Hospital Menonita Humacao

Summary Statement of Deficiencies D0000 During a recertification survey on February 18, 2025, the laboratory was found out of compliance with the following condition: 42 CFR 493.1208 GENERAL IMMUNOLOGY 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 Mono Test quality control /patient test worksheet records (years 2024- 2025), written procedures for quality control records review and laboratory director interview on February 18, 2025, at 2:15 P.M., it was determined that the laboratory failed to ensure compliance with the analytic system requirements for Mono Test. The findings include: 1. The laboratory failed to include reactive and non-reactive control material each day of patient's testing. Refer to D5449. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on Mono Test quality control/patient test worksheet records (years 2024-2025), written procedures for quality control records review and laboratory director interview, on February 18, 2025, at 1:38 P.M, it was determined that the laboratory failed to include reactive and non-reactive control material each day of testing, when 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 -- 58 out of 62 Mono Test patient samples were processed and reported from January 18, 2024 to February 17, 2025. The findings include: 1. The laboratory used Asi Color Mono II Test system to perform Mono test patient samples. (Reviewed February 18, 2025, at 1:38 P.M.) 2. Review of the written procedures for quality control records stated that the controls must be processed with each day of patient's testing. (Reviewed February 18, 2025, at 1:40 P.M.) 3. On February 18, 2025, at 1:45 P.M, the Mono Test quality control and patient test worksheet records were reviewed. The records showed that the laboratory did not include reactive and non-reactive control material each day of patient's testing. 4. The laboratory processed and reported 58 out of 62 Mono Test patient samples from January 18, 2024, to February 17, 2025. 5. The laboratory director confirmed on February 18, 2025, at 2:00 P.M. that the laboratory failed to include reactive and non-reactive control material each day of patient's testing. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and 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 Mono Test quality control and patient test worksheet records review, written procedures for quality control records review and laboratory director interview on February 18, 2025, at 2:15 P.M., it was determined that the laboratory director failed to ensure that the general supervisor monitor the requirement for analytic systems for the Mono Test patient samples. Refer to D6144. 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 Mono Test quality control and patient test worksheet records review, written procedures for quality control records review and laboratory director interview on February 18, 2025, at 2:15 P.M., it was determined that the laboratory general supervisor did not assure to follow written procedures for quality control records for Mono test patient samples each day of patient's testing. Refer to D5449. -- 2 of 2 --

Summary Statement of Deficiencies 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: Based on manufacturer's instructions of Influenza A & B test (OSOM Ultra FLU A&B Test), virology quality control records review and laboratory general supervisor and testing personnel interview on January 10, 2019 at 10:22 AM, it was determined that the laboratory failed to follow the manufacturer's instruction for evaluate and document the internal quality control (internal positive procedural control) when performed Influenza A & B test by OSOM Ultra FLU A&B Test method. The findings include: 1. The laboratory performed Influenza A & B test by OSOM Ultra FLU A&B Test method. 2. The manufacturer's establishes that the laboratory must include a positive and a negative control material, evaluate the internal quality control (internal positive procedural control) for valid the Influenza A&B tests. 3. The Influenza A&B tests quality control records showed that the laboratory did not evaluate and document the internal quality control (internal positive procedural control) from January 1, 2018 to January 10, 2019. 4. The laboratory performed and reported 1,651 Influenza A& B patient's samples tests during those months. 5. The general supervisor confirmed on January 10, 2019, that the laboratory did not evaluate and document the internal quality control from January 1, 2018 to January 10, 2019. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory working areas and general supervisor interview on January 10, 2019 at 8:30 AM, it was determined that the laboratory failed to ensure that an adequate space were available for handling and testing of patient samples in the routine chemistry, endocrinology and toxicology areas. The findings include: 1. On January 10, 2019 at 8:30 AM, its observed that the laboratory have two working areas for handling and testing of routine chemistry, endocrinology and toxicology patient samples. 2. The size of one out of two working areas is approximately 11 ' ( length) and 7' ( width). In this area, the laboratory located the system Cobas e- 411 in the front of the Integra 800 system. The testing personnel have a working space of approximately 7 ' ( length) and 2' ( width) to process the patients specimens by the two systems. The area did not have a counter top for the patients specimens handling. The testing personnel used the top of the Integra 800 system to placed the rack with the patients serum specimens. Also, the printer of this area was located in the floor. 3. The size of the second area is approximately 6 ' ( length) and 3' ( width). This areas includes the Cobas c501 system, two waters tanks, one refrigerator and one chair, 6 boxes with Cobas c501 system reagents and devices ( 5 boxes located at the top of the refrigerator and one large box located in the floor). The area did not have a counter top for the patients specimens handling. 4. The general supervisor confirmed on January 10, 2019 at 8:30 AM, that the those testing areas were very crowded and letting few space to process the routine chemistry, endocrinology and toxicology patient specimens. 5. The laboratory processed and reported 2530 patient specimens by the Cobas e-411 system from August 1, 2018 to November 30, 2018; 171,565 patient specimens by the Integra 800 system from January 1, 2018 to January 10, 2019 and 26, 034 patient specimens by the Cobas c501 system from October 1, 2018 to December 31, 2018. 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 review of personnel file and hospital staff interview on January 10, 2019 at 12:00 PM, it was determined that the laboratory failed to follow written policies to assess the blood gases superviosr competency since January 31, 2015. The findings include : 1. On January 10, 2019 at 12:00 PM, the personnel file showed that the annual competency of the blood gases supervisor was not performed since January 31, 2015. 2. The hospital staff confirmed on January 10, 2019 at 12:00 PM, that the competency of the blood gases supervisor was not performed since January 31, 2015. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT 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. -- 2 of 10 -- This STANDARD is not met as evidenced by: Based on Quality Assessment (QA) records review and interview with the blood gases supervisor on January 10, 2019 at 12:00 PM, it was determined that laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirements for general laboratory systems (testing personnel annual competence). Refer to D 5209 ( The laboratory failed to follow written policies to assess the blood gases superviosr competency since January 31, 2015). 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 (QA) records (years 2017 to 2018) review and interview with the blood gases tests supervisor on January 10, 2019 at 12:00 PM, it was determined that the laboratory failed to follow the established Quality Assessment Program to monitor and evaluate the requirement for pre- analytic systems (tests request). The findings include: 1.On January 10, 2019 at 12:00 PM, the quality assessment program showed that evaluations to patient test request must be evaluated every month. 2. Review of the quality assessment records showed that the laboratory did not perform the patient test evaluation since October 2018. 3. The blood gases tests supervisor confirmed on January 10, 2019 at 12:00 PM, that the laboratory did not perform the patient test request evaluations since October 2018. 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)