HospitalInspections.org

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for the Provision of Services.

Based on observation, interview, and record review, the facility failed to:

- ensure laboratory personnel followed established policy and procedures for the immediate notification to the ordering provider of critical value laboratory test results (See C1028).

- establish policy and procedures for critical value reference ranges which were consistent and reflected the utilized computerized critical value reference ranges utilized to determine critical value laboratory results (See C1028).

- establish and implement procedures to ensure laboratory personnel reported in-house laboratory results to out of network providers in a manner which ensured the timely notification of those results (See C1028).

- ensure ancillary nursing staff performed quality control testing effectively per the facility's established policy and procedures and the glucometer testing devices manufacturer's guidelines for the point of care testing (POCT) of bedside glucose monitoring, overseen by the laboratory manager or designee (See C1028).

Based on observation, interview, and record review, the facility failed to:

- ensure laboratory personnel followed established policy and procedures for the immediate notification to the ordering provider of critical value laboratory test results for 8 (#s 1, 3, 4, 5, 6, 7, 8, and 9) of 17 sampled patients;

- establish policy and procedures for critical value reference ranges which were consistent and reflected the utilized computerized critical value reference ranges utilized to determine critical value laboratory results. This deficient practice had the potential to affect the accuracy of reported critical laboratory results;

- establish and implement procedures to ensure laboratory personnel reported in-house laboratory results to out of network providers in a manner which ensured the timely notification of those results for 3 (#s 1, 3, and 15) of 17 sampled patients; and

- ensure ancillary nursing staff performed quality control testing effectively per the facility's established policy and procedures and the glucometer testing devices manufacturer's guidelines for the point of care testing (POCT) of bedside glucose monitoring, overseen by the laboratory manager or designee. This deficient practice had the potential to affect the accuracy of patients' blood glucose management.

The cumulative effect of these deficient practices had the potential to affect safe patient outcomes related to the essential diagnosis and treatment of patients. Findings include:

1. Critical Laboratory Value Notification

A review of the facility's policy and procedure titled Standard Operating Procedure, with an effective date of 9/1/23, showed:
"Reporting Results
D. All results will be accurately recorded by personnel who are determined to be qualified and competent to perform testing.
E. All critical values will be immediately re-tested. If the result is verified, a comment will be placed on the critical result and the provider or designee will be notified within 30 minutes of the final report.
F. Test results will be reported to the ordering provider.
H. If the ordering provider is not available to receive a critical value, the on-call provider will be notified.
I. Notification of critical values will be documented in the Critical Queue in Cerner..."

A review of the facility's policy and procedure titled, Critical Value Immediate Notification, with an effective date of 12/12/23, showed:
"Procedure:
2. Once the specimen has been checked for accuracy, the result will be immediately
reported.
3. The responsible provider, inpatient location, or private office, is to be called with the results. If the provider is not available, a nurse or other designee can be given the result but should be instructed on the necessity to give this result to the provider in a timely manner.
a. Give the result(s) and request a read-back of "what was written down" and document as comment in the LIS [sic].
b. If the results are not given to the provider directly (nurse or designee ), confirm that the recipient acknowledges the severity of the result and that it should be
communicated to the provider within 15 minutes.
c. When critical results need to be called after hours or when the office is not open, an on-call provider or answering service must be available on a 24-hour basis to take responsibility for receiving the result. If an answering service is called, the urgency of the result and necessity to give this result to the responsible provider is explained, but the result is not reported, and an appropriate call-back number is left. The time and person receiving the call is recorded as a comment in the LIS [sic]. The responsibility for contacting the responsible provider rests with the office/answering service but follow-up must be ensured by the laboratory staff.
e. Patient history will be checked and if a similarly abnormal value was reported within the past few days, the repeat critical value will not be treated as an emergency, and will be reported according to our standard protocol (i.e., will not be immediately called)"

During an interview on 8/6/25 at 12:52 p.m., NF1 stated patient #1 was receiving frequent blood transfusions and would have a CBC (Complete Blood Count- a blood test that measures the levels of red blood cells, white blood cells, and platelets. These measurements help assess various conditions like anemia, infections, or bleeding disorders) completed at the facility prior to driving to another town for blood transfusions. NF1 stated on 4/28/25, patient #1 had a critically low hemoglobin level of 5.5 gm/dL (a critically low hemoglobin (HGB) level, also known as severe anemia, can lead to serious health complications and even death. It's a condition where the blood doesn't carry enough oxygen to the body's tissues, causing various symptoms and potentially damaging vital organs. A hemoglobin test is often part of a complete blood count). NF1 stated on 4/28/25, the patient had labs drawn at the facility at 7:43 a.m. NF1 stated at 9:42 a.m., the transfusion clinic called and needed orders and the test results for patient #1. NF1 stated she called the facility at 9:57 a.m., and was told by staff member D that staff member I had forgotten to send the results. NF1 stated they received the test results from the facility at 9:59 a.m. NF1 stated the critical value should not only have been faxed but the facility should have immediately called the ordering provider because it was a critical lab value.

Review of patient #1's EHR for the CBC result dated 4/28/25, showed the blood sample was collected at 7:35 a.m., and was processed, resulted, and verified, by the facility at 7:43 a.m. The patient's HGB was 5.5 gm/dL. The facility's EHR showed an established critical value reference range for HGB of 6.0 gm/dL to 18.2 gm/dL. A result comment on the report showed, "HGB, sent to [NF1] Clinic. The following result was called back by [staff member I] on 7/28/25 at [2:20 p.m.]: HGB". The comment utilized to indicate the immediate notification of the critical value did not show the critical value on 4/28/25, was immediately communicated to the ordering provider until 7/28/25 (three months later).

During an interview on 8/12/25 at 9:25 a.m., staff member D stated it was the expectation when a critical value was identified, that value was to be immediately reported to the ordering provider and a notation made in the computer system with the date and time the critical value was reported and to whom it was reported. Staff member D stated she had returned to work after being on leave for a couple weeks at the beginning of July 2025, to find that the "Critical Queue" in the EHR had not been monitored while she was away. She stated she provided re-education with staff member I on the process for the "Critical Queue". Staff member D stated that was why the comment on patient #1's CBC, dated 4/28/25, showed the critical value was reported to the provider on 7/28/25. She stated however, this would not account for why the "Critical Queue" was not monitored the day of patient #1's critical value for the HGB. Staff member D stated she monitored the "Critical Queue" a couple times a week. Staff member D stated she had not checked her "Critical Queue" system since 7/28/25.

During an interview on 8/12/25 at 11:04 a.m., staff member G stated the expectation for reporting critical lab values was to notify the ordering provider within one hour of the results being verified. She stated the EHR had a "Critical Queue" which notified the lab technicians of any critical lab values. She stated she kept her "Critical Queue" open all day long and checked it frequently for any critical lab values that populate. However, the expectation was to check it at least hourly.

A review of staff member D's "Critical Queue" on 8/12/25 at 9:00 a.m., showed the following patients were identified to have critical lab values which had not been completed in the "Critical Queue" from 5/1/25 to 8/2/25:

- 5/1/25 at 2:24 p.m., patient #3,
- 5/24/25 at 1:52 p.m., patient #4,
- 6/10/25 at 2:49 p.m., patient #5,
- 6/23/25 at 12:08 p.m., patient #6,
- 7/1/25 at 11:32 a.m., patient #7,
- 7/21/25 at 11:56 a.m., patient #8, and
- 8/2/25 at 8:39 a.m., and 11:43 a.m., patient #9.

During an interview on 8/12/25 at 9:00 a.m., staff member D stated she was not sure why the following patients were still listed in the "Critical Queue". She stated she thought it was because they had not been completed or finalized. Staff member D stated the ordering providers should have already been notified of all the critical lab values that were currently in the "Critical Queue".

A review of patient #4's CBC dated 5/24/25, which had been verified/resulted at 2:49 p.m., showed a critically high HGB value of 18.3 gm/dL (A critically high HGB level, which indicates an excess of red blood cells in the blood, can lead to various health complications, including blood clots, stroke, and heart attack). Further review of patient #4's EHR and laboratory results for 5/24/25 did not show a comment which indicated the critical lab value was immediately reported to the ordering provider.

During an interview on 8/12/25 at 1:45 p.m., staff member D stated there was no comment in patient #4's EHR or for the critical lab value on 5/24/25, which would indicate the critical lab value was not immediately reported to the ordering provider.

2. Critical Value Reference Ranges Consistent with Computer Module

A review of the facility's policy and procedure titled, Critical Value Immediate Notification, with an effective date of 12/12/23, showed their established critical value reference ranges for:
- HGB set for a low value at less than 8.0 gm/dL and a high value greater than 18.3 gm/dL.
- White Blood Cells (WBC) set for a low value at less than 2,000 mm and a high value greater than 50,000 mm.

Review of the facility's computerized established critical value reference ranges for HGB and WBC showed:
- WBC critical low at less than 2,500 mm, and a critical high value at 30,000 mm.
- HGB critical low at less than 6.0 gm/dL, and a critical high value greater than 18.2 gm/dL.

3. Timely Notification of In-House Laboratory Results to Out of Network Providers

A review of the facility's policy and procedure titled Standard Operating Procedure, with an effective date of 9/1/23, showed:
"... Reporting Results
A. All results of in-house testing will be reported within 4 hours unless referred to another facility.
C. Testing received after 4:30 p.m. may be reported the following day, if appropriate.
F. Test results will be reported to the ordering provider.
J. Reference laboratory results will not be modified in any way and will be reported as soon as possible after receipt..."

During an interview on 8/6/25 at 12:52 p.m., NF1 stated they were not faxed the results of ordered labs timely by the facility. NF1 stated they would often have to call the facility and ask for the results to be sent to them.

During an interview on 8/12/25 at 1:45 p.m., staff member D stated to send out of network providers the laboratory results, the facility would print a hard copy of the lab and fax it to them using the fax machine and then keep a paper copy of the faxed report. She stated the facility recently changed their faxing system to Right Fax. Staff member D stated she wasn't sure how to obtain a fax verification for any older faxes.

A review of the following patient medical charts for April 2025, showed the facility did not have a faxed validation report that showed the out of network provider was faxed a report for their lab results for: Patient #s 1, 3, and 15.

During an interview on 8/12/25 at 1:45 staff member D stated she checked, and the facility did not have any fax validation reports for April of 2025 to show that out of network providers were timely faxed the results of ordered labs.

4. Glucose Point of Care Testing Quality Controls

A review of the facility's policy and procedure titled Standard Operating Procedures, with an effective date of 9/1/23, showed:
"Laboratory Personnel:
C. Day to day operations of the laboratory will be overseen by an individual(s) who meet the CLIA standards for General Supervisor in a high complexity laboratory...
Reagents, Controls, Test Kits, and Media:
A. All reagents, controls, test kits and media will be marked with the date received, date opened and the expiration date.

A review of the facility's policy and procedure titled, POC Glucose Testing, with an effective date of 5/30/25, showed:
"Quality Control Procedure:
6. ...Record the result in the quality logbook.
7. Remove the test strip and dispose.
8. Repeat steps 1-6 with a second control solution.
Meter Preparation:
1. Check the QC log to see that the QC was performed on the testing day. If not, run two levels of control as described in the Quality Control procedure section..."

A review of the Quality Assurance/Quality Control Reference Manual Manufacturer Guidelines for the Assure Platinum Glucometer, showed:
"Assure Platinum Test Strips Storage and Handling
... Do not re-use an Assure Platinum Test Strip.
Only use Assure Platinum Test Strips with an Assure Platinum Blood Glucose Meter...
Assure Dose Control Solutions
...Use the Assure Dose Control solution within 90 days (3 months) of first opening. It is recommended that you write the date of opening on the control solution bottle label ("Date Opened") as a reminder to dispose of the opened solution after 90 days..."

a. During an observation and interview on 8/11/25 at 2:30 p.m., there were two Assure Platinum Glucose Meters being utilized outside the lab in the facility's emergency department and the swing-bed long-term care department. The first meter was in the emergency department in a blue basket. The meter had a container of glucose test strips with a lot number of: 634635U. There were no control solutions in the blue basket. There was not a glucose quality control log for the meter in the emergency department. Staff member D stated the log was kept at the nurses' station. She stated the test strips kept with the glucometer in the emergency department would be utilized for testing a patient's bedside glucose.

During an observation and Record Review on 8/11/25 at 2:30 p.m., the Glucometer Quality Control Logbook at the nurses' station showed quality controls were ran on both glucometers using the test strips with a lot number of: 634325U. The test strips with lot number 634635U, kept in the blue basket with the glucometer, that was used in the emergency department, did not have quality control documented in the logbook.

During an interview on 8/12/25 at 10:30 a.m., staff member B stated the quality controls for the glucometers were ran by the night shift nurses after midnight every night. Staff member B stated both meters and both test strips used with each meter should be quality controlled every night. She stated the test strips in the blue basket were used with the glucometer that was used in the emergency department. Staff member B stated she could not tell from the Glucometer Quality Control Log if the test strips used with the glucometer in the emergency department with lot number 634635 had been quality controlled.

b. During an observation on 8/11/25 at 2:30 p.m., a second Assure Platinum Glucose Meter was kept in a pink basket at the nurses' medication cart. The pink basket contained the glucometer, test strips with a lot number of 634325U, a normal control solution with a lot number of 22224A, and a high control solution with a lot number of 022824A. Both control solutions were opened but there was no date when opened.

During an interview on 8/11/25 at 2:30 p.m., staff member D stated it was the expectation that the quality control solutions used to test the normal and high glucose controls should be dated when opened.

c. During an observation on 8/11/25 at 2:30 p.m., a second Assure Platinum Glucose Meter was kept in a pink basket at the nurses' medication cart. The pink basket contained the glucometer, test strips with a lot number of 634325U, a normal control solution with a lot number of 22224A, and a high control solution with a lot number of 022824A.

Review of the facility's Glucometer Quality Control Logs from 7/1/24 to 8/2/25, did not have the lot control numbers for the low or high controls solutions documented.

During an interview on 8/11/25 at 2:30 p.m., staff member D stated she thought the nurses were completing the quality controls for the bedside glucometers and it was not something she had been providing oversight on.