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007.05.10-19. Laboratory.

AR ADC 007.05.10-19Arkansas Administrative Code

West's Arkansas Administrative Code
Title 007. Department of Health
Division 05. Health Facility Services
Rule 10. Rules for Critical Access Hospitals in Arkansas (Refs & Annos)
Ark. Admin. Code 007.05.10-19
007.05.10-19. Laboratory.
A. General.
1. Each Critical Access Hospital shall provide onsite laboratory services essential to the immediate diagnosis and treatment of patients served by the facility. Provision shall be made for the following laboratory services:
a. Chemistry and microscopic examination of urine;
b. Complete blood count including hemoglobin, hematocrit, red blood cells, white blood cells and platelets;
c. Routine chemistry procedures including blood glucose, blood urea nitrogen, sodium, potassium, chloride, arterial blood gases and cardiac enzyme(s);
d. Fecal occult blood;
e. Pregnancy tests;
f. Primary culturing for transmittal to a certified laboratory;
g. Procurement, safekeeping and transfusion of blood or blood products on an emergency basis either directly or through written arrangement with another facility.
2. The requirements of the most current rule of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) shall be met.
3. All laboratory testing that is performed at any site owned and/or operated by the facility shall be approved, in writing, by the Governing Body. The Governing Body shall authorize the director of the hospital laboratory to provide oversight of all testing to ensure the quality of the laboratory services provided. A comprehensive list of all testing sites shall be made available to the Medical Staff.
4. A laboratory shall refer specimens for testing only to a laboratory possessing a valid Clinical Laboratory Improvement Amendments (CLIA) certificate authorizing the performance of testing in the specialty or subspecialty of service for the level of complexity in which the referred test is categorized.
5. Only results from the Critical Access Hospital laboratory or from other approved laboratories, as determined by hospital policy, shall be placed in the patient's medical record.
6. Laboratory tests shall be authorized by a physician or other persons authorized by the Medical Staff and the Governing Body to order laboratory examinations.
7. The laboratory shall maintain accurate counts of total patient procedures for each specialty in which tests are performed.
8. Current reference material, such as textbooks, shall be available for every laboratory category in which tests are performed.
9. The laboratory shall make available to the Medical Staff a list of all tests performed onsite, including the reference range for each test.
B. Personnel.
1. A member of the Medical Staff shall be appointed to act as a liaison between the laboratory and the Medical Staff.
2. The laboratory shall be under the oversight of a pathologist who is board certified or eligible. A pathologist who is not based at the hospital shall make at least a monthly visit and submit a monthly written report to the Hospital Administrator.
NOTE: A hospital which provides only limited laboratory services (e.g., blood gas laboratory only) shall not be subject to the requirement of oversight of a pathologist.
3. The laboratory director, as defined by CLIA 88, shall be responsible for the overall operation of the laboratory but may delegate specific responsibilities to supervisory personnel. However, the director remains responsible for ensuring that all duties are properly performed and documented. The laboratory director shall be responsible for the following:
a. Ensuring that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic and post-analytic phases of testing;
b. Ensuring that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards;
c. Ensuring that:
1) The test methodologies selected have the capability of providing the quality of results required for patient care;
2) Verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method;
3) Laboratory personnel are performing the test methods as required for accurate and reliable results;
d. Ensuring that the laboratory is enrolled in a proficiency testing program approved by Health and Human Services (HHS) for the testing performed and that:
1) The proficiency testing samples are tested in the same manner as the patient samples;
2) The results are returned within the time frames established by the proficiency testing program;
3) All proficiency testing reports are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require corrective action;
4) An approved corrective action plan is followed when any proficiency testing result is found to be unacceptable or unsatisfactory;
e. Ensuring that the quality control and quality assurance/performance improvement programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur;
f. Ensuring the establishment and maintenance of acceptable levels of analytical performance for each test system;
g. Ensuring that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified and that patient test results are reported only when the system is functioning properly;
h. Ensuring that reports of test results include pertinent information required for interpretation;
i. Ensuring that consultation is available to the laboratory's clients and to the Medical Staff on matters relating to the quality of the test results reported and interpretation concerning specific patient conditions;
j. Ensuring there is a sufficient number of laboratory personnel with the appropriate education and either training or experience to provide appropriate consultation, properly supervise and accurately perform tests and report test results;
k. Ensuring all personnel have the appropriate education and experience, receive the appropriate training for the type of services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results;
l. Ensuring there is documentation of training for laboratory personnel who perform special procedures such as arterial punctures and therapeutic phlebotomies;
m. Ensuring that qualified testing personnel are on duty or on call at all times;
n. Ensuring that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. The procedures for evaluation of the competency of the staff shall include, but are not limited to the following:
1) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
2) Monitoring the recording and reporting of test results;
3) Review of intermediate test results or worksheets, quality control records, proficiency testing results and preventive maintenance records;
4) Direct observation of performance of instrument maintenance and function checks;
5) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;
6) Assessment of problem solving skills;
7) Evaluation and documentation of the performance of all personnel with at least the following frequency:
a) Semiannually during the first year of employment in the laboratory;
b) Annually after the first year;
c) Prior to reporting patient test results if test methodology or instrumentation changes;
o. Ensuring that an approved procedure manual is available to all personnel responsible for any aspect of the testing process;
p. Ensuring there is a plan for providing continuing education for the laboratory staff and there is documentation of each employee's participation.
q. Specifying the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the pre-analytic, analytic and post-analytic phases of testing;
r. Specifying the examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results;
4. There shall be a supervisor accessible at all times when testing is performed.
5. Personnel responsible for day-to-day supervision of the laboratory shall meet at least one of the following qualifications:
a. A bachelor's degree in medical technology from an accredited institution and at least one (1) year of clinical laboratory training or experience relative to the specialties being supervised;
b. A bachelor's degree in a chemical, physical, biological or clinical laboratory science from an accredited institution with at least two (2) years of clinical laboratory training or experience relative to the specialties being supervised;
c. An associate degree in a laboratory science or medical laboratory technology from an accredited institution with at least two (2) years of clinical laboratory training or experience relative to the specialties being supervised;
d. A passing score on the Clinical Laboratory Technology Proficiency examination approved by HHS (HEW) and at least six (6) years of clinical laboratory experience with at least two (2) years of experience relative to the specialties being supervised;
e. Employment as a laboratory supervisor prior to January 1, 1995, in a hospital licensed by the Arkansas Department of Health.
6. Testing personnel shall meet at least the following qualifications:
a. Have earned a high school diploma or equivalent;
b. Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training shall ensure that the individual has the following:
1) Skills required for proper patient preparation and specimen collection, to include the following:
a) Labeling;
b) Handling;
c) Preservation or fixation;
d) Processing or preparation;
e) Transportation and storage.
2) The skills required for implementing all standard laboratory procedures;
3) The skills required for performing each test method and for proper instrument use;
4) The skills required for performing preventive maintenance, trouble-shooting and calibration procedures related to each test performed;
5) A working knowledge of reagent stability and storage;
6) The skills required to implement the quality control policies and procedures of the laboratory;
7) An awareness of the factors that influence test results;
8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting test results.
C. Procedure Manual.
1. There shall be a procedure manual for the performance of all analytical methods used by the laboratory readily available and followed by laboratory personnel. Textbooks may be used as supplements but shall not be used in lieu of the laboratory's written procedures for testing or examining specimens. The procedure manual shall include, when applicable to the test procedure, the following:
a. Requirements for patient preparation, specimen collection and processing, labeling, preservation and transportation, including criteria for specimen rejection;
b. Procedures for microscopic examinations, including the detection of inadequately prepared slides;
c. Step-by-step performance of the procedure, including test calculations and interpretation of results;
d. Preparation of slides, solutions, calibrators, controls, reagents, stains and other materials used in testing;
e. Calibration and calibration verification procedures;
f. The reportable range for patient test results as verified by the laboratory;
g. Quality control procedures for each test to include the following:
1) Type of control;
2) Identity of control;
3) Number of controls;
4) Frequency of testing controls;
5) Criteria for determining acceptability of control results.
h. Remedial actions to be taken when any of the following occur:
1) Calibration results are unacceptable;
2) Control results are unacceptable;
3) Equipment or test methodologies fail;
4) Patient test values are outside the laboratory's reportable range of patient test results;
5) The laboratory cannot report patient test results within its established time frames;
6) Errors in reported patient test results are detected.
i. Limitations in methodologies, including interfering substances;
j. Reference ranges (normal values);
k. A list of “panic values” with written instructions for reporting such values;
l. Pertinent literature references;
m. Appropriate criteria for specimen storage and preservation to ensure specimen integrity until testing is completed;
n. The laboratory's system for reporting patient test results;
o. Description of the course of action to be taken in the event that a test system becomes inoperable;
p. Criteria for the referral of specimens, including procedures for specimen submission and handling and for record keeping.
2. The procedure manual shall be reviewed, approved, signed and dated by the current director of the laboratory or by an individual designated by the director in compliance with the CLIA 88 requirements.
3. Each revision or addition to the procedure manual shall be reviewed, approved, signed and dated by the current director of the laboratory or by an individual designated by the director in compliance with the CLIA 88 requirements.
4. The laboratory shall maintain a copy of each discontinued procedure for two years, with the dates of initial use and discontinuance.
D. Record System.
1. The laboratory shall have policies and procedures for a record system which shall assure positive identification of patient specimens from the time of specimen collection until the time of test completion and results reporting. The record system shall include provisions for test requisitions, test records and test reports. The configuration of the system may be established by the laboratory, provided all of the required information is readily retrievable for at least two years.
2. The laboratory shall perform tests at the written or electronic request of an authorized person.
3. Records of test requisitions or test authorizations shall be retained for a minimum of two years.
4. The test requisition shall include:
a. Identification of the patient;
b. The name of the authorized person who ordered the test;
c. The test(s) requested;
d. The date the test is to be performed;
e. For Pap smears, the patient's last menstrual period, age or date of birth and indication of whether the patient had a previous abnormal report, treatment or biopsy;
f. Any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results (Examples: age, sex, current medications, time of specimen collection, diagnosis, type of specimen, fasting).
5. Records of patient testing, including instrument printouts, shall be retained for at least two years. Immune hematology records and transfusion records shall be retained for at least five years. (Exception: If an instrument is interfaced with a computer, and the electronic data cannot be edited, the instrument printouts do not have to be retained.)
6. Test records shall provide documentation of the information required for test requisitions as well as the following information:
a. Unique identification of the patient specimen;
b. The date and time of specimen receipt into the laboratory;
c. The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability;
d. The tests and date of performance of each;
e. The time of completion of testing;
f. The identity of the person who performs each test.
7. The laboratory report shall be sent promptly to the authorized person who requested the test.
8. A duplicate of each test report, including both preliminary and final reports, shall be retained for at least two years. The duplicate may be retained electronically as long as it contains the exact information sent to the individual ordering the test and utilizing the test results. For test reports requiring an authorized signature or containing personnel identifiers, the exact duplicate must include the signature or identifiers. Immunohematology reports shall be retained for at least five years, and pathology reports shall be retained for at least 10 years.
9. The test report shall include the following:
a. Identification of the patient;
b. Date of specimen collection;
c. The test(s) performed;
d. Test results and, if applicable, the units of measurement;
e. Date results were reported;
f. The condition and disposition of specimens that do not meet the laboratory's criteria for acceptability;
g. Any additional information relevant and necessary for the interpretation of the results of a specific test (Examples: Type of specimen, time of specimen collection, fasting).
10. The laboratory shall have policies and procedures for referring patient specimens to reference laboratories, to include:
a. Current list of reference laboratories, with the following information:
1) CLIA number;
2) Specialties and subspecialties in which the laboratory is certified;
3) Expiration date of CLIA certificate;
b. Specimen submission and handling;
c. Record keeping system.
11. The laboratory shall not revise results or information directly related to the interpretation of results provided by a reference laboratory.
12. The laboratory shall retain an exact duplicate of each reference laboratory report, including each preliminary and corrected report, for at least two years. Pathology reports from reference laboratories shall be retained for 10 years, and immunohematology reports shall be retained for five years.
13. The laboratory's report shall indicate the test(s) performed by a reference laboratory and the name and address of each laboratory location at which a test was performed.
E. General Quality Control.
1. The laboratory shall be constructed, arranged and maintained to ensure the space, ventilation and utilities necessary for conducting all phases of testing.
2. The laboratory shall have appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing performed and for the maintenance of quality during all phases of testing.
3. The manufacturer's instructions shall be followed when using an instrument, kit or test system.
4. Components of reagent kits of different lot numbers shall not be interchanged unless otherwise specified by the manufacturer.
5. The laboratory shall define criteria for those conditions that are essential for proper storage of reagents and specimens and for accurate and reliable test system operation and test result reporting. These conditions shall include if applicable water quality, temperature, humidity and protection of equipment and instrumentation from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. There shall be documentation of the remedial actions taken to correct problems with these conditions.
6. Reagents, solutions, culture media, control materials, calibration materials and other supplies, as appropriate, shall be labeled to indicate the following:
a. Identity and, when significant, titer, strength or concentration;
b. Recommended storage requirements;
c. Preparation and expiration dates;
d. Other pertinent information required for proper use.
7. Reagents, solutions, culture media, control materials, calibration materials and other supplies shall be prepared, stored and handled in a manner to ensure that they are not used when the expiration date has been exceeded or when they have deteriorated or are of substandard quality.
8. The laboratory shall comply with the Food and Drug Administration (FDA) product dating requirements of 21 CFR 610.53 for blood, blood products and other biologicals and with labeling requirements in 21 CFR 809.10 for all other in vitro diagnostics. Any exception to the product dating requirements in 21 CFR 610.53 shall be granted by the FDA in the form of an amendment of the product license, in accordance with 21 CFR 610.53(d). All exceptions shall be documented by the laboratory.
9. Test methodologies and equipment shall be selected and testing performed in a manner that provides test results within the laboratory's stated performance specifications for each test.
10. Before the laboratory reports patient test values using a new method or device, it shall first verify or establish for each method the performance specifications for the following performance characteristics, as applicable:
a. Accuracy;
b. Precision;
c. Analytical sensitivity and specificity, to include interfering substances;
d. Reportable range of patient test results;
e. Reference range (normal values);
f. Any other performance characteristics required for test performance;
The laboratory shall have documentation of the verification or establishment of all applicable test performance specifications and shall establish control and calibration procedures based upon those specifications.
11. The laboratory shall perform maintenance and function checks for all equipment, instruments and test systems according to the manufacturers' instructions. If the manufacturer does not define maintenance or function checks, the laboratory shall establish protocols ensuring equipment, instruments or test systems perform accurately and reliably. Maintenance and function checks shall be performed with at least the frequency of the manufacturer's instructions.
12. All function checks and maintenance activities shall be documented. The function checks shall be within the laboratory's or manufacturer's established limits before patient testing is conducted.
13. For each method or device the laboratory shall perform calibration procedures:
a. At a minimum, in accordance with manufacturer's instructions, if provided, using calibration materials provided as specified, as appropriate, and with at least the frequency recommended by the manufacturer; and
b. In accordance with established laboratory criteria to include:
1) The number, type and concentration of calibration materials, acceptable limits for calibration and the frequency of calibration; and
2) Using calibration materials appropriate for the methodology and, if possible, traceable to a reference method or reference material of known value; and
c. Whenever calibration verification fails to meet the laboratory's established acceptable limits for calibration verification.
14. For each method or device the laboratory shall perform calibration verification procedures:
a. At a minimum, in accordance with the manufacturer's instructions, if provided; and
b. In accordance with established laboratory criteria to include:
1) The number, type and concentration of calibration materials, acceptable limits for calibration verification, and frequency of calibration verification;
2) Calibration materials appropriate for the methodology and, if possible, traceable to a reference method or reference material of known value;
3) Verification of the laboratory's established reportable range of patient test results, which shall include at least a minimal (or zero) value, a mid-point value, and a maximum value at the upper limit of that range;
4) Performance of calibration verification at least every six months or when the following occur:
a) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results and control values are not adversely affected by reagent lot number changes;
b) There is a major preventive maintenance or replacement of critical parts that may influence test performance;
c) Controls reflect an unusual trend or shift or are outside the laboratory's acceptable limits and other means of assessing and correcting unacceptable control values have failed to identify and correct the problem;
d) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification than specified by the manufacturer.
15. All calibration and calibration verification activities shall be documented.
16. Control Procedures -(Controls shall be performed as defined or as otherwise defined under a specific category heading.)
a. For each device the laboratory shall evaluate instrument and reagent stability and operator variance in determining the number, type and frequency of testing calibration or control materials and establish criteria for acceptability used to monitor test performance during a run of patient specimen(s). A run is an interval within which the accuracy and precision of a testing system is expected to be stable, but it cannot be greater than 24 hours or less than the frequency recommended by the manufacturer. For each procedure, the laboratory shall monitor test performance using calibration materials or control materials or a combination thereof. Controls shall be performed as follows:
1) For qualitative tests, the laboratory shall include a positive and a negative control with each run of patient specimens. Internal procedural controls (both positive and negative) may be used to satisfy this requirement.
2) For quantitative tests, the laboratory shall include at least two samples of different concentrations of either calibration materials, control materials, or a combination thereof with the frequency not less than two levels per 24 hours of operation.
3) If calibration and control materials are not available, the laboratory shall have an alternative mechanism to assure the validity of patient test results.
4) Control samples shall be tested in the same manner as patient test specimens.
5) When calibration or control materials are used, statistical parameters (e.g., mean and standard deviation) for each lot number of calibration or control material shall be determined through repetitive testing. Levy-Jennings plots or other visual representation methods shall be used to evaluate statistical data for trends and shifts. Weekly supervisory review is required. Control values shall be evaluated as follows:
a) The stated values of assayed control material may be used as the target values provided the stated values correspond to the methodology and instrumentation employed by the laboratory and are verified by the laboratory;
b) Statistical parameters for unassayed materials shall be established over time by the laboratory through concurrent testing with calibration materials or control materials having previously determined statistical parameters; and
c) Control results shall meet the laboratory's criteria for acceptability prior to reporting patient test results.
17. The laboratory shall document all control activities. Documentation shall be retained for a period of two years. Immunohematology quality control records shall be retained for a period of five years. Cytology and histopathology quality control records shall be retained for a period of 10 years.
F. Chemistry.
1. The following requirements apply only to blood gas analysis, regardless of the testing site:
a. Follow the manufacturer's instructions regarding calibration of the blood gas analyzer;
b. Test at least one (1) level of control material each eight hours of patient testing;
c. Rotate the order in which the controls are performed so that normal, alkalosis and acidosis levels are tested; and
d. Test one (1) sample of calibration material or control material each time patients are tested if the instrument does not internally verify calibration at least every 30 minutes.
2. For electrophoretic determinations:
a. At least one control sample shall be used in each electrophoretic cell;
b. The control sample shall contain fractions representative of those routinely reported in the patient specimens.
G. Hematology.
1. There shall be at least two levels of controls for non-manual hematology testing systems each eight hours in which patient testing is performed.
2. There shall be at least one level of control for manual cell counts each eight hours in which patient testing is performed.
3. Manual cell counts shall be performed in duplicate with documentation of both counts. The laboratory shall establish criteria for the acceptable difference between duplicate counts.
4. There shall be two levels of controls for non-manual coagulation testing systems each eight hours in which patient testing is performed and each time a change in reagents occurs.
5. Each individual shall test two levels of controls before performing manual coagulation testing on patient samples and each time a change in reagents occurs.
6. Manual coagulation tests on both patient and control specimens shall be performed in duplicate with documentation of both times. The laboratory shall establish criteria for the acceptable difference between duplicate times.
7. Background counts of diluents shall be performed daily and results recorded.
8. If the microhematocrit centrifuge is used, the maximum packing time shall be determined at least every six months.
9. The laboratory director shall establish written criteria for abnormal cell morphology requiring review by a qualified physician who is board-certified or board-eligible in either pathology or hematology.
10. The laboratory shall maintain a file of unusual hematology slides to be used in the orientation, training and continuing education of laboratory personnel.
H. Immunology.
1. The equipment, glassware, reagents, controls and techniques for tests for syphilis shall conform to manufacturers' specifications.
2. The laboratory shall run serologic tests on patient specimens concurrently with a positive serum control of known titer or controls of graded reactivity plus a negative control. (If patient results are reported in terms of graded reactivity, controls of graded reactivity shall be used; if patient results are reported as a titer, controls of known titer shall be used with results reported as a titer.)
3. The laboratory shall employ controls that evaluate all phases of the test system to ensure reactivity and uniform dosages when positive and negative controls alone are not sufficient.
4. A facility manufacturing blood and blood products for transfusion or serving as a referral laboratory for such a facility shall meet the following:
a. Syphilis serology testing requirements of 21 CFR 606.65(c&e) and 640.5(a);
b. HIV testing requirements of 21 CFR 610.45; and
c. Hepatitis testing requirements of 21 CFR 610.40.
I. Immunohematology.
1. There shall be provision for prompt ABO blood grouping, D(Rho) typing, unexpected antibody detection, compatibility testing and laboratory investigation of transfusion reactions, either through the facility or under arrangement with an approved facility that is certified in Immunohematology and Transfusion Services and Blood Banking under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88).
2. If the facility does not provide immunohematological or blood banking services onsite, there shall be a written agreement with an outside laboratory or blood bank that governs the procurement, transfer and availability of blood and blood products. The agreement shall be reviewed and approved by the laboratory director.
3. The laboratory shall perform and document ABO group and D(Rho) typing on all donor red cells received from outside sources prior to transfusing.
4. The laboratory shall perform ABO group and D(Rho) typing, unexpected antibody detection, antibody identification and compatibility testing in accordance with manufacturers' instructions, if provided, and as applicable, with 21 CFR Part 606 (with the exception of 21 CFR 606.20.a, Personnel) and 21 CFR 640 et seq.
5. The laboratory shall perform ABO group by concurrently testing unknown red cells with anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum shall be tested with known A1 and B red cells. All reactions shall be documented.
6. The laboratory shall determine the D(Rho) type by testing and documenting the reaction of unknown red cells with anti-D(Rho) blood grouping reagent.
7. If required in the manufacturer's package insert for anti-D(Rho) reagents, the laboratory shall employ a control system (Rh-hr control) capable of detecting false positive D(Rho) test results.
8. Each day of use the laboratory shall perform and document the following quality control checks for each vial of antisera and reagent red cells:
a. Positive control only for ABO antisera, ABO reagent red cells and antibody screening cells (at least one known antibody); and
b. Positive and negative controls for D(Rho) antisera, other antisera and anti-human globulin (Coombs serum).
9. Records shall identify the source and lot number of each reagent on each day of use.
10. Policies and procedures to ensure positive identification of a blood or blood product recipient shall be established and followed.
11. Donor blood and blood products shall be stored or maintained for transfusion under conditions required to prevent deterioration and to ensure optimum integrity, whether in the blood bank or in a remote storage refrigerator.
12. Donor blood shall be stored in a refrigerator which meets the following criteria:
a. The refrigerator shall be connected to an emergency power source;
b. An audible alarm system shall monitor proper storage temperature and shall sound at a location that is staffed 24 hours per day;
c. The refrigerator shall not be used for the storage of hazardous or contaminated items;
d. The refrigerator shall have adequate space to provide for segregated storage of the following:
1) Donor blood prior to completion of tests;
2) Donor blood not suitable for use; and
3) Autologous units;
e. A temperature recorder shall be connected to the refrigerator.
13. The high and low activation temperatures of the alarm system shall be checked and documented at least quarterly. The response to the activated alarm shall be documented.
14. The temperature recorder shall be compared daily to a thermometer in the refrigerator. Results of the temperature checks shall be documented.
15. The temperature recorder chart shall be changed weekly, and the individual who changes the chart shall initial and date it.
16. Written criteria shall be established for daily inspection of the blood storage unit for:
a. Outdated blood;
b. Hemolysis;
c. Bacterial contamination; and
d. Unit integrity.
e. Blood shall be visually inspected at the time of issue. Results of all inspections shall be recorded.
17. Records shall be maintained of all blood or blood components received, cross matched, transfused, expired or returned to the supplier.
18. Patient's serum less than 72 hours old shall be used in the compatibility procedure.
19. All blood for transfusions, except for autologous transfusions, shall be tested for hepatitis and for HIV antibodies before it is transfused. The tests for hepatitis and/or HIV antibodies may be performed by the supplier or by the institution in which the blood is transfused.
20. Samples of both patient and donor blood shall be retained at least seven days following transfusion.
21. Procedures shall be established for the prompt investigation of all suspected transfusion reactions. The laboratory director shall review all suspected transfusion reactions, and a report shall be given to a committee of the Medical Staff.
22. Criteria shall be established for the reissuing of donor blood to ensure that the blood has been maintained under conditions required to ensure the safety of individuals being transfused within the facility.
23. Records of therapeutic phlebotomies shall be maintained, detailing the patient name, date, time, amount drawn, phlebotomist and disposition of the blood. Blood drawn as a therapeutic phlebotomy shall not be used for transfusion.
24. A committee of the Medical Staff shall fulfill the following responsibilities:
a. Establish criteria for the proper use of blood and its components;
b. Monitor the transfusion of blood and its components to ensure the established criteria for proper use are met;
c. Review the reports of suspected transfusion reactions;
d. Establish criteria for therapeutic phlebotomies.
25. Blood banking policies and procedures shall conform to the current Standards for Blood Banks and Transfusion Services of the American Association of Blood Banks.
J. Urinalysis.
1. Routine urinalysis shall be performed within two hours of collection of the specimen unless the specimen is refrigerated.
2. Manufacturers' instructions shall be followed for all tests.
3. Two levels of controls shall be performed and documented each day of patient testing utilizing an automated strip reader.
4. A refractometer for measuring urine specific gravity shall be checked each day of use with a low (1.000) and upper level standard or control.
K. Microbiology.
1. Each day of use, the laboratory shall evaluate the detection phase of direct antigen systems using an appropriate positive and negative control organism or antigen extract. When direct antigen systems include an extraction phase, the system shall be checked, each day of use, using a positive organism.
2. The laboratory shall check each batch or shipment of reagents, discs, stains, antisera and identification systems (systems using two or more substrates) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable.
3. Unless otherwise specified, each day of use the laboratory shall test staining materials for intended reactivity to ensure predictable staining characteristics.
4. The laboratory shall check fluorescent stains for positive and negative reactivity each time of use (unless otherwise specified).
5. The laboratory shall check each batch or shipment of media for sterility, if it is intended to be sterile and sterility is required for testing. Media shall be checked for its ability to support growth and, as appropriate, selectivity/inhibition and/or biochemical response.
6. The laboratory may use the manufacturer's control checks of media provided the manufacturers' product insert specifies that the manufacturer's quality control checks meet the National Committee for Clinical Laboratory Standards (NCCLS) for media quality control. The laboratory shall document that the physical characteristics of the media are not compromised and report any deterioration of the media to the manufacturer.
7. The laboratory shall follow the manufacturer's specifications for using the media and be responsible for the test results.
8. The following media shall be retested using NCCLS standards for growth, inhibition and selectivity, as applicable:
a. Campylobacter agar;
b. Media for the selective isolation of pathogenic Neisseria;
c. Media used to isolate parasites, viruses, Mycoplasma, Chlamydia;
d. Mueller-Hinton media used for antimicrobial susceptibility tests; and
e. Media commercially prepared and packaged as a unit or system consisting of two or more different substrates, primarily used for microbial identification.
9. The laboratory shall check positive and negative reactivity with control organisms as follows:
a. Each day of use for catalase, coagulase, beta-lactamase, and oxidase reagents and DNA probes;
b. Each week of use for Gram and acid-fast stains and for bacitracin, optochin, ONPG, X and V discs or strips;
c. Each month of use for antisera;
d. Each week of use the laboratory shall check XV discs or strips with a positive control;
e. For antimicrobial susceptibility tests, the laboratory shall check each new batch of media and each lot of antimicrobial discs or wells before or concurrent with initial use using approved reference organisms:
1) The laboratory's zone sizes or minimum inhibitory concentrations (MIC) for reference organisms shall be within established limits before reporting patient test results;
2) Each day tests are performed the laboratory shall use the appropriate control organisms to check the procedure unless adequate precision can be demonstrated. Once adequate precision is demonstrated, the controls may be performed each week of use. Documentation of precision studies is required.
10. Antibiotic sensitivities shall be performed using a recognized method. If the Kirby-Bauer method is utilized:
a. Proper sized petri dishes shall be used;
b. Disc zone sizes shall be measured and recorded, or a template shall be used; and
c. A standardized inoculum shall be used.
11. Records shall reflect all tests used to isolate and identify organisms.
12. For laboratories performing mycobacteriological testing, the laboratory shall:
a. Each day of use check the iron uptake test with at least one positive and one negative acid-fast control organism. Check all other reagents or test procedures used for identification with at least a positive acid-fast control organism.
b. Each week of use check the fluorochrome acid-fast stain's reactivity with a positive and a negative control organism;
c. Each week of use check the acid-fast stain's reactivity with a positive control organism; and
d. Each week of use, check the procedure for susceptibility tests performed on Mycobacterium tuberculosis isolated with a strain of Mycobacterium tuberculosis susceptible to all antimycobacterial agents tested.
13. For laboratories conducting mycological testing, the laboratory shall:
a. Each day of use, if using the auxanographic medium for nitrate assimilation, check the nitrate reagents with a peptone control;
b. Each week of use check the acid-fast stain's reactivity with a positive and a negative control organism; and
c. Each day of use test each drug for susceptibility tests with at least one control strain that is susceptible to the drug and ensure that patient test results are reported only when control results are within the laboratory's established control limits.
14. For laboratories performing parasitology tests, the laboratory shall:
a. Have available a reference collection of slides or photographs and, if available, gross specimens for identification of parasites and use these references in the laboratory for appropriate comparison with diagnostic specimens;
b. Calibrate and use the calibrated ocular micrometer for determining the size of ova and parasites, if size is a critical parameter. Calibration of the micrometer shall be checked annually or after microscope repair or major maintenance. Documentation of the calibration is required; and
c. Check permanent stains each month of use using a fecal sample control that will demonstrate staining characteristics.
15. For laboratories performing virology tests, the laboratory shall:
a. Have available host systems for the isolation of viruses and identification methods that cover the entire range of viruses that are etiologically related to clinical diseases for which services are offered;
b. Maintain records that reflect the systems used and the reactions observed; and
c. Simultaneously culture, for identification tests, uninoculated cells or cell substrate controls as a negative control to detect erroneous identification results.
16. A microbiological safety cabinet shall be used when mycobacteriology or mycology cultures are manipulated. The cabinet shall meet the following special requirements:
a. Have a face velocity of at least 75 feet per minute;
b. Be connected to an independent exhaust system;
c. Have filters with 99.97 percent efficiency (based on the dioctylphthalate (DOP) test method) in the exhaust system;
d. Be designed and equipped to permit the safe removal, disposal and replacement of contaminated filters; and
e. Be provided with a means of disinfection.
17. Mycology, mycobacteriology or virology cultures shall be disinfected prior to leaving the control of the laboratory.
L. Pathology (Histopathology and Cytology).
1. The ventilation system shall be adequate to properly remove vapors, fumes and excessive heat.
2. Staining dishes shall be properly labeled and covered when not in use.
3. Flow charts that reflect the staining procedure used shall be available.
4. A control slide of known reactivity shall be included with each slide or group of slides for differential or special stains. Reaction of the control slide with each special stain shall be documented.
5. For cytology stains:
a. All gynecologic smears shall be stained using a Papanicolaou (PAP) or modified PAP staining method;
b. Effective measures shall be taken to prevent cross-contamination between gynecologic and non-gynecologic specimens during the staining process;
c. Non-gynecologic specimens that have a high potential for cross-contamination shall be stained separately from other non-gynecologic specimens, and the stains shall be filtered or changed following staining.
6. All cytology slide preparations shall be retained for five years.
7. For histopathology:
a. All stained slides shall be retained at least 10 years;
b. All specimen blocks shall be retained at least two years; and
c. All remnants of tissue specimens shall be retained in a manner that assures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis has been made.
8. An exact duplicate of each test report shall be retained for at least 10 years.
9. The following reports shall be signed to reflect the review of a board-certified pathologist, or, as applicable, another individual meeting the qualifications specified in the CLIA requirements:
a. All tissue pathology reports;
b. All non-gynecologic cytology reports;
c. All gynecologic cytology reports on smears containing cells exhibiting reactive or reparative changes, atypical squamous/glandular cells, premalignant or malignant condition.
NOTE: If an electronic signature is used, the laboratory shall ensure that only the authorized person can release the signature. Refer to Section 14, Health Information Services.
10. The laboratory shall compare clinical information, when available, with cytology reports and shall compare each malignant and premalignant gynecology report with the histopathology report, if available, and determine the causes of any discrepancies.
11. All tissues surgically removed shall be examined by an anatomic pathologist. The Medical Staff shall develop a list of tissues that need not be examined.
12. A frozen section diagnosis, as reported to the surgeon, shall be documented and signed by the pathologist at the time the frozen section is performed. The documentation may be on the requisition, a patient test log, or a report form.
13. Autopsy services shall be under the supervision of a board-certified pathologist.
14. Autopsy findings in a complete protocol shall be filed in the patient's medical record within 60 days of the autopsy. A provisional anatomical diagnosis shall be recorded within 72hours after autopsy. A duplicate copy of the autopsy report shall be maintained in the laboratory autopsy file.
M. Radiobioassay.
1. Background checks shall be performed each day at the proper window setting for each type of isotope being used, as applicable.
2. Criteria for unacceptable changes in background levels shall be established.
3. Safety precautions shall be written and appropriately displayed. Film badges and/or rings shall be worn, as applicable.
4. There shall be written procedures to assure reliability of testing and safety of patients and personnel.
5. All procedures for safety and disposal of radioactive waste shall conform to the most current Rules and Regulations for Control of Sources of Ionizing Radiation adopted and promulgated by the Arkansas State Board of Health.
N. Quality Assurance/Performance Improvement.
1. Each laboratory shall establish a Quality Assurance/Performance Improvement plan. The plan shall follow written policies and procedures for a comprehensive program which monitors and evaluates the ongoing and overall quality of the total testing process. The plan shall evaluate the effectiveness of the laboratory's policies and procedures, identify and correct problems, assure the accurate, reliable and prompt reporting of test results, and assure the adequacy and competency of the staff. As necessary, the laboratory shall revise policies and procedures based upon the results of those evaluations.
2. All Quality Assurance/Performance Improvement activities shall be documented.
3. The laboratory shall have an ongoing mechanism for monitoring and evaluating the following:
a. The criteria established for patient preparation, specimen collection, labeling, preservation and transportation;
b. The information solicited and obtained on the laboratory requisition for its completeness, relevance and necessity for testing patient specimens;
c. The use and appropriateness of criteria established for specimen rejection;
d. The completeness, usefulness and accuracy of the test report information necessary for the interpretation or utilization of test results;
e. The timely reporting of test results based on testing priorities (STAT, routine, manufacturer's instructions, etc.);
f. The accuracy and reliability of test reporting and record storage and retrieval;
g. The effectiveness of corrective actions taken for:
1) Problems identified during the evaluation of calibration and control data for each test method;
2) Problems identified during the evaluation of patient test values for the purpose of verifying the reference range of a test method;
3) Errors detected in previously reported test results.
h. The effectiveness of corrective actions taken for any unacceptable, unsatisfactory or unsuccessful proficiency testing results.
4. Laboratories that perform the same testing using different methodologies or instruments, or perform the same test at multiple testing sites, shall have a system that twice a year evaluates and defines the relationship between test results using different methodologies, instruments or test sites.
5. Laboratories that perform tests that are not challenged with a proficiency testing program shall have a system for verifying the accuracy and reliability of its test results at least twice per year.
6. The laboratory shall have a mechanism to identify and evaluate patient test results that appear inconsistent with relevant criteria such as patient age, sex, diagnosis or pertinent clinical data, when provided; distribution of patient test results, when available; and relationship with other test parameters, when available.
7. The laboratory shall have an ongoing mechanism to evaluate the effectiveness of its policies and procedures for assuring employee competence.
8. The laboratory shall have a system in place to document problems that occur as a result of breakdowns in communication between the laboratory and the authorized individual who orders or receives the results of test procedures or examinations. Corrective actions shall be taken, as necessary, to resolve the problems and minimize communication breakdowns.
9. The laboratory shall have a system in place to assure that all complaints and problems reported to the laboratory are documented. Investigations of complaints shall be made, when appropriate, and, as necessary, corrective actions shall be instituted.
10. The laboratory shall have a mechanism for documenting and assessing problems identified during quality assurance/performance improvement reviews and discussing them with the staff. The laboratory shall take corrective actions that prevent reoccurrences.
11. The laboratory shall maintain documentation of all quality assurance/performance improvement activities, including problems identified and corrective actions taken. All quality assurance/performance improvement records shall be available and maintained for a period of two years.
O. Safety.
1. The physical plant and environmental conditions of the laboratory shall provide a safe environment in which employees, as well as all other individuals, are protected from physical, chemical and biological hazards.
2. Safety precautions shall be established, posted and observed to ensure protection from physical, chemical, biochemical and electrical hazards as well as biohazardous materials.
P. Point of Care Testing.
1. The requirements under this section apply only to the following tests which employ simple and accurate methodologies, as defined by the Centers for Disease Control and Prevention (CDC):
a. Dipstick or tablet reagent urinalysis;
b. Fecal occult blood;
c. Urine pregnancy tests (visual color comparison);
d. Hemoglobin by single analyte instrument with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout;
e. Whole blood glucose by devices approved for home use;
f. Spun microhematocrit;
g. Whole blood immunoassay for Helicobacter pylori;
h. Rapid test for Group A streptococcal antigen from throat swabs; and
i. Glycosylated hemoglobin (Hgb Alc).
2. All testing personnel shall have earned a high school diploma or equivalent.
3. There shall be documentation that prior to testing patients' specimens each individual has received training for each test to be performed and has demonstrated the ability to perform all testing operations reliably.
4. Manufacturer's instructions for each of the tests shall be available in each area in which the specific test is performed and shall be followed by all testing personnel.
5. Components of reagent kits of different lot numbers shall not be interchanged unless otherwise specified by the manufacturer.
6. Reagents, control and calibration materials and other supplies shall be stored and handled in a manner to ensure that they are not used when the expiration date has been exceeded or when they have deteriorated or are of substandard quality.
7. Quality control procedures shall be performed in accordance with the manufacturer's instructions, at a minimum. Additional quality control procedures shall be performed as determined by the director of the hospital laboratory.
8. Maximum packing time of the microhematocrit centrifuge shall be determined at least every six months.
9. The test record system shall include at least the following:
a. Identification of the patient;
b. Name of the authorized person who ordered the test;
c. Test performed;
d. Date and time of test performance;
e. Identity of the person who performed the test;
f. Test results; and
g. Any additional information relevant and necessary for the interpretation of the results of a specific test.
10. The configuration of the test system shall be determined by the facility.
11. All required records shall be readily retrievable for at least two (2) years.
12. Point of Care Testing shall be included in the hospital laboratory's Quality Assurance/Performance Improvement program.
13. Any tests other than those specified in P(1) above shall be subject to all of the requirements of Section 19.

Credits

Amended Jan. 1, 2016.
<Statutory authority: Promulgated under the Authority of Ark. Code Ann. § 20-7-123, 20-9-201 et seq.>
Current with amendments received through May 15, 2024. Some sections may be more current, see credit for details.
Ark. Admin. Code 007.05.10-19, AR ADC 007.05.10-19
End of Document