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Based on interview and record review, the facility failed to promptly investigate a grievance for 1 (P-4) of 3 grievances reviewed, resulting in the loss of the patient's right to a prompt resolution of a grievance, and the potential for less-than-optimal outcomes. Findings include:

On 7/10/24 at 1400, record review of patient experience documentation dated 3/1/24 at 1640 revealed a phone call was received from P-4 stating she had surgery on 2/15/24, and she was concerned she did not receive an abdominal binder prior to discharge, the recovery room staff left her in the bathroom with no assistance to dress, her black shirt was wet at time of discharge and when she arrived home she noticed she was bleeding heavily from one of the abdominal incisions, and had to call an ambulance to take her back to the emergency room for evaluation.

On 7/10/24 at 1430, record review of the complaint and grievance logs revealed an entry for P-4 categorized as a complaint on 3/1/24.

On 3/8/24 patient experience (email) documentation revealed that P-4 called back asking why no one has contacted her regarding her concerns. Documentation in patient experience emails revealed P-4 received a phone call from the Recovery Room Manager on 3/8/24 and Director of Surgical Services on 3/18/24, indicating P-4's concerns were discussed during calls.

The above stated concerns reported by P-4 initially on 3/1/24, were categorized as a grievance, and entered in the facility's "Safety First" process on 4/15/24.

On 9/11/24 at 1000, an interview with Staff ZZ revealed that P-4's concerns were not recognized or handled as a grievance until 4/15/24.

On 9/11/24, review of policy titled, "Patient Complaint and Grievance Policy" (SE 004) dated revised 11/8/23 revealed: "Grievance - A written or verbal expression of dissatisfaction with the resolution of a complaint or communication received after discharge. This does include allegations of abuse, neglect, or harm ... All grievances ordinarily shall be documented within McLaren Safety First under the Feedback module. Documentation ordinarily shall include the allegation as stated by the patient/representative, a summary of the investigation, the actions taken to resolve the complaint, date of completion, date(s)/time(s) of verbal and written communications, and the attached document(s) of written response ...All grievances ordinarily shall require a written response to the patient/representative acknowledging receipt of the complaint/concern within 7 business days of original receipt if not related to serious injury, harm, impairment, or death. The response ordinarily shall be written in clear and easily understandable language, and tailored to the complainant's age, language, and ability to understand.

Based on interview and record review, the facility failed to ensure that nursing staff documented meal intake for one (P-1) of three patient records reviewed, resulting in the potential for less than optimal outcomes for all patients receiving meals at the facility. Findings include:

A review of P-1's medical record was conducted on 09/10/24 at approximately 1430 with 9 South manager Staff F and revealed that P-1 was admitted on 09/02/2023 for nausea, persistent vomiting, and high blood pressure. P-1 left against medical advice (AMA) on 09/07/2023. Staff F was requested to demonstrate documentation of P-1's meal intake. Two entries were displayed in "ml" format. Staff F was questioned what this represented. Staff F stated that this is documentation of liquids the patient drank. Staff F was next requested to demonstrate the diet orders for P-1. Staff F displayed "Regular Diet" orders. Staff F was questioned if P-1 received meals during his stay. Staff F replied that she was positive that P-1 was fed, due to his diabetic condition, but that she was disappointed that no meal intake was recorded. No other documentation was located in the medical record which indicated that P-1 was provided or consumed meals during the visit.

Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Pharmaceutical Services by failing to maintain a clean medication storage area, resolve a controlled substance medication discrepancy promptly, review medication allergies before allowing the medication to be dispensed and administered, and ensure outdated medications were not available for use in the patient care areas resulting in the potential for the spread of infectious agents, misappropriation of controlled substances, less than optimal patient care outcomes, and a patient experiencing a medical emergency. Findings include:

See specific tags:

A-0491: Failure to ensure a clean location for storing medications

A-0494: Failure to promptly resolve a controlled substance discrepancy

A-0500: Failure to ensure medications were appropriately assessed for allergies before allowing the medication to be entered into the dispensing system

A-0505: Failure to ensure outdated medications were not available for use in patient care areas

Based on observation, interview, and record review, the facility failed to ensure a clean location for storing medications resulting in the potential for less-than-optimal outcomes for all patients admitted to the patient care area. Findings include:

On 9/10/2024 at 1030, the medication refrigerator in the medication room on the 12 South patient care area was observed. The bottom surface of the refrigerator contained dirt, debris and rust. The bin labeled IV Returns (bin used to store intravenous solutions pending return to pharmacy) located on the bottom surface of the refrigerator contained dirt and debris. At the time of this observation, Nurse Manager Staff N was queried and acknowledged the condition of the medication refrigerator storage area.

On 9/11/2024 at 1020, the Director of Pharmacy Staff NN was interviewed about who is responsible for cleaning the medication refrigerators, and they responded "Pharmacy" for the inside and "Housekeeping" for the outside of the refrigerator. Staff NN acknowledged the condition of the refrigerator after observing a photo of the dirt, debris, and rust in the medication refrigerator.

Upon review of the facility's policy "Storage of Medication in Patient Care Areas," dated 3/2024, it revealed that "Pharmacy Services in collaboration with nursing, respiratory, radiology, medical and administrative staff ensure that medications stored outside of the Pharmacy Department are stored safely and securely and in accordance with professional practice standards consistent with Federal and State regulations" and "Patient care areas maintain a properly controlled medication storage area and a functionally separated preparation area that is clean and orderly."

Based on observation, interview, and record review, the facility failed to promptly resolve a controlled substance discrepancy for 1 of 1 unresolved discrepancies observed, resulting in the potential for less-than-optimal patient care outcomes. Findings include:

On 9/10/2024 at 1120, the screen on the automated dispensing machine screen in the Post Anesthesia Care Unit revealed that a medication count discrepancy was present. At the time of this observation, Nurse Manager Staff R was queried about the discrepancy, and she revealed that the discrepancy was for hydromorphone 2 mg injection (Schedule II opioid controlled substance). The automated dispensing machine inventory for hydromorphone 2 mg injection was expected to be 6 syringes but the actual count was 5 syringes. The discrepancy verbiage from the screen revealed that the discrepancy occurred on 9/9/2024 at 1402.

On 9/10/2023 at 1130, Nurse Manager Staff R was interviewed on the policy for resolving controlled substance discrepancies, they stated that they "usually receives an e-mail communication and hasn't been to their office today to review e-mails."

On 9/11/2024 at 1030, Director of Pharmacy Staff NN was interviewed about the process for resolving controlled substance discrepancies. They acknowledged that the discrepancy should be resolved by the end of the shift. For this discrepancy, they stated that a "staff member was coming into the facility (on 9/11/2024) at 1100" to resolve the discrepancy (about 45 hours after the discrepancy was initiated).

Upon review of the facility's policy "Controlled Substance and Prevention of Drug Diversion," dated 1/9/2024, the policy revealed that "Discrepancies identified during a shift count or inventory verification counts must be resolved immediately, if possible but no later than the end of the shift. Any discrepancies that remain unresolved at the end of the shift must be reported to the immediate supervisor and the director of pharmacy."

Based on interview and record review, the facility failed to follow standards of practice to ensure medications were assessed for allergies before allowing the medication to be entered into the medication dispensing system for 1 (P-3) of 1 patient resulting in P-3 experiencing a medical emergency. Findings include:

A review of P-3's medical record revealed that P-3 was admitted to the facility on 11/3/2023. The patient's history and physical record revealed that P-3 was allergic to Symbicort, clindamycin (hypertension), and sulfa drugs. The type of reaction, severity, or side effects were not noted for both Symbicort and sulfa drug medication allergies and were not clarified before any medications were ordered entered into the medication dispensing system.

The Physician Assistant Staff RR history and physical note on 11/3/2023 at 0542 revealed the plan for treating P-3 ' s chronic obstructive pulmonary disease included "Pt asymptomatic no cough, shortness of breath present" and "continue home medications - albuterol, fluticasone-salmeterol, Spiriva." On 11/4/2023 at 0728, the Pulmonology progress note revealed that the assessment and plan for P-3 included "Patient reports that he is on Spiriva and Wixela (fluticasone propionate - salmeterol) inhaler at home. Albuterol inhaler as needed. No recent exacerbations."

Additional medical record review revealed that on 11/3/2023 at 0221, Physician Assistant Staff RR ordered budesonide-formoterol (Symbicort) 2 puffs twice a day to start at 11/3/2023 at 0900. On 11/3/2023 at 0227, Pharmacist Staff W verified the Symbicort medication order. Both Staff RR and Staff W received an alert about the allergy and both individuals entered "prescriber's judgement" as the reason for overriding the alert for Symbicort allergy. P-3 received three doses of Symbicort on 11/3/2023 at 0858, 11/3/2023 at 1930, and 11/4/2023 at 0804.

On 11/5/2023 at 0006, P-3 experienced shortness of breath and a rapid response was called (when a rapid response is called providers immediately go to patient bedside to address the patient's deteriorating condition).

On 11/5/2023 at 0021, the medication order for Symbicort was discontinued.

On 11/8/2023 at 1522, the facility staff updated P-3's allergy information in the electronic medical record by adding Symbicort's generic name (budesonide-formoterol) to the allergy checks with reactions including respiratory distress, blood pressure abnormal - severe, and itching.

On 11/8/2023 at 1723, reactions under the trade name (Symbicort) allergy (i.e., allergy entered previously) were updated by the facility's staff to include reactions of respiratory distress, blood pressure abnormal - severe, and itching. The other allergies in P-3's medication profile, clindamycin (Hypertension) and sulfa drugs were present but not changed.

On 9/11/2024 at 1030, Director of Pharmacy Staff NN was interviewed and stated that Physician Assistant Staff RR overrode the electronic medical record alert and selected "prescriber's judgement" as the reason for the override. Staff NN stated that Pharmacist Staff W verified the order and overrode the alert and selected "prescriber's judgement" as the reason for the override.

A review of the facility's policy "Pharmacist Review of Medication Orders," dated 2/2024 revealed that Medication orders are reviewed for the following: "real or potential allergies or sensitivities; contraindications; and any concerns, issues or questions identified by the pharmacist during the order review are clarified with the prescriber prior to medication dispensing and documented in accordance with hospital policy."

According to the American Society of Health-system Pharmacist's technical assistant bulletin "Drug Distribution and Control," dated 11/1981, "A pharmacist must review and interpret every medication order and resolve any problems or uncertainties with it before the drug is entered into the dispensing system. This means that he must be satisfied that each questionable medication order is, in fact, acceptable. This may occur through study of the patient's medical record, research of the professional literature, or discussion with the prescriber or other medical, nursing, or pharmacy staff."

According to the American Society of Health System Pharmacist's "Minimum Standard for Pharmacies in Hospitals," dated 2013, "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. Any questions regarding an order shall be resolved with the prescriber prior to administration, and any action taken as a result of this intervention should be documented in the patient's medical record. Information concerning changes shall be communicated to the appropriate health professionals caring for the patient."

Based upon observation, interview and record review, the facility failed to ensure outdated medications were not available for use in 1 of 1 patient care areas resulting in less-than-optimal outcomes for all patients admitted to the patient care area. Findings include:

On 9/10/2024 at 1055, the Respiratory Therapy cart on the 5 South Medical Intensive Care unit was observed and two ampules of lidocaine 4% for injection, 5 milliliters each with an expiration date of 7/1/2024 were found in a bin inside the cart.

On 9/10/2024 at 1100, Respiratory Therapist Staff E was queried, and they acknowledged the expiration dates.

Upon review of the facility's policy "Outdated and Unusable Medication," dated 2/1/2024, the policy revealed that "Unusable Medications: Medication that is outdated, recalled, defective contaminated, broken or deteriorate, mislabeled (improper, illegible, missing or worn) and any other situation that renders the product unsuitable for administration or use." The policy also revealed that "Unusable medications identified on a patient care unit during medication area inspection or by clinical/support staff are returned to the pharmacy for proper disposition."

Based on observation, interview and record review, the facility failed to ensure staff complied with facility policies and nationally accepted standards of practice, resulting in the potential for the spread of infection, and poor outcomes for all surgical patients. Findings include:

On 09/10/2024 between the times of 1000 and 1240, during observations in the surgical services/operating rooms (OR), and sterile corridors, five male staff were observed in the restricted area wearing Skull caps (disposable surgical caps intended to cover ears and hair). At 1130 Staff W Director of perioperative services was asked if skull caps were an acceptable practice, and if the five male staff were following the expected standards of practice. Staff W stated, "No, the skull caps do not completely contain their hair. The anesthesia tech has facial hair not covered, and his hair is hanging out of the skull cap." Staff W then confirmed the five staff members were indeed wearing skull caps with exposed hair at the nape, as well as side-burn hair which was not covered.

On 09/10/2024 at 1150, Staff W was asked to look through the window of operating room nine, where a female staff member was sitting at the head of a patient stretcher. The female staff at the head of the stretcher was identified by Staff W, as an ear nose and throat (ENT) physician. The ENT was observed to be wearing a cloth bonnet, with a hospital issued disposable bouffant covering half of the cloth bonnet. Staff W was queried as to what the policy was on wearing cloth bonnets and laundering practices. Staff W stated, "Yes, cloth caps can be worn if they are covered by a disposable bouffant cap. I can see that a lot of the cloth hat is not covered. It looks like the bouffant has slipped back. I am not sure how they are laundered."

The tour proceeded to the nursing station where four female staff (two scrub techs, one registered nurse, and one perfusionist), were observed to be wearing cloth bonnets under disposable bouffant. All four staff observed had a bouffant over the back portion of the cloth bonnets leaving the front portion of the cloth bonnet exposed. All four staff were queried in the presence of their director and manager, who launders the cloth bonnets. The perfusionist stated, "They don't get laundered, because we cover them with a bouffant." The registered nurse described how she laundered her bonnets at home, and neither scrub technician responded. Staff W confirmed that the process being followed for laundering was not acceptable.

On 09/11/2024 at 1035, during an interview with Staff PP (Chief Medical Officer) the findings noted above were reviewed and Staff PP confirmed the observations did not follow national standards of care and the facility's policy.

On 09/10/2024 at 1400, review of Policy No: SS-03, Title: Protocol for Proper Operating Room / PACU / Anesthesia / CPD / ENDO Attire, Revised date: 06/2015, Reviewed: 05/2022.

4.4. Surgical attire should be laundered in a health care accredited laundry facility. Home laundering is not monitored for quality, consistency, or safety. Typical home laundering practices do not eradicate organisms commonly found in the hospital environment. Exposure of healthcare personnel and their family members to blood and other potentially infectious materials may result from improper handling and decontamination of surgical attire.

4.11. Disposable scrub hats or surgical hoods that completely cover all possible head and facial hair are to be worn by all personnel entering the operating room's restricted and semi restricted areas.

4.12. Because hair can harbor bacteria, skull caps that fail to cover side hair above the ears, hair, and at the nape of the neck are unacceptable; A disposable bouffant cap must be worn.

4.13. Cloth caps must cover and contain all hair, should be laundered daily and be COMPLETELY covered with a disposable bouffant cap.

Reference: AORN (Association of Operating Room Nurses) Guidelines for perioperative practices.