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Based on observation, review of documentation, and interview, the hospital failed to:


A. Ensure that all essential mechanical, electrical, and patient-care equipment was maintained in safe operating condition, as evidenced by failing to perform preventive maintenance on critical patient-care equipment on 16 of 16 pieces of critical equipment observed during the tour.

Cross Refer to Tag C 0914


B. Ensure hospital's pharmacy staff stored 9 (nystatin 5-milliliter suspension) of 9 medications in the hospital were in a secure area that was not accessible to unauthorized persons. Also, the hospital's pharmacy staff failed to follow the "Security of Medication Storage and Prep Areas" policy.

Cross Refer to Tag C 0922


C. Ensure the hospital's departmental staff completed corrective actions for the findings of the hospital's infection control surveillance rounds.

Cross Refer to Tag C 0924

Based on observation, record review, and staff interviews,

A. the hospital's pharmacy staff failed to ensure 2 (Intravenous Potassium and Intravenous Succinylcholine) of 2 high-risk medications were properly labeled. Also, the hospital's pharmacy staff failed to follow the "High-Risk Medications" policy.

Cross Refer to Tag C 1016



B. the hospital's nursing staff failed to identify and report a medication error that occurred on 1 (Patient # 23) of 1 patient medical records reviewed when a registered nurse administered intravenous medications through a central venous catheter that had not been verified through imaging.

Cross Refer to Tag C 1018



C. the hospital's nursing leadership failed to ensure nursing care was provided in accordance with the patient's needs and the specialized qualifications and competence of the hospital staff when Licensed Vocational Nurses (LVNs) administered intravenous medications without prior training and competencies on 3 (Patient # 17, # 19, and # 27) of 3 patient medical records reviewed.

Cross Refer to Tag C 1046

Based on observation, document review, and interview the hospital failed to ensure:

A. that the infection preventionist/infection control professional (Staff #29) and (Staff #46) was qualified through education, training, experience, or certification in infection prevention and control.

Cross Refer to Tag C 1204


B. to maintain a clean and sanitary environment to avoid sources and transmission of infection in 6 (Emergency Department, Radiology Department, Medical-Surgical Floor, Pharmacy, Materials Management, and Dietary Department) of 6 areas observed.

Cross Refer to Tag C 1208


C. the infection control preventionist monitored the tracking and trending of the hospital's culture reports.

Cross Refer to Tag C 1235


D. communicate and collaborate actively with the hospital's QAPI (Quality Assurance and Performance Improvement) Program.

Cross Refer to Tag C 1237


E. the infection preventionist (Staff #46) was actively involved with the Antibiotic Stewardship Program.

Cross Refer to Tag C 1242

Based on observation, review of documentation, and interview, the hospital failed to ensure that all essential mechanical, electrical, and patient-care equipment was maintained in safe operating condition, as evidenced by failing to perform preventive maintenance on critical patient-care equipment on 16 of 16 pieces of critical equipment observed during the tour.

Findings include:

During a tour of the hospital on 2/3/2025 at 1:30 PM the following critical patient care equipment was observed:

Crash cash X 2 in the emergency room had cardiac defibrillators with a preventive maintenance tag of 1/2025

Defibrillator on a single metal cart in the trauma room with a preventive maintenance tag 1/2025.

The electrocardiogram machine (12 lead) was located in the hallway of the Emergency Room with a preventive maintenance tag of 1/2025.

Bi pap Vision Machine (Bi level positive airway pressure (Bi PAP) is a noninvasive ventilator that helps people breathe by delivering pressurized air into their airways. It's used to treat a variety of medical conditions that make breathing difficult.) in the hallway of the Emergency Room with a preventive maintenance tag 1/2025.

Level One Fluid system (The level 1 Rapid Infuser is kept in resuscitation for use in emergencies. Its primary indication is the prevention and treatment of clinical shock through rapid infusion of warmed blood and crystalloid fluid. Common clinical indications include major hemorrhage, trauma, and placental abruption.) was tagged with a Sticker that stated "DANGER DO NOT REMOVE THIS TAG! TO DO SO WITHOUT AUTHORITY WILL MEAN DISCIPLINARY ACTION! It is here for a purpose. Remarks were faded out. There was no current preventive maintenance tag.

An interview with Staff #5 on 2/3/2025 at 2:00 PM was asked what the "Level One System" was used for. Staff #5 stated, "We use the machine to hang "Ambu" bags on." Staff #30 (Director of Maintenance) was on tour with the surveyor and immediately removed the "Level One System."


Bi pap Vision Machine X 3 was observed in the respiratory department with a preventive maintenance tag of 1/2025.

The electrocardiogram machine (12 lead) was observed in the respiratory department with a preventive maintenance tag of 1/2025.

A ventilator machine was observed in the respiratory department with a preventive maintenance tag of 1/2025.

The Kangaroo pump machine in the equipment room on the medical-surgical floor had no preventive maintenance tag.

A 'Baxter" infusion pump in the equipment room on the medical-surgical floor had no preventive maintenance tag.

There were 3 glucometers in the hospital located in the Surgery department, Emergency Room, and Medical-surgical floor that did not have preventive maintenance tags. The glucometers had never been checked by bio-medical technician and were being used daily by the nursing staff.

An interview with Staff #30 (Director of Maintenance) reported that the hospital has contact with SPBS (South Plains Biomedical & Imaging) to perform preventive maintenance on all hospital equipment. SPBS supplies a bio-medical staff member to keep all equipment current. Staff #30 was told by Staff #43 (SPBS Bio-medical technician) that all equipment was current and that he had left on vacation.



A review of the hospital policy titled, "POM Utility Management PM Program" dated 04/2024 revealed the following:

"Purpose: Utility Management Program

Documentation of the Preventive Maintenance Program is in the plant operations department.

Policy: Utility Management

1. It is the policy of the Maintenance Connection Plant Operations Program to maintain a comprehensive preventative maintenance program that includes a written testing and maintenance program for all facility equipment and utility systems included in the program at established intervals."

A review of the hospital policy titled; "Medical Equipment Management Plan" dated 11/2024

"MEDICAL EQUIPMENT MANAGEMENT POLICIES AND PROCEDURES
SPBS clinical support
As an employee-owned organization, it is our mission to deliver more than basic repair and maintenance of clinical equipment. We deliver responsive support, high-quality and cost-effective service and solutions tailored to our clients' needs.
It is the policy of SPBS to provide the best possible service to our clients. We are dedicated to establishing a quality Preventive Maintenance (PM), Performance Testing and Electrical Safety program, tailored to specific customer needs, to ensure instrumentation reliability and to satisfy inspecting agency requirements including but not limited to: AAAHC, CAP, CIHQ, CUA, CMS, DNV GL, HFAP, NFPA, and TJC.

1. PROCESS FOR PROCEDURES
SPBS utilizes as its reference for our service the most current FDA, OSHA, CMS, DNV GL, NFPA, and TJC requirements. The objectives, scope, performance, and effectiveness of the equipment management program will be evaluated and amended annually.
2. CLINICAL ENGINEERING COMPANY POLICY
Our comprehensive medical equipment management program promotes the safe and effective use of medical equipment. Our program addresses the following criteria:
* A process for selecting and acquiring medical equipment
* Identify, evaluate, and inventory medical equipment included in the program
* Assessing and minimizing the clinical and physical risks associated with medical equipment use through periodic inspection and testing
* Performance standards for equipment inspection, preventive maintenance, and testing
* Annual evaluation of the objectives, scope, performance, and effectiveness of the equipment management program."

In an interview Staff #30 acknowledged that the preventive maintenance was not current on critical patient care equipment and that the hospital policy and contract with SPBS were not performed as written in the policies.

Based on observation, record review, and staff interview, the hospital's pharmacy staff failed to ensure 9 (nystatin 5-milliliter suspension) of 9 medications in the hospital were properly stored in a secure area that was not accessible to unauthorized persons. Also, the hospital's pharmacy staff failed to follow the "Security of Medication Storage and Prep Areas" policy.

Findings include:

During a tour of the hospital's Medication Surgical Unit with Staff # 31 on 02/03/2025 at 1:30 PM the surveyor observed the following,

The Medical-Surgical Unit Medication Room was unlocked, and the door was propped open. There were no nursing or pharmacy staff in the medication room at the time of the observation. The surveyor observed 9 medication syringes filled with 5 ml (milliliters) of nystatin suspension (Nystatin is a medication used to treat fungal or yeast infections of the mouth) sitting on the medication counter. The medication was not stored in a secure area and was accessible to unauthorized persons.

A review of the hospital's Security of Medication Storage and Prep Areas" policy revealed the following:

"Policy: Security of drug storage areas shall be maintained in accordance with federal laws, the laws of this state, and local laws.
Protection of Medications:
All personnel have the responsibility to protect against the theft or diversion of medications.
Requirement for Lockable Storage:
Lockable storage units or lockable drug carts shall be provided for each drug storage area throughout the facility. Medications shall be kept in locked storage and be inaccessible to unauthorized individuals.
Access to Medication Storage Areas:
Access to medication storage areas is limited to pharmacy personnel and nursing/respiratory staff authorized to handle and administer these drugs.
Medical staff, ancillary nursing services, administration, housekeeping, and other personnel are authorized access to drug storage areas only in conjunction with their duties and under direct supervision."


An interview was conducted with Staff # 10 and # 31 on 02/03/2025 at 4:30 PM. Staff # 10 and # 31 acknowledged the medication room door should never be propped open and there should not be any medications left out on the counters in the medication room.

Based on observation, record review, and interview, the hospital failed to ensure the hospital's departmental staff completed corrective actions for the findings of the hospital's infection control surveillance rounds. The hospital failed to follow its "Sanitary Environment" policy.


A review of the hospital's "Environmental Rounds Worksheet for Infection Prevention" forms revealed that Staff #46 completed environmental rounds for each department in the hospital. Further review revealed that Staff #46 documented sending a copy of the findings for each department to that department's leadership and quality. There was no documentation found to support that all of the findings were corrected or that work orders were submitted for correction. The Hospital failed to follow its "Sanitary Environment" policy.

A review of the facility's "Sanitary Environment" policy dated 04/2024 revealed the following:

"Purpose: To ensure Mid Coast Health System provides a sanitary environment in all facilities.
Policy:

A. Mid Coast Health System shall provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases.

B. All areas within the facilities must be clean and sanitary.

C. Infection prevention and control policies and procedures for maintenance of a sanitary physical environment are based on national guidelines and address the following:

1. Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal and external construction/renovation.
2. Maintaining safe air handling systems in areas of special ventilation, such as operating rooms, intensive care rooms, and negative air pressure rooms.
3. Techniques for food sanitation
4. Techniques for cleaning and disinfecting environmental surfaces, carpeting, and furniture.
5. Techniques for textiles reprocessing storage and distribution.
6. Techniques for disposal of regulated and non-regulated waste.
7. Techniques for pest control.

D. The Infection Control Nurse and Safety/Health Risk Committee shall work with at least the following departments to ensure sanitary conditions are maintained throughout the system:

1. Environmental Services
2. Engineering Department (Plant Operations)
3. Materials Management
4. Dietary Department
5. and other applicable departments to ensure a sanitary environment."

A review of the Safety Huddle Meeting minutes for January 2025 revealed that there were no discussions documented regarding the findings of the environmental rounds for the hospital.

An interview with Staff #7 was conducted on 02/05/2025 at 08:50 AM. The surveyor questioned how the environmental round findings were being addressed. Staff #7 reported the environmental rounds are discussed during the Monday/Wednesday safety huddles. Staff #7 reported that the Infection Control Preventionist would follow up on the findings to ensure they were being worked on.

Based on interview and record review, the Governing body failed to ensure their medical staff bylaws were implemented. The facility failed to ensure physicians and allied health staff had complete credentialing files prior to providing patient care in 7 of 10 files that were reviewed (Physician #26, Physician #27, Physician #28, Certified surgical first assist (CSFA) #39, Physician #40, Physician #41, and Certified registered nurse anesthetist (CRNA)
#42).


Findings include:


Review of the credential files revealed the following:

CSFA #39

Certified surgical first assist (CSFA) #39 had a "Texas Standardized Credentialing Application" that was signed on 08/15/2022. The delineation of privileges form did not list what privileges CSFA #39 was requesting. The approval letter was signed on 08/15/2022 by the credentialing committee, medical staff executive committee, chief executive officer and the board of directors. There were three boxes of choices on the form which read "Recommend approval, Recommend approval with provisions listed or do not recommend approval." All four members failed to check which category they were signing for.

There was another "Texas Standardized Credentialing Application" signed on 08/22/2024 by CSFA #39. The delineation of privileges form did not list what privileges CSFA #39 was requesting. There were also no physician approval signatures on the form. There was no appointment letter in the file.


Physician #40

Physician #40 had a "Texas Standardized Credentialing Application "on file, but it was dated. The delineation of privileges form was signed on 09/17/2024 and there was a request for Miscellaneous surgery core. There was no appointment letter in the file.


Physician #41

Physician #41 had a "Texas Standardized Credentialing Application" on file that was signed off on 08/20/2020 over 4 years ago. There was no delineation of privileges for the 08/20/2020 application.

A delineation of privileges was found which was dated 10/20/2022 with request for anesthesiology core, conscious sedation, colon and rectal surgery, colonoscopy, and other surgical procedures. The privileges were approved on 10/20/2022. There was no application or letter of appointment in the file. The physician's medical license on file expired on 08/31/2024.

CRNA #42

Certified registered nurse anesthetist (CRNA) #42 had a "Texas Standardized Credentialing Application "on file that was signed off on 11/27/2022. The delineation of privileges was approved on 12/29/2022. There was no letter of appointment in the file.

There was no new application and request for privileges for 2024 on file.


During an interview on 02/03/2025 after 1:32 p.m., Staff #4 revealed that she was over credentialing for the facility and that the staff were supposed to be recredentialed every two years. Staff #4 confirmed the missing and expired items in the files. Staff #4 said that CSFA #39 had completed the wrong credentialing application.

During an interview on 02/05/2025 after 12:00 p.m., Staff #4 revealed that a new credentialing file was not completed on Physician #40 because he had some health issues. Staff #4 said that Physician #40 had just came back to work in November 2024.

Review of the facility's "BYLAWS OF THE MEDICAL STAFF OF ALL CURRENT AND FUTURE HOSPITAL WITHIN THE MIDCOAST HEALTH SYSTEM" revealed the following:

"...3.3. Conditions and Duration of Appointment...
a. Initial appointments and reappointments to the Medical Staff shall be made by the Board. The Board shall act on appointments, reappointments only after there has been a recommendation from the Medical Staff as provided in these Bylaws...

...4.1 Application for Appointment ...
a. All applications for appointment to the Medical Staff shall be in writing, shall be signed by the applicant, and shall be submitted in a form prescribed by the Board after consultation with the Medical Staff. The Hospital shall use the Standardized Credentialing Form prescribed by the Texas Department of Insurance, with addenda as the Board may determine to be necessary ...4.4. Action by Board
The Board may accept or reject the recommendations of the Medical Staff or may refer the matter back for further consideration, stating the purpose for such referral and setting a reasonable time limit for making a subsequent recommendation. The Board shall take final action on the application within sixty (60) days of receiving the recommendation of the Medical Staff ...

...4.5 Notice of Final Decision ...
The CEO shall, within twenty (20) days of the Board's final decision, give notice of the final decision to the Medical Staff and the Applicant. A decision to appoint or reappoint shall include, if applicable: the staff category to which the Applicant is appointed; the clinical privileges granted; and any special conditions attached to appointment..."


...4.7 Reappointment ...
a. All Medical Staff reappointments will be for a period of two years ...

...Allied Health Professionals...
...10.4 Application procedure AHP Applicants shall fill out the appropriate AHP application and delineate all requested clinical privileges. Each AHP Applicant shall be evaluated by the Medical Staff which shall recommend the scope of practice and /or clinical privileges the AHP Applicant shall be permitted to exercise in the Hospital, either in general or on a per case basis. The recommendations of the Medical Staff shall be sent to the Board for final decision. The delineation of an AHP's scope of practice shall be based upon the AHP Applicant's academic and clinical training, experience, judgment and demonstrated competence to provide patient care under the supervision and responsibility of a licensed physician ..."


48749


Physician #26 (Radiologist)

A review of the credentialing file revealed:

*An insurance policy with an expiration date of 07/24/2024.

* A Drug Enforcement Administration (DEA) license (grants qualified medical providers the legal authority to prescribe controlled substances in the United States) with an expiration date of 01/31/2025.

There was no documentation found in the credentialing file to support that Physician #26 (Radiologist) had a current insurance policy or DEA licensure.


Physician #27 (Radiologist)

A review of the crdentialing file revealed:

* No documentation was found to support that the Physician had licensure.

* There was no documentation to support that the Physician had a background check

* There was no documentation found to support that the Physician had an application completed for the hospital.

There was no documentation found in the credentialing file to support that Physician #27 (Radiologist) had a current licensure, a background check or a current application to provide services for the hospital.


Physician #28 (Radiologist)

A review of the credentialing file revealed:

* A license with an expiration date of 05/31/2024.

* There was no documentation to support that the Physician had a background check.

* There was no documentation was found to support that the Physician had an application completed for the hospital.

* There was no documentation was found to support that the Physician had reference checks.

* There was no documentation was found to support that the Physician had a DEA license.

There was no documentation found in the credentialing file to support that Physician #28 (Radiologist) had a current licensure, a background check, reference check or a current application to provide services for the hospital.


A review of the "Telemedicine Physician Credentialing Agreement" dated 06/08/2022 revealed the following:

"4. Practice Credentialing and Licensure. Practice represents and warrants that
each telemedicine Physician (i) will be credentialed and privileged by Practice according to the Practice's credentialing and privileging processes and standards. (ii) shall render Contracted services within the scope of the Telemedicine Physician's respective Practice privileges and the privileges granted by the Client's medical staff; (iii) will hold a license issued or recognized in the state in which Client is located while providing the Contracted Services to the Client.

7. Credentialing-Related Materials. Practice shall provide electronic copies of
credentialing materials and other reasonable evidence of Practice's compliance with the Client Standards. However, Practice will not provide Client or its agent a copy of any information it receives from the National Practitioner Data Bank or Healthcare Integrity and Protection Data Bank."

An interview with Staff #4 was conducted on the afternoon of 02/03/2025. Staff #4 confirmed that there were missing credentialing documents. Staff #4 stated, "I have reached out to Radiology Partners and requested the missing documents."

Based on record review and staff interviews, the hospital's nursing leadership failed to ensure a registered nurse was present and immediately available to provide patient care and oversight of licensed vocational nurses in 1 (medical-surgical Unit) of 1 nursing unit in the hospital. Also, the hospital's nursing organization failed to follow the hospital policy, "Nurse Staffing Plan".

During a review of the hospital's nurse staffing assignments from November 2024 to January 2025, it was revealed that the hospital did not have a registered nurse on-site and immediately available to provide patient care and oversight to licensed vocational nurses on the medial-surgical unit.

According to the staffing schedule, assignments, and employee timesheets, there was no registered nurse (RN) scheduled and working in the medical-surgical unit on the following dates:

November 2024

On the night shift of 11/06/2024, Staff # 50 (LVN) was clocked in from 6:47 PM to 7:15 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 6.

On the night shift of 11/20/2024, Staff # 50 (LVN) was clocked in from 6:50 PM to 6:49 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 6.


December 2024

On the night shift of 12/04/2024, Staff # 50 (LVN) was clocked in from 6:49 PM to 7:02 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 8.

On the night shift of 12/15/2024, Staff # 50 (LVN) was clocked in from 6:47 PM to 7:52 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 4.

On the night shift of 12/18/2024, Staff # 50 (LVN) was clocked in from 6:45 PM to 6:56 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 4.


January 2025

On the night shift of 01/15/2024, Staff # 50 (LVN) was clocked in from 6:38 PM to 6:59 AM. According to employee timesheets, there was no other Registered Nurse clocked in and working in the Medical-Surgical Unit. The patient census was 5.

A review of the hospital's policy, "Nurse Staffing Plan" with an effective date of 05/2024 revealed the following:

"POLICY: In compliance with Legislative findings, Sec. 257.002, the Nursing Administration of Mid-Coast Medical Center Crockett, supported by the Board of Directors, shall adopt, implement, and enforce a nurse staffing place ensuring that an adequate number and skill mix of nurses are available to meet the level of patient care needed at all times.
PROCESS:
Nurse Staffing Committee
The hospital shall establish a nurse staffing committee as a standing committee (Sec. 257.003)
A. The Committee shall be composed of members who are representative of the types of nursing services provided at the hospital, to include Medical Surgical and Emergency Department.
B. The Director of Nurse (DON) will be a voting member of the Committee.
C. At least 60% of the Committee members will be Registered Nurses who:
1. Provide direct patient care during at least 50% of their work time.
2. Are selected by their peers who provide direct patient care at least 50% of their work time.
D. The committee shall meet at least quarterly.
E. Participation on the Committee by a hospital employee as a Committee member is part of the employee's work time, and the hospital shall compensate that member for that time accordingly. The hospital shall relieve a Committee member of other work duties during Committee meetings.
F. MCMCCr is committed to give significant consideration to the nurse staffing plan recommendations by the nurse staffing Committee and to that Committee's evaluation of any existing plan as well as to use the official nurse services staffing plan as a component in setting the nurse staffing budget.
G. The committee shall:
1. Develop and recommend to the hospital's Board of Directors a nurse staffing plan that meets the requirements of Section 257.003.
2. Review, assess, and respond to staffing concerns expressed to the Committee.
3. Identify the nurse-sensitive outcome measures the Committee will use to evaluate the effectiveness of the official nurse services staffing plan. Some example measures are:
I. Patient falls
II. Patient complains related to staffing
III. Medical errors
IV. Work-related injuries.
V. Vacancy and turnover rates
4. Evaluate, at least semiannually, the effectiveness of the official nurse services staffing plan and variations between the plan and the actual staffing, and
5. Submit to the hospital's Board of Directors, at least semiannually, a report on nurse staffing and patient care outcomes, including the Committee's evaluation of the effectiveness of the official nurse services staffing plan and aggregate variations between the staffing plan and actual staffing.
6. In evaluating the effectiveness of the official nurse services staffing plan, the Committee shall consider patient needs, nursing-sensitive quality indicators, nurse satisfaction measures collected by the hospital, and evidence-based nurse staffing standards.

NURSE STAFFING PLAN:
The Nurse Staffing Plan will reflect current standards established by private accreditation organizations, governmental entities, and other health professional organizations. It will follow approved staffing guidelines for patient care units that allow for adequate licensed personnel to provide nursing care to all patients which will be based on multiple nurse and patient considerations.

1. Patient characteristics and number of patient-admissions, discharges, and or transfers.
2. Intensity of care provided.
3. Scope of services provided.
4. Consideration of architecture, and geography of the unit, availability of technology.
5. Staff characteristics including tenure, preparation, experience, and competencies of staff.
6. Determined by the nursing assessment and in accordance with evidence-based safe nursing standards.
A. It will set a minimum staffing levels for acute patient care units that are:
a. Based on multiple nurse and patient considerations, and
b. Determined by the nursing assessment and in accordance with evidence=based safe nursing standards,
c. Include a method of adjusting the staffing plan for each patient care unit to provide staffing flexibility to meet patient needs, and.
d. Include a contingency plan when patient care needs unexpectedly exceed direct patient care staff resources.
e. A Nurse will be on-call, 24 hours/day, 7 days per week in order to ascertain that staffing is adequate and safe on a daily, shift by shift basis.

B. Nurses will be encourage to provide input related to nurse staffing concerns to the Committee.
C. Nurses who provide input to the Committee will be protected from retaliation.
a. The hospital will report annually to te department of State Health and Human Services on whether the hospital's governing body has adopted a nurse staffing policy as required by Section 257.003.
STANDARD STAFFING GUIDELINES GRID
Census: 1-3 patients Licensed Staff: 1 RN, 1 LVN, or 1 CNA
Census 4-8 patients Licensed Staff: 1 RN, 1 LVN or 1 CNA based on acuity.
Census: 9-12 patients Licensure Staff: 1 RN, 2 LVN, or 1 CNA"

According to the Texas Board of Nursing regarding the LVN Scope of Practice,

"The Texas Nursing Practice Act (NPA) and the Board's Rules and Regulations define the legal scope of practice for licensed vocational nurses (LVNs). The LVN scope of practice is a directed scope of practice and requires the appropriate supervision of a registered nurse, advanced practice registered nurse, physician assistant, physician, dentist, or podiatrist. The LVN, with a focus on patient safety, is required to function within the parameters of the legal scope of practice and in accordance with the federal, state, and local laws, rules, regulations, policies, procedures, and guidelines of the employing health care institution or practice setting. The LVN is responsible for providing safe, compassionate, and focused nursing care to assigned patients with predictable health care needs."

An interview was conducted with Staff # 3 (Director of Nursing) on 02/05/2025 at 1:00 PM which confirmed the medical-surgical unit was staffed multiple nights without a registered nurse supervising the licensed vocational nurse. Staff # 3 reported that new registered nurse positions would be posted for the medical-surgical unit.

Based on observation, record review, and staff interviews, the hospital's pharmacy staff failed to ensure 2 (Intravenous Potassium and Intravenous Succinylcholine) of 2 high-risk medications were properly labeled. Also, the hospital's pharmacy staff failed to follow the "High-Risk Medications" policy.

Findings include:

During a tour of the hospital's medication storage areas with Staff # 31 on 02/03/2025 at 1:30 PM the surveyor observed the following:

Medical Surgical Unit Medication Room

There were two 10 ml vials of Succinylcholine Chloride 200 mg/10 ml (milligrams per milliliter) stored in the door of the medication refrigerator. The vials were not labeled as "high risk" and there were no cautionary labels and storage bins for the high-risk medications to be stored in, as required by the hospital's policy, "High-Risk Medications". Succinylcholine Chloride is a neuromuscular blocking agent used to cause paralysis to the muscles needed in respiration. Paralysis occurs seconds after administration.


Emergency Room Department Medication Room

There were 8 vials of Succinylcholine Chloride 200 mg/10 ml stored in the medication refrigerator. The vials were not labeled as "high risk" and there were no cautionary labels and storage bins for the high-risk medications to be stored in, as required by the hospital's policy, "High-Risk Medications".

There were 6 bags of intravenous potassium chloride bags stored in the medication pyxis. The bags were not labeled as "high-risk" and there were no cautionary labels and storage bins for the high-risk medications to be stored in. Potassium Chloride is a concentrated electrolyte that can cause cardiac arrest if given improperly.


A review of the hospital's policy, "High-Risk Medications" with an effective date of 09/2023 revealed the following:

"Purpose: To promote patient safety through the safe use of high-risk medications.

Policy: 1. It is the policy of the hospital to ensure patient safety through the safe use of potentially toxic, high-risk, or problem-prone medications.

Procedure: A. 'High-Alert' medications refer to those medications that are potentially toxic, sound-alike or look-alike medications, or problem prone medications including concentrated electrolytes (Potassium Chloride, Potassium Phosphate, Sodium Chloride >0.9%). "High Alert" medications will be highlighted within the Pharmacy and ancillary areas by labeling them with cautionary labels. The labels will draw attention to the added precautions that should be taken to prevent inadvertent administration. Colored bins and physical separation of medications may be utilized as an additional precaution ....

C. Premixed IV solutions obtained from the manufacturer will be utilized whenever possible to reduce the need for the addition of concentrated electrolytes to an IV. Potassium Chloride premixed piggybacks will be utilized ...

D. The hospital has established a list of high-alert medications. This list has been designed with medications actually on the Formulary which have caused problems in the past or have been identified as having the potential to cause confusion or problems in medication orders. The Pharmacy and Therapeutics Committee reviews the list annually and reviews the list when needed. Special storage, handling, labeling, cautions, and safety strategies may be required for these medications.

E. All "High Risk" medications require extra attention from the pharmacy and nursing during routine workflow to minimize risk. Certain medications will require special precautions as specified in the attachment.

F. High Alert Drug List: ...

13. Neuromuscular Blocking Agents: Succinylcholine, Rocuronium ...

An interview was conducted with Staff # 10 and # 31 on 02/03/2025 at 4:30 PM. Staff # 10 and # 31 acknowledged the high-risk medications should be labeled and clearly distinguished from other medications.

Based on record review and staff interview, the hospital's nursing staff failed to identify and report a medication error that occurred on 1 (Patient # 23) of 1 patient medical records reviewed when a registered nurse administered intravenous medications through a central venous catheter that had not been verified through imaging.

Findings include:

A review of medical records for Patient # 23 was conducted on 02/04/2025 at 2:00 PM with Staff # 9.

Patient # 23

Patient # 23 was seen in the hospital's emergency room on 11/07/2024 with a diagnosis of urinary retention. Physician # 36 inserted a central venous catheter in the patient's left subclavian vein on 11/07/2024 at 8:15 PM. The left subclavian vein is a large, deep vein that allows blood to flow directly into the heart.

A review of medication administration for Patient # 23 revealed Staff # 44 (Registered Nurse) administered the following intravenous medications into the patient's central venous catheter:

1,000 milliliters of Normal Saline at 8:15 PM
5 milligrams of Reglan at 8:16 PM
30 milligrams of Toradol at 8:19 PM
4 milligrams of Zofran at 9:09 PM
1,000 milligrams of Normal Saline at 11:10 PM.

A review of Patient # 23's "XR CHEST 1 VIEW" taken on 11/07/2024 at 9:04 PM revealed,

"Findings: 1 view of the chest was obtained. No prior films are available at this time for comparison. There is a slight decreased lung volume. Mediastinum: The cardiomediastinal silhouette appears normal in size and shape. Lungs: There is an increase in reticular nodular densities throughout the lungs and lower lungs suggesting the possibility of interstitial lung disease such as UIP IPF versus viral pneumonia, sarcoidosis and/or other uncommon pneumonic process. Heart: The heart is in the upper normal size. Thoracic aorta: The thoracic aorta demonstrates minimal intimal calcification. Pulmonary vasculature: The pulmonary vasculature is normal in distribution. Pleura: The costophrenic angles demonstrate to be sharp. Osseous structures: The bony structures demonstrate to be within normal limits. Other: None.

Impression: Increased reticular nodular densities throughout the lungs and lower lungs suggesting the possibility of interstitial lung disease such as UIP IPF versus viral pneumonia, sarcoidosis and/or other uncommon pneumonic process.

Electronically signed by: Physician # 45 on 11/07/2024 at 9:31 PM"

There was no documentation to support that the central venous catheter placed in the patient's left subclavian vein was in the correct position and therefore safe to administer medications through.

Ensuring proper verification of the central line is imperative due to the risks and complications associated with central line placement such as arterial puncture (a hole in the artery), catheter malposition (incorrect positioning), pneumothorax (air entering the space between the lung and chest wall), and hematomas (localized collection of blood).

An interview was conducted with Staff # 23 (Emergency Room Director) on 02/04/2025 at 3:30 PM. Staff # 23 confirmed there were medications given through the patient's central line without verification of proper placement. Staff # 23 provided education to the nurses working in the emergency room on 02/04/2025 after confirmation of the event.

Based on record review and staff interview, the hospital's nursing leadership failed to ensure nursing care was provided in accordance with the patient's needs and the specialized qualifications and competence of the hospital staff when Licensed Vocational Nurses (LVNs) administered intravenous medications without prior training and competencies on 3 (Patient # 17, # 19, and # 27) of 3 patient medical records reviewed.

Findings include:

A review of patient medical records for Patients # 17 and # 19 was conducted with Staff # 9 on 02/04/2025 at 10:00 AM.

Patient # 17

Patient # 17 was admitted to the hospital on 08/01/2024 with a diagnosis of aspiration and bacterial pneumonia. The patient required long-term intravenous antibiotics through a PICC (peripheral inserted central catheter) line. A PICC line is a thin flexible intravenous catheter in the upper arm and threaded into a large vein near the heart. The patient had a right upper extremity PICC line.
A review of medication administration for Patient # 17 revealed Staff # 32 (LVN) administered an antibiotic, Vancomycin (1 gram/250 milliliters Normal Saline) through the PICC line on 08/05/2024 at 12:41 PM and on 08/06/2024 at 12:49 PM.

Patient # 19

Patient # 19 was admitted to the hospital on 01/08/2025 with a diagnosis of weakness and gait instability.
The patient required intravenous antibiotics through a peripheral intravenous (PIV) line.
A review of medication administration for Patient # 19 revealed Staff # 32 (LVN) administered an antibiotic, Daptomycin (500mg/50 milliliters Normal Saline) through the PIV line on 01/10/2025 at 12:59 PM.

A review of Staff # 32's personnel file revealed Staff # 32 did not have any documentation of PIV or PICC line training.

An interview conducted with Staff # 3 (Director of Nursing) on 02/04/2025 at 3:00 PM confirmed that the LVN should have proper training and competencies before accessing and administering through intravenous catheters, especially PICC lines. Staff # 3 stated, "No, LVNs should not be doing that without training."



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Patient # 27

Review of the Emergency department (ED) record on Patient #27 revealed he was a 58- year- old male who presented on 01/31/2025 at 3:42 a.m. Patient #27 was triaged and classified as having an emergency severity index (ESI) of 3 (meaning urgent). Patent #27's chief complaint was shortness of breath and chronic obstructive pulmonary disease (COPD) issues.

According to nurses notes the following was documented:

At 0350 a.m., LVN #37 documented that an 18-gauge intravenous (IV) was established to the right antecubital (ac) with one attempt and using aseptic technique. Blood was drawn from the site then flushed with normal saline (ns). Site secured with Tegaderm and tape.

At 3:58 a.m., LVN #37 documented that the steroid medication Decadron 10 milligrams was given via intravenous push.

Review of a facility's form named "YEARLY CLINICAL COMPENTENCIES FOR RN OR LVN EMERGENCY DEPARTMENT" dated 06/18/2024 revealed LVN #37 did not have any documentation of IV training.

During an interview on 02/04/2025 after 2:00 p.m., Staff #5 (ED Director) confirmed that LVN #37 started the IV and administered the medication via IV push. Staff # 5 (ED Director) stated that the facility did not have IV training for the LVNs and that LVN #37 did not IV training on file.


According to the "Texas Board of Nursing (2022). Position statement 15.27, The Licensed Vocational Nurse Scope of Practice, provides additional clarification of the Standards of Nursing Practice Rule as it applies to LVN scope of practice. Instruction and skill evaluation relating to LVNs performing insertion of peripheral IV catheters and/or administering IV fluids and medications as prescribed by an authorized practitioner may allow an LVN to expand his/her scope of practice to include IV therapy.

It is the opinion of the Board that the LVN shall not engage in IV therapy related to either peripheral or central venous catheters, including venipuncture, administration of IV fluids, and/or administration of IV push medications, until successful completion of a validation course that instructs the LVN in the knowledge and skills applicable to the LVN's IV therapy practice. The BON does not define or set qualifications for an "IV Validation Course" or for "LVN IV certification." The LVN who chooses to engage in IV therapy must first have been instructed in the principles of IV therapy congruent with prevailing nursing practice standards."

Based on record review and interview, the hospital failed to ensure that the person designated as infection control nurse (Staff #29 and Staff #46) was qualified either through education, training, experience, and/or certification.

Findings included:

Staff #46 was hired into the Infection Control Preventionist position on September 27, 2024. There was no documentation provided that Staff #46 had education, received training, and/or a certification in infection control. The hospital's leadership reported to the Surveyor that January 31, 2025 was the last day that Staff #46 held the Infection Control Preventionist position.

Staff #29 was hired into the Infection Preventionist position January 22, 2025. A review of the personnel file revealed there was no documentation to support that Staff # 29 had any education, training, experience, and/or certification in infection control.

A review of the job description titled, "Infection Preventionist" revealed the following requirements:

"Job Title: Infection Preventionist

Job Summary:

The Infection Preventionist (IP) is responsible for identifying, investigating, monitoring, and
reporting healthcare-associated infections. The IP collaborates with teams and individuals to
create infection prevention strategies, provide feedback, and sustain infection prevention strategies.

Qualified Candidate:

Educational and Certification Requirements
* Licensed or degreed Nurse, public health, epidemiology, clinical laboratory science,
medical technology, or related field.
* Certification in Infection Control and Epidemiology (CIC, IPC, a -lPC, etc.); preferred.

Reports to: Infection Preventionist Director

Performance Standards (Job Expectations):

1. Professional Accountability
* Pursue professional growth and development of required knowledge and skills.
* Maintain certification and licensure requirements.
* Establish at least 1 professional goal per year.
* Advocate for patient safety, health worker safety, and safe practices.
* Participate in an infection prevention and control professional
organization/association (i.e.: APIC)."

A review of the hospital's "Infection Prevention and Control Plan" dated 01/2025 revealed the following:

"2. Primary responsibility for the activities of the Infection Prevention and Control Program belongs to the Infection Preventionist. The Infection Preventionist position is within the Department of Nursing. Advanced training in healthcare infection prevention and control is required, including knowledge of prevention, surveillance, and epidemiologic methods. At a minimum, the Infection Preventionist has completed training in Infection Prevention and Control."


An interview with Staff #29 was conducted on 02/03/2025 at 4:29 PM. Staff #29 stated, "Today is my first day at the hospital. I have received a copy of my job description, but I have not signed one yet." When the surveyor questioned about infection control background, Staff #29 stated, "I have no infection control background. I've done some case management and worked at a skilled nursing facility." The surveyor asked if Staff #29 would be working with another infection control preventionist. Staff #29 stated, "I will be going to El Campo for a week for training and then it will be just me for both facilities."

An interview with Staff # 7 on 02/04/2025 at 11:45 AM. Staff # 7 reported the new Infection Preventionist would go for training at El Campo for a week. The surveyor questioned who would assist the new Infection Preventionist at the hospital. Staff #7 stated, "I will do like I did with the previous nurse. I'll oversee her training. or education in her file We will have her enrolled in the Association for Professionals in Infection Control and Epidemiology (APIC) today." Staff #7 had no training or education in her file for infection control.

Based on observation and interview, the hospital's infection prevention and control program failed to maintain a clean and sanitary environment to avoid sources and transmission of infection in 6 (Emergency Department, Radiology Department, Medical-Surgical Floor, Pharmacy, Materials Management, and Dietary Department) of 6 areas observed. The hospital failed to follow its "Sanitary Environment" Policy.

These findings had the likelihood to cause harm by increasing the risk of infection to all patients and staff at the facility.

A review of the hospital's "Sanitary Environment" policy dated 04/2024 revealed the following:

"Purpose: To ensure Mid Coast Health System provides a sanitary environment in all facilities.
Policy:

A. Mid Coast Health System shall provide and maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases.

B. All areas within the facilities must be clean and sanitary.

C. Infection prevention and control policies and procedures for maintenance of a sanitary physical environment are based on national guidelines and address the following:

1. Ventilation and water quality control issues, including measures taken to maintain a safe environment during internal and external construction/renovation.
2. Maintaining safe air handling systems in areas of special ventilation, such as operating rooms, intensive care rooms, and negative air pressure rooms.
3. Techniques for food sanitation
4. Techniques for cleaning and disinfecting environmental surfaces, carpeting, and furniture.
5. Techniques for textiles reprocessing storage and distribution.
6. Techniques for disposal of regulated and non-regulated waste.
7. Techniques for pest control.

D. The Infection Control Nurse and Safety/Health Risk Committee shall work with at least the following departments to ensure sanitary conditions are maintained throughout the system:

1. Environmental Services
2. Engineering Department (Plant Operations)
3. Materials Management
4. Dietary Department
5. and other applicable departments to ensure a sanitary environment."


During a tour of the facility on 02/04/2025 at 10:45 AM with Staff #7, the surveyor observed the following infection control issues:

Emergency Department:

*There was an accumulation of dust on the air vents in the Emergency Department (ED) waiting area.

Exam Room #1

* There was an accumulation of dust on the ceiling air vent and accumulation of dust and rust on the wall air vent.

* There were chipped and missing pieces of Formica on the cabinet doors. The areas were covered with black electrical tape. This had the likelihood of preventing thorough disinfection and cleaning of the surface.

Exam Room #2

* There was an unknown dried brown substance on a ceiling tile.

* Observed dust and debris on the cabinet shelf.

Soiled Utility Room

* There was rust on the drain cover of the sink.

* There was a build-up of dust on the ceiling air vent.

* There was rust on the rim of the Hopper (a sink used for disposal of liquid clinical waste).

* There was a build-up of debris on the rubber tips of the bedside commodes. The bolts securing the legs were rusted. This had the likelihood of preventing thorough disinfection and cleaning of the surface.

Clean Utility Room

*There was an accumulation of dust and debris on the floor and the shelves were cluttered with dust, supplies, and equipment.

Back Hallway

* There was an accumulation of dust on the Panda Warmer (a compact heater used to keep newborns warm while they are being assessed by medical staff).

* There was a build-up of dust on top of the pediatric cart.

* There were 2 bottles of Ensure with an expiration date of 12/2024 inside the drawer of the pediatric cart.

Nurses Station

* There was an accumulation of an unknown brown substance on the inside and the top of the Smart Sink (a secure waste disposal for controlled substances).

* There was an accumulation of dust and rust on the base of an intravenous (IV) pole.

* There was an accumulation of dust and debris on the base of the electrocardiogram (EKG) machine (a non-evasive medical test that records the electrical activity of the heart).

Medication Preparation Area

* There was an unknown sticky black substance on the counter and there was an accumulation of dust and cluttered supplies in the cabinet under the counter.

Medication Room

* An accumulation of dust and debris on the bottom of the Pyxis (an automated medication storage and dispensing system) and accumulation of dust and debris on the outside of the door for the Pyxis.

* There was an unknown dried brown substance on top of the refrigerator.

* There was an accumulation of dust and debris on the bottom of the patient nutrition refrigerator.

* There was an accumulation of dust and clutter on top of the patient's nutrition refrigerator.

* There was an unknown dried white substance on the sink and an accumulation of an unknown green substance around the sink faucet.

* There was an unknown dried white substance on the drain pan for the ice maker. There was an unknown brown liquid sitting in the drain pan.

Radiology Department

*There were cracked and broken floor tiles in the main hallway. This had the likelihood of preventing thorough disinfection, cleaning, and sealing of the floor surface.

Computed Tomography Scan (CT) Room

* There was an unknown dried, gray-colored substance on the floor tiles and an accumulation of dust and debris on the floor behind the CT scan machine.

* There was peeling and chipping in the paint on the wall behind the CT scan machine.

* There was a build-up of dust on top of the emergency cart.

* There was a nasal cannula (a device that gives you oxygen through your nose) not in a sterile or original packaging, hanging from the oxygen regulator on the wall.

* There were external ventilation ducts taped to the ceiling tiles and through the ceiling tiles. The tiles were lifted and broken around the ducts. This could allow for dust and insects to enter the CT room.

Medical-Surgical Floor

Medication Room

* There was a build-up of dust and debris on 2 of 2 pill crushers.

* There was chipped and peeling paint on the countertops. This had the likelihood of preventing thorough disinfection and cleaning of the surface.

* There was an accumulation of dust and debris on the shelves in the cabinet.

* There was an unknown dried white substance on the outside of the door to the Pyxis. There was an accumulation of dust and debris on the bottom of the Pyxis.

* There were 23 blood tubes with an expiration date of 01/31/2025 in the cabinet.

* There was a bin on the counter full of lancets (a small device used to obtain blood for testing). The lancets were not in their original packaging. The surveyor was unable to determine an expiration date.

* There was an expired Colorimetric Meter (a device that helps confirm endotracheal tube placement).

* There was an open package of electrodes (small adhesive disc placed on the skin to detect or deliver electrical signals) with an expiration date of 09/13/2024 written on the packaging.

Clean Utility

* There was an accumulation of dust, debris, and dead insects in the bins that store intravenous fluids. There was an unknown brown dried liquid on the bottom of a bin.

* There was an accumulation of dust, debris, and dead insects in the bins that store sterile supplies.

* There was cracking and peeling of the paint and drywall on the ceiling.

* There were dead bugs in the light covers.

Soiled Utility

* There was a hole in the ceiling tile. This could allow for dust and insects to enter the room.

* There was an accumulation of dust, debris, and bugs on the floor in the corners.

* There was dust build-up in the air vent.

* There was a build-up of dust and debris inside a tote sitting on the counter.

* There was an unknown dried brown substance on the floor.

Pharmacy

* During the tour of the Pharmacy, Staff #31 was observed not wearing shoes while in the Pharmacy.

* There was no soap dispenser at the sink.

* There was an accumulation of dust, debris, and dead bugs in the medication bins.

Materials Management

* There was an unknown dried brown stain on 3 ceiling tiles.

* There were cardboard boxes stored on the top shelf, above sterile supplies.

"External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust." (AAM1 ST46-Section 5.2 Receiving items).

*There were boxes of sterile supplies stored on shelving in an anterior room that was not monitored for temperature and humidity.

An interview was conducted with Staff #7 on the afternoon of 02/04/2025. Staff #7 confirmed the infection control issues found during the tour.



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Findings include:

An observation tour of the kitchen was conducted on 2/4/2025 at 10:00 AM with Dietary Staff #13. The following infection control concerns were observed.

Upon entrance to the kitchen, it was noted that the baseboards were coated with an unknown brown/black substance all along the perimeter of the kitchen floor. Multiple tiles were missing and/or chipped in the kitchen flooring.

There were bug lamps on the wall outside of the manager's office. Stationed under the bug lamps were carts with clean dishes ready for use. The carts being parked under the bug lamp have the likelihood to have dead bugs falling on the clean dishes.

Along the wall, there were dish carts with baking/serving pans ready for use that had an unknown baked-on brown/black substance. The wheels and locks of the carts were coated with an unknown black substance. Next to these carts were sinks for hand-washing dishes.

Dietary staff #13 was asked how she ensured enough sanitizer was in the water. Staff #13 reported that she uses Hydrion QT-44 strips. These strips verify the strength of sanitizer solutions, ensure sanitizers are at the proper concentration, detect when solutions need to be replaced and help avoid using too much sanitizer. Both sets of stripes expired: on July 30, 2020, and March 15, 2022.

Next to the sink was another cart with plastic bins. These bins were used to store bags of flour. Dust and debris were in the bottom of the plastic bins, where open bags of flour were stored.

Across from the sinks were the ovens. The inside of the oven and the oven racks had an unknown black baked-on substance.

The toasters had copious amounts of an unknown dried crusted substance in the cleaning tray and on the walls of the toaster.

Next to the oven was the fryer. Dietary Staff #13 was asked how old was the oil. Dietary Staff #13 stated, "It wasn't very old and that they don't fry very much anyway." There was no way to determine how old the oil was. The light above the fryer was coated with an unknown thick yellow substance. In the cabinet under the fryer was the drain for removal of the oil. The bottom of the cabinet was covered in an unknown yellow thick liquid.

The walk-in freezer had rust, dust, and debris on the floor. The walk-in refrigerator had rust, dust, and debris on the floor. There were multiple shelves for food storage that were rusted. Rusted shelves cannot be sanitized.

Behind the walk-in freezer and refrigerator were piles of dead insects.

Inside the food storage area were wooden shelves with chipped paint. This results in exposure of the wood underneath the chipped paint. Porous surfaces cannot be sanitized. There were also multiple Orkin (a container that holds bait to attract and trap pests) boxes with dead insects inside the boxes.

Three cans of Campbell's cream of chicken soup were dented and, on the shelf, ready for use in food preparation. Dented cans can cause Botulism.

Full water bottles used for a water cooler were left sitting on the floor outside of the dishwashing room. Water bottles cannot be stored on the floor.

An interview was conducted with Dietary Staff #13 on 2/4/2025 after 10:00 AM. Dietary Staff #13 was asked if she was aware and had reported the issues found during the observation tour of the Kitchen. Dietary Staff #13 acknowledged the infection control concerns found during the observation tour. Staff #13 reported that she was aware of some of the issues and the issues had been reported to the Director.

A review of the document title "Sanitation Audit Reports" recorded by Dietician #49 did not reveal any infection control issue noted during the observation tour.

The Surveyor requested a policy on infection control for the dietary department multiple times, but no policy was provided for review.

Based on observation, record review, and staff interview, the hospital's infection control program failed to ensure the Infection Control Preventionist monitored the tracking and trending of the hospital's culture reports. The hospital failed to follow its "Follow-Up on Positive Culture Reports" policy.


Findings include:

A review of the hospital's "Lab-Follow-Up" forms revealed that 16 of 30 culture (the process of growing microorganisms in a laboratory to identify them and treat them) results reviewed were not completed by the hospital's Infection Control Preventionist. Also, 21 of 30 culture reports reviewed were not signed off by the Hospitalist per the hospital's "Follow-Up on Positive Reports" policy. Further review of the hospital's tracking form does not indicate which hospital staff member was uploading and monitoring tracking and trending of the cultures in the hospital's database.

A review of the facility's "Follow-Up on Positive Reports" policy dated 02/24 revealed the following:

"PURPOSE:

To follow-up on Lab culture results not available during the ER visit or after discharge of the Inpatient or Observation patient.

POLICY:

For Positive Culture Reports:

1. All positive Culture reports will be forwarded to the Infection Control nurse.

2. The Infection Control nurse will obtain the appropriate information from the EMR.

3. If the nurse finds that the patient is still in-house, the culture report will be given to the Hospitalist or Med-Surg charge nurse.

4. If the nurse finds that the patient was transferred to another facility, the nurse will contact the receiving facility and fax the report.

5. For patients no longer in the facility, the Infection Control nurse will verify that the patient was prescribed an antibiotic that is sensitive to the cultured bacteria. If the antibiotic was listed as sensitive to the bacteria on the culture sensitivity report then no follow-up is required. The Hospitalist will sign off that no action is needed.

6. If the patient was not prescribed an antibiotic or prescribed an antibiotic that is resistant to the bacteria on the culture sensitivity report, then the Infection Control nurse will forward the chart and culture report to the Hospitalist.

7. The Hospitalist will document on the Lab Follow-up Form what needs to be communicated to the patient and write/escribe a prescription with the appropriate antibiotic for the patient.

8. The Hospitalist will return the chart and Lab Follow-up Form to the Infection Control nurse who will contact the patient and inform them of the information the Hospitalist documented on the Lab Follow-up Form. The Infection Control nurse will call in the prescription to the patient's
pharmacy of choice if not escribed.

9. When completed, the Lab Follow-Up form will be turned in to Medical Records who will scan
the form into the patient's EMR. The Lab Follow-Up form will then be forwarded to the Quality
Director.

10. After three attempts, if the patient cannot be contacted by telephone, the Lab Follow-up form
will be forwarded to the Quality Director who will send a certified letter to the patient with the
follow-up information.

11. The Lab Follow-up Form, and as indicated, a copy of the certified letter will be attached to the patient's chart and scanned into the EMR."

An interview with Staff #9 on 02/05/2025 at 9:40 AM. Staff #9 reported the culture reports came to me. I would review the charts for additional information and then give the forms to the Hospitalist for disposition. Once the Hospitalist signed them, I would give them to the Infection Control Preventionist. The surveyor asked Staff #9 if she was trained and had education or certification in Infection Control. Staff #9 stated, "No, I do not have any infection control training or certifications." Staff #9 was asked if the Infection Control Preventionist was following up on the cultures or adding them to the database. Staff #9 stated, "I don't know if she is following up on the reports or if she is adding them to the share drive. I was asked to take this over for her."

An interview was conducted with Staff #3, Staff #7, and Staff #9 on 02/05/2025 at 10:50 AM. Staff #3 reported the current Infection Control Preventionist's last day in the position was on 01/31/2025 and Staff #9 was completing the culture reports. Staff #9 reported all the culture reports went to station #2. Staff #9 reported picking up the cultures, reviewing charts, and then sending them to the Hospitalist for review. Staff #9 reported that the forms were received back from the Hospitalist and sent to the Infection Control Preventionist. Staff #9 reported that the reports have not been reviewed for approximately the last week. The surveyor asked if there were any Performance Improvement (PI) indicators being monitored or tracked. Staff #7 reported not at this time.

Based on chart review and interview, the Infection Control Preventionist failed to communicate and collaborate actively with the hospital's QAPI (Quality Assurance and Performance Improvement) Program. The hospital failed to follow its "Infection Prevention and Control Plan."


There was no documentation found or provided to ensure communication and collaboration between the Infection Preventionist and QAPI. A review of the Quality Council Meeting minutes dated 12/11/2024 and 01/17/2025 revealed that Infection Control data was reported by Staff #3.

A review of the list of attending participants revealed that Staff #46 did not attend the meeting on 12/11/2024 and 01/17/2025.

A review of the facility's "Infection Prevention and Control Plan" policy dated 01/2025 revealed the following:

"MONITORING:

1. Monitoring the results of the Infection Prevention and Control Program allows the hospital to determine if the processes in place are effective or should be revised.

2. Monitoring is achieved through:

1. Committee interaction, especially the Safety/Risk/Health Subcommittee/Quality Council and Medical Staff Committee.

2. Primary responsibility for the activities of the Infection Prevention and Control Program belongs to the Infection Preventionist. The Infection Preventionist position is within the Department of Nursing. Advanced training in healthcare infection prevention and control is required, including knowledge of prevention, surveillance, and epidemiologic methods. At a minimum, the Infection Preventionist has completed training in Infection Prevention and Control.

3. The Infection Preventionist maintains a close working relationship with Performance Improvement/Quality Assurance for the quality assessment and improvement of patient process/function and will interface through all departments to achieve the goals and objectives of the Infection Prevention and Control Program.

4. The Infection Preventionist will serve on the Safety/Risk/Health Subcommittee/Quality Council and any other committees and teams as indicated.

5. The Infection Preventionist is responsible for:
a. Performance Improvement Indicators, Quality Control reports, Statistical data, Disease reporting.
b. Policy and procedure reviews.
c. Surveys and inspections."


An interview with Staff #7 was conducted on 02/05/2025 at 08:50 AM. Staff #7 reported that the Infection Control and Quality meetings are combined in the monthly Quality Council meetings with all corporate facilities. Staff #7 reported that Staff #46 did not attend the Quality Council meetings on 12//11/2024 and 01/17/2025. Staff #7 stated, "An invite was sent for the meetings in December and January." Staff #7 reported that Staff #46 last day in the Infection Control Preventionist position was 01/31/2025 and a new employee has been selected for the position.


Staff #3 (Director of Nursing) was interviewed on 02/05/2025 at 09:15 AM. Staff #3 reported that Staff #46 has just been completing Environmental Rounds and Hand Hygiene Rounds for the facility. Staff #3 stated, "The reports have been uploaded on the share drive and I present the information from the report during the meetings."

Based on medical record review, policy review, and staff interviews, the hospital's staff failed to ensure the physician's order for blood products was complete with the blood component type, rate, and/or duration in 2 (Patient # 2, and # 3) of 2 patient medical records reviewed.

Findings include:

A review of medical records with Staff # 9 on 02/04/2025 at 2:00 PM revealed patients were receiving blood products that were administered based on an incomplete physician's order.

Patient # 2

A review of medical records for Patient # 2 revealed the patient was admitted to the hospital on 02/08/2024 with a diagnosis of generalized weakness, congestive heart failure, and valvular heart disease. The patient had anemia (low blood count) requiring a blood transfusion.

Physician # 47 ordered the following on 03/03/2024 at 7:19 PM, "Transfuse 2 units of PRBCs. Give Tylenol 325 mg PO prior to transfusion. Give Lasix 20 mg IVP after the first unit complete."

The order was incomplete and did not contain a rate and/or duration for which the blood should be transfused. Patients with significant cardiac history and a diagnosis of congestive heart failure cannot tolerate large volumes of fluid and transfusion rates are highly important in these patients.


Patient # 3
A review of medical records for Patient # 3 revealed the patient was admitted to the hospital on 12/15/2024 with a diagnosis of syncope (passing out), and vomiting. The patient had a low blood level requiring a blood transfusion.
Physician # 48 ordered the following on 12/16/2024 at 7:05 PM, "Obtain Blood Transfusion Consent, Transfuse 2 units PRBC".

The order was incomplete and did not contain a rate and/or duration for which the blood should be transfused.


A review of the hospital's policy, "Administration of Blood Products" with an effective date of 12/2024 revealed,

"Purpose: To provide a policy that guides Nursing Service in the safe administration of blood and blood components to reduce the possibility of transfusion-related error.
Policy: 1. To follow the American Association of Blood Bank (AABB) and Federal Drug Administration (FDA) guidelines when administering blood products. Mid Coast Medical Center Crockett attempts to keep 2 units of O-Negative (occasionally supplemented by O-positive) Packed Red Blood Cells (PRBC's) for emergency purposes. All blood bank testing is performed at Gulf Coast Regional Blood Center (GCRBC) ....
Rate of Transfusion:
A. In order to avoid circulatory overload reaction, patients with compromised cardiac or pulmonary status and/or chronic anemia with expanded plasma volume should receive blood/blood products at a rate not to exceed 1 ml/kg of body weight/hour ....
E. The appropriate rate depends upon the patient's ability to tolerate increased intravascular volume. This can be generalized to a rate of 4 to 10 ml/minute or as tolerated ..."


An interview was conducted with Staff # 3 (Director of Nursing) on 02/05/2025 at 10:45 AM. Staff # 3 confirmed the physician's orders for blood products were incomplete.

Based on record review and staff interviews, the hospital's nursing leadership failed to ensure a registered nurse was present and immediately available to provide patient care and oversight of licensed vocational nurses in 1 (medical-surgical Unit) of 1 nursing unit in the hospital. Also, the hospital's nursing organization failed to follow the hospital policy, "Nurse Staffing Plan".


Cross Refer to Tag C 0974

Based on observation, document review, and interview, the hospital failed to:

A. ensure the temperature and humidity was monitored daily in 6 (Operating Room #1, Operating Room #2, Sterile supply room, Post Anesthesia Care Unit/Day Surgery Unit storage, overflow supply/equipment storage, and Anesthesia workroom) of 6 rooms observed.

B. ensure that a dedicated hand washing sink was available in 2 (Endoscope decontamination and Surgical decontamination) of 2 decontamination rooms observed.

C. ensure a properly executed informed consent was complete before surgical procedure in 1 (patient #11) of 1 patient reviewed.

D. ensure chemical test strips were used for endoscope reprocessing according to the manufacturer's Instructions for Use (IFU).

E. follow hospital policies titled, "AORN Standards of Practice", "Temperature and Humidity Monitoring", "Informed Consent Policy and Procedure", and "Flexible Endoscopy Processing ".


Findings include:

A.

An observation tour was conducted on 2/3/2025 at 10:00 AM with Operating Room (OR) Staff #19. It was noted that during the tour of the Post Anesthesia Care Unit (PACU)/Day Surgery Unit (DSU) storage, overflow supply/equipment storage, and Anesthesia workroom sterile supplies were stored in each of these areas. There was no temperature or humidity control devices to monitor these rooms.

A review of the temperature and humidity logs for OR #1, OR #2, and sterile supply revealed the temperature and humidity was not documented on the weekends or the holidays.

Staff #19 was asked how staff ensured the temperature and humidity remained within the normal range in PACU/DSU storage, overflow supply/equipment storage, and Anesthesia workroom. Staff #19 stated, "I didn't realize that the temperature and humidity controls were needed in any of these rooms." Staff #19 was asked how she ensured the temperature and humidity remained within the normal range in OR #1, OR #2, and the sterile supply room during weekends and holidays. Staff #19 confirmed she could not ensure these areas were in normal range over weekends and holidays.


According to the standards of the Association of Peri-Operative Registered Nurses (AORN) eGuidelines+ 2012-2025 Perioperative Practice: Design and Maintenance:

" ...Table 5; Design Parameters for Heating, Ventilation, and Air Conditioning

OR temperature must be maintained between 68-75 degrees Fahrenheit (F).
OR relative humidity must be maintained between 20%-60%.

Gastrointestinal Endoscopy room temperature must be maintained between 68-73 degrees F.
Gastrointestinal Endoscopy relative humidity must be maintained between 20%-60%.

Sterile Processing Clean Assembly Room temperature must be maintained between 68-73 degrees F.
Sterile Processing Clean Assembly Room's relative humidity maximum is 60%.

Sterile Storage Rooms' maximum temperature is 75 degrees F.
Sterile Storage Rooms' maximum humidity is 60%..."


A review of the hospital policy titled, "AORN Standards of Practice" effective date of December 15, 2022, and the next review date of December 15, 2023 revealed the following:

"Purpose:
The Operating Room will follow the Standards of Practice as set forth by AORN (Association of Operating Room Nurses). These Standards are the core by which this OR is organized and administered ..."


A review of the hospital policy titled, "Temperature and Humidity Monitoring" Effective date of December 15, 2022, the next review date of 11/2024 revealed the following:

"Purpose:
Standards by the Association of Perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice are set for the Perioperative environment which include those for temperature and Humidity control ...

Policy:
The Operating Room (OR) suites ... should be maintained between 68-75 degrees Fahrenheit ... Humidity lowers the amount of static electricity on the surfaces and in the air, and should be kept approximately 20% to 60%...
...Sterile storage should be maintained at 72-78 degrees Fahrenheit ... with a humidity level no greater than 60%.


In an interview on 2/4/2025 after 11:00 AM, Staff #19 was asked if this policy was still in effect. Staff #19 confirmed the policy was still in use and they are in the process of getting all policies updated. Staff #19 confirmed the policy was past the review date. Also, Staff #19 confirmed that the facility policy was not followed and did not include the proper parameters for sterile storage according to the AORN Guidelines 2012-2025.



B.

During the observation tour on 2/3/2025 at 10:00 AM with staff #19, it was revealed that there was not a designated handwashing sink for staff in the Endoscopic decontamination room (a separate room where endoscopes are cleaned and disinfected) and the Surgical decontamination room (a room where contaminated surgical instruments are cleaned and disinfected).

An interview was conducted with staff #19 on 2/3/2025 after 10:00 AM. Staff #19 was asked if she knew there needed to be a designated hand-washing sink for staff to use after cleaning scopes or instruments. Staff #19 stated, "No one had ever told her that they needed a sink just for handwashing in these rooms".

According to the standards of the Association of Peri-Operative Registered Nurses (AORN) eGuidelines+ 2012-2025 Perioperative Practice: Flexible Endoscopes

"3.5
Endoscope Processing Areas, including satellite areas, should have ...
A minimum of two decontamination sinks of sink basins, preferably three, that are deep and wide enough to allow complete submersion of the endoscope without tight coiling;
A separate sink designated for hand hygiene; ..."


According to the standards of the Association of Peri-Operative Registered Nurses (AORN) eGuidelines+ 2012-2025 Perioperative Practice: Instrument Cleaning
"2.5
The decontamination area must contain.
an eyewash station and
a dedicated hand hygiene sink ...."


A review of the hospital policy titled "AORN Standards of Practice" Effective date of December 15, 2022, and the next review date of December 15, 2023 revealed the following:

" ...Purpose:
The Operating Room will follow the Standards of Practice as set forth by AORN (Association of Operating Room Nurses). These Standards are the core by which this OR is organized and administered ..."


In an interview on 2/4/2025 after 11:00 AM, Staff #19 was asked if this policy was still in effect. Staff #19 confirmed the policy was still in use and they are in the process of getting all policies updated. Staff #19 confirmed the policy was past the review date. Also, Staff #19 confirmed that the hospital policy was not followed.



C.

An observation tour was conducted on 2/4/2025 after 8:00 AM. This observation consisted of following a patient throughout the process of checking in for a surgical procedure through discharge from surgical services.

Patient #11 was brought back to surgical services by Registered Nurse (RN) #15. During the preparation of Patient #11, RN #15 asked Patient #11 if he understood what Physician #41 was doing for Patient #11. Patient #11 reported he understood the procedure being performed on him today. RN #15 asked Patient #11 if he consented to the use of blood. Patient #11 asked why would he need blood. RN #15 explained in the event of an emergency that Patient #11 needed blood to save his life would he consent to getting blood? Patient #15 agreed to the blood consent and placed his initials on the consent form.

An interview was conducted on 2/04/2025 after 8:30 AM with Patient #15. Patient #15 was asked if anyone had explained the risks and benefits of blood transfusion to him before he signed the consent for treatment. Patient #15 stated, "I don't remember anyone explaining why he would need blood, but I have had a stroke so the doctor might have explained it, I just don't remember".

A review of Physician #41's history and physical revealed that the risks and benefits of a colonoscopy had been explained. However, there was no documentation that the risks and benefits of blood transfusion had been discussed with Patient #15.

An interview was conducted with Physician #41 on 2/04/2025 after 10:00 AM. Physician #41 was asked if he explained the risks and benefits of a blood transfusion with his patient when he explained the risks and benefits of the surgical procedure. Physician #41 stated, "I don't, I let the nurses explain the blood risks and benefits to the patient before their procedure". Physician #41 was asked if he understood that a blood transfusion was considered a treatment and that explaining treatment to a patient was outside the RN's scope of practice. Physician #41 stated, "I did not realize that".


A review of the hospital policy titled, "Informed Consent Policy and Procedure" Effective date 11/2023 and the next review date of 11/2024 revealed the following:

"1. POLICY Statement

1. Informed Consent is required for complex procedures. The medical staff determines which procedures are complex by considering whether the procedure involves material risks which are not commonly understood. The patient's physician is responsible for providing the information the patient needs in order to make an informed decision and for obtaining the patient's informed consent or informed refusal for the recommended treatment or procedure ...."


An interview on 2/4/2025 after 11:00 AM, Staff #19 was asked if this policy was still in effect. Staff #19 confirmed the policy was still in use and leadership are in the process of getting all policies updated. Staff #19 confirmed the policy was past the review date. Also, Staff #19 confirmed that the hospital policy was not followed.


D.

An observation tour was conducted on 2/4/2025 after 8:30 AM in the Endoscopy decontamination room. Staff #19 was observed washing the scope and preparing the scope to be processed for high-level disinfection (HLD). Staff #19 placed the flexible endoscope in the HLD processor and started the processor.

An interview was conducted on 2/04/2025 after 8:30 AM with Staff #19. Staff #19 was asked if she had already done an ACECIDE strip test (the test strips are indicators that show that the chemical high-level disinfected is within normal limits to accurately disinfect the endoscope) and if she would show me that the HLD was within normal limits to process the scope. Staff #19 stated, "We never use the test strips to check the HLD. It is only good for 5 days and we only use it a couple of times". Staff #19 was asked to show the surveyor the IFU for the ACECIDE-C HLD stating that they do not need to test the HLD before each use.

Staff #19 produced the IFU for the ACECIDE-C High-Level Disinfectant & Sterilant. The IFU stated:
"DIRECTIONS FOR USE ...

Monitor the contact or immersion time, temperature, and MRC of PAA of the ACECIDE-C High-Level Disinfectant and Sterilant utilizing the AER process control or a manual timing device, thermometer, and ACECIDE strips. Maintain the solution at 20° (68°F) over the reuse period. Monitor the PAA concentration prior to each reprocessing using ACECIDE test strip ..."


Staff #19 acknowledged that ACECIDE-C HLD was not tested and that surgical staff should test the ACECIDE-C HLD & Sterilant prior to each use.


According to the standards of the "Association of peri-Operative Registered Nurses (AORN) eGuidelines+ 2012-2025 Perioperative Practice: High-Level Disinfection states:

"7.
Preparation of High-level Disinfectants
7.1
Personnel must prepare and use high-level disinfectants in accordance with the disinfectant and compatible device manufacturers' IFU ...
7.2
Use activated high-level disinfectants at the concentration recommended by the disinfectant manufacturer ...
7.2.1
Use a test strip or other FDA-cleared testing device that is compatible with the high-level disinfectant before each use ..."

A review of the hospital policy titled, "FLEXIBLE ENDOSCOPES-PROCESSING" Effective date 04/2023 and the next review date of 04/2024 revealed the follwing:

"Purpose:

To provide guidance to perioperative, endoscopy, and sterile processing personnel for processing all types of reusable flexible endoscope accessories. The Expected outcome is that the patient will be free from signs and symptoms of infection.

Policy: ...

...Chemicals and solutions used for cleaning and processing flexible endoscopes and endoscope accessories will be handled in accordance with local, state, and federal regulations and the manufacturer's IFU ..."

An interview on 2/4/2025 after 11:00 AM, Staff #19 was asked if this policy was still in effect. Staff #19 confirmed the policy was still in use and Leasdership are in the process of getting all policies updated. Staff #19 confirmed the policy was past the review date. Also, Staff #19 confirmed that the hospital policy was not followed.

Based on document review and interview, the hospital failed to ensure the infection preventionist (Staff #46) was actively involved with the Antibiotic Stewardship Program. The hospital failed to follow its "Infection Prevention and Control Plan" Policy.


Findings include:

A review of the Quality Council Meeting minutes dated 12/11/2024 and 01/17/2025 did not reveal any documentation of the collaboration between the Infection Control Preventionist and the Antibiotic Stewardship Leadership team. The meeting minutes included the data for all of the hospitals within the corporation. There was no documentation provided to support that Staff #46 attended the meetings or had communication regarding the hospital with the Antibiotic Stewardship team.

A review of the hospital's "Infection Prevention and Control Plan" policy dated 01/2025 revealed the following:

"Monitoring:

1. Monitoring the results of the Infection Prevention and Control Program allows the hospital to determine if the processes in place are effective or should be revised.

2. Monitoring is achieved through:

1. Committee interaction, especially the Safety/Risk/Health Subcommittee/Quality Council and Medical Staff Committee.

2. Primary responsibility for the activities of the Infection Prevention and Control Program belongs to the Infection Preventionist. The Infection Preventionist position is within the Department of Nursing. Advanced training in healthcare infection prevention and control is required, including knowledge of prevention, surveillance, and epidemiologic methods. At a minimum, the Infection Preventionist has completed training in Infection Prevention and Control.

3. The Infection Preventionist maintains a close working relationship with Performance Improvement/Quality Assurance for the quality assessment and improvement of patient process/function and will interface through all departments to achieve the goals and objectives of the Infection Prevention and Control Program.

4. The Infection Preventionist will serve on the Safety/Risk/Health Subcommittee/Quality Council and any other committees and teams as indicated.

5. The Infection Preventionist is responsible for:
a. Performance Improvement Indicators, Quality Control reports, Statistical data, Disease reporting.
b. Policy and procedure reviews.
c. Surveys and inspections."


An interview with Staff #7 was conducted on 02/05/2025 at 08:50 AM. Staff #7 reported that the Antibiotic Stewardship and Infection Control meetings are combined in the monthly quality meetings with all corporate hospitals. Staff #7 reported that Staff #46 did not attend the Quality Council meetings on 12//11/2024 and 01/17/2025. Staff #7 stated, "An invite was sent for the meetings in December and January."


Staff #3 (Director of Nursing) was interviewed on 02/05/2025 at 09:15 AM. Staff #3 reported that Staff #46 has just been completing Environmental Rounds and Hand Hygiene Rounds for the facility. Staff #3 stated, "The reports have been uploaded on the share drive and I present the information from the report during the meetings."

Based on record review and interview, the hospital QAPI (Quality Assurance and Performance Improvement) failed to address outcome indicators related to the prevention and reduction of adverse events.

Findings include:

A review of occurrence reports from August 2024 revealed that 111 occurrences had not been reviewed by the "Director Of Nurses".


A review of the QAPI minutes for December 2024 reflected the occurrences had been addressed by the department heads but the occurrences had not been addressed or closed by the Director of Nurses.


An interview with Director of Nurse Staff #3 on 02/05/2025 at 1:00 PM reported that she did not know anything about the open occurrences.

An interview with Staff #7 (Quality Director) on 02/05/2025 at 1:15 PM reported the Director of Nurses should get an email notification on the occurrence report once it has been entered into the system "Safety Net".

During the interviews with the Quality Director and Director of Nurses, it was discovered that there was a glitch in the system "Safety Net and no notifications were being sent.

An interview with Staff #3 (Director of Nurses) on 2/05/2025 at 1:30 PM acknowledged that the 111 occurrences should have been addressed and that the Quality department should address the outcomes of the occurrences in the quality meeting.

Based on a record review and interview, the hospital's QAPI (Quality and Performance Improvement) program did not use the data that was collected from the departments to analyze and track the outcomes. The hospital failed to follow the QAPI (Quality Assurance/Performance Improvement Plan).

Findings include:

A review of QAPI (Quality and Performance Improvement) meeting minutes of December 2024 revealed the following:

The departments were reporting data and findings, but there was no evidence to show that the departments had taken the data and analyzed the information to form a plan to achieve the goals of the QAPI program.

There was no evidence to support that the Performance Improvement Plan establishes a network for continually and systematically planning, designing, measuring, assessing, and improving performance to support high-quality and safe patient care.


A review of the hospital policy titled; "Quality Assurance/Performance Improvement Plan" dated 09/2024 revealed the following:

"PURPOSE:

"The purpose of the Quality Assurance/Performance Improvement Plan at Mid Coast Medical Center - Crockett {MCMCC) is to ensure that the Governing Board, Medical Staff, and staff are committed to fostering an environment that promotes high-quality care and patient safety.
This Performance Improvement Plan establishes a network for continually and systematically planning, designing, measuring, assessing, and improving performance of hospital-wide key functions and processes that support high-quality and safe patient care. Central components of this network are as follows:

* Incorporate quality planning throughout the facility;
* Creates an organizational structure that allows personnel and clinical units to integrate their efforts in performance improvement and collaborate across departmental boundaries;
* Communicate performance improvement efforts throughout the organization to foster institutional learning and encourage innovation and problem-solving at the clinical unit level;
* Assure process design and redesign are consistent with the hospital's mission, vision, and values; Reduce unexplained practice variation by promoting evidence-based clinical practices that are consistent with current professional knowledge as defined by practice guidelines, information from relevant systematic reviews, high-quality clinical investigations, and professional standards;
* Integrate error reduction procedures in healthcare processes; and
* Integrate the utilization of quality improvement and performance improvement principles in the daily activities of the workplace;
* Educate all staff on the science of performance improvement;

OBJECTIVES OF PERFORMANCE IMPROVEMENT:

* To identify opportunities to improve patient care and services.
* To provide guidance and knowledge to individuals for improving processes in which they are involved.
* Assure compliance with the requirements of all federal and state agencies regarding quality assessment and performance improvement activities.
* Avoid injuries to patients from the care that is intended to help them.
* Provide services using evidence-based practice.
* Provide care that is responsive to individual patient preferences, needs, and values by assuring that patient values are used in clinical decisions.

QUALITY COUNCIL:

Is responsible for performance improvement activities. This group ensures that improvements
are planned, designed, measured, analyzed, and sustained. Etc."

An interview with Staff # 7 (Director of Quality) on 02/05/2025 at 10:00 AM acknowledged that all departments of the hospital were reporting, but there was no plan to evaluate if the departments were meeting objective measures to evaluate their processes, functions, and services to provide safe patient care.

Based on record review and staff interview, the hospital failed to:

A. protect and promote each patient's rights when 2 (Patient # 25 and # 30) of 2 patient's pain was not appropriately assessed and managed. Also, the hospital failed to follow the "Patient Rights and Responsibilities" policy.

Cross Refer to Tag C 2500

B. establish a process for prompt resolution of patient complaints and grievances for 4 (#33, #34, #35, and #36) of 4 patients.

Cross Refer to Tag C 2507

C. ensure a properly executed informed consent was obtained for 2 (Patient # 3 and Patient # 23) of 2 patient medical records reviewed when the physician failed to sign an informed consent and a procedure was completed before obtaining informed consent. Also, the hospital failed to follow the "Patient Rights and Responsibilities" policy.

Cross Refer to Tag C 2513


A.

Findings include:

A review of patient medical records for Patient's # 25 and # 30 was conducted on 02/04/2025 at 3:00 PM with Staff # 9.

Patient # 25

A review of medical records for Patient # 25 revealed the patient was admitted to the hospital on 01/21/2024 with a diagnosis of left femur fracture.

A review of the patient's medication administration revealed an order for "oxycodone IR 5 milligram tablet by mouth as needed every 6 hours for pain. Indication: Severe pain".

The patient received the pain medication and there was no reassessment of the patient's pain on the following dates:

01/22/2025 2:19 AM
01/22/2025 9:32 AM
01/23/2025 1:50 AM
01/23/2025 12:49 PM
01/23/2025 7:35 PM
01/24/2025 4:52 AM
01/24/2025 12:49 PM

Patient # 30

A review of medical records for Patient # 30 revealed the patient was seen in the emergency room on 12/04/2024 with a diagnosis of a crush injury. A crush injury occurs when a body part is subjected to excessive force, often caused by being squeezed between two heavy objects.

According to nursing triage notes on 12/04/2024 at 9:45 AM, the patient rated their pain "9/10" and described the pain as "aching". There was no documentation to support the patient was given pain medication or offered any pain-relieving interventions.

A review of the hospital's "Patient Rights and Responsibilities" policy with an effective date of 12/2024 revealed,

POLICY: A. Mid Coast Medical Center-Crockett and Medical Staff have adopted the following statements on patient rights. This list shall include but is not limited to the:
1. Patient's right to: ...
C. Considerate and respectful care, provided in a safe environment, free from all forms of abuse and harassment.
D. Appropriate assessment and management of pain ...."

An interview was conducted with Staff # 9 on 02/04/2025 at 3:00 PM. Staff # 9 confirmed the hospital staff failed to assess and manage patients pain properly.

Based on record review and interview, the hospital failed to establish a process for prompt resolution of patient complaints and grievances for 4 (#33, #34, #35, and #36) of 4 patients.


Findings include:

A review of the facility's document titled, "Complaint/Grievance log 2024" revealed there were four patients on the log.

Patient #33 11/15/2024 complaint was "Provider customer service"

Patient #34 12/15/2024 complaint was "Infant medication"

Patient #35 12/18/2024 complaint was "pain during the procedure"

Patient #36 01/29/2025 complaint was 'Rude ED provider"

A review a document which was the Complaint/Grievance form filled out by the hospital administrator "handwritten" that described the event with a small amount of action to resolve the complaint /grievance.

An interview with the Hospital Administrator on 02/05/2024 at 10:30 AM reported that he had sent a letter to the patients but was only able to provide one letter for patient #36.

A review of the letter to Patient #36 that was provided to the surveyor had no date to determine when the letter was sent. There was no way to determine if the letter was sent in seven working days per the facility policy from the time the complaint /grievance was filed. There were no steps provided on how the grievance was investigated, or the results of the grievance process.


The hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.


A review of the facility policy titled; "Patient Complaint/Grievance Policy" dated 12/2024 revealed the following:

"a. Complaint means an oral or written expression of displeasure or dissatisfaction with
services(s) received that can be immediately resolved by the staff present.
b. Grievance means an oral or written complaint that is not immediately resolved at the time of the complaint by staff present. A grievance may be made by the patient or the patient's representative regarding, but not limited to, the patient's care, allegations of abuse or neglect; complaints related to not meeting needs based on disability; issues related to the hospital's compliance with the Medicare Hospital Conditions of Participation (CoP); or a Medicare beneficiary billing complaint related to rights and limitations provided by 42 CFR 489. However, many billing issues are not usually considered grievances. A written complaint is always considered a grievance and may be submitted by fax or email. Whenever the patient or the patient's representative requests that the complaint be handled as a formal complaint or grievance or when the patient requests a response from the hospital, then the complaint is a grievance. A patient's attorney is considered a patient representative. Except for any Notice of Malpractice Suit, all communications from a patient's attorney that meet the definition of a grievance must be treated as a grievance under this policy.

A. Initiate an Incident/Occurrence Report or a written narrative of the details of the complaint.
B. Any member of the hospital staff can start the grievance process and help the patient/patient's representative.
C. If the patient is unable to file a grievance, MCMC Crockett's Patient Advocate is available and/or the patient representative can assist. Contact the hospital's Patient Advocate at 361-972-2511.
D. After the hospital receives a complaint/grievance, the Administrator, Patient Advocate and appropriate department manager will review the complaint to see if the issue can be quickly resolved; The Administrator and Patient Advocate will determine if the hospital is the right organization to investigate the complaint/grievance. The patient may have a valid complaint, but some issues may deal outside the hospital control, e.g., insurance coverage, problem with another provider, etc. When these instances occur, the Patient Advocate will assist the patient
in filing the complaint and/or grievance with the correct agency or organization. Providing phone numbers and addresses. If the grievance is one that will be handled by the hospital, then the complaint/grievance process is initiated by the Administrator and Patient Advocate.
E. A letter will be sent to the patient/patient representative explaining the grievance process steps within seven working days.

F. The written notification will explain how the grievance will be resolved, describing each step in the process, the time frame for each step, and the patient's rights or responsibilities at each step. The written notice will offer to assist the patient as needed completing forms or taking other necessary steps to achieve resolution of the issue. The patient will be informed of any additional methods for resolving issues externally such as issues involving the quality of care or premature discharge, the patient will be reminded of voicing concerns (e.g., state regulatory agencies, professional review organization, CMS, etc). The Patient Advocate will provide assistance to the patient or his/her representative to request an immediate review from the QIO (Quality Improvement Organization.


A. The first level review process will include the Patient Advocate, Administrator or his/her
designee, department administrative team leader and the department manager involved in the complaint. If the complaint/grievance is about the quality of care provided by physicians or a discharge decision with which the patient disagrees, then the chief of staff, the department's medical director, or Peer Review will be included in the first-level review discussions. If the complaint/grievance cannot be resolved, or the investigation cannot be completed within
seven days then the Patient Advocate will inform the patient that the hospital is still working on it and will follow up with a written response.
B. Any employee involved in the complaint will not be allowed to participate in the review process. The Administrator will appoint other individuals as needed for the review process.
C. If the complainant is satisfied at this level, the complaint/grievance and its resolution will be documented on the complaint log and the information will be available for internal performance opportunities for improvement.
D. If the Complainant is satisfied with the outcome of the resolution the complaint or grievance, the information will be filed in the Patient Advocate office for future reference. If the Complainant is not satisfied with the resolution offered he/she will be reminded of the option to contact the appropriate Quality Improvement Organization or the issue can be forwarded to the Governing Board for final resolution. There may be situations where the hospital has taken appropriate and reasonable actions on the patient's behalf in order to resolve the patient's complaint or grievance and the patient or the patient's representative remains dissatisfied with the hospital's actions. In these situations, the hospital may consider the complaint/grievance closed for the purposes of these requirements. The hospital must maintain documentation of its efforts and demonstrate compliance with CMS requirements.

E. The Governing Board will be provided a summary of the complaints/grievance review and conclusions bimonthly during the Quality Report."


An interview with the Hospital Administrator on 02/05/2024 at 10:30 AM confirmed there was no response letter with written notice of its decision that contained the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion.

Based on record review and staff interview, the hospital staff failed to ensure a properly executed informed consent was obtained for 2 (Patient # 3 and Patient # 23) of 2 patient medical records reviewed when the physician failed to sign an informed consent and a procedure was completed before obtaining informed consent. Also, the hospital failed to follow the "Patient Rights and Responsibilities" policy.

Findings include:

A review of medical records was conducted with Staff # 9 on 02/04/2025 at 11:30 AM.

Patient # 3

A review of medical records for Patient # 3 revealed the patient was admitted to the hospital on 12/15/2024 with a diagnosis of syncope (passing out), and vomiting. The patient had a low blood level requiring a blood transfusion.

Physician # 48 ordered the following on 12/16/2024 at 7:05 PM, "Obtain Blood Transfusion Consent, Transfuse 2 units PRBC".

A review of the "Blood and Blood Component Transfusion Consent Form" revealed the patient signed the consent on 12/16/2024 at 11:10 PM. There was no physician's signature on the blood consent form and no documentation was provided to support the patient had been informed on the risks and benefits of receiving a blood transfusion by Physician # 48.

Patient # 23

Patient # 23 was seen in the hospital's emergency room on 11/07/2024 with a diagnosis of urinary retention. Physician # 36 inserted a central venous catheter in the patient's left subclavian vein on 11/07/2024 at 8:15 PM. The left subclavian vein is a large, deep vein that allows blood to flow directly into the heart.

A review of the "Disclosure and Consent Medical and Surgical Procedures" revealed that Patient # 23 and Physician # 36 signed the consent for the insertion of the central venous catheter on 11/07/2024 at 8:20 PM, 5 minutes after the central venous catheter was inserted.

A review of the hospital's "Patient Rights and Responsibilities" policy with an effective date of 12/2024 revealed the following:

"Policy: A. Mid Coast Medical Center Crockett and Medical Staff have adopted the following statements of patient rights. This list shall include but is not limited to the:
1. Patients right to:
a. To receive the Notice of Patient's Rights and be informed of his or her rights as a patient in advance of, or when discontinuing, the provision of care ....
g. The patient or his/her representative has the right to make informed decisions regarding his/her care; including being informed of his/her health status, being involved in care planning and treatment, and being able to request or refuse treatment or services deemed medically unnecessary if appropriate.
h. Receive as much information about a proposed treatment or procedure as needed in order to give informed consent or to refuse the course of treatment. This right must not be constructed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate ...."

An interview with Staff # 9 on 02/04/2025 at 11:35 AM confirmed the informed consents were not properly executed.