Bald Mountain Behavioral Medicine

Summary Statement of Deficiencies D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to have the final toxicology test report maintained as part of the patients' electronic medical record (EMR) for 12 of 12 patient charts reviewed. Findings include: 1. On 1/05/2022 at approximately 10:00 am, the surveyor requested 12 test orders and final toxicology test reports maintained in the patients' EMR system. 2. Record review revealed a lack of documentation of the final toxicology test report in the patient's EMR system for the following: a. Patient 02 tested on 3/01/2020 b. Patient 03 tested on 5/16/2020 c. Patient 05 tested on 7/24/2020 d. Patient 02 tested on 9/13/2020 e. Patient 02 tested on 11/07/2020 f. Patient 02 tested on 1/09/2021 g. Patient 01 tested on 3/13/2021 h. Patient 02 tested on 5/19 /2021 i. Patient 01 tested on 7/21/2021 j. Patient 05 tested on 9/25/2021 k. Patient 04 tested on 11/09/2021 l. Patient 07 tested on 1/02/2022 3. An interview on 1/05/2022 at 10:54 am, the LD confirmed the patient testing was not available in the patient's EMR. 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 D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant (TC), the laboratory failed to retain quality control (QC) records for the chemistry toxicology testing for 5 (October 2019 to February 2020) of 5 months reviewed. Findings include: 1. Record review of the laboratory's QC records revealed a lack of documentation of the QC testing between October 2019 to February 2020 for the following days of testing when patient final reports were generated: a. 10/17/2019 b. 11/12/2019 c. 11/13/2019 d. 12/12/2019 e. 12/16/2019 f. 12/17/2019 g. 12/19/2019 2. During the interview on 2/18/2020 at approximately 1:30 pm, the TC confirmed that all QC records had not been retained. D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to establish a 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 -- written procedure for