HospitalInspections.org

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ITEM #1 - Use of Succinylcholine
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Based on review of policy and interviews, the hospital failed to have some drugs and biologicals available to treat certain possible side effects of drugs used in moderate sedation.
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Failure to have the drugs and biologicals available could lead to serious patient harm and/or death.
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Findings:
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1. The hospital policy titled, "Procedural Sedation" (Revised 6/18/2016) under, "Roles and Responsibilities of Clinical Staff: Moderate Sedation 1st Care Provider: Privileged Provider (MD/PA/ARNP) - The Privileged Provider directs the treatment and/or administration of drugs for moderate sedation. . . .Responsibilities include: . . . Manage complications or side effects from moderate sedation or the procedure."
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2. On 11/18/2016 at approximately 2:00 PM, Surveyor #1 interviewed the hospital pharmacist (Staff Member #1) and the CNO (Chief Nursing Officer) (Staff Member #2) regarding the presence of Succinylcholine vials (a skeletal muscle relaxant) in Rapid Intubation Kits kept with crash carts. Surveyor #1 asked the pharmacist how often the kits were used. S/he stated about one time a week. Surveyor #1 asked if pharmacy stocked Dantrolene (a muscle relaxant used to treat malignant hyperthermia) available if patients experienced the side effect of malignant hyperthermia (a rare life-threatening condition that is usually triggered by exposure to certain drugs including Succinylcholine). The pharmacist stated the pharmacy did not stock Dantrolene or a substitute drug on site.
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3. On 11/19/2016 at approximately 1:30 PM, Surveyor #1 met with the hospital CNO (Staff Member #2), CEO (Chief Executive Officer) (Staff Member #3) and the CMO (Chief Medical Officer) (Staff Member #4). Surveyor #1 expressed concern that Dantrolene was not available if Succinylcholine was utilized to treat the possible side effect of malignant hyperthermia. The CMO noted that the Medical Committee had been discussing this issue and planned to discontinue the use of Succinylcholine in the facility.


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ITEM #2 - Crash Cart checks
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Based on observation, document review, and policy and procedure review, the facility failed to ensure that crash carts were regularly checked per hospital policy.
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Failure to regularly check crash carts places patients at risk from inadequate care should the need for emergency services arise.
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Findings:
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1. The hospital policy titled, "Restocking Crash Cart & Rapid Sequence Intubation Kit" (Effective 9/12/2012) states in part, "At the start of each shift, the Charge Nurse for the unit or their designee will check the crash cart to ensure it is sealed."
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2. On 11/15/2016 at 9:50 AM, Surveyor #2 checked the crash cart in the acute care unit of the hospital. The crash cart log was missing at least one check on November 3, 6, 8, 11, and 12.

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Based on observation, the hospital failed to ensure that mattresses were adequately maintained and easily cleanable.
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Failure to adequately maintain mattresses places patients at risk of infection due to the inability to ensure equipment is adequately cleaned.
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Findings:
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On 11/15/2016 at 1:17 PM, Surveyor #2 observed a torn mattress in a patient room in the acute care unit. The mattress had multiple tears along the sides, making the mattress difficult to properly disinfect. The Facilities Manager (Staff Member #5) confirmed this finding.
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Based on observation, document review, policy and procedure review, and interview, the hospital failed to ensure that temperatures in nourishment room refrigerators were adequately checked and maintained.
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Failure to adequately maintain refrigerator temperatures places patients at risk for food-borne illness.
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Findings:
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1. The hospital policy titled, "Patient Nutrition Refrigerator Temperature Log" (Effective: 9/12/2012) states in part, "Each nursing unit Charge Nurse is responsible for ensuring the nutrition room refrigerator temperature is correctly logged at least twice daily."
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2. On 11/15/2016 at 9:46 AM, Surveyor #2 inspected a nourishment room in the acute care unit of the hospital. The document titled, "Refrigerator Temperature Chart" had missing temperature checks for two dates in November in the morning and five dates in the evening.
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3. On 11/15/2016 at 9:46 AM, Surveyor #2 interviewed the nurse manager (Staff Member #6) about temperature checks for unit patient refrigerators. S/he indicated that the charge nurse for each shift was supposed to perform the nourishment room refrigerator check.
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4. On 11/15/2016 at 10:00 AM, Surveyor #2 checked temperatures of food in the emergency department patient nutrition refrigerator. A pudding was 47 degrees Fahrenheit, jello was 45 degrees Fahrenheit, and a grape juice was 45 degrees Fahrenheit. The internal thermometer read 42 degrees Fahrenheit. Potentially hazardous foods (meat and cheese sandwiches) were also stored in the refrigerator.
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Reference: 2009 FDA Food Code 3-501.16
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Based on observation, record review and staff interviews, it was determined that the Critical Access Hospital ' s Governing Body failed to meet the requirements for the Conditional of Participation for Organizational Structure.

Failure to meet established organizational structure requirements resulted in an unsafe healthcare environment.

Reference: 42 CFR 485.627(a) Standard: Governing Body or Responsible Individual

The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH ' s total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment.

Findings:

Due to the cumulative effect of deficiencies detailed under the Condition of Participation at 42 CFR 485.635 Provision of Services, the Condition of Participation for Organizational Structure was NOT MET.

Cross-reference: C-270, C-272, C-276, C-278, C-294

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Based on observations, interviews and review of hospital policies and procedures, the Critical Access Hospital failed to meet the requirements for the Condition of Participation for Provision of Services, specifically the hospital failed to:

· Review policies and procedures annually
· Store medications at proper temperature
· Ensure that drugs were compounded in a manner consistent with USP 797
· Properly label premixed medications
· Develop a system for tracking and securely storing controlled substances
· Educate housekeeping staff in the proper use of cleaning supplies and processes
· Ensure single use devices were disposed of after use
· Ensure that only qualified staff were taking telephone medication orders

Failure to ensure that staff follow policies and procedures, state laws and accepted standards of practice impairs the hospitals ability to provide quality care in a safe environment.

Findings:

Due to the cumulative effect of deficiencies detailed under the Condition of Paricipation at 42 CFR 485.635 Provision of Services, the Condition was NOT MET.

Cross-reference: C-272, C-276, C-278, C-294

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Based on review of hospital policies and interview, the hospital failed to ensure that policies are reviewed on an annual basis.
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Failure to review hospital policies and procedures on an annual basis may lead to poor patient care outcomes.
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Findings:
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1. The hospital policy titled, "Policy and Procedure Review"(Revised 12/28/2012) states in part, ". . . Policies, once approved and considered official documents, will be scanned and uploaded to the 'Intranet Policies Page' and will be reviewed annually or as needed for updates."

2. On 11/17/2016 around 1:30 PM, Surveyor #1 reviewed numerous hospital policies, including but not limited to:

-Controlled Substances-(Reviewed 10/20/2013)
-Compounded Sterile Products-(Reviewed 10/23/2013)
-Swing Bed Program-(Reviewed 5/21/2013)
-Care Team Conference-(Reviewed 4/1/2013)
-Organ and Tissue Donation-(Reviewed 2/4/2013)
-Telephone, Written, Verbal Orders-(Reviewed 3/18/2013)
-Discharge Planning-(Reviewed 4/1/2013)

On 11/17/2016 at approximately 2:00 PM, Surveyor #1 discussed this finding with the CNO (Staff Member #2) who acknowledged that not all polices are up to date for annual review but that the administration has been working on updating all polices and it is "a work in progress."

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ITEM #1 - Improper Medication Storage
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Based on observation and interview the facility failed to ensure that medications were stored in proper environmental conditions such as temperature.
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Failure to store medication at proper temperature could lead to decreased efficacy of medication and poor patient outcomes.
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Findings:
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1. During observation Surveyor #3 found Rapid Sequence Intubation (RSI kits) stored in the Acute Care and Emergency Department (ED) unit refrigerators contained the following drugs: Fentanyl, Succinylcholine, Midazolam, Etomidate, Rocuronium, and Ketamine. The Pharmacist (Staff Member #1) reported the RSI kits are stored refrigerated for stability for the Succinylcholine and the Rocuronium. However, appropriate storage temperatures for the other drugs are room temperature: 68°F - 77°F. Therefore, the Fentanyl, Midazolam, Etomidate and Ketamine are being stored out of appropriate temperature range.
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2. A vial of a patient's own medication, Oxycontin 80 mg, brought from home was stored in the Pyxis refrigerator. Appropriate storage for this medication is room temperature.
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ITEM #2 - Compounding Sterile Products
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Based on observation and interview the hospital failed to ensure that drugs were compounded in a manner consistent with accepted professional principles of United States Pharmacopeial Convention (USP) 797 standards.
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Failure to perform drug compounding using USP 797 standards could lead to physical or chemical contamination and unintended variations in strentgth that could be harmful to patients.
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Reference:2016 USPC Official 8/1/2016 - 11/30/16 General Chapters : <797> Pharmaceutical Compounding – Sterile Preparations
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Findings:
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1. Policies and procedures (P&P)s- Absence of robust P&Ps addressing sterile compounding to include, but not be limited to: (where applicable): Environmental Monitoring, Sampling, Quality and Control; Cleaning and Disinfecting the Compounding Area; Personnel Cleansing and Garbing; Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices and Cleaning/Disinfection Procedures; Personnel Training and Evaluation of Aseptic Manipulation Skills; Parenteral Admixture Practices and Preparation; Verification of Compounding Accuracy, Finished Preparation Release Checks and Tests; Storage and Beyond-Use-Dating; Quality Assurance Program; Media fill testing; Delivery and Storage of Sterile Preparations in Patient-Care Areas.
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2. Compounding Procedure -USP 797 requirements were not followed during the observed sterile compound: the compounding pharmacist (Staff Member #1) was wearing a watch and ring; the compounding pharmacist did not use a nail pick during hand hygiene; paper towels used were not lint-free; the compounding pharmacist used non-sterile gloves and did not gown or garb; the compounding pharmacist cleaned the inside of the hood with regular paper towels that were not lint-free; the compounding pharmacist did not use a surgical hand scrub with persistent activity; regular (non-sterile) 70% alcohol was used; USP specifies sterile alcohol; observation of compounding activity found that the pharmacist was blocking "first air" (the air from the high-efficiency particulate arrestance (HEPA) filter that passes over materials; this air is contaminant free).
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3. Compounding Area -Based on observation: 1. the segregated compounding area was not defined with an appropriate Line of Demarcation. 2. the hood has not been classified as ISO 5 (Class 100) 3. The most recent Primary Enginerring Control (PEC) certification report does not contain particulate counts. Only airflow velocity and high-efficiency particulate arrestance (HEPA) filter leak test results are listed on the report.
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4. Cleaning and Disinfecting the Compounding Area - Based on observation and interview there is no cleaning log and pharmacy is not using sterile isopropyl alcohol.
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5. Personnel Cleansing and Garbing - Based on observation and interview, the following was identified: 1. gloves available for use are not sterile gloves 2. absence of gowns for garbing 3. pharmacist (Staff Member #1) did not garb (head cover, facial hair cover, shoe cover, mask, gown) nor don sterile gloves prior to compounding. 4. pharmacist (Staff Member ##1) did not perform appropriate hand cleansing prior to compounding 5.towels used for drying hands are not lint-free 6. improper aseptic technique was observed. 7.training records available for review are not compliant with USP 797 training requirements.
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6. Personnel Training and Evaluation in Aseptic Manipulation Skill/Garbing/Cleaning and Disinfection Procedures. Based on observation and interview:

a. There were no current aseptic manipulation competency evaluation records for the pharmacist (Staff Member #1) which included no surface sampling, no gloved finger tip sampling, no gloving or garbing evaluation and no media fill testing.

b. The "Competency Assessment: Aseptic Technique" evaluation for Staff Member #1 dated 10/16/2013 was prior to pharmacy obtaining the hood. Four line items were noted "in process"; two line items noted "n/a". The hood was obtained March 2014. Staff Member #1 reported no subsequent competency evaluations; no end product testing on a sampling basis; no media fill testing performed; no gloved finger-tip sampling performed; no environmental sampling performed: viable air sampling, surface sampling; no environmental sampling plan identified.
All persons who compound (including pharmacists) need to have quarterly end product testing completed.
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ITEM #3 - Medication Storage and Labeling
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Based on observation, individual drug containers were stored in refrigerators and other drug storage areas without being labeled with the name of the drug and strength and compounded medications specific to patients were not labeled with patient's name.
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Failure to label medications with name of drug and strength of medication or specific patient names could lead to patient harm due to inappropriate administration of drugs.
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Reference: 2016 USPC Official 8/1/2016 - 11/30/16 General Chapters : <797> Pharmaceutical Compounding – Sterile Preparations
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Findings:
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a. Based on observation, in the Emergency Department (ED) medication room refrigerators, Surveyor #3 observed multiple unlabeled lidocaine/epinephrine/tetracaine (LET) topical Solution pre-drawn syringes. There were no labels on the syringes indicating drug, lot numbers, or expiration dating.

b. Based on observation, Pharmacist (Staff Member #1) took a sterile compounded intravenous medication s/he had prepared to the Acute Care Medication Room on a tray. S/he then left the medication in the medication room and went to the nurses' station. S/he told nursing staff that the medication was ready.The label applied to the sterile compound drug did not include the name of the patient or any patient identifier. The compound was labeled with the following:
o Drug Ceftriaxone
o Amount 2 gram
o Added By AB
o Date 11/16/16
o Time 1413
o Exp. Date 12 hours
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The expiration date of "12 hours" requires staff to "do the math" to determine exactly what the Beyond Use Date (BUD) is for the product. Standard of practice is to indicate a specific BUD. The orange labels used are not appropriate for non-emergent use.
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ITEM #4 - Controlled Substances
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Based on observation and interview the hospital failed to ensure that controlled substances were tracked and stored appropriately.
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Failure to ensure approriate storage and tracking of controlled substances can lead to diversion and poor pateint care outcomes.
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1. Based on observation, pre-packs of medications, including CII meds, prepared for ED dispensing for patients to take home are labeled with prescription numbers that are manually and arbitrarily assigned by the Pharmacist (Staff Member #1) using a WORD document. However, the prescription number is not recorded, nor is it cross-referenced to the patient profile or the prescription hard copy. There is no reconciliation of hard copies from the ED of the Controlled Substances that were supplied in the pre-packs. Because there is no tracking or accounting performed, there would be no way to determine diversion
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2. Based on observation and interview, RSI kits stored in unit refrigerators contain multiple Controlled Substances in a small plastic container and are not secured. Each entry into the refrigerator provides undocumented access to the contents of the RSI kit.

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ITEM #1 - Environmental Services
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Based on observation and policy and procedure review, the hospital failed to ensure that staff members properly performed housekeeping functions.
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Failure to properly perform housekeeping functions places staff and patients at risk of infection.
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Reference: Guidelines for environmental infection control in health-care facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2004. Pg 134. "E. Recommendations - Environmental Services. I. Cleaning and Disinfecting Strategies for Environmental Surfaces in Patient-Care Areas. G. Avoid large-surface cleaning methods that produce mists or aerosols or disperse dust in patient-care areas."
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Findings:
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1. On 11/15/2016 at 1:17 PM, Surveyor #2 observed the discharge cleaning of a patient room. A housekeeper (Staff Member #7) used a large-scale cleaning method by spraying disinfectant throughout the bathroom and onto horizontal surfaces and furniture throughout the patient room. This cleaning method has the potential to aerosolize contaminants. This process is also not listed in the policy titled, "Patient Room Cleaning Policy" (Effective 2/1/2013).
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2. On 11/16/2016 at 9:55 AM, Surveyor #1 observed a daily cleaning of an emergency department room. The housekeeper (Staff Member #8) bunched the cords from a patient care monitor and then wiped them with disinfectant. Each cord should be cleaned individually to ensure that the entire surface is contacted with disinfectant.
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ITEM #2 - Ice Machine Cleaning
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Based on observation, the hospital failed to ensure that ice machines used for food service were properly cleaned.
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Failure to properly clean ice machines places patrons of the cafeteria at risk of food-borne illness.
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Findings:
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On 11/16/2016 at 10:20 AM, Surveyor #2 inspected the hospital kitchen. While inspecting the ice machine, the surveyor ran his/her finger along the water curtain of the ice machine and discovered brown slime along the bottom. This portion of the apparatus is above the freshly made ice. This finding was confirmed by the executive chef (Staff Member #9).
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ITEM #3 - Single Use Devices
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Based on observation, interview, and document review, the hospital failed to ensure that single use items are not reused.
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Failure to ensure that single use items are not reused places patients at risk for unsafe care or infection.
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Findings:
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On 11/15/2016 at 10:00 AM, Surveyor #2 inspected the emergency department of the hospital. The surveyor noticed Infu-Surg Pressure Infuser Bags hanging in a room in the emergency department and asked a registered nurse (RN) (Staff Member #10) if the pressure infuser bags are single-use or reusable. S/he indicated that the bags are wiped down with a disinfectant after use and reused on subsequent patients. S/he did not know if the bags were specifically labelled as single use or reusable. The manufacture's materials regarding the infuser bags indicate that they are single use.

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Based on review of records and hospital policy and procedure, the hospital failed to ensure that only registered nurses were taking telephone orders per hospital policy.
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Failure to follow hospital policy regarding verbal orders could put patients at risk of harm due to lack of adherence to nursing policy.
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Findings:
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1. The hospital policy titled, "Telephone, Verbal and Written orders" (Revised 6/19/13) stated in part, "Procedure:. . .Telephone Orders: Only telephone orders from an approved provider will be taken. Telephone orders of medication shall be received and recorded by the registered nurse (RN). . ."
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2. Surveyor #1 reviewed the record of Patient #1 on 11/18/2016 at 1:00 PM. In reviewing physician orders for 10/12/2016 at 2210 (10:10 PM), it was noted that a LPN (Liscensed Practical Nurse) (Staff Member #14) signed the "RN Signature/Readback VO/TO" (verbal order, telephone order) portion of the order. Additionally, the same LPN signed off in the RN signature space for influenza screening and ED (emergency department) Transition Orders.

3. On 11/18/2016 at 3:00 PM Surveyor #1 discussed the finding with the Chief Nursing Officer (Staff Member #2). S/he verified that the signature was indeed an agency LPN that worked at the hospital and agreed that per hospital policy the LPN should not be signing telephone orders or signing in a space that was designated for the RN signature.


37243

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Based on observation and interview, the hospital failed to provide adequate window coverings to ensure privacy for patients in the acute care wing of the hospital.
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Failure to provide adequate window coverings places patients at risk for lack of privacy.
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Findings:
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1. On 11/17/2016 at 5:00 PM, Surveyor #2 toured the outside of the acute care unit to determine if window coverings provided adequate privacy for patients. The window coverings were made of a sheer fabric that did not appear to provide full view obstruction. The surveyor saw staff and patients through the window coverings from the exterior of the building.
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2. The Chief Nursing Officer (Staff Member #2) confirmed that the blinds were inadequate for providing privacy and that new window coverings were on order. No documentation was provided that the new window coverings had been ordered.
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