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Based on observation of one of one segregated compounding area (SCA), record review, policy review, and staff interview, the pharmacist failed to provide pharmaceutical services that meet the needs of patients, as evidenced by failure to: prevent and/or minimize the potential risk of contamination of compounded sterile medications (CSPs), from exposure to particles in air, by placing an Oceanaire (brand) spot cooling unit, in the SCA (A-0492); follow the hospital policy for compounding CSPs; document the monitor, label and track CSPs; and ensure supervision of pharmacy activities and services, and compounding practices (A-0501).

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

Based on medical record review, policy review, and staff interview, the medical staff failed to ensure an order for management of a left ventricular assisted device (LVAD), and a Miami J Brace (cervical collar) for three of three patients (Patients #5, #13 and #14).

Findings included ...

Record review of the hospital policy titled, "Mechanical Circulatory Support (MCS) Drive Line Exit Site Care," revised 12/18, showed that the LVAD driveline dressing will be done twice a week and as needed. Modified dressing changes can be ordered at the physician's discretion.

Record review of the hospital policy titled, "Physician's Orders," revised 07/17, showed that "All physician orders pertaining to the care and treatment of the patient must be written directly by the physician, on the Physician Order Form and contain all the elements of a complete order."

A. On 10/08/19 at approximately 10:40 AM, review of Patient #5's medical record revealed the physician admitted the patient with diagnoses to include Status Post Craniotomy and C5 (Cervical 5th vertebrae) Transection Quadriplegia.

A review of the physician's history and physical, in the head, ears, eyes, neck and throat assessment, dated 09/26/19 at 8:50 PM, revealed the patient had a cervical collar in place.

A review of the attending 'Critical Care Medicine' progress note dated, 09/28/19 at 8:00 AM showed the patient had a neck brace in place.

According to a treatment progress note dated 10/01/19, the physical therapist assessed the patient at the bedside, with a neck collar in place.

Further review of the medical record, lacked documented evidence of a physician's order for management of the cervical collar.

The practice lacked evidence that the physician followed the hospital policy for physician's orders for management of the cervical collar.

The surveyor conducted a face-to-face interview with Employees #21 and #22, Registered Nurses, on 10/08/19 at approximately 11:00 AM, regarding the aforementioned findings. Both acknowledged the collar is removed during am care; and placed back on after care is completed. Both acknowledged the findings at the time of the record review.

The surveyor conducted a follow-up interview on 10/09/19 at approximately 2:00 PM, with Employee #73 Respiratory Therapist, regarding the removal of the cervical collar during trach care. She stated that the brace is removed "carefully," and a nurse is available, if assistance is needed.

B. On 10/08/19 at approximately 10:45 AM, review of Patient's #13's medical record revealed the physician admitted the patient with a LVAD.

A review of the medical record revealed the registered nurse changed the patient's LVAD dressing twice a week.

Further review of the medical record lacked documented evidence of a physician's order for management of the LVAD.

The practice lacked evidence that the physician followed the hospital policy for orders of care and treatment.

The surveyor conducted a face-to-face interview with Employees #21 and #22, Registered Nurses, on 10/08/19 at approximately 11:00 AM, regarding the aforementioned findings. Both acknowledged the findings at the time of the record review.

C. On 10/09/19 at 9:40 AM, review of Patient #14's medical record revealed the physician admitted the patient with a LVAD.

A review of the medical record revealed the registered nurse changed the patient's LVAD dressing twice a week.

Further review of the medical record, lacked documented evidence of a physician's order for management of the LVAD.

The practice lacked evidence that the physician followed the hospital policy for orders of care and treatment.

The surveyor conducted a face-to-face interview with Employees #21, Registered Nurse and #22, Registered Nurses, on 10/09/19 regarding the aforementioned findings. Both acknowledged the findings at the time of the record review.

Based on observation, record review, policy review and staff interview, the Governing Body failed to establish a mechanism to ensure contracted staff provided pharmacy services, in accordance with hospital polices and acceptable standards of practice, as evidenced by pharmacy staff failure to prevent and/or minimize the potential risk of contamination of compounded sterile medications (CSPs), from exposure to particles in air; follow the hospital policy for compounding CSPs; document, monitor, label and track CSPs; and ensure supervision of pharmacy activities and services, and compounding practices.

Findings included ...

Cross reference A-0492 and A-0501-1.

There was no evidence that the Governing Body ensured that pharmacy services were conducted in compliance with hospital polices and acceptable standards of practice.

During a face to face interview on 10/10/19 at approximately 9:00 AM, Employee #1, Chief Executive Officer, acknowledged the findings.

Based on observation, record review, policy review and staff interview, the Governing Body failed to ensure contracted staff provided care in a safe and effective manner, as evidenced by pharmacy staff failure to prevent and/or minimize the potential risk of contamination of compounded sterile medications (CSPs), from exposure to particles in air; follow the hospital policy for compounding CSPs; document, monitor, label and track CSPs; and ensure supervision of pharmacy activities and services, and compounding practices.

Findings included ...

Cross reference A-0492 and A-0501-1.

There was no evidence that the Governing Body ensured a mechanism to evaluate the quality of pharmacy services to ensure patient safety.

During a face to face interview on 10/10/19 at approximately 9:00 AM, Employee #1, Chief Executive Officer, acknowledged the findings.

Based on observation and staff interview, the hospital staff failed to ensure a safe patient environment, in one of four observations.

Findings included ...

A. During a tour of the 2 North Intensive Care Unit (ICU) on 10/07/19 at approximately 11:30 AM, with Employees #25, Vascular Access Registered Nurse and Employee #2, Charge Nurse; the surveyor observed four pairs of scissors, stored in a slot on an unsecured ultrasound Site-Rite scanner (used for insertion of intravenous access) cart. The cart was located in an area accessible to passersby.

The practice failed to demonstrate that the staff ensured a safe patient setting.

The surveyor conducted a face-to-face interview with Employees #2 and #25, at the time of observation. Both acknowledged the findings.

Based on the Quality Assurance Performance Improvement (QAPI) review, record review, policy review and staff interviews, the QAPI staff failed to measure, analyze and track quality indicators, to monitor the effectiveness of pharmacy services' practices to improve health outcomes.

Findings included...

Cross reference A-0492 and A-0501-1.

Review of the hospital policy titled, "Compounding Sterile Preparations," revised 01/19, showed that "the sterile compounding quality assurance program is part of the pharmacy department process and is reported accordingly."
Review of the QAPI plan on 10/10/19 at approximately 12:00 PM, lacked evidence that the QAPI staff monitored the contracted pharmacy services to assess processes of care, related to the Oceanaire spot cooling unit and pharmacy staff failure to maintain a compounding log; and to implement and monitor performance improvement activities.

During a face-to-face interview on 10/08/19 at approximately 11:00 AM, with Employee #4, Interim Director of Quality, she stated that the hospital was slowly replacing air handlers but did not specifically know where; and denied taking effective measures in the pharmacy department to identify, monitor, and track health outcomes and patient safety.

During a subsequent interview on 10/10/19 at approximately 3:00 PM, with Employee #4, she denied having knowledge of pharmacy staff failure to appropriately handle compounded sterile medications; therefore, there were no performance improvement measures in place.

Employees #4 acknowledged the findings.

Based on the Quality Assurance Performance Improvement (QAPI) review, record review, and staff interviews, the QAPI staff failed to identify, monitor and track, patient safety risks and performance improvement measures, related to pharmacy services.

Findings included...

Review of the QAPI plan on 10/10/19 at approximately 12:00 PM, lacked evidence that the QAPI staff evaluated the contracted pharmacy services to identify quality and performance problems, related to the Oceanaire spot cooling unit and pharmacy staff failure to maintain a compounding log; and to implement and monitor performance improvement activities.

Cross reference A-0273.

1. Based on record review and staff interview, the nursing staff failed to weigh patients, in accordance with the physician order, in two of two medical records reviewed (Patients #4 and #14).

Findings included ...

Record review of the hospital policy titled, "Patient Weights," revised 10/18, showed that weights are documented in the patient's medical record in kgs (kilograms). If a patient refuses to be weighed or circumstances prevent weighing a patient, staff are to document the reason in the patient's medical record, notify the doctor, and document the notification.

A. Review of Patient #4's medical record on 10/08/19 at 2:15 PM, showed the physician admitted the patient, with diagnoses to include Status Post Repair Suprarenal Abdominal Aortic Aneurysm, Hypertension and Upper Gastrointestinal Bleed.

Review of physician order dated 10/02/19 at 10:00 AM, directed the patient to have daily weights.

Review of the medical record revealed weights were not recorded on 10/04/19 and 10/05/19.

The practice lacked evidence that the nursing staff followed the hospital policy for weight measurement.

The surveyor conducted a face-to-face interview with Employee #21, Registered Nurse, on 10/08/19 at approximately 2:30 PM, regarding the aforementioned findings. He acknowledged the findings at the time of the record review.

B. Review of Patient #14's medical record on 10/09/19 at 9:40 AM, showed the physician admitted the patient, with diagnoses to include Heart Failure, Adrenal Insufficiency, End Stage Renal Disease, and Severe Malnutrition. The patient received hemodialysis on Tuesdays, Thursdays and Saturdays.

Review of physician dated, 10/08/19 [time not indicated], directed the patient to be weighed Mondays and Fridays.

Review of the medical record revealed weights were not recorded on 08/27/19, 09/07/19, 09/8/19, 09/19/19, 09/24/19, 09/28/19, 09/29/19, 10/05/19 and 10/08/19.

The surveyor conducted a face-to-face interview with Employee #21, Registered Nurse, on 10/08/19 at approximately 3:00 PM, regarding the aforementioned findings. He acknowledged the findings at the time of the record review.


2. Based on medical record review and staff interview, the nursing staff failed to perform Left Ventricular Access Device (LVAD) assessments, every four hours, as directed for three of four patient record reviews (Patients #13, 14 and 3).

Findings included ...

Review of the "Ventricular Assist Device (VAD) Patient Daily Flowsheet," revealed the nurse should check and document the functionality of the VAD, every four hours and notify the physician for dizziness, fainting or palpations.


A. Review of Patient #13's medical record on 10/08/19 at approximately 10:45 AM, revealed the physician admitted the patient with a LVAD.

Further review of the nursing documentation revealed the nursing staff failed to perform LVAD assessments, every four hours on 09/12/19 at 12:00 Noon and at 4:00 PM.

During a face-to-face interview on 10/09/19 at approximately 1:00 PM, Employee #21, Charge Nurse, reviewed the record and acknowledged the findings.

B. Review of Patient #14's medical record on 10/09/19 at 9:40 AM, revealed the physician admitted the patient with a LVAD.

Further review of the nursing documentation revealed the nursing staff failed to perform LVAD assessments, every four hours on 09/14/19 at 4:00 PM, 9/10/19 at 12:00 AM and at 4:00 AM.

During a face-to-face interview on 10/09/19 at approximately 1:00 PM, Employee #21, Charge Nurse, reviewed the record and acknowledged the findings.

C. Review of Patient #3's medical record on 10/07/19 at approximately12:00 PM, revealed a physician order dated 10/02/19, for every four hour LVAD assessments.

Further review of the nursing documentation revealed the nursing staff failed to perform LVAD assessment every four hours on 10/08/19 at 4:00 PM.

During a face to face interview on 10/09/19 at approximately 1:00 PM, Employee #21, Charge Nurse, reviewed the record and acknowledged the findings.




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3. Based on medical record review and staff interview, the nursing staff failed to follow physician orders in one out of six charts reviewed, (Patient # 8).

Findings included ...

The surveyor conducted a medical record review with Employee #19, Registered Nurse Manager 3 North, on 10/07/19 at 2:40 PM. The physician admitted Patient # 8 on 09/04/19, due to aspiration pneumonia, dysphasia, and history of a (CVA) cerebral vascular accident. A physician order was written 09/27/19 at approximately 2:00 PM, for orthostatic blood pressure measurements to be taken every shift. There is no evidence that orthostatic blood measurements were taken in the medical record, from 09/27/19 thru 10/07/19 at 2:40 PM.

The practice lacked evidence that the nursing staff followed physician orders.

The surveyor conducted a face to face interview with Employee # 19 at the time of the medical record review, who acknowledged the finding.

Based on medical record, policy review and staff interview, the nursing staff failed to establish a care plan, based on the patient's identified needs, in seven of 32 records reviewed (Patients #5, 13, 14, and 3).

Findings included ...

Record review of the hospital policy titled, "Interdisciplinary Care Plan," revised 08/19, showed "patients will have an "individualized, multidisciplinary plan of care, which will be continuously updated based on current patient needs, goals, and planned interventions to reach the identified care goals. Based on the admission assessment the nurse will initiate and implement the plan of care within 24 hours of admission ..."

A. On 10/08/19 at approximately 10:40 AM, review of Patient #5's medical record revealed diagnoses to include Status Post Craniotomy and C5 (Cervical 5th vertebrae) Transection Quadriplegia.

Review of the nurse's admission note dated 09/26/19 at 11:45 PM, showed the patient had a neck collar in place.

Further review of the medical record showed that nursing staff did not develop a plan of care, with goals and interventions, to address the management of the patient's cervical neck collar.

The surveyor conducted a face-to-face interview on 10/09/19, at approximately 4:00 PM, with Employee #21, Registered Nurse, regarding the development of care plan, related to the cervical neck collar. He acknowledged the findings at the time of the chart review.

B. On 10/08/19 at approximately 10:45 AM, review of Patient's #13's medical record revealed the physician admitted the patient, with a Left Ventricular Assistive Device (LVAD).

Review of the medical record showed that the registered nurse assessed the driveline exit site every four hours and performed dressing changes twice a week.

Further review of the medical record showed that nursing staff did not develop a plan of care, with goals and interventions, to address the patient's LVAD.

The surveyor conducted a face-to-face interview on 10/09/19, at approximately 3:30 PM, with Employee #21, Registered Nurse, regarding the development of care plan related to the LVAD. He acknowledged the findings at the time of the chart review.

C. On 10/09/19 at 9:40 AM, review of Patient #14's medical record revealed the physician admitted the patient, with a Left Ventricular Assistive Device (LVAD).

Review of the medical record showed that the registered nurse assessed the driveline exit site every four hours and performed dressing changes twice a week.

Further review of the medical record showed that nursing staff did not develop a plan of care, with goals and interventions, to address the patient's LVAD.

The surveyor conducted a face-to-face interview on 10/09/19, at approximately 3:30 PM, with Employee #21, Registered Nurse, regarding the development of care plan related to the LVAD. He acknowledged the findings at the time of the chart review.


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D. Review of the Patient #3's medical record 10/07/19 at approximately12:00 PM, revealed the patient had a Left Ventricular Assistive Device (LVAD); however, the patient's care plan lacked goals and interventions that addressed the patient's identified needs for LVAD services.

During a face to face interview on 10/09/19 at approximately 1:00 PM, Employee #21, Charge Nurse, reviewed the record and acknowledged the findings.


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E. The surveyor conducted a medical record review with Employee # 19 on 10/07/19 at 3:00 PM. The physician admitted Patient # 7 on 09/23/19 due to chronic obstructive pulmonary disease and left knee septic arthritis with multidrug-resistant staphylococcus aureus (MRSA). Patient #7 Nursing care plan lacked identification of her isolation status, pain management, and wound status on 09/30/19.

The practice lacked evidence that the nursing staff individualized nursing care plans to include isolation status, pain management, and wound status, and to update weekly or change in medical condition, per hospital policy.

A face to face interview was conducted with Employee #19 at the time of the medical review, who acknowledged the finding.

F. The surveyor conducted a medical record review with Employee # 34, Registered Nurse (RN) on 10/07/19 at 3:20 PM. The physician admitted Patient #9 on 10/04/19, with a diagnosis of Liver Cirrhosis, End-Stage Renal Disease, and stage three sacral ulcer with coagulase-negative Staphylococcus aureus bacteremia, on Enteric isolation. The Nursing care plan lacked isolation precautions and alteration in comfort due to wound care.

The practice lacked evidence that the nursing staff individualized nursing care plans to include isolation precautions and alteration in comfort due to wound care.

A face to face interview was conducted with Employee # 34 at the time of the medical review, who acknowledged the finding.

G. The surveyor conducted a medical record review with Employee # 34 on 10/07/19 at 3:45 PM. The physician admitted the patient to 3 North on 09/19/19 with Psoas abscess of the left hip with osteomyelitis, and positive blood cultures for staph aureus showing Methicillin sensitive Staphylococcus aureus (MRSA), treated with antibiotics. Patient # 37's nursing care plan failed to be individualized, to include wound care, pain management and updated weekly on 09/23/19, and 09/30/19.

The practice lacked evidence that the nursing care plan identified individualized problems, and was updated weekly per hospital policy.

A face to face interview was conducted with Employee # 34 at the time of the medical review, who acknowledged the finding.

Based on observation of one of one segregated compounding area (SCA), record review, policy review, and staff interview, the pharmacist failed to supervise pharmacy activities and services.

Findings included...

Review of the United States Pharmacopeia (USP) <797> revealed the avoidance of equipment not essential to compounding, in SCA's, to ensure environmental quality. It further states that the placement of Primary Engineering Controls, which include compounding aseptic isolator (CAI), shall be located out of traffic patterns and away from room air currents that could disrupt the intended airflow patterns.

During inspection of the SCA, in the pharmacy department, on 10/07/19 at approximately 10:00 AM, the surveyor observed an Oceanaire spot cooling unit, located near the CAI. The surveyor queried the Director of Pharmacy about the cooling unit. She said that it was installed to maintain adequate room temperature, as the temperature was hot, during the summer months and now.

The practice lacked evidence that pharmacy staff ensured an environment that minimized the risk of contamination.

Review of the hospital policy titled, "Compounding Sterile Preparation," last reviewed 01/19, showed that all finished preparations must undergo release checks and tests before a CSP is dispensed or administered. This process includes: CSP solutions are visually examined for the presence of particulate matter; a copy of the order, written compounding procedure (master formula), preparation records, and expended materials used to make CSPs are inspected for accuracy of correct identities and amounts of ingredients, aseptic mixing, packaging, labeling, and expected physical appearance; and CSP labels include at minimum the correct names and amounts or concentrations of ingredients, the total volume (when indicated), the beyond-use-date, the appropriate route(s) of administration, the storage conditions, and other information, for safe use. A pharmacist must check and sign off on all products prepared by pharmacy technicians, including label accuracy, visual confirmation of additives, and their volumes or quantities. The compounding log must contain the manufacturer's name and lot number to facilitate drug recall procedures; and records of sterile compounding; including personnel training and competency are retained for three years, or as defined by regulations and/or hospital policy.

The surveyor requested the compounding log or documentation of compounding practices, from 01/01/19 to present. Employee #5, The Director of Pharmacy, stated the pharmacy staff did not maintain a compounding log for medications compounded for the outside hospital. She further stated that the outside hospital system would not allow the pharmacy to print out prescription labels for their patients. Therefore, the pharmacy staff had to manually write the labels, then affix them to the CSPs. However, the pharmacy did not maintain a copy of the labels. The only form the pharmacy kept were the chain of custody forms, which only identified the product and the quantity shipped to the outside hospital. They did not identify the patient, product content, and other labeling requirements, per policy; and the hospital did not have an electronic system to maintain compounding records.

The findings demonstrate evidence of a lack in supervision in coordinating and supervising pharmacy activities, in accordance with the hospital's policy, related to compounding CSPs; and failure to maintain complete and accurate records of all prescription drugs that were compounded.

Employee #5 acknowledged the findings.

1. Based on a review of hospital documents to include Pyxis Automated Dispensing Machine (ADM) Schedule II, III, IV, and V Controlled Substance Transactions by patient report, physicians' orders, and the Medication Administration Record and staff confirmation, the hospital staff failed to properly document the administration or handling of controlled substances, in two of eight records reviewed (Patients #2 and 42).

Findings included ...

On 10/09/19, the ADM, for controlled substances schedule II-V, generated a seventy-two (72) hour all stations event report for nursing units: 2 North Intensive Care Unit (ICU) and 3 North Medical Surgical Unit. All patients were randomly selected for this audit. The survey of records was started on 10/09/19, at approximately 11:00 and was completed on 10/09/19, at approximately 15:00.

On 09/26/19, at 16:32, Patient #2, in the ICU, was ordered Oxycodone 5 mg (milligrams) by mouth, every six hours as needed for pain. On 10/4/19, at 10:37, only one removal from the ADM was documented; however, two different administration times were documented at 10:37 and 10:39.

On 09/26/19, Patient #42, on 3 North, was ordered Oxycodone 5 mg, every four hours as needed for pain. On 10/03/19 at 15:16, one tablet was removed and returned to the ADM at 21:12, over six hours later.

The observations were in the presence of Employee #5, the Director of Pharmacy, who acknowledged the findings.


2. Based on policy review, record review, and staff interview, the staff failed to follow the Methadone treatment policy and regulations, in two of two patient records reviewed (Patients #11 and 41).

Review of hospital policy titled, "Methadone and Buprenorphine Authorized Use for Opioid Dependence," last review 01/18, showed that Methadone dose must be verified by the patient's addiction treatment specialist, prior to administration.

Review of The Code of Federal Regulations for administering or dispensing narcotic drugs, showed a practitioner may administer or dispense directly (but not prescribe) a narcotic drug, listed in any schedule, to a narcotic dependent person for the purpose of maintenance or detoxification treatment; and is separately registered with the Drug Enforcement Agency, as a narcotic treatment program. Emergency treatment may be carried out for not more than three days and may not be renewed or extended.

On 09/27/19, Patient #11 was ordered Methadone 40 milligrams (mg), once daily for chronic pain. However, review of the patient's medication history showed the patient was in a methadone clinic; and the record lacked evidence that the medication was verified with the treatment clinic.

On 09/23/19, Patient #41 was ordered Methadone 80 mg by mouth, once daily for pain. However, review of the patient's medication history showed the patient was in a methadone clinic; and the record lacked evidence that the medication was verified with the treatment clinic.

The practice lacked evidence that the pharmacy staff followed the hospital policy to contact the Methadone treatment clinic, for dosing.

During a face to face interview on 10/09/19 at approximately 2:30 PM, with Employee #5, Director of Pharmacy, and Employees #42 and #43, Clinical Pharmacists, they acknowledged the findings.

1. Based on observation of one of one segregated compounding area (SCA), record review, policy review, and staff interview, the pharmacist failed to ensure pharmacy supervision, during compounding of sterile medications (CSPs).

Review of the hospital policy titled, "Compounding Sterile Preparation," last reviewed 01/19, showed that a compounding log, containing the manufacturer's name and lot number is maintained to facilitate drug recall procedures; and records of sterile compounding, including personnel training and competency are retained for three years, or as defined by the regulations and hospital policy. The pharmacy staff must immediate affix labels to the containers, after manual preparation of CSPs.

Review of the United States Pharmacopeia (USP) <797> Identity and Strength Verification of Ingredients, showed that compounding facilities shall follow written procedures for verifying the correct identity and quality of CSPs, before they are dispensed and administered as follows:

1. Labels of CSPs bear correct names and amounts or concentrations of ingredients, the total volume, the beyond-use-date, the appropriate route(s) of administration, the storage conditions, and other information for safe use.

2. There are correct identities, purities, and amounts of ingredients by comparing the original written order with the written compounding record for the CSP.

3. Correct fill volumes in CSPs and correct quantities of filled units of the CSPs were obtained. When the strength of finished CSPs cannot be confirmed to be accurate, based on the above three inspections, the CSPs shall be assayed by methods that are specific for the active ingredients.

The surveyor requested the compounding log or documentation of compounding practices, from 01/01/19 to present. Employee #5, The Director of Pharmacy, stated the pharmacy staff did not maintain a compounding log for medications compounded for the outside hospital. She further stated that the outside hospital system would not allow the pharmacy to print out prescription labels for their patients. Therefore, the pharmacy staff had to manually write the labels, then affix them to the packet. However, the pharmacy did not maintain a copy of the labels. The only form the pharmacy kept were the chain of custody forms, which only identified the product and the quantity shipped to the outside hospital. They did not identify the patient, product content, and other labeling requirements; and the hospital did not have an electronic system to maintain compounding records.

The findings demonstrate evidence of a lack in supervision in coordinating and supervising pharmacy activities, in accordance with the hospital's policy, related to compounding CSPs and failure to maintain complete and accurate records of all prescription drugs that were compounded.

Employee #5 acknowledged the findings.



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

Findings included...

Cross reference A-0492 and A0501-1.

There was no evidence that the pharmacy staff notified the Infection Preventionist or the committee of the potential patient safety risks of the Oceanaire spot cooling unit, located near the compounding aseptic isolator, that was installed to maintain adequate room temperature or the potential patient safety risks of failing to maintain a compounding log.

During a face to face interview on 10/07/19 at approximately 2:15 PM, with Employee #5, Director of Pharmacy, she shared that hospital staff was aware of the air handler situation. She provided no answer, regarding the reason for the absence of a compound log.

During a face to face interview on 10/07/19 at approximately 2:30 PM, with Employee #6, Director of Plant Operations, he shared that the air handler that supplied the pharmacy area needed repair because it could not push cool air into the area. The spot cooler that had a basic filter, versus a HEPA (High Efficiency Particulate Air) filter, was placed in the pharmacy to maintain adequate room temperature, especially in the summer months.

During a face-to-face interview on 10/08/19 at approximately 11:00 AM, with Employee #9, Infection Preventionist, she explained that she was aware of the spot cooling unit in the pharmacy, as she discovered it, during routine rounds with the Environmental Services staff, but denied having knowledge of potential patient safety risks, related to compounding. Employee #9 explained that pharmacy staff participated in the quarterly meetings, but had not reported the concerns and she relied on the Director of Pharmacy to convey concerns.

Employees #5 and 9 acknowledged the findings.


3. 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 convey identified risks to patient safety, and to monitor and track the risks and performance improvement measures.

Findings included...

Cross reference A-0492 and A0501-1.

Review of the hospital policy titled, "Compounding Sterile Preparations," revised 01/19, showed that "the sterile compounding quality assurance program is part of the pharmacy department process and is reported accordingly."
There was no evidence that the pharmacy staff notified the QAPI staff of the potential patient safety risks of the Oceanaire spot cooling unit, located near the compounding aseptic isolator, that was installed to maintain adequate room temperature or the potential patient safety risks of failing to maintain a compounding log.

During a face to face interview on 10/07/19 at approximately 2:15 PM, with Employee #5, Director of Pharmacy, she shared that hospital staff was aware of the air handler situation. She provided no answer, regarding the reason for the absence of a compound log; and she did not convey the findings to the quality assurance performance improvement staff.

During a face-to-face interview on 10/09/19 at approximately 3:00 PM, with Employee #4, Interim Director of Quality, she denied having knowledge of pharmacy staff failure to appropriately handle compounded sterile medications. She was aware that the hospital was in the process of replacing air handlers, but did not specifically know the air handler in the pharmacy was affected.

Employees #4 and 5 acknowledged the findings.

Based on observations during the survey, it was determined that dietary services were not adequate to ensure that foods are served and prepared under sanitary conditions.

Findings included...

The surveyor conducted a tour of the dietary services department on 10/07/19 at 10:45 AM and 10/08/19 at 9:30 AM respectively, with Employee # 8, Director of Dietary Services.

1. The bottom shelf surfaces of two racks in the condiment area of the dietary storage room were soiled with debris.

2. The top surfaces of the sugar, flour, rice, and brown sugar bins were soiled with spillages.

3. Floor tiles were damaged, soiled and stained, in the cook's areas, along with the tray line, and cafeteria serving areas.

4. The interior areas of open drains under the work stations in the cook's preparation area was soiled.

5. The interior surfaces of cereal bowls were soiled with food residue, [grits], after having been washed in the dishwasher, in six of 19 observations.

6. The interior surfaces of the ice machine in the main kitchen was soiled with debris.

7. In the pressure washer area, floor surfaces were soiled and damaged. Furthermore, the painted surfaces were peeling and in a state of needing repair.

8. Floor surfaces at the entrance to the walk-in freezer were damaged and concrete surfaces were not secured.

Based on observations during the survey, it was determined that Housekeeping and Maintenance Services were not adequate to ensure that the facility is maintained in a safe and sanitary manner.

Findings included ...

The surveyor conducted a tour of the facility on 10/8/19, with Employee #14. The following observations were made during the tour:

A tour of the Morgue at 11:05 AM on 11/8/19, showed:

1. The inner surfaces of Morgue Trays were soiled with dust.

A tour of the Second and Third Floors on 10/8/19 showed:

A. Floor and baseboards were soiled and stained around the perimeter; window and window sill surfaces were soiled; water drains slowly when the faucet was turned on, floor surfaces were stained in ambulating areas; Venetian blind slats were damaged along the hallway side of the room; door surfaces were marred and the exterior surfaces of Windows were stained in Room 2011.

B. Bed frame surfaces were soiled with dust; floor and baseboard surfaces were soiled around the perimeter; a plate cover was missing in the toilet area.

C. The top surfaces of the Pyxis Machine near the nurse's station were soiled with dust.

D. Floor tile surfaces were cracked in front of the toilet; the hot water temperature was 98 degrees, below the required minimum temperature of 105 degrees Fahrenheit, in the hallway restroom.

D. The top surfaces of the over-bed lamp were soiled; wall surfaces were marred; grids near the bed were marred; the exhaust vent was dusty in the bathroom; the closet and bathroom doors lack latches and the entrance door was marred, in room 2017.

E. Handrails surfaces were marred in the hallway near room 2019 and the entrance door was marred.

F. Baseboards surfaces along walls were soiled and stained, the wall outlet cover was cracked and damaged; the seat surfaces of the chair were worn; window sill surfaces were soiled; the bath door is stained, the backsplash on the sink needed repair and the closet door lacks a latch in Room 2021.

G. Entrance door surfaces were marred, window sill surfaces were soiled; bed frame surfaces were soiled; the over bed lamp was lacked a cover; walls were marred and the closet door was marred in Room 2023.

H. Bathroom walls were marred and the toilet seat was not secured in the patient Visitors Lounge on the Second Floor.

I. Cabinet walls and rail surfaces were marred; Venetian blind surfaces were soiled; floor surfaces were stained; bed frame surfaces were soiled with dust; floor surfaces in the rear of the toilet were in poor condition; the light switch plate cover was missing, and the hot water temperature was below the required minimum temperature of 105 degrees Fahrenheit in Room3128.

J. The front and rear surfaces of the bathroom door was marred; bed frame surfaces and floor surfaces were soiled. The rear of the toilet was stained and the hot water temperature was 85 degrees Fahrenheit, below the required temperature of 105 degrees Fahrenheit in Room 3132.

K. The clean Linen Room on the third floor has baseboard surfaces marred, penetration in the wall, and the light switch lacked a plate cover.

L. Floor tiles located at the entrance to the toilet room were soiled and stained, wall surfaces around the perimeter were soiled and marred and the bathroom floor and baseboard surfaces were worn in Room 3113.

M. The heating ventilation and air conditioning cover was not secured; the over bed lamp lacked a cover; the baseboard was not secured in the bathroom and was soiled, damaged, and stained. The hot water temperature was 77 degrees Fahrenheit, below the minimum temperature of 105 degrees in Room 3106.

N. The wall was marred; window surfaces were stained, and penetrations were observed around the shower light in Room 3156.

O. The top surfaces of the lamp cover, bed frame, and shower stall floor were soiled. Spillages were observed on the floor near the head of the bed and the hot water temperature was determined to be 72 degrees Fahrenheit, below the required temperature of 105 degrees Fahrenheit, in Room 3158.

P. Wall surfaces and floor surfaces in the rear of the Ice Machine were marred, and ceiling tile grids were stained in the pantry.

Q. Wall and floor surfaces adjacent to the bed were marred; bed frame surfaces were dusty, floor surfaces were soiled and damaged behind the toilet and the hot water temperature was determined to be 75 degrees Fahrenheit, below the required temperature of 105 degrees Fahrenheit. Furthermore, ceiling tiles were stained near the vent in Room 3147.

R. Wall surfaces and the double entrance doors were marred at the entrance to the Clean Utility room on unit 3.

S. The over headlamp was damaged, wall surfaces were soiled, damaged and marred, in the Soiled Utility Room.

T. Floors, walls, and exhaust vents were soiled in the Staff Locker Area, of unit 3

2. Elevators floors in the east end of the building were soiled and worn, and door tracks were very soiled.

3. The following findings were observed during a tour of Materials Management at 3:26 PM on 10/09/19.

A. Painted floor surfaces were marred in various areas of Materials Management, including the changing areas.

B. Floor and wall surfaces outside of Materials Managements were marred and worn, including the doors and walls of the receiving area.

Based on observation and staff interview, the hospital staff failed to ensure expired supplies were not stored, ready and available for use, to ensure an acceptable level of safety and quality, in three of 10 observations.

Findings included ...

A. The surveyor conducted a tour of unit 3 North on 10/07/19 at 10:35 AM with Employee #19. The surveyor observed 16 expired red top lab tubes, and 54 yellow top lab tubes, open and available for use both with an expiration date of 08/31/19, in the unlocked clean utility room.

The practice lacked evidence that hospital staff ensured expired supplies were not ready and available for use, to ensure an acceptable level of safety and quality.

The surveyor conducted a face to face interview with Employee # 19 at that time, who acknowledged the finding.

B. The surveyor conducted a tour of the medication room for unit 3 North on 10/07/19 at 10:50 AM with Employee # 19. The surveyor observed an expired 500 milliliter (ml) bag of Dextrose solution dated 09/19, ready and available for use in the intravenous (IV) supply bin.

The practice lacked evidence that hospital staff ensured expired supplies were not ready and available for use, to ensure an acceptable level of safety and quality.

The surveyor conducted a face to face interview with Employee # 19 at that time, who acknowledged the finding.

Based on the Infection Control Program review, policy review, record review, and staff interviews, the hospital's Infection Preventionist failed to identified risks to patient safety relative to pharmacy services; and failed to effectively address the risks to protect patients.

Findings included...

Cross reference A-0492 and A-0501-1.

There was no evidence that the Infection Preventionist identified the potential patient safety risks of the Oceanaire spot cooling unit, located in pharmacy, near the compounding aseptic isolator, that was installed to maintain adequate room temperature.

During a face-to-face interview on 10/07/19 at approximately 2:15 PM, with Employee #5, Director of Pharmacy, she shared that hospital staff was aware of the air handler situation.

During a face-to-face interview on 10/07/19 at approximately 2:30 PM, with Employee #6, Director of Plant Operations, he shared that the air handler that supplied the pharmacy area needed repair because it could not push cool air into the area. The spot cooler that had a basic filter, versus a HEPA (High Efficiency Particulate Air) filter, was placed in the pharmacy to maintain adequate room temperature, especially in the summer months.

During a face-to-face interview on 10/08/19 at approximately 11:00 AM, with Employee #9, Infection Preventionist, she explained that she was aware of the spot cooling unit in the pharmacy, as she discovered it, during routine rounds with the Environmental Services staff, but denied having knowledge of potential patient safety risks. Additionally, she did not have knowledge of the potential safety risks to patients related to the pharmacy compounding practices. Employee #9 explained that pharmacy staff participated in the quarterly meetings, but had not reported the concerns and she relied on the Director of Pharmacy to convey concerns.

Employees #9 acknowledged the findings.

Based on observation, and staff interviews, the hospital failed to keep sharps safe and secure, in a clean storage room, to protect patient safety, in one of three observations.

Findings Included ...

The surveyor conducted a tour of unit 3 North on 10/07/19 at 10:35 AM with Employee #19, Registered Nurse Manager 3 North. The surveyor observed two 18 gauge one and one half inch needles in an unsecured drawer in the unlocked clean utility room.

The practice lacked evidence that the hospital kept sharps secure in the clean utility room, to protect patient safety.

The surveyor conducted a face to face interview with Employee # 19 at the time of the observation, who acknowledged the finding.