Spine And Wellnes Centers Of America

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 --