Charleston Pain And Rehabilitation Center

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 09/25/2023 and concluded on 09/25/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D6121 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(i) The procedures for evaluation of the competency of the staff must include, but are not limited to direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. This STANDARD is not met as evidenced by: Based on interview and document and policy review, the laboratory failed to ensure an annual competency evaluation was documented in 2022 for 1 (Testing Personnel [TP] #1) of 1 testing personnel reviewed. Findings included: A review of a facility policy titled "Personnel Competency Assessment" signed 04/15/2015 by the Laboratory Director revealed, "The competence, qualifications, and responsibilities of all laboratory personnel will be assessed on a bi-annual and annual basis." Further review revealed, "Evaluation will be performed at 6 months after the techs [sic] start date and 1 year after the start date. Evaluation will be performed annually from then on. Each laboratory testing personnel will have a file maintained in the lab with the following information:" which included "Semi-Annual and Annual Personnel Evaluation." A review of an annual competency evaluation form for TP #1 revealed that the last documented competency evaluation was dated 12/20/2021. During an interview on 09/25/2023 at 11:20 AM, TP #1 stated their competency evaluation was performed annually in December. Regarding a competency evaluation being performed in December 2022, TP #1 stated the Laboratory Director (LD) assessed her competency by observing as she performed laboratory testing, but did not document or date on an evaluation form. 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 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: During an onsite recertification on 07/24/2018, based on instrument operator manual review, instrument maintenance record review and testing personnel interview, it was determined that the laboratory failed to document quarterly maintenance on the Pictus 400 toxicology instrument for twenty two of twenty two months reviewed (October 2016 through July 2018). Findings include: 1. Review of the Pictus 400 toxicology analyzer operator's manual on 07/24/2018 at 11:30am revealed that all operators should routinely perform scheduled maintenance to ensure optimum performance of the instrument including a quarterly optical filters cleaning, replacement of the distilled water aspiration tube, and cleaning of the distilled water reservior. 2. Review of the Pictus 400 toxicology analyzer maintenance logs on 07/24/2018 at 11:35am revealed that quarterly maintenance had not been documented for twenty two of twenty two months reviewed (October 2016 through July 2018). 3. Testing personnel confirmed during an onsite interview on 07/24/2018 at 1:00pm that the quarterly maintenance had not been performed for the reviewed months. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When 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 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: During an onsite recertification survey on 07/24/2018, based on procedure manual review, toxicology quality control (QC) record review, and confirmation by testing personnel, the laboratory failed to verify the stated assay values of toxicology QC materials prior to testing for twenty two of twenty two months reviewed (October 2016 through July 2018). Findings include: 1. The laboratory procedure manual stated that upon changing toxicology control lots, the stated values of each level would be verified prior to use through repeat testing and comparison on different days. 2. Review of the laboratory's toxicology QC records revealed that the laboratory failed to verify the stated assay values of toxicology QC materials prior to testing for twenty two of twenty two months reviewed (October 2016 through July 2018). There was no