Laboratorio Clinico Valparaiso

Summary Statement of Deficiencies D0000 A Proficiency Test (PT) Desk Review off site survey was performed on June 2, 2025 to Laboratorio Clinico Valparaiso, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1403 Laboratory Director, Moderate Complexity 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 proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory failed an unsuccessful participation in a Proficiency Testing Program for routine chemistry subspecialties. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two consecutive testing events for the routine chemistry tests. The finding includes: 1.The Puerto Rico Proficiency Testing and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Triglycerides a.Third testing event year 2024 - 60% b.First testing event year 2025 - 60% 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 proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for routine chemistry tests. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of proficiency testing records (years 2024-2025) and Casper Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory has a satisfactory participation for routine chemistry test during the third testing event 2024 and first testing event 2025. Refer to D2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review off site survey was performed on April 7, 2025 to Laboratorio Clinico Valparaiso, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, High complexity 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 Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained a unsuccessful participation in a Proficiency Testing Program for Bacteriology tests. Refer D2028. 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 -- D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Puerto Rico Proficiency Testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory obtained an initial unsuccessful performance in two consecutive testing events for Bacteriology tests. The finding includes: 1. The Puerto Rico Proficiency and Casper Report 0155D scores, showed that the laboratory obtained the following unsuccessful scores: Analyte: Bacteriology (Gram stain, Bacteriology identification & sens) a. First testing event year 2024 - 66% b. Third testing event year 2024 - 60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 review of Puerto Rico proficiency testing scores (year 2024) and CASPER Report 0155D scores, its was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for bacteriology tests. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on Puerto Rico proficiency testing scores (year 2024) and CASPER Report 0155D scores, it was determined that the laboratory director did not ensure that the laboratory had a satisfactory participation for bacteriology tests during the second testing event of the year 2024 and third testing event of the year 2024. Refer to D2028. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review survey was conducted on May 29, 2024 to Laboratorio Clnico Valparaiso, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, high complexity 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 Puerto Rico Proficiency Testing (PRPT) events and CASPER Report 0155 D review (2023-2024), it was determined that the laboratory obtained a subsequent unsuccessful participation for hematocrit test. Refer to D2130. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 PRPT events scores, CASPER Report 0155D, Complete Cell Count (CBC) workload records reviewed and laboratory director interview on May 29, 2024 at 9:00 A.M., it was found that the laboratory failed to attain successful participation in a Proficiency Testing (PT) events for hematocrit tests. The findings include: a. Review of the PRPT scores on May 29, 2024 at 9:30 A.M. and CASPER Report 0155D showed that the laboratory had a subsequent PT failure for analyte hematocrit. The laboratory obtained the following testing scores: 1st event 2023 Hematocrit 20 % 3rd event 2023 Hematocrit 40 % 1st event 2024 Hematocrit 60 % b. During interview the laboratory director confirmed on May 29, 2024, at 9:40 A.M. that the laboratory had three out of four unsatisfactory PT testing events for Hematocrit. c. Review of the CBC workload records showed that laboratory reported 329 CBC tests since April 2024. D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 lack of syphilis serology testing record ( year 2023-2024 ) and laboratory director interview on May 29, 2024 at 12:30 P.M. , it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphilis serology tests. The finding includes: 1. The laboratory failed to follow the manufacturer's instruction when patient specimens were tested for RPR (Rapid plasma reagin) by ASI method. ( refer to D5411 ) 2. The laboratory failed to perform syphilis serology test as required by manufacturer's instructions.( refer to D5411) 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 review of the Mycoplasma pneumoniae IgM quality control records ( year 2023-2224 ) on May 29, 2024 at 11:15 A.M.., and laboratory director interview, it was determined that the laboratory failed to meet the quality control requirements for Mycoplasma pneumoniae IgM test. Refer to D5449. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 5 -- 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. This STANDARD is not met as evidenced by: A-Based on syphillis serology records review ( year 2023-2024 ) and laboratory director on May 29, 2024 at 12:30 P.M., it was determined that the laboratory failed to perform syphillis serology test as required by manufacturer's instructions by the ASI- RPR method. The findings include: 1. The laboratory syphillis serology quality control records were review from January 2023 to May 29, 2024. 2. The manufacturer's requires that the laboratory must perform the needle calibration, clean needle, verify the rotator rpm and monitor the room temperature in the laboratory. 3. From January 2023 to May 29, 2024, the lrecords showed that the laboratory did not document nor verify the needle calibration, clean needle , rotator rpm nor the room temperature monitoring in the RPR (Rapid plasma reagin) testing area the following days : year 2023 : 1/23/23, 1/31/23, 2/10/23, 2/16/23, 2/28/23, 3/20/23, 5/8/23, 5/17 /23, 5/23/23, 6/12/23, 8/4/23, 8/7/23, 8/8/23, 8/10/23, 8/11/23, 8/28/23, 9/2/23, 9/19 /23, 9/28/23, 10/4/23, 10/5/23, 10/6/23, 10/7/23, 10/21/23, 11/2/23, 11/3/23, 11/14/23, 11/16/23, 11/29/23, 12/6/23, 12/13/23, 12/16/23 and 12/20/2023. year 2024 : 1/3/24, 1 /15/24, 1/17/24, 2/3/24, 2/5/24, 2/13/24, 2/20/24, 2/24/24, 2/29/24, 3/12/24, 4/4/24, 4 /24/24 and 5/6/2024. 4. The laboratory processed and reported 67 RPR (Rapid plasma reagin) patient's samples tests those days. 5. The director confirmed on May 29, 2024 at 12:50P.M.. that the laboratory failed to perform syphillis serology test as required by manufacturer's instructions by the ASI-RPR method. B- Based on syphillis serology quality control review ( year 2023-2024 ) and laboratory director interview on May 29, 2024 at 12:30 P.M. , it was determined that the laboratory failed to follow the manufacturer's instruction when patient specimen were tested for RPR (Rapid plasma reagin) by RPR card test ASI method. The findings include: 1. The syphillis serology quality control records were reviewed since January 2023. ( review on May 29, 2024 at 12: 35 P.M ) 2. The manufacturer's instruction establishes that three levels of control material ( non reactive, minimal to moderate and reactive) must be included each day of testing. ( review on May 29, 2024 at 12: 40 P.M . ) 3. Review of records from January 2023 to May 29, 2024, showed that the laboratory did not include any control material the following days: year 2023 : 1/23/23, 1/31/23, 2/10/23, 2/16/23, 2 /28/23, 3/20/23, 5/8/23, 5/17/23, 5/23/23, 6/12/23, 8/4/23, 8/7/23, 8/8/23, 8/10/23, 8/11 /23, 8/28/23, 9/2/23, 9/19/23, 9/28/23, 10/4/23, 10/5/23, 10/6/23, 10/7/23, 10/21/23, 11 /2/23, 11/3/23, 11/14/23, 11/16/23, 11/29/23, 12/6/23, 12/13/23, 12/16/23 and 12/20 /2023. For year 2024 the laboratory did not include any control material on 1/3/24, 1 /15/24, 1/17/24, 2/3/24, 2/5/24, 2/13/24, 2/20/24, 2/24/24, 2/29/24, 3/12/24, 4/4/24, 4 /24/24 and 5/6/2024. ( review on May 29, 2024 at 12: 45 P.M. ) 4. The laboratory processed and reported 67 syphilis serology samples those days. ( review on May 29, 2024 at 12: 50 P.M . ) 5. The director confirmed on May 29, 2024 at 12:50P.M.. that the laboratory did not include the three levels of control material ( non reactive, minimal to moderate and reactive) those days. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 3 of 5 -- 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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2023-2024) and laboratory director interview on May 29, 2024 at 11:15 A.M. , it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records were review on May 29, 2024, at 11:20 A.M., from January 2023 to May 29, 2024. 2. Review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include any control material each day of patient testing since 2023. 3. The laboratory director confirmed on May 29, 2024 at 11:25 A.M., that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma pneumonia test. 4. The laboratory did not include any control material, when 697 out 697 patient specimen were processed and reported since January 2023. ( Review on May 29, 2024 at 11:20 A.M. ) D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 review of PRPT event scores and CASPER Report 0155 D (years 2023- 2024), it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for hematocrit tests. Refer to D6079 D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 on PRPT event scores and CASPER Report 0155 D for the first and second -- 4 of 5 -- testing events of year 2023 and the first testing event of year 2024, it was determined that the laboratory director failed to ensure that the laboratory had a satisfactory participation in the hematocrit tests. Refer to D 2130 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 and syphilis serology quality control records review ( year 2023-2024 ) , it was determined that the laboratory director did not ensure that quality control procedures related to Mycoplasma pneumoniae IgM and syphilis serology quality control procedures were performed as established by the manufacturer's instructions. Refer to D5411 and D5449. The findings include: 1. This laboratory ia a sole facility practitioner. 2. The laboratory director did not assure that control procedure for Mycoplasma pneumoniae and syphilis serology were performed as established by the manufacturer's instructions. -- 5 of 5 --

Summary Statement of Deficiencies D0000 A Proficiency Test Desk Review survey was conducted on May 29, 2024 to Laboratorio Clnico Valparaiso, the laboratory was found out of compliance with the following conditions: 42 CFR 493.803 Proficiency Testing, Successful Participation 42 CFR 493.1441 Laboratory Director, high complexity 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 Puerto Rico Proficiency Testing (PRPT) events and CASPER Report 0155 D review (2023-2024), it was determined that the laboratory obtained a subsequent unsuccessful participation for hematocrit test. Refer to D2130. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 PRPT events scores, CASPER Report 0155D, Complete Cell Count (CBC) workload records reviewed and laboratory director interview on May 29, 2024 at 9:00 A.M., it was found that the laboratory failed to attain successful participation in a Proficiency Testing (PT) events for hematocrit tests. The findings include: a. Review of the PRPT scores on May 29, 2024 at 9:30 A.M. and CASPER Report 0155D showed that the laboratory had a subsequent PT failure for analyte hematocrit. The laboratory obtained the following testing scores: 1st event 2023 Hematocrit 20 % 3rd event 2023 Hematocrit 40 % 1st event 2024 Hematocrit 60 % b. During interview the laboratory director confirmed on May 29, 2024, at 9:40 A.M. that the laboratory had three out of four unsatisfactory PT testing events for Hematocrit. c. Review of the CBC workload records showed that laboratory reported 329 CBC tests since April 2024. D5012 SYPHILIS SEROLOGY CFR(s): 493.1207 If the laboratory provides services in the subspecialty of Syphilis serology, 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 lack of syphilis serology testing record ( year 2023-2024 ) and laboratory director interview on May 29, 2024 at 12:30 P.M. , it was determined that the laboratory failed to ensure compliance with the analytic system requirements for syphilis serology tests. The finding includes: 1. The laboratory failed to follow the manufacturer's instruction when patient specimens were tested for RPR (Rapid plasma reagin) by ASI method. ( refer to D5411 ) 2. The laboratory failed to perform syphilis serology test as required by manufacturer's instructions.( refer to D5411) 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 review of the Mycoplasma pneumoniae IgM quality control records ( year 2023-2224 ) on May 29, 2024 at 11:15 A.M.., and laboratory director interview, it was determined that the laboratory failed to meet the quality control requirements for Mycoplasma pneumoniae IgM test. Refer to D5449. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 5 -- 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. This STANDARD is not met as evidenced by: A-Based on syphillis serology records review ( year 2023-2024 ) and laboratory director on May 29, 2024 at 12:30 P.M., it was determined that the laboratory failed to perform syphillis serology test as required by manufacturer's instructions by the ASI- RPR method. The findings include: 1. The laboratory syphillis serology quality control records were review from January 2023 to May 29, 2024. 2. The manufacturer's requires that the laboratory must perform the needle calibration, clean needle, verify the rotator rpm and monitor the room temperature in the laboratory. 3. From January 2023 to May 29, 2024, the lrecords showed that the laboratory did not document nor verify the needle calibration, clean needle , rotator rpm nor the room temperature monitoring in the RPR (Rapid plasma reagin) testing area the following days : year 2023 : 1/23/23, 1/31/23, 2/10/23, 2/16/23, 2/28/23, 3/20/23, 5/8/23, 5/17 /23, 5/23/23, 6/12/23, 8/4/23, 8/7/23, 8/8/23, 8/10/23, 8/11/23, 8/28/23, 9/2/23, 9/19 /23, 9/28/23, 10/4/23, 10/5/23, 10/6/23, 10/7/23, 10/21/23, 11/2/23, 11/3/23, 11/14/23, 11/16/23, 11/29/23, 12/6/23, 12/13/23, 12/16/23 and 12/20/2023. year 2024 : 1/3/24, 1 /15/24, 1/17/24, 2/3/24, 2/5/24, 2/13/24, 2/20/24, 2/24/24, 2/29/24, 3/12/24, 4/4/24, 4 /24/24 and 5/6/2024. 4. The laboratory processed and reported 67 RPR (Rapid plasma reagin) patient's samples tests those days. 5. The director confirmed on May 29, 2024 at 12:50P.M.. that the laboratory failed to perform syphillis serology test as required by manufacturer's instructions by the ASI-RPR method. B- Based on syphillis serology quality control review ( year 2023-2024 ) and laboratory director interview on May 29, 2024 at 12:30 P.M. , it was determined that the laboratory failed to follow the manufacturer's instruction when patient specimen were tested for RPR (Rapid plasma reagin) by RPR card test ASI method. The findings include: 1. The syphillis serology quality control records were reviewed since January 2023. ( review on May 29, 2024 at 12: 35 P.M ) 2. The manufacturer's instruction establishes that three levels of control material ( non reactive, minimal to moderate and reactive) must be included each day of testing. ( review on May 29, 2024 at 12: 40 P.M . ) 3. Review of records from January 2023 to May 29, 2024, showed that the laboratory did not include any control material the following days: year 2023 : 1/23/23, 1/31/23, 2/10/23, 2/16/23, 2 /28/23, 3/20/23, 5/8/23, 5/17/23, 5/23/23, 6/12/23, 8/4/23, 8/7/23, 8/8/23, 8/10/23, 8/11 /23, 8/28/23, 9/2/23, 9/19/23, 9/28/23, 10/4/23, 10/5/23, 10/6/23, 10/7/23, 10/21/23, 11 /2/23, 11/3/23, 11/14/23, 11/16/23, 11/29/23, 12/6/23, 12/13/23, 12/16/23 and 12/20 /2023. For year 2024 the laboratory did not include any control material on 1/3/24, 1 /15/24, 1/17/24, 2/3/24, 2/5/24, 2/13/24, 2/20/24, 2/24/24, 2/29/24, 3/12/24, 4/4/24, 4 /24/24 and 5/6/2024. ( review on May 29, 2024 at 12: 45 P.M. ) 4. The laboratory processed and reported 67 syphilis serology samples those days. ( review on May 29, 2024 at 12: 50 P.M . ) 5. The director confirmed on May 29, 2024 at 12:50P.M.. that the laboratory did not include the three levels of control material ( non reactive, minimal to moderate and reactive) those days. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 3 of 5 -- 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 General Immunology (Mycoplasma pneumoniae test) quality control records review (years 2023-2024) and laboratory director interview on May 29, 2024 at 11:15 A.M. , it was determined that the laboratory did not include an external positive and negative control material each day of Mycoplasma pneumoniae patient testing. The findings include: 1. General Immunology (Mycoplasma pneumoniae test) quality control records were review on May 29, 2024, at 11:20 A.M., from January 2023 to May 29, 2024. 2. Review of Mycoplasma pneumoniae quality control and patient results record showed that the laboratory did not include any control material each day of patient testing since 2023. 3. The laboratory director confirmed on May 29, 2024 at 11:25 A.M., that the laboratory failed to include a negative and positive control material each day of testing when performed Mycoplasma pneumonia test. 4. The laboratory did not include any control material, when 697 out 697 patient specimen were processed and reported since January 2023. ( Review on May 29, 2024 at 11:20 A.M. ) D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 review of PRPT event scores and CASPER Report 0155 D (years 2023- 2024), it was determined that the laboratory director failed to ensure the laboratory's successful participation in a Proficiency Testing Program for hematocrit tests. Refer to D6079 D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 on PRPT event scores and CASPER Report 0155 D for the first and second -- 4 of 5 -- testing events of year 2023 and the first testing event of year 2024, it was determined that the laboratory director failed to ensure that the laboratory had a satisfactory participation in the hematocrit tests. Refer to D 2130 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 and syphilis serology quality control records review ( year 2023-2024 ) , it was determined that the laboratory director did not ensure that quality control procedures related to Mycoplasma pneumoniae IgM and syphilis serology quality control procedures were performed as established by the manufacturer's instructions. Refer to D5411 and D5449. The findings include: 1. This laboratory ia a sole facility practitioner. 2. The laboratory director did not assure that control procedure for Mycoplasma pneumoniae and syphilis serology were performed as established by the manufacturer's instructions. -- 5 of 5 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on lack of routine chemistry quality control records, routine chemistry calibration verification records and laboratory director interview at 11:30 a.m. on April 10, 2018, it was determined that the laboratory failed to keep quality control records and calibration verifications records . Refer to D3031. 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 lack of routine chemistry quality controls records reviewed (2017) , laboratory director interview on April 10, 2018 at 11:00 A.M., it was determined that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- the laboratory failed to retain the routine chemistry quality control records. The findings include: a. The laboratory performed routine chemistry tests in 2017 by Vitros 250 system. b. The laboratory did not have available quality control records since January 2017. c. The laboratory director confirmed on April 10, 2018 at 11:00 A. M. that the laboratory did not have available the quality control records for routine chemistry tests since January 2017. d. The laboratory processed and reported 136 patient's sample since January 2017. 2. Based on lack of routine chemistry calibration verifications records (2017) , laboratory director interview on April 10, 2018 at 11:00 A.M., it was determined that the laboratory failed to retain the routine chemistry calibration verifications records. The findings include: a. The laboratory performed routine chemistry tests by Vitros 250 system. b. The laboratory did not have available calibration verifications records since January 2017. c. The laboratory director confirmed on April 10, 2018 at 11:00 A.M. that the laboratory did not have available the calibration verifications records for routine chemistry tests since January 2017. D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on bacteriology quality control records review from year 2017-2018 and interview with the laboratory director on April 10, 2018 at 11:45 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements of bacteriology. The finding includes: a. The laboratory did not check the ability to support growth of the cultures media used since August 2017. Refer to D 5477. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology calibration verification records review, manufacturer's instructions and laboratory director interview on April 10,2018 at 10:20 A.M., it was determined that the laboratory failed to perform the calibration verification procedures with at least the frequency recommended by the manufacturer (each six months) for the hematology tests performed by the Coulter Act 5 system. The findings include: 1. The laboratory uses a Coulter Act 5 hematology system for CBC (Complete blood -- 2 of 5 -- count) patient's tests. 2. The manufacturer's instructions establishes that the calibration verification procedures must be perform each six months. 3. From June 2016 to April 2018, the calibration verification records showed that the laboratory did not perform at least every 6 months the calibration verification procedures for the Coulter Act 5 hematology system. In year 2017 the calibration verification for Coulter Act 5 system was performed on January 2017 and December 2017. 4. The laboratory director confirmed on April 10, 2018 at 10:20 A.M., that the laboratory did not perform at least 6 months the calibration verification procedures for Coulter Act 5 system. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on bacteriology quality control records review (years 2017) and interview with the laboratory director on April 10, 2018 at 11:35 AM, it was found that since August 2017 the laboratory did not check each batch of agar culture media plates for its ability to support growth. The finding includes: a. The laboratory performed bacteriology culture patient samples since August 2017. b. The laboratory performed primary inoculation on Blood agar (BA) , Tryptic soy broth, ( TSB), Mac Conkey ( MCK) , Muller hinton ( MH), Xavier Lindon Dawson agar ( XLD), Gram Negative broth ( GN broth), Brain heart infusion agar ( BHI), Thioglycolate agar ( THIO) and Mannitol salt agar ( MSA) c. Review of bacteriology quality control records showed that the laboratory did not check the following lot numbers of blood agar culture media plates for it's ability to support growth since January 2018: Lot number Date (mm/dd/yy) 17230 8/28/2017 4111683 12/18/2017 407734 1/15/2018 411168 3/5 /2018 d. Review of bacteriology quality control records showed that the laboratory did not check the following lot numbers of Mac Conkey agar culture media plates for it's ability to support growth: Lot number Date (mm/dd/yy) 17221 8/28/2017 4111431 12 /18/2017 4078104 1/15/2018 411431 3/5/2018 c. Review of bacteriology quality control records showed that the laboratory did not check the following lot numbers of culture media plates for it's ability to support growth: Media Lot number Date (mm/dd /yy) CA 17229 9/5/2017 TSB 17208 12/18/2017 MH 17221 8/28/2017 XLD 17222 8 /28/2017 GN 17186 8/28/2017 BHI 17283 8/28/2017 Thio 17325 1/15/2018 e. The laboratory processed 88 patient's samples from August 2017 to April 2018. d. The laboratory director stated on April 10, 2018 that no evaluation of the ability to support growth was performed since August 2017. 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. -- 3 of 5 -- This STANDARD is not met as evidenced by: Based on quality assessment (QA) records review and laboratory director on April 10, 2018 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 manual showed that the laboratory establishes a monthly assessment for each analytic process to keep track the laboratory performance. 2. From January 2017 to April 2018, the laboratory did not evaluate aspects regarding the analytic system in the following areas: hematology and bacteriology. Refer to D 5437 and D5477. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 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 hematology calibration verification records review , bacteriology quality control records and laboratory director interview on April 10, 2018 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 and retention requirements. Refer to D6079 and D6093. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 on lack of routine chemistry quality control records and laboratory director interview on April 10, 2018 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 retention requirements. Refer D3031. 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 -- 4 of 5 -- failures in quality as they occur. This STANDARD is not met as evidenced by: Based on hematology calibration verification records review,bacteriology quality control records and laboratory director interview on April 10, 2018 at 11:30 AM, it was determined that laboratory failed to ensure compliance with the requirements for analytic systems. Refer to D5437 and D5477. -- 5 of 5 --