Vega Alta Community Health

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) conducted an unannounced CLIA recertification survey at Best Medical Options on February 25, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The following standard level deficiencies were found during the recertification CLIA survey ending on February 25, 2025. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the Human Chorionic Gonadotropin (hCG) quality control records reviewed, manufacturer instructions and laboratory director interview on February 25, 2025 at 11:52 A.M., it was determined that the laboratory did not perform the external positive and negative control material each day of patient testing. The laboratory processed and reported 5 patients sample in the following days: December 12, 2024; January 8, 2025; January 16, 2025; January 14, 2025; February 18, 2025. The findings include: 1. The manufacturer's instructions were reviewed on February 25, 2025 at 11: 40 A.M. The manufacturer established that the external control must be performed every day of patient testing. 2. Review of the hCG quality control records on February 25, 2025 at 11:45 A.M., showed that the laboratory did not perform the external 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 -- positive and negative control material each day of patient testing. The laboratory processed and reported 5 patients sample in the following days: December 12, 2024; January 8, 2025; January 16, 2025; January 14, 2025; February 18, 2025. 3. The laboratory director confirmed on February 25, 2025 at 11:52 A.M., that the laboratory failed to perform the hCG positive and negative external control material each day of patient testing. The laboratory processed and reported 5 patients sample in the following days: December 12, 2024; January 8, 2025; January 16, 2025; January 14, 2025; February 18, 2025. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on review of the hCG quality control records, manufacturer's instructions review, and interview with the laboratory director on February 25, 2025 at 12:36 PM; it was determined that the laboratory director failed to fulfill her responsibilities and duties to ensure compliance with the manufacturer's instructions and laboratory quality control requirements. Refer to D5445. -- 2 of 2 --

Summary Statement of Deficiencies D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Mycoplasma pneumoniae quality control records patient records review ( 2019-2021 ) and interview with the laboratory general supervisor on April 14, 2021 at 11:20 AM, it was determined that the laboratory failed to meet the requirements in the subspecialty of General Immunology. The finding includes: 1. The laboratory did not include each day of testing a negative and a positive control materials when patients serum specimens were tested for qualitative Mycoplasma IgM by the Immuno Card Mycoplasma method. Refer to : 5449- The laboratory did not include positive and negative control material D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on quality assessment procedure manual and quality assessment records review (2019-2020) and laboratory general supervisor interview on April 14, 2021 at 10:10 A. M., it was determined that laboratory failed to monitor and evaluate the following QA activities: test request. The findings include: a. Review of the quality assessment 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 -- procedure manual showed that evaluations to laboratory test request must be performed every three months. b. Review of the quality assessment records showed that the last evaluations to test requisitions was performed in December 2019. c. The laboratory general supervisor confirmed on April 14, 2021 at 10:15 A.M. that evaluations to test requisitions were not performed since December 2019. 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 review of Mycoplasma pneumoniae IgM quality control results ( 2019-2021 ) , patient test results records and interview with the laboratory supervisor on April 14, 2021 at 11:20 AM, it was found that the laboratory did not include a positive and a negative control material each day of patient testing. The findings include: 1. The laboratory began to perform patient's test for Mycoplasma pneumoniae on November 2019. 2. Review of the quality control and patient test results records showed that positive and negative controls were included when a new reagent box was opened. 3. The mycoplasma quality control records ( 2019-2021) and patient test results records showed that from November 2019 to April 2021 the laboratory processed and reported 468 mycoplasma IgM . 2019-28 patient 2020-380 patient 2021 -60 patient 4. The laboratory supervisor stated on April 14, 2021 at 11:30A.M., that they included a negative and a positive control material when a new reagent box was opened and documented the procedural control with each patient. 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 quality assessment procedures manual, quality assessment records review (2019-2020) and laboratory general supervisor interview on April 14, 2021 at 10:10 A. M., it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for post-analytic systems. The findings include: a. Review of the quality assessment program showed that evaluations to turn around time ( TAT) must be evaluated every three months. b. Review of the quality assessment records showed that the last turn around time evaluation was performed in March 2019. c. The laboratory general supervisor confirmed on April 14, 2021 at 10:30 A.M. that turn around time evaluations were not performed since March 2019. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 2 of 4 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on general immnunology quality control records review ( 2019-2021) and laboratory supervisor interview on April 14, 2021 at 11:30 A.M., it was determined that the laboratory director failed to fulfill his responsibilities and duties to ensure compliance with the laboratory quality control requirements. Refer to D6093 D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on general immunology quality control record review from November 2019 to April 2021 and laboratory general supervisor interview on April 14, 2021 at 11:45 A. M. it was determined that the laboratory director failed to ensure compliance with the requirement for analytic systems. The finding includes: 1. The laboratory did not include a positive and a negative control material when performed Mycoplasma IgM each day of patient testing. Refer to D5449. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review ( 2019-2020) and laboratory general supervisor interview on April 14, 2021 at 10:00 A.M, it was determined that laboratory failed to ensure compliance with quality assessment (QA) requirements. The findings include: 1. Quality Assessment records showed that the laboratory did not evaluate the established Quality Assessment Program to monitor and evaluate the requirements for preanalytic and postanalytic systems. 2. The laboratory general supervisor confirmed on April 14, 2021 at 10:00 A.M, that the laboratory failed to evaluate the requirements for preanalytic and postanalytic systems. Refer to D5391 and D5891. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on general immunology quality control record review from November 2019 to April 2021 and laboratory general supervisor interview on April 14, 2021 at 11:45 A. M. it was determined that the laboratory general supervisor failed to ensure compliance with the requirement for analytic systems. The finding includes: 1. The laboratory did not include a positive and a negative control material when performed Mycoplasma IgM each day of patient testing. Refer to D5449. -- 4 of 4 --

Summary Statement of Deficiencies D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on quality assessment procedure manual, quality assessment records review (2017-2019) and laboratory director interview on May 8,2019 at 9:20 A.M. it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the following requirements for pre analytic laboratory systems: test request. The findings include: a. Review of the quality assessment procedure manual showed that evaluations to test requisitions must perform each 3 months. b. Review of the quality assessment records showed that the laboratory did not evaluate the test requisitions in year 2018. c. The laboratory director confirmed on May 8, 2019 at 9:20 A.M. that evaluations to test requisitions were not performed in year 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on manufacturer's written procedures, routine chemistry preventive maintenance records review ( 2018-2019) and laboratory general supervisor and 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 -- laboratory director interview on May 8, 2019 at 9:45 A.M., it was determined that the laboratory failed to follow written instructions for the preventive maintenance of routine chemistry systems. The findings include: 1. The laboratory uses the Konelab and Easy Lyte system to perform routine chemistry tests. 2. The manufacturer's written procedures establishes that the laboratory must document and perform the daily, weekly and monthly preventive maintenance. 3. Review of Kone Lab system preventive maintenance records from January 2018 to May 2019 , showed that the laboratory did not perform nor document the weekly preventive maintenance (wash dionised and wastewater container, wipe off condensing water under reagent disk) and the monthly preventive maintenance ( wash tubes with diluted washing solution 4.5%). 4. Review of Easy Lyte system preventive maintenance records from January 2018 to May 2019 , showed that the laboratory did not perform nor document since March 2018 the biannual preventive maintenance (membrane change, change pump sleeve, change fill filling solution, sample sleeve change. 4. The laboratory processed and reported 39,473 routine chemistry patient samples on 2018. 5. The laboratory director confirmed on May 8, 2019 at 9:45 A.M that the laboratory failed to follow written instructions for the preventive maintenance of routine chemistry systems. 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 lack of hematology statistical parameters , hematology quality control review and interview with the laboratory director and the laboratory general supervisor on May 8, 2019 at 10:45 A.M., it was determined that the laboratory did not evaluate nor define the statistical values of quality control material used by the Sysmex KX-21N instrument from September 1, 2018 to September 23, 2018 and from November 22, 2018 to November 29, 2018. The findings include: 1. The laboratory use the Sysmex KX-21N to perform hematology tests. 2. The laboratory did not have any statistical data (Levy-Jennings, control value mean and limits) of the control materials used from September 1, 2018 to September 23, 2018 and from November 22, 2018 to November 29, 2018. 3. The laboratory general supervisor stated on May 8, 2019 at 10:45 A.M.that the laboratory lost the quality control data due a problem with the system on September 2018. The laboratory retain the quality control print out, however, did not evaluate the controls value in Levy Jennings graphs. 4. The laboratory performed 559 hematology patient samples during those days. 5. The laboratory director confirmed on May 8, 2019 at 11:00 A.M , that the laboratory failed to evaluated the statistical data of the quality control material used during those days. -- 2 of 4 -- 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 quality assessment (QA) records review ( 2017-2019), laboratory director and laboratory general supervisor interview on May 8, 2019 at 11:30 AM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for analytic systems. The findings include: 1. Review of the laboratory quality assessment records showed that the laboratory establishes a monthly assessment for each analytic process to keep track the laboratory performance. 2. The laboratory did not evaluate aspects regarding the analytic system. Refer to D 5429 and D 5469. 3. The laboratory director confirmed on ay 8, 2019 at 11:00 A.M., that the laboratory failed to evaluate aspects regarding the analytic system. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on hematology and routine chemistry records review ( 2017-2019) and interview with the laboratory director on May 8, 2019 at 11:30 A.M. , it was found that the laboratory director failed to ensure compliance with the requirements for analytic systems. The findings include: 1. The laboratory failed to follow written instructions for the preventive maintenance of routine chemistry systems. Refer to D 5429. 2. The laboratory did not evaluate nor define the statistical values of quality control material used by the Sysmex KX-21N instrument from September 1, 2018 to September 23, 2018 and from November 22, 2018 to November 29, 2018. Refer to D 5469. D6144 GENERAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1463 The general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation and personnel performing testing and reporting test results. This STANDARD is not met as evidenced by: Based on hematology and routine chemistry records review ( 2017-2019) and interview with the laboratory director on May 8, 2019 at 11:30 A.M. , it was found that the laboratory general supervisor failed to ensure compliance with the requirements for analytic systems. The findings include: 1. The laboratory failed to follow written instructions for the preventive maintenance of routine chemistry -- 3 of 4 -- systems. Refer to D 5429. 2. The laboratory did not evaluate nor define the statistical values of quality control material used by the Sysmex KX-21N instrument from September 1, 2018 to September 23, 2018 and from November 22, 2018 to November 29, 2018. Refer to D 5469. D6177 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(3) Each individual performing high complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on routine chemistry records review ( 2017-2019) and interview with the laboratory director on May 8, 2019 at 11:30 A.M. , it was found that the laboratory testing personnel failed to ensure compliance with the requirements for analytic systems. The finding includes: 1. The laboratory testing personnel failed to follow written instructions for the preventive maintenance of routine chemistry systems. Refer to D 5429. -- 4 of 4 --