Spine And Wellnes Centers Of America

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at SPINE AND WELLNESS CENTERS OF AMERICA on June 29, 2026. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiency cited as follows: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on records review and staff interview, the laboratory failed to have a mechanism to monitor that samples were within the acceptable temperature range during transportation from collection sites to Laboratory from February 2025 to present. Findings included: 1-Review of CMS-116 CLINICAL LABORATORY IMPROVEMENT AMENDEMENTS (CLIA) APPLICATION FOR CERTIFICATION, signed by the Laboratory Director (LD) on 06/02/2026 revealed that the laboratory performed the following tests in urine using Liquid Chromatography Tandem Mass Spectrometry (LC/MS): Screening of the following drugs: Amphetamines, Benzoylecgonine, Buprenorphine, 3,4- Methylenedioxymethamphetamine (MDMA), Methadone, Morphine, Oxazepam, Oxycodone, Phencyclidine and Secobarbital. Confirmation of the following drugs: 6- MAM (6-Monoacetylmorphine), 7-Aminoclonazepam, Alpha-Hydroxyalprazolam, Amitriptyline, Amphetamine, Benzoylecgonine, Buprenorphine, Bupropion, Butalbital, Carisoprodol (SOMA), Clonazepam, Codeine, Cyclobenzaprine, 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 -- Desipramine, Diazepam, Doxepin, Duloxetine, EDDP (Methadone metabolite), ETS, Fentanyl, Fluoxetine, Gabapentin, Hydrocodone, Hydromorphone, Imipramine, Ketamine, Levorphanol, Lorazepam, MDMA, Meperidine, Meprobamate, Methadone, Methamphetamine, Midazolam, Mitragynine, Morphine, Naloxone, Naltrexone, N- desmethyl-Tapentadol, Norbuprenorphine, Norcodeine,Nordiazepam, Norfentanyl, Norhydrocodone, Normeperidine, Noroxycodone, Nortriptyline, 0- Desmethyltramadol, Oxazepam, Oxycodone, Oxymorphone, Phenobarbital, Phencyclidine, Pregabalin, Ritalinic Acid, Secobarbital, Sertraline, Tapentadol, Temazepam, Venlafaxine, Zolpidem. The laboratory had an annual volume of 360, 000 tests. 2-Review of procedure signed by LD on 10/23/2025 revealed that the policy "SPE 100.1 Laboratory Sample Collection" -Section "Retrieval of specimens from facilities and transport of specimens to laboratory" stated: -Specimens are picked up by Fedex courier hired by the practice. -Specimens are transported within a climate- controlled environment. -The samples can be stored post collection at room temperature, 20-25 C for up to 24 hours. -Specimens can be sent at ambient temperature." -Section "Specimen Stability" stated "Specimen's stability for the conditions below has been established by the laboratory. 1- Room Temperature: 4-5 days 2-Refrigerated: 14 days" -The policy failed to describe how to monitor sample temperature during the transportation (acceptable range of 20-25 C) and failed to provide instructions to ensure the "climate-controlled environment" to the courier. 3- Review of CHAIN OF CUSTODY FORM from the collection sites for the following months: February 2025, July 2025, April 2026 and May 2026, revealed the laboratory received the following sample quantities: February 2025: The laboratory received 276 samples. July 2025: The laboratory received 298 samples. April 2026: the laboratory received 318 samples. May 2026: The laboratory received 285 samples. 4-Review of the laboratory CHAIN CUSTODY FORM of the laboratory for the following months: February 2025, July 2025, April 20226 and May 2026, revealed that the laboratory failed to monitor the transit time and sample temperature during the transit time based on the acceptable range of 20-25 C. 5-During an interview on 06/29/2026 at 02:30 PM, the Technical Supervisor confirmed that the laboratory was not monitoring the temperatures of the samples during transportation and could not provide documentation that the samples were in a climate-control environment (of 20-25 C) as per their policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 08/19/2024 found the SPINE AND WELLNESS CENTERS OF AMERICA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and technical supervisor (TS) interview, the laboratory failed to verify the accuracy of testing method at least twice annually for 11 out of 11 analytes tested in urine toxicology screening test at least from October 2022 to August 2024. Findings included: -Review of the test menu provided with the FORM CMS- 116 Clinical Laboratory Improvement Amendment (CLIA) Application for Certification signed by the Laboratory Director on 08/13/2024 indicated that the urine screening test included the following analytes: Amphetamine, Benzoylecgonine, Buprenorphine, 3,4-Methylenedioxymethamphetamine (MDMA), methadone, Morphine, Oxazepam, Oxycodone, Phencyclidine, Secobarbital and Tetrahydrocannabinol (THC). -Review of Proficiency testing records revealed that the laboratory failed to perform the twice a year accuracy verification for the screening test. -The laboratory tested 3,525 patients from October 2022 to August 2024. During an interview on 08/19/2024 at 12:00 PM with TS, she confirmed that the laboratory failed to do twice a year verification for the screening test for the analytes listed above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 09/13/2022 found the SPINE AND WELLNESS CENTERS OF AMERICA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and interview, the laboratory failed to have documentation that proved if samples received after 2 days of collection were stored at 4 C for up to two days or frozen -20 for long term storage at the collection site before sending them to the laboratory for four out of six samples reviewed from 03/01/2021 to 07/01/2022. Findings include: -Review of procedure manual signed by the laboratory director on 09/12/2022 revealed that in the policy SPE 100.0 Laboratory Sample Collection Policy in section "Retrieval of specimens from facilities and transport of specimens to laboratory" stated that "The samples can be stored post collection at room temperature, 20-25C for up to 24 hours. Specimens can be stored at 4 C (refrigerator) for up to two days before being sent via courier to laboratory as defined above. Specimens can be stored long term (1 week) at -20 (freezer) before being sent to the laboratory as defined above." -Review of method validation signed by the laboratory director on 03/21/2022 revealed that the stability study for samples stored at room temperature was performed for up to five days. -Review of six sample requisition/tests reports revealed the following: a) Sample # 1: collected on 03/01/2021, received on 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 2 -- /11/2022. Transit time of ten days. No documentation found if the sample was stored at 4 C for up to two days or frozen in the collection site or not. b) Sample # 2: collected on 10/01/2021, received on 10/06/2021. Transit time of five days. No documentation found if the sample was stored at 4 C for up to two days or frozen in the collection site or not. c) Sample # 3: collected on 11/01/2021 received 11/03/2021. Transit time of two days. Aceptable d) Sample # 4: collected on 04/01/2022 received on 04/07/2022, Transit time of six days. No documentation found if the sample was stored at 4 C for up to two days or frozen in the collection site or not. e) Sample # 5: collected on 05/02/2022, received on 05/03/2022. Transit time of one day. Aceptable f) Sample # 6: collected on 07/01/2022, received 07/07/2022. Transit time of six days. No documentation found if the sample was stored at 4 C for up to two days or frozen in the collection site or not. During an interview on 09/13/202 at 2:10 PM, the Technical Supervisor confirmed that the laboratory failed to have documentation if the samples were stored at 4 C for up to two days or frozen in the collection site or not for the samples of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial survey conducted on 01/05/2021 found that the Spine and Wellnes Centers of America clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 record review and staff interview, the laboratory failed to document the initial competency assessment for 1 out of 1 Technical Supervisor (TS) and 1 out of 1 General Supervisor (GS) when the laboratory started on 8/26/2020 after Laboratory Director signed the procedure manual. Findings include: 1)Review of CMS 209 Laboratory Personnel Report dated and signed by the Laboratory Director (LD) on 01 /04/2021 revealed that: -The laboratory had 1 TS and 1 GS as the same person. 2) Review of employee folders revealed that there was no documentation of the initial evaluations performed by the LD for the TS and GS. During an interview on 01/05 /2021 at 10:30 AM, with TS, she confirmed that the laboratory failed to document the initial competency assessment for the TS and GS. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --