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101 COLE AVENUE

BISBEE, AZ 85603

PATIENT CARE POLICIES

Tag No.: C1006

Based on record reviews and staff interviews, it was determined the facility failed to ensure:

1. The patient or patient's representative receives a written copy of their patient rights for 8 of 20 patients (Patients #8, #9, #11, #12, #13, #14, #17, #19). This deficient practice poses the potential risk that patients are not informed of their rights at the time of admission. This is a repeat deficiency from Event #IRBV11 on 10/15/2020, Tag 1006.
2. A medical staff or surgeon performs a medical history and physical examination within 30 days before a surgical procedure on two of three patients (Patients #9 and #21). This deficient practice poses a potential risk to the health and safety of patients if surgeons are unaware of the patient's updated medical history, including potential contraindications to the surgery.
3. A physician order was in place before a patient received a chemical restraint. This deficient practice poses a risk to the health and safety of patients, if patients are chemically restrained unnecessarily.
4. A patient is monitored and assessed according to restraint policies and procedures. This deficient practice poses the risk of physical harm of the patient when they are restrained without proper monitoring.
5. Patients that are placed in restraint/seclusion have a face to face examination by a physician or other licensed practitioner. This deficient practice poses a risk to the health and safety of patients, when a patient is not evaluated to determine the reaction to the restraint or seclusion.

Findings include:

1. Policy titled, "Patient Rights & Responsibilities" dated 10/06/2023, revealed: " ...II. Authority and Responsibility: Administration and staff members must read and comply with this policy ....All patients must sign the HIPAA/Patient Rights document stating they have been informed of their rights for each visit and or have been given the opportunity for a copy of said documents. This encompasses hospital outpatient ...or hospital Emergency Department/admitted patients. The signed consent must be placed in the patient's chart for each encounter ...."

Document titled, "Conditions of Admission", revealed: " ...The undersigned ...consents and agrees to the following terms of admission and treatment provided at CQCH ...9. Notice of Privacy Practices/Patient Rights and Responsibilities: I acknowledge that I have been presented with the Notice of Privacy Practices/Patient Rights and Responsibilities and understand that I can request a paper copy during my visit ...."

Review of medical records conducted on 11/14/2023 revealed Patients #8, #11, #12, #13, #14, #17, and #19 did not sign the Conditions of Admission (COA) form, and the forms had "Implied Consent" written on the patient's signature line. Further review of Patients #8, #11, #12, #13, #14, #17, and #19's medical records revealed they were alert, and physically able to sign documents at the time of admission.

Review of Patient #9's medical record conducted on 11/15/2023 revealed Patient #9 did not sign the COA form.

Employee #13 confirmed during an interview conducted on 11/14/2023 that Patients #8, #11, #12, #13, #14, #17, and #19 were physically able to sign the COA at the time of admission. Employee #13 further confirmed there was no documentation that Patients #8, #11, #12, #13, #14, #17, and #19 received a copy of their patient rights.

Employee #15 confirmed during an interview conducted on 11/15/2023 that there was no documentation that Patient #9 received a copy of their patient rights.


2. Policy titled, "History and Physical - Surgical Services Department" dated 04/26/2023, revealed: " ...Procedure: A written (dictated and transcribed or handwritten) patient history and physical examination must be readily available in the medical record prior to surgery. If H&P is greater than 30 days a new H&P is required, or the physician may make an addendum stating no changes since last visit ...."

Document titled, "Rules and Regulations of the Medical Staff dated 05/24/2023, revealed: " ...V. Medical Records: ...D. The medical record should be completed in a timely fashion which is sufficient to permit continuity of care and transferability .....VIII. Surgical H&P: Surgical H&P can be written up to 30 days prior and updated on day of procedure prior to procedure and anesthesia ....VII. Surgical Care: ...D. Preoperative Evaluation: ...IV. The preoperative evaluation will be updated on the day of the procedure with an addendum noting any relevant changes in the patient's history or physical examination ...."

Review of Patient #9's medical record revealed they had a colonoscopy on 08/03/2023. Further review of Patient #9's medical record revealed a history and physical examination performed on 06/23/2023.

Review of Patient #21's medical record revealed they had an endoscopy with biopsy on 11/14/2023. Further review of Patient #21's medical record revealed a history and physical examination performed on 09/14/2023.

Employee #15 confirmed during an interview conducted on 11/15/2023 that Patient #9 had a history and physical examination performed more than 30 days prior to their surgical procedure.

Employee #1 confirmed during an interview conducted on 11/15/2023 that Patient #21 had a history and physical examination performed more than 30 days prior to their surgical procedure.


3. Policy titled "Restraint Policy", revealed: " ...VII. Orders for Use of Restraint or Seclusion: ...3. A physician or LP responsible for the care of the patient orders of restraint or seclusion prior to the application of restraint or seclusion ...."

Two (2) medical charts were review where restraint were used, one (1) out of the two (2) medical charts did not have chemical restraint orders.

Employee #16 confirmed during an interview conducted on 11/15/2023 that a physician order is required to place a patient in a chemical restraint.


4. Policy titled "Restraint Policy", revealed: " ...B. The condition of the restraint patient or secluded patient must be continually assessed, monitored and re-evaluated to ensure that the patient is released from restraint or seclusion at eh earliest possible time. This documentation should include: ...Documentation of vital signs and continuous observation every 15 minutes by a medical PSA on the Violent Flowsheet for patients being restrained for violent behaviors ...."

Two (2) medical charts were reviewed where restraints were used, one (1) out of the two (2) medical charts did not have documentation of continuous observation every 15 minutes for a patient that received chemical restraint.

Employee #16 confirmed during a medical record review conducted on 11/15/2023, that one (1) patient did not have documentation of continuous observation performed every 15 minutes after the patient received chemical restraint.


5. Policy titled "Restraint Policy", revealed: " ...VI. When Restraint or Seclusion is used (Including Drugs or Medications Used as Physical Restraint): ...9. A physician or other licensed practitioner must see and evaluate the need for restraint or seclusion within one hour (1) after the initiation of the intervention ...VII. Orders for Use of Restraint or Seclusion: ...9. The attending physician must be consulted as soon as possible if the attending physician did not order the restraint or seclusion. This can occur via telephone if the attending physician is unavailable for a face-to-face consultation.

Two (2) medical charts were reviewed where restraints were used, one (1) out of the two (2) medical charts did not have a face to face consultation with the physician one (1) hour of the initiation of the chemical restraint.

Employee #16 confirmed during a medical record review conducted on 11/15/2023, that one (1) patient did not have a documentation that a physician conducted a face to face evaluation of the patient after a chemical restraint was used.

PATIENT CARE POLICIES

Tag No.: C1016

Based on hospital records, observation, and interview, it was determined the hospital failed to ensure:
1. Medications were kept locked in a secure location, under direct supervision, and not in unattended patient care areas. This failure poses the risk of patient and visitor access to medications that are left unsecured in areas without supervision by hospital staff.
2. Single use medications were discarded after use. This failure poses the risk of potential contamination when a single used medication is used on multiple patients, as well as possible deterioration of medication efficacy, when not used per manufacturer instructions.

Findings Include:

1. A hospital policy for medication storage was requested. A policy was received for a rural health clinic, titled "Medication Storage and Inspections at the Rural Health Clinics," which revealed: "...The drug preparation area...shall be well lighted and have locked areas...The medication room will be secured at all times...."

During a tour of the hospital, conducted on 11/13/2023, in the Pre-op/PACU area, in patient bay 2, there was a lock box installed on the wall with a push button key pad. The box was identified as the narcotics safe. The keypad was in direct view from the head of the patient bed, and in direct line of sight of chairs for visitors. On a return visit to the pre-op/PACU on 11/15/2023, a patient was in bed 2, and the entire bay, including the lock box, was enclosed by the curtain.

During the same tour, on 11/13/2023, a cart identified as an anesthesia med cart, was found unlocked in an unoccupied room. There were multiple unopened boxes and vials of propofol in the cart, along with other medications used for resuscitation and anesthesia purposes. There was also a refrigerator containing multiple vials of medication, with an unlocked lock hanging on the door.

Employee #15 confirmed in an interview on 11/13/2023, that the lock box on the wall was the narcotics safe, and it was in a patient care area. Employee #15 also confirmed that when there was a patient in bay 2, they would close the curtain, and the narcotics safe and patient in the bay were concealed from view. Employee #15 further confirmed that the anesthesia cart and refrigerator were opened and left unattended in the room, and all medications should be secured and locked.

Employee #1 confirmed in an interview on 11/15/2023, that there was a patient in bay 2, and in order to view or access the narcotics safe, s/he would have to open the curtain and enter the patient care bay.

2. Document titled "Guide to Infection Prevention for Outpatient Podiatry Settings," revealed: "...Single use products are recommended whenever possible, and should only be used on a single patient...As with any medications, topical products intended for single use and/or labeled as single-use by the manufacturer must be disposed of after use...."

A policy on single use and multi use topical medications, wound care practices, or dressing changes was requested and none could be provided.

On a tour of the hospital, conducted on 11/13/2023, in the hospital's infusion room, a supply cart identified as a podiatry procedure cart, contained two (2) opened tubes of MediHoney Gel with manufacturers instructions "Single Use Only."

An email communication dated 11/14/2023, revealed: "...(Provider #17) was not aware that medi-honey is single use...."

Employee #1 confirmed in an interview on 11/13/2023, that the single use MediHoney Gel was used for multiple patients.

RECORDS SYSTEM

Tag No.: C1110

Based on record reviews and staff interviews, it was determined the facility failed to obtain consent for treatment from the patient or patient's representative before or at the time of admission for 8 of 20 patients (Patients #8, #9, #11, #12, #13, #14, #17, #19). This deficient practice poses the risk of the patient receiving treatment without giving consent.

Findings include:

Policy titled, "Consent-Informed and Implied" dated 08/25/2023, revealed: " ...Procedure: ...B. Implied Consent: 1. The patient ...is unable to physically sign for treatment or the billing of insurance shall be deemed to give "Implied Consent." ...C. During the Registration process and gathering of insurance information, all patients must electronically sign the Conditions of Admission and HIPAA/Patient Rights documents. 1. The e-signature confirms that the patient gives consent for treatment ...2. The e-signature automatically uploaded into the electronic medical record ("EMR"). The Registration documents can also be manually signed or an implied consent taken, witnessed by two staff members ...3. The signed hard copy of the consent form must be placed in the patient's chart within the EMR for each encounter ...."

Document titled, "Conditions of Admission", revealed: " ...The undersigned ...consents and agrees to the following terms of admission and treatment provided at CQCH ...1. Medical and Surgical Consent: My healthcare providers will provide the direction for my health care and treatment. I consent to receive all medical, surgical and anesthesia treatment and hospital services as ordered by my healthcare providers, including physician and provider services, nursing services, diagnostic ...therapeutic ...technical and all other hospital services ...provided under the instruction of my healthcare providers ...."

Review of medical records conducted on 11/14/2023 revealed Patients #8, #11, #12, #13, #14, #17, and #19 did not sign the Conditions of Admission (COA) form, and the forms had "Implied Consent" written on the patient's signature line. Further review of Patients #8, #11, #12, #13, #14, #17, and #19's medical records revealed they were alert, and physically able to sign documents at the time of admission.

Review of Patient #9's medical record conducted on 11/15/2023 revealed Patient #9 did not sign the COA form.

Employee #13 confirmed during an interview conducted on 11/14/2023 that Patients #8, #11, #12, #13, #14, #17, and #19 were physically able to sign and consent to treatment at the time of admission. Employee #13 further confirmed there was no documentation that Patients #8, #11, #12, #13, #14, #17, and #19 consented to treatment.

Employee #15 confirmed during an interview conducted on 11/15/2023 that there was no documentation that Patient #9 consented to treatment.

QAPI

Tag No.: C1309

Based on a review of hospital records and interview, it was determined the hospital failed to evaluate the Quality Assurance and Performance Improvement Plan on an annual basis. This failure poses the risk of an inability to monitor and evaluate patient outcomes and address needed changes and improvements to patient care services.

Findings include:

Hospital policy titled "Quality Assurance/Performance Improvement Plan," revealed: "...Last Periodic Review Date: 04/23/2020 Next Periodic Review Date: 04/23/2024...The goal of this plan is to systematically monitor, analyze, and improve CQCH's services that affect patient health outcomes. The hospital's performance of important functions significantly affects the quality and value of its services and ultimately the care of the patients...The Chief Executive Officer ("CEO"), Chief of Staff ("COS), Chief Nursing Officer ("CNO"), and Chief Quality and Compliance Officer ("CQCO") are responsible for the implementation of this Policy...Annual Evaluation: The QAPI Committee will conduct an annual evaluation of the program...."

A review of QAPI and Governing Board meeting minutes from the last 12 months showed no evaluation of the QAPI program.

Employee #1 confirmed in an interview conducted on 11/15/2023, that the QAPI program was last reviewed on 04/23/2020.