Hematology Oncology Associates Of North

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 lack of proficiency testing (PT) records from 2021, 2022 and 2023, review of patient records, and interview with the facility personnel, the laboratory failed to enroll in an approved proficiency testing program for the regulated analytes: white blood cell (WBC), red blood cell (RBC), hematocrit, hemoglobin, platelets, and WBC Differential in the speciality of hematology. Findings include: 1. The laboratory performed Complete Blood Count (CBC) testing from July 19, 2021 through November 1, 2023 on the Cell Dyn Emerald analyzer. 2. No documentation was presented for review during the survey conducted on February 21, 2024 to indicate the laboratory was enrolled in an approved PT program during 2021, 2022 and 2023 for the regulated analytes of white blood cell (WBC), red blood cell (RBC), hematocrit, hemoglobin, platelets, and WBC Differential. 3. The facility personnel interviewed on February 21, 2024 at 03:54 PM confirmed the laboratory failed to enroll in an approved PT program for the regulated analytes of white blood cell (WBC), red blood cell (RBC), hematocrit, hemoglobin, platelets, and WBC Differential in the speciality of hematology. 4. The laboratory performed 1,254 patient tests from July 19, 2021 through November 1, 2023. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the number and severity of deficiencies identified during the survey conducted on February 21, 2024, it was determined the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493.1281 through 493.1299 for patient testing performed in the specialty of Hematology. See D5203, D5209, D5291, D5311, D5391, D5401, D5403, D5413, D5415, D5421, D5425, D5431, D5439, D5445, D5791, D5801, D5805, and D5891 for findings. 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 instrument printouts for the Cell Dyn Emerald analyzer, review of patient test reports and interview with the facility personnel, the laboratory failed to establish written policies and procedures to ensure positive identification of the patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory performed Complete Blood Count (CBC) testing on the Cell Dyn Emerald analyzer in the specialty of hematology from July 19, 2021 through November 1, 2023. 2. The laboratory failed to provide evidence of an established written policy and procedure to 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, for testing performed on the Cell Dyn Emerald analyzer. 3. Instrument printouts scanned into the patient's electronic health record (EHR) as the final test report for two out of two patients (ID# MO2829 and #562707663) failed to include positive patient identification of the sample. The instrument printouts contained only the name of the patient, and failed to include at least one other unique patient identifier. 4. The facility personnel interviewed on February 21, 2024 at 4:25 PM confirmed the laboratory failed to establish policies and procedures to ensure positive identification and optimum integrity of a patient's specimen throughout the entire testing process, for testing performed on the Cell Dyn Emerald analyzer. 5. The laboratory performed 1,254 patient tests from July 19, 2021 through November 1, 2023. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, -- 2 of 17 -- consultant competency. This STANDARD is not met as evidenced by: Based on lack of employee competency policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures to assess the competency of the Clinical Consultant (CC) and the Technical Consultant (TC). Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on February 21, 2024 listed one Technical Consultant (TC-1) who provides technical oversight for testing performed in the specialty of hematology. 2. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on February 21, 2024 listed one Clinical Consultant (CC-1) who provides clinical consultation for testing performed in the specialty of hematology. 3. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Consultant and Clinical Consultant. 4. The facility interviewed on February 21, 2024 at 12:35 PM confirmed the laboratory failed to establish policies and procedures to assess the competency of the TC and CC indicated above. 5. The laboratory performed 1,254 CBC tests from July 19, 2021 through November 1, 2023. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on February 21, 2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the general laboratory system requirements specified at 493.1231 through 493.1236. 2. The facility personnel interviewed on February 21, 2024 at 4:55 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. 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. -- 3 of 17 -- This STANDARD is not met as evidenced by: Based on lack of written policies and procedures for review and interview with the facility personnel, the laboratory failed to establish policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. Findings include: 1. The laboratory performed Complete Blood Count (CBC) testing on the CellDyn Emerald analyzer from July 19, 2021 through November 1, 2023. 2. No documentation was presented for review during the survey conducted on February 21, 2024 to indicate the laboratory established policies and procedures for patient preparation, specimen collection, specimen labeling, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, and specimen referral. 3. The facility personnel interviewed on February 21, 2024 at 4: 01 PM confirmed the laboratory failed to provide evidence of the above referenced policies and procedures at the time of the survey. 4. The laboratory performed 1,254 patient tests from July 19, 2021 through November 1, 2023. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a lack of established quality assessment (QA) policies and procedures and interview with the facility personnel, the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the preanalytic laboratory systems requirements specified at 493.1241 through 493.1242. Findings include: 1. No QA documentation was provided for review during the survey conducted on February 21, 2024 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the preanalytic laboratory system requirements specified at 493.1241 through 493.1242. 2. The facility personnel interviewed on February 21, 2024 at 4:55 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the preanalytic laboratory systems requirements. 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 lack of written test procedures for review and interview with the facility personnel, the laboratory failed to have written test procedures for CBC testing -- 4 of 17 -- performed on the Cell Dyn Emerald analyzer in the specialty of hematology. Findings include: 1. The laboratory performed Complete Blood Count (CBC) testing on the Cell Dyn Emerald analyzer from July 19, 2021 through November 1, 2023. 2. No evidence of a written procedure manual for CBC tesing performed on the Cell Dyn Emerald analyzer was presented for review during the survey. 3. Facility personnel interviewed on February 21, 2024 at 04:03 PM confirmed the laboratory failed to provide evidence of a written procedure manual for CBC testing performed on the Cell Dyn Emerald analyzer. 4. The laboratory performed 1,254 patient tests from July 19, 2021 through November 1, 2023. 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)