Norman Regional Porter

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of cytology proficiency testing (PT) enrollment records and interview it was determined that the laboratory failed to enroll in an approved PT program for gynecologic examination (refer to D2001). D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews it was determined that the laboratory failed to enroll in an HHS-approved cytology PT program for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- gynecologic examination for 2019 and 2020. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2019 and 2020. 2. During an interview on September 7, 2021 at 1:50 PM, these findings were confirmed with the Pathology/Histology Supervisor. 3. During an interview on September 7, 2021 at 4:00 PM, these findings were confirmed with Technical Supervisor C. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, slide preparations and interviews it was determined the laboratory failed to establish written policies and procedures to ensure specimen slides were labeled with a unique patient identifier (refer to D5203); failed to establish written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens (refer to D5311); failed to establish written policies and procedures for five laboratory test processes (refer to D5403); failed to establish written policies and procedures for identifying nongynecologic specimens with a high potential for cross- contamination (refer to D5619); failed to establish written policies and procedures to ensure unsatisfactory cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report cytology test results (refer to D5657); and failed to ensure final test reports indicated the correct name of the laboratory where the test was performed (refer to D5805). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, specimen slides and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure specimen slides were labeled with a unique patient identifier. The laboratory failed to ensure that five of six patient specimens from January and February 2021 had specimen slides labeled with a unique patient identifier. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure specimen slides were labeled with a unique patient identifier. 2. The Survey Team reviewed specimen slides from six cases from January and February 2021 that had an additional slide preparation made. The additional prepared specimen slide for five of the six cases failed to have a unique patient identifier. Cases include: P21-81 Identifier on additional slide: 21-81 P21-88 Identifier on additional slide: 21-88 P21-261 Identifier on additional slide: 21-261 -- 2 of 12 -- P21-294 Identifier on additional slide: 21-294 P21-438 Identifier on additional slide: 21-438 3. During an interview on September 8, 2021 at 11:45 AM, these findings were confirmed with the Administrative Laboratory Director, Laboratory Manager and Pathology/Histology Supervisor. 4. During an interview on September 9, 2021 at 9:00 AM, the Survey Team requested a procedure detailing how slides were to be labeled. The Pathology/Histology Supervisor stated "I'm pretty sure I don't have that." D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. 2. During an interview on September 8, 2021 at 11:05 AM, these findings were confirmed with the Pathology/Histology Supervisor. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of thirteen laboratory policies and procedures, lack of laboratory records and interviews it was determined that the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure H & E MANUAL STAIN - FROZEN SECTIONS which stated: "H&E stain, HE stain or hematoxylin and eosin stain, is a popular staining method in histology. It is the most widely used stain in medical diagnosis; for example when a pathologist looks at a biopsy of a suspected cancer, the histological section is likely to be stained with H&E and termed H&E section, H+E section, or HE section. It is also used for staining cytology slides from endo bronchial (EBUS) procedures and thyroid adequacy procedures." "the 1st case of the day will be used to QC H&E stain" a. The Survey Team requested and the laboratory failed to provide records documenting that the characteristics of the hematoxylin and eosin (H&E) stain used for the immediate assessment of nongynecologic cytology slides was assessed each day of use in 2020 and to the date of the survey in 2021. b. During an interview on September 7, 2021 at 1:50 PM, these findings were confirmed with the Pathology/Histology Supervisor. -- 3 of 12 -- D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)