Family Medical Management

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and an interview with the Office Manager, the laboratory failed to establish and follow policies and procedures to ensure the overall quality of the general laboratory systems and correct identified problems in the speciality of chemistry. This deficient practice had the potential to affect 26 out of 26 patients tested in the speciality of chemistry at this laboratory from 08/20/2021 through 09/09 /2021. 1. The laboratory failed to establish and follow policies and procedures for the competency assessment for two out of two Testing Personnel (TP) performing moderate complexity testing in the specialty of chemistry. (Refer to D5209) 2. The laboratory failed to establish and follow policies and procedures to verify the accuracy of the moderately complex Vitamin D testing procedures, at least twice annually. (Refer to D5217) 4. The laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. (Refer to D5291) 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- consultant competency. This STANDARD is not met as evidenced by: Based on record review and an interview with the Office Manager, the laboratory failed to establish and follow policies and procedures for the competency assessment for two out of two Testing Personnel (TP) performing moderate complexity testing in the specialty of chemistry. This deficient practice had the potential to affect 26 out of 26 patients tested in the speciality of chemistry at this laboratory from 08/20/2021 through 09/09/2021. Findings include: 1. Review of the laboratory's manual failed to find an approved policy and procedure (by Laboratory Director's signature and date) for TP competency assessment. 2. Review of the laboratory's documentation failed to find evidence of initial training prior to patient testing for TP #1 and TP #2. 3. The surveyor requested competency assessment policy, procedure and associated documentation from the Office Manager, on 09/09/2021 at 1:08 PM. An interview with the Office Manager, on 09/09/2021 at 1:08 PM, confirmed that the laboratory failed to establish and follow policies and procedures for the competency assessment of TP #1 and TP #2. 4. An interview with the Office Manager, on 09/09/2021 at 1:08 PM, confirmed that although they recalled training for both TP #1 and TP #2 on the new instrument form Qualigen (the instrument provider), no documentation could be produced at the time of the inspection. 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 an interview with the Laboratory Director (LD), the laboratory failed to establish and follow policies and procedures to verify the accuracy of the moderately complex Vitamin D testing procedures, at least twice annually. This deficient practice had the potential to affect 26 out of 26 patients tested in the speciality of chemistry at this laboratory from 08/20/2021 through 09/09/2021. Findings include: 1. Review of the laboratory's manual failed to find a policy and procedure to verify the accuracy of the moderately complex Vitamin D testing procedures at least twice annually. 2. An interview with the Manager, on 09/09/2021 at 1:11 PM, confirmed that although the lab had planned to enroll with American Family Physicians program to verify the accuracy of the moderately complex vitamin D, they had not enrolled at the time of the inspection. 2. Review of the laboratory's records failed to find evidence that the lab planned to verify the accuracy of the moderately complex Vitamin D testing procedures at least twice annually, as required. 4. The surveyor requested evidence that the laboratory had enrolled with American Family Physicians program to verify the accuracy of the moderately complex vitamin D analyte. An interview with the Office Manager, on 09/09/2021 at 1:11 PM, confirmed that the lab failed to establish and follow a policy to verify the accuracy of the moderately complex Vitamin D testing, and failed to provide evidence of enrollment with American Family Physicians to verify the accuracy of the moderately complex Vitamin D testing twice annually, as required. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) -- 2 of 10 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on document review and an interview with the Office Manager, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. This deficient practice had the potential to affect 26 out of 26 patients tested in the speciality of chemistry at this laboratory from 08/20/2021 through 09/09/2021. Findings include: 1. Review of the laboratory's manual failed to find policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated correct problems in the general lab systems. 2. Review of the laboratory's documentation failed to find evidence that the laboratory monitored, assessed and corrected problems identified in the General Laboratory Systems. 3. The surveyor requested policies for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. An interview with the Office Manager, on 09/09/2021 at 1:11 PM, confirmed that the lab failed to establish and follow policies and procedures to monitor assess and correct problems in the general laboratory systems. 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: Based on record review and and interview with the Office Manager, the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct problems. This deficient practice had the potential to affect 26 out of 26 patients tested in the speciality of chemistry at this laboratory from 08/20/2021 through 09/09 /2021. Findings Include: 1. Based on record review and an interview with the Office Manager, the laboratory failed to include in the their policies and procedures the chemistry requirements for specimen collection, labeling, storage, preservation, processing and referral, criteria for specimen acceptability and rejection, step-by-step performance of the procedure, interpretation of the results based on the manufacturer's instructions, limitations in the testing, the laboratory's system for entering and reporting the results in the patient record and the laboratory's course of action to take if a test system becomes inoperable. (Refer to D5403) 2. Based on record review and an interview with the Office Manager, the laboratory failed to establish and verify performance specifications of the Qualigen FastPack test system for Vitamin D before reporting patient test results. (Refer to D5421) 3. Based on record review and an -- 3 of 10 -- interview with the Office Manager, the laboratory failed to establish, and verify performance specifications of the Qualigen FastPack test system for Vitamin D before reporting patient test results. (Refer to D5445) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)