Oncology Consultants

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. 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 a review of the laboratory's policy, surveyor observation of the laboratory, a review of the laboratory's submitted CMS 116 form, and staff interview, it was revealed that the laboratory failed to document the revised expiration date on eight of eight individual Abbott i-STAT Chem 8+ cartridges found in the laboratory being stored at room temperature. Findings include: 1. A review of the laboratory's policy titled 'i-STAT Chem 8+ Operational Procedure' revealed the following: "Once opened Store cartridges at room temperature 18 to 30 degrees Celsius and calculate the expiration date by counting 14 days (including the day removed from refrigeration) and mark it on the box/cartridge in the appropriate place. NOTE: If the individual cartridge is not used on the day it is removed from the refrigerator, use a soft felt pen to mark the room temperature expiration date on the pack, taking care not to puncture the pack. Do not use cartridge if this date has passed." 2. Surveyor observation of the laboratory on 1/12/23 at 12:20 p.m. revealed 8 Abbott i-STAT Chem 8+ cartridges (lot H22307, expiration date: 5/2/23) on the counter being stored at room temperature. 3. Further review of the 8 cartridges revealed no open date or revised expiration date were documented on the pack. 4. A review of the laboratory's submitted CMS 116 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 -- application revealed the laboratory indicated the estimated annual test volume for i- STAT Chem 8+ testing at 4000. 5. An interview with the laboratory manager on 1/12 /23 at 12:40 p.m. in the laboratory, after review of the records, confirmed the above findings. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's quality control records for the Abbott i-STAT analyzer from September 2022 to January 2023 and staff interview, it was revealed that the laboratory failed to have a method in place to monitor quality control values over time to detect shifts and trends for eight of eight analytes tested on the Abbott i- STAT analyzer. Findings include: 1. A review of the laboratory's quality control records for the Abbott i-STAT analyzer (serial number: 328049) from September 2022 to January 2023 revealed the laboratory ran the Abbott Tricontrols, levels 1 and 3, with every new lot/shipment of cartridges or control material or every 30 days. 2. Further review of the quality control records revealed the laboratory ran the following lot numbers of Tricontrol quality control material (levels 1 and 3) on the following days: - Date: 9/1/22 Level 1 lot number: 301151 Level 3 lot number: 321151 - Date: 10/3/22 Level 1 lot number: 301151 Level 3 lot number: 321146 - Date: 10/20/22 Level 1 lot number: 301151 Level 3 lot number: 321146 - Date: 11/1/22 Level 1 lot number: 301151 Level 3 lot number: 321146 - Date: 12/1/22 Level 1 lot number: 301151 Level 3 lot number: 321146 - Date 12/8/22 Level 1 lot number: 301145 Level 3 lot number: 321146 - Date: 1/3/23 Level 1 lot number: 301145 Level 3 lot number: 321146 3. Further review of the quality control records revealed the laboratory failed to have a method in place for monitoring and evaluating quality control results over time for the following 8 analytes tested on the Abbott i-STAT analyzer: Sodium Potassium Chloride Ionized Calcium Total Carbon Dioxide Glucose Blood Urea Nitrogen Creatinine 4. An interview with the laboratory manager on 1/12/23 at 11:30 a.m. in the conference room revealed the laboratory only assessed quality control values on the day they are run and did not monitor or evaluate values over time for shifts or trends. This confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory test records from November 2020 to January 2021 and confirmed in interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions when performing the BD Veritor System for the Rapid Detection of SARS-CoV-2 test. Findings were: 1. Review of the instructions for use for the EUA approved BD Veritor System for the Rapid Detection of SARS-CoV-2 (500048916(01) 2020-07) test under Conditions of Authorization for the Laboratory revealed "Authorized laboratories using your product will include with test results, all authorized Fact Sheets." 2. Random review of the patient testing from November 2020 to January 2021 revealed the laboratory performed the following 9 COVID testing without documentation of providing the Fact Sheet to the patient per the manufacturer's instructions. 11/09/20 - Patient ID 275879, Patient ID 281473, Patient ID 281456 11 /30/20 - Patient ID 250262 12/17/20 - Patient ID 281530 01/22/21 - Patient ID 283771 01/25/21 - Patient ID 279897, Patient ID 283799, Patient ID 283797 3. An interview with the technical consultant on 3/2/21 at 1135 hours in the office confirmed the 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 -- above findings. She was unaware the laboratory was required to provide the Fact Sheet for Covid testing with the patient results. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory records from December 2020 to February 2021 and confirmed in interview, the laboratory failed to document a quality control run after a change in reagents on the Sysmex XN450 hematology analyzer for 2 of 7 days reviewed. Findings were: 1. Random review of the December 2020 to February 2021 Reagent Replacement log revealed the 2 of 7 days with no documentation of the quality control run after the following reagent change on the Sysmex XN450 hematology analyzer. 12/17/20 CellPack DCL lot Y0018, exp 2/21/22 12/22/20 Lysercell WDF lot Y0018, exp 2/3/21 2. Review of the patient test records for the above dates revealed the laboratory performed patient testing after the reagent change above with no documentation of the quality control run. 12/17/20 Patient ID 282455 12/22/20 Patient ID 75527, 254524, 62529, 259254 3. An interview with the technical consultant on 3/3/21 at 1120 hours in the office confirmed the above findings. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records from 2020, laboratory patient records, and confirmed in interview with the technical consultant, the laboratory failed to document the positive and negative staining controls each day of testing for the flow cytometry testing on the Beckman Coulter Navios flow cytometer or provide an IQCP (Individualized Quality Control Plan) to reduce the frequency of the positive and negative staining controls to once monthly. Findings were: 1. Review of the laboratory records revealed the laboratory performed flow cytometry evaluating the following 29 markers: CD2 CD3 CD4 CD5 CD8 CD10 CD11b CD13 CD14 CD16 CD19 CD20 CD22 CD23 CD33 CD34 CD38 CD45 CD56 CD57 CD64 CD103 CD117 FMC7 HLA-DR Surface kappa Surface lambda 7-AAD 2. Random review of the laboratory quality control records from January 2020 to November 2020 revealed the laboratory performed positive and negative staining controls using the Streck CD Chex quality control monthly on 1/2/20, 10/20/20 and 11/20/20. 01/02/20: lot 93230041, exp 2/2/20 10/20/20: lot 02440041, exp 11/28/20 11/20/20: lot 02440041, exp 11/28/20 3. Random review of the laboratory patient records from January 2020 -- 2 of 4 -- to November 2020 revealed the laboratory performed 7 patient testing with no documentation of the daily positive and negative staining controls for the following days the laboratory performed patient testing. 01/07/20 - Patient ID 268165 01/09/20 - Patient ID 267883 01/14/20 - Patient ID 265323 01/29/20 - Patient ID 268506 10/28 /20 - Patient ID 279782 10/29/20 - Patient ID 280801 11/10/20 - Patient ID 276943 4. Review of the laboratory quality control records revealed no documentation of an IQCP (Individualized Quality Control Plan) to reduce the frequency of the positive and negative staining controls to once monthly. 5. An interview with the technical supervisor on 3/3/21 at 1130 hours in the office confirmed the above findings. key: CD2 - cluster of differentiation 2 CD3 - cluster of differentiation 3 CD4 - cluster of differentiation 4 CD5 - cluster of differentiation 5 CD8 - cluster of differentiation 8 CD10 - cluster of differentiation 10 CD11b - cluster of differentiation 11b CD13 - cluster of differentiation 13 CD14 - cluster of differentiation 14 CD16 - cluster of differentiation 16 CD19 - cluster of differentiation 19 CD20 - cluster of differentiation 20 CD22 - cluster of differentiation 22 CD23 - cluster of differentiation 23 CD33 - cluster of differentiation 33 CD34 -cluster of differentiation 34 CD38 -cluster of differentiation 38 CD45 - cluster of differentiation 45 CD56 - cluster of differentiation 56 CD57 - cluster of differentiation 57 CD64 - cluster of differentiation 64 CD103 - cluster of differentiation 103 CD117 -cluster of differentiation 117 FMC7 -epitope of CD20 HLA-DR - Human Leukocyte Antigen-antigen D Related 7-AAD - 7- aminoactinomycin D D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of the laboratory records from 2019 and 2020 and confirmed in interview with the technical consultant, the laboratory failed to monitor and evaluate twice yearly the CBC testing (complete blood count) on 2 of 2 Sysmex XN 450 hematology analyzers. Findings were: 1. Surveyor observations on a tour of the laboratory on 3/2/21 at 0910 revealed the laboratory had 2 Sysmex XN450 hematology analyzers: SN11698, SN11758 2. Random review of the laboratory records from 2019 and 2020 revealed the laboratory performed CBC testing using both Sysmex analyzers. 3. Review of the 2019 laboratory records revealed the laboratory performed a comparison assessment 1 of 2 times between the Sysmex analyzers. No documentation was available for review of the other comparison study. 4. Review of the 2020 laboratory records revealed no documentation of a comparison assessment between the Sysmex analyzers. 5. Review of the laboratory policies revealed no documentation of a policy or procedure to evaluate twice yearly the CBC testing using the different hematology instruments. 6. An interview with the technical consultant on 3/2/21 at 1245 hours in the office confirmed the above findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an -- 3 of 4 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory quality assessment records, review of quality control records, reagent logs, and confirmed in interview, the laboratory's quality assessment policies failed to monitor, assess, and correct problems in analytic systems. Refer to D5461, D5475, D5775 -- 4 of 4 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records, laboratory patient records, and confirmed in interview, the laboratory failed to perform positive and negative staining controls each day of testing for the flow cytometry testing on the Beckman Coulter Navios flow cytometer. Findings were: 1. Review of the laboratory records revealed the laboratory performed flow cytometry evaluating the following 29 markers: CD2 CD3 CD4 CD5 CD8 CD10 CD11b CD13 CD14 CD16 CD19 CD20 CD22 CD23 CD33 CD34 CD38 CD45 CD56 CD57 CD64 CD103 CD117 FMC7 HLA-DR Surface kappa Surface lambda 7-AAD 2. Review of the laboratory quality control records from 08/2018 to 01/2019 revealed the laboratory performed positive and negative staining controls using the Streck CD Chex quality control monthly on 08 /10/18, 09/18/18, 10/18/18, 11/12/18, 12/12/18, and 01/15/19. 08/10/18 lot 81900041 , exp 10/06/18 09/18/18 lot 81900041 , exp 10/06/18 10/18/18 lot 82460041, exp 12/01 /18 11/12/18 lot 82460041, exp 12/01/18 12/12/18 lot 83020041, exp 01/26/19 01/15 /19 lot 83020041, exp 01/26/19 3. Random review of the laboratory patient records 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 -- from 08/2018 to 01/2019 revealed the laboratory performed patient testing without daily positive and negative staining controls for the following days the laboratory performed patient testing. 01/04/19 MR 258337 12/18/18 MR 246734 12/06/18 MR 256967 11/30/18 MR 256758 11/14/18 MR 73714 10/05/18 MR 256214 09/20/18 MR 248991 08/09/18 MR 254348 08/03/18 MR 253718 10/31/18 MR 43003 4. Review of the laboratory quality control records revealed no documentation of an IQCP (Individualized Quality Control Plan) to reduce the frequency of the positive and negative staining controls to once monthly. 5. An interview with the technical supervisor on 01/17/19 at 1450 hours in the conference confirmed the above findings. She was unaware that the laboratory was required to perform the key: CD2 - cluster of differentiation 2 CD3 - cluster of differentiation 3 CD4 - cluster of differentiation 4 CD5 - cluster of differentiation 5 CD8 - cluster of differentiation 8 CD10 - cluster of differentiation 10 CD11b - cluster of differentiation 11b CD13 -cluster of differentiation 13 CD14 - cluster of differentiation 14 CD16 - cluster of differentiation 16 CD19 - cluster of differentiation 19 CD20 - cluster of differentiation 20 CD22 - cluster of differentiation 22 CD23 - cluster of differentiation 23 CD33 -cluster of differentiation 33 CD34 -cluster of differentiation 34 CD38 -cluster of differentiation 38 CD45 - cluster of differentiation 45 CD56 - cluster of differentiation 56 CD57 - cluster of differentiation 57 CD64 - cluster of differentiation 64 CD103 - cluster of differentiation 103 CD117 -cluster of differentiation 117 FMC7 -epitope of CD20 HLA-DR - Human Leukocyte Antigen-antigen D Related 7-AAD - 7- aminoactinomycin D D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records, laboratory patient records, and confirmed in interview, the laboratory quality assurance failed to detect failures in the analytic systems. Refer to D5475 D6117 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(4) The technical supervisor is responsible for establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results. This STANDARD is not met as evidenced by: Based on review of the laboratory quality control records, laboratory patient records, and confirmed in interview, the technical supervisor failed to ensure the laboratory established and maintained a quality control program for the flow cytometry testing on the Beckman Coulter Navios flow cytometer. Refer to D5475 -- 2 of 2 --