Standards and Compliance

Standard

Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has -

(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens;

(B) The skills required for implementing all standard laboratory procedures;

(C) The skills required for performing each test method and for proper instrument use;

(D) The skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed;

(E) A working knowledge of reagent stability and storage;

(F) The skills required to implement the quality control policies and procedures of the laboratory;

(G) An awareness of the factors that influence test results; and

(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test

The Proficient Lab Framework for Compliance

Framework for documenting training data is mapped through editable templates in The Proficient Lab.

Framework includes lab specific training components including but not limited to;
Numerical, text, and choice data entry,
Trainer<>Trainee data comparison,
Trainer<>Trainee comments,
Direct observation,
Reference ranges,
Uploads,
Acceptability determination.
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Quiz Framework

Standard

Detailed information concerning the inspection process, including, but not limited to the following:
(iii) The content and frequency of training provided to inspection personnel, including the ability of the organization to provide continuing education and training to inspectors

The Proficient Lab Framework for Compliance

The content of all training records and applicable data entry is stored in The Proficient Lab.
Frequency of training is available through individual user and admin credentials.

• Human Resources Standard of Practice 7 (HR S7): Competency Assessment – Supervisory Personnel
• Human Resources Standard of Practice 8 (HR S8): Competency Assessment – Testing Personnel

Standard

Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to -
(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
(iv) Direct observation of performance of instrument maintenance and function checks;
(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
(vi) Assessment of problem-solving skills; and

The Proficient Lab Framework for Compliance

Framework for documenting competency data is mapped through editable templates in The Proficient Lab.

Framework includes lab specific competency components including but not limited to;
CLIA evaluation methods applied to assessments in advance or in real-time during evaluation,
Employee<>Assessor comments,
Uploads,
Acceptability determination.
+
Quiz Framework

Standard

Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to -
(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records;
(iv) Direct observation of performance of instrument maintenance and function checks;
(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and
(vi) Assessment of problem-solving skills; and

The Proficient Lab Framework for Compliance

Framework for documenting competency data is mapped through editable templates in The Proficient Lab.

Framework includes lab specific competency components including but not limited to;
CLIA evaluation methods applied to assessments in advance or in real-time during evaluation,
Employee<>Assessor comments,
Uploads,
Acceptability determination.
+
Quiz Framework

Standard

Evaluating and documenting the performance of individuals responsible for “high and moderate” complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

The Proficient Lab Framework for Compliance

Competency period (initial, semi-annual, annual or remedial) is specified in The Proficient Lab.
Competencies with due dates can be created in advance to comply with required timeframes.
Competencies created with advanced due dates will trigger email reminders.

Standard

Evaluating and documenting the performance of individuals responsible for “high and moderate” complexity testing at least semiannually during the first year the individual tests patient specimens. Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation.

The Proficient Lab Framework for Compliance

Competency period (initial, semi-annual, annual or remedial) is specified in The Proficient Lab.
Competencies with due dates can be created in advance to comply with required timeframes.
Competencies created with advanced due dates will trigger email reminders.

Standard

Competency assessments must be performed annually for all tasks for which the supervisor is responsible and include, as applicable:
a) the date of the assessment;
b) compliance with policies and procedures;
c) communication, including bringing problems and nonconformities to the attention of laboratory management;
d) leadership and problem-solving capabilities; e) allocation of assets for effective daily laboratory operations; and
f) personnel management.

Competency assessments must be performed by delegated supervisor qualified staff or the director or assistant director(s). For direct report supervisors and assistant directors, the laboratory director must approve these competencies.

The Proficient Lab Framework for Compliance

Competency assessments for supervisors, managers, and directors can be selected and applied to applicable sessions in The Proficient Lab.

Standard

Competency assessments must be performed at least semiannually during the first year the individual tests patient specimens and annually thereafter. If there is a change to the test method or instrument, that causes testing personnel to alter their test process, competency must be reevaluated and documented prior to reporting patient test results and include use of the new test method or instrument.

Competency assessments of testing personnel must be performed at the site where personnel perform their job. Competency assessments must be performed for all tasks for which the testing personnel are responsible and include, as applicable:
a) the date of the assessment and the ability to recreate the test process used for the competency;
b) assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples;
c) direct observation of employee’s duties by supervisor qualified staff for compliance with each test procedure performed;
d) direct observation of compliance with safe practices required to perform specimen testing.
e)direct observation of compliance with procedures for instrument maintenance and function checks and/or preventive maintenance and proper documentation, as applicable;
f) review of intermediate test results or worksheets, quality control records and proficiency testing results;
g) recording and reporting of test results;
h) assessment of problem-solving skills; and
i) assessment of competency of any delegated supervisory functions.

The Proficient Lab Framework for Compliance

All competency assessments are time stamped in The Proficient Lab; this includes the dates of the assessment.
All CLIA and NYS specific evaluation methods are available for selection in The Proficient Lab.

Standard

The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under §§ 493.1447, 493.1453, 493.1459, and 493.1487, respectively.

The Proficient Lab Framework for Compliance

Training and competency may be delegated to qualified personnel while laboratory director maintains oversite of all activities in The Proficient Lab.

Standard

Laboratory supervisor responsibilities include:
d) verifying that personnel are trained and deemed proficient prior to performing testing on patient specimens independently;
e) ensuring that staff have competency assessments as needed; and
f) ensuring action is taken when personnel do not perform as expected on competency assessments.

The Proficient Lab Framework for Compliance

Training and competency verification can be performed by all administrative users and directors in The Proficient Lab.

All competency assessment determined unacceptable can be documented as such.
The Proficient Lab’s framework will require documentation for remedial action.

• Document and Specimen Retention Standard of Practice 2 (DSR S2): Human Resources, Training and Competency Records

Standard

Quality system assessment records.
Retain all laboratory quality systems assessment records for at least 2 years.

The Proficient Lab Framework for Compliance

All records are maintained in The Proficient Lab for the lifetime of the customer’s usage.
All records are available for PDF storge.

Standard

The laboratory must retain human resources, training and competency records for the duration of employment and six (6) years thereafter, unless otherwise indicated below, including:
...
e) training: i. with the exception of safety training which must be retained for three (3) years.
f) competency assessments;
...

The Proficient Lab Framework for Compliance

Training and competency verification can be performed by all administrative users and directors in The Proficient Lab.

All records are maintained in The Proficient Lab for the lifetime of the customer’s usage.
All records are available for PDF storge.

Standard

Accessible records and data. A laboratory must have all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.

The Proficient Lab Framework for Compliance

All training, competency, and quizzes stored in The Proficient Lab is immediately available during inspections in an electronic format or PDF.

Standard

Controls for Closed Systems

Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following:
(a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
(d) Limiting system access to authorized individuals.
(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.
(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks.
(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification.
(k) Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
(b) The items identified in paragraphs (a) (1), (a) (2), and (a) (3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

The Proficient Lab Framework for Compliance

All training, competency, and quizzes stored in The Proficient Lab is immediately available during inspections in an electronic format or PDF.

The Proficient Lab is a closed validated system utilizing biometric signatures.
All data documented electronically can be generated in PDF format with no data loss.
System access is limited to authorized users and all access is based on role designation by the laboratory director.
All data entered in The Proficient Lab is stamped for date, time, and user.
Signatures captured in The Proficient Lab contain all necessary signature manifestations. All signature manifestations are captured for PDF conversion if necessary.

https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

https://www.wadsworth.org/sites/default/files/WebDoc/EFFECTIVE_GeneralSystems_May2021_FINAL.pdf