Animas Surgical Hospital, LLC

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 50313 Based on interviews and document review, the facility failed to ensure medication orders were reviewed for appropriateness by a pharmacist or provider before the first dose of medications were administered. This failure was identified in two of three inpatient medical records reviewed. (Patient #2 and #3) Findings include: Reference: According to the Colorado Department of Regulatory Agencies (DORA) Division of Professions and Occupations, Colorado Nursing Laws, Scope of Practice Algorithm, retrieved from: https://drive.google.com/file/d/0B-K5Dhx XxJZbcm9vcEY2MmhTaTg/view?resourcekey=0-bXsLKpwyAIaWr0TZjBfsEQ, if the skill/task is not taught in the nurse’s basic nursing program, if the nurse has not completed a comprehensive training program, including clinical experience related to the task, if the task is not routine in nursing literature and nursing practice, if the task does not pass the reasonable and prudent standard for nursing, then the task is not in the nurse’s scope of nursing practice. 1. The facility failed to ensure medication orders were reviewed for appropriateness by a pharmacist or provider before the first dose of medications were administered. A. Document Review i. A review of Patient #2’s medical record revealed Patient #2 presented to the facility on 8/12/25 at 11:22 a.m. for a right knee replacement surgery. Following the surgery, Patient #2 was admitted to the inpatient unit on 8/12/25 at 5:33 p.m. The medication administration record (MAR) revealed nursing staff administered cefazolin (an antibiotic) 1 g per (/) 50 mL on 8/13/25 at 8:11 a.m., aspirin (a medication used to reduce pain and prevent heart attacks and strokes) 81 mg and gabapentin (a medication used to treat nerve pain) 800 mg on 8/13/25 at 9:04 a.m., and clopidogrel (a medication used to prevent blood clots) 75 mg on 8/14/25 at 9:30 a.m., prior to a pharmacist or provider reviewing the medication orders for appropriateness. The medication orders revealed a pharmacist verified the cefazolin 1 g/50 mL order on 8/13/25 at 3:38 p.m., approximately seven hours after the medication was administered. The aspirin 81 mg and gabapentin 800 mg orders were verified on 8/13/25 at 3:38 p.m., approximately 6 hours after the medications were administered. Finally, the clopidogrel 75 mg order was verified on 8/14/25 at 7:19 p.m., approximately 10 hours after the medication was administered. ii. A review of Patient #3’s medical record revealed Patient #3 presented to the facility on 10/9/25 at 12:34 p.m. for an endoscopic ethmoidectomy (a procedure to remove tissue and bone in the ethmoid sinuses that blocks natural drainage). Following the surgery, Patient #3 was admitted to the inpatient unit on 10/9/25 at 3:37 p.m. The MAR revealed nursing staff administered diltiazem (a medication used to lower blood pressure and treat irregular heart rhythms) 120 mg on 10/9/25 at 7:23 p.m., and tamsulosin (a medication used to relax the muscles in the prostate and bladder) 0.4 mg on 10/9/25 at 7:24 p.m., prior to a pharmacist or provider reviewing the medication orders for appropriateness. The medication orders revealed a pharmacist verified the diltiazem 120 mg and the tamsulosin 0.4 mg on 10/9/25 at 9:18 p.m., approximately two hours after the medications were administered. iii. Review of the Medication Management policy revealed nursing staff were expected to routinely review medication orders for the appropriateness of the drug, dose, frequency, and route of administration; therapeutic duplication; real or potential allergies or sensitivities; real or potential interactions with other medications, food, or laboratory values; contraindications for use; and other relevant medication-related issues or concerns. Medications were permitted to be administered prior to order verification by a pharmacist or provider. This was in contrast with the to the DORA Scope of Practice Algorithm which read, if the skill/task was not taught in the nurse’s basic nursing program, if the nurse had not completed a comprehensive training program, including clinical experience related to the task, if the task was not routine in nursing literature and nursing practice, if the task did not pass the reasonable and prudent standard for nursing, then the task was not in the nurse’s scope of nursing practice. Upon request, the facility was unable to provide nationally recognized guidelines to support medication orders being reviewed by nursing staff for appropriateness. B. Interviews i. An interview was conducted on 11/25/25 at 9:11 a.m. with registered nurse (RN) #1. RN #1 stated as a nurse, they reviewed medication “rights” such as right patient, right dose, right time, and right route before administering the medication to a patient. RN #1 explained they verified the right order and dose by scanning the medication and comparing it with the medication order. RN #1 stated if they thought a medication order was abnormal, they would reach out to a provider for clarification. RN #1 stated they knew if a medication order was abnormal from their experience administering medications. RN #1 stated if a medication was ordered by a provider, and had not been verified by a pharmacist, they would not have been comfortable administering the medication without calling a doctor or physician assistant. ii. An interview was conducted on 11/24/25 at 3:37 p.m. with provider (Provider) #2. Provider #2 stated they ordered medications for patients in the inpatient unit. Provider #2 stated they were not sure if a pharmacist verified medication orders before nursing staff administered the medications. Provider #2 stated it was the role of a pharmacist to determine if there were any safety concerns with medication orders, including dosing concerns. Provider #2 stated it was in a nurse’s scope of practice to view a medication order and contact a provider with any concerns. Provider #2 stated it was not within a nurse’s scope of practice to review a medication order and make a determination if the medication order was appropriate or if the dose was safe for a patient. Provider #2 stated, similarly, it was not in a nurse’s scope of practice to review medication orders and make determinations regarding interactions with other medications or lab values. Provider #2 stated it was important to have a physician or pharmacist review medications orders to ensure patient safety.”

“This survey was conducted in accordance with the Federal Register at Section 42 CFR Part 482.41(b). The Initial Comments (ID Prefix Tag # K 000) are informational only and are a representation of the facility’s general characteristics. An on-site Life Safety Code recertification survey was conducted on May 14, 2024, at the request of the Centers for Medicare & Medicaid Services (CMS) - Denver Regional Office. The survey scope included the main surgical hospital building under Provider Number 060117 and associated OCLs. The hospital, building A1, is a 30,680 sq ft. one-story Type II (000) construction with no basement; the structure is built on a podium parking garage with a 2-hour fire separation. The building is protected by a full NFPA (National Fire Protection Association) 13 sprinkler system. The main floor consists of the surgical units and an Emergency Department. The 2nd floor of the on-campus medical office building (MOB) consists of one internal medicine office and AIMS; a two-hour firewall separates the MOB and HOSP. All other offices in the MOB do not operate under license. The facility was surveyed using the National Fire Protection Association (NFPA) Life Safety Code (2012) Chapter 19 for Existing Health Care Occupancies. The building is classified as fully sprinkler-protected. The deficiencies cited were discussed with the Operations Manager and during the exit conference conducted at the end of the on-site survey.”

“Multiple Occupancies CFR(s): NFPA 101 Multiple Occupancies - Sections of Health Care Facilities Sections of health care facilities classified as other occupancies meet all of the following: o They are not intended to serve four or more inpatients for purposes of housing, treatment, or customary access. o They are separated from areas of health care occupancies by construction having a minimum two hour fire resistance rating in accordance with Chapter 8. o The entire building is protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7. Hospital outpatient surgical departments are required to be classified as an Ambulatory Health Care Occupancy regardless of the number of patients served. 19.1.3.3, 42 CFR 482.41, 42 CFR 485.623 This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the means of egress requirements in accordance with NFPA 101. This was evidenced by: 1) 2-hour rated wall not finished on east corridor NFPA 101 19.1.3.3* Sections of health care facilities shall be permitted to be classified as other occupancies, provided that they meet all of the following conditions: (1) They are not intended to provide services simultaneously for four or more inpatients for purposes of housing, treatment, or customary access by inpatients incapable of self-preservation. (2) They are separated from areas of health care occupancies by construction having a minimum 2-hour fire resistance rating in accordance with Chapter 8. (3) For other than previously approved occupancy separation arrangements, the entire building is protected throughout by an approved, supervised automatic sprinkler system in accordance with Section 9.7. This deficiency could affect occupants, who might include residents, staff, and visitors within the entire facility. Deficient items were discussed with the facility maintenance director during the exit conference.”

“Egress Doors CFR(s): NFPA 101 Egress Doors Doors in a required means of egress shall not be equipped with a latch or a lock that requires the use of a tool or key from the egress side unless using one of the following special locking arrangements: CLINICAL NEEDS OR SECURITY THREAT LOCKING Where special locking arrangements for the clinical security needs of the patient are used, only one locking device shall be permitted on each door and provisions shall be made for the rapid removal of occupants by: remote control of locks; keying of all locks or keys carried by staff at all times; or other such reliable means available to the staff at all times. 18.2.2.2.5.1, 18.2.2.2.6, 19.2.2.2.5.1, 19.2.2.2.6 SPECIAL NEEDS LOCKING ARRANGEMENTS Where special locking arrangements for the safety needs of the patient are used, all of the Clinical or Security Locking requirements are being met. In addition, the locks must be electrical locks that fail safely so as to release upon loss of power to the device; the building is protected by a supervised automatic sprinkler system and the locked space is protected by a complete smoke detection system (or is constantly monitored at an attended location within the locked space); and both the sprinkler and detection systems are arranged to unlock the doors upon activation. 18.2.2.2.5.2, 19.2.2.2.5.2, TIA 12-4 DELAYED-EGRESS LOCKING ARRANGEMENTS Approved, listed delayed-egress locking systems installed in accordance with 7.2.1.6.1 shall be permitted on door assemblies serving low and ordinary hazard contents in buildings protected throughout by an approved, supervised automatic fire detection system or an approved, supervised automatic sprinkler system. 18.2.2.2.4, 19.2.2.2.4 ACCESS-CONTROLLED EGRESS LOCKING ARRANGEMENTS Access-Controlled Egress Door assemblies installed in accordance with 7.2.1.6.2 shall be permitted. 18.2.2.2.4, 19.2.2.2.4 ELEVATOR LOBBY EXIT ACCESS LOCKING ARRANGEMENTS Elevator lobby exit access door locking in accordance with 7.2.1.6.3 shall be permitted on door assemblies in buildings protected throughout by an approved, supervised automatic fire detection system and an approved, supervised automatic sprinkler system. 18.2.2.2.4, 19.2.2.2.4 This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101. This was evidenced by: 1) The deadbolts on the front and rear egress doors lack proper signage, and the doors also need to be key-operated in accordance with NFPA 101 7.2.1.5.5. NFPA 101 39.2.2.2.2* Locks complying with 7.2.1.5.5 shall be permitted only on principal entrance/exit doors. NFPA 101 7.2.1.5.5 Key-Operated Locks. 7.2.1.5.5.1 Exterior door assemblies shall be permitted to have key-operated locks from the egress side, provided that all of the following criteria are met: (1) This alternative is permitted in Chapters 11 through 43 for the specific occupancy. (2) A readily visible, durable sign in letters not less than 1 in. (25 mm) high on a contrasting background that reads as follows is located on or adjacent to the door leaf: THIS DOOR TO REMAIN UNLOCKED WHEN THE BUILDING IS OCCUPIED. (3) The locking device is of a type that is readily distinguishable as locked. (4) A key is immediately available to any occupant inside the building when it is locked. NFPA 101, 7.2.1.5.10 A latch or other fastening device on a door leaf shall be provided with a releasing device that has an obvious method of operation, and that is readily operated under all lighting conditions. NFPA 101, 7.2.1.5.10.2 The releasing mechanism shall open the door leaf with not more than one releasing operation unless otherwise specified in 7.2.1.5.10.3, 7.2.1.5.10.4, or 7.2.1.5.10.6. This deficiency could affect occupants, including residents, staff, and visitors throughout the facility. Deficient item(s) were discussed with the maintenance team at the exit conference.”

“Exit Signage CFR(s): NFPA 101 Exit Signage 2012 EXISTING Exit and directional signs are displayed in accordance with 7.10 with continuous illumination also served by the emergency lighting system. 19.2.10.1 (Indicate N/A in one-story existing occupancies with less than 30 occupants where the line of exit travel is obvious.) This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the means of egress requirements in accordance with NFPA 101. This was evidenced by: 1) More exit signage is needed for the rear egress access. NFPA 101 39.2.10 Marking of Means of Egress. Means of egress shall have signs in accordance with Section 7.10. NFPA 101 7.10.1.5.1 Access to exits shall be marked by approved, readily visible signs in all cases where the exit or way to reach the exit is not readily apparent to the occupants. This deficiency has the potential to affect occupants, who might include residents, staff, and visitors throughout the entire facility. Deficient items were discussed with the facility maintenance director during the exit conference.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the means of egress requirements in accordance with NFPA 101. This was evidenced by: 1) 1-hour rated smoke barrier PCU hall above smoke doors needs to be topped out 2) 1-hour wall on soiled linen needs top out 3) 1-hour firewall in the mechanical room needs to be topped out 4) 1-hour fire wall west side central supply needs to be repaired NFPA 101 18.3.2.1* Hazardous Areas. Any hazardous areas shall be protected in accordance with Section 8.7, and the areas described in Table 18.3.2.1 shall be protected as indicated. NFPA 101 4.5.8 Maintenance. Whenever or wherever any device, equipment, system, condition, arrangement, level of protection, or any other feature is required for compliance with the provisions of this Code, such device, equipment, system, condition, arrangement, level of protection, or other feature shall thereafter be maintained, unless the Code exempts such maintenance. This deficiency could affect occupants, including residents, staff, and visitors within the entire facility. Deficient items were discussed with the facility maintenance director during the exit conference.”

“Fire Alarm System - Testing and Maintenance CFR(s): NFPA 101 Fire Alarm System - Testing and Maintenance A fire alarm system is tested and maintained in accordance with an approved program complying with the requirements of NFPA 70, National Electric Code, and NFPA 72, National Fire Alarm and Signaling Code. Records of system acceptance, maintenance and testing are readily available. 9.6.1.3, 9.6.1.5, NFPA 70, NFPA 72 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101 and 72. This was evidenced by: 1) Fire alarm annual notes 5 deficiencies that need to be corrected a) horn and strobes not syncing b) 4 Heat detectors are not operational 2) Fire Alarm Sensitivity test (2 Years) (72 14.4.5.3.2): 7.31.21 Alpine security, overdue Based on a record review, it was determined that the facility failed to maintain the fire alarm system components and devices in accordance with the Life Safety Code Section 9.6 and NFPA 72. NFPA 101, Section 9.6.1.5* To ensure operational integrity, the fire alarm system shall have an approved maintenance and testing program complying with the applicable requirements of NFPA 70, National Electrical Code, and NFPA 72, National Fire Alarm and Signaling Code. NFPA 101 19.3.4.1 to comply with section 9.6. Section 9.6.1.3, fire alarm system testing and maintenance to comply with NFPA 72. NFPA 72 14.2.1.2.2 System defects and malfunctions shall be corrected. NFPA 72 Table14.4.5 Testing Frequencies This deficiency could affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Sprinkler System - Maintenance and Testing CFR(s): NFPA 101 Sprinkler System - Maintenance and Testing Automatic sprinkler and standpipe systems are inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintaining of Water-based Fire Protection Systems. Records of system design, maintenance, inspection and testing are maintained in a secure location and readily available. a) Date sprinkler system last checked _____________________ b) Who provided system test ____________________________ c) Water system supply source __________________________ Provide in REMARKS information on coverage for any non-required or partial automatic sprinkler system. 9.7.5, 9.7.7, 9.7.8, and NFPA 25 This Standard is not met as evidenced by: 49177 Through document review during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 101, and 25. This was evidenced by: 1) Fire sprinkler semi-annual report indicates that they are not actuating the supervisory signals 2) Fire sprinkler annual report indicates that they are not exercising the control valves. 3) Fire sprinkler 3 Year Full Trip: 6.10.22 Cooper Fire, Not adequate information on the report 4) missing trim plate in the decontamination room Based on a record review, it was determined that the facility failed to maintain the fire sprinkler system components and devices in accordance with the Life Safety Code Section 9.6 and NFPA 72. NFPA 101, 9.7.5 Maintenance and Testing. All automatic sprinkler and standpipe systems required by this Code shall be inspected, tested, and maintained in accordance with NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems. NFPA 25, Chapter 5 Sprinkler Systems Table 5.1.1.2 shall be used to determine the minimum required frequencies for inspection, testing, and maintenance. NFPA 25, Chapter 13 Common Components and Valves Table 13.1.1.2 shall be used to determine the minimum required frequencies for inspection, testing, and maintenance. NFPA 25 4.3.1* Records shall be made for all inspections, tests, and maintenance of the system and its components and shall be made available to the authority having jurisdiction upon request. 4.3.2 Records shall indicate the procedure performed (e.g., inspection, test, or maintenance), the organization that performed the work, the results, and the date. NFPA 25 5.2.1.1.4 Any sprinkler shall be replaced that has signs of leakage; is painted, other than by the sprinkler manufacturer, corroded, damaged, or loaded; or is in the improper orientation. This deficiency could affect occupants, who might include residents, staff, and visitors within the entire facility. The deficient item was discussed with the maintenance team at the exit conference.”

“Features of Fire Protection - Other CFR(s): NFPA 101 Features of Fire Protection - Other List in the REMARKS section any NFPA 99 Chapter 15 Features of Fire Protection requirements that are not addressed by the provided K-Tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. Chapter 15 (NFPA 99) This Standard is not met as evidenced by: 49177 Through observation during the survey, it was determined that the facility failed to meet the protection requirements in accordance with NFPA 99. This was evidenced by: 1) Defend in Place strategy is being utilized for patient care, fire sprinkler and fire alarm systems do not meet NFPA 99 requirements for Defend in Place. NFPA 99 15.7.4.3 Defend in Place. For new and existing facilities, where the response to a fire is to defend in place within a safe place in the building, occupant notification shall be in accordance with the facility fire plan. 15.7.4.3.1* Where buildings are required to be subdivided into smoke compartments, fire alarm notification zones shall coincide with one or more smoke compartment boundaries or shall be in accordance with the facility fire plan. 15.8.1.2* Defend in Place. For new and existing facilities, where the response to a fire is to defend in place within a safe place in the building and not to automatically evacuate the building, sprinkler system zones shall coincide with smoke compartment boundaries or shall be in accordance with the facility fire plan. This deficiency could affect occupants, who might include residents, staff, and visitors within all smoke compartments. Deficient items were discussed with the facility maintenance director during the exit conference.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 46926 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 Patient’s Rights was out of compliance. A-0144 The patient has the right to receive care in a safe setting. Based on observations, document review, and interviews the facility failed to provide care in a safe setting. Specifically, the facility failed to ensure staff used non-enzymatic (proteins that increased the speed of chemical reactions) detergent on ophthalmic (eye) surgical instruments, which increased the risk for Toxic Anterior Segment Syndrome (an acute, severe swelling in the eye that occurred within one or two days of eye surgery), in one of one observation of staff performing decontamination of ophthalmic instruments in the sterile processing department.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 46926 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.25 Pharmaceutical Services was out of compliance. A-0502 All drugs and biologicals must be kept in a secure area, and locked when appropriate. Based on observations, interviews, and document reviews, the facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 46926 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs was out of compliance. A-0750 The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review, the facility failed to ensure a safe and sanitary environment for patient care. Specifically, the facility failed to ensure staff performed hand hygiene in the pre-operative area, patient care unit, operating room, and sterile processing department, according to facility policy and national guidelines. Also, the facility failed to ensure staff did not store items under the sinks in the sterile processing department (SPD) in two of two observations of the decontamination of surgical instruments. Additionally, the facility failed to ensure medical devices and patient care supplies were not readily available for patient use and were discarded once expired. The failure was observed in one observation of the urgent care emergency cart.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 46926 Based on observations, document review, and interviews the facility failed to provide care in a safe setting. Specifically, the facility failed to ensure staff used non-enzymatic (proteins that increased the speed of chemical reactions) detergent on ophthalmic (eye) surgical instruments, which increased the risk for Toxic Anterior Segment Syndrome (an acute, severe swelling in the eye that occurred within one or two days of eye surgery), in one of one observation of staff performing decontamination of ophthalmic instruments in the sterile processing department. Findings include: Facility policy: The Sterile Processing Department (SPD): Cleaning, Disinfection and Sterilization of Instruments policy read, cleaning solutions and detergents should be measured, mixed, labeled, and discarded appropriately according to the manufacturer’s instructions for use (IFU) and should be compatible with the instruments and equipment for which they are used. References: The Prolystica 2X Concentrate Enzymatic Presoak and Cleaner IFU read, Prolystica is a low-foaming enzymatic detergent for the removal of a broad range of soils on surgical instruments and medical devices in both the manual and automated cleaning process. The Corza Medical/Katena Products, Inc. Ophthalmic Surgical Instruments IFU read, Katena does not recommend using toxic disinfectants or enzymatic detergents for ophthalmic surgical instruments; they add chemical burden to the cleaning process and increase the potential of causing Toxic Anterior Segment Syndrome (TASS). The risk of contamination and infection during surgery is a significant concern for all healthcare facilities. This concern is what drives how much time and effort is expended on cleaning and sterilizing surgical instruments. Specific to cataract surgery is TASS. TASS is an acute inflammation (swelling) of the anterior (in the front) chamber of the eye following cataract surgery, resulting in toxic damage to the intraocular (in the eye) tissue. The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities read, the device manufacturer’s current written IFU should be accessible, reviewed, and followed. Rationale: The device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized with the means and methods available in healthcare facilities. Sterilization validation of a device requires microbiological, engineering, toxicological, and sometimes clinical evaluations of the device, which are beyond the abilities of most healthcare facilities. To ensure patient safety, a reusable device needs to be capable of being thoroughly cleaned and sterilized. The device labeling describes specific methods of cleaning and sterilization that the manufacturer has validated. 1. The facility failed to ensure staff used non-enzymatic detergent when decontaminating ophthalmic surgical instruments. a. On 4/22/24 at 3:44 p.m., SPD supervisor (Supervisor) #3 was observed decontaminating eye instruments, including instruments made by Corza Medical/Katena Products, using Prolystica 2x Concentrated Enzymatic Presoak and Cleaner. The IFU for the Prolystica read the product was a low-foaming enzymatic detergent for removing a broad range of soils on surgical instruments and medical devices. The use of the enzymatic detergent on ophthalmic instruments was in contrast to the Corza Medical/Katena Products Ophthalmic Surgical Instruments IFU, which instructed to not use enzymatic detergents for ophthalmic surgical instruments. The IFU read enzymatic detergents added chemical burden to the cleaning process and increased the potential of causing TASS. The IFU defined TASS as an acute inflammation of the anterior chamber of the eye following cataract surgery, resulting in toxic damage to the intraocular tissue. The use of an enzymatic detergent on ophthalmic surgical instruments was also in contrast to the facility policy SPD: Cleaning, Disinfection, and Sterilization of Instruments, which instructed to use detergents compatible with the instruments. Finally, the use of the enzymatic detergent to decontaminate ophthalmic surgical instruments was in contrast to the ANSI/AAMI ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities which instructed to access, review, and follow the device manufacturer’s current written IFU. b. On 4/22/24 at 3:44 p.m., an interview was conducted with Supervisor #3. Supervisor #3 said they had heard about TASS but did not know much about it. They explained they heard the ophthalmic surgeons discussing the condition. Supervisor #3 was not aware of the connection between TASS and the use of enzymatic detergents when decontaminating ophthalmic surgical instruments. Supervisor #3 said the facility followed ANSI/AAMI guidelines in the SPD. c. On 4/23/24 at 12:20 p.m., an interview was conducted with ophthalmic surgeon and chief medical officer (CMO) #4. CMO #4 described TASS as an inflammatory condition that presented as endophthalmitis (swelling of the inner layers of the eye). They said patients with TASS experienced extreme eye redness but no pain. They stated TASS potentially occurred secondary to a surgical instrument that was contaminated, perhaps by enzymatic detergents. CMO #4 explained if TASS continued untreated the patient developed permanent vision changes and loss due to scar tissue and adhesions (a band of scar tissue that joined two internal surfaces that normally would not touch). They said the inflammation in the eye could also lead to swelling in the retina (light-sensitive tissue at the back of the eye that received images and sent them to the brain). CMO #3 said retinal swelling caused cystoid macular edema. CMO #4 explained cystoid macular edema was characterized by the loss of contrast, loss of color, micropsia (objects look smaller than objective size), and central scotoma (blind spots in the middle of vision).”

“SECURE STORAGE CFR(s): 482.25(b)(2)(i) §482.25(b)(2)(i) - All drugs and biologicals must be kept in a secure area, and locked when appropriate. This Standard is not met as evidenced by: 46926 Based on observations, interviews, and document reviews, the facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access. Findings include: Facility policy: According to the Medication Management policy, medications are properly and safely stored throughout the facility. Emergency medications are consistently available, controlled, and secured in the facility’s patient care area. Proper storage of medications shall be adhered to at all times, including security. 1. The facility failed to ensure medications in the urgent care emergency cart were securely stored to prevent unauthorized access. A. Observations i. On 4/24/24 at 10:00 a.m., observations of the urgent care department revealed the emergency cart located in the patient care hallway was unlocked, which allowed for unmonitored access. At this time, licensed practical nurse (LPN) team lead (Team Lead) #1 stated this cart was always unlocked. The top drawer of the emergency cart contained a plastic box labeled “Anaphylaxis/Cardiac Medications” which contained the following medications: a. Epinephrine (relaxes the muscles and raises blood pressure) 0.3 milligram (mg), one autoinjector b. Epinephrine 1 mg/milliliter (mL), two vials c. Diphenhydramine (helps with allergic reactions and causes drowsiness) 50 mg/mL, two vials d. Diphenhydramine hydrochloride 25 mg, four capsules e. Solumedrol (anti-inflammatory) 125 mg, one vial f. Nitroglycerin (dilates blood vessels to relieve chest pain) 0.4 mg, one vial of 25 sublingual (under the tongue) tablets g. Aspirin (non-steroidal anti-inflammatory and blood thinner) 81 mg, eight tablets h. Naloxone (blocks the effects of opioids) hydrochloride 0.4 mg/ml, one vial i. Famotidine (reduces heartburn) 20 mg, three tablets This observation was in contrast to the Medication Management policy which read, medications were properly and safely stored. Emergency medications were consistently secured in the patient care area. Proper storage of medications was adhered to at all times. B. Interviews i. On 4/24/24 at 10:21 p.m., an interview was conducted with Team Lead #1. Team Lead #1 stated the medication and supply room, located across the hallway from the emergency cart, was always locked to protect patients from unauthorized medication access. However, Team Lead #1 stated the emergency cart containing emergency medications in the patient care hallway was always left unlocked which was in contrast to their earlier statement about the necessity of securing medications and the Medication Management policy which read, medications were properly and safely stored throughout the facility. Team Lead #1 stated the cart was left unlocked so the emergency medications in the top drawer and other emergency medical supplies were immediately available to staff in an emergency. They stated it was important to secure medications because if patients gained access to, and consumed medications intended for use in emergencies, they could experience drowsiness, a decrease in blood pressure, or a cardiac (heart) event. ii. On 4/24/24 at 3:32 p.m., an interview was conducted with quality and risk director (Director) #2. Director #2 stated they were not sure where the emergency cart was located in the urgent care department and added that the emergency cart was not considered a crash cart (a self-contained, mobile unit with all of the materials, drugs, and devices necessary to perform a code (an emergency event), although it contained emergency supplies, equipment, and medications, and would not need to be tracked and secured like a crash cart would be. This statement was in contrast to the Medication Management policy which read, medications were properly and safely stored throughout the facility and emergency medications were consistently secured in the facility’s patient care area.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 46926 Based on observations, interviews, and document review, the facility failed to ensure a safe and sanitary environment for patient care. Specifically, the facility failed to ensure staff performed hand hygiene in the pre-operative area, patient care unit, operating room, and sterile processing department, according to facility policy and national guidelines. Also, the facility failed to ensure staff did not store items under the sinks in the sterile processing department (SPD) in two of two observations of the decontamination of surgical instruments. Additionally, the facility failed to ensure medical devices and patient care supplies were not readily available for patient use and were discarded once expired. The failure was observed in one observation of the urgent care emergency cart. Findings include: Facility policies: According to the Hand Hygiene policy, all personnel will use the appropriate hand hygiene techniques, following the Centers for Disease Control (CDC) guidelines. All personnel will wash hands when hands are contaminated with potentially infectious materials, before having direct contact with patients, after coming in contact with a patient’s intact skin, after moving from a contaminated body site to a cleaned body site, after contact with inanimate objects (including medical equipment), and after removing gloves. If hands are not visibly soiled hands may be cleaned with an alcohol-based hand sanitizer for 20 seconds. Staff are also to wear gloves according to standard precautions. The SPD: Cleaning, Disinfection and Sterilization of Instruments policy read, packaging will be considered non-sterile (compromised) when certain events occur, including contamination with moisture. Arrange storage areas in a manner that prevents splashing from personnel or housekeeping. Do not store sterile items under plumbing valves and traps. According to the Rotation of Expired Supplies policy, all supplies maintained in the inventory must be rotated to ensure that the items are used on a first-in, first-out basis. When processed properly, the oldest supplies will be consumed first thereby reducing the possibility of supplies outdating on the storeroom shelves. All supplies must be rotated in the same fashion. The newest product must be placed to the bottom right, and the oldest product to the top left. According to the Safety, Infection, and Quality Plan, the plan is to provide a safe, functional, and sanitary environment of care. References: According to the CDC Hand Hygiene in Healthcare Settings guidance, retrieved from https://www.cdc.gov/handhygiene/providers/index.html and last reviewed on 4/25/24, hand hygiene reduces the spread of potentially dangerous germs to patients. Multiple opportunities for hand hygiene occur during a single care episode. Clinical indications for hand hygiene include: immediately before touching a patient; when hands are visibly soiled; before performing an aseptic task or handling invasive medical devices; before moving from work on a soiled body site to a clean body site on the same patient; after touching the patient or the patient’s immediate environment; after contact with blood, body fluids, or contaminated surfaces; and immediately after glove removal. The American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities read, sterile items should not be stored next to or under sinks, beneath exposed water or sewer pipes, or in any location where they could become wet. Rationale: Adequate space is needed around sterile materials to allow for air circulation in the room, to prevent contamination during cleaning of floors, and to prevent contact between sterile items and the condensation that might form on the interior surfaces of outside walls. Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces. 1. The facility failed to ensure hand hygiene was performed according to facility policy and national guidelines. A. Observations conducted in the pre-operative area (pre-op), patient care unit (PCU), operative room (OR), and sterile processing department (SPD) revealed multiple staff failed to perform hand hygiene when indicated. i. On 4/23/24 from 1:38 p.m. to 2:22 p.m., observations conducted in pre-op revealed a surgeon exited patient bay #5 without performing hand hygiene. Another surgeon entered patient bay #2 without performing hand hygiene. Later observations revealed a surgeon entered patient bay #2 and donned gloves without first performing hand hygiene. Observations during this time also revealed an anesthesia assistant exited patient bay #2 without performing hand hygiene. The anesthesia assistant then pulled medicine from a vial into a syringe without donning gloves or performing hand hygiene before or after. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before touching a patient, before performing an aseptic task or handling invasive medical devices, after touching the patient or the patient’s immediate environment, and immediately after glove removal. ii. On 4/23/24 at 4:27 p.m., an observation conducted in the PCU revealed a surgeon entered patient room #4 without first performing hand hygiene. Observations later revealed this same surgeon then exited patient room #4 after interacting with the patient and proceeded to enter patient room #5 without performing hand hygiene in between. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before touching a patient and after touching the patient or the patient’s immediate environment. iii. On 4/24/24 at 10:59 a.m., observations conducted in the OR revealed a registered nurse (RN) cleaned the operating room with CaviWipes (a cleansing towelette that decontaminates (removes germs) and disinfectants (destroys microorganisms) while wearing gloves. The RN removed the gloves without performing hand hygiene. This RN then opened a new anesthesia (a state of controlled, temporary loss of sensation or awareness induced for medical purposes) circuit (individual patient use tubes for administering anesthetic gases during surgery) and attached these to the anesthesia machine. The RN left the operating room without performing hand hygiene and returned with sterile supplies for the next procedure, which they then opened. These observations were in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials including immediately before performing an aseptic task or handling invasive medical devices and immediately after glove removal. iv. On 4/25/24 at 8:25 a.m., observations conducted in the SPD revealed SPD supervisor (Supervisor) #3 did not perform hand hygiene before or after decontaminating a flexible endoscope (a medical device that looks inside the body). This observation was in contrast to the Hand Hygiene policy and CDC Hand Hygiene in Healthcare Settings guidance which read, all personnel washed hands when hands were contaminated with potentially infectious materials, before handling invasive medical devices, and immediately after glove removal. B. Document review revealed the facility’s hand hygiene goal of 90% compliance was not achieved by most of the facility staff. i. A review of the January 2024 Peri-Operative meeting minutes revealed a chart titled “2023 Hand Hygiene Compliance by Quarter.” This chart revealed the facility goal for hand hygiene in 2023 was 90% compliance but in the last quarter of 2023, anesthesia providers were 70% compliant with hand hygiene, physicians were 67% compliant, physician assistants (PAs) and nurse practitioners (NPs) were 68% compliant, physical therapists were 75%, scrub technicians were 95% compliant, diagnostic imaging was 40% compliant, and registered nurses (RNs) were 91% compliant. C. Interviews i. On 4/24/24 at 11:38 a.m., an interview was conducted with certified anesthesia assistant (Assistant) #7. Assistant #7 stated handwashing was important to prevent the spread of microorganisms from patient to patient, or staff to patient, and causing disease. They stated if hand hygiene was not performed, this could transmit an infection to a patient. ii. On 4/24/24 at 3:32 p.m., an interview was conducted with quality and risk director (Director) #2. Director #2 stated hand hygiene was a facility quality improvement project. They stated observations and audits had revealed a lack of hand hygiene, especially among providers. They stated when performing patient care, for example, staff had been educated that doors and curtains were both to be perceived as barriers and hand hygiene was to be performed when entering and exiting. This statement was in contrast to multiple observations in the pre-op and PCU which revealed multiple hand hygiene opportunities. Director #2 stated all staff were to perform hand hygiene as this was important to prevent healthcare-associated infections. 2. The facility failed to ensure items in the SPD were not stored under sinks. a. On 4/22/24 at 3:19 p.m., observations were conducted on the decontamination side of the facility’s SPD while SPD supervisor (Supervisor) #3 decontaminated surgical instruments. The decontamination area was arranged with three large, metal sinks against one wall and a second set of three smaller metal sinks against another wall. The areas below the sinks were not enclosed, leaving plumbing valves and traps exposed. Under the row of smaller metal sinks were several baskets with cleaning brushes. These were not wrapped and therefore were exposed to splashing and contaminants from the floor. Observations revealed Supervisor #3 using these brushes to decontaminate surgical instruments. Observations further revealed syringes in sterile packaging in a bucket under the smaller sinks. Supervisor #3 used the syringes to flush the inside of surgical instruments. Also under the smaller sinks was a bucket of plastic-wrapped sponges saturated with detergent and equipment to test for leaks in flexible endoscopes (cameras used to see the inside of the body). The front of the larger sinks were labeled with a sticker that read, “do not place anything below the sink here.” Multiple bottles of unopened detergent, used to decontaminate surgical instruments, were stored in a corner under that sink. b. On 4/24/24 at 8:25 a.m., observations were conducted of Supervisor #3 while they decontaminated a flexible endoscope. Supervisor #3 used equipment stored under the smaller sinks to perform this task. Further, under the sticker labeled “do not place anything below the sink here,” were two additional bottles of unopened detergent and four mesh brackets. Supervisor #3 used these mesh baskets to place surgical instruments in an automatic washer after they had been decontaminated. The observations of items stored under the sinks were in contrast to the SPD: Cleaning, Disinfection and Sterilization of Instruments policy which instructed to consider packaging non-sterile (compromised) after contamination with moisture. The policy further instructed to arrange storage areas in a manner that prevented splashing from personnel or housekeeping. Finally, the policy instructed to not store sterile items under plumbing valves and traps. The observations were also in contrast to ANSI/AAMI ST79:2017 & 2020 Amendments Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities which instructed to not store sterile items next to or under sinks, beneath exposed water or sewer pipes, or in any location where they could become wet. The guideline read sterile items that become wet were considered contaminated because moisture brought with it microorganisms from the air and surfaces. c. On 4/22/24 at 3:19 p.m., an interview was conducted with Supervisor #3. Supervisor #3 said the items stored under the sink stayed dry because staff used the row of smaller sinks to decontaminate ophthalmic surgical instruments. They explained staff did not splash as much at the smaller sinks because ophthalmic instruments were smaller and more delicate. However, Supervisor #3 said they had previously found wet items under the sinks. They explained the sinks leaked on the supplies. Supervisor #3 explained the wet supplies were ruined and had to be thrown away because they were contaminated by water, which could have led to a patient infection. Supervisor #3 said the facility used ANSI/AAMI guidelines in the SPD. d. On 4/24/24 at 4:39 p.m., an interview was conducted with infection preventionist (IP) #5. IP #5 explained items should not have been stored under the sinks because ultimately it increased the risk of patient harm. They stated items stored under the sinks could have been contaminated. IP #5 further stated if those items were used to decontaminate surgical instruments, it increased the risk of infections. 3. The facility failed to ensure expired medical devices and patient care supplies were not readily available for patient use and were discarded once expired. A. Observations i. Observations conducted on 4/24/24 at 9:15 a.m. in the urgent care department revealed expired supplies in the emergency cart, including: a. BD Insyte Autoguard BC Pro Shielded intravenous (IV) catheter (tubing), one package expired 8/31/22, and one package expired 3/31/24. b. Medichoice IV start kit (containing two gauze sponges, one tourniquet, one 3M Transpore tape, one dressing change label, one transparent dressing, and one PDI Chlorascrub Pad), one package expired 11/20/23. c. Sourcemark nasopharyngeal airway (tubing that bypasses airway obstructions) 24FR, expired 11/20/22. d. Vyvaire nasal cannula (tubing to deliver oxygen), one package expired 12/30/22, and one package expired 2/15/24. This observation of the emergency cart was in contrast to the Rotation of Expired Supplies policy and Safety, Infection, and Quality Plan which read, the plan was to provide a safe, functional, and sanitary environment of care. All supplies were rotated to ensure the items were used on a first-in, first-out basis. The oldest supplies were consumed first, reducing the possibility of outdated supplies. B. Interviews i. On 4/24/24 at 10:22 a.m., an interview was conducted with licensed professional nurse (LPN) team lead (Team Lead) #1. Team Lead #1 stated all of the urgent care staff checked for outdated supplies monthly, which was in contrast to the observation of expired supplies in the emergency cart. Team Lead #1 stated using current emergency patient care supplies was important to ensure patient safety and further elaborated the specific risk would depend on the nature of each supply. ii. On 4/24/24 at 3:32 p.m., an interview was conducted with Quality and Risk Director (Director) #2. Director #2 stated they had previously found expired supplies in the urgent care department, but were informed staff had implemented a new process to audit supplies. They stated they were led to understand expired supplies had been removed from all areas of urgent care. Director #2 stated it was important not to use expired supplies to ensure the integrity of the patient care supply.”