Grady Memorial Hospital

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 41506 Based on record review and interview, the hospital’s Governing Body failed to ensure at least 30 of 30 patient care contract services were reviewed and evaluated periodically, to ensure these services were provided safely and effectively. Findings: A review of the Governing Body meeting minutes for 2024 and 2025 and the facility’s contract binder showed no documented evidence the Governing Body reviewed and evaluated the hospital’s contract services for 2024 or 2025 to show that the Governing Body exercised responsibility in overseeing the delivery of the contract services. On 05/07/25 at 2:00 p.m. Staff C stated the facility had a policy on contract service review and evaluation (by the Governing Body) and they were unable to locate it. On 05/07/25 at 2:55 p.m. Staff O stated contract services used to be reviewed and evaluated by the Governing Body annually. Staff O further stated annual contract service review and evaluation “fell off the grid a couple of years ago” and they need to get it back on the Governing Body agenda again.”

“PATIENT RIGHTS: INFORMED DECISION CFR(s): 482.13(b)(3) The patient has the right to formulate advance directives and to have hospital staff and practitioners who provide care in the hospital comply with these directives, in accordance with §489.100 of this part (Definition), §489.102 of this part (Requirements for providers), and §489.104 of this part (Effective dates). This Standard is not met as evidenced by: 41506 Based on observation, record review and interview, the hospital failed to ensure 3 of 3 (Patient #21, #22, #23) patients being processed for admit were provided information regarding the hospital’s policy on advance directives and information on the state’s advance directives to assure patients could effectively exercise their right to make informed decisions about their care. Findings: On 05/06/25 from 8:30 a.m. to 9:00 a.m. observations of 3 (three) patients (Patients #21, #22, #23) being admitted to the hospital by the admitting personnel showed no documented evidence in the admit forms being presented to the patients of any information on advance directives. A review of the hospital policy titled “Advance Directives,” dated 01/1993, read in part, “Admitting will provide all admitted patients with information explaining the hospital policy concerning advance directives ... and on state laws concerning advance directives.” On 05/06/25 at 10:30 a.m. Staff N stated advance directive information was not provided to patients upon admit and patients were only asked if they had an advance directive.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 41506 Based on record review and interview, the hospital failed to ensure the nursing staff developed a nursing care plan for each patient based on assessing all the patient’s nursing care needs and not solely those needs related to the admitting diagnosis for 4 of 4 (Patient #1, #2, #3, #4) medical records reviewed for nursing care plans out of 20 medical records. Findings: A review of Patient #1 medical record read in part: Patient #1 was admitted to the hospital with a diagnosis of foot ulcer. A review of the patient’s medical history showed the patient also had a present history of diabetes and hypertension. The care plan showed the patient only had a documented care plan with goals and treatment plans for falls and wound care. A further review of the nursing care plan and the medical record showed no documented evidence that the patient had nursing care plans developed for the other medical diagnoses of diabetes and hypertension. A review of Patient #2 medical record read in part: Patient #2 was admitted to the hospital with a diagnosis of urinary tract infection. A review of the patient’s medical history showed the patient also had a present history of bipolar, anxiety, and depression. The care plan showed the patient only had a documented care plan with goals and treatment plans for reflux and urinary infection. A further review of the nursing care plan and the medical record showed no documented evidence that the patient had nursing care plans developed for the other medical diagnoses of bipolar, anxiety, and depression. A review of Patient #3 medical record read in part: Patient #3 was admitted to the hospital with a diagnosis of needing a total knee arthroplasty. A review of the patient’s medical history showed the patient also had a present history of diabetes, hypertension, and chronic obstructive pulmonary disease. The care plan showed the patient only had a documented care plan with goals and treatment plans for skin integrity, postoperative care, and tissue perfusion. A further review of the nursing care plan and the medical record showed no documented evidence that the patient had nursing care plans developed for the other medical diagnoses of diabetes, hypertension, and chronic obstructive pulmonary disease. A review of Patient #4 medical record read in part: Patient #4 was admitted to the hospital with a diagnosis of wound infection. A review of the patient’s medical history showed the patient also had a present history of coronary artery disease and diabetes. The care plan showed the patient only had a documented care plan with goals and treatment plans for infection, tissue perfusion relating to the wound, and pain. A further review of the nursing care plan and the medical record showed no documented evidence that the patient had nursing care plans developed for the other medical diagnoses of coronary artery disease and diabetes. A review of the hospital policy titled “Care Planning,” dated 05/31/23, read in part, “Care plans are planned on each patient’s unique needs (including age-specific needs), expectations, and characteristics with effective, efficient, and individualized care.” On 05/06/25 at 3:50 p.m. Staff C stated the nurses only captured the main diagnoses when developing patient care plans. On 05/06/25 at 5:10 p.m. Staff H stated the nurses developed the patient care plans based only on the admitting diagnoses and stated the care plans were not comprehensive and developed for all the patient’s current diagnoses.”

“FORM AND RETENTION OF RECORDS CFR(s): 482.24(b) The hospital must maintain a medical record for each inpatient and outpatient. Medical records must be accurately written, promptly completed, properly filed and retained, and accessible. The hospital must use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all record entries. This Standard is not met as evidenced by: 41506 Based on observation, record review, and interview, the hospital failed to ensure 3 of 3 open cabinets containing original medical records were stored in a manner to protect them from water damage. Findings: On 05/05/25 at 1:30 p.m. an observation of the medical record file room showed the medical record file room had original medical records stored on multiple open shelves in open cabinets, with no evidence of a water-resistant covering or a closed system cabinet in place to protect the medical records from water damage in the event the sprinkler system was activated in a fire. The medical record file room was observed to be fully sprinkled. A review of the hospital policy titled “Retention and Storage of Medical Records,” dated 01/10/25, read in part, “In order to safely preserve patient medical records for future use, the records will be kept in a secure area ... and shall be stored at the hospital for a minimum of 10 (ten) years following the last encounter.” On 05/05/25 at 2:00 p.m. Staff J stated the medical records file room stored original patient medical records that were prior to 2022 and only patient medical records after 2022 were stored electronically. They stated there were over 2000 original medical records stored in the room. Staff J stated the medical record room was fully sprinkled, and there was no protection in place to protect the medical records from water damage in the event the sprinkler system was activated in a fire. They further stated the medical record policy did not address how the original medical records would be protected from (water, fire) damage and they were unaware that original medical records had to be protected from damage.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 41506 Based on observation, record review, and interview, the hospital failed to ensure staff maintained a functional and sanitary environment relating to safe food and dietetic practices by observations of nutritional items being stored in 8 of 8 cardboard boxes in the refrigerator/freezer. Findings: On 05/05/25 at 3:40 p.m. observations in the dietary department’s refrigerator and freezer showed nutritional food items being stored in their original cardboard boxes. At least 8 (eight) of these cardboard boxes were observed to be weakened and damaged by the moisture in the refrigerator and freezer and the bottom boxes were visibly collapsing under the weight of the boxes stored on top of them. A review of the hospital policy titled “Refrigerator Storage and Freezer Storage,” dated 08/2024, read in part, “To maintain the integrity of refrigerated and freezer food supplies, proper refrigerator and freezer storage will be maintained according to approved standards ... Food will be stored so that air flow is not blocked.” The CDC guidelines on Food Safety in Healthcare, read in part, The USDA and the CDC advise against storing cardboard boxes in refrigerators and freezers. While cardboard boxes can be a convenient storage solution, it’s not recommended for food safety due to the potential for moisture, bacteria, and increasing the risk of contamination. Moisture can damage the cardboard, potentially affecting the contents or creating a breeding ground for bacteria. Cardboard may not be as effective at maintaining consistent temperatures of food items, causing temperature fluctuations which can potentially affect the stored items. On 05/05/25 at 4:05 p.m. Staff K stated the dietary department personnel kept nutritional foods items in their original cardboard boxes and stacked the boxes on top of one another, due to space limitations in the refrigerator and freezer. Staff K stated they were not aware of the food safety guidelines on cardboard box use in refrigerators and freezers.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 41506 Based on observation, record review, and interview, the hospital failed to ensure the staff followed acceptable professional standards of practice governing surgical services as evidenced by: 1. failing to ensure staff processed surgical items according to acceptable sterilization guidelines and/or manufacturer’s IFU when processing and sterilizing surgical items in paper-plastic peel pouches in observations of 20 of 20 paper-plastic peel pouches that were not light weight or low profile and were double-pouched, and 2. failing to ensure 25 of 25 clean surgical attire sets (pants and tops) were covered in the dressing lounges and failing to ensure 30 of 30 sterile surgical supplies (suture boxes), located outside of a designated storage area and stored on an open wire cart in the surgical semi-restricted hallway, were stored in a closed cabinet or a covered cart. Findings: 1. failing to ensure staff processed surgical items according to acceptable sterilization guidelines and/or manufacturer’s IFU when processing and sterilizing surgical items in paper-plastic peel pouches in observations of 20 of 20 paper-plastic peel pouches that were not light weight or low profile and were double-pouched, On 05/05/25 at 12:30 p.m., observations in the Sterile Supply Room showed several sterile items processed in paper-plastic peel pouches that were not low profile with visible tenting and creasing of the sterile packages. Further observations showed several sterile items processed in paper-plastic peel pouches that were not light weight with visible stress on the package’s sealed seams. Many sterile paper-plastic peel pouches were also observed to be double-pouched. A review of the AORN Guidelines for Perioperative Practice 2021 edition: Guidelines for Packaging Systems, read in part, “Use peel pouches (i.e., paper-plastic, polyethylene material, polyester film) according to a manufacturer IFU and/or according to AORN packaging guidelines. Sterile items processed in peel pouches should be light weight and low profile to maintain the sterility of the package contents and not compromise the package or the seal integrity (caused by heavy items or tenting). Sterile peel pouches should not be double-pouched (placing the item in one pouch and then placing this pouch inside another) unless the pouch manufacturer’s IFU allows this practice. Double pouching may entrap air and/or inhibit sterilant contact and can lead to polyethylene material seal failure. Sterility is event-related and not time-related. The sterility of an item does not change with the passage of time, but may be affected by events such as, amount of handling, improper storage, and properties of the packing material.” A review of the hospital policy titled “Sterilization Decontamination and Storage,” dated 04/2024, read in part, “Items double wrapped in plastic, pullback wrappers, and heat-sealed or pre-manufactured pouches will be considered sterile unless there is an event-related incident.” On 05/05/25 at 12:35 p.m. Staff G stated that staff preferred sterile items to be sterilized in paper-plastic peel pouches, so the sterile items were easily identifiable through the plastic. On 05/05/25 at 12:40 p.m. Staff F stated they knew that items processed in paper-plastic peel pouches were supposed to be low profile, light weight, and not double-pouched. They further stated the hospital did not have a policy specific on paper-plastic peel pouch guideline requirements when packaging these items for sterilization or a policy stating the manufacturer’s IFU guidelines. 2. failing to ensure 25 of 25 clean surgical attire sets (pants and tops) were covered in the dressing lounges and failing to ensure 30 of 30 sterile surgical supplies (suture boxes), located outside of a designated storage area and stored on an open wire cart in the surgical semi-restricted hallway, were stored in a closed cabinet or a covered cart. On 05/05/25 at 11:30 a.m. an observation of the clean surgical attire storage area in the dressing rooms (locker rooms) showed the clean surgical attire was being stored uncovered on a clothes rack with no visible covering in place. Another observation revealed the sterile suture boxes, located in the semi- restricted hallway on a wire cart, had no visible covering in place. A review of the AORN Guidelines for Perioperative Practice 2021 edition: Guideline for Surgical Attire read in part, “Store laundered surgical attire in enclosed (e.g., covered) carts, cabinets, or dispensing machines. Storing clean surgical attire uncovered in a facility locker, or locker room, or in a location with personal items from outside the facility, may contaminate the clean surgical attire.” A review of the AORN Guidelines for Perioperative Practice 2021 edition: Guideline for Sterilization read in part, “Store sterile items in a controlled environment. Limit exposure to dust, direct sunlight, handling, and temperature and humidity variances. Events that compromise the sterility of a sterile item include in part: air movement, humidity, temperature, location of storage, dust, multiple handling that leads to seal breakage, loss of package integrity (e.g., yellowing, holes, tears), moisture penetration (e.g., wet package), exposure to airborne contaminates (e.g., storing on open shelves in hallways). Controlled conditions reduce the risk of contaminating sterile items. Sterile items outside a designated sterile storage room should be stored in closed cabinets or covered carts.” A review of the hospital policy titled “Sterile Supplies,” dated 04/2024, read in part, “Sterile stock ... is stored in an environment that maintains the integrity of the sterile stock.” On 05/05/25 at 11:45 a.m. Staff E stated they were not aware that clean surgical attire had to be covered or contained in a closed or covered cabinet in the dressing lounges. Staff E further stated they were not aware of the guideline to cover sterile items when they were removed from a (designated) sterile room and stored in a hallway. They stated their policy on sterile packaging and sterile supplies were more general in nature.”