Dyersburg Family Walk In Clinic

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing (PT) events for the red cell count (RBC) analyte resulting in the first unsuccessful PT occurrence. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. 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 a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three PT events for the red cell count (RBC) analyte in 2021. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory RBC analyte scores: 2021 Event one = 60% 2021 Event three = 60% 2. Review of the laboratory's 2021 PT hematology event one performance evaluation report revealed unacceptable RBC scores for HEM-03 and HEM-05, resulting in an overall score of 60%. 3. Review of the laboratory's 2021 PT hematology event three performance evaluation report revealed unacceptable RBC scores for HEM-11 and HEM-13, resulting in an overall score of 60% and the first unsuccessful PT occurrence for the RBC analyte. -- 2 of 2 --

Summary Statement of Deficiencies D6041 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(3) (b) The technical consultant is responsible for-- (b)(3) Enrollment and participation in an HHS approved proficiency testing program commensurate with the services offered; This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records, the laboratory's procedure manual, and interview with the laboratory liaison, the technical consultant failed to perform

Summary Statement of Deficiencies D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: The laboratory failed to follow written policies to assess testing personnel for the whiff test (Refer to D5209); failed verify at least twice a year, the accuracy of the whiff test (Refer to D5217); failed to have a procedure for the whiff test (Refer to D5401); and, failed to perform verficiation of performance specifications for the whiff test (Refer to D5421). 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 observation of the laboratory, review of the laboratory personnel records, one patient final report, interview with testing personnel number one and the technical consultant, the laboratory failed to follow written policies to assess testing personnel for using potassium hydroxide (KOH) for the whiff test, in 2018. The findings include: 1) Observation of the laboratory on July 16, 2018 at 1:40 p.m. revealed a bottle of potassium hydroxide (KOH) lot number 1735206 expiration date 12-18-18 , open date 2-6-18, in use for patient testing. 2) Review of the laboratory personnel Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- records revealed no personnel were assessed for the use of KOH for patient testing. 3) Review of patient number one final report revealed on June 15, 2018 the Whiff test was reported as negative. 4) Interview on June 16, 2018 at 1:50 p.m. with testing personnel number one confirmed the family nurse practitioner uses the KOH to perform the Whiff test for patient testing. 5) Interview on June 16, 2018 at 2:30 p.m. with the technical consultant confirmed no personnel were assessed for the Whiff testing using KOH. 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 observation of the laboratory, review of all the laboratory records, one patient final report, interview with testing personnel number one and the technical consultant, the laboratory failed verify at least twice a year, the accuracy for using potassium hydroxide (KOH) for the whiff test, in 2018. The findings include: 1) Observation of the laboratory on July 16, 2018 at 1:40 p.m. revealed a bottle of potassium hydroxide (KOH) lot number 1735206 expiration date 12-18-18 , open date 2-6-18, in use for patient testing. 2) Review of the laboratory personnel records revealed no twice per year accuracy for the use of KOH for patient testing. 3) Review of patient number one final report revealed on June 15, 2018 the Whiff test was reported as negative. 4) Interview on June 16, 2018 at 1:50 p.m. with testing personnel number one confirmed the family nurse practitioner uses the KOH to perform the Whiff test for patient testing. 5) Interview on June 16, 2018 at 2:30 p.m. with the technical consultant confirmed no accuracy verification twice per year for the Whiff testing using KOH was performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory procedure manual, one patient final report, interview with testing personnel number one and the technical consultant, the laboratory failed to have a procedure for using potassium hydroxide (KOH) for the whiff test, in 2018. The findings include: 1) Observation of the laboratory on July 16, 2018 at 1:40 p.m. revealed a bottle of potassium hydroxide (KOH) lot number 1735206 expiration date 12-18-18 , open date 2-6-18, in use for patient testing. 2) Review of the laboratory procedure manual revealed no procedure for using KOH for the Whiff test. 3) Review of patient number one final report revealed on June 15, 2018 the Whiff test was reported as negative. 4) Interview on June 16, 2018 at 1:50 p.m. with testing personnel number one confirmed the family -- 2 of 3 -- nurse practitioner uses the KOH to perform the Whiff test for patient testing. 5) Interview on June 16, 2018 at 2:40 p.m. with the technical consultant confirmed no procdure for the Whiff testing using KOH. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the complete blood count (CBC) quality control (QC) records and interview with the technical consultant, the laboratory failed to ensure the CBC QC was not in use after the expiration date, in October and November 2017. The findings include: 1) Observation of the laboratory on July 16, 2017 at 1:40 p.m. revealed the Drew 3 CBC instrument in use for patient testing. 2) Review of the October and November 2017 CBC QC records revealed lot number 0717 expiration date 10-05-17 was in use until 11-28-17. 3) Interview on July 16, 2017 at 3:00 p.m. with the technical consultant confirmed the CBC QC records have the lot number 0717 with expiration date 10-05-17 in use until 11-28-17. 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 observation of the laboratory, review of all the laboratory records, one patient final report, interview with testing personnel number one and the technical consultant, the laboratory failed to perform verficiation of performance specifications for using potassium hydroxide (KOH) for the whiff test, in 2018. The findings include: 1) Observation of the laboratory on July 16, 2018 at 1:40 p.m. revealed a bottle of potassium hydroxide (KOH) lot number 1735206 expiration date 12-18-18 , open date 2-6-18, in use for patient testing. 2) Review of all the laboratory records revealed no accuracy and precision verfication of performance specifications records for the Whiff testing using KOH were available for review. 3) Review of patient number one final report revealed on June 15, 2018 the Whiff test was reported as negative. 4) Interview on June 16, 2018 at 1:50 p.m. with testing personnel number one confirmed the family nurse practitioner uses the KOH to perform the Whiff test for patient testing. 5) Interview on June 16, 2018 at 2:30 p.m. with the technical consultant confirmed no verficiation of performance specificaiton was performed for the Whiff testing using KOH. -- 3 of 3 --