WAIVED LAB MANUAL

TABLE OF CONTENTS

 

Outpatient Service test responsibilities	page 2
Inpatient test responsibilities	page 6
Waived testing requirements	page 9
Procedures
#1   Blood Glucose:   Precision PCx #1a Glucometer Elite	page 10 page 13
#2   Bladder Tumor Antigen	page 15
#3   Coloscreen (quaiac)	page 17
#4   Gastrocult	page 20
#5    hCG -Urine Pregnancy Test: Quick Vue® #5a  Sure-Vue®	page 22 page 24
#6    Hematocrit- Manual	page 26
#7    Hemocue Glucose	page 29
#8    Hemocue B- Hemoglobin	page 32
#9    H Pylori	page 35
#10  KOH Prep	page 38
#11  Nitrazine	page 40
#12  Saline Wet Mount	page 42
#13  Semen Analysis	page 44
#15  Urinary Sediment Exam    Urinalysis (microscopic)	page 45
#16  Urine Dipstick	page 48
Quality Control Logs
Bladder Tumor Antigen	page 51
hCG Urine Pregnacy	page 52
Nitrazine Test	page 53
Urine Dipstick	page 54

 

OUTPATIENT SERVICES TEST RESPONSIBILITIES

 

Outpatient Services Waived Testing:

The director of clinical lab service is responsible for all Outpatient lab services and will ensure compliance with applicable regulations except for waived tests and PPMs. The CLIA Director named on the CLIA certificate is responsible for all waived and PPM testing and compliance with applicable regulations done under this certificate.

 

Medical direction:

(See list of clinics, medical directors, and waived tests performed)

The clinic specific medical director is responsible for operation and administration of waived laboratory testing provided in their clinic in the Outpatient Services at UAMS, and for assuring compliance with applicable regulations.  The clinic medical director is responsible for ensuring quality control of waived tests.

 

The clinic manager will ensure that:

1.      Personnel involved in testing patient samples are competent to perform test procedures and that test results are reported and recorded as required.

2.      Tests done in OPS follow an established procedure approved by the clinic medical director.

3.      Procedure manuals for all tests being used in OPS are available to personnel performing the testing.

4.      Quality control programs are maintained to assure the quality of the laboratory service provided.

5.      Quality control records are maintained and reviewed.  Corrective actions are taken and documented on unacceptable quality control test results.

6.      Instrumentation used in laboratory testing is properly maintained.

7.      The physical area provided for laboratory testing is appropriate and provides a safe environment in which employees are protected from physical, chemical and biological hazards.

8.      Regulatory records are maintained as required.

9.      Staff members have knowledge of current information relating to laboratory testing.

10.  Quality control records are reviewed.

 

OPS Waived Testing Personnel:

1.      Personnel will have specific training before being authorized to perform laboratory patient testing.

2.      Personnel will participate in an annual recertification/competency skills check to determine proficiency to perform laboratory testing on patient specimens.

3.      Personnel are knowledgeable about the location and contents of the laboratory test procedure manual.

4.      Only authorized personnel should perform laboratory testing on patient samples.  An authorized person is defined to be one who meets the above requirements.

5.      Personnel will report/document test data as required by the individual practice.

OPS  Patients Test System:

1.      Patient testing is ordered by the clinician (written, verbal, or by phone) unless the patient is experiencing symptoms and quality of care dictates STAT test be performed.  The clinician is to be notified of the STAT test.

2.      Confirm patient identity before performing laboratory testing.

3.      The patient is to be prepared as described in the test procedure manual.

4.      Adequate samples of material to be tested are to be collected as described in the test procedure.

5.      Follow test procedure as described in the procedure manual.

6.      Test results are to be documented in the patient’s medical record.  The report should include test date, result, specimen type, initials or name of person performing the test.

 

Quality control should be performed as described in the test procedure manual.  Quality control testing for external controls is to be documented in the quality control log according to instructions found in the procedure manual.  Out of range control results should be documented on the quality control log.  Lot numbers and exp. dates of reagents.or kits must be documented in either the log book or patient record. Corrective action taken to correct deficiencies should be documented.  Repeat quality control testing and document repeat quality control test results.  Acceptable quality control testing must occur before proceeding with patient testing. Patient test should be sent to lab for testing if unable to achieve successful controls. Contact the Point of Care Coordinator at 501-686-7044 with any unresolved control problems. 

 

 

OUTPATIENT SERVICES

POINT OF SERVICE-WAIVED TESTS

 

	Urine dipstick	hCG	Guaiac	BTA	pH paper	U/A microscopic M.D. only	Saline wet mount M.D. only	Blood Glucose	Other
JEI
Ortho								ü
Rheumatology
Urology	ü		ü			ü			Semen analysis M.D. only
Medicine	ü		ü			ü	ü	ü
ENT/laser
Senior Health	ü		ü			ü	ü	ü
UPMG	ü		ü			ü	ü	ü
Neurology
Dermatology		ü							KOH for fungus MD only
Surgery			ü					√
Family Medicine			ü					ü glucometer elite
Freeway- Renal Dialysis	ü		ü
Neurosurgery

 

 

	Urine dipstick	hCG	Guaiac	BTA	pH paper	U/A microscopic	Saline wet mount	Blood glucose	Other
Chemotherapy
LONC	ü		ü				ü		KOH Prep M.D. only
DONC
JONC
HONC
MONC			ü
SONC			ü
BONC