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310 WOODSTOWN ROAD

SALEM, NJ 08079

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, staff interview, and review of facility documents, it was determined the facility failed to ensure a sanitary environment is provided to prevent and control the transmission of infections concerning: 1.) proper storage and management of blood products, and 2.) proper medication storage.

Findings include:

1. On 6/22/22, during a tour of the laboratory and blood bank in the presence of Staff #2 and Staff #6, the surveyor observed the following inside a large refrigerator with three clear doors:

At 10:06 AM, stored on the right side of the refrigerator, on the second shelf, was a urine specimen in a biohazard bag. Upon interview at 10:32 AM, Staff # 6 stated, "Before we moved the blood to this refrigerator, histology used this shelf to store their specimens ... "

At 10:40 AM, on the bottom shelf behind the center refrigerator door, there was a white plastic basket containing two partially infused units of packed red blood cells (PRBC) with the used intravenous blood tubing still attached. Upon interview at 10:42 AM, Staff #6 stated, " ... the units are quarantined ... I'm not sure what we are going to do with them at this time ... "

At 3:02 PM, on the right side of the refrigerator, on the bottom shelf, a corrugated cardboard box with two units of PRBC in a clear plastic bag on top was observed with an expiration date of May 2022. Upon interview at 3:05 PM, Staff # 6 stated, " ... those are expired units waiting to be discarded ..."

Review of the facility policy titled, "Issue, return and Re-Issue of Blood Components," dated 3/29/21, stated, " ... B. In cases, where a patient has not received the complete unit of blood and the bag is returned to the Blood Bank ... the remaining portion of the unit is discarded in a "Biohazard" bag for incineration ... "

Review of the facility policy titled, "Inventory Management," dated 4/27/21, stated, " ... A. Red Blood Cells ... 2. Separation of Red Blood Cells Units ... c. Quarantined Units; Suspicious units will be placed in quarantine immediately. The units remain quarantined until its fate is decided by the supervisor, medical director or ARC ... "

2. At 3:02 PM, on the left side of the refrigerator, on the second shelf, twelve (12) boxes of Alcon DuoVisc (ophthalmic surgical aid) were observed stored adjacent to multiple packages of laboratory reagents. Multiple packages of laboratory reagents were also observed directly above and below the DuoVisc. Further observation revealed that approximately two feet adjacent on the same shelf were twelve (12) units of unused PRBCs.

Upon interview at 3:05 PM, Staff #6 stated, " ... DuoVisc should probably not be stored there, but it was delivered to the blood bank earlier this year and was tossed in the refrigerator for follow-up ... "

Review of the facility policy titled, "Medication and Device Storage: General," dated 11/13/19, stated, " ... 2.2 Storage conditions: 2.2.1 Drugs shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety, and security ...2.4 Separation of Internals for Externals: 2.4.1 Antiseptics, disinfectants, poisons, test reagents, and other drugs for external use (e.g. otics [sic] and opthalmics[sic]) shall be stored separately for internal and injectable drugs (e.g. on separate shelves or in separate containers for internal injectable drugs) ... "

The above findings were confirmed with Staff #2 and Staff #6 at the time of discovery.

EMERGENCY SERVICES

Tag No.: A1100

Based on review of staff and patient interviews and review of medical records and facility documents, it was determined the facility failed to ensure the emergency needs of patients presenting to the Emergency Department (ED) are met.

Findings include:

The facility failed to ensure that CT (computed tomography) scan and laboratory services and personnel were immediately available to all ED patients requiring these services. (Cross-refer to Tag A1103)

INTEGRATION OF EMERGENCY SERVICES

Tag No.: A1103

Based on staff and patient interviews and review of medical records and facility documents, it was determined the facility failed to ensure personnel for CT (computed tomography) scan and laboratory services are available to the Emergency Department (ED) for patients requiring CT and laboratory services to rule out an emergency medical condition (EMC); and, failed to ensure patients requiring medical transfer was provided with transportation to the facility that would provide the medical treatment. This deficient practice was identified for three of six patients (#19, #22, and #30).

Findings include:

1. A review of Patient #19's medical record revealed the following:

On 6/10/22 at 20:36 [8:36 PM], in the ED Physician Documentation section, it was indicated the patient arrived in the ED with complaints of abdominal cramping, nausea, vomiting, pounding headache, pain to forehead. Pain was rated 10 out of 10. The patient was pregnant (unknown gestation). "She has not had prenatal care for this pregnancy."

The ED Physician documentation at 20:58 [8:58 PM] stated, "Differential diagnosis: ... Concern for a subarachnoid hemorrhage based on history. No CT available at this time. She is attempting to find a ride as a transfer make [sic] take some time. Will reassess. At 21:00 [9:00 PM] physician documented "Pt [patient] found a ride. Will d/c[discharge]."

A review of the ED Physician Documentation section indicated the patient was administered Acetaminophen 1000 mg at 20:55 [8:55 PM] and Zofran ODT 4 mg at 20:59 [8:59 PM]. The patient was discharged at 21:05 [9:05 PM]. The ED Nurse Documentation stated, "Discharged to Advised to go to nearest hospital with CT capability."

Review of the CT Staff Schedule with Staff #6 revealed that on 6/10/22 there was no staff coverage from 7:00 PM- 7:00 AM.

On 6/22/22 at 1:41 PM, during an interview with Staff #5, an ED Physician, it was stated that there was a concern for subarachnoid hemorrhage and ectopic pregnancy due to the patient presenting with the worst headache (pain 10/10) and abdominal cramping. Staff further stated, "there was no lab or CT services available on 6/10/22. The patient was offered an ambulance which might take a significant delay, or the patient can find a ride to go to another facility with CT capability."

During the interview, Staff #5 stated the patient's vital signs were stable, no neurological deficits, and was not bleeding vaginally, thus it was safe for the patient to be discharged to go to another facility.

2. A review of Patient #22's medical record revealed the following:

On 6/10/22 at 23:55 [11:55 PM], in the ED Physician Documentation section, the patient arrived at the facility with complaints of leg swelling. On 6/11/22 at 00:17 [12:07 AM], the ED Physician documentation under assessment indicated, " ... Respiratory: airway is compromised Trachea midline Respiratory effort is labored, shallow, Respiratory pattern is apnea ... the patient has severe shortness of breath ... Reassessment: Patient placed on CPAP ..." The ED physician documented at 00:17 [12:17 AM] under Differential diagnosis, " ... concerns for heart failure ...", lab work and Chest X-Ray was ordered.

At 5:35 AM, the ED Physician documentation stated, "The labs are still pending results as they have to go to Vineland to be analyzed. The patient then requested to leave."

The ED Nurse Documentation section indicated that the patient left against medical advice on 6/11/22 at 5:46 AM.

Review of the ED Divert Log indicated that on 6/10/22, the ED was on Total Care Divert from 19:00 - 23:00 [7:00 PM - 11:00 PM] due to "No Lab, No Blood Bank, No CT Scan." The facility continued to be on Total Care Divert from 2300 - 300 [11:00 PM - 3:00 AM] due to "No lab".

3. A review of Patient #30's medical record revealed the following:

On 6/13/22 at 21:35 [9:35 PM], in the ED Physician Documentation section it was indicated that the patient arrived in the ED with complaints of chest pain from an injury.

At 21:43 [9:43 PM], in the ED Physician Documentation section, it was stated that the patient fell three days prior and developed worsening pain and shortness of breath. In addition, the ED Physician documentation included, "D/W [discussed with] PT [patient] and family going to Elmer as we do not have CT at all and that's what I think [he/she] needs regardless of X-Ray."

Review of the ED Nurse Documentation indicated that the patient was ordered for discharge on 6/13/22 at 21:47 [9:47 PM] and left the ED at 22:03 [10:03 PM]. At 21:47 [9:47 PM], the ED Nurse's Documentation stated, "... Discharge instructions given to patient. Instructed on need for CT at closest facility. EDP [ED Physician] called [facility name] Elmer to let them know pt [patient] would be arriving shortly ... 22:03 [10:03 PM] Patient left the ED."

Review of the CT Staff Schedule with Staff #6 revealed that there was no staff coverage to provide CT services on 6/10/22 for the 7:00 PM - 7:00 AM shift.

Review of the ED Divert Log indicated that on 6/10/22, the ED was on Total Care Divert from 19:00 - 23:00 [7:00 PM - 11:00 PM], due to "No Lab, No Blood Bank, No CT Scan."

On 6/23/22 at approximately 3:15 PM, during an interview with Staff #3 regarding transfers and transportation, Staff #3 was stated that the arrangement with [facility name - Hospital B] was made "a long time ago.'' Staff #3 further stated that a request was made to place an ambulance (rig) at the facility property; however, this was not agreed upon. Staff #3 then stated that the final agreement was for a rig to be placed on stand-by between this facility and Hospital B. Upon request, Staff #3 was unable to provide a written contract or documentation of the agreement that was established between the facility and Hospital B.

The above findings were confirmed with Staff #1, Staff #2, and Staff #3 on 6/23/22 at 3:20 PM.

The failure of the facility to provide CT scan and laboratory services resulted in an Immediate Jeopardy (IJ). The Administrator was informed of the IJ on 6/22/22 at 4:30 PM, and the IJ template was provided.

On 6/23/22, an acceptable removal plan was received. The IJ was removed upon on-site verification that the facility had coverage for all open shifts for both CT Scan and Laboratory department. The removal plan included future plans to fill all open shifts by using agency and regular staff offering incentive pay to staff.