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Based on observation, interview and document review, the facility failed to ensure 1 of 44 sampled patients was provided personal privacy (Patient # 35).

Findings include:

Patient #35 (P35)

P35 was admitted on 01/08/2020 for a scheduled caesarean section.

On 01/08/2020 at 9:40 AM, in the Labor and Delivery Unit, P35 was walking in the hallway to the operating room in a hospital gown. P35 held the backside of gown at the waistline. The gown was not wide enough so that a triangular area approximately 12 inches long and 12 inches wide was open and exposed P35's buttocks. The Director of Women's Services was present in the same hallway.

On 01/08/2020 at 9:49 AM, the Director of Women's Services acknowledged the nurse should have provided double gowns (front and back) for P35.

On 01/08/2020 at 11:33 AM, the Registered Nurse indicated P35 walked from the room to the operating room, approximately 25 feet. The Registered Nurse did not realize P35's buttocks were exposed. The Registered Nurse verbalized double gowns should have been used or staff could have walked behind P35 to hold the gown.

On 01/10/2020 in the morning, P35 indicated a double gown was not offered.

The facility's policy titled Patient's Bill of Rights and Patient Responsibilities dated November 2018, indicated the hospital had an obligation to the community it served in terms of communication, respect, dignity and trust in meeting the needs of patients. The patient rights included considerate and respectful care.

Based on observation, interview and document review, the facility failed to ensure electronic record privacy for an unsampled patient.

Findings include:

On 01/07/2020 at 10:45 AM in front of a patient's room, a Laboratory Technician left a mobile computer station in the middle of the hallway with an unsampled patient's information exposed.

Upon discovery, the Laboratory Technician came out of the patient's room and indicated just returning briefly to the room at the moment of discovery. The Intermediate Medical Care Director of Nursing and Registered Nurse Facilitator present acknowledged the exposed computer information.

The facility's Acceptable Use Policy (#IS 2.01.01 last reviewed 01/20/2016) revealed:

Page 4, 1. Workstation Physical Safeguards: Users should log off of applications, or otherwise secure access, before leaving a computer workstation unattended.

Based on observation, interview and document review, the facility failed to ensure a compounded medication was requested through its non-formulary drug request process.

Findings include:

On 01/08/2020 at 9:00 AM:

The Pharmacy Director showed compounded medication syringes referred to as the "ortho cocktail" for total hip and total knees procedures both with and without Ketorolac, depending on patient allergies.

The ingredients in the 60 milliliter syringe containing the "ortho cocktail" were the following:

Dexamethasone 4 milligrams/milliliter.
Keterolac 30 milligrams/milliliter.
Ketamine 10 milligrams/milliliter.
Epinephrine 1 milligram/milliliter.
Ropivacaine 0.5% 30 milliliters.
Normal Saline 0.9% to fill the balance of the syringe for a total of 60 milliliters.

The "ortho cocktail" had the non-formulary name of intra-articular ortho injection #1. A second version without Keterolac was dubbed #2.

The Pharmacy Director indicated the facility had been using the ortho injections for about a year and had discussed it last in an orthopedic committee meeting 05/07/2019.

The Pharmacy Director acknowledged there was no formal request to get the compounded medication approved or added to the facility's formulary.

The Pharmacy section of the facility's Medical Rules and Regulations (dated 08/01/2019) revealed:

All drugs and medications administered to patients shall be those listed in the latest edition of:

5. The Hospital's formulary or requested via the non-formulary drug requesting mechanism.

The hospital's formulary lacked documented evidence of a medication entitled intra-articular ortho injection or ortho cocktail #1 or #2.

The Non-Formulary Medications policy (last reviewed 11/2013) revealed non-formulary medication was any medication that had not received approval by the Pharmacy and Therapeutics Committee for addition to the hospital's approved medication formulary.

The Therapeutic Alternatives policy (S, last revised 01/2019) revealed under its definition: a therapeutic alternative may include B) a combination of products dispensed to "make up" another chemical entity.

Medications considered therapeutic alternatives must be approved by the Pharmacy and Therapeutics Committee.

The Formulary Additions and Deletions policy (last reviewed 01/2019) revealed:

Page 3, e. A provisional formulary drug is a drug that has been added temporarily to the formulary so that designated hospitals could use it and then conduct a Medication Use Evaluation which would include a recommendation on whether or not to permanently add it to the formulary.

The orthopedic committee meeting minutes, dated 05/07/2019, showed the facility used the compounded preparation and discussed the effects on patients at the time: drop in hypotensive events and post-operative nausea after removing Clonidine from the formula. There was no evidence a Formulary request for the inclusion of the compounded medication was made.

The Formulary Additions and Deletions policy (last reviewed 01/2019) revealed:

Page 3, 5. Formulary Additions:

a. A request for inclusion of a pharmaceutical preparation in the Hospital Formulary shall be made by submitting a Formulary Addition Request Form with included Disclosure Statement (Attachment 1).

b. The Formulary Request Form must be completed by the requesting physician and NOT a Pharmaceutical Representative.

c. The physician requesting the drug for Formulary must include information supporting the use of the agent for a specific indication and he/she must complete all parts of the Formulary Request Form. The Department of Pharmacy, working independently, will prepare a Formulary Review. This review should include an evaluation of any clinical trials, and provide a comparison to similar agents on the formulary which may be used for this indication.

d. The requesting physician (or appointed physician associate) must present the drug to the Pharmacy and Therapeutics Committee.

On 01/10/2020 at noon, the Medication Safety Committee representatives were unable to provide any concrete information or documentation the facility followed its policy/procedures to add the compounded medication to the formulary.

Based on a review of laboratory policy and an interview with laboratory personnel, the director failed to ensure that the established policy and procedure for transfusion of potentially infectious blood products addressed patient notification requirements.

Findings include:

The VHS Document ID TRM-394 entitled "Transfusion Transmitted Disease Lookback Process" did not specify that all attempts for patient notification by the transfusion service must be made over a period of 12 weeks after the blood supplier notifies the transfusion service that it received potentially infectious blood and blood components. The finding was confirmed by an interview with Laboratory Employee #2 on 1/7/2020.

Based on observation, interview and document review, the facility failed to ensure sterile instruments were reprocessed and stored per facility policy.

Findings include:

On 1/7/20 at 10:30 AM, the 5th floor Intensive Care Unit storage room revealed:

One 6" Mayo NH packed in fabric instead of a peel pack dated 08/21/17.

Sterile instruments in punctured peel packs dated 2012 and 2013.

Two gold-handled instruments in the same peel pack without a cycle/load label.

On 01/07/2020 at 3:10 PM, a storage shelf in the outpatient wound care clinic revealed:

4 Symmetry 314 clamps in peel packs without cycle/load labels.

1 Symmetry 314 clamp in a peel pack without a chemical indicator and cycle/load label.

7 curettes for debridement and a reflex hammer in peel packs without cycle/load labels.

On 01/09/2020 at 3:18 PM, the Sterile Processing Department Supervisor acknowledged sterilized instruments should have cycle/load labels, should not be with multiple instruments in peel packs, punctured peel packs no longer contained sterile items, peel packs were no longer used and fabric wrapped items had a year expiration on sterility.

The Sterilization policy (last reviewed 01/2017) revealed:

Page 2, section 4. The sterilization function should be monitored with mechanical, chemical and biological indicators to meet all monitoring standards. Use of monitoring devices provides information to demonstrate that the parameters necessary for sterilization were met.

Page 3, Lot Control Numbers: All sterilized items should have a lot number that identifies the sterilizer used, the cycle or load, and the date of sterilization. The lot number provides a means to identify and/or retrieve items in the event of a sterilizer failure or malfunction.

Page 3, Quality Control: 1. The quality control parameters should include the following: Sterilization process monitoring by biological, chemical, or mechanical devices. Visual inspection of packaging materials. Lot control and traceability of load contents.

Based on observation, interview, record review, and document review the facility failed to ensure 1) an open packet of a syringe needle was discarded; 2) an equipment cart used in 1 of 7 operating rooms (OR) was maintained in a sanitary condition; 3) a peripherally inserted central catheter (PICC) line dressing was changed per facility's policy for 1 of 44 sampled patients (Patient #11); and 4) a peripheral intravenous (IV) line dressing was initialed and dated per facility's policy for 1 of 44 sampled patients (Patient #40).

Findings include:

1) On 01/08/2020 at 6:20 AM, an open packet of a syringe needle was found inside the top drawer of an anesthesia cart in OR #6. The Director of Surgical Services and the OR Clinical Supervisor confirmed the observation and indicated the syringe needle should have been discarded in the sharps container. The syringe needle was no longer sterile once the packet was opened.

2) On 01/08/20/20 at 6:36 AM, an equipment cart around four feet tall, three feet wide, and with three shelves was found inside OR #4. The front edges of the cart had reddish brown discoloration. The equipment placed in the cart were an electrocautery unit, a harmonic scalpel machine, and a smoke evacuator. The Director of Surgical Services and the OR Clinical Supervisor confirmed the observation and revealed the equipment placed in the cart were used in the OR. The Director of Surgical Services and the OR Clinical Supervisor acknowledged the equipment cart was rusty and should have been replaced.




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3) Patient #11 (P11) was admitted on 01/02/2020, with diagnoses including anorexia/severe malnutrition status post percutaneous endoscopic gastrostomy (PEG).

On 01/07/2020 at 11:23 AM, P11 had a peripherally inserted central catheter (PICC) line on the right upper arm. The dressing was soiled and loosened. The dressing was dated 12/27/19.

On 01/07/2020 at 11:25 AM, a Medical/Surgical Nurse assigned to P11 indicated the PICC line was necessary for long term antibiotic treatment - Zosyn every six hours. The Nurse explained P11 came from a rehabilitation facility. The Nurse verbalized the dressing should have been changed when P11 was admitted on 01/02/2020.

On 01/10/2020 at 8:33 AM, the Medical/Surgical Manager indicated P11 had a PICC line for intravenous antibiotics. The Medical/Surgical Manager confirmed the PICC line was present on admission. The Medical/Surgical Manager explained P11's PICC line dressing should have been changed on 01/02/2020, when the patient was admitted.

On 01/10/2020 at 1:48 PM, a Medical/Surgical Nurse reported PICC line dressings were changed every Thursday or earlier if the dressing was soiled or if the patient was admitted from the emergency room. The Nurse explained it was important to change the dressing to prevent blood borne infection.

The facility's policy on PICC Line dated 09/2017 indicated PICC line dressing changes were to be done every seven days unless the dressing site became soiled, damp or loosened, to reduce the risk for infection.


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4) Patient #40 (P40) was admitted on 01/03/2020 with diagnoses including difficulty with urination.

A nursing note dated 01/03/2020 indicated an intravenous catheter was inserted to P40's right arm.

On 01/07/2020 in the morning P40 had a peripheral intravenous (IV) catheter to the right arm covered with a transparent dressing bordered by tape. The IV site lacked labeling regarding the date inserted and staff initials.

On 01/07/2020 in the morning the 7th Floor Medical/Surgical Manager described the facility practice was to label each IV site with the date inserted and staff initials. The 7th Floor Medical/Surgical Manager verified P40's IV site lacked labeling. The 7th Floor Medical/Surgical Manager indicated the labeling was important in determining how long the IV catheter had been in the patient.

The facility policy titled IV Therapy dated 02/2019 indicated peripheral IV catheters should be replaced every 96 hours and to label the site with date and initials.