Or. Admin. Code § 333-024-0037

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-024-0037 - Specialty and Subspecialty Quality Control

(1)Bacteriology quality control requirements are:

(a) The laboratory must check positive and negative reactivity with control organisms:

(A) Each day of use for catalase, coagulase, betalactamase, oxidase reagents and DNA probes;

(B) Each week of use for Gram and acid-fast stains, bacitracin, optochin, ONPG, X and V discs or strips; and

(C) Each month of use for antisera.

(b) Each week of use, the laboratory must check XV discs or strips with a positive control organism;

(c) For antimicrobial susceptibility tests, the laboratory must check each new lot shipment of media and each lot of antimicrobial discs before, or with initial use, using approved reference organisms, following the National Committee for Clinical Laboratory Standards (NCCLS) approved procedures for antimicrobial susceptibility quality control:

(A) The laboratory's zone sizes or minimum inhibitory concentration for reference organisms must be within established quality control limits before reporting patient results;

(B) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure.

(d) The laboratory must check each batch or lot shipment of media for sterility. Media must also be checked for its ability to support growth, and as appropriate, selectivity/inhibition and/or biochemical response.

(2)Mycobacteriology quality control requirements are:

(a) Each day of use, the laboratory must check the iron uptake test with at least one acid-fast organism that produces a positive reaction and with an organism that produces a negative reaction and check all other reagents or test procedures used for mycobacteria identification with at least one acid-fast organism that produces a positive reaction;

(b) The laboratory must check fluorochrome acid-fast stains for positive and negative reactivity each week of use;

(c) The laboratory must check acid-fast stains each week of use with an acid-fast organism that produces a positive reaction; and

(d) For susceptibility tests performed on Mycobacterium tuberculosis isolates, the laboratory must check the procedure each week of use with a strain of Mycobacterium tuberculosis susceptible to all antimycobacterial agents tested.

(3)Mycology quality control requirements are:

(a) Each day of use, the laboratory using the auxanographic medium for nitrate assimilation must check the nitrate reagent with a peptone control;

(b) Each week of use, the laboratory must check all reagents used with biochemical tests and other test procedures for mycological identification with an organism that produces a positive reaction;

(c) Each week of use, the laboratory must check acid-fast stains for positive and negative reactivity; and

(d) For susceptibility tests, the laboratory must test each drug each day of use with at least one control strain that is susceptible to the drug. The laboratory must establish control limits. Criteria for acceptable control results must be met prior to reporting patient results.

(4)Parasitology quality control requirements are:

(a) The laboratory must have available a reference collection of slides or photographs, and, if available, gross specimens for identification of parasites;

(b) The laboratory must calibrate the ocular micrometer for determining the size of ova and parasites; and

(c) Each month of use, the laboratory must check permanent stains using a fecal sample control that will demonstrate staining characteristics.

(5)Virology quality control requirements are:

(a) The laboratory must have available host systems for the isolation of viruses and test methods for the identification of viruses that cover the entire range of viruses that are etiologically related to clinical diseases for which services are offered;

(b) The laboratory must maintain records that reflect the systems used and the reactions observed; and

(c) In tests for the identification of viruses, the laboratory must simultaneously culture uninoculated cells or cell substrate controls as a negative control to detect erroneous identification results.

(6)Syphilis Serology quality control requirements are:

(a) The equipment, glassware, reagents, controls, and techniques for tests for syphilis must conform to manufacturers' specifications;

(b) The laboratory must run serologic tests on patient specimens concurrently with a positive serum control of known titer or controls of graded reactivity plus a negative control;

(c) The laboratory must employ positive and negative controls that evaluate all phases of the test system to ensure reactivity and uniform dosages; and

(d) The laboratory must not report test results unless the predetermined reactivity pattern of the controls is observed.

(7)General Immunology quality control requirements are:

(a) The laboratory must run serologic tests on patient specimens concurrently with a positive serum control of known titer or controls of graded reactivity, if applicable, plus a negative control;

(b) The laboratory must employ controls that evaluate all phases of the test system (antigens, complement, erythrocyte indicator systems, etc.) to ensure reactivity and uniform dosages when positive and negative controls alone are not sufficient; and

(c) The laboratory must not report test results unless the predetermined reactivity pattern of the controls is verified.

(8)Routine Chemistry and Endocrinology quality control requirements are:

(a) A minimum of two different levels of controls covering the full range of expected results shall be tested with each run of patient specimens, each change of reagents or major maintenance performed;

(b) Control samples must be tested in the same manner, if applicable, as a patient specimen; and

(c) The laboratory must not report test results unless the control results are within the laboratory's acceptable limits.

(9)Blood Gas Analysis quality control requirements are:

(a) Calibrate or verify calibration according to the manufacturer's specifications and with at least the frequency recommended by the manufacturer;

(b) Test one sample of control material each eight hours of testing;

(c) Use a combination of calibrators and control materials that include both low and high values on each day of testing; and

(d) Include one sample of calibration material or control material each time patients are tested unless automated instrumentation internally verifies calibration at least every thirty minutes.

(10)Toxicology quality control requirements are those listed in general chemistry, in addition, for drug abuse screening using thin layer chromatography:

(a) Each plate must be spotted with at least one sample of calibration material containing all drug groups identified by thin layer chromatography which the laboratory reports; and

(b) At least one control sample must be included in each chamber, and the control sample must be processed through each step of patient testing, including extraction procedures.

(11)Urinalysis quality control requirements are those listed in general chemistry, except for those tests categorized as waived.

(12)Hematology quality control requirements are:

(a) Cell counts performed manually using a hemocytometer must be tested in duplicate. One control is required for each eight hours of operation;

(b) For non-manual hematology testing systems, excluding coagulation, the laboratory must include two levels of controls each eight hours of operation;

(c) For all non-manual coagulation testing systems, the laboratory must include two levels of control each eight hours of operation and each time a change in reagents occurs;

(d) For manual coagulation tests:

(A) Each individual performing tests must test two levels of controls before testing patient samples and each time a change in reagents occurs; and

(B) Patient and control specimens must be tested in duplicate.

(13)Cytology quality control requirements are:

(a) All gynecologic smears are stained using a Papanicolaou or modified Papanicolaou staining method;

(b) Effective measures are taken to prevent cross-contamination between gynecologic and nongynecologic specimens during the staining process;

(c) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains are filtered or changed following staining;

(d) Diagnostic interpretations must not be reported on unsatisfactory smears; and

(e) All cytology slide preparations must be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology.

(14) A cytology laboratory is responsible for ensuring that:

(a) Each individual engaged in the evaluation of cytology preparations by nonautomated microscopic technique examines no more than 100 slides (one patient per slide, gynecologic or nongynecologic, or both) in a 24 hour period, irrespective of the site or laboratory. Previously examined gynecologic and nongynecologic cytology preparations, and tissue pathology slides examined by a technical supervisor are not included in the 100 slide limit;

(b) For purposes of workload calculations, each slide preparation (nongynecologic) made using automated, semi-automated, or other liquid-based slide preparatory techniques which result in cell dispersion over one-half or less of the total available slide area and which is examined by nonautomated microscopic technique counts as one-half slide; and

(c) Records are maintained of the total number of slides examined by each individual during each 24 hour period, irrespective of the site or laboratory, and the number of hours each individual spends examining slides in the 24 hour period:

(A) The maximum number of 100 slides described in this section is examined in no less than an 8 hour workday;

(B) For the purposes of establishing workload limits for individuals examining slides by nonautomated microscopic technique on other than an 8 hour workday basis (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours must be used to prorate the number of slides that may be examined.

(15) The individual who provides technical supervision of cytology must ensure that:

(a) All gynecologic smears interpreted to be showing reactive or reparative changes, atypical squamous or glandular cells of undetermined significance, or to be in the premalignant (dysplasia, cervical intraepithelial neoplasia or all squamous intraepithelial lesions including human papillomavirus-associated changes) or malignant category are confirmed and signed by a technical supervisor in cytology;

(b) All nongynecologic cytologic preparations are reviewed and signed by the technical supervisor in cytology;

(c) The slide examination performance of each cytotechnologist is evaluated and documented, including performance evaluation through the re-examination of normal and negative cases and feedback on the reactive, reparative, atypical, malignant or premalignant cases; and

(d) A maximum number of slides, not to exceed the maximum workload limit, is established by the technical supervisor for each individual examining slide preparations by nonautomated microscopic technique.

(A) The actual workload limit must be documented for each individual;

(B) Records are available to document that each individual's workload limit is reassessed at least every 6 months and adjusted when necessary.

(16) The laboratory must establish and follow a program designed to detect errors in the performance of cytologic examinations and the reporting of results:

(a) The laboratory must establish a program that includes a review of slides from at least 10 percent of the gynecologic cases interpreted to be negative for reactive, reparative, atypical, premalignant or malignant conditions. This review must be done by a technical supervisor in cytology, a cytology general supervisor, or a qualified cytotechnologist:

(A) The review must include negative cases selected at random from the total caseload and from patients or groups of patients that are identified as having a high probability of developing cervical cancer, based on available patient information;

(B) Records of initial examinations and rescreening results must be available; and

(C) The review must be completed before reporting patient results on those cases selected.

(b) The laboratory must compare clinical information, when available, with cytology reports and must compare all malignant and premalignant gynecology reports with the histopathology report, if available in the laboratory (either on-site or in storage), and determine the causes of any discrepancies;

(c) For each patient with a current high grade intraepithelial lesion or above (moderate dysplasia or CIN-2 or above), the laboratory must review all normal or negative gynecologic specimens received within the previous five years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that would affect patient care, the laboratory must notify the patient's physician and issue an amended report;

(d) The laboratory must establish and document an annual statistical evaluation of the number of cytology cases examined, number of specimens processed by specimen type, volume of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation), number of gynecologic cases where cytology and available histology are discrepant, the number of gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as malignant or premalignant, and the number of gynecologic cases for which histology results were unavailable to compare with malignant or premalignant cytology cases;

(e) The laboratory must evaluate the case reviews of each individual examining slides against the laboratory's overall statistical values, document any discrepancies, including reasons for the deviation, and document corrective action, if appropriate;

(f) The laboratory report must:

(A) Clearly distinguish specimens or smears, or both, that are unsatisfactory for diagnostic interpretation; and

(B) Contain narrative descriptive nomenclature for all results.

(g) Corrected reports issued by the laboratory must indicate the basis for correction;

(h) The laboratory must retain all slide preparations for five years from the date of examination, or slides may be loaned to proficiency testing programs, in lieu of maintaining them for this time period, provided the laboratory receives written acknowledgement of the receipt of slides by the proficiency testing program and maintains the acknowledgement to document the loan of such slides. Documentation for slides loaned or referred for purposes other than proficiency testing must also be maintained. All slides must be retrievable upon request;

(i) The technical supervisor must ensure that reports are signed, or if a computer report is generated with signature, it must reflect an electronic signature authorized by the technical supervisor in cytology.

(17)Histopathology quality control requirements are:

(a) A control slide of known reactivity must be included with each slide or group of slides for differential or special stains;

(b) The laboratory must retain stained slides, and test reports at least ten years from the date of examination and retain specimen blocks at least two years from the date of examination;

(c) The laboratory must retain remnants of tissue specimens in a manner that assures proper preservation of the tissue specimens until the portions submitted for microscopic exam ination have been examined and a diagnosis made by a qualified individual;

(d) Only those individuals who meet the specific requirements in OAR 333-024-0023 for histology, dermatopathology, opthalmic pathology or oral pathology may examine and provide reports in these subspecialties;

(e) All tissue pathology reports must be signed by a qualified individual. If a computer report is generated with an electronic signature, it must be authorized by a qualified individual; and

(f) The laboratory must utilize acceptable terminology of a recognized system of disease nomenclature in reporting results.

(18)Oral Pathology quality control requirements are the same as those for histopathology.

(19)Radiobioassay quality control requirements are: the laboratory must comply with the applicable requirements of OAR 333-024-0035 and OAR 333-024-0037.

(20)Histocompatibility quality control for renal allotransplantation includes the requirements for OAR 333-024-0035, OAR 333-024-0037(7) and (23); and

(a) The laboratory must have available and follow criteria for:

(A) Selecting appropriate patient serum samples for crossmatching;

(B) The technique used in crossmatching;

(C) Preparation of donor lymphocytes for crossmatching; and

(D) Reporting crossmatch results.

(b) The laboratory must:

(A) Have available results of final crossmatches before an organ or tissue is transplanted; and

(B) Make a reasonable attempt and document efforts to have available serum specimens for all potential transplant recipients at initial typing, for periodic screening, for pre-transplantation crossmatch and following sensitizing events, such as transfusion and transplant loss.

(c) The laboratory's storage and maintenance of both recipient sera and reagents must:

(A) Be at an acceptable temperature range for sera and components;

(B) Use a temperature alarm system and have an emergency plan for alternate storage; and

(C) Ensure that all specimens are properly identified and easily retrievable.

(d) The laboratory's reagent typing sera inventory (applicable only to locally constructed trays) must indicate source, bleeding date and identification number, and volume remaining.

(e) The laboratory must properly label and store cells, complement, buffer and dyes.

(f) The laboratory must:

(A) HLA type all potential transplant recipients;

(B) Type cells from organ donors referred to the laboratory; and

(C) Have available and follow a policy that establishes when antigen redefinition and retyping are required.

(g) The laboratory must have available and follow criteria for:

(A) The preparation of lymphocytes for HLA-A, B and DR typing;

(B) Selecting typing reagents, whether locally or commercially prepared;

(C) The assignment of HLA antigens; and

(D) Assuring that reagents used for typing recipients and donors are adequate to define all major and International Workshop HLA-A,B and DR specificities for which reagents are readily available.

(h) The laboratory must:

(A) Screen potential transplant recipient sera for preformed HLA-A and B antibodies with a suitable lymphocyte panel on sera collected:

(i) At the time of the recipient's initial HLA typing; and

(ii) Thereafter, following sensitizing events and upon request.

(B) Use a suitable cell panel for screening patient sera (antibody screen), a screen that contains all the major HLA specificities and common splits.

(i) If the laboratory does not use commercial panels, it must maintain a list of individuals for fresh panel bleeding;

(j) If the laboratory uses frozen panels, it must have a suitable storage system;

(k) The laboratory must check:

(A) Each typing tray using positive and negative control sera;

(B) Positive controls for specific cell types when applicable (i.e., T cells, B cells, and monocytes); and

(C) Each compatibility test (i.e. mixed lymphocyte cultures, homozygous typing cells or DNA analysis) and typing for disease-associated antigens using controls to monitor the test components and each phase of the test system to ensure an acceptable performance level.

(l) Compatibility testing for cellularly-defined antigens must utilize techniques such as the mixed lymphocyte culture test, homozygous typing cells or DNA analysis;

(m) If the laboratory reports the recipient's or donor's, or both, ABO blood group and D(Rho) typing, the testing must be performed in accordance with the applicable requirements of OAR 333-024-0035, and OAR 333-024-0037(23);

(n) If the laboratory utilizes immunologic reagents (such as antibodies or complement) to remove contaminating cells during the isolation of lymphocytes or lymphocyte subsets, the efficacy of the methods must be verified with appropriate quality control procedures;

(o) At least once each month, the laboratory must have each individual performing tests evaluate a previously tested specimen as an unknown to verify his or her ability to reproduce test results. Records of the results for each individual must be maintained;

(p) The laboratory must participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another laboratory in order to validate inter-laboratory reproducibility.

(21)Histocompatibility, other testing for:

(a) Transfusions and other non-renal transplantation, excluding bone marrow and living transplants, all the requirements specified in this section and OAR 333-024-0035 and OAR 333-024-0037(20), as applicable, except for the performance of mixed lymphocyte cultures, must be met;

(b) Bone marrow transplantation, all the requirements specified in this section and OAR 333-025-0035 and OAR 333-024-0037(20), including the performance of mixed lymphocyte cultures or other augmented testing to evaluate class II compatibility, must be met;

(c) Non-renal solid organ transplantation, the results of final crossmatches must be available before transplantation when the recipient has demonstrated presensitization by prior serum screening except for emergency situations. The laboratory must document the circumstances, if known, under which emergency transplants are performed, and records must reflect any information concerning the transplant provided to the laboratory by the patient's physician;

(d) HLA typing for disease-associated studies must meet all the requirements specified in this section and OAR 333-024-0035 and OAR 333-024-0037(20), except for the performance of mixed lymphocyte cultures, antibody screening and crossmatching;.

(e) Organ donor HIV testing, the requirements of general immunology in OAR 333-024-0035 and OAR 333-024-0037(7) must be met.

(22) Clinical Cytogenetics quality control requirements are:

(a) When determination of sex is performed by X and Y chromatin counts, these counts must be based on an examination of an adequate number of cells. Confirmatory testing such as full chromosome analysis must be performed for all atypical results;

(b) The laboratory must have records that reflect the media used and document the reactions observed, number of cells counted, the number of cells karyotyped, the number of chromosomes counted for each metaphase spread, and the quality of the banding; that the resolution is sufficient to support the reported results; and that an adequate number of karyotypes are prepared for each patient;

(c) The laboratory also must have policies and procedures for assuring an accurate and reliable patient sample identification during the process of accessioning, cell preparation, photographing or other image reproduction technique, and photographic printing, and storage and reporting of results or photographs;

(d) The laboratory report must include the summary and interpretation of the observations, number of cells counted and analyzed, and the use of appropriate nomenclature.

(23) Immunohematology quality control requirements are:

(a) The laboratory must perform ABO group and D(Rho) typing, unexpected antibody detection, antibody identification and compatibility testing in accordance with manufacturer's instructions;

(b) The laboratory must 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 must be tested with known A1 and B red cells;

(c) The laboratory must determine the D(Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent;

(d) If required in the manufacturer's package insert for anti-D reagents, the laboratory must employ a control system capable of detecting false positive D(Rho) test results;

(e) If a facility provides services for the transfusion of blood and blood products, the facility must be under the adequate control and technical supervision of a pathologist or other qualified doctor of medicine or osteopathy. The facility must ensure that there are facilities for procurement, safekeeping and transfusion of blood and blood products and that blood and blood products must be available to meet the needs of the physicians responsible for the diagnosis, management, and treatment of patients;

(f) The requirements for blood and blood products storage facilities are:

(A) The blood and blood products must be stored under appropriate conditions, which include an adequate temperature alarm system that is regularly inspected:

(i) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period; and

(ii) Inspections of the alarm system must be documented.

(B) If blood is stored or maintained for transfusion outside of a monitored refrigerator, the facility must ensure and document that storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product.

(g) In the case of services provided outside the blood bank, the facility must have an agreement reviewed and approved by the director that governs the procurement, transfer and availability of blood and blood products;

(h) There must be provision for prompt ABO blood group, D(Rho) type, unexpected antibody detection and compatibility testing in accordance with the requirements in immunohematology and for laboratory investigation of transfusion reactions, either through the facility or under arrangement with an approved facility on a continuous basis, under the supervision of a pathologist or other qualified doctor of medicine or osteopathy;

(i) According to the facility's established procedures, samples of each unit of transfused blood must be retained for further testing in the event of reactions. The facility must promptly dispose of blood not retained for further testing that has passed its expiration date;

(j) The facility, according to its established procedures, must promptly investigate all transfusion reactions occurring in all facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. The facility must document that all necessary remedial actions are taken to prevent future recurrences of transfusion reactions and that all policies and procedures are reviewed to assure that they are adequate to ensure the safety of individuals being transfused within the facility;

(k) Policies to ensure positive identification of a blood or blood product recipient must be established, documnented and followed.

Or. Admin. Code § 333-024-0037

HD 6-1995, f. & cert. ef. 9-13-95

Stat. Auth.: ORS 438.320

Stats. Implemented: ORS 438.320