Laboratorio Clinico Cossma Humacao

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on tests report records review and laboratory director visor interview on May 14, 2021 at 11:47 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 9 out of 27 days reviewed from April 1, 2021 to May 14, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 test by ID Now method and the Covid-19 rapid test by Healgen method. 3. The tests report records showed that the laboratory did not send the Covid-19 ID Now results in the required frequency (24 hrs) to the Bioportal in 9 out of 27 days reviewed from April 1, 2021 to May 14, 2021: Date Patients Date tested specimens reported tested 04/01/2021 4 04/05/2021 04/05/2021 6 04/07/2021 04 /07/2021 1 04/09/2021 04/09/2021 1 04/14/2021 04/12/2021 5 04/14/2021 04/22/2021 3 04/26/2021 04/23/2021 6 04/26/2021 04/28/2021 3 04/30/2021 05/12/2021 3 05/14 /2021 4. The laboratory director confirmed on May 14, 2021 at 11:47 AM, that the tests report records showed that the laboratory did not sent those results of Covid-19 in 24 hrs. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method. The findings include : 1. The Covid-19 IgG/IgM test quality control records showed that the laboratory did not include the negative nor the positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method: Day tested patients specimens 01/14/2021 1 01/26/2021 13 2. The laboratory director confirmed on May 14, 2021 at 12:24 PM, that the Covid-19 IgG /IgM test quality control records showed that the laboratory did not include the negative nor the positive control materials those days. 3. The laboratory tested and reported 14 out of 14 patients specimens for qualitative Covid-19 IgG/IgM test from January 14, 2021 to January 26, 2021 by the Healgen method. 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the laboratory director failed to ensure compliance with the requirements for the Covid-19 IgG/IgM tests. Refer to D 5449 (The laboratory failed to include each day of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method). 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the it was determined that testing personnel failed to follow quality control procedures for the Covid-19 IgG/IgM tests. Refer to D 5449 (The laboratory failed to include each day -- 2 of 3 -- of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method). -- 3 of 3 --

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on tests report records review and laboratory director visor interview on May 14, 2021 at 11:47 AM, it was determined that the laboratory failed to report the Covid- 19 results as required for 9 out of 27 days reviewed from April 1, 2021 to May 14, 2021. The findings include: 1. The laboratory utilized the Health Department written instruction to reports the Covid-19 results to the Bioportal. 2. The laboratory processed the Covid-19 test by ID Now method and the Covid-19 rapid test by Healgen method. 3. The tests report records showed that the laboratory did not send the Covid-19 ID Now results in the required frequency (24 hrs) to the Bioportal in 9 out of 27 days reviewed from April 1, 2021 to May 14, 2021: Date Patients Date tested specimens reported tested 04/01/2021 4 04/05/2021 04/05/2021 6 04/07/2021 04 /07/2021 1 04/09/2021 04/09/2021 1 04/14/2021 04/12/2021 5 04/14/2021 04/22/2021 3 04/26/2021 04/23/2021 6 04/26/2021 04/28/2021 3 04/30/2021 05/12/2021 3 05/14 /2021 4. The laboratory director confirmed on May 14, 2021 at 11:47 AM, that the tests report records showed that the laboratory did not sent those results of Covid-19 in 24 hrs. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the laboratory failed to include each day of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method. The findings include : 1. The Covid-19 IgG/IgM test quality control records showed that the laboratory did not include the negative nor the positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method: Day tested patients specimens 01/14/2021 1 01/26/2021 13 2. The laboratory director confirmed on May 14, 2021 at 12:24 PM, that the Covid-19 IgG /IgM test quality control records showed that the laboratory did not include the negative nor the positive control materials those days. 3. The laboratory tested and reported 14 out of 14 patients specimens for qualitative Covid-19 IgG/IgM test from January 14, 2021 to January 26, 2021 by the Healgen method. 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the laboratory director failed to ensure compliance with the requirements for the Covid-19 IgG/IgM tests. Refer to D 5449 (The laboratory failed to include each day of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method). 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 Covid-19 IgG/IgM test quality control records review and interview with the laboratory director on May 14, 2021 at 12:24 PM, it was determined that the it was determined that testing personnel failed to follow quality control procedures for the Covid-19 IgG/IgM tests. Refer to D 5449 (The laboratory failed to include each day -- 2 of 3 -- of testing a negative and a positive control materials when 14 out of 14 patients specimens were tested and reported for qualitative Covid-19 IgG/IgM tests from January 14, 2021 to January 26, 2021 by the Healgen method). -- 3 of 3 --

Summary Statement of Deficiencies 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 Puerto Rico Proficiency Testing Program (P.R.PTP) records ( years 2016, 2017 and 2018 ) review and laboratory general supervisor interview on February 27, 2019 at 9:50 A.M., it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for Complete blood count (CBC) with white blood cell (WBC) differential with three parameters and failed to test the CBC proficiency testing samples in the same manner as patients' specimens from March 2017 to November 2018. The findings include: 1. Refer to D 2001 ( The laboratory failed to enroll in an HHS approved Proficiency Testing Program for the complete blood count (CBC) with the three parameters of white blood cell differential results from March 1, 2017 to August 31, 2017). 2. Refer to D 2010 ( The laboratory failed to test the CBC proficiency testing samples the same number of times that it routinely tests patient samples in the March 2017 event). 3. Refer to D 2013 ( The Laboratorio Clnico Central I (CLIA 40 D 0673051) processed the proficiency testing samples for CBC of the July 2018 and November 2018 P.R.PT events at Laboratorio Clinico Central II (CLIA 40 D 0952483) and reported the those PT results as its own). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (P.R.PTP) records ( years 2017 and 2018 ) , P.R.PTP test catalog ( years 2017 and 2018 ) review and laboratory general supervisor interview on February 27, 2019 at 9:30 A.M., it was determined that the laboratory failed to enroll in an HHS approved Proficiency Testing Program for CBC tests with three parameters WBC differential since March 1, 2017. The findings includes: 1. The laboratory had a Coulter Act Dif 2 system as their primary tests method. They reported WBC, RBC, Hgb, Hct , platelet and three parameters WBC differential " lymphocytes, granulocytes and mixed". 2. Review of the P.R.PTP test catalog showed that the PT program did not offer any proficiency materials for those laboratories that performed and reported for three parameters WBC differential. 3. On February 27, 2019 at 9:30 A.M., the P.R.PTP records showed that the laboratory was enrolled for WBC, RBC, Hgb, Hct , platelet tests, but with three parameters WBC was not challenged. 4. The laboratory did not enroll in an HHS approved Proficiency Testing Program for the method used by them. 5. The laboratory general supervisor confirmed on February 27, 2019 at 9:30 A.M., the laboratory did not enroll in an HHS approved Proficiency Testing Program for WBC, RBC, Hgb, Hct , platelet tests, but with three parameters WBC differential. She also stated theta she was not aware of the PT requirement. 6. The annual test volume records for the year 2017 showed that the laboratory processed and reported 2,100 out of 2,100 patients specimens for CBC with WBC differential of three parameters. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (P.R.PTP) records review ( years 2016, 2017 and 2018 ) and laboratory general supervisor interview on February 27, 2019 at 9:50 A.M., it was determined that the laboratory failed to test the CBC proficiency testing samples the same number of times that it routinely tests patient samples in the first testing event of year 2017 (March). The findings include: 1. On February 27, 2019 at 9:50 A.M., the P.R.PTP records showed that the laboratory tested in duplicate the 5 out of 5 CBC proficiency testing samples on 3/21/2017 ( 2017-131 to 2017-135) of the first testing event of year 2017 (March ). 2. The laboratory general supervisor confirmed on February 27, 2019 at 9:50 A.M., that the laboratory did not test those CBC proficiency testing samples the same number of times that it routinely tests patient samples. She stated that the laboratory tested in duplicated the patients samples that showed panic value or value that showed discrepancy with the patients information or other parameters. -- 2 of 9 -- D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on Puerto Rico Proficiency Testing Program (P.R.PTP) records review ( years 2016, 2017 and 2018 ), laboratory general supervisor interview on February 27, 2019 at 9:30 A.M, and laboratory director phone interview on February 28, 2019 at 10:15 am., it was determined that the Laboratorio Clnico Central I (CLIA 40 D 0673051) processed the proficiency testing samples for CBC of the July 2018 and November 2018 P.R.PT events at Laboratorio Clinico Central II (CLIA 40 D 0952483) and reported those PT results as it's own. The findings include: 1. On February 27, 2019 at 9:30 A.M., the laboratory general supervisor stated that the laboratory did not perform the CBC tests since September 2017 due to the Hurricane Maria (the laboratory utilized the Coulter Act Diff 2 system for CBC tests and this system is out of service since the Hurricane Maria). However, the general supervisor stated that the laboratory processed proficiency testing samples for CBC tests during the year 2018. 2. The P.R. PTP records ( Events of July 2018 and November 2018) showed that the Laboratory Central I (CLIA 40 D 0673051) processed the CBC's proficiency testing samples of July 2018 and November 2018 events at Laboratory Central II (CLIA 40 D 0952483) and reported those PT results as its own. 3. The P.R.PT P records for the Events of July 2018 showed the following documents: a. Laboratory sheet standard 493.1236 for PT sample handling and processing: The laboratory director signed as evidence that she processed and reported the CBC proficiency samples by the Coulter Act Diff 2. However, those samples were processed by the Cell Dyn 1700 system at the Laboratorio Clnico Central II. Dated July 9, 2018. b. Proficiency Test form report of the Laboratorio Clnico Central I (CLIA 40 D 0673051); results reported by Internet and copy of the attestation) submitted on July 26, 2018. c. 6 out of 6 Prints out (poorly legible) of the five proficiency CBC testing sample results that were analyzed by the cell Dyn 1700 (CD1700 specimen data report ). The first print out included the name of "Brenda". d. P.R. PT evaluation results sheet for Laboratorio Clnico Central I (CLIA 40 D 0673051): This records showed that the laboratory informed "120 Coulter" as the CBC tests method for the RBC, HCT HGB, WBC and platelet count. The laboratory obtained the following unsatisfactory results: RBC 60 %, HCT 20 % and Platelet count 40 %. e. The Standard #6 493.1236 sheet for PT evaluation was documented but not dated nor signed and includes the following documentation: Investigation: " The tests of platelet, hematocrit and RBC exceeded the established -- 3 of 9 -- limits. The system of the Central I could not be fixed. They don't get the spare part. I called up the P.R. PT program and they told me that the CBC proficiency testing sample of the Laboratorio Central I can be run by the Laboratory Central II due to the Laboratorio Central II is the Referral laboratory of the Laboratorio Central I". Action plan: "observe the next event. Evaluation plan and