Chapter 05. Quality Assurance
Regulation .01 Quality Assurance — General.LinkCopy Citation
To obtain or maintain a permit to operate a forensic laboratory, a person or licensee shall ensure that the forensic laboratory:
A.
Establishes and follows policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total examination and forensic analysis process;
B.
Maintains a quality assurance program that:
(1)
Continually evaluates the effectiveness of the laboratory’s policies and procedures;
(2)
Routinely revises policies and procedures based on the results of ongoing evaluation;
(3)
Identifies and corrects problems;
(4)
Assures:
(a)
Accurate, complete, and reliable reporting of results of examinations and analyses;
(b)
Technical procedures are validated and are accepted practice in the forensic discipline; and
(c)
Adequate and competent employees;
(5)
Requires documentation of all quality assurance and quality control activities; and
(6)
Includes policies and procedures for:
(a)
Handling and preservation of evidence;
(b)
Calibration and maintenance of equipment;
(c)
Handling, maintaining, and securing laboratory records including case records and reports;
(d)
Evaluation and approval of employees;
(e)
Laboratory security;
(f)
Identifying and implementing corrective actions;
(g)
Documenting and investigating complaints;
(h)
The operation of individual characteristic databases, where appropriate; and
(i)
Data integrity and ethics;
C.
Develops and maintains:
(1)
An organizational chart of all employees;
(2)
Job requirements and a job description for each contractor; and
(3)
Employee records that include, but are not limited to:
(a)
Job requirements and a job description for each employee;
(b)
Educational background and qualifications;
(c)
Curriculum vitae;
(d)
Court testimony evaluations and a record that the evaluations are reviewed with each examiner and analyst;
(e)
Documentation of successful completion of a training program set forth by the laboratory, including competency testing;
(f)
Authorization to perform independent casework; and
(g)
Performance evaluations;
D.
Establishes and maintains a forensic laboratory safety program;
E.
Employs appropriately trained employees and possesses equipment to conduct the scope of forensic services offered;
F.
Maintains reference literature in physical or electronic form that covers all disciplines and subdisciplines for which services are offered;
G.
Designates an individual as the quality assurance manager;
H.
Defines and maintains a document retention policy;
I.
Maintains a facility that is designed to ensure the integrity of the forensic analyses and the evidence;
J.
Conducts:
(1)
Administrative review of all cases and reports before issuing a report; and
(2)
Technical review, of no less than 5 percent of cases as determined by the laboratory director or designee, to ensure conclusions and supporting data are within the constraints of scientific knowledge; and
K.
Establishes a mechanism to address unresolved discrepant conclusions between an analyst and the technical reviewer.
Regulation .02 Quality Assurance — Specific.LinkCopy Citation
A.
Policies and Procedure.
(1)
A licensee shall develop, establish, maintain, implement, and follow quality assurance policies and procedures that ensure that the laboratory’s quality system is maintained.
(2)
A licensee shall ensure that the laboratory has a clear procedure describing the process to uniquely identify evidence.
(3)
Chain of Custody. The licensee shall:
(a)
Maintain a record of chain of custody in written or electronic form in order to maintain accurate tracking of all evidence; and
(b)
Document each transfer of evidence with the date of transfer and the signature of the person receiving the evidence at the time of transfer.
B.
Identifying and Handling Evidence. A licensee shall:
(1)
Ensure that each item of evidence received by the forensic laboratory:
(a)
Is permanently marked and includes a unique identifier either on the:
(i)
Evidence itself; or
(ii)
Proximal container of the evidence; and
(b)
Has a documented record that includes the:
(i)
Identity of the evidence submitter;
(ii)
Date the item of evidence was submitted; and
(iii)
Description of the item of evidence submitted;
(2)
Establish and follow a procedure to identify evidence that cannot be marked or identified as set forth in §B(1) of this regulation;
(3)
Ensure all items produced during a forensic analysis or examination are:
(a)
Marked with a unique identifier that can be traced back to the original evidence;
(b)
Appropriately packaged;
(c)
Documented in case notes, reports, and the evidence tracking system; and
(d)
Packed with the original evidence when applicable or a disposition will be noted;
(4)
Ensure documentation of the date of receipt of each test item and evidence;
(5)
Establish, maintain, and follow a procedure to define proper packaging and sealing of evidence requiring that:
(a)
Evidentiary seals:
(i)
Are initialed or marked by the person sealing the evidence; and
(ii)
Prevent the evidence from being removed, lost, altered, or contaminated; and
(b)
Evidence is protected from:
(i)
Loss;
(ii)
Cross-contamination; and
(iii)
Any harmful change; and
(6)
Consider evidence containers properly sealed only if:
(a)
The contents cannot readily escape; and
(b)
Entering the container results in obvious damage or alteration to the container or the container’s seal.
C.
Deficiencies, Errors, and Corrective Actions. A licensee shall have:
(1)
A procedure for corrective actions to be taken when a deficiency or error is identified with:
(a)
A forensic analysis procedure or method; or
(b)
The casework or proficiency testing of a forensic analyst or examiner; and
(2)
The procedure and required documentation for the corrective actions include:
(a)
A determination of the cause of the deficiency or error;
(b)
An evaluation of the deficiency or error to determine if the deficiency or error causes or has caused an adverse effect on the quality of a forensic analysis;
(c)
An indication of the individual responsible for corrective action;
(d)
A timeline of corrective action or actions; and
(e)
Verification that the corrective action was:
(i)
Implemented; and
(ii)
Monitored for effectiveness in correcting the deficiency or error.
D.
A licensee shall designate a quality assurance manager to oversee and ensure that the quality assurance program is implemented, maintained, and routinely evaluated.
E.
A licensee shall ensure that a change to an entry on an examination document, whether written or electronic, is:
(1)
Trackable to the person who made the change; and
(2)
Not erased, hidden, obscured, disguised, or obliterated.
F.
A licensee shall establish and follow a procedure to document any:
(1)
Evidence discrepancies;
(2)
Compromise of evidence integrity; or
(3)
Lost or misplaced evidence.
G.
A licensee shall document all quality assurance and quality control activities as set forth in this subtitle.
H.
A licensee shall establish a procedure to:
(1)
Investigate, resolve, and document a forensic analysis discrepancy; and
(2)
Allow for a request and approval from the director or designee for a deviation from standard operating procedures.
I.
Public Record.
(1)
A licensee shall establish and follow a procedure to make discrepancy logs, contamination records, and test results available to the public within 30 days of a written request.
(2)
A contamination record shall include the following information:
(a)
Unique case identifier;
(b)
Encoded sample identification;
(c)
Description of results; and
(d)
Identifiers that led to an incident report.
Regulation .03 Quality Assurance — Specific for Postmortem Forensic Toxicology.LinkCopy Citation
A.
In addition to any applicable requirement in this chapter, a forensic laboratory performing postmortem forensic toxicology shall establish a:
(1)
Procedure for responding to requests for the laboratory’s information and documentation; and
(2)
Policy for:
(a)
Retention and release of laboratory information;
(b)
Addressing the confidentiality of laboratory data; and
(c)
Identifying:
(i)
The extent to which interpretations may be provided with test results; and
(ii)
Who is authorized to provide interpretations.
B.
Specimen Collection and Handling.
(1)
A laboratory director shall develop and provide, to all agencies or parties that submit or request postmortem toxicology analyses, instructions that include the specific requirements for the:
(a)
Type and minimum amount of specimen needed to perform the:
(i)
Requested analysis; and
(ii)
Subsequent interpretations;
(b)
Type and size of specimen container;
(c)
Type and amount of preservative to be added to biological fluids, when applicable;
(d)
Labeling of each individual specimen container;
(e)
Packaging and transport of a specimen;
(f)
Submission of relevant medical history on decedents who may carry a highly infectious disease, such as tuberculosis, hepatitis, or human immunodeficiency virus (HIV);
(g)
Labeling of each specimen as to type and source, if applicable; and
(h)
Proper sealing of containers to prevent:
(i)
Leakage of the specimen container; and
(ii)
Cross-contamination between specimens.
(2)
A licensee shall ensure that a specimen submitted for postmortem toxicology testing includes documentation that provides pertinent case information, including the:
(a)
Name of decedent;
(b)
Date of specimen collection; and
(c)
Pertinent history of the case.
(3)
For a specimen received for postmortem toxicology testing, a laboratory shall maintain a written or electronic record documenting the:
(a)
Condition of the specimen;
(b)
Handwritten initials or electronic signature of the individual who received the specimen;
(c)
Date the specimen was received;
(d)
Name of the decedent;
(e)
Unique identifier assigned to the specimen;
(f)
Specimen type;
(g)
Date the specimen was collected; and
(h)
Identification of the individual who collected the specimen.
(4)
A licensee shall develop and follow a policy for the retention, release, and disposal of specimens submitted for postmortem toxicology testing.
Regulation .04 Quality Control Program.LinkCopy Citation
A.
A licensee shall:
(1)
Develop, establish, maintain, implement, and follow quality control policies and procedures that ensure accurate and reliable:
(a)
Forensic analysis results; and
(b)
Case reports;
(2)
Ensure that all quality control activities set forth in this chapter are documented;
(3)
Ensure that the quality control program is able to detect shifts and trends that could result in an adverse impact on the quality of forensic analysis results;
(4)
Ensure that quality control data are evaluated routinely and when found to be contaminated, out of range, incorrect, or otherwise unacceptable:
(a)
Corrective actions are taken; and
(b)
Incorrect results are not reported;
(5)
Ensure that quality control material and reference standards are specified in the SOPM and the results of quality control testing are documented in the case record;
(6)
Ensure that a reagent used for a forensic analysis:
(a)
Is tested for reliability before being put into use;
(b)
Is identified with the:
(i)
Name of the reagent;
(ii)
Lot number or date the reagent was prepared; and
(iii)
Expiration date;
(c)
Is checked for reliability on a cycle determined by the technical leader;
(d)
Has a record documenting:
(i)
Who prepared the reagent; and
(ii)
Completion of a reliability check before use; and
(e)
Has storage, safety, and handling requirements specified;
(7)
Ensure that a reagent that is not used for a forensic analysis on a regular basis is tested for reliability before each use;
(8)
Discard a reagent, make a new reagent, and check the new reagent’s reliability before any casework being performed, if the reagent reliability is found to be compromised;
(9)
Use reagents that are suitable for the forensic analysis methods employed;
(10)
Have procedures for tracking the receipt and use of commercial reagents;
(11)
Have procedures for the formulation of in-house reagents in the SOPM; and
(12)
Test the forensic analysis method, before reporting a forensic analysis result, using:
(a)
A positive and negative external control for a qualitative forensic analysis; and
(b)
Known levels of external controls for each analyte in a quantitative forensic analysis.
B.
Postmortem Forensic Toxicology. In addition to applicable requirements of this regulation, a laboratory performing postmortem forensic toxicology shall meet the requirements of this section.
(1)
Screening Tests. A licensee shall:
(a)
Ensure a postmortem toxicology screening test is appropriate and validated for the type of biological specimen being analyzed; and
(b)
Perform and document precision studies for a method that uses cut-off values for analyte concentrations.
(2)
Confirmatory Tests. A licensee shall:
(a)
Confirm, if possible, the detection or initial identification of controlled dangerous substances or other toxicants by a second method based on a different chemical principle; and
(b)
Ensure the confirmatory test is more specific than the initial test for the target analyte, if possible.
(3)
Immunoassay. A laboratory shall:
(a)
Be able to demonstrate sufficient separation in the response between a negative and positive specimen at the cut-off concentration of the immunoassay;
(b)
Validate the use of an immunoassay method or procedure on a specimen if the method or procedure is not recommended by the manufacturer of the immunoassay; and
(c)
Use matrix-matched quality control materials for each batch of specimens analyzed with the immunoassay.
(4)
Chromatography. A laboratory shall:
(a)
Analyze calibrators or controls with each batch of specimens for qualitative and quantitative chromatography assays;
(b)
Establish an acceptable range for each quantitative quality control material; and
(c)
Use a suitable internal reference standard, when available.
(5)
Spectrophotometry. A laboratory shall maintain cuvettes used for spectrophotometry in good optical condition.
(6)
Mass Spectrometry. A laboratory shall:
(a)
Establish and adhere to criteria for acceptable mass spectrometric tune;
(b)
Have written criteria for full scan mass spectrometric identification through library searching; and
(c)
Compare ion ratios and retention times between reference standards, calibrators, quality control materials, and case specimens when using selected ion monitoring or selected reaction monitoring.
Regulation .05 Standard Operating Procedures Manual (SOPM).LinkCopy Citation
A.
Policies and Procedures. A licensee shall ensure that all policies and procedures affecting the scope of activities performed in the laboratory are:
(1)
Documented; and
(2)
Communicated to, understood by, available to, and implemented by employees performing the activities.
B.
A licensee shall ensure that:
(1)
Documents issued to employees are reviewed and approved for use by authorized employees before issue;
(2)
The current revision status and distribution of documents is established to preclude use of archived documents;
(3)
Authorized documents are available at all locations where casework is performed;
(4)
Archived documents are promptly removed from access or otherwise identified to ensure against unintended use;
(5)
Documents are uniquely identified, including date of issue or version, page numbering, total number of pages or a mark to signify the end of the document, and the issuing authority;
(6)
Changes to documents are approved by the same authority that issued the document and altered or new text is clearly identified; and
(7)
Documents in computerized systems have equivalent procedures.
C.
A licensee shall develop, establish, maintain, implement, and require that technical procedures meet the following:
(1)
The procedures included are:
(a)
Generally accepted in the appropriate forensic field or supported by data gathered and recorded in a scientific manner;
(b)
Available to all appropriate employees;
(c)
Able to produce valid and accurate results; and
(d)
Reviewed annually by the director or the director’s designee and this review shall be documented;
(2)
All procedures include, at a minimum:
(a)
Sample or specimen preparation, as needed for the method;
(b)
Required quality control, standard, and reference material;
(c)
Calibration requirements and instructions;
(d)
Interfering substances and potential sources of error;
(e)
Literature references;
(f)
Special analytical and safety precautions;
(g)
Step-by-step instructions; and
(h)
Calculations, if required;
(3)
The laboratory has a document control procedure to determine when the technical procedure has been discontinued or retired.
(4)
A laboratory procedure identifies which documents are to be maintained in the case file;
(5)
All changes to a procedure are approved and signed by the director;
(6)
The SOPM is available to all forensic analysts and examiners;
(7)
A departure from the SOPM is:
(a)
Approved by the laboratory director or qualified designee before implementation;
(b)
Scientifically validated before implementation;
(c)
Written; and
(d)
Communicated to the quality assurance manager;
(8)
The laboratory has a procedure for determining the reasons, criteria, or conditions for when a report is not produced;
(9)
The laboratory has a procedure or policy for technical review of reports that:
(a)
Defines criteria for the technical review, for example, number or percent of case reports reviewed or corrective action protocol if discrepancies are found;
(b)
Ensures that a review cannot be performed by the examiner or analyst who prepared the report; and
(c)
Ensures that a technical review of a one-individual unit is performed at a review percentage determined by the laboratory director by an analyst or examiner of another licensed forensic laboratory, who is qualified within the same disciplines or subdisciplines; and
(10)
The laboratory has a procedure for administrative review that:
(a)
Requires that reviews be performed on all case reports;
(b)
Specifies who may perform the administrative review;
(c)
Clearly defines how the administrative review is documented; and
(d)
Requires that reviews be performed before case reports are issued.
D.
A licensee shall ensure that the laboratory has a policy and procedure for the handling of written or oral complaints received from customers, laboratory employees, or other parties.
E.
Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall have:
(1)
A record of sample signatures and initials of all employees handling specimens and performing analytical work; and
(2)
A procedure:
(a)
For periodically monitoring the purity of chemicals used as reference standards; and
(b)
That defines which postmortem forensic toxicology tests are to be performed on each type of case.
Regulation .06 Calibration — General.LinkCopy Citation
A.
A licensee shall develop, establish, implement, maintain, and follow calibration procedures.
(1)
If computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of calibration data, the licensee shall ensure that:
(a)
Computer software is performance checked after updates occur or validated;
(b)
Procedures are established, maintained, and followed to protect and secure the data; and
(c)
Computers and automated equipment are maintained to ensure proper functioning.
(2)
A licensee shall ensure that:
(a)
Reference standards are calibrated by an entity that can provide traceability;
(b)
Measuring devices including rulers, weights, pipettes, balances, thermometers, and other devices that affect a forensic analysis result are calibrated against a reference standard traceable to the International System of Units, if available, as required by the manufacturer or forensic laboratory’s quality assurance program;
(c)
Calibration, if applicable, is performed:
(i)
Before initial use and before the recalibrated item is returned to service;
(ii)
Following service or maintenance; and
(iii)
At intervals specified by the manufacturer or more frequently as determined by the technical leader or quality assurance manager; and
(d)
All calibration activities are documented.
B.
Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:
(1)
Include in the method calibration:
(a)
A sufficient number of calibrators and quality control samples in each batch that are consistent with the analysis being performed; and
(b)
Analyses being performed on unusual specimens that:
(i)
Use appropriate matrix-matched calibrators, when possible; and
(ii)
Are prepared and tested concurrently with the specimen; and
(2)
Have a policy that defines a specimen that has a unique matrix.
Regulation .07 Validation and Performance Checks.LinkCopy Citation
A.
The licensee shall:
(1)
Separately perform a validation or conduct a performance check on standard methods before use;
(2)
Validate non-standard methods, laboratory designed methods, laboratory designed tests, and modifications of standard methods before use; and
(3)
Maintain documentation of all method validation and performance check activities.
B.
A licensee shall ensure that validation includes, but is not limited to:
(1)
Literature references;
(2)
Limitations of the method;
(3)
Sources of error;
(4)
Specificity;
(5)
Sensitivity;
(6)
Accuracy; and
(7)
Reproducibility.
C.
A licensee shall ensure that performance checks, if applicable, are performed:
(1)
Before:
(a)
Initial use of computers and automated equipment; and
(b)
Computers or automated equipment are returned to use for casework;
(2)
Following servicing or maintenance;
(3)
At intervals specified by the manufacturer; and
(4)
As needed as determined by the laboratory director or the laboratory director’s designee.
D.
A technical leader and a laboratory director shall approve all testing methods before the testing methods are put into use.
E.
A licensee shall ensure that:
(1)
Reference samples are used for method validation and performance checks;
(2)
Validation and performance checks include a statement as to whether the method is fit for the intended use; and
(3)
All new procedures and modifications of current procedures are validated and documented before being used in case work.
Regulation .08 Examination and Analysis.LinkCopy Citation
A.
A licensee shall develop, establish, maintain, implement, and follow examination and analysis procedures.
B.
A licensee shall:
(1)
Ensure that all evidence is given a unique identifier;
(2)
Ensure that, when computers or automated equipment are used for the processing, recording, reporting, storage, or retrieval of examination or analysis data:
(a)
Computer software is validated;
(b)
Procedures are established and maintained to protect and secure the data; and
(c)
Computers and automated equipment are maintained to ensure proper functioning;
(3)
Have a policy for securing short-term and long-term storage of documents, evidence, and reports, which includes:
(a)
Limited access; and
(b)
Environmental controls;
(4)
Ensure each individual sub-sample has a unique identifier, when evidentiary samples are subdivided;
(5)
Ensure that all positive comparative analyses are verified by a second independent qualified examiner or analyst who has documented expertise in the examination that was performed, and the verification is documented; and
(6)
Have a policy for securing evidence that is in the process of being examined or analyzed.
C.
Examinations and Analysis by Subcontractors.
(1)
All subcontractors shall be licensed as a forensic laboratory in the State, regardless of location, unless a waiver has been obtained for a rare or unique test as required by COMAR 10.51.03.01A(4).
(2)
A licensee shall ensure:
(a)
The customer who ordered the analyses is notified of the laboratory’s intention to subcontract specific services for testing;
(b)
All subcontractors issue reports only to the forensic laboratory that ordered the testing; and
(c)
All remaining evidence is returned to the forensic laboratory by the subcontractor.
Regulation .09 Test Reports — General.LinkCopy Citation
A.
A licensee shall ensure that a test report includes but is not limited to the following:
(1)
Name and physical address of the laboratory;
(2)
A unique identifier on each page of the report;
(3)
Identification of the forensic analysis method used;
(4)
A clear identification of each item tested including a description of the item’s condition;
(5)
The date each forensic analysis was completed;
(6)
Units of measurement, if applicable;
(7)
The name and written or electronic signature of the examiner or analyst responsible for:
(a)
Performance of the forensic analysis;
(b)
Interpretations of forensic analysis results; and
(c)
Opinions;
(8)
Opinions and interpretations;
(9)
When applicable, a statement of uncertainty of measurement if the uncertainty of measurement may affect the interpretation of the results of the forensic analysis;
(10)
The date report was generated;
(11)
The indication of the end of the report on the report’s last page; and
(12)
If applicable, a statement that the analysis was performed by another laboratory and identifies the facility that actually performed the analysis.
B.
A licensee shall ensure that any information from §A(1)—(12) of this regulation that is not included in the test report is documented in the case record.
C.
A licensee shall ensure that test reports:
(1)
Are produced when analytical testing is performed on evidence;
(2)
Contain opinions and conclusions and the name of the report’s author;
(3)
Report results accurately, clearly, unambiguously, and objectively; and
(4)
Utilize a page numbering system that includes either the total number of pages or a mark to signify the end of the document.
D.
A licensee shall ensure that amended reports:
(1)
Clearly state that the report has been amended;
(2)
Reference the original report;
(3)
Are placed or associated with the original report in the case file; and
(4)
Are provided to the customers.
E.
Reports — Postmortem Forensic Toxicology. In addition to applicable sections of this regulation, a laboratory performing postmortem forensic toxicology shall:
(1)
Have a procedure or policy for technical review of reports, which includes at a minimum:
(a)
Chain of custody documentation;
(b)
Validity of analytical data; and
(c)
Quality control data;
(2)
Include on the test report the name of the submitting agency or individual;
(3)
Indicate qualitative test results using the:
(a)
Term “Positive” if the test result is positive for the presence of the substance tested; and
(b)
Term “None detected” if the test result is negative for the presence of the substance tested;
(4)
Have quantitative results identified using correct nomenclature;
(5)
Have preliminary reports clearly indicate that the:
(a)
Results are unconfirmed and subject to verification;
(b)
Testing is incomplete; and
(c)
Subsequent results, where appropriate, may affect the final report and interpretation of the report;
(6)
Clearly identify test results performed by a subcontractor;
(7)
Clearly identify revised reports or addenda using the same identifying information as the original report, for reports that contain additional testing after the original test results were reported; and
(8)
Indicate on the final report the name of the laboratory that actually performed the test if specimens were referred to another laboratory for analysis.
Regulation .10 Employee Training and Competency.LinkCopy Citation
A.
A licensee shall develop, establish, maintain, implement, and follow a written training program for all technical skills in each discipline and subdiscipline for each new or untrained employee and employees who need remedial training.
B.
A licensee shall ensure that available to all technical employees is a discipline-specific training program that includes:
(1)
All aspects of the work being performed by the laboratory for each discipline and subdiscipline in which the laboratory performs case work;
(2)
Ethics and data integrity;
(3)
Criminal and civil law procedures;
(4)
Criteria or requirements to demonstrate competence;
(5)
Moot court training if court testimony may be required; and
(6)
Expert witness training if expert witness testimony may be required.
C.
A licensee shall ensure that training records include at least:
(1)
Competency assessments;
(2)
Proficiency testing results;
(3)
Documentation of all training;
(4)
Documentation of training that occurred at a previous job, if applicable;
(5)
Written authorization by the laboratory director and technical leader to conduct independent casework in each type of testing assigned; and
(6)
Documentation of all continuing education.
Regulation .11 Equipment Maintenance.LinkCopy Citation
A.
General. The laboratory shall develop, establish, maintain, implement, and follow an equipment calibration and maintenance procedure and policy.
B.
A licensee shall ensure that equipment, before being placed into use, is calibrated or checked to establish that the equipment meets either the laboratory’s or manufacturer’s specifications, or both, as determined by the director.
C.
A licensee shall ensure that records are maintained on all items of equipment including at a minimum:
(1)
Identity of the item of equipment and the equipment’s ancillary parts;
(2)
Manufacturer’s name and serial number or other unique identifier;
(3)
Performance checks ensuring the equipment complies with the manufacturer’s specifications;
(4)
Current location, if applicable;
(5)
Manufacturer’s instructions or operating manual;
(6)
Dates and results of calibrations, adjustments, and service and date of next calibration;
(7)
Documentation of all maintenance performed, including date and signature of the individual performing the maintenance; and
(8)
Documentation of any damage, malfunction, modification, or repair to the equipment.
D.
A licensee shall ensure that any equipment that gives questionable results or is not functioning properly is immediately taken out of use and the equipment:
(1)
Is clearly labeled as out of service;
(2)
Is examined and repaired or retired;
(3)
Is calibrated or shown to perform correctly before being put back into service; and
(4)
Has forensic analysis results on previously examined evidence evaluated for accuracy back to the previous calibration.
E.
A licensee shall ensure that the equipment, including both hardware and software, is safeguarded from adjustments that invalidate or alter calibrations or test examinations and analyses.
F.
A licensee shall ensure that operator’s manuals for all equipment and instruments are available to all examiners and analysts who use the equipment or instruments.
Regulation .12 Case Records.LinkCopy Citation
A.
A licensee shall create and maintain a unique identifier system for all administrative and examination documents originating from or received by the laboratory for each case by:
(1)
Writing all documents in permanent ink and defining exceptions in the laboratory SOPM;
(2)
Using electronic signatures only if a security protocol is in place;
(3)
Having a tracking policy and system for electronic record changes, when the electronic document is complete; and
(4)
Identifying all administrative documents with a unique identifier and signing or initialing by the individual who prepared or received the document.
B.
In regard to examination documents, a licensee shall ensure that:
(1)
If information is recorded on both sides, each side of a page is considered a separate page;
(2)
If examination documents consist of multiple pages, a page numbering system that includes either the total number of pages or a mark signifying the end of the document is used;
(3)
In the absence of the examiner or analyst, another competent examiner or analyst is able to evaluate and interpret the data;
(4)
An examination document:
(a)
Includes details to support the conclusions and opinions reported by each examiner or analyst;
(b)
Is free of erasures or obliterations;
(c)
Is marked with a unique identifier and the examiner’s or analyst’s handwritten initials or electronic signature; and
(d)
Includes each date casework or an analysis was performed;
(5)
If an individual in addition to the examiner or analyst interprets or reports the results, both individuals initial or electronically sign each page of the examination documents;
(6)
Abbreviations and symbols are defined in the SOPM;
(7)
Erroneous results, corrections, and amendments:
(a)
Are crossed out with a single line, not erased, and not deleted or made illegible; and
(b)
Have corrections entered beside the erroneous result;
(8)
All corrections and amendments are initialed and dated;
(9)
If electronically signed, measures are taken to ensure the signature is secure; and
(10)
There is no loss or change of the original documents.
Regulation .13 Complaints.LinkCopy Citation
A.
A licensee shall retain all complaint records and documentation of the investigations and corrective actions taken by the laboratory.
B.
A licensee shall ensure that complaint documents include at least the:
(1)
Name and organization of complainant, if applicable;
(2)
Date of complaint;
(3)
Details of complaint;
(4)
Corrective action and resolution; and
(5)
Notification of the complainant as to the resolution of the complaint.
C.
A licensee shall forward all complaints to the laboratory director.
Regulation .14 Subcontractors.LinkCopy Citation
A licensee shall:
A.
Maintain a list of all subcontractors to which forensic analyses are referred;
B.
Be responsible for the subcontractor’s forensic analysis or examination;
C.
Ensure that forensic analysis results from the subcontractor are written or in a secured electronic form;
D.
Ensure that if alternative methods are used, the customer is notified before performing the examination or analysis;
E.
Establish and use appropriate review procedures to ensure the integrity of:
(1)
Outsourced samples; and
(2)
Data received from the subcontractor; and
F.
Establish and use appropriate review procedures to verify compliance with applicable State regulations.
Regulation .15 Facilities.LinkCopy Citation
A.
Facility Administration. A licensee shall ensure that a laboratory:
(1)
Is adequate for the testing services offered;
(2)
Has lighting, plumbing, wiring, ventilation, heat, air conditioning, and humidity to meet the laboratory’s requirements; and
(3)
Has the required safety equipment as defined by the laboratory SOPM.
B.
Security. A licensee shall:
(1)
Control and limit access to areas of the laboratory to those persons who regularly work in an area or are designated by the laboratory director as having access to an area; and
(2)
Ensure that:
(a)
Entrances and exits have adequate security measures;
(b)
Internal areas that are required to have controlled or limited access are protected by a locked system;
(c)
The distribution of all keys, magnetic cards, and entry devices is documented and authorized by the director;
(d)
The facility is secure; and
(e)
All short-term and long-term storage areas have controlled or limited access and have a lock system in place.
C.
Safety. A licensee shall:
(1)
Have a safety policy and procedure, that is reviewed annually;
(2)
Designate an employee as the safety officer with responsibilities defined by the licensee;
(3)
Have appropriate safety policies and procedures;
(4)
Demonstrate appropriate safety policies and procedures;
(5)
Have appropriate safety devices and equipment available and in close proximity to the appropriate areas; and
(6)
Be in compliance with all federal, State, and local regulations regarding the handling and disposal of infectious materials, chemicals, radioactive materials, sharps, and glassware.
Regulation .16 Ethics and Data Integrity Policy — Requirement.LinkCopy Citation
A.
A licensee shall:
(1)
Establish and maintain a written ethics and data integrity policy to be followed by all forensic laboratory employees, which includes the items set forth in §B of this regulation;
(2)
Provide access to the information, training, and resources needed by all forensic laboratory employees to comply with applicable federal and State laws, including ethics laws and regulations and the ethics and data integrity policy required in §A(1) of this regulation;
(3)
Provide formal ethics and data integrity training:
(a)
As part of new employee orientation; and
(b)
On an annual basis for all current employees;
(4)
Develop and utilize an employee ethics and data integrity agreement, for each employee to sign annually after training, acknowledging, and certifying that the employee has read, understands, and will follow the forensic laboratory ethics and data integrity policy; and
(5)
Provide a working environment in the forensic laboratory that:
(a)
Prevents employees from being subject to inappropriate pressures, coercion, intimidation, unethical laboratory dilemmas, or bribery from internal or external sources; and
(b)
Promotes and maintains effective bilateral communication through the chain-of-command, regarding concerns, inquiries, and allegations pertaining to:
(i)
Suspected or actual unethical conduct;
(ii)
Data integrity issues;
(iii)
Questionable practices; or
(iv)
Questions concerning forensic analysis procedures or results.
B.
A licensee shall ensure that a licensee’s ethics and data integrity policy includes at least the following topics, requirements, and procedures:
(1)
An employee’s responsibility to report any activity or behavior by any other employee, subcontractor, or vendor that the employee has reason to believe violates applicable laws, rules, and regulations or the forensic laboratory’s ethics and data integrity policy;
(2)
The disciplinary action an employee will be subject to if the employee:
(a)
Makes or produces a report that the employee knows to be false or misleading;
(b)
Is found falsifying, short-cutting, camouflaging, or misrepresenting any information or facts about forensic analysis procedure, result, reports, or data management; or
(c)
Otherwise engages in conduct or behavior that violates the:
(i)
Forensic laboratory’s ethics and data integrity policy; or
(ii)
Established forensic laboratory practices;
(3)
Procedures for reporting, handling, and investigating complaints of unethical conduct and violations or suspected violations of the forensic laboratory’s ethics and data integrity policy;
(4)
Requiring employees to:
(a)
Act impartially and not give preferential treatment to any person;
(b)
Exhibit exemplary conduct and use honest efforts in the performance of duties and responsibilities;
(c)
Perform a forensic analysis in a manner that:
(i)
Is independent of internal and external influences;
(ii)
Is objective; and
(iii)
Assures that results are accurate, precise, and of known and documented quality; and
(d)
Understand the:
(i)
Serious implications and consequences of unethical conduct, intent to defraud, or any impropriety in performing forensic analyses; and
(ii)
Zero tolerance policy regarding an employee who engages in any form of conduct or behavior that is a violation of the ethics and data integrity policy required in §A of this regulation or any forensic laboratory practice that is not authorized by a licensee’s established procedures; and
(5)
Prohibiting an employee from:
(a)
Soliciting or accepting any gift of goods or services or other benefit of value from a person or entity:
(i)
Seeking action from or doing business with the forensic laboratory; or
(ii)
Whose interests may be substantially affected by the performance or nonperformance of the employee’s duties and responsibilities;
(b)
Holding a financial or personal interest that conflicts with the conscientious and ethical performance of duties and responsibilities;
(c)
Engaging in a transaction allowing the improper use of confidential information to further a private interest;
(d)
Conducting an action that violates the standards and requirements set forth in this subtitle or the licensee’s ethics and data integrity policy; and
(e)
Engaging in outside employment or activities that conflict with the conscientious and ethical performance of duties and responsibilities.
Regulation .17 Nonretaliation.LinkCopy Citation
A.
A licensee shall establish, maintain, and follow a nonretaliation policy that ensures that an employee who in good faith reports to the Secretary or the Department an issue related to data integrity or unethical or fraudulent conduct will not be subject to any form of discrimination or retaliation.
B.
An employee who works in a forensic laboratory may disclose information to the Secretary that the employee believes evidences a violation or possible violation of a standard or requirement set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, including a standard or requirement related to data integrity or unethical or fraudulent conduct.
C.
A licensee shall post the document developed by the Secretary and approved by the Department informing employees of a forensic laboratory of the procedures to report instances of noncompliance or other violations of the standards and requirements set forth in this subtitle or Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland.
D.
The Department shall develop a forensic laboratory noncompliance document that:
(1)
Has contact information for reporting violations of standards and requirements for forensic laboratories, including address, phone numbers, fax number, and website;
(2)
Has a statement about nonretaliation and nondiscrimination against anyone reporting noncompliance or other violations for forensic laboratories; and
(3)
Is signed by the director of the Office of Health Care Quality.
E.
The Department shall distribute to each quality assurance manager of a forensic laboratory the document referenced in §D of this regulation.
F.
A licensee shall ensure that the document referenced in §D of this regulation is posted in a conspicuous place visible to all forensic laboratory employees.
G.
A licensee may not discriminate or retaliate against an employee of a forensic laboratory who:
(1)
In good faith makes a report to the Secretary as set forth in this regulation; or
(2)
Has agreed to cooperate with an investigation of the forensic laboratory.
H.
A licensee may be subject to the sanctions set forth in this subtitle and Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland, if the licensee discriminates or retaliates against an employee who in good faith makes a report to the Secretary as set forth in this regulation, including:
(1)
Failing to promote the employee or provide an employment-related benefit for which the employee would otherwise be eligible;
(2)
Making an adverse evaluation or decision in relation to accreditation, certification, credentialing, or licensing of the employee; or
(3)
Taking a personnel action that is retaliatory to the employee.
I.
An employee of a forensic laboratory who has been discriminated or retaliated against in violation of this regulation or Health-General Article, §17–2A–10, Annotated Code of Maryland, may initiate an action within 2 years of the discrimination or retaliation that is the basis for the action, and, on prevailing, shall be entitled to:
(1)
Reinstatement;
(2)
Reimbursement for lost wages;
(3)
Work benefits lost as a result of the unlawful acts of the licensee; and
(4)
Reasonable attorney’s fees and costs associated with pursuing the action.
Chapter annotations
Authority: Health-General Article, Title 17, Subtitle 2A, Annotated Code of Maryland
History: Effective date: May 28, 2012 (39:10 Md. R. 660)
History: Regulation .01K amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .02A, B amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .05C amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .07C amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .09C, D amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .10B amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .12B amended effective July 20, 2015 (42:14 Md R. 880)
History: Regulation .15A, C amended effective July 20, 2015 (42:14 Md R. 880)