Brownsville Family Medicine

Summary Statement of Deficiencies D0000 During a recertification survey performed on 04/08/2024, the laboratory was found out of compliance with the following conditions: 493.801 Condition: Enrollment and testing of samples 493.1205 Condition: Virology 493.1443 Condition: Laboratories performing high complexity testing; laboratory director 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor 493.1459 Condition: Laboratories performing high complexity testing; general supervisor 493. 1487 Condition: Laboratories performing high complexity testing; testing personnel 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 observation of the laboratory, review of the manufacturer instructions for use, patient test records, proficiency test records, and staff interviews, the laboratory failed to ensure the laboratory was enrolled and participated in proficiency testing (PT) for the BinaxNow respiratory syncytial virus (RSV) antigen test that was used as a non-waived test from 02/01/2023 to the date of the survey on 04/08/2024 and failed to ensure the laboratory was enrolled and participated in proficiency testing (PT) in 2023 or 2024 with a total of 24 patients reported. The findings include: 1. Observation of the laboratory on 04/08/2024 at 9:35 am revealed the BinaxNow RSV Card antigen test kit used for patient testing. During the observation, the laboratory testing person Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- (TP) seven stated the laboratory performed RSV antigen testing on all patient age ranges. 2. A review of the manufacturer instructions for use revealed the BinaxNow RSV card antigen test kit was waived for patients five years of age and younger. 3. A review of the patient test records revealed the laboratory reported RSV antigen results on 24 patients over the age of five from 02/01/2023 until the date of the survey (04/08 /2024). 4. A review of the laboratory's PT records revealed the laboratory was not enrolled in PT for the RSV antigen test that was used as a non-waived test in 2023 and 2024. 5. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and office manager confirmed the laboratory used the BinaxNow RSV Card antigen test kit as a non-waived test in 2023 and 2024 and was not enrolled in proficiency testing. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's quality control (QC) records, lack of records, and staff interview, the laboratory failed to retain statistical parameters of QC (12 of 12 lots reviewed) for the Sysmex XP 300 instrument used for CBC patient testing in 2023 and 2024. The findings include: 1. Observation of the laboratory revealed the Sysmex XP 300 instrument (Serial # B3505) used for CBC patient testing. 2. A review of the laboratory's CBC QC records revealed no documentation of statistical parameters (mean or standard deviation) of QC used by the laboratory for 12 of 12 lot numbers reviewed as follows: 23610710, 23610711, 23610712 Expiration date 04/05/2023 32480710, 32480711, 32480712 Expiration date 12/13/2023 33320710, 33320711, 33320712 Expiration date 03/06/2024 40510710, 40510711, 40510712 Expiration date 05/29/2024 3. Interview on 04/08 /2024 at 2:30 pm with the laboratory director, TP seven, and office manager, confirmed the laboratory failed to retain statistical parameter QC data used by the laboratory for the Sysmex XP 300 CBC instrument in 2023 or 2024. D5010 VIROLOGY CFR(s): 493.1205 If the laboratory provides services in the subspecialty of Virology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1265, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer package insert, patient test records, and staff interviews, the laboratory failed to establish performance specifications for the BinaxNow RSV Card antigen test that was used with modifications to the manufacturer-authorized age group (Refer to D5423). D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) -- 2 of 18 -- 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 a review of the laboratory's College of American Pathology (CAP) PT records and staff interview, the laboratory failed to verify the accuracy of the vaginal wet prep testing in 2023. The findings include: 1. Review of the laboratory's CAP PT records revealed the following for vaginal wet prep: CM-A 2023 Clinical Microscopy photomicrograph CMMP-26 with an unacceptable result CM-B 2023 Clinical Microscopy photomicrograph CMMP-36 with an unacceptable result Resulting in failure to verify the accuracy of the vaginal wet prep testing in 2023. 2. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and the office manager, confirmed the laboratory failed to verify the accuracy of vaginal wet prep testing twice a year in 2023. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's operating manual, laboratory environmental records, annual test volumes reported on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification (Form CMS-116), and staff interview, the laboratory failed to monitor room humidity for the Sysmex XP 300 complete blood count (CBC) instrument with approximately 6,027 patients reported in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/08/2024 at 9:35 am revealed the Sysmex XP 300 (Serial # B3505) used for patient CBC testing. 2. Review of the Sysmex XP 300 manufacturer operator's manual revealed an operating relative humidity of 30-85 percent (%). 3. Review of the laboratory's environmental records from February 2023 through April 2024 (14 of 14 months reviewed) revealed no documentation that room humidity was monitored where the Sysmex XP 300 CBC instrument was used for patient testing. 4. Review of the Form CMS-116 annual test volume estimates revealed approximately 6,027 patient CBC results reported using the Sysmex XP 300 instrument in 2023 and 2024 (02/01/2023-04/08/2024). 5. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and office manager confirmed the laboratory did not monitor room humidity for the Sysmex XP 300 in 2023 or 2024. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) 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) -- 3 of 18 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer quality control (QC) package insert, and staff interview, the laboratory failed to label (three of three) complete blood count (CBC) QC vials with corrected expiration date. The findings include: 1. Observation of the laboratory on 04/08/2024 at 9:35 am revealed a Sysmex XP 300 (Serial # B3505) instrument used for CBC patient testing. None of the three observed EIGHTCHECK-3WP X-TRA control vials were labeled with corrected expiration dates (lot numbers 40510710, 40510711, 40510712). 2. A review of the manufacturer package insert revealed that opened control vials were stable for 14 days. 3. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and office manager confirmed the laboratory failed to label three of three CBC control vials with a corrected expiration date. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer package instructions for use, patient test records, lack of records, and staff interview, the laboratory failed to establish the performance specifications for the use of the BinaxNow RSV Card antigen test used for patient testing over the age of five from 02 /01/2023 to 04/08/2024 with 24 patients older than five years reported. The findings include: 1. Observation of the laboratory on 04/08/2024 at 9:35 am revealed the BinaxNow RSV Card antigen test used for patient testing. During the observation, TP seven stated that the laboratory performs RSV testing on all patient age ranges. 2. A review of the manufacturer instructions for use revealed the BinaxNow RSV Card antigen test kit was waived when used for testing patients five years or younger. 3. A review of patient test records revealed the laboratory reported RSV antigen results on 24 patients over the age of five from 02/01/2023 until the date of the survey (04/08 /2024). 4. Documentation for performance specification establishment for patients over the age of five was not available. 5. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and office manager, confirmed the laboratory used the BinaxNow RSV Card antigen kit in a manner that was outside the manufacturer- approved group and did not establish the performance specifications for the use of the test in patients over the age of five. D5441 CONTROL PROCEDURES -- 4 of 18 -- CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, quality control (QC) record review, and staff interview, the laboratory failed to have a procedure in place to monitor over time the accuracy and precision of QC for the Sysmex XP 300 instrument used for CBC patient testing in 2023 or 2024. The findings include: 1. Observation of the laboratory revealed the Sysmex XP 300 instrument (Serial # B3505) used for CBC patient testing. 2. A review of the laboratory QC records revealed the laboratory did not include records that monitor precision and accuracy over a period of time. 3. Interview on 04/08/2024 at 2:30 pm with the laboratory director, TP seven, and office manager confirmed the laboratory did not have a process in place to monitor accuracy and precision over a period of time for the Sysmex XP 300 QC used for patient testing in 2023 or 2024. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the available procedure manuals and interview with testing personnel number one, the laboratory failed to have the Sysmex XP-300 complete blood count (CBC) instrument operator's manual available for testing personnel, in 2017, 2018 and 2019. The findings include: 1) Observation of the laboratory on July 23, 2019, at 2:30 p.m. revealed the Sysmex XP-300 CBC instrument, serial number B3505, in use for CBC patient testing. 2) Review of all available procedure manuals revealed the Sysmex XP-300 CBC instrument operator's manual was not available in written form or disk. 3) Interview on July 23, 2019, at 3: 30 p.m. with testing personnel number one confirmed the Sysmex XP-300 CBC instrument was installed November 9, 2017 with no operator's manual available in the laboratory. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: 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 technical consultant failed to provide documentation of either training or experience in the specialties of Hematology and Parasitology (Refer to D6034). D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Laboratory Personnel Report Centers for Medicare and Medicaid (form CMS-209), personnel records and interview with testing personnel number one, the technical consultant failed to provide documentation of either training or experience in the specialties of Hematology and Parasitology. The findings include: 1) Observation on July 23, 2019, at 2:30 p.m. of the laboratory revealed a microscope and a Sysmex XP-300 complete blood count (CBC) instrument in use for wet prep and CBC patient testing. 2) Review of the CMS- 209 Laboratory Personnel Report revealed no technical consultant listed. 3) Review of the available personnel records revealed no documentation of either training or experience for anyone, in the specialties of Hematology and Parasitology. 4) Interview on July 23, 2019 at 3:30 p.m. with testing personnel number one confirmed the CBC and wet prep are performed for patient testing. The technical consultant training and experience for Hematology and Parasitology were not available for review. The previous technical consultant retired December 2018. -- 2 of 2 --