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Based on observation, interview, and record review, the facility's Governing Body:

(a) Failed to maintain laboratory services according to Clinical Laboratory Improvement Act (CLIA) requirements and had to cease laboratory testing as of 9/2/2016 due to non compliance with CLIA requirements;

(b) The facility failed to ensure emergency laboratory services are available 24 hours a day to meet the needs of patients seen at the hospital.

( c) The facility failed to ensure laboratory staff were qualified for their job position; and

(d) The facility failed to ensure new laboratory equipment was tested and approved by the Laboratory Medical Director prior to putting the equipment in use;

(e) The facility failed to maintain the capability to provide needed blood/blood product transfusion services to patients.

This failed practice resulted in the facility's inability to adequately meet the laboratory needs of all patients that were seen at the hospital.

Patients requiring blood transfusion services had to be transferred to other facilities.

Emergency Room services were scaled down to seeing only patients with minor complaints and ,surgical services were canceled.

Findings:

Observation on 9/7/2016 through 9/8/2016 at the laboratory suite at the facility revealed the lab had implemented contract services which was not able to provide emergency laboratory services twenty four hours a day.

The blood bank was closed and patients requiring blood transfusion had to be transferred to other facilities.

During an interview on 9/7/2016 at 10:30 am with the Medical Director of the Lab, she stated the current laboratory Manager was not qualified for his position and new equipment that was in use was not approved for use by the Medical Director.

During an interview on 9/7/2016 at 10:10 am with the Chief Nursing Officer, he stated surgical services were canceled and the Emergency Room was on drive by. Walk in patients had to be transferred out for higher level of care due to the disruption in the laboratory services.

During an interview on 9/7/2016 at 11:10 am with the Medical Director of the hospital, he stated prior to the cease testing order of the laboratory he was not aware there were problems with the lab.

Refer to 482.27(Tag 0576),482.27(a), (Tag 0582) and ,482.27(a)(1)(Tag 0583) for details.

Based on observation, interview, and record review, the facility failed to maintain laboratory services according to Clinical Laboratory Improvement Act (CLIA) requirements and had to cease laboratory testing on 9/2/2016 due to non compliance with CLIA requirements.

The facility failed to ensure new laboratory equipment was tested and approved by the Laboratory Medical Director prior to putting the equipment in use;

The facility failed to ensure laboratory staff was qualified for their job position in accordance with CLIA requirements.

This failed practice resulted in the facility's inability to adequately meet the laboratory needs of all patients that were seen at the hospital.

Findings:

Observation on 9/7/2016 at 1:25 pm in the laboratory (lab) revealed three (3) new pieces of laboratory equipment as follows:

(1) Olympus AU 400 use for testing eighteen (18) different components from blood specimen.

(2) Roche Cobas e411 used to test five (5) blood components and;

(3) The SYSMEX XT 2000 use to test for CBC (complete blood count) and Retic.

Observation on 9/7/2016 at 1:35 pm in the lab revealed, lab equipment titled Stago used for testing PT, PTT, and D-Dimer had a label with information that the last biomed test was done 2/10/2015. (needed testing since 2/2015).

The Centrifuge had a label with information the electrical safety check was due for inspection on 2/2016.

During an interview on 9/7/2016 at 10:30 am with Staff (C53), Medical Director of the laboratory (lab), she gave the following information:

The laboratory Manager Staff (A 51) purchased three(3) pieces of new equipment and put the equipment in service and did not inform her of the purchase and use of the equipment.

According to the Medical Director , per CLIA requirements all new equipment must be approved for use by the Medical Director prior to implementation.

She stated the Medical Director is the authorized person to perform the proficiency testing of the new equipment and train the laboratory staff on use and testing of the equipment.

The Medical Director stated staff were not trained on the use of the new equipment and the Laboratory Manager is not qualified to conduct staff training in the lab.

According to the Medical Director the "title of Laboratory Manager" assigned to Staff (A 51) is not correct per CLIA requirements he did not have the required training/qualification for the position.

The Medical Laboratory Director stated (Staff A 51) had been performing the duties of a Technical Supervisor without the required qualification as a result the lab was found out of compliance with CLIA requirements and a cease testing order was made on 9/2/2016.

During an interview with on 9/7/2016 at 2:10 pm in the Lab with Staff (B 52), Medical Technologist she stated the centrifuge and the Stago equipment were in use daily up to 9/2/2016 when the lab was ordered to cease testing.

She stated the inspections were not done on the two identified equipment which should have been inspected in February 2016.

During an interview on 9/7/2016 at 11:10 am with the Medical Director in charge of the hospital he stated he was not aware prior to the cease testing order that there were problems with the lab.

According to the Medical Director, he did not have an understanding of the " nuts and bolts " of the problems but is willing to ensure corrective measures are implemented.

During an interview on 9/8/2016 at the facility at 9:15 am with Staff (A 51), Laboratory Manager, he stated the new laboratory equipment was put in use since July and August 2016 and had been in use daily until 9/2/2016 when the Lab was ordered to cease testing.

The Manager stated the equipment was not approved for use by the Medical Director of the laboratory as required.

According to Staff (A 51) he trained staff on the use of the equipment but he failed to document the training.

He stated there were lab protocols that he developed that are still awaiting approval from the Laboratory Director.

During the interview the Surveyor asked the Manager if he was authorized to train staff on the use of new equipment, According to Staff A 51 he was qualified to perform the activities he performed in the lab.

Review of Job/Position Description presented on 9/8/2016 for Staff (A 51) revealed his job title was documented as Laboratory Manager dated 2/20/2016.


Review of the job summary revealed in part the following information:


The Laboratory Manager is responsible for providing department specific guidance, and training for staff Medical Technologist, Medical Laboratory Technicians, and Phlebotomist.


Review of the Regulatory Requirements listed on the job description revealed the following requirements:

(1) Bachelor of Science Degree in Medical Technology, Biology or Chemistry.

(2) Current Medical Technologist Licensure

(3) Masters degree in Public Health, hospital administration business administration preferred.

(4)Recent managerial experience in the clinical laboratory of an acute care hospital.

(5) Preferred managerial experience with regulatory and accreditation of laboratory operations.


Review of education certification presented for Staff # (A 51), revealed the following information:

Degree of Bachelor of Science,
Associate of Applied Science , Medical Laboratory Technology
Clinical Laboratory Technician
ASCP membership valid through December,2016.


During a telephone interview on 9/12/2016 at 11:20 am with Staff (E 55), Human Resource (HR) Manager, to discuss the presented credentials for Staff A 51. The HR Manager stated Staff A 51 was qualified for his position as Manager of the laboratory services.

She stated the degree of Bachelor of Science is in Health Sciences and is acceptable. The Director of HR stated a degree in health sciences is not the same a degree in biology or chemistry.

She stated licensure is not required the ASCP(American Society of Clinical Pathology) membership is acceptable.

During a telephone call from the HR Manager on 9/13/2016 at 3:43 pm she stated a review of Staff A51's qualification was done and as it stands he is not qualified for his job position.

Based on observation, interview, and record review, the facility failed to maintain the capability to provide blood/blood product transfusion services and emergency laboratory services to patients, due to noncompliance with CLIA requirements.

This failed practice resulted in the transfer of patients who needed blood transfusion to other facilities for transfusion, and the ability to provide complete laboratory services when needed. Citing 3 of 6 patients #s 1,2,and 3.

Findings:

Observation on 9/7/2016 at 1:25 pm in the laboratory (lab) at the facility revealed there were no specimen testing activities in the lab. None of the testing equipment were currently in use.

The Blood bank was closed and the refrigerator for blood and blood products was empty.

The facility had a bed capacity for 69 inpatients.

Review of medical record for three (3) patients revealed the following information:

Patient (#1)
Patient # 1 was admitted to the facility on 9/2/2016 with history of hidradentitis of bilateral groin and suprapubic area.

Review of Physician orders dated 9/4/2016 revealed an order at 8:55 am to "transfer patient to any accepting facility for blood transfusion. Hgb 7.0 Type and cross match for three(3) units and transfuse three (3) units PRBC(Packed Red Blood Cell).

Review of memorandum of transfer (MOT) revealed the patient was transferred out on 9/4/2016 and returned to the facility on 9/5/2016.

Patient (# 2)
Patient # 2 was admitted to the facility on 8/24/2016 with complaints of dizziness and multiple falls at home in a short time.

Review of Physician orders dated 9/3/2016 at 2:00pm revealed an order to "transfer patient to any accepting facility for blood transfusion. Hgb 6.8, type and cross match for three(3) units and transfuse three(3) units PRBC(Packed Red Blood Cell).

Review of memorandum of transfer (MOT) revealed the patient was transferred out on 9/3/2016 and returned to the facility on 9/4/2016.

Patient (# 3)
Patient (# 3) was admitted to the facility on 8/31/2016 with complaints of lower back pain radiating to the lower extremity with associated pain,weakness and numbness.

Review of Physician orders dated 9/3/2016 at 2:00pm revealed an order to "transfer patient to any accepting facility for blood transfusion. Hgb 7.1. Type and cross match for two(2) units PRBC, transfuse two(2) units PRBC(Packed Red Blood Cell).

Review of memorandum of transfer (MOT) revealed the patient was transferred out on 9/3/2016 and returned to the facility on 9/4/2016.
Review of the facility's Reference Range for Hgb (hemoglobin) revealed less than or equal to 7.9 is considered to be in the Critical Range.

All three patients had hemoglobin levels that were in the critical range.
Review of a memo sent to the Emergency Room dated 9/7/2016 revealed the following information:

The laboratory can perform iSTAT procedure for chem 8 which includes Na, K, Cl, iCA,Co 2, Glucose,Bun,Creatine, and Hct with calculated result for Hgb and AnGap.

These tests can be performed STAT 24 hours a day, 7 days a week. The turnaround time is about 15 minutes after receipt of proper specimen".

The document stated "S" Medical Lab, an independent lab located on the 8th floor can perform the basic laboratory testing. "S" is available to run tests from 7 am to 9pm Monday -Friday, and 7 am to 2pm Saturday and Sunday. Turnaround time for their in house testing is about an hour.

All other testing is is performed by "M" Diagnostic Laboratory. they are opened to receive specimen 24 hours a day, 7 days a week.

The turn around time for their in house testing is about 3 hours. Any and all reference testing is sent out via Methodist and reported when available.

Moreover, all blood bank services (including type and screen or cross matches) cannot be performed in house or sent to "G.C"(blood bank) until further notice.

Review of Surgery list reveal 27 minor procedures were done on 9/7/2016 and two (2) were done on 9/8/2016.

During the survey on 9/7/2016 through 9/8/2016 there were seventeen (17 ) inpatients on 9/7/2016 and;

(16) patients on 9/8/2016.

On 9/2/2016 when there was a cease testing order there were 20 inpatients.

on 9/3/2016 --20 patients

On 9/4/2016---8 patients

9/5/2016---7 patients

9/6/2016---15 patients

Review of emergency room logs revealed on 9/2/2016 there were seven (7)walk- in patients seen in the Emergency Room.

On 9/3/2016 one (1) was seen

On 9/4/2016 two(2) were seen

On 9/5/2016 one(1) patient came via ambulance and was transferred out.

On 9/6/2016 six (6) patients were seen three (3) came via ambulance and were admitted.

On 9/7/2016 four(4) patients were seen, three came via ambulance.

During an interview on 9/7/2016 at 10:10 am with Staff (D 54)Chief Nursing Officer (CNO), he stated Lab testing is currently done by outside labs.

The staff stated the Blood Bank was closed as of 9/2/2016 as a result three (3) patients needing blood transfusion were sent to other hospitals for the transfusion.

Staff (D 54) CNO , stated Surgical services were disrupted and some cases had to be canceled and other surgical activities were scaled down to performing basic minor procedures.

The Staff stated the Emergency Room is on drive by because some laboratory services are not available on a twenty four(24) hour basis.

During a telephone interview on 9/7/2016 at 12:20 pm with Staff G 57(Physician), he stated the physicians are aware of the cease testing of the laboratory as a result the ER is on drive by and very ill patients that walk in are transferred out for a higher level of care.

Based on observation, interview, and record review, the facility failed to maintain compliance with Clinical Laboratory Improvement Act (CLIA) requirements to ensure emergency laboratory services are available 24 hours a day to meet the needs of patients seen at the hospital.

This failed practice resulted in a cease testing at the lab and closure of the blood bank with the potential to adversely affect all patients at the hospital.

Findings:

Observation on 9/7/2016 at 1:25 pm in the laboratory (lab) revealed there were no specimen testing activities in the lab. None of the testing equipment were currently in use.

The Blood bank was closed and the Refrigerator for blood and blood products was empty.

During an interview on 9/7/2016 at 10:10 am with Staff (D 54) Chief Nursing Officer (CNO) he stated Lab testing was currently done by outside laboratory services.

The staff stated the Blood Bank was closed as of 9/2/2016 as a result three (3) patients needing blood transfusion were sent to other hospitals for the transfusion.

The Staff stated the Emergency Room is on drive by because some laboratory services are not available on a twenty four(24) hour basis.

Staff D 54 stated STAT/Emergency orders are only available between the hours of 7:00 am to 9:00 pm Monday -Fridays and 7:00 am to 3:30 pm on Saturdays and Sundays.

Review of a memo sent to the Emergency Room dated 9/7/2016 stated:

"The laboratory can perform iSTAT procedure for chem 8 which includes Na, K, Cl, iCA,Co 2, Glucose, Bun,Creatine, and Hct with calculated result for Hgb and AnGap.

These tests can be performed STAT 24 hours a day, 7 days a week. The turnaround time is about 15 minutes after receipt of proper specimen".

The document stated "S Medical" Lab, an independent lab located on the 8th floor at the facility can perform the basic laboratory testing. "S Medical" is available to run tests from 7 am to 9pm Monday -Friday, and 7 am to 2pm Saturday and Sunday.

Turn around time for their in house testing is about an hour(60 minutes).

All other testing is is performed by "M" Diagnostic Laboratory. they are opened to receive specimen 24 hours a day, 7 days a week.

The turnaround time for their in house testing is about three (3 )hours.

Any and all reference testing is sent out via "M" and reported when available.

Moreover, all blood bank services (including type and screen or cross matches) cannot be performed in house or sent to "G. C" until further notice."

Review of the facility's policy/procedure titled Turn Around Time dated 11/2010 revealed the following information:

"Laboratory test performance will be prioritized according to the clinical needs of patients. The Attending physicians communicates these to the laboratory by written orders including test priority.


There are four(4) priorities used at U G Hospital.

(1) Emergency Blood Release...Extreme life or death situation. Highest priority. Test done on an Emergency basis are Type and Cross match".

This emergency laboratory service is not currently available to the physicians.

(2) "STAT.. Critical situation, life or death,other laboratory work interrupted for performance of STAT tests.

Result of tests should be completed within 60 minutes upon receipt of the specimen in the Laboratory".

This service is not available from "S" Medical lab on a twenty four(24) hour basis, and the turn around time at ''M Diagnostic lab is three (3) hours, not the required 60 minutes for STAT labs.

The list of tests available on a 24 hour basis ,which can be ordered as a STAT Priority include the following:

Hematology: CBC( Complete Blood Count) including platelet count and diff.

H&H(hemoglobin and hematocrit), ProTime,APTT.

The facility's 24 hours a day iSTAT laboratory tests does not include any of the listed Hematology tests.

The onsite contract LAB "S Medical", does not provide type and screen and cross match services , nor APTT, Troponin listed as emergency labs.