American Bio-Clinical Laboratories

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, interview with the technical supervisor (TS), and review of four (4) randomly chosen patients records; it was determined that the laboratory failed to attain at least 80% of the acceptable score in routine chemistry for DHEA, ferritin, TSH, and urine sediments tests. The findings included: 1. Based on review of PT records for the second event of 2023 (Q2-2023), AAB-MLE reported an unsatisfactory score report as follow: a. DHEA and ferritin 0%. b. urine sediment 50% 2. Upon further review of PT records, the surveyors also reviewed the TSH results from the third event of 2023 (Q3-2023) that resulted to a score 40%. 3. During the survey on 2/28/2024, the submitted laboratory testing declaration stated that the laboratory analyzed and reported approximately 4,962,309 routine chemistry tests including DHEA, ferritin, TSH and urine sediment during the time the laboratory had unsatisfactory proficiency testing results. 4. The TS affirmed on 2/28/2024 at approximately 12:00 p.m. that the laboratory received the above unsatisfactory proficiency testing scores. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's proficiency testing (PT) records from American Association of Bioanalysts Medical Laboratory Evaluation (AAB- MLE), and interview with the technical supervisor (TS); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for hematology on the second event of 2023 (Q2-2023). The findings included: 1. The AAB-MLE proficiency program gave an overall unsatisfactory score of 60% for coagulation for Q2-2023. 2. The TS confirmed on February 29, 2024, at approximately 12:00 p.m. that the laboratory received the above proficiency score of 60% for coagulation as described in statement #1. 3. Based on the laboratory's annual testing declaration submitted on the day of the survey February 29, 2024; the laboratory analyzed and reported approximately 1,403,217 hematology samples that include coagulation tests during the time the laboratory had unsatisfactory proficiency testing results. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on the surveyors' observation during the laboratory tour and interviews with the technical supervisors (TS) and testing personnel (TP) the laboratory failed to label reagents and solutions preparation and expiration dates in various sections of the laboratory. The findings included: 1. Based on the surveyor's observation during the laboratory's tour on February 28, 2024, at approximately 4:00 p.m..; no opening, preparation, or expiration date labels were used or documented for the reagents and solutions (ex: immersion oil, bleach and distilled water). 2. The TS and TP affirmed in an interview conducted 2/29/2024, at approximately 4:00 p.m. that the reagents and solutions mentioned in statement 1 were not labeled with the opening, preparation, and expiration dates or documented. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 18,183,433 test samples. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's records and interviews with the laboratory's technical supervisors (TS) and laboratory director (LD) on February 28, -- 2 of 3 -- 2024; it was determined that the laboratory director is cited herein due to failure to ensure that several aspects of the preanalytic and analytic phases of the laboratory testing were monitored. See D5415. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on interviews with the technical supervisors (TS), review of proficiency test reports documents for chemistry and hematology on February 28, 2024; the laboratory director failed to ensure that laboratory personnel are properly trained and competent when performing the test methods as required for accurate and reliable results. See D2087 and D2121. -- 3 of 3 --

Summary Statement of Deficiencies D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's test requisitions, client complaint log, and interview with the laboratory technical supervisor on April 26, 2022, at 12:30 pm, the laboratory failed to accurately enter the test requisition information into the laboratory's information system (LIS) for 5 patients out of 15 patients, reviewed. The findings include: 1. The laboratory used a 3rd party foreign data entry service to enter the test requisition information into the laboratory's information system which inaccurately entered the data affecting patient care adversely. a) The laboratory did not enter RPR test into its LIS for the patient # 3202145. b) The laboratory did not enter HIV test into its LIS for the patient # 3103565. c) The laboratory did not enter HIV, T cell CD3/4/8 test into its LIS for the patient # 3083740. d) The laboratory did not enter UA test into its LIS for the patient # 3138866. e) The laboratory did not enter CMP test into its LIS for the patient # 3353767. 2. The laboratory technical supervisor on April 26, 2022, at 12:30 pm, confirmed that the laboratory missed data entry from the test requisition into the LIS. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/25/2022, stated that the laboratory performed 6,049,813 tests, annually. 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 Surveyor review of laboratory's test records, problem log, and interview with the laboratory technical supervisor on April 26, 2022, at 1:30 pm, the laboratory staff failed to follow procedure to accurately label and handle patient specimens for 3 patients out of 10 patients, reviewed. The findings include: 1. The laboratory collected patient sample at its patient service center (PSC). The staff at the PSC mislabeled the sample tube # 2720139 and 3301876 and did not draw lavender top tube for sample # 2925314. This caused sample rejection and adversely affected patient care. 2. The laboratory technical supervisor on April 26, 2022, at 1:30 pm, affirmed that the staff made mistake in labeling and handling the specimens. 3. The laboratory's testing declaration form, signed by the laboratory director on 4/25/2022, stated that the laboratory performed 6,049,813 tests, annually. 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 Surveyor review of laboratory's quality assessment policy and procedure, and interview with the laboratory technical supervisor on April 26, 2022, at 1:40 pm, the laboratory failed to assess preanalytic systems quality. The findings include: 1. The laboratory received multiple complaints from the providers regarding inaccurate test order entry and it had problems in sample labeling and handling. However, the laboratory's quality assessment program was unable to monitor and improve the system. Some examples of quality assessment include monitoring the frequency of specimen handling problems, perform periodic or spot checks for accurate transfer of information into the LIS. The preanalytic systems assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency for one of one Technical Supervisor in 2019, 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency for one of one Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for the one of one Technical Supervisor who performed microscopic evaluations in 2019, 2020 and to the date of the survey in 2021. Technical Supervisor includes: - Laboratory Director/Technical Supervisor 3. During an interview on April 21, 2021 at 12:30 PM Laboratory Director/Technical Supervisor confirmed these findings. D5659 CYTOLOGY CFR(s): 493.1274(e)(6) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(6) Corrected reports issued by the laboratory indicate the basis for correction. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of laboratory policies and procedures, final test reports and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure that corrected reports indicated the basis for the correction on the report. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for issuing a corrected report. 2. The Survey Team randomly identified one of one corrected report from April 19 thru April 21, 2021, which did not indicate the basis for the correction on the report. Corrected report includes: - N21-01922 3. During an interview on April 20, 2021 at 4:15 PM the Cytology Manager stated that there was not a reason for the correction on the report. 4. During an interview on April 21, 2021 at 12:30 PM the Laboratory Director/Technical Supervisor confirmed these findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the Laboratory Director failed to ensure written policies and procedures were established to assess, monitor and maintain the competency for one of one Technical Supervisor in 2019, 2020 and to the date of the survey in 2021. Cross refer to D5209. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Surveyor review of random patient testing records, quality control data, and interview with the laboratory technical supervisor, the laboratory failed to include a negative and a positive control material in each day patient specimens are assayed or follow an established IQCP. The findings include: a. The laboratory tested and reported Quantiferon-TB Plus result for the patients, ID # 2098792 and 2098783 as negative and positive, respectively, however no quality control material was included at the day of patient testing. Since no proper quality control materials were used at the day of the patient sample testing, the validity of the obtained and reported result can not be assured. b. The laboratory technical supervisor, on 3/1/2019 at 3:45 pm, confirmed that no quality control material is used for the above tests. c. The laboratory testing declaration form signed by the laboratory director on 2/26/2019 states that the laboratory performs 1,599 tests in mycobacteriology, annually. D5621 CYTOLOGY CFR(s): 493.1274(c)(1) (c) Control procedures. The laboratory must establish and follow written policies and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (1) A review of slides from at least 10 percent of the gynecologic cases interpreted by individuals qualified under 493.1469 or 493.1483, to be negative for epithelial cell abnormalities and other malignant neoplasms (as defined in paragraph (e)(1) of this section). (c)(1)(i) The review must be performed by an individual who meets one of the following qualifications: (c)(1)(i)(A) A technical supervisor qualified under 493. 1449(b) or (k). (c)(1)(i)(B) A cytology general supervisor qualified under 493.1469. (c)(1)(i)(C) A cytotechnologist qualified under 493.1483 who has the experience specified in 493.1469(b)(2). (c)(1)(ii) Cases must be randomly selected from the total caseload and include negatives and those from patients or groups of patients that are identified as having a higher than average probability of developing cervical cancer based on available patient information. (c)(1)(iii) The review of those cases selected must be completed before reporting patient results. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory policy & procedure, random patient testing records, quality control data, and interview with the laboratory coordinator, the laboratory failed to complete the review of the selected gynecological control cases before reporting patient results. The findings include: a. The laboratory's cytotechnologist screened some patient gynecological slides including sample ID: 1527495 on 08/07/2017. The laboratory picked 10% of the screened cases including sample ID: 1528561 for quality control purposes. The record shows that the picked quality control slides were reviewed by the technical supervisor on 08/09/2017. Nonetheless, prior to the completion of control review the laboratory reported the negative result for sample ID: 1527495 on 08/07/2017. Therefore, the validity of the reported result could not be assured. b. The laboratory coordinator, on 3/1/2019 at 3: 35 pm, confirmed that the patient results were reported prior to the completion of the review of the control. c. The laboratory testing declaration form signed by the laboratory director on 2/26/2019 states that the laboratory performs 15,965 tests, annually. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Surveyor review of patient test records, and policy, procedure and quality control records for cytology and mycobacteriology, and interview with the laboratory technical supervisor and coordinator, it was determined that the laboratory director failed to ensure the quality controls are established to assure the quality of laboratory services provided (See D5445 and 5621). -- 2 of 2 --