Register Cliff Rural Health Clinic

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of patient testing records, review of quality control (QC) records, review of the laboratory's individualized quality control plan (IQCP), policy and procedure review, and staff interview, the laboratory failed to ensure QC was performed each day of patient testing for the MedTox urine drug screen test system for 2 of 2 patient tests performed between 4/23/25 and 11/19/25. The findings were: 1. Review of the "Orders Report by Provider" document, provided by the laboratory, showed a MedTox urine drug screen was performed on patient #1029599682 on 6/19 /25 and on patient #135447499 on 8/7/25. Review of the QC records showed no evidence QC had been performed on the day of testing. 2. Interview with testing personnel (TP) #1 on 12/18/25 at 9:50 AM revealed QC was to be performed each day of patient testing. At 10:44 AM TP #1 confirmed no QC documentation could be located for the dates of 6/19/25 and 8/7/25. 3. Interview with the laboratory director (LD) on 12/18/25 at 11 AM confirmed the expectation was for staff to perform QC each day of patient testing due to the low volume of testing performed at the laboratory. 4. Review of the laboratory's IQCP, last approved by the LD on 12/1/25, showed "In the clinic locations where patient testing is performed less frequently than 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 -- weekly, it is acceptable to perform QC testing on day of use based on the following: 1. Proficiency testing has been successful 2. QC performs as expected even when tested less than once each week 3. No harm to patients by performing QC testing only on day of patient testing rather than each week." 5. Review of the "Urine Drug Testing (Medical) 2200-1210" policy, last reviewed 3/5/24, showed "CONTROL PROCEDURE...You should run external controls routinely or as needed for any of the following reasons...3. Once per week in locations performing patient testing more often than weekly or on day of patient testing in locations performing testing less frequently than weekly." -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on new instrumentation and new test method verification study review, lack of documentation, and staff interview, the laboratory failed to verify precision for 1 of 1 new test methodologies (Medtox urine drug screens). The laboratory performed approximately 5 urine drug screens per year. The findings were: 1. Review of the 12 /18/19 new instrument and test method verification study for the Medtox urine drug screen test system showed the performance specification of precision had not been verified prior to testing patient samples. 2. Interview with the laboratory manager on 10/6/21 at 10:25 AM confirmed the laboratory had not completed the verification studies to include precision prior to testing patient samples. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on review of personnel competency assessments, review of policy and procedure, and staff interview, the technical consultant failed to ensure 1 of 1 testing personnel (TP #1) was evaluated semiannually for competency during the first year of patient testing. The laboratory performed approximately 5 urine drug screens per year. The findings were: 1. Review of the initial competency assessment for TP #1 showed training and education was provided on 3/17/20 for performing urine drug screens on the Medtox test system. There was no documentation to show a semiannual competency assessment had been completed. 2. Interview with the technical consultant on 10/6/21 at 10:25 AM confirmed the semiannual competency assessment had not been completed. 3. Review of the policy and procedure titled "Competency Monitoring of Laboratory Personnel", last revised 6/2016, showed "Laboratory employees will be evaluated after initial training, semi-annually during the first year for new employees, and annually there after." D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel competency assessments, review of policy and procedure, and staff interview, the technical consultant failed to ensure 1 of 1 testing personnel (TP #1) had an annual competency assessment after the first year of patient testing. The laboratory performed approximately 5 urine drug screens per year. The findings were: 1. Review of the initial competency assessment for TP #1 showed training and education was provided on 3/17/21 for performing urine drug screens on the Medtox test system. There was no documentation to show an annual competency assessment had been completed after the first year of patient testing. 2. Interview with the technical consultant on 10/6/21 at 10:25 AM confirmed the annual competency assessment had not been completed. 3. Review of the policy and procedure titled "Competency Monitoring of Laboratory Personnel", last revised 6/2016, showed "Laboratory employees will be evaluated after initial training, semi-annually during the first year for new employees, and annually there after...After the employee has performed his/her duties for approximately one year, competency will be assessed annually." -- 2 of 2 --