Summit Medical Group

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Urine Chemistry tests for two out of three PT events in 2022. The TP confirmed on 2/9/23 at 1:00 pm the laboratory did not enrolled in PT for Urine Chemistry tests. 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 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 -- 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 surveyor review of the Proficiency Testing (PT) evaluation records, work records and interview with Testing Personnel (TP) the laboratory failed to participate in PT 3rd event 2020 Hematology/Coagulation with the American Proficiency Institute (API). D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP) the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology/Coagulation tests performed with the American Proficiency Institute (API), for 1st event 2021. The findings include: 1. The laboratory received an 0% grade for Hemoglobin, Glucose, Ketones, Leukocyte, Nitrite, and Protein. 2. There was no documented evidence that the laboratory ran the PT samples and compared them with API PT results. 3. The TP confirmed on 2/9/23 at 12:45 pm that the laboratory did not review and document an evaluation of unacceptable PT results. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to verify commercially assayed QC material with each new lot and/or shipment for Urinalysis testing performed on the -- 2 of 3 -- Clinitek Advantus analyzer from 5/23/18 to the date of survey. The TC confirmed on 2 /9/23 at 12:45 pm the assayed values of QC material were not verified before putting in use. Note: This was previously cited 10/16/19. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to establish a procedure for verifying manually entered results from 10/16/19 to the date of survey. The TP confirmed on 2/9 /23 at 1:00 pm that the laboratory did not have the procedure mentioned above. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to have appropriate education documentation on all Testing Personnel (TP) performing laboratory testing on the date of survey. The findings include: 1. The laboratory did not have education records for six out of nine TP listed on the CMS form 209. 2. The TP confirmed on 2/9/23 at 123: 40 pm the above records were not on file. -- 3 of 3 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to retain Urinalysis 2-18 PT event printouts performed with the American Institute of Proficiency. The finding includes: 1. The laboratory did not retain urinalysis printout to substantiate reported values. 2. The TC confirmed on 10/16/19 at 10:30 am that PT printouts were not retained. 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 survey review of the Competency Assessment (CA) records and interview with the Technical Consultant (TC), the laboratory failed to follow its Competency Assessment (CA) procedures in 2019 assessment on 12 out of 12 Testing Personnel (TP). The findings include: 1. The laboratory failed to assess criteria # 5, assessment of test performance through testing Proficiency Samples or internal blind samples correctly. a. The TC used audit of EMR for criteria #5. b. The TC put proficiency testing for all 12 TP assessed where as only two events were performed and by same personnel. 2. The TC confirmed on 10/16/19 at 10:30 am the laboratory did not follow the CA procedure. 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 -- 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 lack of Performance Specifications (PS) records and interview with the Technical Consultant (TC), the laboratory failed to verify PS for Urinalysis tests performed on the Clinitek Advantus analyzer from 5/23/18 to the date of survey. The TC confirmed on 10/16/19 at 10:45 am that the PS were not performed. NOTE: 1. This deficiency was cited in the survey report dated 5/23/18. 2. The

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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to maintain Urinalysis work records and attestation statement for 1, 2 and 3 of 2017 PT event with American Proficiency Institute at the time of survey. The TP # 1 listed on CMS form 209 confirmed on 5/23 /18 at 1:30 pm that PT records were not maintained. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Operator Manual and interview with the Testing Personnel (TP), the laboratory failed to follow calibration procedure for Urinalysis test performd on the Clinitek Advantus analyzer from Augusy 2017 to the date of survey. The finding includes: 1. The calibration must be performed on each day of patient testing but the laboratory did not have any records to substantiate that calibration was done. 2. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 2:00 pm that calibration procedure was not followed. 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 lack of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to verify PS for Urinalysis tests performed on the Clinitek Advantus analyzer from August 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 1:45 pm that the PS were not performed. D5463 CONTROL PROCEDURES CFR(s): 493.1256(d)(7)(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-- Over time, rotate control material testing among all operators who perform the test. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the surveyor review of the Quality Control (QC) Records and interview with the Testing Personnel (TP), the laboratory failed to rotate control material testing among all TP who perform Urinalysis test from August 2017 to the date of survey. The TP #1 listed on the CMS form 209 confirmed on 5/23/18 at 1:35 pm that only one TP performed QC on each day of testing. 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. -- 2 of 4 -- This STANDARD is not met as evidenced by: a) Based on surveyor review of Temperature Records (TR), observation of TR in closet and interview with the Testing Personeel (TP), the laboratory failed to records room temperature accurately from January 2017 to the date of survey. The findings include: 1. The room TR where urinalysis strips were stored did not include year and acceptable range of storage in 2017. 2. The room temperature from January 2018 to the date of survey was records on the refrigerator TR without year on it. 3. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 2:00 pm that TR for room was not accurate. b) Based on the surveyor review of Quality Control (QC) records and interview with the TP, the laboratory failed to establish a written policy for new QC lot verification used for Urinalysis tests performed on the Clinitek Advantus analyzer from August 2017 to the date of the survey. The TP # 1 confirmed on 5/23/18 at 1:30 pm the laboratory did not establish written policies for new QC lot verification. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Final Report (FR) and interview with the Testing Personnel (TP), the laboratory failed to have correct name of the laboratory where the Urinalysis tests were performed from August 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 1:30 pm that the correct name of the laboratory was not on FR. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to have a procedure to verify manually entered results into electronic medical records for accuracy from August 2017 to the date of survey. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 2:15 pm that the laboratory did not have the procedure mention above. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of -- 3 of 4 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Testing Personnel (TP), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements from August 2017 to the date of the survey. The TP # 1 listed on the CMS form 209 confirmed on 5/23/18 at 2:00 pm that a CA procedure was not established. 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 surveyor review of the Personnel Files and interview with the Testing Personnel (TP), the Technical Consultant (TC) failed to ensure Competency Assessment (CA) was evaluated by a qualified individual in 2017. The finding includes: 1. CA on six out of six TP reviewed revealed that it was performed by the License Practice Nurse who had an Associate Degree. 2. The TP # 1 listed on CMS form 209 confirmed on 5/23/18 at 1:40 pm that the TC did not ensure that a qualified personnel performed CA. -- 4 of 4 --