Dr Edwin Maldonado, Md Pl

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Dr Edwin Maldonado MD PA on April 2, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D3000 - Facilities 493.1101 D5400- Analytic Systems 493.1250 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). This CONDITION is not met as evidenced by: Based on review of the Clinical Laboratory Improvements Amendments (CLIA)) Applications, observation, and interview, the laboratory failed to have separate supplies for Toxicology testing from 05/07/2024 to 04/02/2025. This is a repeat deficiency from the Initial survey on 04/12/2023. (See D3007) D3007 FACILITIES CFR(s): 493.1101(b) (b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvements Amendments (CLIA)) Applications, observation, and interview, the laboratory failed to have separate supplies for Toxicology testing from 05/07/2024 to 04/02/2025. This is a repeat 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 -- deficiency from the Initial survey on 04/12/2023. Findings: Record review of the CLIA Applications for this laboratory (Lab A) and another Certificate of Compliance laboratory (Lab B) revealed the two laboratories were located at the same physical address. During a tour of the laboratory on 04/02/2023 at 9:25 AM, there was a single Abbott ImmTox 270 instrument located in the laboratory. This Toxicology instrument was being used by Lab A and Lab B. During a tour of the laboratory on 04/02/2025 at 9:25 AM, it was noted the laboratory had one bottle of Acid Washing Solution (lot #240729) and one bottle of Alkaline Washing Solution (lot #240730). No other bottles of the wash solutions were found. Review of the CMS 116 signed by the Laboratory Director on 03/25/2025 revealed the Laboratory performed Toxicology screens for the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Benzoylecgonine, Buprenorphine, EDDP (Methadone primary metabolite), Methamphetamine, Opiates, Oxycodone, and, Phencyclidine. The annual testing volume was documented as 15,000. On 04/02/2025 at 9:25 AM, the Technical Consultant stated they used the two bottles of wash solutions for each laboratory. 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: Based on review of the test menu, procedure manual and Proficiency Testing (PT) records, and interview, the laboratory failed to verify the accuracy (PT) of their Toxicology testing between 05/01/2024 and 12/31/2024. Findings: Review of the CMS 116 signed by the Laboratory Director on 03/25/2025 revealed the Laboratory performed Toxicology testing for the following drugs: Amphetamine, Barbiturates, Benzodiazepines, Benzoylecgonine, Buprenorphine, EDDP (Methadone primary metabolite), Methamphetamine, Opiates, Oxycodone, and Phencyclidine. Review of the procedure titled, Proficiency Testing (PT) read, "For those analytes (non-regulated analytes) which are not included in a formal proficiency testing program, the laboratory must provide a method to assess and verify the accuracy and reliability of their analytes." Review of the PT records showed there was no PT performed from 05 /01/2024 and 12/31/2024 for their moderate complexity Toxicology analytes. During an interview on 04/02/2025 at 1:38 AM, the Technical Consultant stated the laboratory switched to moderate level complexity on 05/01/2024. During an interview on 04/02/2025 at 10:38 AM, the Technical Consultant acknowledged there was no PT done between 05/01/2024 and 12/31/2024. 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: -- 2 of 4 -- Based on record review, and interview, the Laboratory failed to complete performance specifications for their urine stability study for drug screening test before patient testing. (See D5423) D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) (b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (b)(2)(i) Accuracy. (b)(2)(ii) Precision. (b)(2)(iii) Analytical sensitivity. (b) (2)(iv) Analytical specificity to include interfering substances. (b)(2)(v) Reportable range of test results for the test system. (b)(2)(vi) Reference intervals (normal values). (b)(2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory failed to complete performance specifications for their urine stability study for drug screening test before patient testing. Findings: Review of drug test menu revealed the following drugs were tested for: Amphetamine Barbiturate Benzodiazepine Cocaine Metabolite EDDP Specific Methamphetamine Opiates Oxycodone Phencyclidine Review of Buprenorphine Urine HEIA assay package insert read, "Urine specimens may be stored at 22-30 degrees Celsius (C) for up to 3 days prior to analysis." Review of specimen stability study revealed temperatures were not recorded and negative urine specimens were not used for stability study for 7 days. Review of

Summary Statement of Deficiencies D0000 An initial certification survey was conducted in conjunction with an unannounced complaint survey, #2023004762, on 04/10/2023 to 04/12/2023 at Dr. Edwin Maldonado MD PL clinical laboratory. The facility was not in compliance with 42 CFR 493, Requirements for Clinical Laboratories. The following Condition was cited: D3000- Facility Administration 493.1100 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on observation, review of laboratory records, and interview, the laboratory failed to have separate supplies and records for Toxicology testing since 06/01/2022 (See D3007). D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. 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 observation, review of chemical safety data sheets (SDS), and interview, the laboratory failed to have a fume hood since the instrument was installed and in use for toxicology testing on 04/29/2022. Findings Included: During a tour of the laboratory on 04/10/2023 at 11:00 AM the following chemicals for toxicology were observed in use: Acetonitrile Non-UV for Gas Chromatography and Residue Analysis Omnisolv (R), Methanol LC-MS Grade For Liquid Chromatography, and Formic acid 98 - HPLC LiChropur. No fume hood was observed. Review of the SDS for "Acetonitrile Non-UV For Gas Chromatography and Residue Analysis Omnisolv(R)" stated under handling and storage "Work under hood." Review of SDS for "Methanol LC-MS Grade For Liquid Chromatography- Mass Spectrometry OmniSolv" stated under handling and storage "Work under hood." Review of SDS for "Formic acid 98 - HPLC LiChropur" stated under handling and storage "Work under hood." During interview on 04/11/2023 at 2:00 PM, the Technical Supervisor confirmed that the chemicals had been used since the installation of the LCMS Toxicology instrument on 04/29/2022 and that a hood was required per the SDS. D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on observation, review of laboratory records, and interview, the laboratory failed to have separate supplies and records for Toxicology testing since 06/01/2022. Findings Included: Record review of the CLIA 116 Application and observation on April 10, 2023 revealed 2 laboratories located at the same physical address, this laboratory and another Certificate of Registration laboratory (to be referred to as Lab A). During a tour of the laboratory on 04/10/2023 at 11:00 AM it was observed there was a single Sciex Exion LC + Sciex 4500 MD Mass Spectrometer instrument that was located in the laboratory. This Toxicology instrument was being used by this Laboratory and Lab A. There was no hours of operation for when this laboratory and Lab A would be using the instrument. The hours of operation were corrected while on- site during survey. There was no differentiation between this Laboratory and Lab A in the flammable cabinet, refrigerator, or freezer. During an interview on 04/10/2023 at 12:02 PM, the General Supervisor stated that this Laboratory and Lab A Patient samples were ran on the instrument at the same time and were only separated by the account number. Review of the CMS 116 signed by the Laboratory director on 04/10 /2023 revealed that the Laboratory performed Toxicology screens for the following drugs: Amphetamine, MDMA, Barbiturates, Methadone, Benzodiazepines, Opiates, Benzoylecgonine, Oxycodone, Buprenorphine, and PCP and confirmation testing for the following drugs: 6-MAM, Meprobamate, 7-amino-Clonazepam, Methadone, alpha- hydroxy-Alprazolam, Methamphetamine, Alprazolam, Mitragynine, Amitriptyline, Morphine, Amphetamine, Naloxone, Benzoylecgonine, Naltrexone, Buprenorphine, N-desmethyl-Tapentadol, Bupropion, Norbuprenorphine, Butalbital, Norcodeine, Carisoprodol, Nordiazepam, Clonazepam, Norfentanyl, Codeine, Norhydrocodone, Cyclobenzaprine, Normeperidine, Desipramine, Noroxycodone, O-Desmethyl- Tramadol, Nortriptyline, Diazepam, Oxazepam, Doxepin, Oxycodone, Duloxetine, Oxymorphone, EDDP (Methadone primary metabolite), PCP, Ethyl Sulfate, -- 2 of 3 -- Phenobarbital, Fentanyl, Pregabalin, Fluoxetine, Ritalinic Acid, Gabapentin, Secobarbital, Hydrocodone, Sertraline, Hydromorphone, Tapentadol, Imipramine, Temazepam, Ketamine, Tramadol, Lorazepam, Venlafaxine, MDMA, Zolpidem, and Meperidine. The annual testing volume was documented as 500,000. Review of the Laboratory records revealed that since there was one instrument with samples being ran together, this Laboratory and Lab A had the same documents. There was one validation performed in May 2022 being used by this Laboratory and Lab A. All of the maintenance, calibrations, quality control, and preparation logs contained the same data but were each on separate letterhead for this Laboratory and Lab A since the labs were intermingled. On 04/11/2023 at 9:30 AM, the Technical Supervisor confirmed this Laboratory and Lab A had everything combined. 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 review of Patient final reports and interview, the laboratory failed to accurately indicate the address of where the testing was performed for 2 out of 2 Patient final reports reviewed. Findings Included: Review of the final reports for Patient #1 (performed on 04/05/2023) and Patient #2 (performed on 03/28/2023) revealed the testing was performed at the laboratory. During an interview on 04/12 /2023 at 10:00 AM, the Technical Supervisor stated the interpretation of results were occasionally performed remotely and confirmed that the final reports for Patients #1 and #2 did not reflect the interpretation being performed off-site. -- 3 of 3 --