Department of Health & Human Services

Centers for Medicare & Medicaid Services
Form Approved

OMB No. 0938-0391
Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number 01C0001008 (X3) Date Survey Completed 10/12/2023
Name of Provider or Supplier Birmingham Outpatient Surgery Center, Ltd Street Address, City, State 2720 University Boulevard, Birmingham, AL
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.
(X4) ID Prefix Tag Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)
E0000 Based on a recertification survey conducted on 10/10/23 to 10/12/23, Outpatient Care Center was found to be in substantial compliance with the Centers of Medicare/Medicaid Services requirements for Emergency Preparedness.
Q0000 A recertification survey was conducted on 10/10/23 to 10/12/23 at Outpatient Care Center with standard level deficiencies cited.
Q0101 PHYSICAL ENVIRONMENT
CFR(s): 416.44(a)(1)

The ASC must provide a functional and sanitary environment for the provision of surgical services. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.


This STANDARD is not met as evidenced by:
Based on review of the facility policy and procedure, the facility temperature and humidity log documentation, and staff interviews, it was determined the facility failed to ensure the temperature (temp) and humidity was within the acceptable range. This had the potential to negatively affect all patients served by the facility.


Findings include:


Facility Policy No. (number) IC (Infection Control) 11


Title: IC-Air Exchanges, Temperature and Humidity Settings in the Operating Room (OR)/Procedure Room (PR)


Date Reviewed or Revised…10/23.


Policy:


An effective ventilation system is in place to minimize airborne microbial contamination. Temperature and humidity control is in place to maintain integrity of sterile packaging.


Procedure:


A. Humidity and Temperature


Room temperature and humidity is recorded…daily…for each OR. Daily a.m. (morning) checks of temperature and humidity will be recorded by a designated employee. A log sheet will be maintained to reflect reading for each OR. In the event…the humidity or temperature is outside the acceptable range, the nursing manager will be notified immediately for appropriate action.


1. OR humidity is maintained between 20%-60% relative humidity.... A relative humidity…too high can result in damp or moist supplies with added opportunity for mold growth... Room temperature is maintained between 68-75 degrees F (Fahrenheit).


…AORN (Association perioperative Registered Nurses) Guidelines for perioperative practice: Design and Maintenance.


Table 3. Heating, Ventilating, and Air Conditioning Design Parameters



Area…Sterile processing clean workroom…Design Temperature F 68-73 degrees, Design Relative Humidity maximum 60%


Sterile processing decontamination room...Design Temperature F 68-73 degrees...


…Sterile storage room…Design Relative Humidity Maximum 60%


…Procedure room (PR)…Design Temperature F 70-75 degrees, Design Relative Humidity 20-60%...














Review of the July 1-31 2023 Eye Center/Surgical Services log documentation revealed omitted temp and humidity and temps recordings outside the acceptable range temp 68-73 degrees F and humidity 20-60%:


7/17/23, 7/18/23, and 7/20/23 no temp and no humidity documented in St (Sterile) Supply.





7/27/23 Temp OR 2 64.2


7/28/23 Temp St Supply 65.2


Review of the August 1-31 2023 OR/Surgical Services log documentation revealed the following temps and humidity recordings outside the acceptable range 73 F, and 20-60% humidity:


8/1/23 Temp OR 4 63.4, OR 5 63


8/2/23 Temp OR 1 64.4, OR 4 64.3, OR 5 63.2


8/3/23 Temp OR 4 64, OR 5 64.7


8/4/23 Humidity OR 3 61; Temp OR 4 64, OR 5 63.7


8/7/23 Humidity OR 3 63, OR 4 62; Temp OR 4 63.8, OR 5 62


8/8/23 Temp OR 5 63.9


8/9/23 Humidity OR 1 61, OR 3 61; Temp OR 4 64.3, OR 5 62.5


8/10/23 Temp OR 1 64.5, OR 4 64.8, OR 5 63.4


8/11/23 Humidity OR 1 63, OR 3 67, OR 4 68, OR 5 61; Temp OR 4 64.6


8/14/23 Temp OR 4 64.6, OR 5 63.4, Humidity OR 1 62, OR 3 62


8/15/23 Humidity OR 1 62, OR 3 65, OR 4 61; Temp OR 3 64.5, OR 4 64, OR 5 64.6


8/16/23 Temp OR 1 64.1, OR 4 63.3; Humidity OR 1 63.


8/17/23 Temp OR 1 63.1, OR 4 64, OR 5 62.3 PR 63.8 (70-75 F acceptable temp)


8/22/23 Humidity OR 3 63, SPD (sterile processing decontamination[decon]) -Clean 66 (20-60 % acceptable)


8/23/23 Humidity OR 1 63, OR 2 63, OR 3 63, OR 4 61; Temp OR 4 63.4, OR 5 63.2


8/24/23 Temp OR 4 64.3, OR 5 63.5; Humidity OR 1 61, OR 3 62, Sterile Supply (SS) 61, SPD-Clean 65


8/25/23 Humidity OR 3 61, OR 4 61; Temp OR 4 63.4


8/28/23 Humidity OR 3 63; Temp OR 4 64.8, OR 5 63


8/29/23 Humidity OR 1 62, OR 3 61; Temp OR 1 64.8, OR 3 64.8, OR 4 64.5, OR 5 64, SPD- Clean 63.2


8/30/23 Temp OR 1 64.5, OR 4 63.4, OR 5 62.6; Humidity OR 3 61, SPD-Clean 62


8/31/23 Temp OR 1 63.7, OR 4 62.6, OR 5 63.5


Review of the August corrective action log documentation revealed on 8/3/23 dehumidifier left overnight, temp adjusted; on 8/4/23 dehumidifier out; on 8/14/23 adjusted temps continue dehumidifier, and on 8/21/23 CCSI (climate control systems incorporated) contacted to adjust setpoints. There was no documentation the facility temps and humidity levels were achieved within the acceptable range after corrective action.


Review of the September 1-29 2023 OR Temp/Humidity log documentation revealed the following temps and humidity recordings outside the acceptable 20-60 % for humidity, temp 68-73 F in OR, Sterile Processing Clean, Sterile Supply Rooms; Sterile Processing Decontamination temp 60-73 F:


9/1/23 Humidity Suture/Supp 62, CU (clean utility) 62, SPD-Clean 62; Temp OR 4 64.1, OR 5 63.7, Suture/Supp 63.9, SS 64.1, CU 63.4, SPD-Clean 64.1


9/5/23 Temp OR 4 64, OR 5 63.5, Suture/Supp 63.3, Sterile Supply 64.3 CU 62.4; Humidity OR 1 61, Suture/Supp 64, CU 61, SPD-Clean 61


9/6/23 Temp OR 1 64.4, OR 4 63.5, OR 5 64.4, Suture/Supp 64.1; SS 64.4, CU 63.2


9/7/23 Temp OR 1 64.5, OR 4 64, OR 5 64.2, CU 63.4


9/8/23 Humidity OR 3 61, OR 5 65; Temp OR 4 63.5, OR 5 63.5, SS 64.9, CU 64.1


9/11/23 Temp OR 1 64, OR 4 63, OR 5 64


9/12/23 Temp OR 1 63.9, OR 4 64.6, OR 5 64.2, SR 64


9/13/23 Temp OR 1 64, OR 3 64.7, OR 4 64, OR 5 64.4


9/14/23 Temp OR 1 63.9, OR 2 64.6, OR 3 64.8, OR 4 64, OR 5 63


9/15/23 Humidity OR 1 62, Temp OR 1 63.4, OR 4 63.3, OR 5 63.7


9/18/23 Temp OR 1 62, OR 4 63.3, OR 5 64.6


9/19/23 Temp OR 1 64.4, OR 4 63, SR 55, Suture/Supp 56.9, SS 55.7, CU 56.2, SPD-Clean 54.2, SPD-Decon 55


9/20/23 Temp OR 4 64, OR 5 64, PR 62, SR (Storage Room) 56.2, Suture/Supp 55.7, SS 56.1, CU 56.3, SPD-Clean 54.4. SPD-Decon 56.


9/21/23 Temp OR 1 64.1, OR 4 63.8, OR 5 63.2, PR 63, SR 55.4, Suture/Supp 56, SS 56.5, SPD-Clean 55, SPD-Decon 55.2; Humidity OR 1 61


9/22/23 Temp OR 1 63.7, OR 3 64.8, OR 5 64, PR 61, SR 58.4, Suture/Supp 56.1, SS 56, CU 56.3, SPD-Clean 55.1, SPD-Decon 54.9


9/25/23 Temp OR 1 63.1, OR 4 64.6, OR 5 64.4, SR 56.5, Suture/Supp 56.2, SS 55.4, CU 56.5, SPD-Clean 55.4, SPD-Decon 55.6


9/26/23 Temp OR 4 64.5, OR 5 63.5, SR 56.2, Suture/Supp 56.3, SS 56, CU 56.1, SPD-Clean 56.6, SPD-Decon 54.9


9/27/23 Temp OR 1 63.1, OR 3 64, OR 4 63.3, OR 5 64.4, PR 65.1, SR 56.3, Suture/Supp 56.1, SS 56.1, CU 55.9, SPD-Clean 54.9, SPD-Deco 55.2; Humidity OR 1 63


9/28/23 Temp OR 4 64.1, OR 5 63.5, PR 63.2, SR 56.4, Suture/Supp 56, SS 56.7, CU 55.6, SPD-Clean 53.9, SPD-Decon 55; Humidity OR 3 62


9/29/23 Temp OR 4 62.9, OR 5 63.5, Suture/Supp 54.1, SS 55.9, CU 55.4, SPD-Clean 54.7, SPD-Decon 55.4


Review of the September corrective actions revealed on 9/5/23 and 9/11/23 humidity multiple rooms, adjusted temperatures in rooms accordingly. There was no documentation the facility temps and humidity were within an acceptable range.


Review of the October 1-12 2023 OR Temp and Humidity Log documentation revealed the following temp recordings outside the acceptable range 68-73 F:


10/2/23 Temp OR 5 62.5, PR 56, SR 56.4, Suture/Supp 55.9, SS 56.3, CU 55.7, SPD-Clean 55.2, SPD-Decon 54.1


10/3/23 Temp OR 1 63.9, OR 3 64.9, OR 5 62, SR 55.9, Suture/Supp 55.2, SS 55.3, CU 53, SPD-Clean 55.1, SPD-Decon 54.1


10/4/23 Temp OR 1 63.7, OR 2 65.6, OR 3 64, OR 4 63.6, OR 5 63.5, PR 55.1, SR 56.1, Suture/Supp 54.9, SS 54.1, CU 54.7, SPD-Clean 55.2, SPD-Decon 54


10/5/23 Temp OR 1 64.9, OR 2 64.4, OR 3 65.9, OR 4 63.6, OR 5 62.2, PR 54.9, SR 56, Suture/SUPP 59, SS 58.1, CU 57.1, SPD-Clean 56, SPD-Decon 53.9


10/6/23 Temp OR 5 63.5, PR 55.1, SR 55.2, Suture/Supp 57, SS 56.9, CU 53.9, SPD-Clean 55.2. SPD-Decon 54.2


10/9/23 Temp OR 1 61.5, OR 4 62, OR 5 63, SR 54.4, Suture/Supp 59.1, SS 53.1, CU 54.7, SPD-Clean 55, SPD-Decon 53.9


10/10/23 Temp OR 1 62.1, OR 4 62.3, OR 5 64, PR 64.9, SR 59.9, Suture/Supp 58.2, SS 56.1, CU 55, SPD-Clean 56.9, SPD-Decon 54.


Review of October corrective action log documentation revealed one entry, adjusting temps QD (every day) for parameters. There were no date(s) specified and no documentation the temperatures were within the acceptable range per policy.


An interview was conducted on 10/11/23 at 11:10 AM with EI (Employee Identifier) # 1, Administrator who confirmed the initial morning temp and humidity log recordings were outside the acceptable range. EI # 1 reported the facility would retrieve additional documentation from the software vendor as evidence daily acceptable temperature/humidity ranges were adjusted and within range.


An interview was conducted on 10/12/23 at 9:51 AM with EI # 2, Director of Nursing who confirmed there was no documentation the daily temperature and humidity were within an acceptable range.

Q0241 SANITARY ENVIRONMENT
CFR(s): 416.51(a)

The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.


This STANDARD is not met as evidenced by:
Based on observations, review of facility policies and procedures, Centers for Disease Control and Prevention (CDC): Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, Manufacturer Directions for Use (DFU) for Medline Enzymatic Detergent, Sterilization Logs, and interviews, it was determined the facility failed to:


1. Maintain a sanitary environment for patients and staff.


2. Ensure staff followed the facility procedure and cleaned and disinfected all environmental surfaces between patients.


3. Ensure staff performed hand hygiene and gloving per facility policy.


4. Ensure staff followed the manufacturer's DFU for Medline Enzymatic Detergent when performing cleaning of surgical instruments.


5. Maintain an adequate number of sterilized surgical instruments/trays to prevent the need to perform Immediate Use Steam Sterilization (flash sterilization) of surgical instruments for the scheduled procedures on a routine basis.


This affected PI (Patient Identifier) # 19 and had the potential to negatively affect all patients at this facility.


Findings include:


Facility Policy: Infection Control (IC) - Standard, Universal and Transmission-based Precautions


Policy No: IC.29


Date reviewed or revised: 10/2023


Policy:


The Outpatient Care Center IC Plan recognizes the unique protocols for the ambulatory surgery setting in maintaining a safe environment for patients and healthcare workers...


Procedure:


...2. Universal Precautions (UP)


... All reusable patient equipment is to be cleaned between patients with germicidal cleaner or wipes... (See Appendix A).


...Procedures will be in place and followed for the routine care, cleaning, and disinfection of environmental surfaces, beds, and other frequently touched surfaces.


Appendix A:


Area:


All horizontal surfaces (... tops of counters, ... fixed shelving...): At least daily and whenever soiled.


All furniture and equipment...: At least daily and whenever soiled.


Stretchers: Between patients and whenever soiled.


...Shelves: At least daily and whenever soiled.


... Walls...: As needed...


Facility Policy Hand Hygiene


Policy No. IC. 31


Revision or Review 11/22


Purpose: Effective hand hygiene reduces the incidence of healthcare associated infections.


Policy:


…the healthcare team will comply with…hand hygiene guidelines.


Procedure:


1. Indications for handwashing and hand antisepsis:


A…wash hands with either a non-antimicrobial soap and water…


B. If hands are not visibly soiled use an alcohol-based rub…


D. Decontaminate hands before donning gloves.


...E. Decontaminate hands after contact with a patient’s intact skin.


...I. Decontaminate hands after removing gloves...


Facility Policy: IC - Sterilization Standards: Processing Instruments and Equipment for Immediate Use


Policy No: IC.22


Date reviewed or revised: 11/2022


Policy:


When sterile instruments and equipment are needed immediately for a procedure or when wrapped instruments and equipment are not available...


(CDC): Guideline for Disinfection and Sterilization in Healthcare Facilities 2008


...13. Flash Sterilization:


... b. Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time...


e. When necessary, use flash sterilization for patient-care items that will be used immediately (...to reprocess an inadvertently dropped instrument)...


Medline Enzymatic Detergent


Manufacturer's Directions For Use


Manual Cleaning:


...3. For instrument holding solution, ... use 1 oz (ounce) of concentrate solution per gallon of water...





1. A tour of the first floor Pre-Op (Operative)/Post-Op area was conducted with Employee Identifier (EI) # 8, Clinical Coordinator (CC), on 10/10/23 from 9:15 AM to 10:18 AM and the following sanitary and environmental issues were identified:


a. Pre-op Room (Rm) 1, 2, 3: Broken shelving on the countertop at the head of bed (HOB) with border of shelving hanging loosely from the countertop. Peeling paint on Left (Lt) wall bumper guard.


b. Pre-op Rm 4 and 6: Broken shelving on the countertop at HOB.


c. Pre-op Rm 4, 5, and 6: Broken floor tiles running across the entire length of the rooms with a buildup of dust, dirt, and rust.


d. Post-op Rm 7 and 8: Wallpaper torn loose from the wall underneath the shelving at the HOB.


e. Nourishment area: Wood panel sheet approximately 2 feet pulled away from the wall on the left side and wood panel under the beverage dispenser torn and smashed.


EI # 8 was present during the tour and confirmed the findings.


An interview was conducted on 10/12/23 at 11:01 AM with EI # 1, Administrator, who confirmed the facility failed to maintain a functional and sanitary environment for patients and staff.


2. A tour of the Procedure Rm was conducted with EI # 2, Director of Nursing (DON), on 10/10/23 at 10:45 AM and the following sanitary and environmental issues were identified:


a. Large amount of torn clear and black tape on metal head rest of the procedure bed.


b. White adhesive buildup markings on the mattress pad on the head of bed.


c. Brown stains on the lead shields at the head of the bed.


d. Rubber matting on the bed loose on left and right side of the bed at the foot of the bed.


e. Bottom rail of the bed with moderate amount of dust and small amount of rust.


An interview was conducted with EI # 2 during the tour. The surveyor asked EI # 2 when terminal cleaning is performed. EI # 2, replied, "At the end of the day." EI # 2 then confirmed there were no procedures scheduled today and the room had not been terminally cleaned after procedures performed on 10/9/23.


3. An observation of care was conducted on 10/10/23 at 11:20 AM during cleaning and disinfection of the PACU (post-acute care unit) observation room 1 between patients. EI # 9, Perioperative RN (Registered Nurse) cleaned the top of the stretcher mattress and the seat and back of the chair with disinfecting wipes. EI # 9 failed to disinfect the sides and bottom of the mattress. EI # 9 failed to disinfect the chair armrests.


After disinfection of the room, EI # 9 removed his/her gloves, but failed to perform hand hygiene after glove removal. EI # 9 retrieved a patient supply bag from the supply closet. With dirty hands, EI # 9 removed the linen, gown, safety socks and supplies from the bag, and placed the clean supplies on the stretcher.


An interview was conducted on 10/12/23 at 10:55 AM with EI # 1, who confirmed staff failed to follow facility cleaning/disinfection and hand hygiene procedures.


4. A tour of the 3rd floor surgical services was conducted on 10/10/23 at 3:25 PM with EI # 2, and EI # 10, Operating Room (OR) Manager, 3rd Floor. In OR 5, there was a carbon piece(the hard base surface) missing/chipped from the top left corner of the OR table, the left upper corner OR table pad was worn, the black leather cover was not present, a brown cloth underneath was visible, and there was adhesive buildup surrounding the brown cloth edge of the OR table pad.


An interview was conducted with EI # 2 on 10/10/23 at 3:30 PM, who confirmed the OR table carbon surface was not intact, the OR table pad edge was sheared, and adhesive was left on the table pad.


5. An observation was conducted in central sterile on 10/11/23 at 11:07 AM to observe EI # 6, OR Technician (Tech) perform pre-cleaning of surgical instruments with Medline Enzymatic Detergent.


EI # 6 stated, "I use two ounces of Enzymatic Detergent to one gallon of water" to clean the instruments. EI # 6 then proceeded to pre-clean the surgical instruments using two ounces of Enzymatic Detergent to one gallon of water. EI # 6 failed to follow the manufacturer's DFU for Enzymatic Detergent of one ounce of detergent to one gallon of water when pre-cleaning surgical instruments.


An interview was conducted on 10/12/23 at 9:34 AM with EI # 1 who confirmed the staff failed to follow the DFU for Enzymatic Detergent when pre-cleaning surgical instruments.


A review of the September and October 2023 Sterilization Logs was conducted on 10/11/23 at 1:30 PM with EI # 7, Sterile Processing Department Lead Tech, EI # 10, and EI # 1. Documentation revealed, "Load Type" column, IUSS (Immediate Use Steam Sterilization {Flash}), was circled on numerous days. The surveyor asked EI # 7, what types of trays were being flashed sterilized routinely and EI # 7 replied, "ENT (Ear, Nose, Throat) and Ortho (Orthopedic)."


Review of the Sterilization Logs for September and October 2023 revealed the facility flashed sterilized ENT and Ortho trays in:


September: 11 ENT trays and 5 Ortho trays


October: 4 ENT trays


An interview was conducted during the review of the sterilization logs with EI # 1 who confirmed the facility failed to maintain an adequate number of sterilized surgical instruments/trays (ENT and Orth) to prevent the need to flash sterilize surgical instruments for scheduled ENT and Ortho procedures on a routine basis.