Statement of Deficiencies

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)

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.