LifeBridge Health - NORTHWEST HOSPITAL CENTER   GENERAL INFORMATION

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Section 1.1 Overview of Operations

A. General Information

Northwest Hospital Center Laboratory, Sinai Hospital of Baltimore Laboratory and Belvedere Pathology make up LifeBridge Laboratories. LifeBridge Laboratories form a consolidated LifeBridge entity, which is dedicated to providing laboratory services for the patients, employees and clinical staff of LifeBridge Health. LifeBridge Laboratories share a common laboratory information system, and have standardized equipment, polices and procedures.

The Northwest Hospital Center Laboratory is accredited by the College of American Pathologists, the Joint Commission for the Accreditation of Healthcare Organizations, the American Association of Blood Banks, and certified by HCFA via CLIA 88. The Northwest Hospital Center Laboratory is overseen by the Northwest Hospital Center Laboratory Medical Director and the LifeBridge Laboratory Administrative Director. The department is organized into the following sections:

Central Processing / Send Outs
Blood Bank / Blood Gases / Serology
Automated Testing (Chemistry/Hematology/Coagulation/Urinalysis)
Microbiology (referred to Sinai Microbiology Lab)
Anatomical Pathology

The department offers comprehensive services in clinical and anatomical pathology at the request of a physician and according to the plan of care. Laboratory staff members serve as active members on interdisciplinary, collaborative committees to improve the care to the patients of Northwest Hospital Center. The in house and reference test menus are revised annually to provide laboratory services to each patient as part of the plan of care in a manner consistent with the Northwest Hospital Center scope of services. Approved reference laboratories are utilized when appropriate.

B. Hours of Operation

Laboratory services are provided 24 hours a day, 7 days per week. Staff is scheduled based on priority and volume requirements for both inpatient and outreach work.

Inpatient Phlebotomy services are provided 4AM to 5 PM, on weekdays. Inpatient phlebotomy services are provided 4AM to 11AM on weekends and holidays. Outpatient phlebotomy services are provided by multidisciplinary staff in the Outpatient Center from 7:30 AM. to 6 PM, M � F, and from 9 AM until 1 PM on Saturday.

C. Pathology Lab Users Guide

This guide has been made available on the LifeBridge Health web site to assist patient care staff to utilize the LifeBridge Health / Northwest Hospital Center Laboratories. The content is updated periodically.

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Section 1.2 Ordering and Handling of Laboratory Specimens

Many preanalytical factors play a large part in the quality of the final result generated by the laboratory. Among them are proper ordering, proper specimen collection and labeling and transport from the collection site to the laboratory.

ORDERING:

By law the laboratory performs only testing which is documented by the physician to be medically necessary for the treatment of the patient. Medical necessity is assumed when the order is written by the physician or physician assistant, or when the order is issued by another caregiver, but signed off by the physician or physician assistant. Verbal orders are not acceptable unless documented in writing within 24 hours. Laboratory personnel receiving verbal or phone orders must read back the entire order to verify the accuracy of transmission.

Inpatients: Orders for specimens to be collected by the Phlebotomy Team are transcribed by nursing and forwarded to the ACC for entry into Powerchart orders.

Orders for specimens to be collected by nursing, are transcribed by nursing, as usual, but ordered by the ACC as "nurse collect specimen".

Emergency Department: Orders are entered as with Inpatients, depending on whether or not the specimens have already been collected and awaiting physician confirmation.

Outpatients (Outpatient Center): Orders must be documented by a prescription or faxed order from the physician�s office. Orders are entered into Cerner by Ancillary Services Technicians in the Out Patient Draw Station and by nursing personnel in the Outpatient Treatment Unit.

PATIENT INDENTIFICATION:

Inpatients, Emergency Department, ASU and Out Patient Treatment Unit: The patient armband is the primary identifier. Always check the armband against the name on the order or collection label before collecting the specimen. It is recommended that the nurse, or phlebotomist also ask the patient his name as a second check. Do not collect a specimen from a patient without an armband.

Outpatient Draw Station: The patient chart and prescription are used as the patient identifier. It is the responsibility of the phlebotomist collecting the specimen to positively identify the patient before collection. The patient armband is only required for patients submitting specimens for type and cross or type and screen testing. In no case is a specimen to be used for transfusion purposes to be collected from a patient without an armband.

COLLECTIONS:

Collect and preserve specimens according to the protocols contained in the Clinical Laboratory Manual, the Nursing Alcove Manual and/or the Outreach Service Manual, as appropriate. Specimen requirements may be found in Section 12 of the Clinical Laboratory Manual.

Specimens which are not properly collected may not be accepted by the laboratory. Refer to Procedure 1.6 of the Clinical Laboratory Manual for current rejection criteria.

ORDER OF DRAW: When multiple samples are collected at once, the following order of draw is recommended. Please note that a discard tube is not required when collecting a single blue top tube for coagulation studies:

1. Blood culture

2. Red top tube

3. Light blue top tube (citrate)

4. Serum gel separator tube (gold or tiger top)

5. Green top tubes (heparin, with or without gel)

6. Lavender top tube (EDTA)

7. Gray top (oxalate)

DISCARD VOLUME WHEN COLLECTING SAMPLES FROM CVP LINES: Venous blood samples for laboratory testing should be collected via peripheral veinipuncture whenever possible. If a blood sample must be collected from a CVP line, 10 to 20 ml of blood (based on the length and diameter of the line) must be discarded from the line before the tubes are filled.

LABELING:

All specimens, regardless of where they are collected, should be labeled immediately after collection by the person who collected it or witnessed the collection. Specimens should be labeled at the site of collection, whenever possible, particularly if multiple patients are seen in that setting.

Specimens may be labeled with a Cerner bar-coded label, a GTE addressograph label or a handwritten label, in that order of preference. Cerner labels should be used if the order is already in the Cerner system (except Emergency Dept. specimens). If there is no test order for the specimen in the Cerner / Powerchart computer system, the specimen must be accompanied by a paper requisition.

Label should include the following information:

• Patient Full Name

• Medical Record Number (inpatients, ED and outpatients), social security number or date of birth (outreach patients)

• Date and Time of Collection

• Initials of Collector (First Initial and Full Last Name for Blood Bank Specimens)

For Hemogaurd tubes, Cerner labels should be affixed lengthwise directly over the Vacutainer label with the patient name towards the stopper. Place the label just below the stopper. Avoid wrinkles. For rubber stoppered tubes, affix the Cerner label lengthwise directly over the vacutainer label approximately � inch below the stopper.

Specimen Delivery

All specimens must have a Cerner label or be accompanied by an appropriate requisition, either manual or electronic. Prompt delivery of specimens is imperative for specimen quality and reliability of results. Specimens which arrive in the lab after the published acceptable time will not be processed. (see Procedure 1.6 � Unacceptable specimens)

Specimens may also be sent to the lab via the PEVCO pneumatic tube system. Refer to the Pneumatic Tube procedure 1.17.

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Section 1.3 Testing Priorities

Order lab tests using one of the following priorities:

STAT:

For emergency testing only. The test will be performed as rapidly as possible, but generally 60 minutes or less from the time of receipt of specimen in the lab unless the test is referred to another lab. Turnaround time for referred tests that are available as stat tests is 4 hours from the time the specimen is picked up (test dependent). Only the tests listed below may be ordered STAT.

TIMED:

Specimens which require collection at a specific time (e.g. peak drug levels) are requested as "Timed" collections. These specimens are treated as STATs by the Laboratory.

ROUTINE:

All other tests. Lab orders not specifically requested STAT or will be processed with a routine priority. Most are completed the same day if performed in-house.

A.M.:

Routine collections which may be done together should be ordered as "A.M.". These specimens will be collected during early morning rounds and will be processed with a routine priority.

NOTE:

The requesting physician will be notified in cases where testing is significantly delayed beyond the above goals.

TESTS AVAILABLE WITH STAT/URGENT PRIORITY

CHEMISTRY:

Acetaminophen
Acetone
Ammonia
Amylase
BMP
Carbamazepine
Cerebrospinal fluid chemistries
CMP
CPK (total) and MB isoenzyme
Drug abuse screen (urine)
Digoxin
Electrolytes
Ethanol (blood)
Gentamicin
Lithium
Lipase
Magnesium
Osmolality
Phenobarbital
Phenytoin
Procainamide + NAPA (Referred to Quest Diagnostics)
Pro BNP
Quinidine
Salicylates
Theophylline
Troponin I
Valproic Acid
Vancomycin

HEMATOLOGY:

CBC
WBC
RBC
Hemoglobin
Indices
WBC differential
Platelet count
Spinal fluid - cell count and diff
Joint fluid crystals
Sickle cell screen

COAGULATION:

Prothrombin Time (PT)
Activated partial thromboplastin time (PTT)
Fibrinogen, quantitative
D-Dimer

URINALYSIS:

Dipstick screen and microscopic, if indicated

BLOOD BANK:

Blood typing
Crossmatch
Emergency release of uncrossmatched blood
Transfusion reaction investigation

MICROBIOLOGY:

Staining and examination of smears in emergency cases, e.g. CSF in suspected meningitis.

OTHER:

Pregnancy test - serum qualitative
                             serum, quantitative
Monotest
Rapid strep screen
RSV rapid screen
Flu A / B rapid screen

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Section 1.4 Reporting of STAT Test Results

1. STAT results are called per special request only.

2. STAT results are available in the Cerner system as soon as they are verified.

3. Emergency Department and Critical Care results print in the ED and Critical Care Unit automatically upon verification.

4. Laboratory personnel internally document special notification of caregivers in Cerner.

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Section 1.5 Reporting of Critical Values

Critical values (panic values) will be reported by Laboratory personnel immediately upon completion of the test.

For critical values on inpatients, the performing technologist will notify the appropriate house staff member. The technologist will provide the patient name, time of draw, panic value, and the name and phone number of the attending physician. The house staff member will be asked to repeat back the patient name and critical value to ensure the result was communicated properly. The technologist will also make a nonchartable notation in the Cerner PathNet module to document the initials, time and date the house staff member was contacted.

For critical values on Emergency Department patients, the performing technologist will notify the appropriate Emergency Department physician or nursing clinical coordinator. The technologist will provide the patient name, time of draw, and panic value. The emergency room staff member will be asked to repeat back the patient name and critical value to ensure the result was communicated properly. The technologist will also make a nonchartable notation in the Cerner PathNet module to document the initials, time and date the Emergency Department person who was notified.

For critical values on outpatient and pre-admission testing, a laboratory processor will notify the ordering physician. The physician will be asked to repeat back the patient name and critical value to ensure the result was communicated properly.

When critical values are received from any of the Reference Laboratories. The technologist covering the area will follow the above patient location protocols and document their action in the same manner.

Results are always given verbally or in hard copy to the appropriate health care professional. Critical values are not left on answering machines or faxed without a secondary verbal report.

CRITICAL VALUES (PANIC VALUES) REVISION 4/04

	CHEMISTRY:
	BUN			> 100 mg/dl
	Calcium		< 6.0 mg/dl	>12 mg/dl
	Carbon dioxide		< 10 mEq/L	> 39 mEq/L
	Glucose		< 50 mg/dl	> 400 mg/dl
	Potassium		< 3.0 mEq/L	> 6.0 mEq/L
	Magnesium		< 1.0 mg/dl	> 4.0 mg/dl
	Sodium		<120 mEq/L	> 160mEq/L
	CK MB			> 5.0 ng/ml (w/ index >= 2.7)
				on ER & inpatients on
				nonmonitored beds.
	Troponin			> 1.5 ng/ml
	ARTERIAL BLOOD GASES:
	pH		< 7.200	> 7.550
	pCO2		< 20 mm Hg	> 50 mm Hg
	pO2		< 50 mm Hg
	TDM AND TOXICOLOGY:
	Acetaminophen			>150 ug/ml
	Amikacin			All results
	Aminodarone			> 3.5 mg/ml
	Amitriptyline and Nortriptyline			> 250 ug/L
	Carbamazepine			> 15 ug/ml
	Clonazepam			> 100 ng/ml
	Cyanide			> 2.0 ug/ml
	Cyclosporine			> 400 mg/ml
	Desethylamiodarone			> 3.5 ug/ml
	Diazepam and Nordiazepam			> 5.0 ug/ml
	Digoxin			> 2.0 ng/ml
	Disopyramide			> 8.0 ug/ml
	Ethosuximide			> 100 ug/ml
	Free Phenytoin			> 2.0 mg/L
	Free Valproic Acid			> 30 mg/L
	Gentamicin (peak)			> 12 ug/ml
	Gentamicin (trough)			> 2.0 ug/ml
	Imipramine and Desipramine			> 250 mcg/L
	Lithium			> 1.5 mEq/L
	Nortriptyline			> 140 ug/L
	Phenytoin			> 30 ug/ml
	Phenobarbital			> 50 ug/ml
	Primidone			> 10 mg/L
	Procainamide and NAPA			> 30 mg/L
	Quinidine			> 5.0 ug/ml
	Salicylate			> 30 mg/dl
	Theophylline			> 20 ug/ml
	Tobramycin (peak)			> 8.0 ug/ml
	Tobramycin (trough)			> 2.0 ug/ml
	Valproic Acid			> 100 mg/L
	Vancomycin (peak)			> 40 ug/ml
	Vancomycin (trough)			> 15 ug/ml
	HEMATOLOGY:
	Hematocrit			< 20 %
	Hemoglobin			< 7.0 g/dl
	WBC			< 3.0 K cells / MM3
				>30.0 K cells / MM3
	Platelets			< 20. 0 K cells / MM3
				>1 M cells / MM3
	COAGULATION:
	Prothrombin Time (PT)			> 42 seconds
	INR			> 4.0
	Partial Thromboplastic Time (PTT)			> 100 seconds
	MICROBIOLOGY:
	Blood			Positive culture
	CSF or other sterile body fluid (non-urine)			positive smear or culture
	Positive malaria smear
	Bone marrow			positive smear or culture
	Any specimen			positive acid fast bacilli
	Any specimen			positive pneumocystis carinii
	Any specimen			positive Vancomycin Resistant Enterococcus (VRE)
	Stool			parasites
	BLOOD BANK:
	When unable to obtain compatible blood
	Hemolytic transfusion reactions

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Section 1.6 Specimen Rejection Criteria

Pre-analytical specimen integrity is extremely important to the final result reported by the laboratory. All specimen requirements as noted in the individual sections of this manual should be adhered to.

The laboratory will not process specimens with the following criteria. Depending on the specific problem, the specimen may be rejected / canceled or held until the appropriate requirements are met:

• Mislabeled or unlabeled specimens (only CSF, Surgical, and non urine body fluid specimens can be re-labeled).
• Improperly labeled specimens: full patient name, date and time of collection and initials of the collector must be on the tube (for specimens collected at sites other than NWHC, the time and date of collection can be documented on the requisition).
• Specimens collected in incorrect tube / container.
• Specimens submitted in a syringe with the needle still attached.
• Grossly contaminated specimens.
• Grossly leaking specimens
• Specimens not accompanied by a valid requisition, including the medical record number for hospital patients (or social security number for specimens collected at sites other than NWHC), tests requested, and ordering physician.
• Inconsistent information between the specimen container and the requisition.
• Specimens which require collection on ice, but which are received at ambient temperature, or specimens which require ambient temperature, but are received cold.

• Specimens with inadequate volume for the tests ordered (an inquiry will be made to ascertain the priority of tests to be performed).

In addition, specific criteria are in place for specimens analyzed by each discipline of the laboratory. Those include, but may not be limited to, the criteria listed below.

Blood Bank - Criteria for rejection

• Specimens for crossmatch or potential crossmatch must be labeled with full name of patient, medical record number, time / date of collection, and at least the first initial and full last name of the collector, on the tube.

• Specimens collected at sites other than NWHC are not accepted for compatability testing. Only blood typing and antibody screening accepted

Chemistry - Criteria for rejection

• Spun SST or PST tubes which are received > 48 hours after collection
• Unspun SST or PST tubes or Red Top tubes which are received > 4 hours after collection.

• Grossly or moderately hemolyzed specimens (assay dependent). 24 hour urine collections without the appropriate preservative for the test requested.

Hematology - Criteria for rejection

• Blue Top tubes for PT > 24 hours after collection.
• Blue Top tubes for PTT > 4 hours after collection.
• Coagulation or Hematology specimens which are clotted
• Lavender top tubes received for CBC >greater than 48 hours after collection (CBC specimens received > 24 hours may not be acceptable for Differential WBC counts).

Urinalysis - Criteria for rejection

• Urinalysis specimens received > 24 hours after collection (specimens should be refrigerated if submitted > 2 hours after collection).

• Urinalysis specimens received > 48 hours after collection in a urine preservative / transport tube.

Microbiology - Criteria for rejection

• Specimens for ova and parasites which are received greater than 30 minutes after collection unless appropriately preserved
• Urine cultures received > 24 hours after collection (specimens should be refrigerated if submitted >2 hours after collection).
• Urine for culture received > 48 hours after collection received in a urine C/S transport tube.
• Genital culture swabs received greater than 8 hours after collection.

Anatomic Pathology - Criteria for rejection

• Broken slides
• Slides for PAP smear without a name on the slide
• Dry brushes for cytology

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Section 1.7 Detection, Correction and Prevention of Errors

1. Errors come from many sources including clerical, pre-analytical, analytical, and post-analytical. Clerical and pre-analytical and post-analytical errors are more common than analytical errors and are inherent in the process of patient identification and specimen collection. The specimen collection/delivery/ analysis/reporting sequence involves several steps:
   

   Preparation of patient I.D. band and plate
   

   Proper I.D. of the patient at the bedside
   Collection of specimen by proper technique
   Handling of specimen, including labeling and transport
   Analysis of specimen
   Result entry
   Posting hard copy on chart
   Physician/other caregiver review and response

2. Positive identification of the patient is critical. Before collecting a specimen, the collector should check the name of the patient and patient medical record number against the name and medical record number on the patient�s I.D. band. Do not collect specimens from patients who do not have an armband. It is also necessary to ask the patient who he is, e.g. "What is your name?" Do not ask, "Are you Mr. Smith?"

3. Proper and timely transport of the specimen from the bedside to the Laboratory is also critical. Many analytes will be altered by standing too long at room temperature.

4. The technologist who performs the test monitors the results of the quality control materials and reviews all patient�s results before reporting. Any unacceptable quality control results will be investigated and resolved before reporting patient results. All grossly abnormal patient results will be reviewed and/or reanalyzed before reporting. A new sample will be requested if there is suspicion of contamination or misidentification.

5. Certain tests have "Delta Check" logic assigned and the computer flags results if they change beyond specific limits within a given time limit (0- 3 days). The following tests have Delta Check logic: WBC, MCV, Hgb, Hct, PLT, PT, PTT, Na, Ca, Creatinine, Mg. When a sample has a delta check flag, the technologist will investigate by checking the sample labeling, repeating the test, checking transfusion history, and / or requesting a new sample.

6. Clerical personnel must be meticulous when reporting results verbally or posting hard copy results so that the results report or posted match with the patient name/I.D.

7. All errors detected will be corrected immediately and documented using standard laboratory and/or hospital procedures.

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Section 1.8 Result Reporting and Availability

Results generated by the Laboratory are reported in several ways.

1. Most routine results from the a.m. phlebotomy rounds are available by 11 a.m. Results may be accessed via the Powerchart computer terminals throughout the hospital. Phone calls to the lab for routine results are discouraged, since these results are already available and the call can disrupt work flow.

2. Hard copy patient results are printed and distributed once daily from the Cerner system. The report at 4 a.m. is a cumulative summary of all previous results. This summary is charted in the early morning. All previous chart copies are removed from the medical record when a new cumulative report is charted. Reports for anatomical pathology and descriptive reports from reference laboratories are charted by the charting tech as they become available.

3. Final patient charts are printed for discharged patients one day post discharge. Any outstanding test results which are finalized after this copy is printed, are contained in an addendum report, which prints on the day the new result is finalized. A patient may have multiple addendum charts. Each addendum copy will indicate if there is any further outstanding work. The final copy and addendum copies remain permanently in the patient�s medical record.

4. Copies of inpatient discharge summaries are mailed or placed in folders in the physician�s lounge. All other reports are automatically faxed from the Cerner System unless otherwise requested by a physician.

5. Emergency Department and Critical Care results are printed automatically in those locations at result verification.

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Section 1.9 Erroneous Results

The College of American Pathologists, the Joint Commission on the Accreditation of Health Care Organizations standards and good practice dictate that once a result has had the opportunity to be seen by anyone outside the Laboratory, it cannot be changed or deleted.

When an erroneous result has been verified, the technologist discovering the error is responsible for appending a correction comment to the result. The Cerner computer system allows for this type of correction without deleting the original result through the program ECR. Should the results be reported, but there remains a question about the integrity of the specimen, the technologist will append an appropriate comment to that result, e.g. "Suspected IV contamination."

Any time a result is corrected, the tech responsible for generating that result will assure that the nurse or primary caretaker is notified. If the result involved a critical value or surgical pathology specimen, the technologist will consult the supervising pathologist. The pathologist will decide whether or not the attending physician also needs to be contacted.

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Section 1.10 Referred Testing

The Laboratory refers some testing to outside laboratories for reasons of cost effectiveness, required technical expertise or medico-legal considerations.

The outside laboratories used by Northwest Hospital Center have demonstrated the following:

1. Certification by approved accrediting agencies, e.g. College of American Pathologists, CLIA/HHS, State of Maryland, National Institute of Drug Abuse (NIDA).
2. Consistently successful proficiency testing.
3. A written quality assurance program.
4. A satisfactory turnaround time for tests requested.
5. Competitive pricing.

Recommendations for use of a reference laboratory are approved by the Medical Executive Committee.

Ongoing communication with technical and sales personnel from all laboratories used is maintained through the sendout area and occasionally through individual sections.

Information on which tests are referred and to which lab they are sent is found in Section 12.

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Section 1.11 Record Retention and Preservation of Laboratory Records and Materials

This policy meets standards which are required by accrediting, regulatory, and governmental agencies.

Material/Specimen/Record	Retention	Comments
Surgical Pathology
Surgical specimens (wet tissues)	2 weeks	After final report
Paraffin Blocks	10 years
Slides	10 years
Accession Log Records	2 years
Pathology Requisition Forms	2 years
Pathology Report; Lab Copy	10 years	Original in Medical Records
Patient Name Card File	Permanent	Until HX is entered in computer
Cytology
Gyn Slides	5 years
Non Gyn Slides	5 years
FNA Slides	10 years
Cytology Requisition Forms	2 years
Cytology Report: Lab Copy	10 years	Original in Medical Records
Cytology Accession Log Records	2 years
Paraffin Blocks	10 years
Autopsy Material
Tissues	6-12 months	3 Months after final report
Paraffin Blocks	10 years
Slides	10 years
Report, Lab Copy	10 years	Original in Medical Records
Accession Log Records	2 years
Autopsy Permit, Lab Copy	3 years	Original in Medical Records
Quality Control
Detailed Data Reports	2 years
Levy Jennings Graphs	2 years
Instrument Maintenance Records	2 years	After method / instrument is D/C
Quality Control, Continued
CAP Surveys 2 years	2 years
Statistics Records	2 years
Workload Reports	2 years
Hematology
Bone marrow slides	10 years
Bone marrow reports, lab copy	10 years	Original in Medical Records
Bone marrow/peripheral blood log	2 years
Blood smear, routine	1 week
Blood smear, unusual	10 years	Filed with bone marrow slides
Blood samples	3 days
Body fluid specimens	7 days
Paraffin blocks	10 years
Worksheets containing results	2 years
Work Center Activity Reports	2 years
Worksheets/Instrument Printouts	2 years
Blood Bank
Patient Blood Samples	10 days
Donor Unit Segments	7 days after exp. date
Final Disposition Reports and Logs	10 years
Work Center Activity Reports	10 years
Patient problem / antibody records	permanent
Transfusion Slips, Issue Forms	10 years
Post-Transfusion Hepatitis Reports	10 years
Look-Backs HIV, HCV	10 years
Quality Control records	5 years
Chemistry/Microbiology/Reference Laboratory
Instrument Printout (offsite)	2 years
Work Center Activity Reports	2 years
Worksheets containing results	2 years
Reference lab logs	2 months
Reference lab report copies	2 years
Serum / blood samples	3 days
Body fluid samples	7 days
24 hour urine samples	7 days
Drug of abuse urine samples	4 days
Cumulative Results
Laboratory results in Power Chart:	indefinitely

Purging of Old Records / Laboratory Specimens, Slides and Blocks:

The laboratory records, specimens, slides, and blocks listed above will be periodically purged and destroyed.

Surgical and General Pathology specimens are red bagged and incinerated on site.

Surgical Pathology slides and blocks are to be returned from off site storage for destruction / incineration on site. The Anatomic Pathology Manager, Anatomic Pathology Team Leader or Anatomic Pathology Assistant will witness and document the destruction of Surgical Pathology slides and blocks.

Paper documents such as quality control records, instrument print outs, etc. can be destroyed by the off site storage vendor as long as the vendor is bonded and provides proof of destruction.

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Section 1.12 The Use of Electronic Signature

PURPOSE:

To define the policy for the use of electronic signatures on pathology reports generated by the Laboratory.

POLICY STATEMENT:

With the installation of the Cerner Laboratory Information System, the Department of Pathology has instituted the use of electronic signatures for Anatomic Pathology reports. The following criteria are met:

1. The electronic signature is only a substitute for the written signature of the verifying physician.
2. The specific electronic signature for each physician can be used only for cases dictated by that physician. This is governed by the physician log-on to the Cerner system.
3. The established procedure for reviewing the reports prior to signature has not changed
4. Any standard procedure that would apply without electronic signature will still apply with the exception of actually signing the final hand written signature.

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Section 1.13 Confidentiality of Results

Confidentiality of Laboratory results must be maintained at all times. The Laboratory has a comprehensive privacy policy which meets federal Health Insurance Portability and Accountability Act (HIPAA) guidelines. The policy includes the following safeguards to ensure that the confidentiality of protected health information is maintained at Northwest Hospital Center:

1. Laboratory staff may disclose protected health information to healthcare professionals and insurance companies for treatment, payment or operational purposes without prior consent from the patient. The provider must properly identify him or herself, and also provide the following: patient name, date of birth, date of service, and name of test. Results may be faxed to LifeBridge providers without verification of the fax number. Results may be faxed to non LifeBridge providers after a fax verification form is completed and returned to the NWHC laboratory.

2. Should a person call requesting results and there is a question about the person�s dentity, the requestor is asked for his/her name and phone number where they can be called back. The phone number will be checked against known physician office numbers before returning the call.

3. Patients are required to complete an Authorization for Release of Medical Information Form to have extra copies of results released to non LifeBridge physicans, or to themselves.

4. Results are available through inquiry in the Cerner system. Access to these results is based on the security assigned to individual users based on their job codes and or duties. All Employees sign a confidentiality agreement before being assigned a Cerner log-on.

5. Sensitive results, i.e. HIV, are sequestered to inquiry to all but Lab personnel and direct care givers. Access is gained in PowerChart by creating a role. Documentation of access to sensitive results is maintained in the Cerner system.

6. Hard copies of patient results are mailed to physicians in sealed envelopes. Copies posted to patient charts are handled only by DP personnel and the charting tech and are accessed only by those having direct access to patient charts.

7. Protected health information is not left unattended on printers, desks, etc. Computer screens are protected by screen saver / time out functionality.

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Section 1.14 Unique Identifier for HIV Testing

1. As mandated by COMAR 10.52.09, a UI (Unique Identifier) must be assigned by the physician ordering an HIV or CD4. It is the responsibility of the physician to maintain a log of UI numbers assigned, linking that number with a patient name, and to inform the patient about the use of his/her Social Security number as part of the UI.

2. The NWHC Laboratory sends HIV and CD4 specimens to the LifeBridge Core Laboratory at Sinai Hospital for analysis.

3. When a positive result is received, (confirmed HIV or CD4 lymphocyte count less than 200/mm³), the Core Laboratory Manager or designee is responsible for obtaining the UI number from the physician (if it is not already on the request form): or generate the number based on demographic information and the consent form on the patient�s chart