's ED visit on 10/12/17, the laboratory reported a positive result for Chlamydia on 10/13/17. There was no documented evidence that the ED staff attempted to communicate the positive result with the patient or the patient's primary care.

e. Review of Patient #76 closed record revealed that a specimen collected at the time of the patient's ED visit on 3/7/18, the laboratory reported a positive result for Chlamydia on 3/13/18. There was no documented evidence that the ED staff attempted to communicate the positive result with the patient or the patient's primary care.

f. Review of Patient #77 closed record revealed that a specimen collected at the time of the patient's ED visit on 3/3/18, the laboratory reported a positive result for Chlamydia on 3/6/18. There was no documented evidence that the ED staff attempted to communicate the positive result with the patient or the patient's primary care.

B. According to interview with Employee #3 there was no mechanism for tracking patients or their primary care physician after discharge to notify abnormal results that require intervention.



17578


3. Based on medical record review, policy review, staff interview and observation of video surveillance, the medical and nursing staff failed to document pertinent information in one of three records reviewed, (Patient #3).

Findings included ...

Record review of hospital's policy titled "Medical Record Content", dated 6/17 showed
Clinical observations are made daily in the progress notes by the physician and other persons making observations. The staff documents observations in the progress notes. 'These progress notes give a pertinent chronological report of the patient's course in the hospital and reflect any change in condition and the results of treatment...Nursing notes and entries by non-physicians contain pertinent and meaningful information and observations. This information is documented on the respective forms/templates ..."

Review of Patient #3's medical record showed that the nursing staff documented the patient exhibited aggressive behavior and attempted to assault the nursing staff physically. The nursing staff called the hospital Special Police to assist with the patient because the patient sat then laid on the floor in the hallway in front of the nurses' station and refused to go to her room.

The surveyor conducted face to face interviews with Employee #11, Director of Hospital Special Police and Employee #16, Nurse Manager, on April 6, 2018, at 10:45 AM and 12:00 PM respectively. Also, review of video footage of the Behavior Health Unit on April 10, 2018, at 11:20 AM showed that the staff later identified as the nurse practitioner assessed the patient while lying on the floor in the hallway.

Further review of the patient's medical record on April 6, 2018, at approximately 12:10 PM lacked documented evidence that the nurse practitioner documented the assessment in the medical record.

Additionally, the nursing staff failed to document that the hospital police assisted in removing the patient from the floor and that the nurse practitioner saw the patient.

Employees # 11 and 27, reviewed and acknowledged the findings n April 10, 2018, at 11:45 AM, and Employee
#16 on April 6, 2018, at approximately 12:10 PM.





34093


4. Based on record review, policy review, and staff interview, the nursing staff failed to ensure complete and accurate documentation of care and treatment to monitor patients' conditions, in three of 10 patient records reviewed (Patients #34, 35, and 42).

Findings included...

Record review of the hospital's policy titled, "Medical Record Content," revised 06/17, shows that persons other than the physician are to document on designated forms, to provide a pertinent, chronological report of the patient's course and results of treatment.

A. Record review of Patient #34's medical record on 04/09/18 at 3:00 PM, revealed he underwent removal of a right pleural drain on 04/04/18; for which the patient received Lidocaine, subcutaneously at 1:55 PM.

Record review of the 'Department of Radiology Special Procedures Flow Sheet' lacked evidence that nursing staff documented the dose and reason for administration, as indicated on the form. Additionally, the allocated space to document the pre-operative diagnosis and symptoms was left blank; there was a discrepancy relative to the time out performance. The nursing staff documented the time out was performed at 1:55 PM and at 2:00 PM.

The practice lacked evidence that the nurse ensured accurate and complete documentation to assure appropriate and continuity of care and treatment.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, Registered Nurse, he explained the patient was prepped for the procedure at 1:55 PM, and the time out occurred at 2:00 PM. He explained that he did not receive orientation to the necessary paperwork for Catheterization Laboratory and Special Procedures department. Employee #95, stated, "I did the best I could." He acknowledged the findings.

B. Record review of Patient #35's medical record on 04/09/18 at 3:45 PM, revealed he underwent cardiac catheterization and bilateral lower extremity angiograms on 03/29/18; for which Versed one milligram (mg), Fentanyl 25 mg, and Heparin 2,000 units were ordered at 11:30 AM, and Fentanyl 25 mg was ordered at 12:15 PM.

Record review of the 'Department of Radiology Special Procedures Flow Sheet lacked evidence that nursing staff documented all medications, dose, route, time, reason for administration, and initials, as indicated on the form. All medications lacked evidence of the reason for administration and initials, and there was no route documented for Versed, and the Fentanyl given at 12:30 PM. Additionally, nursing staff documented the procedure was performed on 03/29/19 (not 03/29/18).

The practice lacked evidence that the nurse ensured accurate and complete documentation to assure appropriate and continuity of care and treatment.

During a face-to-face interview on 04/09/18 at approximately 4:00 PM, with Employee #95, Registered Nurse, he explained that he did not receive orientation to the necessary paperwork for Catheterization Laboratory and Special Procedures department. He stated, "I did the best I could." He acknowledged the findings.

C. Record review of the hospital's policy titled, "Outpatient Triage Policy," revised 02/17, shows that the reception or medical assistant staff are to perform an initial triage/screening to include the Con-current disease; and the Medical Assistant is to sign the form.

Review of Patient #42's medical record on 04/10/18 at approximately 1:00 PM, revealed the patient was seen in the Infectious Disease Clinic on 04/04/18; however, the record lacked evidence of a complete initial screening/triage to include the Con-current disease and the signature of the Medical Assistant.

During a face-to-face interview with Employee #30, Medical Assistant, on 04/05/18 at approximately 1:10 PM, she reviewed the record and acknowledged the findings.

5. Based on medical record review, policy and staff interview, the respiratory therapy staff failed to document a justification for the omission of inhalation treatments of Albuterol and Ventolin, in one of three patient records reviewed (Patient #38).

Findings included...

Record review of the hospital's policy titled, "Medical Order Information," reviewed 10/15, shows that staff are to document a reason for omission of a medication dose.

Review of Patient #38's medical record on 04/05/18 at approximately 11:40 AM revealed a physician order dated, 04/04/18 at 12:00 AM, for Atrovent and Ventolin nebulizer treatments, every six hours. Review of the Medication Administration Record and respiratory staff documentation lacked evidence that staff administered the treatment on 04/04/18 at 6:00 AM; however, the record lacked documented evidence of the reason for omission of the dose of medication.


38011


6. Based on medical record review, hospital policy review, and staff interview, the nursing staff failed to accurately document a wound assessment, in accordance with hospital policy, in one of one medical records reviewed (Patient #62).

The findings included....

Refer to CFR §482.23(b)(4)- A0396

Based on observations, a review of facility documents and through staff interview for one (1) of one (1) pharmacy sterile compounding room, the hospital failed to have pharmaceutical services that meet the needs of patients as evidenced by failure to practice standard precautions to protect from potential widespread nosocomial infections. There was a pattern of ineffective infection control precautions, as evidenced by failure to monitor and evaluate air sample and surface sample test results that were identified as "highly pathogenic" or required remedial action, in ISO [International Organization for Standardization] 5 [air quality of the laminar airflow workbench] and ISO 7 [air quality in the buffer area] Class rooms. There was an absence of follow-up related to the samples that required action; and staff failed to ensure a sanitary environment to protect the quality of the environment, during sterile compounding of pharmaceutical products.

The cumulative effect of these systemic practices, resulted in the hospital's failure to comply with Conditions of Participation for the Pharmacy Services.

An Immediate Jeopardy was identified on 04/06/18 at 6:00 PM under 42CFR 482.25, Pharmacy Services, for failure to ensure a pharmacist competently supervises and coordinates pharmacy activities and services. The lack of follow through on Air Sample results identified as "highly pathogenic" potentially subjects all patients receiving compounded sterile preparations (93 was the total patient census on 04/06/18) potential exposure to nosocomial infection.

The findings include:

Noncompliance was identified under Pharmaceutical Services as follows:

42 CFR §482.25- A-0492 A Pharmacist must be responsible for developing, supervising and coordinating all the activities of the pharmacy services

42 CFR §482.25- A-0494 Current and accurate records must be kept of the receipt and
disposition of all scheduled drugs

42 CFR §482.25- A-0501 All compounding, packaging, and dispensing of drugs
and biologicals must be under the supervision of a pharmacist and
performed consistent with State and Federal laws

42 CFR §482.25- A-0505 Outdated, mislabeled, or otherwise unusable drugs and
biologicals must not be available for patient use

Based on observations, a review of facility documents and through staff interview for one (1) of one (1) pharmacy sterile compounding room, it was determined that the pharmacist failed to competently supervise and coordinate pharmacy activities and services. The pharmacist failed to monitor, evaluate and act on Air Sample test results that were identified as "highly pathogenic" in the ISO [International Organization for Standardization]-7 [Sterile Compounding Room]. This practice revealed a failure to implement infection control precautions as to protect from potential widespread nosocomial infections.

The findings include:

Review of the USP <797> revealed, " ...the Total Particle Counts-Certification that each ISO classified area, for example, ISO Class 5 and 7, is within established guidelines shall be performed no less than every 6 months. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

ISO Class 5: not more than 3520 particles 0.5 µm (micrometers) and larger size per cubic meter of air for any Laminar Airflow Workbench (LAFW), Biological Safety Cabinet (BSC), Compounding Aseptic Isolator (CAI), and Compounding Aseptic Containing Isolator (CACI);

ISO Class 7: not more than 352,000 particles of 0.5 µm size and larger per cubic meter of air for any buffer area;

All certification records shall be maintained and reviewed by supervising personnel or other designated employees, to ensure that the controlled environments comply with the proper air cleanliness, room pressures, and ACPHs [Air Changes Per Hour]. ISO Classification of Particulate Matter in Room Air (limits are in particles of 0.5 µm and larger per cubic meter [current ISO] and cubic feet ..."

Record review of the hospital policy, titled, "Infection Control," revised 09/17, shows " ... 9.4.1, If a drug is suspected of being contaminated (bacterial, fungal, etc.) the Director of Pharmacy or Designee, shall be contacted. The Infection Control Department shall also be notified of the problem and its possible extent. A sample(s) of the suspected product shall be sent to the Microbiology Laboratory for culturing and/or analysis of contents ..."

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

The surveyor requested review of the environmental quality and control of the sterile compounding room. Employee #10, Director of Pharmacy, provided the "Biological Sample Report," for 03/22/18 and 03/05/18.

Review of 'Biological Sample Report' on 04/06/18 at approximately 2:00 PM revealed the following:

"Reporting Information: Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) must be immediately remedied, regardless of CFU [colony forming unit] count. Any CFU count that exceeds its respective action level shall have and investigation into the source of contamination, shall be eliminated, the affected area cleaned and resampling performed."

A. The air sample specimen collected on 03/22/18, revealed the Fungal Count, in ISO 7, showed 2 cfu/ m³ [colony forming units/meters cube], as highly pathogenic.

However, there was no documented evidence of remedial actions.

B. The air sample specimen collected on 03/05/18, revealed the Fungal Count, in ISO 7, showed 23 cfu/m³ and Bacteria 20 cfu/m³, as "above action level."

However, there was no documented evidence of remedial actions.

During a face to face interview with Employee #10, on 04/06/18 at approximately 2:45 PM, he stated that he was not aware of the test results, until the surveyor made the inquiry, regarding the air sample test results on 04/05/18. At that point, he inquired with the contractor, regarding the results. Employee #10 acknowledged he did not follow through on the test results, prior to the surveyor's inquiry; and he did not convey the findings to the infection control staff or the quality assurance performance improvement staff.

Further record review on 04/09/18 at 12:00 PM revealed the following:

C. The air sample specimen collected on 09/18/17, revealed the Bacteria Read showed 5 cfu/m³ (Micrococcus Bacteria) on 9/21/17, and the Fungal showed 2 cfu/m³ (Cladosporium - mold) on 9/25/17, as "above action level."

However, there was no documented evidence of remedial actions.

D. The air sample specimen collected 04/24/17 revealed the Fungal Read showed 2 CFU/m³ (non sporulating colony) on 5/1/17, as "above action level."

However, there was no documented evidence of remedial actions.

E. The air sample specimen collected 02/16/17 revealed the Bacterial Read showed Bacterial Penicillium species 1 CFU/m³ on 2/22/17, as "out of compliance."

However, there was no documented evidence of remedial actions.

F. The air sample specimen collected 06/15/16 revealed the Fungal Read showed "out of compliance or presence of actionable microorganisms" in ISO 5 Fungal 2 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 1 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 2 CFU/25 cm² (cladosporium species).

However, there was no documented evidence of remedial actions.

During a subsequent interview on 04/11/18 at approximately 5:00 PM with Employees #10 and 70, additional findings from air samples collected on 06/15/16, 02/16/17, 04/24/17, and 09/18/17, that required action, were revealed. Employee #10 denied having knowledge of the findings, and denied taking effective measures to protect patient safety.

1. Based on the review of hospital documents, Medication Administration Records (MAR), patients' charts, and records for controlled substances transactions from a Med-Dispense Automated Dispensing Machine (ADM), the nursing staff for Patient Care Units 8 West, 5 West, Emergency Department (ED), Post Anesthesia Care Unit (PACU), and Intensive Care Unit (ICU), failed to administer and document controlled substances with timeliness, in seven of seven observations (Patients #21, 34, 35, 44, 46, 48, and 51).

Findings include ...

On 04/09/18, the surveyor requested the seventy-two-hour reports, generated by the ADM for Patient Care Units 5 and 8 West, and twenty-four hour (24) reports for the ED, PACU, and ICU. The surveyor checked the MAR for the time of medication administration, using a seventy-two (72) hour period for the part of this survey.

A. On 04/01/18, at 23:00, in the ICU, the physician ordered Fentanyl Citrate 100 mcg (micrograms) intravenously (IV) push every 2 hours as needed, for Patient #21. On 04/02/18, one vial of Fentanyl Citrate was removed from the ADM. There was no documentation of administration or medication returned to ADM.

B. On 03/31/18, at 1030, in the ICU, the physician ordered Hydromorphone 2 mg (milligram) every 2 hours as needed, for Patient #34. On 04/03/18 at 01:00, 2 mg of Hydromorphone administered; however there was no documentation that the medication removed from ADM.

C. On 03/29/18, at 11:30, the physician ordered Fentanyl 25 mcg IV once, for Patient #35, in the Cath Lab Special Procedures, On 03/29/18 at 10:46, the staff removed one vial of Fentanyl Citrate. There was no documentation that the drug was administered or returned to the ADM.

D. On 03/30/18 at 10:36, on 8 West, the physician ordered Methadone 50 mg by mouth once daily for Patient #44. On 04/03/18, 50 mg of Methadone was removed at 09:00 and administered at 11:00 AM. 04/04/18, staff removed 50 mg of Methadone at 07:57, and administered it at 10:00 AM. Both medications were administered two hours late.

E. On 04/02/18 at 06:00, on 8 West, the physician ordered Oxycodone/Acetaminophen 5/325 mg one tablet by mouth every 4 hours as needed, for Patient #46. On 04/03/18, staff removed one tablet of Oxycodone/Acetaminophen 5/325 mg at 01:58 and administered at 00:00; staff removed one tablet at 05:18 and administered 04:00; and staff removed 1 tablet of
Oxycodone/Acetaminophen 5/325 mg at 22:09 and administered at 20:00. The doses were documented, as administered, before they were removed from the ADM.

Additionally, on 04/04/18, staff pulled one tablet of Oxycodone/Acetaminophen 5/325 mg at 08:34, and administered it at 11:55 (over 3 hours later).

F. 03/31/18, at 04:00, on 5 West, the physician ordered Oxazepam 20 mg (milligram) by mouth every 8 hours as needed, for Patient #48. On 04/02/18, staff removed 20 mg of Oxazepam at 07:30, with no documentation of administration. The medication was returned to ADM at 11:51 (4 hours after removal).

G. On 04/04/18 at 06:14, the physician ordered Lorazepam 1 mg IV one time dose, for Patient #51, in the ED. On 04/04/18, the staff removed one vial of Lorazepam from the ADM, with no documentation of administration or wasting. At 06:30, the staff removed one vial of Lorazepam, with no documentation of administration or wasting.

Employee #10 acknowledged the findings.

1. Based on observation, record review of the Biological Sampling Report, and interviews, the pharmacy failed to evaluate and take corrective actions for unacceptable levels of pathogenic organisms and organisms that required remedy, to ensure compliance with USP (United States Pharmacopeia) CSP (Compounding Sterile Preparations), chapter <797>, in ISO [International Organization for Standardization] 5 [air quality of the laminar airflow workbench] and ISO 7 [air quality in the buffer area] Class room. There was no documented evidence of corrective action for six out of the six biological air sample testing results, and one of six surface samples that revealed pathogenic organisms. The finding had the potential to effect all patients that received compounded sterile preparations.

Findings included ...

Review of the USP <797> revealed, " ...the Total Particle Counts-Certification that each ISO classified area, for example, ISO Class 5 and 7, is within established guidelines shall be performed no less than every 6 months. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

ISO Class 5: not more than 3520 particles 0.5 µm (micrometers) and larger size per cubic meter of air for any Laminar Airflow Workbench (LAFW), Biological Safety Cabinet (BSC), Compounding Aseptic Isolator (CAI), and Compounding Aseptic Containing Isolator (CACI);

ISO Class 7: not more than 352,000 particles of 0.5 µm size and larger per cubic meter of air for any buffer area;

All certification records shall be maintained and reviewed by supervising personnel or other designated employees, to ensure that the controlled environments comply with the proper air cleanliness, room pressures, and ACPHs [Air Changes Per Hour]. ISO Classification of Particulate Matter in Room Air (limits are in particles of 0.5 µm and larger per cubic meter [current ISO] and cubic feet ..."

Record review of the hospital policy, titled, "Infection Control," revised 09/17, shows " ... 9.4.1, If a drug is suspected of being contaminated (bacterial, fungal, etc.) the Director of Pharmacy or Designee, shall be contacted. The Infection Control Department shall also be notified of the problem and its possible extent. A sample(s) of the suspected product shall be sent to the Microbiology Laboratory for culturing and/or analysis of contents ..."

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

The surveyor requested review of the environmental quality and control of the sterile compounding room. Employee #10, Director of Pharmacy, provided the "Biological Sample Report," for 03/22/18 and 03/05/18.

Review of 'Biological Sample Report' on 04/06/18 at approximately 2:00 PM revealed the following:

"Reporting Information: Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) must be immediately remedied, regardless of CFU [colony forming unit] count. Any CFU count that exceeds its respective action level shall have and investigation into the source of contamination, shall be eliminated, the affected area cleaned and resampling performed."

A. The air sample specimen collected on 03/22/18, revealed the Fungal Count, in ISO 7, showed 2 cfu/ m³ [colony forming units/meters cube], as highly pathogenic.

However, there was no documented evidence of remedial actions.

B. The air sample specimen collected on 03/05/18, revealed the Fungal Count, in ISO 7, showed 23 cfu/m³ and Bacteria 20 cfu/m³, as "above action level."

However, there was no documented evidence of remedial actions.

During a face to face interview with Employee #10, on 04/06/18 at approximately 2:45 PM, he stated that he was not aware of the test results, until the surveyor made the inquiry, regarding the air sample test results on 04/05/18. At that point, he inquired with the contractor, regarding the results. Employee #10 acknowledged he did not follow through on the test results, prior to the surveyor's inquiry; and he did not convey the findings to the infection control staff or the quality assurance performance improvement staff.

Further record review on 04/09/18 at 12:00 PM revealed the following:

C. The air sample specimen collected on 09/18/17, revealed the Bacteria Read showed 5 cfu/m³ (Micrococcus Bacteria) on 9/21/17, and the Fungal showed 2 cfu/m³ (Cladosporium - mold) on 9/25/17, as "above action level."

However, there was no documented evidence of remedial actions.

D. The air sample specimen collected 04/24/17 revealed the Fungal Read showed 2 CFU/m³ (non sporulating colony) on 5/1/17, as "above action level."

However, there was no documented evidence of remedial actions.

E. The air sample specimen collected 02/16/17 revealed the Bacterial Read showed Bacterial Penicillium species 1 CFU/m³ on 2/22/17, as "out of compliance."

However, there was no documented evidence of remedial actions.

F. The air sample specimen collected 06/15/16 revealed the Fungal Read showed "out of compliance or presence of actionable microorganisms" in ISO 5 Fungal 2 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 1 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 2 CFU/25 cm² (cladosporium species).

However, there was no documented evidence of remedial actions.

During a subsequent interview on 04/11/18 at approximately 5:00 PM with Employees #10 and 70, additional findings from air samples collected on 06/15/16, 02/16/17, 04/24/17, and 09/18/17, that required action, were revealed. Employee #10 denied having knowledge of the findings, and denied taking effective measures to protect patient safety.

2. Based on the Infection Control Program review, record review, and staff interviews, the pharmacy staff failed to ensure pharmacy services were integrated with the infection control program, to effectively convey identified risks to patient safety, and to effectively remedy the risks to protect patients.

Findings included...

Record review of the hospital's policy titled, "PHA 1.41," revised 09/26/17, showed that pharmacy staff are to participate in the infection control program to facilitate monitoring and tracking risks, and performance improvement measures, to assure patient safety.

Record review of the hospital policy, titled, "Infection Control," revised 09/17, shows " ... 9.4.1, If a drug is suspected of being contaminated (bacterial, fungal, etc.) the Director of Pharmacy or Designee, shall be contacted. The Infection Control Department shall also be notified of the problem and its possible extent. A sample(s) of the suspected product shall be sent to the Microbiology Laboratory for culturing and/or analysis of contents ..."

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

The surveyor requested review of the environmental quality and control of the sterile compounding room. Employee #10, Director of Pharmacy, provided the "Biological Sample Report," for 03/22/18 and 03/05/18.

Review of 'Biological Sample Report' on 04/06/18 at approximately 2:00 PM revealed the following:

"Reporting Information: Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) must be immediately remedied, regardless of CFU [colony forming unit] count. Any CFU count that exceeds its respective action level shall have and investigation into the source of contamination, shall be eliminated, the affected area cleaned and resampling performed."

A. The air sample specimen collected on 03/22/18, revealed the Fungal Count, in ISO 7, showed 2 cfu/ m³ [colony forming units/meters cube], as highly pathogenic.

However, there was no documented evidence of remedial actions.

B. The air sample specimen collected on 03/05/18, revealed the Fungal Count, in ISO 7, showed 23 cfu/m³ and Bacteria 20 cfu/m³, as "above action level."

However, there was no documented evidence of remedial actions.

There was no evidence that the pharmacy staff notified the Infection Preventionist or the committee of organism growth identified in air samples that were deemed highly pathogenic and/or required action, to ensure effective measures was taken to protect patients.

During a face-to-face interview on 04/06/18 at approximately 12:00 PM, with Employee #74, she denied having knowledge of the results of the air samples or the unsanitary condition in the ISO [International Organization for Standardization]-7, Sterile Compounding Room]. Employee #74 explained that pharmacy staff participated in the quarterly meetings, but had not reported the concern, for which she would have performed a risk assessment to determine the cause and course of action. She explained that she did not routinely, physically tour or inspect the area, but relied on the pharmacy staff to convey concerns.

During a face to face interview with Employee #10, on 04/06/18 at approximately 2:45 PM, he stated that he was not aware of the test results, until the surveyor made the inquiry, regarding the air sample test results on 04/05/18. At that point, he inquired with the contractor, regarding the results. Employee #10 acknowledged he did not follow through on the test results, prior to the surveyor's inquiry; and he did not convey the findings to the infection control staff.

During a subsequent interview on 04/11/18 at approximately 5:00 PM with Employees #10 and 70, additional findings from surface and air samples collected on 06/15/16, 02/16/17, 04/24/17, and 09/18/17, that required action, were revealed. Employee #10 denied having knowledge of the findings, and denied taking effective measures to protect patient safety.

Employees #10, 70, and 74 acknowledged the findings.

2. Based on the Quality Assurance Performance Improvement (QAPI) review, record review, and staff interviews, the pharmacy staff failed to ensure pharmacy services were integrated with the QAPI program, to effectively convey identified risks to patient safety, and to monitor and track the risks and performance improvement measures.

Findings included...

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

The surveyor requested review of the environmental quality and control of the sterile compounding room. Employee #10, Director of Pharmacy, provided the "Biological Sample Report," for 03/22/18 and 03/05/18.

Review of 'Biological Sample Report' on 04/06/18 at approximately 2:00 PM revealed the following:

"Reporting Information: Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) must be immediately remedied, regardless of CFU [colony forming unit] count. Any CFU count that exceeds its respective action level shall have and investigation into the source of contamination, shall be eliminated, the affected area cleaned and resampling performed."

A. The air sample specimen collected on 03/22/18, revealed the Fungal Count, in ISO 7, showed 2 cfu/ m³ [colony forming units/meters cube], as highly pathogenic.

However, there was no documented evidence of remedial actions.

B. The air sample specimen collected on 03/05/18, revealed the Fungal Count, in ISO 7, showed 23 cfu/m³ and Bacteria 20 cfu/m³, as "above action level."

However, there was no documented evidence of remedial actions.

There was no evidence that the pharmacy staff notified the QAPI staff of fungal growth identified in air samples on 03/05/18 and 03/22/18 that were deemed highly pathogenic, to ensure effective action was taken to protect patients.

During a face-to-face interview on 04/06/18 at approximately 5:00 PM with Employee #70, Director of Quality, she denied having knowledge of the results of the air and surface samples.

During a face to face interview with Employee #10, on 04/06/18 at approximately 2:45 PM, he stated that he was not aware of the test results, until the surveyor made the inquiry, regarding the air sample test results on 04/05/18. At that point, he inquired with the contractor, regarding the results. Employee #10 acknowledged he did not follow through on the test results, prior to the surveyor's inquiry; and he did not convey the findings to the quality assurance performance improvement staff.

During a subsequent interview on 04/11/18 at approximately 5:00 PM with Employees #10 and 70, additional findings from surface and air samples collected on 06/15/16, 02/16/17, 04/24/17, and 09/18/17, that required action, were revealed. Employee #10 denied having knowledge of the findings, and denied taking effective measures to protect patient safety.

Employees #10, 70, and 74 acknowledged the findings.

Based on observation and staff interview, the Catheterization and Special Procedures Room staff failed to ensure unusable and expired biologicals were not stored and available for use, in three of 15 observations.

Findings included ...

A. During a tour of the Catheterization and Special Procedures Room on 04/09/18 at approximately 11:15 AM, the surveyor observed the following expired supplies in Room 1031R:

One bottle Ethyl Chloride Topical Anesthetic with an expiration date of 12/17; 33 packages of double antibiotic ointment with expiration dates of 11/17; and one open bottle of hydrogen peroxide, unlabeled with an open date.

The observation was in the presence of Employees #94, Catherization Laboratory and Special Procedures Coordinator, and #95, Registered Nurse.

The practice lacked evidence that the staff ensured that unusable and expired supplies were not available for patient use.

During a face-to-face interview on 04/04/18 at approximately 1:00 PM, with Employees #94 and 95, Employee #94 explained that he is responsible for all supplies. Both employees acknowledged the findings.





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B. During a tour of The Infectious Disease (ID) Clinic, on 04/11/18 at approximately 11:00 AM, with Employees #27, Registered Nurse and 30, Patient Care Technician. The surveyor discovered a box containing nine tablets of the medication, Ribasphere that expired on 06/17, on top of a filing cabinet in an open and unsecured provider's office.

C. In exam room 9, an exam table drawer contained 17 packets of Povidone-Iodine that expired 06/17.

The practice lacked evidence that the ID clinic staff ensured expired supples were not available for patient use.

During a face to face interview on 4/11/18 at 11:05 AM, with Employee #30, the surveyor inquired why medications and biologicals were expired, unsecured, and available to passersby in the clinic. She stated that she was not aware that expired medications or supplies were unsecured in the clinic, and proceeded to discard the items found. Employees #30 and 27 acknowledged the findings.

Based on observation, document review and staff interviews, the hospital failed to maintain, or have available comprehensive radiologic services to include gastrointestinal services, performed under fluoroscopy. This is a repeat finding from 07/07/17.

Findings included ...

On 04/09/18 at approximately 10:00 AM, the surveyor was informed, during a tour of the Radiology Department by Employee #144, X-ray Technician, that some fluoroscopic procedures were not conducted, due to the sole fluoroscopic unit being inoperable, since September of 2016.

During a face to face interview on 04/10/18 at approximately 1:30 PM, with Employee #77, Director of Radiology, she confirmed the finding, explaining that the fluoroscopy equipment, in the Radiology Department is inoperable; and new equipment is expected to be installed by 07/18. She added that C-arm Fluoroscopy is available in the Operating Room.

During a subsequent interview on 04/10/18 at 1:35 PM, with Employees #77 and 147, Chairman of Radiology, he shared documentation that gastrointestinal services requiring fluoroscopy were unavailable, since February 15, 2017; however, alternative tests and services are available. In addition, the hospital implements physician to physician referrals for services to be performed in outside hospitals; however, there is no written agreement or arrangement.

The hospital failed to maintain, or have available, radiologic services according to the needs of the patients.

Employees #77 and 147 acknowledged the findings.

Based on observations and staff confirmation, dietary services were not adequate to ensure that foods are always prepared and served in a safe and sanitary manner. Employees #14 and 15, Director and Assistant Director of Dietary observed the findings, in the Main Kitchen.

Findings included ...

1. The shelf surfaces of racks in walk-in refrigerator # 1, were soiled with accumulated debris in one (1) of one (1) observation at 9:45 AM on April 4, 2018.

2. Wall surfaces in refrigerators #1 and #2, were damaged and paint was peeling away from walls near the entrance door in two (2) of two (2) observations at 9:50 AM on April 4, 2018.

3. A four (4)-prong wall outlet near the Walk-in Freezer door was damaged. One outlet cover was missing and could potentially create a hazard to staff, and corrosion observed around the perimeter of the cover plate, in one (1) of one (1) observation at 9:55 AM on April 4, 2018.

4. Dust accumulation was observed on the exterior surfaces of the compressor and fan covers in, Walk-in Refrigerators # 1 and #2 in two (2) of two (2) observations at 9:55 AM on April 4, 2018.

5. A tank of Carbon Dioxide, used for pressuring soda machines, was not racked or secured to prevent accidental tip over in the hallway, near the ice machine in one (1) of seven (7) observations at 10:50 AM on April 4, 2018.

6. Floor surfaces were marred, soiled and damaged in the Paper Storage Room and Dry Storage Room, in one (1) of one (1) observation at 11:10 AM on April 4, 2018.

7. Chinaware plates were not cleaned as evidenced by food particles and a film on plates after washing in the dishwasher, in 21 of 31 observations at 2:30 PM on April 4, 2018.

8. Salad bowls stored on racks near the dishwasher were ready for use; however, the bowls were not cleaned of food residue, as evidenced by stains and food particles on the interior surfaces in 12 of 13 observations at 2:45 PM on April 4, 2018

9. Metal food preparation bowls stored on a rack in the Pot and Pan Preparation Area not cleaned as evidenced by stains on the interior surfaces in four (4) of five (5) observations at 2:55 PM on April 4, 2018.

10. Cutting boards stored on a rack in the Pot and Pan Storage Area, were worn, as evidenced by deep grooves on the cutting surfaces and board surfaces were stained, in one (1) of one (1) red; three (3) of four (4) White, and one (1) of one (1) Green at 3:00 PM on, April 4, 2018.

11. The interior surfaces of Adaptive three (3) compartment plates, were not cleaned after washing; as evidenced by food residue on the interior surfaces of plates in seven (7) of seven (7) of seven observations, The interior and bottom surfaces of China Ware Plates, were not thoroughly cleaned, residual food stains observed on the eating and bottom surfaces plates in 21 of 31 observations at 11:20 AM on April 4, 2018.

12. Sprinkler sprinklers and sprinkler supply line surfaces in the hallway were soiled with dust near cook's preparation area in the main kitchen, in four (4) of four (4) observations at 10:45 AM on April 4, 2018.

13. The gas supply lines and electrical wires of deep fryers and the inner surfaces of convection ovens were soiled with grease, in two (2) of two (2) deep fryer observations. The interior areas of convection ovens were soiled with food spillages in three (3) of three (3) observations at 11:00 AM on April 4, 2018.

14. The rear surfaces of the manual can opener were soiled with grease accumulation in one (1) of one (1) observation. The rear surfaces of the flat skillet were soiled with grease and dust accumulation in one (1) of one (1) observation at 11:25 AM on April 4, 2018.

15. During a tray line observation; plasticware was used instead of silverware on patient trays. Review of the hospital policy titled "Patient Food Services" dated 10/2014 showed that "Hot Food should be served on Usual Service Ware, and Cold Foods can be served on Usual Service Ware or Quality Disposable Ware Services." Through interview and observation Usual Ware can be interpreted as China Ware, which enhances the dignity and well being of patients in one (1) of one (1) observation on April 4, 2018.

16. During a tour of the Main Kitchen, the Ansul System tag showed the last service date as 05/2017. The system was not maintained every six (6) months, to ensure proper operation as required.

Employees #14 and 15 acknowledged the findings.

Based on observations, record review, policy review, and staff interviews, the hospital staff failed to maintain the physical plant and the overall environment in a safe and sanitary manner to ensure the safety and well-being of patients; have a mechanism to in place to ensure air samples in the ISO-7 (sterile compounding room) were within the acceptable range (A-0701); and ensure that outdated supplies and biologicals were not stored and available for patient use (A-0724).

The cumulative effect of these systemic practices, resulted in the hospital failure to comply with Conditions of Participation for the Physical Environment.

1. Based on record review, policy review, the USP (United States Pharmocopeia) CSP (Compounding Sterile Preparations)-797, and staff interviews, the pharmacy staff failed to ensure the condition of the physical environment, in the ISO-7 (sterile compounding room), is maintained in a manner to ensure the safety and well-being of patients.

Findings included...

Review of the USP, CSP (Compounding Sterile Preparations), chapter <797>, for the cleanliness of compounding areas, reveals disinfecting shall occur on a regular basis, when surfaces are visibly soiled and when microbial contamination is known to have been or is suspected of having been introduced into the compounding areas. Trained compounding personnel are responsible for cleaning and disinfection practices. All cleaning materials shall be non-shedding, and dedicated and restricted for use in the compounding areas, only.

Review of the hospital policy, "Infection Control," revised 09/17 stipulates staff shall maintain, " ...4.1 A clean work area with adequate lighting, isolated from heavy traffic, and separated from contaminated supplies shall be available for compounding sterile supplies. 4.2 Floors shall be maintained on a daily basis, using hospital approved detergent/disinfectant ...4.4 Work surfaces, bench tops, and countertops shall be cleaned daily with hospital approved detergent/disinfectant ..."

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

There was no evidence that staff performed cleaning and disinfecting practices in the sterile compounding area consistent with contemporary standards of practice (e.g. USP, CSP guidelines). Additionally, there was no documented evidence that the environmental services staff was trained and competent, in accordance to USP requirements.

The practice lacked evidence that Employee #10 performed oversight of the activities in the sterile compounding area, to ensure a sanitary environment and infection prevention.

During a face to face interview with Employee #10, Director of Pharmacy, on 04/05/18 at 4:15 PM, he stated that he was not aware of the unsanitary environment and conditions in the sterile compounding area, until the surveyor brought it to his attention. Although the checklist indicated environmental cleanliness, he relied on his staff to maintain a clean environment. He acknowledged that he did not personally, inspect the environment, routinely.

Employees #104, Director of Environmental Services and 79, House keeping Supervisor, observed the findings on 04/06/18, and were not aware of the USP requirements for cleaning and disinfecting, in the sterile compounding area. Employees #10, 104 and 79 acknowledged the findings.

2. Based on observation staff interview and confirmation, the housekeeping and maintenance services were not adequate to ensure that the facility is maintained in a safe and sanitary manner. Employee #2, Director of Engineering, observed the findings.

Findings included ...

1. The surveyor observed and recorded the following findings during a tour of the Emergency Department on April 6, 2018.

A. The top surfaces of the monitor and the base surfaces of the stretcher were soiled in Room 8 in two (2) of two (2) observations.

B. Windowsill surfaces were dusty, and baseboard surfaces were uneven behind the headboard of the bed, the overbed lamp was dusty, curtain hooks were missing, and the horizontal surfaces of blinds were soiled in four (4) of four (4) observations in Room 7.

C. The horizontal surfaces of the bed frame were soiled with dust, curtain mesh surfaces torn, and hooks were missing, in Room 4 in there (3) of three (3) observations.

D. Venetian blinds were damaged, hot water temperatures were measured and below the minimum temperature of 105 degrees. Wall surfaces damaged below the windows and the base surfaces of the bed frame was dusty in Room 3, in five (5) of five (5) observations.

E. Toilet Floor surfaces were damaged and soiled, behind the toilet, baseboard surfaces soiled and damaged; exhaust vent surfaces and sprinkler head surfaces were soiled with dust and paint observed on the shaft of escutcheon ring surfaces, in six (6) of six observations in Room 1081A.

F. Floors soiled in the Supply Closet.

G. The base surfaces of the stretcher were soiled, floor and baseboards along the wall were soiled in in two (2) of two (2) observations in room 19.

H. Sprinkle head surfaces soiled with dust and baseboards damaged in Room 19 in two (2) of two observations in Room 16.

II. Walls were marred, penetrations observed around four (4) pipes, and the lower portions of the entrance door marred, in three (3) of three (3) observations in the Soiled Utility Room.

J. Bed frame surfaces were soiled; the overbed lamp soiled with dust, and wall surfaces marred in Room 18, in three (3) of three (3) observations.

K. Walls were marred, and floor surfaces soiled, around the perimeter in Room 17, in two (2) of two (2) observations in the Patient's Restroom.

L. Wall surfaces were marred, and paint unevenly applied over four (4) outlet covers in Room 14.

M. Wall surfaces were marred and bed frame surfaces soiled with dust in Room 9, in two (2) of two (2) observations.

N. Wall surfaces were damaged near the bed; the horizontal surfaces of the bed frame soiled, and the top surfaces of the examination lamp were dusty in Room 8, in three (3) of three (3) observations.

O. The top surfaces of the suction container; exam lamp and floors around the perimeter soiled in Room 5 in two (2) of two (2) observations.

P. The top surfaces of the hazardous waste receptacle and, stretcher and wheel surfaces were soiled. Mattresses were worn and cracked on the top surfaces, and privacy curtains mesh surfaces torn, in Room 3, in four (4) of four (4) observations.

Q. Doors and door edge surfaces were marred; the base surfaces of the Blood Pressure Holder were soiled, in two (2) of two (2) observations in the Holding Room.

R. The lower surfaces of walls in the Waiting Room were marred.

S. Sprinkler head surfaces and the interior and exterior louver surfaces of the supply vents were soiled; a four (4) outlet -plate cover was not secured in three (3) of three observations in Room 11.

T. Wall surfaces were marred, and sprinkler heads soiled in Area Core, in two (2) of two (2) observations.

U. Venetian blind were damaged, and the baseboard heater vents were covered with excess paint in the Ambulance Bay in two (2) of two (2) observations.

V. Wall surfaces were marred; Oxygen Tanks were not racked or chained to prevent accidental tip over; sprinkler and exhaust vents were soiled; walls and corner surfaces were marred; the lower surfaces of guardrails were marred in the hallway area of the Triage Area in five (5) of five (5) observations.

W. Sprinkler heads surfaces were soiled in six (6) of six (6) observations, and the seat surfaces of chairs were cracked and worn in the Emergency Waiting Room.

X. Floor tile grout was soiled and dingy. Supply vents soiled and stained; call bell strings were missing in two stalls; doorjamb surfaces marred; accumulated mineral deposits observed on the flush valve stack, and water was leaking from a fitting on the valve stack in six (6) of six observations in the Men's Toilet Room.

Y. Wall surfaces were damaged; floor surfaces soiled under shelves in the Assessment Room, in two (2) of two (2) observations.

2. The surveyor observed the following findings during a tour of the Behavioral Health Unit 11:45 AM and 12:30 PM on April 6, 2018.

A. During a tour of the Behavioral Health Unit, the surveyor determined through observation and interview, that the overhead lamp switch for the Seclusion Room, was not in a convenient location for staff to turn the light on, in the event of an emergency. The light switch is located in a room in the rear and down the hall from the Nurses station in one (1) of one (1) observation.

B. The Group Session Room, door hinges were damaged, and the door failed to close without assistance.

C. Baseboard surfaces were soiled in the in corners and not fully secured to the wall. The wall camera had stains on the lens cover in the Seclusion Room.

D. The horizontal surfaces of the bed were soiled, and the lower recessed area of the bed dusty. The toilet baseboards failed to fit properly around the perimeter of the room. Hot water temperatures at the sink in the toilet were tested and determined to be 72 degrees Fahrenheit, which is below the minimum temperature of 105 degrees Fahrenheit in Room 4408.

E. A section of molding on the heating Ventilation Unit was damaged, and sharp-edged visibly noted on the unit cover, and the bathroom mirror was soiled in Room 4404.

F. Wall surfaces were marred; the Heating Ventilation and Air Conditioning cover failed to fit properly and in need of adjusting in the Dayroom in two (2) of two (2) observations.

G. Hot water temperatures were below the required minimum temperature of 105 degrees Fahrenheit. Excess adhesive was on tiles near the toilet and baseboards failed to fit properly behind the toilet, in three (3) of three (3) observations in Room 4422.

H. The lower recessed the areas of the bed and bed frame were soiled, and floor surfaces soiled in the bathing area of Room 4425.

I. The entrance door was marred on the corner surfaces and window surfaces smeared. The recessed area of the bed frame and the interior surfaces of the overhead vent soiled, and bathroom tiles were not installed to fit properly neared the toilet ion Room4428 in five (5) of five (5) observations.

J. Signage was not present on the wall outside of the Dining room; floor and walls surfaces were soiled and marred in the Room 4416.

3. The surveyor observed the following findings during a tour of the Operating Room and the Ambulatory Surgical Areas at 10:10 AM on April 9, 2018.

A. The top surfaces of Monitors soiled with dust in Operating Room 7.

B. Door surfaces marred at the entrance to the Restroom and the Soiled Utility Room.

C. Hard water stains observed on the Ice Machine tray and chute surfaces.

D. Several privacy curtain hooks missing in Bays 2, 3, and 8.

E. The interior surfaces of vents were soiled in the Isolation Room.

F. The Anesthesia Room entrance room door was marred.

4. The surveyor observed the following findings during a tour of the Radiology Department at 11:30 AM on April 9, 2018.

A. Uncovered clean linens not properly stored in the linen closet; linen stored on the Computerized Tomography Stretcher.

B. During the tour, it was determined that, an employee's backpack was improperly stored in a cabinet above the sink.

C. Multiple wires were on the floor in the Control Room area of the Computerized Tomography Scanner.

D. Exhaust vents soiled with dust in the Computer Tomography Area.

E. Multiple electrical and computer wires stored on the floor in the Control Room Area of the Interventional Radiology Area.

F. The top surfaces of the monitor, examination lamp and the base surfaces of the stretcher were dusty in Interventional Radiology Room 1030.

G. The overhead speaker not secured to the ceiling in the Mammography Area.

H. Residual tape observed on the top of the Power Supply Unit, floors and walls were marred, in the in X-Ray Room 1.

5. The surveyor observed the following findings during a tour of the Physical Therapy Department at 12:45 PM on April 9, 2018.

A. Floor tiles not thoroughly cleaned and damaged near the telephone

B. The lower surfaces of supply closet doors were soiled and stained.

C. The interior and exterior areas of exhaust vents soiled in the Documentation Room.

D. Floor tile and baseboards surface were soiled and damaged in staff and patients bathrooms.

E. Numerous privacy curtain hooks were missing on curtains in the Treatment Area.

F. Penetrations observed in the ceiling tiles; supplies improperly stored on top of the cabinet. The distance between the top of the cabinet, and supplies stored on top of the cabinet failed to provide at least 18 inches between the cabinet and the ceiling, and stretcher surfaces soiled in the Treatment Area.

G. Floor surfaces marred in the Therapy Room.

6. The surveyor observed the following findings during a tour of the Sterile Processing at 2:30 PM on April 9, 2018.

A. Floor surfaces soiled under the sink in the decontaminated area.

B. The door between the decontaminated and sterile sides soiled and marred.

C. Baseboards were missing along the wall in the decontaminated and clean sides within in the Department.

7. The surveyor observed the following findings during a tour of the Intensive Care Unit at 2:00 PM on April 9, 2018.

A. The overbed lamp cover was cracked, damaged, and sharp edges noted on the cracked portion of the cover. The sink was clogged and drained slowly when the faucet was turned on, and the door jamb surfaces marred in Room 8 in three (3) of three (3) observations.

B. Hot water temperatures were determined to be 98 degrees Fahrenheit in Room 4 and 94 degrees in Room 3; 99 degrees Fahrenheit in Room 16, and 97 degrees Fahrenheit in Room 10, which is below minimum 105 degrees Fahrenheit minimum temperature requirement in four (4) of four observations.

C. Venetian blind slats were damaged on the door and window on the hallway side, and door surfaces marred in Room 1, in two (2) of two (2) observations.

8. The surveyor observed the following findings during a tour of the Wound Care Department at 9:30 AM on April 11, 2018.

A. The mop bucket and sink were soiled with debris in the Janitorial Closet and baseboards were recessed in the Janitorial Closet.

B. Floor surfaces were marred near the rear of the stretcher and bed frame surfaces soiled, in two (2) of two (2) observations in Room 122.

C. The top surfaces of the cabinet were soiled with dust in Room 123.

D. The ceiling lamp cover failed to fit properly against grids in Room 124.

E. The straight back chair was soiled and stained in Room 119.

F. The interior and exterior surface of exhaust vents soiled with dust accumulation in four (4) of four (4) observations in the Treatment Room.

G. Door jamb surfaces were marred at the entrance to the Treatment Area.

Employee #2 acknowledged the findings.

1. Based on observations and confirmation by interview with Employee # 50 and #58 at the time of observation, the hospital failed to establish a monitoring mechanism for expired supplies. Expired specimen collection tubes, culture swabs and Quality Control materials were removed to prevent accidental use in four (4) of the eight (8) areas of the hospital randomly selected for inspection (Emergency Department, 8 West, Obstetrics and Gynecology Clinic Laboratory Specimen Processing Room).

Findings included...

A. On April 4, 2018 at approximately 10:45 AM several expired specimen collection tubes, culture swabs, and quality control materials were observed in the hospital's Emergency Department (ED).

In the hospital's ED Fast Track area, the surveyor observed the following:

-Urine analysis quality control lot# UB151702 expired February 28, 2017;

- Blue top tubes lot Number (#) 72129977 expired on November 31, 2017 and lot# 7214938 that expired February 28, 2018; and

-Gray top Lot # 66173981 expired October 31, 2017

In the hospital's ED Triage area, the surveyor observed the following:

- Blue top tubes lot Number (#) 72129977 expired on November 31, 2017 and lot# 7214938 that expired February 28, 2018; and

- Lavender top tubes lot number 5357519 expired in June 2017 and lot #6253714 expired on February 28, 2018.

In the hospital's Main ED, the surveyor observed the following:

-BBL Culture swabs lot# 101L28 expired in September 2017 and lot #010B51 expired in March 2018;

- Lavender top tubes lot #6253714 expired on February 28, 2018; and

- Gray top tubes Lot # 525-1734 expired in January 2017.

B. On April 4, 2018 at approximately 11:45 AM, on Unit 8 West, the surveyor observed blue top tubes lot# 7214938 that expired on February 28, 2018 on a phlebotomy tray.

C. On April 5, 2018 at approximately 11:55 AM, the surveyor observed urinalysis quality control material with opened date of January 22, 2018 and a use by date of March 5, 2018 in the hospital's Obstetrics and Gynecology (OB) Clinic.

D. On April 6, 2018 at approximately 11:30 AM, the surveyor observed small red top tubes lot# 6028895 that expired in June 2017 on a phlebotomy tray in the hospital's laboratory specimen processing room.

E. The surveyor observed the aforementioned outdated items stored mixed with in dated items.

F. It should be further noted that aforementioned outdated items were confirmed by Employee #50 and #58.






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2. Based on record review, policy review, and staff interviews, the hospital staff failed to maintain supplies and equipment, in a manner that the safety and well-being of patients is assured, in 10 of 15 observations.

Findings included...

Record review of the hospital's policy titled, "Inventory," revised 09/20/16, showed that staff are to check supplies for expiration dates and remove those which have reached or passed the expiration dates, from the stock.

Review of the hospital's policy titled, "Drug Storage and Unit Inspections," dated 09/17 shows that all medications and medical supplies [i.e. needles] are to be locked and secured.

A. During a tour of the Catheterization and Special Procedures Room on 04/09/18 at approximately 11:15 AM, the surveyor observed one set of Heartstart' (defibrillator) pads, with an expiration of 11/17, stored on the code cart, available for patient use. The observation was in the presence of Employee #95, Registered Nurse.

The practice lacked evidence that staff ensured the supplies, likely used in emergency situations, were up to date and ready for use.

During a face to face interview on 04/04/18 at approximately 1:00 PM, Employee #95 explained he was responsible for code cart maintenance. He acknowledged the findings.


B. During a tour of the Emergency Department (ED) on 04/04/18 at approximately 12:30 PM, the surveyor observed an unlocked intravenous supply cart, located in the front of Room #5, displaying #20, 22, and 24 angiocatheters and insulin syringes. The cart faced the hallway and the sharps were exposed to patients and passersby.

C. The Central Line cart, located near Room #2 was unlocked. It contained sharps to include a lumbar puncture tray with spinal needles and two pleuravacs with needles and scalpels.

The observations were made in the presence of Employee #3, Nurse Manager.

The practice lacked evidence that staff maintained a safe environment to prevent the risk of sharps injury.

The surveyor queried, Employee #3, regarding the staff practice. He explained that the hospital is expecting new carts "today," and in the meantime staff are aware to ensure the drawers are closed and the cart is facing the wall, away from patient view. He explained that the central line cart should have been locked. Employee #3 acknowledged the findings.

D. During a tour of the Emergency Department (ED) on 04/04/18 at approximately 3:45 PM, the surveyor observed Employee #78, Emergency Department Technician, obtain a flush from the intravenous cart (located in the hallway, across from Room #2), and leave the drawer open, exposing sharps to patients and passersby.

The practice lacked evidence that staff maintained a safe environment to prevent the risk of sharps injury.

The surveyor queried, Employee #3, regarding the staff practice. He explained that the hospital is expecting new carts "today," and in the meantime staff are aware to ensure the drawers are closed and the cart is facing the wall, away from patient view. Employee #3 and 78 acknowledged the findings.




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E. Record review of the hospitals policy titled, "Monitoring of Code Cart and Monitoring Defibrillator," dated 10/15, showed that the code cart will be checked by a nurse every 24 hours.

During a tour of the Primary Care clinic (PCC) on 04/06/18, at approximately 9:15 AM, the surveyor observed supply room 302-2 unlocked and open, facing several patient exam rooms. The supply room contained multiple medications, both, oral and injectable, and medical supplies. Furthermore, multiple syringes in various sizes of 1, 3, 5, 10, and 20 milliliter (ml) with needle sizes; 27 gauge (G), 18, and 22, were noted to be available in the open and unsecured storage room. In the hallway, an unlocked and unsecure cabinet was found to contain medication sample packets.

The practice lacked evidence that the PCC staff insured the patient's right to receive care and treatment in a safe environment.

A face to face interview at that time, with the Primary Care Director Employee #31 Physician, on 04/06/18, regarding the medication room. Employee #31 reported that the clinic staff keeps the medication and storage room door open and unlocked, throughout the time the clinic is open to patients, but, it is locked and secure when the clinic is closed at night. He further stated that a locking key pad would be put on the storage room door "today", and the interview concluded in the presence of Employee #27 Registered Nurse

F. During a tour of The Infectious Disease (ID) Clinic on 04/11/18 at approximately 11:00 AM, with Employee's # 27 Registered Nurse and 30 Patient Care Technician. The surveyor discovered a box containing 9 tablets of the medication Ribasphere expired 06/17; on top of a filing cabinet in an open and unsecured provider's office. In exam room 9, an exam table drawer contained 17 packets of Povidone-Iodine, expired 06/17.

The practice lacked evidence that the ID clinic staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with ID clinic Employee #30, the surveyor inquired why medications and biologicals were expired, unsecured, and available to passersby in the clinic. She stated that she was not aware that expired medications or supplies were unsecured in the clinic, and proceeded to discard the items found. Employees # 30 and 27 acknowledged the findings.

G. During a tour of the 5th floor medical surgical area with Employee's #25 Assistant Director of Nursing , #49 Registered Nurse, and #27 Registered Nurse, on 04/04/18 at 10:35 AM, the surveyor observed a rolling computer station with drawers underneath, found unlocked and unsecured by the nursing station.The unlocked medication drawers contained syringes with needles.

The practice lacked evidence that the 5th floor medical surgical unit staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with Employee's #25, and 49, on 04/04/18 at approximately 10:55 AM, the Employees acknowledged the findings of the unsecured and unlocked syringes with needles available to passersby, and locked the computer station. Furthermore, Employee # 25, stated, "Those items should never be in the computer station", in the presence of Employee #27.

H. During a tour of the 8th floor medical surgical area, conducted on 04/05/18 at 03:15 PM with Employee's #27 Registered Nurse (RN), and #36 RN, a rolling computer station with medication drawers was observed with unlocked medication drawers, by the nursing station, containing syringes with needles, and patient medications (Patients 49 and 65).

The practice lacked evidence that the 8th floor medical surgical unit staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview completed with Employee #36, at approximately 3:25 PM on 04/05/18. Employee #36 acknowledged the findings of unsecured and unlocked Patient medications, and syringes with needles available to passersby, in the presence with Employee #27.

I. During a tour of The Wound Clinic, conducted on 04/11/18 at 9:25 AM, with Employee's #27 Registered Nurse, and 29, Wound Clinic Director, the surveyor observed multiple expired items on the Code Cart, to include defibrillator pads expired 08/12, and electrodes expired 01/13. An Accucheck Glucose Monitor with a full bottle of Test Strips expired 01/31/18, was found in treatment room #3. Furthermore, multiple scalpels, biopsy needles, and curettes were found expired, unlocked and unprotected from passersby, in multiple patient treatment rooms.

The practice lacked evidence that the Wound Clinic staff ensured the patient's right to receive care and treatment in a safe environment.

During a face to face interview with Wound Clinic Employee #29 was conducted at that time, in the presence of # 27. She stated that there had been a complete staffing change, and that she was in the process of re-organizing the clinic. Both Employees #29 and 27 acknowledged the findings.

J. Record review of the hospital's undated Code Cart Signature Sheet lists: carbon monoxide gas detector, cardiac board and two defibrillator pads as part of the code cart contents.

During a tour of the 5 West Medical Surgical Unit on 04/04/18, at approximately 10:00 AM, with Employee's #25 Assistant Director of Nursing , #49 RN, and #27 RN, The surveyor observed code cart #1, without a cardiac board, and two defibrillator pads. The code cart daily check list, for 04/04/18, reflected that all items [including back board and defibrillator pads] required for the code cart were readily available at that time.

The practice failed to provide evidence that staff followed hospital policy to ensure code cart readiness, the integrity of the code cart, and patient safety, in the event of a Code Blue.

During an interview on 04/04/18 at 10:15 AM regarding the missing items from the code cart, Employee's #25 and 49 acknowledged the findings, in the presence of Employee # 27.

Based on observations, record review, policy review, and staff interviews the hospital staff failed to ensure that the program established for infection prevention, included surveillance, monitoring, analysis and evaluation of the pharmacy environment. This investigation identified that the facility failed to practice standard precautions to protect from potential widespread nosocomial infections. There was a pattern of ineffective infection control precautions as evidenced by failure to monitor and evaluate Air Sample results that were repeatedly identified as "highly pathogenic" in the ISO-7 [Sterile Compounding Room]. There was no evidence that the Infection Control Program integrated surveillance of pharmacy services as a method to avoid sources and transmission of infections and communicable disease. As a result, all patients receiving compounded sterile preparations (93 was the total patient census on 4/6/18) had the potential for exposure to nosocomial infection.

The cumulative effect of these systemic practices, resulted in the hospital's failure to comply with Conditions of Participation for the Infection Control.

An Immediate Jeopardy (IJ) was identified on 04/06/18 at 6:00 PM for failure to protect from potential widespread nosocomial infections.

1. Based on record review, policy review, and staff interviews, the infection control officer failed to develop a system for identifying, reporting, investigating and controlling infection, related to pharmacy services.

Findings included...

Review of the hospital policy, "Infection Control," revised 09/1,7 stipulates staff shall maintain, " ...4.1 A clean work area with adequate lighting, isolated from heavy traffic, and separated from contaminated supplies shall be available for compounding sterile supplies. 4.2 Floors shall be maintained on a daily basis, using hospital approved detergent/disinfectant ...4.4 Work surfaces, bench tops, and countertops shall be cleaned daily with hospital approved detergent/disinfectant ..."

During inspection of the pharmacy sterile compounding intravenous room [IV room] on 04/05/18 at approximately 10:55 AM, the surveyor observed trash (to include labels, medication package inserts, syringes, needle caps and papers); empty medication vials; debris; and saline bags, scattered around and under laminar airflow workbenches; and dirt and dust, inside the laminar airflow workbench surface grill.

The surveyor requested review of the environmental quality and control of the sterile compounding room. Employee #10, Director of Pharmacy, provided the "Biological Sample Report," for 03/22/18 and 03/05/18.

Review of 'Biological Sample Report' on 04/06/18 at approximately 2:00 PM revealed the following:

"Reporting Information: Highly pathogenic microorganisms (e.g. Gram-negative rods, coagulase positive staphylococcus, molds and yeasts) must be immediately remedied, regardless of CFU [colony forming unit] count. Any CFU count that exceeds its respective action level shall have and investigation into the source of contamination, shall be eliminated, the affected area cleaned and resampling performed."

A. The air sample specimen collected on 03/22/18, revealed the Fungal Count, in ISO 7, showed 2 cfu/ m³ [colony forming units/meters cube], as highly pathogenic.

However, there was no documented evidence of remedial actions.

B. The air sample specimen collected on 03/05/18, revealed the Fungal Count, in ISO 7, showed 23 cfu/m³ and Bacteria 20 cfu/m³, as "above action level."

However, there was no documented evidence of remedial actions.

During a face to face interview with Employee #10, on 04/05/18 at approximately 4:15 PM, he stated that he was not aware of the test results, until the surveyor made the inquiry, regarding the air sample test results on 04/05/18. At that point, he inquired with the contractor, regarding the results. Employee #10 acknowledged he did not follow through on the test results, prior to the surveyor's inquiry; and he did not convey the findings to the infection control staff or the quality assurance performance improvement staff.

Further record review on 04/09/18 at 12:00 PM revealed the following:

C. The air sample specimen collected on 09/18/17, revealed the Bacteria Read showed 5 cfu/m³ (Micrococcus Bacteria) on 9/21/17, and the Fungal showed 2 cfu/m³ (Cladosporium - mold) on 9/25/17, as "above action level."

However, there was no documented evidence of remedial actions.

D. The air sample specimen collected 04/24/17 revealed the Fungal Read showed 2 CFU/m³ (non sporulating colony) on 5/1/17, as "above action level."

However, there was no documented evidence of remedial actions.

E. The air sample specimen collected 02/16/17 revealed the Bacterial Read showed Bacterial Penicillium species 1 CFU/m³ on 2/22/17, as "out of compliance."

However, there was no documented evidence of remedial actions.

F. The air sample specimen collected 06/15/16 revealed the Fungal Read showed "out of compliance or presence of actionable microorganisms" in ISO 5 Fungal 2 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 1 CFU/25 cm² (non sporulating colonies) and in ISO 7 Fungal 2 CFU/25 cm² (cladosporium species).

However, there was no documented evidence of remedial actions.

There was no evidence that the Employee #74, Infection Preventionist, and the infection control staff developed systemic measures to monitor and track the identified findings, and to effectively remedy the risks to protect patient safety.

Additionally, There was no evidence that staff performed cleaning and disinfecting practices in the sterile compounding area, and there was no documented evidence that the environmental services staff was trained and competent, in accordance to USP requirements.

Employees #104, Director of Environmental Services and 79, House keeping Supervisor, observed the findings on 04/06/18, and were not aware of the USP requirements for cleaning and disinfecting, in the sterile compounding area.

During a face-to-face interview on 04/06/18 at approximately 12:00 PM, with Employee #74, she denied having knowledge of the results of the air samples or the unsanitary condition in the ISO [International Organization for Standardization]-7, Sterile Compounding Room]. Employee #74 explained that pharmacy staff participated in the quarterly meetings, but had not reported the concern, for which she would have performed a risk assessment to determine the cause and course of action. She explained that she did not routinely, physically tour or inspect the area, but relied on the pharmacy staff to convey concerns.

During a face-to-face interview on 04/06/18 at approximately 2:45 PM, with Employee #10, Director of Pharmacy, in the presence of Employee #70, Director of Quality, Employee #10 denied having knowledge of the air sample results, until identified by the surveyor. He explained that he was aware samples were performed on 03/05/18 and 03/22/18, but he did not follow up on the results, and he did not convey the findings to the infection control staff.

During a subsequent interview on 04/11/18 at approximately 5:00 PM, with Employees #10 and 70, additional findings from surface and air samples collected on 06/15/16, 02/16/17, 04/24/17, and 09/18/17, that required action, were revealed. Employee #10 denied having knowledge of the findings, and denied taking effective measures to protect patient safety.

The practice lacked evidence that the Infection Control staff developed a hospital wide program to include all areas in the hospital, for identifying, reporting, investigating and controlling infection.

Employees #10, 70, and 74 acknowledged the findings.

2. Based on the Infection Control Program review and staff interview, the infection control program failed to integrate surveillance of pharmacy services, related to Antibiotic Stewardship, to ensure appropriate use of antimicrobials (antibiotics), to improve patient outcomes, reduce microbial resistance, and decrease the transmission of infections caused by multidrug-resistant organisms.

Findings included:

During an interview on 04/11/18, at approximately 2:00 PM, Employee #74, Infection Preventionist, stated that she is not involved with the antibiotic stewardship program for ongoing monitoring. When queried about the ongoing monitoring and tracking, she stated, the information (laboratory report; organism identified...) is reported to the pharmacist, who monitors the ongoing patient antibiotic usage and outcomes.

The practice failed to ensure that antibiotic stewardship is included in the Infection Control program to ensure ongoing monitoring to improve antibiotic stewardship and to minimize the risk of development of MDRO's.

Employees #70 and #74 acknowledged the findings.

3. Based on record review, policy review, and staff interviews, the respiratory therapy staff failed to follow the hospital's hand hygiene policy, to prevent the spread of infection, in two of five observations (Patients #36, and 86).

Findings included...

Record review of the hospital's policy titled, "Hand Hygiene," revised 10/16, shows that staff are to sanitize their hands, prior to the application of gloves and providing patient care.

Record review of the hospital's policy titled, "Hand Hygiene," revised 10/16, shows that staff are to sanitize their hands, prior to the application of gloves and providing patient care. Staff are to vigorously rub hands together for at least 15 seconds, covering all surfaces of hands, fingers, and between fingers. Indications for hand antisepsis include before and after dressing changes.

A. During a tour of the 8 West unit on 04/05/18 at approximately 4:21 PM, the surveyor observed Employee #93, Respiratory Therapist, entering Patient #36's room, applying gloves, without first sanitizing her hands, and discontinuing the patient's nebulizer treatment.

The practice failed to ensure that staff followed the hospital policy for hand hygiene to prevent the potential spread of infection.

During a face-to-face interview on 04/05/18 at approximately 4:30 PM with Employee #93, regarding the practice, she acknowledged the findings.






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B. Record review of the hospital's policy titled, "Hand Hygiene," revised 10/16, showed that staff are to sanitize their hands, prior to the application of gloves and providing patient care. Staff are to vigorously rub hands together for at least 15 seconds, covering all surfaces of hands, fingers, and between fingers. Indications for hand antisepsis include before and after dressing changes.

On 04/05/18, at approximately 11:30 AM, during a wound dressing change observation, Employee #49, Registered Nurse, was observed beginning to perform wound care for Patient #86 right sacral ulcer, with the assistance of Employee #150, Patient Care Technician. The surveyor alerted the employees of the visibly soiled chux [protective plastic towel for incontinence] with feces under the patient. The employees changed and cleaned the patient at that time. During the dressing change, both employees failed to sanitize their hands for longer than five seconds, after removing gloves, to obtain other necessary items, and prior to providing patient care, which is less than the 15 seconds required per hospital hand hygiene policy.

The practice failed to provide evidence that the nursing staff followed the hospital policy for hand hygiene, follow standards to prevent the spread of infection, and provide a clean treatment area.

During an interview on 04/05/18, at approximately 12:25 PM, with Employee #25, Assistant Director of Nursing,
Employees #49 and 150 were asked, "What is the amount of time required to properly wash hands, per the hospital policy?" The employees stated that the time spent on hand hygiene had not been long enough to meet hospital policy. When asked about the soiled chux, Employees #49 and 150 both stated that they had not noticed the soiled chux, until it was pointed out to them. Employees #25, 49, and 150 acknowledged the findings.The interview occurred in the presence of Employee #27, Registered Nurse.

4. Based on observation, standards of care, and staff interview, the nursing staff failed to follow standards of care for contact isolation precautions, in one of one observation (Patient # 78).

Findings included ...

Review of standards of care regarding contact isolation precautions-used for infections, diseases, or germs that are spread by touching the patient or items in the room (examples: MRSA Methicillin-resistant Staphylococcus aureus, VRE Vancomycin-Resistant Enterococci , diarrheal illnesses, open wounds, RSV Respiratory syncytial virus), reveals healthcare workers should wear a gown and gloves, while in the patient's room.
professionals.site.apic.org/protect

During an observation of a wound dressing change on 04/04/18, at approximately 11:30 AM, the surveyor observed contact isolation precautions signage, hanging on Patient #78's door. The surveyor observed Employee #149, Patient Care Technician (PCT) sitting with Patient #78, wearing personal protective equipment (PPE), to include a gown, gloves, and a facial mask. The surveyor asked Employee #49, Registered Nurse (RN) about Patient #78's isolation status. At that time, Employee #49 put on PPE including gown, gloves, and a mask, and entered the patient's room. The surveyor put on PPE, followed Employee #49 into the room, and asked why both employees were wearing masks. Both employees answered that contact isolation required a mask.

The practice lacked evidence that nursing staff followed standards of care for contact isolation precautions.

During a face to face interview, at that time, with Employee's #149 and 49, the surveyor asked them to explain the difference between contact and droplet isolation. Neither employee could differentiate the difference between contact versus droplet isolation.The employees acknowledged the findings, in the presence Employee #25, Assistant Director of Nursing.