Kenneth A Giraldo Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kenneth A. Giraldo MD PA on 04/23/2024 - 05/08/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D5300 Preanalytic Systems 493.1240 D5400 Analytic Systems 493.1250 D5800 Postanalytic Systems 493.1290 D6076 Laboratory Director 493.1441 D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing and interview the laboratory failed to document why they failed to participate in 1 (1st testing event 2023) out of 2 testing events (1st and 2nd testing event in 2023) reviewed. Findings Included: Review of API proficiency testing revealed the 1st testing event of 2023 had a 0% in pH, UDS (Urine Drug Screen) Cannabinoids, and UDS Opiates for failure to participate. The proficiency testing was due 05/12/2023. The proficiency testing performance evaluation stated "Instrument down lamp issues self evaluation review done all results acceptable summary data attached". This was dated 07/23/2023 by the Testing Person. There was no record that the laboratory notified the inspecting agency or API of why the testing was not performed within 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 6 -- required timeframe. There was no documentation on the monthly instrument maintenance logs that the machine was down May or June 2023. Interview on 04/23 /2024 at 12:30 PM the Testing Person confirmed that there was no documentation of the machine being down during this time or of notifying API. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observations, record review, and interviews, the Laboratory failed to ensure the urine specimens were stored properly prior to testing and failed to have a policy for specimen storage based on manufacturer's instructions (See D5311). 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 observation, record review, and interview the laboratory failed to have a policy of how the urine specimens are stored, failed to have temperature charts for the refrigerator where urine is stored prior to transport to the laboratory since testing resumed 03/22/2023. Findings Included: Observations during the tour of the Laboratory on 04/23/2024 at 10:36 AM revealed that no Patients came to the Laboratory to submit urine samples for testing. Review of Patient testing logs revealed that testing occurred on 03/22/2023, 04/18/2023, 07/23/2023, 09/11/2023, 11 /19/24, and 01/21/2024. The Policy and Procedure manual (last reviewed by the Laboratory Director 12/29/2023) stated "All samples will be stored in the freezer until tested". The manufacturer's instructions (MI) for Opiate testing stated to "Use fresh urine specimen for the test. If the sample cannot be analyzed immediately, it may be stored refrigerated (2 degrees C to 8 degrees C) for up to 3 days. For longer storage, keep sample frozen at -20 degrees C". The MI for Cannabinoid testing stated to "Use fresh urine specimens for the test. If the sample cannot be analyzed immediately, it may be stored refrigerated at 208 degrees C for up to seven days. For longer storage keep sample frozen at -20 degrees C". Interview on 04/23/2024 at 1:15PM the Testing Person confirmed that the storage of urines were not per their policy. Interview on 04 /23/2024 at 1:25 PM the Laboratory Director stated that he collects urine specimens 2- 3 days a week and put them in a mini fridge. He stated that he brings them to the Laboratory in the evening and confirmed that there was no log to capture when -- 2 of 6 -- brought to the Laboratory. He also confirmed that there was no temperature charts for the mini fridge nor was there a thermometer in the mini fridge. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observations, record review, and interview, the Laboratory failed to ensure calibration were performed (See D5437) and failed to ensure instrument maintenance was performed (See D5429). D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to document maintenance on the Mindray BS-200 Chemistry analyzer for 3 (September 2023, November 2023, and January 2024) out of 6 months (March 2023, April 2023, July 2023, September 2023, November 2023, and January 2023) reviewed. Findings Included: Review of the Mindray BS-200 Chemistry analyzer maintenance revealed no maintenance for September 2023, no monthly maintenance for November 2023 and January 2024. Review of the manufacturer's instructions revealed that daily maintenance required checking syringe, checking probe, checking mixing bar, checking connection of deionized water, checking connection of waste water, checking remaining deionized water, and emptying waste tank. Weekly maintenance included cleaning probe, cleaning mixing bar, washing DI water tank, washing waste tank, cleaning sample /reagent compartment and barcode reader, and cleaning panel of analyzing unit. Monthly maintenance included cleaning wash well of probe and cleaning wash well of mixing bar. The six month maintenance included washing dust screens and replacing filter assembly. The six month maintenance was done 03/2023 and 03/2024 (12 months apart). Interview on 04/23/2024 at 2:00 PM the Testing Person confirmed there were no other documentation of maintenance. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) -- 3 of 6 -- Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on observation, record review, and interview the laboratory failed to calibrate the thermometer for the refrigerator since 12/19/2018 and the room temperature /humidity thermometer since 03/18/2015. Findings Included: During a tour of the laboratory on 044/23/2024 at 10:36 AM a thermometer was observed on the refrigerator that had a sticker on the back that stated the calibration was due on 12/19 /18, and a Fisher Scientific room temperature/humidity thermometer that had a sticker on the back that stated the calibration was due 03/18/2015. Review of the maintenance records found no thermometer calibrations. Interview on 04/23/2024 at 12:00 PM the Testing Person confirmed that the thermometers had not been calibrated. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory failed to ensure accuracy of final reports (See D5805) and failed to have a quality assurance plan that included postanalytic systems (See D5891). D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview the Laboratory failed to record an accurate draw times for the urine specimens for 13 (#1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, and 15) out of 18 Patient reports (#1-18) reviewed. Findings Included: Review of 18 randomly selected Patient reports revealed the following draw times: 1- 8:00:49 PM -- 4 of 6 -- 2- 8:15:23 PM 3- 11:00:02 PM 4- 10:30:55 PM 5- 9:00:34 PM 6- 9:00:10 PM 7- 11: 00:26 PM 9- 9:00:23 PM 10- 10:00:10 PM 11- 8:00:15 PM 12- 8:00:33 PM 13- 8:00: 39 PM 15- 11:00:56 PM Interview on 04/23/2024 at 2:00 PM the Testing Person confirmed that Patients were not in the office at the aforementioned times and that times should have been AM instead of PM. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review of Quality Assurance (QA) and interview, the Laboratory failed to establish QA for postanalytic systems since performing QA in January 2024. Findings Included: Review of the Monthly QA performed on 01/21/2024 revealed that the Laboratory QA did not address postanalytic systems. Interview on 04/23/2024 at 2: 28 PM the Testing Person confirmed that she only does QA on months she has testing and it did not address postanalytic systems. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on observations, record review, and interview the Laboratory Director failed to ensure thermometers were calibrated, failed to have documentation when instruments were down resulting in 0% in proficiency, failed to have accurate policies and failed to ensure urine specimens were stored per manufacturer's instructions, failed to ensure instrument maintenance was performed, failed to ensure final reports were accurate, failed to have quality assurance that included postanalytic systems, and failed to have job descriptions that included Laboratory Director, Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Person (See D6079). D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on observations, record review, and interview the Laboratory Director failed to ensure thermometers were calibrated (See D5437), failed to have documentation when instruments were down resulting in 0% in proficiency (See D2111), failed to have accurate policies and failed to ensure urine specimens were stored per manufacturer's instructions (See D5311), failed to ensure instrument maintenance was performed (See D5429), failed to ensure final reports were accurate (See D5805), failed to have quality assurance that included postanalytic systems (See D5891), and failed to have job descriptions that included Laboratory Director, Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Person. -- 6 of 6 --

Summary Statement of Deficiencies D5785

Summary Statement of Deficiencies D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on observation, record review, and staff interviews, the laboratory failed to follow manufacturer's instructions for proper specimen storage (See D5311), failed to have an effective quality assurance (QA) plan that identified manual data entry errors (See D5391), and failed to document quality assurance activities for preanalytic systems when specimens were rejected for testing (See D5393). 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 observation, record review, and interview with the Laboratory Director, the laboratory failed to have an effective quality assurance (QA) plan that identified issues with data entry during the pre-analytic phase of testing for 9 of 117 patient specimens tested for one (01/30/2022) out of eight days (01/30/2022, 02/20/2022, 03 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 -- /05/2022, 03/22/2022, 04/02/2022, 04/25/2022, 05/08/2022, and 06/20/2022) that testing was performed. Findings Included: Record review of the laboratory's procedure "Quality Assurance" revealed the laboratory believes in a strong QA program. The entire laboratory staff will review potential problems and document all

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Kenneth A Giraldo MD PA on 09/23/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was cited: D5200 493.1230 Condition: General Laboratory Systems D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing and interview with the General Supervisor the laboratory failed to verify the accuracy of opiates and Tetrahydrocannabinol (THC) testing using the methodology used in patient testing for 2 out of 2 years reviewed (2017-2019). See D5217 This is a repeat deficiency. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 API (American Proficiency Institute) proficiency testing and interview with the General Supervisor, the laboratory failed to verify the accuracy of testing using the methodology used in patient testing for opiates and Tetrahydrocannabinol (THC) for 2 out of 2 years reviewed (2017-2019). This is a repeat deficiency from the 09/23/17 survey. Findings Included: Review of API proficiency testing revealed that the laboratory was using a qualitative method (positive/negative) to verify accuracy for opiates and THC. Review of the Patient test results from 12/15/17 thru 07/23/19 revealed that the laboratory was reporting out semi-quantitative results (Numerical). Interview on 09/23/19 at 11:00 AM with the General Supervisor confirmed that the laboratory was using a semi-quantitative (quantitative numbers and positive/negative) method for patient testing and the laboratory was not using this method for proficiency testing. Also the General Supervisor stated that API would be offering a semi-quantitative panel for 2020 enrollment. Review of the Allegation of Compliance (AOC), signed 10/12/17 by the Laboratory Director, revealed that this was a repeat deficiency from the 09/23/17 recertification survey. The AOC stated: In addition to participation in PT testing, the laboratory will complete split sample 2 times per year to verify the accuracy of testing. We will complete our first split sample in Oct 2017. The completion date was 10/31/17. -- 2 of 2 --