West Texas Pediatrics

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, Medical Laboratory Evaluation. The facility was found to be out of compliance with the conditions of the CLIA program. The conditions not met were: D2016 - 42 C.F.R. 493.803 Condition: Successful participation in a proficiency testing program D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 review of the CMS Casper 153 & 155 proficiency testing reports and the 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 -- Medical Laboratory Evaluation proficiency testing records for the 1st and 2nd testing events in 2020, the laboratory failed to successfully participate in proficiency testing for Hematology (See D2123 and D2130). D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing, the laboratory failed to participate in two consecutive testing events resulting in a test score of 0% in WBC Diff (White Blood Cell Differential), WBC (White Blood Cell Count), RBC (Red Blood Cell Count), HCT (Hematocrit), HGB (Hemoglobin), and Platelets (PLT) in the specialty of Hematology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in WBC Diff, WBC, RBC, HCT, HGB, and PLT for the 1st and 2nd events of 2020. Review of the Medical Laboratory Evaluation Proficiency Testing Evaluation for the 2020 MLE-M1 (1st) and MLE-M2 (2nd) Events, respectively, show scores of 0% for WBC Diff, WBC, RBC, HGB, HCT, and PLT under the specialty of Hematology with the comment Failure to Participate. 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. This STANDARD is not met as evidenced by: Based on desk review of proficiency testing records, the laboratory failed to achieve satisfactory performance for the same analyte in two consecutive events resulting in unsuccesssful performance with a test score of 0% in WBC Diff (White Blood Cell Differential), WBC (White Blood Cell Count), RBC (Red Blood Cell Count), HCT (Hematocrit), HGB (Hemoglobin), and Platelets (PLT) in the specialty of Hematology for the 1st and 2nd Events, respectively in 2020. Findings follow. Review of the CMS Casper Report 153 showed the facility received 2 out of 3 consecutive failures with scores of 0 in the report. Review of the CMS Casper Report 155 showed scores of 0 in WBC Diff, WBC, RBC, HCT, HGB and PLT for the 1st and 2nd events of 2020. Review of the Medical Laboratory Evaluation Proficiency Testing Evaluation for the 2020 MLE-M1 (1st) and MLE-M2 (2nd) Events, respectively, show scores of 0% for WBC Diff, WBC, RBC, HGB, HCT, and PLT under the specialty of Hematology for the two consecutive testing events. -- 2 of 3 -- D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS Casper 153 & 155 proficiency testing reports and the Medical Laboratory Evaluation proficiency testing records for the 1st and 2nd testing events in 2020, the Laboratory Director failed to provide direction and management for the laboratory testing performed (see D6017). D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the CMS Casper 153 & 155 proficiency testing reports and the Medical Laboratory Evaluation proficiency testing records for the 1st and 2nd testing events in 2020, the Laboratory Director failed to ensure the laboratory participated in proficiency testing for Hematology (See D2130). -- 3 of 3 --

Summary Statement of Deficiencies D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based upon review of the CMS Enforcement letter E18-237 (dated February 13, 2019) , review of laboratory records and interview of facility personnel, the laboratory director failed to obtain the services of a qualified Technical Consultant ( from outside the facility) to assist and review the laboratory's performance to be on the premises two days each week (minimum of 16 hours per week) during the duration of the condition level non-compliance as instructed in the enforcement letter received from CMS Dallas regional offices on February 13, 2019. The findings included: 1. Review of the CMS Enforcement letter E18-237 (dated February 13, 2019) found on page 2 under the heading Directed

Summary Statement of Deficiencies D0000 Based on observations, review of laboratory testing records and personnel records it was determined that the laboratory failed to meet the following conditions of the CLIA regulations found at 493.1 through 493.1780 : 493. 801 Condition: Enrollment and Testing of Samples 493. 1215 Condition: Hematology 493. 1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director 493 .1409 Condition: laboratories performing moderate complexity testing; Technical Consultant 493 .1415 Condition: laboratories performing moderate complexity testing; Clinical Consultant 493. 1421 Condition: Laboratories performing moderate complexity testing; Testing Personnel D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Review of the manufacturer's instructions for use, observations and interview of facility personnel found the laboratory failed to follow the manufacturers instructions when using the cobas Chemstrip 10 UA urine test strips and the One Touch ultra glucose monitor. The findings included: cobas Chemstrip 10 UA urine test strips 1. Review of the cobas Chemstrip UA instructions for use found under the heading Quality control- "For quality control, use commercially available urine controls, or other suitable control material. At a minimum, run a positive and negative control in daily routine. It is also recommended to perform quality control when a new container of strips is opened, when starting a new lot of test strips, when there are questionable results and every 30 days to check the storage conditions of the test strips." 2. Observations made during the tour of the facility found that the laboratory was currently using the cobas Chemstrip UA urine strips lot 29190301 expiration 2019-03- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- 31. There were no urine controls available for use in the laboratory. 3. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on October 18, 2018 at 10:25 AM confirmed that the laboratory did not test a positive and negative control each day when using the cobas Chemstrip UA urine strips for patient testing. One Touch ultra glucose monitor 1. Review of the One Touch ultra owners booklet found: on page 13 under the heading Checking the System with Control Solution - "when you should do a control solution test: to practice the test process instead of using blood. When you open a new vial of test strips. Once a week. On page 14 under the heading before you begin: use only One Touch Ultra control solution. Check the expiration date on the control solution vial. Record the discard date (date opened plus 3 months) on the vial label. Do not use after expiration or discard date, whichever comes first." 2. Observations made during the tour the facility found that the laboratory was currently using One Touch Ultra Control Solution Lot 4A2A79 Expiration 11/2006 and One Touch Ultra test strips lot 406-5019 expiration 02/2018. 3. Review of patient test records found that the laboratory tested 25 patient specimens between March 1, 2018 and October 18, 2018 using the expired One Touch ultra test strips. Quality control test records were requested but not provided. 4. Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted on October 18, 2018 at 9:33 AM confirmed that the expired test strips were the only test strips available for use. She went on to say that the laboratory did not do weekly control solution testing when using the One Touch Ultra glucose monitor. 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 a review of the laboratory testing records, CMS 155 report, and interview of facility personnel it was revealed that the laboratory failed to enroll in a proficiency testing program for each of the each of the specialties and subspecialties for which it seeks certification (Hematology). The findings included: 1. A review of facility records found no documentation of the laboratory being enrolled in or participating in a CMS approved proficiency testing program in 2016, 2017 or 2018 for Hematology. The laboratory started testing patient specimens for Complete Blood Counts using the Sysmex pocH-100 i Hematology analyzer on October 3, 2017. Further review found that verification procedures were initiated November 1, 2016. 2. Review of the CMS 155 report found no proficiency testing scores had been reported to the Centers for Medicare and Medicaid Services (CMS). 3. Interview of testing person one listed on the CMS report 209 Laboratory Personnel Report conducted on October 18, 2018 at 10:05 AM confirmed that the laboratory did not enroll in, or participate in a proficiency testing program for hematology. 4. According to the Annual Test Volume recorded in the CMS 116 application obtained during the inspection, the laboratory performs 1390 hematology tests annually. -- 2 of 15 -- D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Review of personnel files, laboratory records, Sysmex pocH- 100i operators manual, quality control records and interview of facility personnel found the laboratory failed to meet the requirements for the specialty of Hematology. Findings Included: 1. The laboratory failed to have a written policy to assess the competency of the technical consultant or testing personnel. (See D5209) 2. Laboratory failed to have procedures available to testing personnel that had been approved signed and dated by the current laboratory director. (See D5407) 3. The laboratory failed to define and monitor the proper temperature and humidity consistent with the manufacturers' instructions for operation of the Sysmex pocH- 100i Hematology Analyzer . (See D5413) 4. The laboratory failed to verify the performance specifications of the Sysmex pocH 100i Hematology Analyzer to ensure it met the manufacturers claims for accuracy, precision, reportable range and establish a reference range suitable for the patient population served by the laboratory. (See D5421) 5. The Laboratory failed to establish a policy defining the frequency of calibration procedures for the Sysmex pocH-100 i hematology analyzer. (See D5403) 6. The Laboratory failed to establish and maintain a quality control program for the Sysmex pocH-100 i hematology analyzer. (See D5441) 7. The laboratory failed to establish written policies and procedures (Quality Assurance) for an ongoing mechanism to monitor, assess and correct problems identified in the Hematology analytic system for testing on the Sysmex pocH 100i Hematology Analyzer before, during and after verification in order to ensure accurate patient results. (See D5791) 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 a review of personnel records, policies and procedures and interview of facility personnel it was revealed that the laboratory failed to have a procedure to assess the competency of consultants, supervisors and testing personnel . Findings included: 1. A review of personnel records found no documentation of competency assessment for the technical consultant or eight of eight testing personnel listed on the CMS 209 Laboratory Personnel Report. 2. Review of policies and procedures found no procedure available to review for assessing the competency of consultants, supervisors or testing personnel. 3. Interview of the testing person one conducted on October 18, 2018 at 9:40 AM confirmed there were no competency assessment records or a procedure for assessing the competency of the technical consultant or testing personnel. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT -- 3 of 15 -- CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview of facility personnel, the laboratory failed to have a quality assessment program to identify and correct problems in general Lab systems. 1. The laboratory failed to enroll in a proficiency testing program for Hematology. (See D 2000) 2. The laboratory failed to have a procedure in place to assess the competency of all consultants, supervisors and testing personnel. (See D5209) 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)