Cottontree Family Practice

Summary Statement of Deficiencies D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with Testing Personnel #1 (TP#1), the technical consultant failed to evaluate the competency of 1 of 1 employees performing serum pregnancy testing. The laboratory performs 10 serum pregnancy tests a year. Findings include: 1. Record review revealed the laboratory failed to document and perform competency assessment for 1 of 1 testing personnel performing serum pregnancy testing. 2. In an interview on 9/5/2024 at approximately 11:26 AM, TP#1 confirmed that the laboratory failed to document and perform competency assessment for 1 of 1 testing personnel performing serum pregnancy testing. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) documentation and an interview with the Lab Manager, the laboratory failed to maintain attestation statements, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens for 2 of 4 PT Events reviewed. Findings include: 1. A review of PT documentation at approximately 2:30 PM on 9/26 /22 revealed that attestation statements for American Proficiency Institute (API) 2022 Chemistry Core 1st Event and 2022 Chemistry Core 2nd Event, were not signed by the person performing the test or by the Lab Director. 2. An interview with the Lab Manager at approximately 2:35 PM on 9/26/22 confirmed that the attestation statements for API 2022 Chemistry Core 1st Event and 2022 Chemistry Core 2nd Event, were not signed by the person performing the test or by the Lab Director. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on inspection of control materials and an interview with the Lab Manager, the laboratory failed to label the OSOM hCG Serum Control Set with the identity, storage requirements, and expiration date. The laboratory performs 141 serum hCG tests annually. Findings include: 1. An inspection of control materials at approximately 2: 00 PM on 9/26/22, revealed that the positive and negative vials of the OSOM hCG Serum control set were not labeled with the identity, storage requirements, and expiration date. 2. An interview with the Lab Manager at approximately 2:05 PM confirmed that the positive and negative vials of the OSOM hCG Serum control set were not labeled with the identity, storage requirements, and expiration date. -- 2 of 2 --

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: Based on American Proficiency Institute (API) performance summary review and confirmation from laboratory practice manager on 8/16/2021, the laboratory failed to achieve successful participation in two consecutirve events for HCG Endocrinology proficiency testing performance. (See D2104). D2104 ENDOCRINOLOGY CFR(s): 493.843(d) Failure to return proficiency testing results to the proficiency testing program within 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 -- the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) performance summary review and confirmation by laboratory manager on 8/16/21, the laboratory failed to submit proficiency testing (PT) results to the proficiency testing program (API) within the time frame specified for two consecutive PT events for HCG Endocrinolgy. Findings include: 1. API summary report included documentation that the laboratory failed HCG Endocrinology in two consecutive events (first and second PT testing events of 2021), with scores of 0% and 0%. 2. API summary report included a note for both the first and second PT testing events of 2021 of "failure to participate". 3. Laboratory manager confirmed via email on 8/16/21 that PT testing results were not submitted to API before the closing date. -- 2 of 2 --

Summary Statement of Deficiencies D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(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-- Test control materials in the same manner as patient specimens. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on direct observation and interview with staff, the laboratory failed to ensure quality control materials were of the same matrix as patient samples for serum pregnancy tests. The laboratory performed approximately 2 serum pregnancy tests per month. Findings include: 1. Direct observation of quality control materials for pregnancy tests revealed the quality control material was a urine matrix for lot KW00076 expiring 2021-09-30. 2. In an interivew with staff on 01/09/2020 at approximately 11:30 A.M. staff was asked to produce the quality control material for serum pregnancy tests. The surveyor was given control material labeled for urine pregnancy test controls. Staff stated they did not realize the controls were not for serum pregnancy tests. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. 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 lack of documentation and interview with staff, the laboratory director failed to ensure a quality assessment program was established and maintained for serum pregnancy tests from January 2018 to January 2020. The laboratory performs approximately 2 tests per week. Findings include: 1. The laboratory procedure manual failed to include an approved quality assessment program for the serum pregnancy tests performed. 2. In an interview conducted on 01/09/2020 the laboratory staff confirmed the lab no longer had an approved qualify assessment procedure for serum pregnancy tests. Based on lack of documentation and confirmation by staff, the laboratory failed to establish and maintain the quality assessment program for their serum pregnancy Individual Quality Control Plan (IQCP). The laboratory failed to monitor that reduced frequency serum pregnancy quality control could identify test problems for 1 of 2 years reviewed (2019). Findings include: 1. The laboratory director approved the IQCP on 03/01/2018. The laboratory lacked documentation the plan was reviewed to ensure quality control was performed at the stated frequency for each new lot number prior to testing patient samples and/or monthly and that testing problems could still be identified with the lowered testing frequency. 2. In an interview with staff on 01/09/2020 at approximately 11:30 A.M. staff confirmed the IQCP was not evaluated annually in 2019. -- 2 of 2 --

Summary Statement of Deficiencies 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 patient test records review, direct observation, lack of documentation, and interview with staff, the laboratory failed to verify the accuracy of Status DS urine drug screens at least twice a year. The laboratory tested approximately 1 urine drug screen per month. Findings include: 1. The laboratory failed to verify moderately complex urine drug screens at least twice a year for tests performed from July 8, 2016 to January 17, 2018 of urine drug screens reviewed. 2. In an interview with staff on 01 /17/2018 at approximately 11:55 A.M. staff confirmed they had not enrolled in proficiency testing or developed a method to verify urine drug screen tests at least twice annually in 2016 and 2017. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, lack of an individualized quality control plan, and interview with staff, the laboratory failed to perform two 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 -- levels of quality control each day of urine drug screen testing for 2 of 2 days of testing reviewed. The laboratory performed approximately 2 tests per month. Findings include: 1. Patient test records reviewed included documentation urine drug screens were performed for patients 136323-5 on 07/18/2016 and for 6439110-1 on 12/12 /2017. 2. Quality control records failed to include documentation the laboratory performed 2 levels of quality control on 07/18/2016 or on 12/12/2017. 3. In an interview conducted on 0117/2018 at approximately 1:15 P.M., staff confirmed the laboratory had not developed an IQCP for drug screening tests and that the laboratory did not perform 2 levels of quality control each day of drug screening testing. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on patient test records review, quality control records review, and interview with staff, the laboratory failed to perform control materials following a complete replacement of testing materials for 1 of 1 new lot number change of serum beta human chorionic gonadotrophin (hCG). The laboratory performed approximately 1 serum pregnancy per week. Findings include: 1. Patient test records review included documentation the laboratory performed a serum pregnancy test on 03/31/2016 for patient 152137-1 using lot number 5100076. Quality control was not performed for this lot number until 04/20/2016. 2. In an interview with staff on 01/17/2018 at approximately 1:15 P.M. staff confirmed the laboratory failed to document two levels of quality control for serum hCG for lot number 5100076. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) 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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of a written quality assessment plan and interview with staff the laboratory failed to define the method to be used to monitor that they verified the accuracy of Solana Streptococci tests at least twice a year. The laboratory tested approximately 4 Solana confirmatory throat screens per week since September 2017. Findings include: 1. The laboratory did not have a written quality assessment plan for Solana Streptococcus testing. 2. The laboratory failed to include a method for verifying test accuracy for the presence or absence of Strep Group A by the Solana method. 3. In an interview with staff on 01/17/2018 at approximately 11:30 A.M. staff confirmed the laboratory had not enrolled in proficiency testing, or have a written quality assessment plan that included Solana test accuracy at least twice a year. -- 2 of 3 -- D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on Individualized Quality Control Plan (IQCP) review, patient test records review, quality control records review, and interview with staff, the laboratory failed to follow the laboratory instructions to perform quality control with each new lot number and once per month for 1 of 5 monthly quality control performance for Affirm VP tests reviewed (January 2018) and failed to perform monthly quality control for serum pregnancy tests (hCG) for one of two months of hCG tests reviewed . The laboratory performed approximately 2 Affirm VP tests per week and one serum pregnancy test per month. Findings include: 1. IQCP review documented the laboratory established the Affirm VP, (detects the presence of Gardnerella, Candida, and Trichomonas from Vaginal swabs) and hCG, quality control plan to include 2 levels of quality control be performed with each new lot number or shipment of Affirm VP cartridges and monthly. 2. Patient test record review included documentation the laboratory performed serum pregnancy testing on 11/01/2017 for patient 6659 and on 01/11/2018 for patient Date of Birth (DOB) 08/12/1959 for Affirm VP lot number 7150924. Patient test records review for hCG tests included documentation patient (DOB) 06/28/1995 was tested for qualitative serum hCG on 07 /11/2017. The laboratory failed to record they performed a positive and negative quality control in July 2017. 3. Quality control records review failed to include documentation for Affirm VP quality control since 07/20/2017 for the new lot number. The exact number of patients tested from July 2017 to January 2018 was not determined. 4. In an interview conducted on 01/17/2018 at approximately 1:00 P.M. staff confirmed they had not performed monthly QC since July 2017 for Affirm VP tests and did not performed monthly quality control for hCG tests in July 2017. -- 3 of 3 --